42 U.S. Code § 1395m - Special payment rules for particular items and services | U.S. Code | US Law | LII / Legal Information In

42 U.S. Code § 1395m - Special payment rules for particular items and services | U.S. Code | US Law | LII / Legal Information Institute
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42 U.S. Code § 1395m - Special payment rules for particular items and services
U.S. Code
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(a)
Payment for durable medical equipment
(1)
General rule for payment
(A)
In general
With respect to a
covered item
(as defined in paragraph (13)) for which payment is determined under this subsection, payment shall be made in the frequency specified in paragraphs (2) through (7) and in an amount equal to 80 percent of the payment basis described in subparagraph (B).
(B)
Payment basis
Subject to subparagraph (F)(i), the payment basis described in this subparagraph is the lesser of—
(i)
the actual charge for the item, or
(ii)
the payment amount recognized under paragraphs (2) through (7) of this subsection for the item;
except that clause (i) shall not apply if the
covered item
is furnished by a public
home health agency
(or by another
home health agency
which demonstrates to the satisfaction of the
Secretary
that a significant portion of its patients are low income) free of charge or at nominal charges to the public.
(C)
Exclusive payment rule
Subject to subparagraph (F)(ii), this subsection shall constitute the exclusive provision of this subchapter for payment for
covered items
under this part or under part A to a
home health agency.
(D)
Reduction in fee schedules for certain items
With respect to a seat-lift chair or transcutaneous electrical nerve stimulator furnished on or after
April 1, 1990
, the
Secretary
shall reduce the payment amount applied under subparagraph (B)(ii) for such an item by 15 percent, and, in the case of a transcutaneous electrical nerve stimulator furnished on or after
January 1, 1991
, the
Secretary
shall further reduce such payment amount (as previously reduced) by 45 percent.
(E)
Clinical conditions for coverage
(i)
In general
The
Secretary
shall establish standards for clinical conditions for payment for
covered items
under this subsection.
(ii)
Requirements
The standards established under clause (i) shall include the specification of types or classes of
covered items
that require, as a condition of payment under this subsection, a face-to-face examination of the individual by a
physician
(as defined in
section 1395x(r) of this title
), a
physician
assistant, nurse
practitioner,
or a
clinical nurse specialist
(as those terms are defined in
section 1395x(aa)(5) of this title
) and a prescription for the item.
(iii)
Priority of establishment of standards
In establishing the standards under this subparagraph, the
Secretary
shall first establish standards for those
covered items
for which the
Secretary
determines there has been a proliferation of use, consistent findings of charges for
covered items
that are not delivered, or consistent findings of falsification of documentation to provide for payment of such
covered items
under this part.
(iv)
Standards for power wheelchairs
Effective on
December 8, 2003
, in the case of a
covered item
consisting of a motorized or power wheelchair for an individual, payment may not be made for such
covered item
unless a
physician
(as defined in
section 1395x(r)(1) of this title
), a
physician
assistant, nurse
practitioner,
or a
clinical nurse specialist
(as those terms are defined in
section 1395x(aa)(5) of this title
) has conducted a face-to-face examination of the individual and written a prescription for the item.
(v)
Limitation on payment for covered items
Payment may not be made for a
covered item
under this subsection unless the item meets any standards established under this subparagraph for clinical condition of coverage.
(F)
Application of competitive acquisition; limitation of inherent reasonableness authority
In the case of
covered items
furnished on or after
January 1, 2011
, subject to subparagraphs (G) and (H), that are included in a competitive acquisition program in a competitive acquisition area under
section 1395w–3(a) of this title
(i)
the payment basis under this subsection for such items and services furnished in such area shall be the payment basis determined under such competitive acquisition program;
(ii)
the
Secretary
may (and, in the case of
covered items
furnished on or after
January 1, 2016
, subject to clause (iii), shall) use information on the payment determined under such competitive acquisition programs to adjust the payment amount otherwise recognized under subparagraph (B)(ii) for an area that is not a competitive acquisition area under
section 1395w–3 of this title
and in the case of such adjustment, paragraph (10)(B) shall not be applied; and
(iii)
in the case of
covered items
furnished on or after
January 1, 2016
, the
Secretary
shall continue to make such adjustments described in clause (ii) as, under such competitive acquisition programs, additional
covered items
are phased in or information is updated as contracts under
section 1395w–3 of this title
are recompeted in accordance with
section 1395w–3(b)(3)(B) of this title
(G)
Use of information on competitive bid rates
The
Secretary
shall specify by regulation the methodology to be used in applying the provisions of subparagraph (F)(ii) and subsection (h)(1)(H)(ii). In promulgating such regulation, the
Secretary
shall consider the costs of items and services in areas in which such provisions would be applied compared to the payment rates for such items and services in competitive acquisition areas. In the case of items and services furnished on or after
January 1, 2019
, in making any adjustments under clause (ii) or (iii) of subparagraph (F), under subsection (h)(1)(H)(ii), or under
section 1395u(s)(3)(B) of this title
, the
Secretary
shall—
(i)
solicit and take into account stakeholder input; and
(ii)
take into account the highest amount bid by a winning
supplier
in a competitive acquisition area and a comparison of each of the following with respect to non-competitive acquisition areas and competitive acquisition areas:
(I)
The average travel distance and cost associated with furnishing items and services in the area.
(II)
The average volume of items and services furnished by
suppliers
in the area.
(III)
The number of
suppliers
in the area.
(H)
Diabetic supplies
(i)
In general
On or after the date described in clause (ii), the payment amount under this part for diabetic supplies, including testing strips, that are non-mail order items (as defined by the
Secretary
) shall be equal to the single payment amounts established under the national mail order competition for diabetic supplies under
section 1395w–3 of this title
(ii)
Date described
The date described in this clause is the date of the implementation of the single payment amounts under the national mail order competition for diabetic supplies under
section 1395w–3 of this title
(I)
Treatment of vacuum erection systems
Effective for items and services furnished on and after
July 1, 2015
, vacuum erection systems described as
prosthetic devices
described in
section 1395x(s)(8) of this title
shall be treated in the same manner as erectile dysfunction
drugs
are treated for purposes of
section 1395w–102(e)(2)(A) of this title
(2)
Payment for inexpensive and other routinely purchased durable medical equipment
(A)
In general
Payment for an item of
durable medical equipment
(as defined in paragraph (13))—
(i)
the purchase price of which does not exceed $150,
(ii)
which the
Secretary
determines is acquired at least 75 percent of the time by purchase,
(iii)
which is an accessory used in conjunction with a nebulizer, aspirator, or a ventilator excluded under paragraph (3)(A), or
(iv)
in the case of devices furnished on or after
October 1, 2015
, which serves as a speech generating device or which is an accessory that is needed for the individual to effectively utilize such a device,
shall be made on a rental basis or in a lump-sum amount for the purchase of the item. The payment amount recognized for purchase or rental of such equipment is the amount specified in subparagraph (B) for purchase or rental, except that the total amount of payments with respect to an item may not exceed the payment amount specified in subparagraph (B) with respect to the purchase of the item.
(B)
Payment amount
For purposes of subparagraph (A), the amount specified in this subparagraph, with respect to the purchase or rental of an item furnished in a
carrier
service area—
(i)
in 1989 and in 1990 is the average reasonable charge in the area for the purchase or rental, respectively, of the item for the 12-month period ending on
June 30, 1987
, increased by the percentage increase in the consumer price index for all urban consumers (U.S. city average) for the 6-month period ending with December 1987;
(ii)
in 1991 is the sum of (I) 67 percent of the local payment amount for the item or device computed under subparagraph (C)(i)(I) for 1991, and (II) 33 percent of the national limited payment amount for the item or device computed under subparagraph (C)(ii) for 1991;
(iii)
in 1992 is the sum of (I) 33 percent of the local payment amount for the item or device computed under subparagraph (C)(i)(II) for 1992, and (II) 67 percent of the national limited payment amount for the item or device computed under subparagraph (C)(ii) for 1992; and
(iv)
in 1993 and each subsequent year is the national limited payment amount for the item or device computed under subparagraph (C)(ii) for that year (reduced by 10 percent, in the case of a blood glucose testing strip furnished after 1997 for an individual with diabetes).
(C)
Computation of local payment amount and national limited payment amount
For purposes of subparagraph (B)—
(i)
the local payment amount for an item or device for a year is equal to—
(I)
for 1991, the amount specified in subparagraph (B)(i) for 1990 increased by the
covered item update
for 1991, and
(II)
for 1992, 1993, and 1994, the amount determined under this clause for the preceding year increased by the
covered item update
for the year; and
(ii)
the national limited payment amount for an item or device for a year is equal to—
(I)
for 1991, the local payment amount determined under clause (i) for such item or device for that year, except that the national limited payment amount may not exceed 100 percent of the weighted average of all local payment amounts determined under such clause for such item for that year and may not be less than 85 percent of the weighted average of all local payment amounts determined under such clause for such item,
(II)
for 1992 and 1993, the amount determined under this clause for the preceding year increased by the
covered item update
for such subsequent year,
(III)
for 1994, the local payment amount determined under clause (i) for such item or device for that year, except that the national limited payment amount may not exceed 100 percent of the median of all local payment amounts determined under such clause for such item for that year and may not be less than 85 percent of the median of all local payment amounts determined under such clause for such item or device for that year, and
(IV)
for each subsequent year, the amount determined under this clause for the preceding year increased by the
covered item update
for such subsequent year.
(3)
Payment for items requiring frequent and substantial servicing
(A)
In general
Payment for a
covered item
(such as IPPB machines and ventilators, excluding ventilators that are either continuous airway pressure devices or
intermittent
assist devices with continuous airway pressure devices) for which there must be frequent and substantial servicing in order to avoid risk to the patient’s health shall be made on a monthly basis for the rental of the item and the amount recognized is the amount specified in subparagraph (B).
(B)
Payment amount
For purposes of subparagraph (A), the amount specified in this subparagraph, with respect to an item or device furnished in a
carrier
service area—
(i)
in 1989 and in 1990 is the average reasonable charge in the area for the rental of the item or device for the 12-month period ending with June 1987, increased by the percentage increase in the consumer price index for all urban consumers (U.S. city average) for the 6-month period ending with December 1987;
(ii)
in 1991 is the sum of (I) 67 percent of the local payment amount for the item or device computed under subparagraph (C)(i)(I) for 1991, and (II) 33 percent of the national limited payment amount for the item or device computed under subparagraph (C)(ii) for 1991;
(iii)
in 1992 is the sum of (I) 33 percent of the local payment amount for the item or device computed under subparagraph (C)(i)(II) for 1992, and (II) 67 percent of the national limited payment amount for the item or device computed under subparagraph (C)(ii) for 1992; and
(iv)
in 1993 and each subsequent year is the national limited payment amount for the item or device computed under subparagraph (C)(ii) for that year.
(C)
Computation of local payment amount and national limited payment amount
For purposes of subparagraph (B)—
(i)
the local payment amount for an item or device for a year is equal to—
(I)
for 1991, the amount specified in subparagraph (B)(i) for 1990 increased by the
covered item update
for 1991, and
(II)
for 1992, 1993, and 1994, the amount determined under this clause for the preceding year increased by the
covered item update
for the year; and
(ii)
the national limited payment amount for an item or device for a year is equal to—
(I)
for 1991, the local payment amount determined under clause (i) for such item or device for that year, except that the national limited payment amount may not exceed 100 percent of the weighted average of all local payment amounts determined under such clause for such item for that year and may not be less than 85 percent of the weighted average of all local payment amounts determined under such clause for such item,
(II)
for 1992 and 1993, the amount determined under this clause for the preceding year increased by the
covered item update
for such subsequent year,
(III)
for 1994, the local payment amount determined under clause (i) for such item or device for that year, except that the national limited payment amount may not exceed 100 percent of the median of all local payment amounts determined under such clause for such item for that year and may not be less than 85 percent of the median of all local payment amounts determined under such clause for such item or device for that year, and
(IV)
for each subsequent year, the amount determined under this clause for the preceding year increased by the
covered item update
for such subsequent year.
(4)
Payment for certain customized items
Payment with respect to a
covered item
that is uniquely constructed or substantially modified to meet the specific needs of an individual patient, and for that reason cannot be grouped with similar items for purposes of payment under this subchapter, shall be made in a lump-sum amount (A) for the purchase of the item in a payment amount based upon the
carrier’
s individual consideration for that item, and (B) for the reasonable and necessary maintenance and servicing for parts and labor not covered by the
supplier’
s or manufacturer’s warranty, when necessary during the period of medical need, and the amount recognized for such maintenance and servicing shall be paid on a lump-sum, as needed basis based upon the
carrier’
s individual consideration for that item.
(5)
Payment for oxygen and oxygen equipment
(A)
In general
Payment for oxygen and oxygen equipment shall be made on a monthly basis in the monthly payment amount recognized under paragraph (9) for oxygen and oxygen equipment (other than portable oxygen equipment), subject to subparagraphs (B), (C), (E), and (F).
(B)
Add-on for portable oxygen equipment
When portable oxygen equipment is used, but subject to subparagraph (D), the payment amount recognized under subparagraph (A) shall be increased by the monthly payment amount recognized under paragraph (9) for portable oxygen equipment.
(C)
Volume adjustment
When the attending
physician
prescribes an oxygen flow rate—
(i)
exceeding 4 liters per minute, the payment amount recognized under subparagraph (A), subject to subparagraph (D), shall be increased by 50 percent, or
(ii)
of less than 1 liter per minute, the payment amount recognized under subparagraph (A) shall be decreased by 50 percent.
(D)
Limit on adjustment
When portable oxygen equipment is used and the attending
physician
prescribes an oxygen flow rate exceeding 4 liters per minute, there shall only be an increase under either subparagraph (B) or (C), whichever increase is larger, and not under both such subparagraphs.
(E)
Recertification for patients receiving home oxygen therapy
In the case of a patient receiving home oxygen therapy services who, at the time such services are initiated, has an initial arterial blood gas value at or above a partial pressure of 56 or an arterial oxygen saturation at or above 89 percent (or such other values, pressures, or criteria as the
Secretary
may specify) no payment may be made under this part for such services after the expiration of the 90-day period that begins on the date the patient first receives such services unless the patient’s attending
physician
certifies that, on the basis of a follow-up test of the patient’s arterial blood gas value or arterial oxygen saturation conducted during the final 30 days of such 90-day period, there is a medical need for the patient to continue to receive such services.
(F)
Rental cap
(i)
In general
Payment for oxygen equipment (including portable oxygen equipment) under this paragraph may not extend over a period of continuous use (as determined by the
Secretary
) of longer than 36 months.
(ii)
Payments and rules after rental cap
After the 36th continuous month during which payment is made for the equipment under this paragraph—
(I)
the
supplier
furnishing such equipment under this subsection shall continue to furnish the equipment during any period of medical need for the remainder of the reasonable useful lifetime of the equipment, as determined by the
Secretary;
(II)
payments for oxygen shall continue to be made in the amount recognized for oxygen under paragraph (9) for the period of medical need; and
(III)
maintenance and servicing payments shall, if the
Secretary
determines such payments are reasonable and necessary, be made (for parts and labor not covered by the
supplier
’s or manufacturer’s warranty, as determined by the
Secretary
to be
appropriate
for the equipment), and such payments shall be in an amount determined to be
appropriate
by the
Secretary.
(6)
Payment for other covered items (other than durable medical equipment)
Payment for other
covered items
(other than
durable medical equipment
and other
covered items
described in paragraph (3), (4), or (5)) shall be made in a lump-sum amount for the purchase of the item in the amount of the purchase price recognized under paragraph (8).
(7)
Payment for other items of durable medical equipment
(A)
Payment
In the case of an item of
durable medical equipment
not described in paragraphs (2) through (6), the following rules shall apply:
(i)
Rental
(I)
In general
Except as provided in clause (iii), payment for the item shall be made on a monthly basis for the rental of the item during the period of medical need (but payments under this clause may not extend over a period of continuous use (as determined by the
Secretary
) of longer than 13 months).
(II)
Payment amount
Subject to subclause (III) and subparagraph (B), the amount recognized for the item, for each of the first 3 months of such period, is 10 percent of the purchase price recognized under paragraph (8) with respect to the item, and, for each of the remaining months of such period, is 7.5 percent of such purchase price.
(III)
Special rule for power-driven wheelchairs
For purposes of payment for power-driven wheelchairs, subclause (II) shall be applied by substituting “15 percent” and “6 percent” for “10 percent” and “7.5 percent”, respectively.
(ii)
Ownership after rental
On the first day that begins after the 13th continuous month during which payment is made for the rental of an item under clause (i), the
supplier
of the item shall transfer title to the item to the individual.
(iii)
Purchase agreement option for complex, rehabilitative power-driven wheelchairs
In the case of a complex, rehabilitative power-driven wheelchair, at the time the
supplier
furnishes the item, the
supplier
shall offer the individual the option to purchase the item, and payment for such item shall be made on a lump-sum basis if the individual exercises such option.
(iv)
Maintenance and servicing
After the
supplier
transfers title to the item under clause (ii) or in the case of a power-driven wheelchair for which a purchase agreement has been entered into under clause (iii), maintenance and servicing payments shall, if the
Secretary
determines such payments are reasonable and necessary, be made (for parts and labor not covered by the
supplier
’s or manufacturer’s warranty, as determined by the
Secretary
to be
appropriate
for the particular type of
durable medical equipment)
, and such payments shall be in an amount determined to be
appropriate
by the
Secretary.
(B)
Range for rental amounts
(i)
For 1989
For items furnished during 1989, the payment amount recognized under subparagraph (A)(i) shall not be more than 115 percent, and shall not be less than 85 percent, of the prevailing charge established for rental of the item in January 1987, increased by the percentage increase in the consumer price index for all urban consumers (U.S. city average) for the 6-month period ending with December 1987.
(ii)
For 1990
For items furnished during 1990, clause (i) shall apply in the same manner as it applies to items furnished during 1989.
(C)
Replacement of items
(i)
Establishment of reasonable useful lifetime
In accordance with clause (iii), the
Secretary
shall determine and establish a reasonable useful lifetime for items of
durable medical equipment
for which payment may be made under this paragraph.
(ii)
Payment for replacement items
If the reasonable lifetime of such an item, as so established, has been reached during a continuous period of medical need, or the
carrier
determines that the item is lost or irreparably damaged, the patient may elect to have payment for an item serving as a replacement for such item made—
(I)
on a monthly basis for the rental of the replacement item in accordance with subparagraph (A); or
(II)
in the case of an item for which a purchase agreement has been entered into under subparagraph (A)(iii), in a lump-sum amount for the purchase of the item.
(iii)
Length of reasonable useful lifetime
The reasonable useful lifetime of an item of
durable medical equipment
under this subparagraph shall be equal to 5 years, except that, if the
Secretary
determines that, on the basis of prior experience in making payments for such an item under this subchapter, a reasonable useful lifetime of 5 years is not
appropriate
with respect to a particular item, the
Secretary
shall establish an alternative reasonable lifetime for such item.
(8)
Purchase price recognized for miscellaneous devices and items
For purposes of paragraphs (6) and (7), the amount that is recognized under this paragraph as the purchase price for a
covered item
is the amount described in subparagraph (C) of this paragraph, determined as follows:
(A)
Computation of local purchase price
Each
carrier
under
section 1395u of this title
shall compute a base local purchase price for the item as follows:
(i)
The
carrier
shall compute a base local purchase price, for each item described—
(I)
in paragraph (6) equal to the average reasonable charge in the locality for the purchase of the item for the 12-month period ending with June 1987, or
(II)
in paragraph (7) equal to the average of the purchase prices on the claims submitted on an assignment-related basis for the unused item supplied during the 6-month period ending with December 1986.
(ii)
The
carrier
shall compute a local purchase price, with respect to the furnishing of each particular item—
(I)
in 1989 and 1990, equal to the base local purchase price computed under clause (i) increased by the percentage increase in the consumer price index for all urban consumers (U.S. city average) for the 6-month period ending with December 1987,
(II)
in 1991, equal to the local purchase price computed under this clause for the previous year, increased by the
covered item update
for 1991, and decreased by the percentage by which the average of the reasonable charges for claims paid for all items described in paragraph (7) is lower than the average of the purchase prices submitted for such items during the final 9 months of 1988;
[1]
or
(III)
in 1992, 1993, and 1994, equal to the local purchase price computed under this clause for the previous year increased by the
covered item update
for the year.
(B)
Computation of national limited purchase price
With respect to the furnishing of a particular item in a year, the
Secretary
shall compute a national limited purchase price—
(i)
for 1991, equal to the local purchase price computed under subparagraph (A)(ii) for the item for the year, except that such national limited purchase price may not exceed 100 percent of the weighted average of all local purchase prices for the item computed under such subparagraph for the year, and may not be less than 85 percent of the weighted average of all local purchase prices for the item computed under such subparagraph for the year;
(ii)
for 1992 and 1993, the amount determined under this subparagraph for the preceding year increased by the
covered item update
for such subsequent year;
(iii)
for 1994, the local purchase price computed under subparagraph (A)(ii) for the item for the year, except that such national limited purchase price may not exceed 100 percent of the median of all local purchase prices computed for the item under such subparagraph for the year and may not be less than 85 percent of the median of all local purchase prices computed under such subparagraph for the item for the year; and
(iv)
for each subsequent year, equal to the amount determined under this subparagraph for the preceding year increased by the
covered item update
for such subsequent year.
(C)
Purchase price recognized
For purposes of paragraphs (6) and (7), the amount that is recognized under this paragraph as the purchase price for each item furnished—
(i)
in 1989 or 1990, is 100 percent of the local purchase price computed under subparagraph (A)(ii)(I);
(ii)
in 1991, is the sum of (I) 67 percent of the local purchase price computed under subparagraph (A)(ii)(II) for 1991, and (II) 33 percent of the national limited purchase price computed under subparagraph (B) for 1991;
(iii)
in 1992, is the sum of (I) 33 percent of the local purchase price computed under subparagraph (A)(ii)(III) for 1992, and (II) 67 percent of the national limited purchase price computed under subparagraph (B) for 1992; and
(iv)
in 1993 or a subsequent year, is the national limited purchase price computed under subparagraph (B) for that year.
(9)
Monthly payment amount recognized with respect to oxygen and oxygen equipment
For purposes of paragraph (5), the amount that is recognized under this paragraph for payment for oxygen and oxygen equipment is the monthly payment amount described in subparagraph (C) of this paragraph. Such amount shall be computed separately (i) for all items of oxygen and oxygen equipment (other than portable oxygen equipment) and (ii) for portable oxygen equipment (each such group referred to in this paragraph as an “item”).
(A)
Computation of local monthly payment rate
Each
carrier
under this section shall compute a base local payment rate for each item as follows:
(i)
The
carrier
shall compute a base local average monthly payment rate per beneficiary as an amount equal to (I) the total reasonable charges for the item during the 12-month period ending with December 1986, divided by (II) the total number of months for all beneficiaries receiving the item in the area during the 12-month period for which the
carrier
made payment for the item under this subchapter.
(ii)
The
carrier
shall compute a local average monthly payment rate for the item applicable—
(I)
to 1989 and 1990, equal to 95 percent of the base local average monthly payment rate computed under clause (i) for the item increased by the percentage increase in the consumer price index for all urban consumers (U.S. city average) for the 6-month period ending with December 1987, or
(II)
to 1991, 1992, 1993, and 1994, equal to the local average monthly payment rate computed under this clause for the item for the previous year increased by the
covered item
increase for the year.
(B)
Computation of national limited monthly payment rate
With respect to the furnishing of an item in a year, the
Secretary
shall compute a national limited monthly payment rate equal to—
(i)
for 1991, the local monthly payment rate computed under subparagraph (A)(ii)(II) for the item for the year, except that such national limited monthly payment rate may not exceed 100 percent of the weighted average of all local monthly payment rates computed for the item under such subparagraph for the year, and may not be less than 85 percent of the weighted average of all local monthly payment rates computed for the item under such subparagraph for the year;
(ii)
for 1992 and 1993, the amount determined under this subparagraph for the preceding year increased by the
covered item update
for such subsequent year;
(iii)
for 1994, the local monthly payment rate computed under subparagraph (A)(ii) for the item for the year, except that such national limited monthly payment rate may not exceed 100 percent of the median of all local monthly payment rates computed for the item under such subparagraph for the year and may not be less than 85 percent of the median of all local monthly payment rates computed for the item under such subparagraph for the year;
(iv)
for 1995, 1996, and 1997, equal to the amount determined under this subparagraph for the preceding year increased by the
covered item update
for such subsequent year;
(v)
for 1998, 75 percent of the amount determined under this subparagraph for 1997; and
(vi)
for 1999 and each subsequent year, 70 percent of the amount determined under this subparagraph for 1997.
(C)
Monthly payment amount recognized
For purposes of paragraph (5), the amount that is recognized under this paragraph as the base monthly payment amount for each item furnished—
(i)
in 1989 and in 1990, is 100 percent of the local average monthly payment rate computed under subparagraph (A)(ii) for the item;
(ii)
in 1991, is the sum of (I) 67 percent of the local average monthly payment rate computed under subparagraph (A)(ii)(II) for the item for 1991, and (II) 33 percent of the national limited monthly payment rate computed under subparagraph (B)(i) for the item for 1991;
(iii)
in 1992, is the sum of (I) 33 percent of the local average monthly payment rate computed under subparagraph (A)(ii)(II) for the item for 1992, and (II) 67 percent of the national limited monthly payment rate computed under subparagraph (B)(ii) for the item for 1992; and
(iv)
in a subsequent year, is the national limited monthly payment rate computed under subparagraph (B) for the item for that year.
(D)
Authority to create classes
(i)
In general
Subject to clause (ii), the
Secretary
may establish separate classes for any item of oxygen and oxygen equipment and separate national limited monthly payment rates for each of such classes.
(ii)
Budget neutrality
The
Secretary
may take actions under clause (i) only to the extent such actions do not result in expenditures for any year to be more or less than the expenditures which would have been made if such actions had not been taken. The requirement of the preceding sentence shall not apply beginning with the second calendar quarter beginning on or after
December 27, 2020
(10)
Exceptions and adjustments
(A)
Areas outside continental United States
Exceptions to the amounts recognized under the previous provisions of this subsection shall be made to take into account the unique circumstances of
covered items
furnished in Alaska, Hawaii, or Puerto
Rico
(B)
Adjustment for inherent reasonableness
The
Secretary
is authorized to apply the provisions of paragraphs (8) and (9) of
section 1395u(b) of this title
to
covered items
and
suppliers
of such items and payments under this subsection in an area and with respect to
covered items
and services for which the
Secretary
does not make a payment amount adjustment under paragraph (1)(F).
(C)
Transcutaneous electrical nerve stimulator (TENS)
In order to permit an attending
physician
time to determine whether the purchase of a transcutaneous electrical nerve stimulator is medically
appropriate
for a particular patient, the
Secretary
may determine an
appropriate
payment amount for the initial rental of such item for a period of not more than 2 months. If such item is subsequently purchased, the payment amount with respect to such purchase is the payment amount determined under paragraph (2).
(11)
Improper billing and requirement of physician order
(A)
Improper billing for certain rental items
Notwithstanding any other provision of this subchapter, a
supplier
of a
covered item
for which payment is made under this subsection and which is furnished on a rental basis shall continue to supply the item without charge (other than a charge provided under this subsection for the maintenance and servicing of the item) after rental payments may no longer be made under this subsection. If a
supplier
knowingly and willfully violates the previous sentence, the
Secretary
may apply sanctions against the
supplier
under
section 1395u(j)(2) of this title
in the same manner such sanctions may apply with respect to a
physician.
(B)
Requirement of physician order
(i)
In general
The
Secretary
is authorized to require, for specified
covered items
, that payment may be made under this subsection with respect to the item only if a
physician
enrolled under
section 1395cc(j) of this title
or an eligible professional under
section 1395w–4(k)(3)(B) of this title
that is enrolled under
section 1395cc(j) of this title
has communicated to the
supplier,
before delivery of the item, a written order for the item.
(ii)
Requirement for face to face encounter
The
Secretary
shall require that such an order be written pursuant to a
physician
, a
physician
assistant, a nurse
practitioner
, or a
clinical nurse specialist
(as those terms are defined in
section 1395x(aa)(5) of this title
) documenting such
physician,
physician
assistant,
practitioner,
or specialist has had a face-to-face encounter (including through use of telehealth under subsection (m) and other than with respect to encounters that are incident to services involved) with the individual involved during the 6-month period preceding such written order, or other reasonable timeframe as determined by the
Secretary.
(12)
Regional carriers
The
Secretary
may designate, by regulation under
section 1395u of this title
, one
carrier
for one or more entire regions to process all claims within the region for
covered items
under this section.
(13)
“Covered item” defined
In this subsection, the term “
covered item
” means
durable medical equipment
(as defined in
section 1395x(n) of this title
), including such equipment described in
section 1395x(m)(5) of this title
, but not including implantable items for which payment may be made under section 1395l(t) of this title.
(14)
Covered item update
In this subsection, the term “
covered item update
” means, with respect to a year—
(A)
for 1991 and 1992, the percentage increase in the consumer price index for all urban consumers (U.S. city average) for the 12-month period ending with June of the previous year reduced by 1 percentage point;
(B)
for 1993, 1994, 1995, 1996, and 1997, the percentage increase in the consumer price index for all urban consumers (U.S. city average) for the 12-month period ending with June of the previous year;
(C)
for each of the years 1998 through 2000, 0 percentage points;
(D)
for 2001, the percentage increase in the consumer price index for all urban consumers (U.S. city average) for the 12-month period ending with June 2000;
(E)
for 2002, 0 percentage points;
(F)
for 2003, the percentage increase in the consumer price index for all urban consumers (U.S. urban average) for the 12-month period ending with June of 2002;
(G)
for 2004 through 2006—
(i)
subject to clause (ii), in the case of class III medical devices described in
section 360c(a)(1)(C) of title 21
, the percentage increase described in subparagraph (B) for the year involved; and
(ii)
in the case of
covered items
not described in clause (i), 0 percentage points;
(H)
for 2007—
(i)
subject to clause (ii), in the case of class III medical devices described in
section 360c(a)(1)(C) of title 21
, the percentage change determined by the
Secretary
to be
appropriate
taking into account recommendations contained in the report of the Comptroller General of the
United States
under section 302(c)(1)(B) of the
Medicare
Prescription Drug, Improvement, and Modernization Act of 2003; and
(ii)
in the case of
covered items
not described in clause (i), 0 percentage points;
(I)
for 2008—
(i)
subject to clause (ii), in the case of class III medical devices described in
section 360c(a)(1)(C) of title 21
, the percentage increase described in subparagraph (B) (as applied to the payment amount for 2007 determined after the application of the percentage change under subparagraph (H)(i)); and
(ii)
in the case of
covered items
not described in clause (i), 0 percentage points;
(J)
for 2009—
(i)
in the case of items and services furnished in any geographic area, if such items or services were selected for competitive acquisition in any area under the competitive acquisition program under
section 1395w–3(a)(1)(B)(i)(I) of this title
before
July 1, 2008
, including related accessories but only if furnished with such items and services selected for such competition and diabetic supplies but only if furnished through mail order, - 9.5 percent; or
(ii)
in the case of other items and services, the percentage increase in the consumer price index for all urban consumers (U.S. urban average) for the 12-month period ending with June 2008;
(K)
for 2010, the percentage increase in the consumer price index for all urban consumers (U.S. urban average) for the 12-month period ending with June of the previous year; and
(L)
for 2011 and each subsequent year—
(i)
the percentage increase in the consumer price index for all urban consumers (
United States
city average) for the 12-month period ending with June of the previous year, reduced by—
(ii)
the productivity adjustment described in
section 1395ww(b)(3)(B)(xi)(II) of this title
The application of subparagraph (L)(ii) may result in the
covered item update
under this paragraph being less than 0.0 for a year, and may result in payment rates under this subsection for a year being less than such payment rates for the preceding year.
(15)
Advance determinations of coverage for certain items
(A)
Development of lists of items by Secretary
The
Secretary
may develop and periodically update a list of items for which payment may be made under this subsection that the
Secretary
determines, on the basis of prior payment experience, are frequently subject to unnecessary utilization throughout a
carrier
’s entire service area or a portion of such area.
(B)
Development of lists of suppliers by Secretary
The
Secretary
may develop and periodically update a list of
suppliers
of items for which payment may be made under this subsection with respect to whom—
(i)
the
Secretary
has found that a substantial number of claims for payment under this part for items furnished by the
supplier
have been denied on the basis of the application of
section 1395y(a)(1) of this title
; or
(ii)
the
Secretary
has identified a pattern of overutilization resulting from the business practice of the
supplier
(C)
Determinations of coverage in advance
carrier
shall determine in advance of delivery of an item whether payment for the item may not be made because the item is not covered or because of the application of
section 1395y(a)(1) of this title
if—
(i)
the item is included on the list developed by the
Secretary
under subparagraph (A);
(ii)
the item is furnished by a
supplier
included on the list developed by the
Secretary
under subparagraph (B); or
(iii)
the item is a customized item (other than inexpensive items specified by the
Secretary
) and the patient to whom the item is to be furnished or the
supplier
requests that such advance determination be made.
(16)
Disclosure of information and surety bond
The
Secretary
shall not provide for the issuance (or renewal) of a provider number for a
supplier
of
durable medical equipment,
for purposes of payment under this part for
durable medical equipment
furnished by the
supplier
, unless the
supplier
provides the
Secretary
on a continuing basis—
(A)
with—
(i)
full and complete information as to the identity of each
person
with an ownership or control interest (as defined in
section 1320a–3(a)(3) of this title
) in the
supplier
or in any subcontractor (as defined by the
Secretary
in
regulations)
in which the
supplier
directly or indirectly has a 5 percent or more ownership interest; and
(ii)
to the extent determined to be feasible under
regulations
of the
Secretary,
the name of any disclosing entity (as defined in
section 1320a–3(a)(2) of this title
) with respect to which a
person
with such an ownership or control interest in the
supplier
is a
person
with such an ownership or control interest in the disclosing entity; and
(B)
with a surety bond in a form specified by the
Secretary
and in an amount that is not less than $50,000 that the
Secretary
determines is commensurate with the volume of the billing of the
supplier
The
Secretary
may waive the requirement of a bond under subparagraph (B) in the case of a
supplier
that provides a comparable surety bond under
State
law. The
Secretary,
at the
Secretary’
s discretion, may impose the requirements of the first sentence with respect to some or all providers of items or services under part A or some or all
suppliers
or other
persons
(other than
physicians
or other
practitioners
, as defined in
section 1395u(b)(18)(C) of this title
) who furnish items or services under this part.
(17)
Prohibition against unsolicited telephone contacts by suppliers
(A)
In general
supplier
of a
covered item
under this subsection may not contact an individual enrolled under this part by telephone regarding the furnishing of a
covered item
to the individual unless 1 of the following applies:
(i)
The individual has given written permission to the
supplier
to make contact by telephone regarding the furnishing of a
covered item
(ii)
The
supplier
has furnished a
covered item
to the individual and the
supplier
is contacting the individual only regarding the furnishing of such
covered item
(iii)
If the contact is regarding the furnishing of a
covered item
other than a
covered item
already furnished to the individual, the
supplier
has furnished at least 1
covered item
to the individual during the 15-month period preceding the date on which the
supplier
makes such contact.
(B)
Prohibiting payment for items furnished subsequent to unsolicited contacts
If a
supplier
knowingly contacts an individual in violation of subparagraph (A), no payment may be made under this part for any item subsequently furnished to the individual by the
supplier
(C)
Exclusion from program for suppliers engaging in pattern of unsolicited contacts
If a
supplier
knowingly contacts individuals in violation of subparagraph (A) to such an extent that the
supplier
’s conduct establishes a pattern of contacts in violation of such subparagraph, the
Secretary
shall exclude the
supplier
from participation in the programs under this chapter, in accordance with the procedures set forth in subsections (c), (f), and (g) of
section 1320a–7 of this title
(18)
Refund of amounts collected for certain disallowed items
(A)
In general
If a nonparticipating
supplier
furnishes to an individual enrolled under this part a
covered item
for which no payment may be made under this part by reason of paragraph (17)(B), the
supplier
shall refund on a timely basis to the patient (and shall be liable to the patient for) any amounts collected from the patient for the item, unless—
(i)
the
supplier
establishes that the
supplier
did not know and could not reasonably have been expected to know that payment may not be made for the item by reason of paragraph (17)(B), or
(ii)
before the item was furnished, the patient was informed that payment under this part may not be made for that item and the patient has agreed to pay for that item.
(B)
Sanctions
If a
supplier
knowingly and willfully fails to make refunds in violation of subparagraph (A), the
Secretary
may apply sanctions against the
supplier
in accordance with
section 1395u(j)(2) of this title
(C)
Notice
Each
carrier
with a contract in effect under this part with respect to
suppliers
of
covered items
shall send any notice of denial of payment for
covered items
by reason of paragraph (17)(B) and for which payment is not requested on an assignment-related basis to the
supplier
and the patient involved.
(D)
Timely basis defined
A refund under subparagraph (A) is considered to be on a timely basis only if—
(i)
in the case of a
supplier
who does not request reconsideration or seek appeal on a timely basis, the refund is made within 30 days after the date the
supplier
receives a denial notice under subparagraph (C), or
(ii)
in the case in which such a reconsideration or appeal is taken, the refund is made within 15 days after the date the
supplier
receives notice of an adverse determination on reconsideration or appeal.
(19)
Certain upgraded items
(A)
Individual’s right to choose upgraded item
Notwithstanding any other provision of this subchapter, the
Secretary
may issue
regulations
under which an individual may purchase or rent from a
supplier
an item of upgraded
durable medical equipment
for which payment would be made under this subsection if the item were a standard item.
(B)
Payments to supplier
In the case of the purchase or rental of an upgraded item under subparagraph (A)—
(i)
the
supplier
shall receive payment under this subsection with respect to such item as if such item were a standard item; and
(ii)
the individual purchasing or renting the item shall pay the
supplier
an amount equal to the difference between the
supplier
’s charge and the amount under clause (i).
In no event may the
supplier
’s charge for an upgraded item exceed the
applicable fee schedule amount
(if any) for such item.
(C)
Consumer protection
safeguards
Any
regulations
under subparagraph (A) shall provide for
consumer protection
standards with respect to the furnishing of upgraded equipment under subparagraph (A). Such
regulations
shall provide for—
(i)
determination of fair market prices with respect to an upgraded item;
(ii)
full disclosure of the availability and price of standard items and proof of receipt of such disclosure information by the beneficiary before the furnishing of the upgraded item;
(iii)
conditions of participation for
suppliers
in the billing arrangement;
(iv)
sanctions of
suppliers
who are determined to engage in coercive or abusive practices, including exclusion; and
(v)
such other safeguards as the
Secretary
determines are necessary.
(20)
Identification of quality standards
(A)
In general
Subject to subparagraph (C), the
Secretary
shall establish and implement quality standards for
suppliers
of items and services described in subparagraph (D) to be applied by recognized independent accreditation organizations (as designated under subparagraph (B)) and with which such
suppliers
shall be required to comply in order to—
(i)
furnish any such item or service for which payment is made under this part; and
(ii)
receive or retain a provider or
supplier
number used to submit claims for reimbursement for any such item or service for which payment may be made under this subchapter.
(B)
Designation of independent accreditation organizations
Not later than the date that is 1 year after the date on which the
Secretary
implements the quality standards under subparagraph (A), notwithstanding
section 1395bb(a) of this title
, the
Secretary
shall designate and approve one or more independent accreditation organizations for purposes of such subparagraph.
(C)
Quality standards
The quality standards described in subparagraph (A) may not be less stringent than the quality standards that would otherwise apply if this paragraph did not apply and shall include consumer services standards.
(D)
Items and services described
The items and services described in this subparagraph are the following items and services, as the
Secretary
determines
appropriate
(i)
Covered items
(as defined in paragraph (13)) for which payment may otherwise be made under this subsection.
(ii)
Prosthetic devices
and
orthotics and prosthetics
described in subsection (h)(4).
(iii)
Items and services described in
section 1395u(s)(2) of this title
(iv)
Lymphedema compression
treatment
items (as defined in
section 1395x(mmm) of this title
).
(E)
Implementation
The
Secretary
may establish by program instruction or otherwise the quality standards under this paragraph, including subparagraph (F), after consultation with representatives of relevant parties. Such standards shall be applied prospectively and shall be published on the Internet website of the Centers for
Medicare
& Medicaid Services.
(F)
Application of accreditation requirement
In implementing quality standards under this paragraph—
(i)
subject to clause (ii) and subparagraph (G), the
Secretary
shall require
suppliers
furnishing items and services described in subparagraph (D) on or after
October 1, 2009
, directly or as a subcontractor for another entity, to have submitted to the
Secretary
evidence of accreditation by an accreditation organization designated under subparagraph (B) as meeting applicable quality standards, except that the
Secretary
shall not require under this clause pharmacies to obtain such accreditation before
January 1, 2010
, except that the
Secretary
shall not require a pharmacy to have submitted to the
Secretary
such evidence of accreditation prior to
January 1, 2011
; and
(ii)
in applying such standards and the accreditation requirement of clause (i) with respect to eligible professionals (as defined in
section 1395w–4(k)(3)(B) of this title
), and including such other
persons,
such as orthotists and prosthetists, as specified by the
Secretary,
furnishing such items and services—
(I)
such standards and accreditation requirement shall not apply to such professionals and
persons
unless the
Secretary
determines that the standards being applied are designed specifically to be applied to such professionals and
persons;
and
(II)
the
Secretary
may exempt such professionals and
persons
from such standards and requirement if the
Secretary
determines that licensing, accreditation, or other mandatory quality requirements apply to such professionals and
persons
with respect to the furnishing of such items and services.
(G)
Application of accreditation requirement to certain pharmacies
(i)
In general
With respect to items and services furnished on or after
January 1, 2011
, in implementing quality standards under this paragraph—
(I)
subject to subclause (II), in applying such standards and the accreditation requirement of subparagraph (F)(i) with respect to pharmacies described in clause (ii) furnishing such items and services, such standards and accreditation requirement shall not apply to such pharmacies; and
(II)
the
Secretary
may apply to such pharmacies an alternative accreditation requirement established by the
Secretary
if the
Secretary
determines such alternative accreditation requirement is more
appropriate
for such pharmacies.
(ii)
Pharmacies described
A pharmacy described in this clause is a pharmacy that meets each of the following criteria:
(I)
The total billings by the pharmacy for such items and services under this subchapter are less than 5 percent of total pharmacy sales, as determined based on the average total pharmacy sales for the previous 3 calendar years, 3 fiscal years, or other yearly period specified by the
Secretary
(II)
The pharmacy has been enrolled under
section 1395cc(j) of this title
as a
supplier
of
durable medical equipment,
prosthetics, orthotics, and supplies, has been issued (which may include the renewal of) a provider number for at least 5 years, and for which a final adverse action (as defined in section
424.57(a)
of title 42, Code of Federal Regulations) has not been imposed in the past 5 years.
(III)
The pharmacy submits to the
Secretary
an attestation, in a form and manner, and at a time, specified by the
Secretary
, that the pharmacy meets the criteria described in subclauses (I) and (II). Such attestation shall be subject to
section 1001 of title 18
(IV)
The pharmacy agrees to submit materials as requested by the
Secretary
, or during the course of an audit conducted on a random sample of pharmacies selected annually, to verify that the pharmacy meets the criteria described in subclauses (I) and (II). Materials submitted under the preceding sentence shall include a certification by an accountant on behalf of the pharmacy or the submission of tax returns filed by the pharmacy during the relevant periods, as requested by the
Secretary
(21)
Special payment rule for specified items and supplies
(A)
In general
Notwithstanding the preceding provisions of this subsection, for specified items and supplies (described in subparagraph (B)) furnished during 2005, the payment amount otherwise determined under this subsection for such specified items and supplies shall be reduced by the percentage difference between—
(i)
the amount of payment otherwise determined for the specified item or supply under this subsection for 2002, and
(ii)
the amount of payment for the specified item or supply under chapter 89 of title 5, as identified in the column entitled “Median FEHP Price” in the table entitled “SUMMARY OF
MEDICARE
PRICES COMPARED TO VA, MEDICAID, RETAIL, AND FEHP PRICES FOR 16 ITEMS” included in the Testimony of the Inspector General before the
Senate
Committee on Appropriations,
June 12, 2002
, or any subsequent report by the Inspector General.
(B)
Specified item or supply described
For purposes of subparagraph (A), a specified item or supply means oxygen and oxygen equipment, standard wheelchairs (including standard power wheelchairs), nebulizers, diabetic supplies consisting of lancets and testing strips,
hospital
beds, and air mattresses, but only if the HCPCS code for the item or supply is identified in a table referred to in subparagraph (A)(ii).
(C)
Application of update to special payment amount
The
covered item update
under paragraph (14) for specified items and supplies for 2006 and each subsequent year shall be applied to the payment amount under subparagraph (A) unless payment is made for such items and supplies under
section 1395w–3 of this title
(22)
Special payment rule for diabetic supplies
Notwithstanding the preceding provisions of this subsection, for purposes of determining the payment amount under this subsection for diabetic supplies furnished on or after the first day of the calendar quarter during 2013 that is at least 30 days after
January 2, 2013
, and before the date described in paragraph (1)(H)(ii), the
Secretary
shall recalculate and apply the
covered item update
under paragraph (14) as if subparagraph (J)(i) of such paragraph was amended by striking “but only if furnished through mail order”.
(23)
Master List inclusion and claim review for certain items
(A)
Master List inclusion
Beginning
January 1, 2029
, for purposes of the Master List described in section
414.234(b)
of title 42, Code of Federal Regulations (or any successor regulation), in determining which items have aberrant billing patterns (as such term is used for purposes of such section), the
Secretary
shall also treat an item for which payment may be made under this subsection as having such an aberrant billing pattern if the
Secretary
determines that, without explanatory contributing factors (such as furnishing emergent care services), a substantial number of claims for such items under this subsection are for such items ordered by a
physician
or
practitioner
who has not previously (during a period of not less than 24 months, as established by the
Secretary)
furnished to the individual involved any item or service for which payment may be made under this subchapter.
(B)
Claim review
With respect to items furnished on or after
January 1, 2029
, that are included on the Master List pursuant to subparagraph (A), if such an item is not subject to a determination of coverage in advance pursuant to paragraph (15)(C), the
Secretary
may conduct prepayment review of claims for payment for such item.
(b)
Fee schedules for radiologist services
(1)
Development
The
Secretary
shall develop—
(A)
a relative value scale to serve as the basis for the payment for
radiologist services
under this part, and
(B)
using such scale and
appropriate
conversion factors and subject to subsection (c)(1)(A), fee schedules (on a regional, statewide, locality, or
carrier
service area basis) for payment for
radiologist services
under this part, to be implemented for such services furnished during 1989.
(2)
Consultation
In carrying out paragraph (1), the
Secretary
shall regularly consult closely with the
Physician
Payment Review Commission, the American College of Radiology, and other organizations representing
physicians
or
suppliers
who furnish
radiologist services
and shall share with them the data and data analysis being used to make the determinations under paragraph (1), including data on variations in current
medicare
payments by geographic area, and by service and
physician
specialty.
(3)
Considerations
In developing the relative value scale and fee schedules under paragraph (1), the
Secretary
(A)
shall take into consideration variations in the cost of furnishing such services among geographic areas and among different sites where services are furnished, and
(B)
may also take into consideration such other factors respecting the manner in which
physicians
in different specialties furnish such services as may be
appropriate
to assure that payment amounts are equitable and designed to promote effective and efficient provision of
radiologist services
by
physicians
in the different specialties.
(4)
Savings
(A)
Budget neutral fee schedules
The
Secretary
shall develop preliminary fee schedules for 1989, which are designed to result in the same amount of aggregate payments (net of any coinsurance and deductibles under sections
1395l(a)(1)(J)
and
1395l(b)
of this title) for
radiologist services
furnished in 1989 as would have been made if this subsection had not been enacted.
(B)
Initial savings
The fee schedules established for payment purposes under this subsection for services furnished in 1989 shall be 97 percent of the amounts permitted under the preliminary fee schedules developed under subparagraph (A).
(C)
1990 fee schedules
For
radiologist services
(other than portable X-ray services) furnished under this part during 1990, after March 31 of such year, the conversion factors used under this subsection shall be 96 percent of the conversion factors that applied under this subsection as of
December 31, 1989
(D)
1991 fee schedules
For
radiologist services
(other than portable X-ray services) furnished under this part during 1991, the conversion factors used in a locality under this subsection shall, subject to clause (vii), be reduced to the adjusted conversion factor for the locality determined as follows:
(i)
National weighted average conversion factor
The
Secretary
shall estimate the national weighted average of the conversion factors used under this subsection for services furnished during 1990 beginning on April 1, using the best available data.
(ii)
Reduced national weighted average
The national weighted average estimated under clause (i) shall be reduced by 13 percent.
(iii)
Computation of 1990 locality index relative to national average
The
Secretary
shall establish an index which reflects, for each locality, the ratio of the conversion factor used in the locality under this subsection to the national weighted average estimated under clause (i).
(iv)
Adjusted conversion factor
The adjusted conversion factor for the professional or technical component of a service in a locality is the sum of ½ of the locally-adjusted amount determined under clause (v) and ½ of the GPCI-adjusted amount determined under clause (vi).
(v)
Locally-adjusted amount
For purposes of clause (iv), the locally adjusted amount determined under this clause is the product of (I) the national weighted average conversion factor computed under clause (ii), and (II) the index value established under clause (iii) for the locality.
(vi)
GPCI-adjusted amount
For purposes of clause (iv), the GPCI-adjusted amount determined under this clause is the sum of—
(I)
the product of (a) the portion of the reduced national weighted average conversion factor computed under clause (ii) which is attributable to
physician
work and (b) the geographic work index value for the locality (specified in Addendum C to the Model Fee Schedule for
Physician
Services (published on
September 4, 1990
, 55 Federal Register pp. 36238–36243)); and
(II)
the product of (a) the remaining portion of the reduced national weighted average conversion factor computed under clause (ii), and (b) the geographic practice cost index value specified in
section 1395u(b)(14)(C)(iv) of this title
for the locality.
In applying this clause with respect to the professional component of a service, 80 percent of the conversion factor shall be considered to be attributable to
physician
work and with respect to the technical component of the service, 0 percent shall be considered to be attributable to
physician
work.
(vii)
Limits on conversion factor
The conversion factor to be applied to a locality to the professional or technical component of a service shall not be reduced under this subparagraph by more than 9.5 percent below the conversion factor applied in the locality under subparagraph (C) to such component, but in no case shall the conversion factor be less than 60 percent of the national weighted average of the conversion factors (computed under clause (i)).
(E)
Rule for certain scanning services
In the case of the technical components of magnetic resonance imaging (MRI) services and computer assisted tomography (CAT) services furnished after
December 31, 1990
, the amount otherwise payable shall be reduced by 10 percent.
(F)
Subsequent updating
For
radiologist services
furnished in subsequent years, the fee schedules shall be the schedules for the previous year updated by the
percentage increase in the MEI
(as defined in
section 1395u(i)(3) of this title
) for the year.
(G)
Nonparticipating physicians and suppliers
Each fee schedule so established shall provide that the payment rate recognized for nonparticipating
physicians
and
suppliers
is equal to the
appropriate
percent (as defined in
section 1395u(b)(4)(A)(iv) of this title
) of the payment rate recognized for participating
physicians
and
suppliers.
(5)
Limiting charges of nonparticipating physicians and suppliers
(A)
In general
In the case of
radiologist services
furnished after
January 1, 1989
, for which payment is made under a fee schedule under this subsection, if a nonparticipating
physician
or
supplier
furnishes the service to an individual entitled to benefits under this part, the
physician
or
supplier
may not charge the individual more than the
limiting charge
(as defined in subparagraph (B)).
(B)
“Limiting charge” defined
In subparagraph (A), the term “
limiting charge
” means, with respect to a service furnished—
(i)
in 1989, 125 percent of the amount specified for the service in the
appropriate
fee schedule established under paragraph (1),
(ii)
in 1990, 120 percent of the amount specified for the service in the
appropriate
fee schedule established under paragraph (1), and
(iii)
after 1990, 115 percent of the amount specified for the service in the
appropriate
fee schedule established under paragraph (1).
(C)
Enforcement
If a
physician
or
supplier
knowingly and willfully bills in violation of subparagraph (A), the
Secretary
may apply sanctions against such
physician
or
supplier
in accordance with
section 1395u(j)(2) of this title
in the same manner as such sanctions may apply to a
physician.
(6)
“Radiologist services” defined
For the purposes of this subsection and section 1395
(a)(1)(J) of this title, the term
“radiologist services”
only includes radiology services performed by, or under the direction or supervision of, a
physician—
(A)
who is certified, or eligible to be certified, by the American Board of Radiology, or
(B)
for whom radiology services account for at least 50 percent of the total amount of charges made under this part.
(c)
Payment and standards for screening mammography
(1)
In general
With respect to expenses incurred for
screening mammography
(as defined in
section 1395x(jj) of this title
), payment may be made only—
(A)
for
screening mammography
conducted consistent with the frequency permitted under paragraph (2); and
(B)
if the
screening mammography
is conducted by a facility that has a certificate (or provisional certificate) issued under
section 263b of this title
(2)
Frequency covered
(A)
In general
Subject to revision by the
Secretary
under subparagraph (B)—
(i)
no payment may be made under this part for
screening mammography
performed on a woman under 35 years of age;
(ii)
payment may be made under this part for only one
screening mammography
performed on a woman over 34 years of age, but under 40 years of age; and
(iii)
in the case of a woman over 39 years of age, payment may not be made under this part for
screening mammography
performed within 11 months following the month in which a previous
screening mammography
was performed.
(B)
Revision of frequency
(i)
Review
The
Secretary
, in consultation with the Director of the National Cancer Institute, shall review periodically the
appropriate
frequency for performing
screening mammography
, based on age and such other factors as the
Secretary
believes to be pertinent.
(ii)
Revision of frequency
The
Secretary
, taking into consideration the review made under clause (i), may revise from time to time the frequency with which
screening mammography
may be paid for under this subsection.
(d)
Frequency limits and payment for colorectal cancer screening tests
(1)
Screening fecal-occult blood tests
(A)
Payment amount
The payment amount for
colorectal cancer screening tests
consisting of screening fecal-occult blood tests is equal to the payment amount established for diagnostic fecal-occult blood tests under
section 1395l(h) of this title
(B)
Frequency limit
No payment may be made under this part for a
colorectal cancer screening test
consisting of a screening fecal-occult blood test—
(i)
if the individual is under 50 years of age; or
(ii)
if the test is performed within the 11 months after a previous screening fecal-occult blood test.
(2)
Screening flexible sigmoidoscopies
(A)
Fee schedule
With respect to
colorectal cancer screening tests
consisting of screening flexible sigmoidoscopies, payment under
section 1395w–4 of this title
shall be consistent with payment under such section for similar or related services.
(B)
Payment limit
In the case of screening flexible sigmoidoscopy services, payment under this part shall not exceed such amount as the
Secretary
specifies, based upon the rates recognized for diagnostic flexible sigmoidoscopy services.
(C)
Facility payment limit
(i)
In general
Notwithstanding subsections (i)(2)(A) and (t) of section 1395
of this title, in the case of screening flexible sigmoidoscopy services furnished on or after
January 1, 1999
, that—
(I)
in accordance with
regulations
, may be performed in an ambulatory surgical center and for which the
Secretary
permits ambulatory surgical center payments under this part, and
(II)
are performed in an ambulatory surgical center or
hospital
outpatient department,
payment under this part shall be based on the lesser of the amount under the fee schedule that would apply to such services if they were performed in a
hospital
outpatient department in an area or the amount under the fee schedule that would apply to such services if they were performed in an ambulatory surgical center in the same area.
(ii)
Limitation on coinsurance
Subject to section 1395
(a)(1)(Y) of this title, but notwithstanding any other provision of this subchapter, in the case of a beneficiary who receives the services described in clause (i)—
(I)
in computing the amount of any applicable copayment, the computation of such coinsurance shall be based upon the fee schedule under which payment is made for the services, and
(II)
the amount of such coinsurance is equal to 25 percent of the payment amount under the fee schedule described in subclause (I).
(D)
Special rule for detected lesions
Subject to
section 1395l(a)(1)(Y) of this title
, if during the course of such screening flexible sigmoidoscopy, a lesion or growth is detected which results in a biopsy or removal of the lesion or growth, payment under this part shall not be made for the screening flexible sigmoidoscopy but shall be made for the procedure classified as a flexible sigmoidoscopy with such biopsy or removal.
(E)
Frequency limit
No payment may be made under this part for a
colorectal cancer screening test
consisting of a screening flexible sigmoidoscopy—
(i)
if the individual is under 50 years of age; or
(ii)
if the procedure is performed within the 47 months after a previous screening flexible sigmoidoscopy or, in the case of an individual who is not at high risk for colorectal cancer, if the procedure is performed within the 119 months after a previous screening colonoscopy.
(3)
Screening colonoscopy
(A)
Fee schedule
With respect to
colorectal cancer screening test
consisting of a screening colonoscopy, payment under
section 1395w–4 of this title
shall be consistent with payment amounts under such section for similar or related services.
(B)
Payment limit
In the case of screening colonoscopy services, payment under this part shall not exceed such amount as the
Secretary
specifies, based upon the rates recognized for diagnostic colonoscopy services.
(C)
Facility payment limit
(i)
In general
Notwithstanding subsections (i)(2)(A) and (t) of
section 1395l of this title
, in the case of screening colonoscopy services furnished on or after
January 1, 1999
, that are performed in an ambulatory surgical center or a
hospital
outpatient department, payment under this part shall be based on the lesser of the amount under the fee schedule that would apply to such services if they were performed in a
hospital
outpatient department in an area or the amount under the fee schedule that would apply to such services if they were performed in an ambulatory surgical center in the same area.
(ii)
Limitation on coinsurance
Subject to section 1395
(a)(1)(Y) of this title, but notwithstanding any other provision of this subchapter, in the case of a beneficiary who receives the services described in clause (i)—
(I)
in computing the amount of any applicable coinsurance, the computation of such coinsurance shall be based upon the fee schedule under which payment is made for the services, and
(II)
the amount of such coinsurance is equal to 25 percent of the payment amount under the fee schedule described in subclause (I).
(D)
Special rule for detected lesions
Subject to
section 1395l(a)(1)(Y) of this title
, if during the course of such screening colonoscopy, a lesion or growth is detected which results in a biopsy or removal of the lesion or growth, payment under this part shall not be made for the screening colonoscopy but shall be made for the procedure classified as a colonoscopy with such biopsy or removal.
(E)
Frequency limit
No payment may be made under this part for a
colorectal cancer screening test
consisting of a screening colonoscopy for individuals at high risk for colorectal cancer if the procedure is performed within the 23 months after a previous screening colonoscopy or for other individuals if the procedure is performed within the 119 months after a previous screening colonoscopy or within 47 months after a previous screening flexible sigmoidoscopy.
(e)
Accreditation requirement for advanced diagnostic imaging services
(1)
In general
(A)
In general
Beginning with
January 1, 2012
, with respect to the technical component of
advanced diagnostic imaging services
for which payment is made under the fee schedule established under
section 1395w–4(b) of this title
and that are furnished by a
supplier,
payment may only be made if such
supplier
is accredited by an accreditation organization designated by the
Secretary
under paragraph (2)(B)(i).
[2]
(B)
Advanced diagnostic imaging services defined
In this subsection, the term “
advanced diagnostic imaging services
” includes—
(i)
diagnostic magnetic resonance imaging, computed tomography, and nuclear medicine (including positron emission tomography); and
(ii)
such other diagnostic imaging services, including services described in
section 1395w–4(b)(4)(B) of this title
(excluding X-ray, ultrasound, and fluoroscopy), as specified by the
Secretary
in consultation with
physician
specialty organizations and other stakeholders.
(C)
Supplier defined
In this subsection, the term “
supplier
” has the meaning given such term in
section 1395x(d) of this title
(2)
Accreditation organizations
(A)
Factors for designation of accreditation organizations
The
Secretary
shall consider the following factors in designating accreditation organizations under subparagraph (B)(i)
and in reviewing and modifying the list of accreditation organizations designated pursuant to subparagraph (C):
(i)
The ability of the organization to conduct timely reviews of accreditation applications.
(ii)
Whether the organization has established a process for the timely integration of new
advanced diagnostic imaging services
into the organization’s accreditation program.
(iii)
Whether the organization uses random site visits, site audits, or other strategies for ensuring accredited
suppliers
maintain adherence to the criteria described in paragraph (3).
(iv)
The ability of the organization to take into account the capacities of
suppliers
located in a
rural area
(as defined in
section 1395ww(d)(2)(D) of this title
).
(v)
Whether the organization has established reasonable fees to be charged to
suppliers
applying for accreditation.
(vi)
Such other factors as the
Secretary
determines
appropriate
(B)
Designation
Not later than
January 1, 2010
, the
Secretary
shall designate organizations to accredit
suppliers
furnishing the technical component of
advanced diagnostic imaging services.
The list of accreditation organizations so designated may be modified pursuant to subparagraph (C).
(C)
Review and modification of list of accreditation organizations
(i)
In general
The
Secretary
shall review the list of accreditation organizations designated under subparagraph (B) taking into account the factors under subparagraph (A). Taking into account the results of such review, the
Secretary
may, by regulation, modify the list of accreditation organizations designated under subparagraph (B).
(ii)
Special rule for accreditations done prior to removal from list of designated accreditation organizations
In the case where the
Secretary
removes an organization from the list of accreditation organizations designated under subparagraph (B), any
supplier
that is accredited by the organization during the period beginning on the date on which the organization is designated as an accreditation organization under subparagraph (B) and ending on the date on which the organization is removed from such list shall be considered to have been accredited by an organization designated by the
Secretary
under subparagraph (B) for the remaining period such accreditation is in effect.
(3)
Criteria for accreditation
The
Secretary
shall establish procedures to ensure that the criteria used by an accreditation organization designated under paragraph (2)(B) to evaluate a
supplier
that furnishes the technical component of
advanced diagnostic imaging services
for the purpose of accreditation of such
supplier
is specific to each imaging modality. Such criteria shall include—
(A)
standards for qualifications of medical personnel who are not
physicians
and who furnish the technical component of
advanced diagnostic imaging services
(B)
standards for qualifications and responsibilities of medical directors and supervising
physicians
, including standards that recognize the considerations described in paragraph (4);
(C)
procedures to ensure that equipment used in furnishing the technical component of
advanced diagnostic imaging services
meets performance specifications;
(D)
standards that require the
supplier
have procedures in place to ensure the safety of
persons
who furnish the technical component of
advanced diagnostic imaging services
and individuals to whom such services are furnished;
(E)
standards that require the establishment and maintenance of a quality assurance and quality control program by the
supplier
that is adequate and
appropriate
to ensure the reliability, clarity, and accuracy of the technical quality of diagnostic images produced by such
supplier
; and
(F)
any other standards or procedures the
Secretary
determines
appropriate
(4)
Recognition in standards for the evaluation of medical directors and supervising physicians
The standards described in paragraph (3)(B) shall recognize whether a medical director or supervising
physician
(A)
in a particular specialty receives training in
advanced diagnostic imaging services
in a residency program;
(B)
has attained, through experience, the necessary expertise to be a medical director or a supervising
physician
(C)
has completed any continuing medical education courses relating to such services; or
(D)
has met such other standards as the
Secretary
determines
appropriate
(5)
Rule for accreditations made prior to designation
In the case of a
supplier
that is accredited before
January 1, 2010
, by an accreditation organization designated by the
Secretary
under paragraph (2)(B) as of
January 1, 2010
, such
supplier
shall be considered to have been accredited by an organization designated by the
Secretary
under such paragraph as of
January 1, 2012
, for the remaining period such accreditation is in effect.
(f)
Reduction in payments for physician pathology services during 1991
(1)
In general
For
physician
pathology services furnished under this part during 1991, the prevailing charges used in a locality under this part shall be 7 percent below the prevailing charges used in the locality under this part in 1990 after March 31.
(2)
Limitation
The prevailing charge for the technical and professional components of an
[3]
physician
pathology service furnished by a
physician
through an independent laboratory shall not be reduced pursuant to paragraph (1) to the extent that such reduction would reduce such prevailing charge below 115 percent of the prevailing charge for the professional component of such service when furnished by a
hospital-
based
physician
in the same locality. For purposes of the preceding sentence, an independent laboratory is a laboratory that is independent of a
hospital
and separate from the attending or consulting
physicians’
office.
(g)
Payment for outpatient critical access hospital services
(1)
In general
The amount of payment for
outpatient critical access hospital services
of a
critical access hospital
is equal to 101 percent of the reasonable costs of the
hospital
in providing such services, unless the
hospital
makes the election under paragraph (2).
(2)
Election of cost-based hospital outpatient service payment plus fee schedule for professional services
critical access hospital
may elect to be paid for
outpatient critical access hospital services
amounts equal to the sum of the following, less the amount that such
hospital
may charge as described in
section 1395cc(a)(2)(A) of this title
(A)
Facility fee
With respect to facility services, not including any services for which payment may be made under subparagraph (B), 101 percent of the reasonable costs of the
critical access hospital
in providing such services.
(B)
Fee schedule for professional services
With respect to professional services otherwise included within
outpatient critical access hospital services
, 115 percent of such amounts as would otherwise be paid under this part if such services were not included in
outpatient critical access hospital services
. Subsections (x) and (y) of
section 1395l of this title
shall not be taken into account in determining the amounts that would otherwise be paid pursuant to the preceding sentence.
The
Secretary
may not require, as a condition for applying subparagraph (B) with respect to a
critical access hospital
, that each
physician
or other
practitioner
providing professional services in the
hospital
must assign billing rights with respect to such services, except that such subparagraph shall not apply to those
physicians
and
practitioners
who have not assigned such billing rights.
(3)
Disregarding charges
The payment amounts under this subsection shall be determined without regard to the amount of the customary or other charge.
(4)
Treatment of clinical diagnostic laboratory services
No coinsurance, deductible, copayment, or other cost-sharing otherwise applicable under this part shall apply with respect to clinical diagnostic laboratory services furnished as an outpatient
critical access hospital
service. Nothing in this subchapter shall be construed as providing for payment for clinical diagnostic laboratory services furnished as part of
outpatient critical access hospital services
, other than on the basis described in this subsection. For purposes of the preceding sentence and
section 1395x(mm)(3) of this title
, clinical diagnostic laboratory services furnished by a
critical access hospital
shall be treated as being furnished as part of outpatient critical access services without regard to whether the individual with respect to whom such services are furnished is physically present in the
critical access hospital,
or in a
skilled nursing facility
or a clinic (including a
rural health clinic)
that is operated by a
critical access hospital,
at the time the specimen is collected.
(5)
Coverage of costs for certain emergency room on-call providers
In determining the reasonable costs of
outpatient critical access hospital services
under paragraphs (1) and (2)(A), the
Secretary
shall recognize as allowable costs, amounts (as defined by the
Secretary)
for reasonable compensation and related costs for
physicians
physician
assistants, nurse
practitioners
, and
clinical nurse specialists
who are on-call (as defined by the
Secretary)
to provide emergency services but who are not present on the premises of the
critical access hospital
involved, and are not otherwise furnishing services covered under this subchapter and are not on-call at any other provider or facility.
(h)
Payment for prosthetic devices and orthotics and prosthetics
(1)
General rule for payment
(A)
In general
Payment under this subsection for
prosthetic devices
and
orthotics and prosthetics
shall be made in a lump-sum amount for the purchase of the item in an amount equal to 80 percent of the payment basis described in subparagraph (B).
(B)
Payment basis
Except as provided in subparagraphs (C), (E), and (H)(i), the payment basis described in this subparagraph is the lesser of—
(i)
the actual charge for the item; or
(ii)
the amount recognized under paragraph (2) as the purchase price for the item.
(C)
Exception for certain public home health agencies
Subparagraph (B)(i) shall not apply to an item furnished by a public
home health agency
(or by another
home health agency
which demonstrates to the satisfaction of the
Secretary
that a significant portion of its patients are low income) free of charge or at nominal charges to the public.
(D)
Exclusive payment rule
Subject to subparagraph (H)(ii), this subsection shall constitute the exclusive provision of this subchapter for payment for
prosthetic devices
, orthotics, and prosthetics under this part or under part A to a
home health agency.
(E)
Exception for certain items
Payment for ostomy supplies, tracheostomy supplies, and urologicals shall be made in accordance with subparagraphs (B) and (C) of subsection (a)(2).
(F)
Special payment rules for certain prosthetics and custom-fabricated orthotics
(i)
In general
No payment shall be made under this subsection for an item of custom-fabricated orthotics described in clause (ii) or for an item of prosthetics unless such item is—
(I)
furnished by a
qualified practitioner
; and
(II)
fabricated by a
qualified practitioner
or a
qualified supplier
at a facility that meets such criteria as the
Secretary
determines
appropriate.
(ii)
Description of custom-fabricated item
(I)
In general
An item described in this clause is an item of custom-fabricated orthotics that requires education, training, and experience to custom-fabricate and that is included in a list established by the
Secretary
in subclause (II). Such an item does not include shoes and shoe inserts.
(II)
List of items
The
Secretary
, in consultation with
appropriate
experts in orthotics (including national organizations representing manufacturers of orthotics), shall establish and update as
appropriate
a list of items to which this subparagraph applies. No item may be included in such list unless the item is individually fabricated for the patient over a positive model of the patient.
(iii)
Qualified practitioner defined
In this subparagraph, the term “
qualified practitioner
” means a
physician
or other individual who—
(I)
is a qualified physical therapist or a qualified occupational therapist;
(II)
in the case of a
State
that provides for the licensing of
orthotics and prosthetics
, is licensed in orthotics or prosthetics by the
State
in which the item is supplied; or
(III)
in the case of a
State
that does not provide for the licensing of
orthotics and prosthetics
, is specifically trained and educated to provide or manage the provision of prosthetics and custom-designed or -fabricated orthotics, and is certified by the American Board for Certification in
Orthotics and Prosthetics
, Inc. or by the Board for Orthotist/Prosthetist Certification, or is credentialed and approved by a program that the
Secretary
determines, in consultation with
appropriate
experts in
orthotics and prosthetics
, has training and education standards that are necessary to provide such prosthetics and orthotics.
(iv)
Qualified supplier defined
In this subparagraph, the term “
qualified supplier
” means any entity that is accredited by the American Board for Certification in
Orthotics and Prosthetics
, Inc. or by the Board for Orthotist/Prosthetist Certification, or accredited and approved by a program that the
Secretary
determines has accreditation and approval standards that are essentially equivalent to those of such Board.
(G)
Replacement of prosthetic devices and parts
(i)
In general
Payment shall be made for the replacement of
prosthetic devices
which are artificial limbs, or for the replacement of any part of such devices, without regard to continuous use or useful lifetime restrictions if an ordering
physician
determines that the provision of a replacement device, or a replacement part of such a device, is necessary because of any of the following:
(I)
A change in the physiological condition of the patient.
(II)
An irreparable change in the condition of the device, or in a part of the device.
(III)
The condition of the device, or the part of the device, requires repairs and the cost of such repairs would be more than 60 percent of the cost of a replacement device, or, as the case may be, of the part being replaced.
(ii)
Confirmation may be required if device or part being replaced is less than 3 years old
If a
physician
determines that a replacement device, or a replacement part, is necessary pursuant to clause (i)—
(I)
such determination shall be controlling; and
(II)
such replacement device or part shall be deemed to be reasonable and necessary for purposes of
section 1395y(a)(1)(A) of this title
except that if the device, or part, being replaced is less than 3 years old (calculated from the date on which the beneficiary began to use the device or part), the
Secretary
may also require confirmation of necessity of the replacement device or replacement part, as the case may be.
(H)
Application of competitive acquisition to orthotics; limitation of inherent reasonableness authority
In the case of orthotics described in paragraph (2)(C) of
section 1395w–3(a) of this title
furnished on or after
January 1, 2011
, subject to subsection (a)(1)(G), that are included in a competitive acquisition program in a competitive acquisition area under such section—
(i)
the payment basis under this subsection for such orthotics furnished in such area shall be the payment basis determined under such competitive acquisition program; and
(ii)
subject to subsection (a)(1)(G), the
Secretary
may use information on the payment determined under such competitive acquisition programs to adjust the payment amount otherwise recognized under subparagraph (B)(ii) for an area that is not a competitive acquisition area under
section 1395w–3 of this title
, and in the case of such adjustment, paragraphs (8) and (9) of
section 1395u(b) of this title
shall not be applied.
(2)
Purchase price recognized
For purposes of paragraph (1), the amount that is recognized under this paragraph as the purchase price for
prosthetic devices
, orthotics, and prosthetics is the amount described in subparagraph (C) of this paragraph, determined as follows:
(A)
Computation of local purchase price
Each
carrier
under
section 1395u of this title
shall compute a base local purchase price for the item as follows:
(i)
The
carrier
shall compute a base local purchase price for each item equal to the average reasonable charge in the locality for the purchase of the item for the 12-month period ending with June 1987.
(ii)
The
carrier
shall compute a local purchase price, with respect to the furnishing of each particular item—
(I)
in 1989 and 1990, equal to the base local purchase price computed under clause (i) increased by the percentage increase in the consumer price index for all urban consumers (
United States
city average) for the 6-month period ending with December 1987, or
(II)
in 1991, 1992 or 1993, equal to the local purchase price computed under this clause for the previous year increased by the
applicable percentage increase
for the year.
(B)
Computation of regional purchase price
With respect to the furnishing of a particular item in each region (as defined by the
Secretary
), the
Secretary
shall compute a regional purchase price—
(i)
for 1992, equal to the average (weighted by relative volume of all claims among
carriers
) of the local purchase prices for the
carriers
in the region computed under subparagraph (A)(ii)(II) for the year, and
(ii)
for each subsequent year, equal to the regional purchase price computed under this subparagraph for the previous year increased by the
applicable percentage increase
for the year.
(C)
Purchase price recognized
For purposes of paragraph (1) and subject to subparagraph (D), the amount that is recognized under this paragraph as the purchase price for each item furnished—
(i)
in 1989, 1990, or 1991, is 100 percent of the local purchase price computed under subparagraph (A)(ii);
(ii)
in 1992, is the sum of (I) 75 percent of the local purchase price computed under subparagraph (A)(ii)(II) for 1992, and (II) 25 percent of the regional purchase price computed under subparagraph (B) for 1992;
(iii)
in 1993, is the sum of (I) 50 percent of the local purchase price computed under subparagraph (A)(ii)(II) for 1993, and (II) 50 percent of the regional purchase price computed under subparagraph (B) for 1993; and
(iv)
in 1994 or a subsequent year, is the regional purchase price computed under subparagraph (B) for that year.
(D)
Range on amount recognized
The amount that is recognized under subparagraph (C) as the purchase price for an item furnished—
(i)
in 1992, may not exceed 125 percent, and may not be lower than 85 percent, of the average of the purchase prices recognized under such subparagraph for all the
carrier
service areas in the
United States
in that year; and
(ii)
in a subsequent year, may not exceed 120 percent, and may not be lower than 90 percent, of the average of the purchase prices recognized under such subparagraph for all the
carrier
service areas in the
United States
in that year.
(3)
Applicability of certain provisions relating to durable medical equipment
Paragraphs (12), (15), and (17) and subparagraphs (A) and (B) of paragraph (10) and paragraph (11) of subsection (a) shall apply to
prosthetic devices
, orthotics, and prosthetics in the same manner as such provisions apply to
covered items
under such subsection, and paragraph (23) of subsection (a) shall apply to
prosthetic devices
, orthotics, and prosthetics in the same manner as such provision applies to items for which payment may be made under such subsection.
(4)
Definitions
In this subsection—
(A)
the term “
applicable percentage increase
” means—
(i)
for 1991, 0 percent;
(ii)
for 1992 and 1993, the percentage increase in the consumer price index for all urban consumers (
United States
city average) for the 12-month period ending with June of the previous year;
(iii)
for 1994 and 1995, 0 percent;
(iv)
for 1996 and 1997, the percentage increase in the consumer price index for all urban consumers (
United States
city average) for the 12-month period ending with June of the previous year;
(v)
for each of the years 1998 through 2000, 1 percent;
(vi)
for 2001, the percentage increase in the consumer price index for all urban consumers (U.S. city average) for the 12-month period ending with June 2000;
(vii)
for 2002, 1 percent;
(viii)
for 2003, the percentage increase in the consumer price index for all urban consumers (
United States
city average) for the 12-month period ending with June of the previous year;
(ix)
for 2004, 2005, and 2006, 0 percent;
(x)
for for
[4]
each of 2007 through 2010, the percentage increase in the consumer price index for all urban consumers
(United States
city average) for the 12-month period ending with June of the previous year; and
(xi)
for 2011 and each subsequent year—
(I)
the percentage increase in the consumer price index for all urban consumers (
United States
city average) for the 12-month period ending with June of the previous year, reduced by—
(II)
the productivity adjustment described in
section 1395ww(b)(3)(B)(xi)(II) of this title
The application of subparagraph (A)(xi)(II) may result in the
applicable percentage increase
under subparagraph (A) being less than 0.0 for a year, and may result in payment rates under this subsection for a year being less than such payment rates for the preceding year.
(B)
the term “
prosthetic devices
” has the meaning given such term in
section 1395x(s)(8) of this title
, except that such term does not include parenteral and enteral nutrition nutrients, supplies, and equipment and does not include an implantable item for which payment may be made under section 1395l(t) of this title; and
(C)
the term “
orthotics and prosthetics
” has the meaning given such term in
section 1395x(s)(9) of this title
(and includes shoes described in
section 1395x(s)(12) of this title
), but does not include intraocular lenses or medical supplies (including catheters, catheter supplies, ostomy bags, and supplies related to ostomy care) furnished by a
home health agency
under
section 1395x(m)(5) of this title
(5)
Documentation created by orthotists and prosthetists
For purposes of determining the reasonableness and medical necessity of
orthotics and prosthetics
, documentation created by an orthotist or prosthetist shall be considered part of the individual’s medical record to support documentation created by eligible professionals described in
section 1395w–4(k)(3)(B) of this title
(i)
Payment for surgical dressings
(1)
In general
Payment under this subsection for surgical dressings (described in
section 1395x(s)(5) of this title
) shall be made in a lump sum amount for the purchase of the item in an amount equal to 80 percent of the lesser of—
(A)
the actual charge for the item; or
(B)
a payment amount determined in accordance with the methodology described in subparagraphs (B) and (C) of subsection (a)(2) (except that in applying such methodology, the national limited payment amount referred to in such subparagraphs shall be initially computed based on local payment amounts using average reasonable charges for the 12-month period ending
December 31, 1992
, increased by the
covered item updates
described in such subsection for 1993 and 1994).
(2)
Exceptions
Paragraph (1) shall not apply to surgical dressings that are—
(A)
furnished as an incident to a
physician
’s professional service; or
(B)
furnished by a
home health agency
(j)
Requirements for suppliers of medical equipment and supplies
(1)
Issuance and renewal of supplier number
(A)
Payment
Except as provided in subparagraph (C), no payment may be made under this part after
October 31, 1994
, for items furnished by a
supplier
of
medical equipment and supplies
unless such
supplier
obtains (and renews at such intervals as the
Secretary
may require) a
supplier
number.
(B)
Standards for possessing a supplier number
supplier
may not obtain a
supplier
number unless—
(i)
for
medical equipment and supplies
furnished on or after
October 31, 1994
, and before
January 1, 1996
, the
supplier
meets standards prescribed by the
Secretary
in
regulations
issued on
June 18, 1992
; and
(ii)
for
medical equipment and supplies
furnished on or after
January 1, 1996
, the
supplier
meets revised standards prescribed by the
Secretary
(in consultation with representatives of
suppliers
of
medical equipment and supplies,
carriers,
and consumers) that shall include requirements that the
supplier—
(I)
comply with all applicable
State
and Federal licensure and regulatory requirements;
(II)
maintain a physical facility on an
appropriate
site;
(III)
have proof of
appropriate
liability insurance; and
(IV)
meet such other requirements as the
Secretary
may specify.
(C)
Exception for items furnished as incident to a physician’s service
Subparagraph (A) shall not apply with respect to
medical equipment and supplies
furnished incident to a
physician
’s service.
(D)
Prohibition against multiple supplier numbers
The
Secretary
may not issue more than one
supplier
number to any
supplier
of
medical equipment and supplies
unless the issuance of more than one number is
appropriate
to identify subsidiary or regional entities under the
supplier
’s ownership or control.
(E)
Prohibition against delegation of supplier determinations
The
Secretary
may not delegate (other than by contract under
section 1395u of this title
) the responsibility to determine whether
suppliers
meet the standards necessary to obtain a
supplier
number.
(2)
Certificates of medical necessity
(A)
Limitation on information provided by suppliers on certificates of medical necessity
(i)
In general
Effective 60 days after
October 31, 1994
, a
supplier
of
medical equipment and supplies
may distribute to
physicians,
or to individuals entitled to benefits under this part, a
certificate of medical necessity
for commercial purposes which contains no more than the following information completed by the
supplier:
(I)
An identification of the
supplier
and the beneficiary to whom such
medical equipment and supplies
are furnished.
(II)
A description of such
medical equipment and supplies
(III)
Any product code identifying such
medical equipment and supplies
(IV)
Any other administrative information (other than information relating to the beneficiary’s medical condition) identified by the
Secretary
(ii)
Information on payment amount and charges
If a
supplier
distributes a
certificate of medical necessity
containing any of the information permitted to be supplied under clause (i), the
supplier
shall also list on the
certificate of medical necessity
the fee schedule amount and the
supplier’
s charge for the medical equipment or supplies being furnished prior to distribution of such certificate to the
physician.
(iii)
Penalty
Any
supplier
of
medical equipment and supplies
who knowingly and willfully distributes a
certificate of medical necessity
in violation of clause (i) or fails to provide the information required under clause (ii) is subject to a civil money penalty in an amount not to exceed $1,000 for each such
certificate of medical necessity
so distributed. The provisions of
section 1320a–7a of this title
(other than subsections (a) and (b)) shall apply to civil money penalties under this subparagraph in the same manner as they apply to a penalty or proceeding under
section 1320a–7a(a) of this title
(B)
“Certificate of medical necessity” defined
For purposes of this paragraph, the term “
certificate of medical necessity
” means a form or other document containing information required by the
carrier
to be submitted to show that an item is reasonable and necessary for the diagnosis or
treatment
of illness or injury or to improve the functioning of a malformed body member.
(3)
Coverage and review criteria
The
Secretary
shall annually review the coverage and utilization of items of
medical equipment and supplies
to determine whether such items should be made subject to coverage and utilization review criteria, and if
appropriate,
shall develop and apply such criteria to such items.
(4)
Limitation on patient liability
If a
supplier
of
medical equipment and supplies
(as defined in paragraph (5))—
(A)
furnishes an item or service to a beneficiary for which no payment may be made by reason of paragraph (1);
(B)
furnishes an item or service to a beneficiary for which payment is denied in advance under subsection (a)(15); or
(C)
furnishes an item or service to a beneficiary for which payment is denied under
section 1395y(a)(1) of this title
any expenses incurred for items and services furnished to an individual by such a
supplier
not on an assigned basis shall be the responsibility of such
supplier
. The individual shall have no financial responsibility for such expenses and the
supplier
shall refund on a timely basis to the individual (and shall be liable to the individual for) any amounts collected from the individual for such items or services. The provisions of subsection (a)(18) shall apply to refunds required under the previous sentence in the same manner as such provisions apply to refunds under such subsection.
(5)
“Medical equipment and supplies” defined
The term “
medical equipment and supplies
” means—
(A)
durable medical equipment
(as defined in
section 1395x(n) of this title
);
(B)
prosthetic devices
(as described in
section 1395x(s)(8) of this title
);
(C)
orthotics and prosthetics
(as described in
section 1395x(s)(9) of this title
);
(D)
surgical dressings (as described in
section 1395x(s)(5) of this title
);
(E)
items and services related to the
administration
of
intravenous immune globulin
furnished on or after
January 1, 2024
, as described in
section 1395x(zz) of this title
(F)
lymphedema compression
treatment
items (as defined in
section 1395x(mmm) of this title
);
(G)
[5]
such other items as the
Secretary
may determine; and
(G)
for purposes of paragraphs (1) and (3)—
(i)
home dialysis supplies and equipment
(as described in
section 1395x(s)(2)(F) of this title
),
(ii)
immunosuppressive
drugs
(as described in
section 1395x(s)(2)(J) of this title
),
(iii)
therapeutic shoes for diabetics (as described in
section 1395x(s)(12) of this title
),
(iv)
oral
drugs
prescribed for use as an anticancer therapeutic agent (as described in
section 1395x(s)(2)(Q) of this title
), and
(v)
self-administered erythropoetin (as described in
section 1395x(s)(2)(P) of this title
).
(k)
Payment for outpatient therapy services and comprehensive outpatient rehabilitation services
(1)
In general
With respect to services described in section 1395
(a)(8) or 1395
(a)(9) of this title for which payment is determined under this subsection, the payment basis shall be—
(A)
for services furnished during 1998, the amount determined under paragraph (2); or
(B)
for services furnished during a subsequent year, 80 percent of the lesser of—
(i)
the actual charge for the services, or
(ii)
the
applicable fee schedule amount
(as defined in paragraph (3)) for the services.
(2)
Payment in 1998 based upon adjusted reasonable costs
The amount under this paragraph for services is the lesser of—
(A)
the charges imposed for the services, or
(B)
the
adjusted reasonable costs
(as defined in paragraph (4)) for the services,
less 20 percent of the amount of the charges imposed for such services.
(3)
Applicable fee schedule amount
In this subsection, the term “
applicable fee schedule amount
” means, with respect to services furnished in a year, the amount determined under the fee schedule established under
section 1395w–4 of this title
for such services furnished during the year or, if there is no such fee schedule established for such services, the amount determined under the fee schedule established for such comparable services as the
Secretary
specifies.
(4)
Adjusted reasonable costs
In paragraph (2), the term “
adjusted reasonable costs
” means, with respect to any services, reasonable costs determined for such services, reduced by 10 percent. The 10-percent reduction shall not apply to services described in
section 1395l(a)(8)(B) of this title
(relating to services provided by
hospitals)
(5)
Uniform coding
For claims for services submitted on or after
April 1, 1998
, for which the amount of payment is determined under this subsection, the claim shall include a code (or codes) under a uniform coding system specified by the
Secretary
that identifies the services furnished.
(6)
Restraint on billing
The provisions of subparagraphs (A) and (B) of
section 1395u(b)(18) of this title
shall apply to therapy services for which payment is made under this subsection in the same manner as they apply to services provided by a
practitioner
described in
section 1395u(b)(18)(C) of this title
(7)
Adjustment in discount for certain multiple therapy services
In the case of therapy services furnished on or after
April 1, 2013
, and for which payment is made under this subsection pursuant to the
applicable fee schedule amount
(as defined in paragraph (3)), instead of the 25 percent multiple procedure payment reduction specified in the final rule published by the
Secretary
in the Federal Register on
November 29, 2010
, the reduction percentage shall be 50 percent.
(l)
Establishment of fee schedule for ambulance services
(1)
In general
The
Secretary
shall establish a fee schedule for payment for ambulance services whether provided directly by a
supplier
or provider or under arrangement with a provider under this part through a negotiated rulemaking process described in title 5 and in accordance with the requirements of this subsection.
(2)
Considerations
In establishing such fee schedule, the
Secretary
shall—
(A)
establish mechanisms to control increases in expenditures for ambulance services under this part;
(B)
establish definitions for ambulance services which link payments to the type of services provided;
(C)
consider
appropriate
regional and operational differences;
(D)
consider adjustments to payment rates to account for inflation and other relevant factors; and
(E)
phase in the application of the payment rates under the fee schedule in an efficient and fair manner consistent with paragraph (11), except that such phase-in shall provide for full payment of any national mileage rate for ambulance services provided by
suppliers
that are paid by
carriers
in any of the 50
States
where payment by a
carrier
for such services for all such
suppliers
in such
State
did not, prior to the implementation of the fee schedule, include a separate amount for all mileage within the county from which the beneficiary is transported.
(3)
Savings
In establishing such fee schedule, the
Secretary
shall—
(A)
ensure that the aggregate amount of payments made for ambulance services under this part during 2000 does not exceed the aggregate amount of payments which would have been made for such services under this part during such year if the amendments made by section 4531(a) of the
Balanced Budget Act of 1997
continued in effect, except that in making such determination the
Secretary
shall assume an update in such payments for 2002 equal to percentage increase in the consumer price index for all urban consumers (U.S. city average) for the 12-month period ending with June of the previous year reduced in the case of 2002 by 1.0 percentage points;
(B)
set the payment amounts provided under the fee schedule for services furnished in 2001 and each subsequent year at amounts equal to the payment amounts under the fee schedule for services furnished during the previous year, increased, subject to subparagraph (C) and the succeeding sentence of this paragraph, by the percentage increase in the consumer price index for all urban consumers (U.S. city average) for the 12-month period ending with June of the previous year reduced in the case of 2002 by 1.0 percentage points; and
(C)
for 2011 and each subsequent year, after determining the percentage increase under subparagraph (B) for the year, reduce such percentage increase by the productivity adjustment described in
section 1395ww(b)(3)(B)(xi)(II) of this title
The application of subparagraph (C) may result in the percentage increase under subparagraph (B) being less than 0.0 for a year, and may result in payment rates under the fee schedule under this subsection for a year being less than such payment rates for the preceding year.
(4)
Consultation
In establishing the fee schedule for ambulance services under this subsection, the
Secretary
shall consult with various national organizations representing individuals and entities who furnish and regulate ambulance services and share with such organizations relevant data in establishing such schedule.
(5)
Limitation on review
There shall be no administrative or judicial review under
section 1395ff of this title
or otherwise of the amounts established under the fee schedule for ambulance services under this subsection, including matters described in paragraph (2).
(6)
Restraint on billing
The provisions of subparagraphs (A) and (B) of
section 1395u(b)(18) of this title
shall apply to ambulance services for which payment is made under this subsection in the same manner as they apply to services provided by a
practitioner
described in
section 1395u(b)(18)(C) of this title
(7)
Coding system
The
Secretary
may require the claim for any services for which the amount of payment is determined under this subsection to include a code (or codes) under a uniform coding system specified by the
Secretary
that identifies the services furnished.
(8)
Services furnished by critical access hospitals
Notwithstanding any other provision of this subsection, the
Secretary
shall pay 101 percent of the reasonable costs incurred in furnishing ambulance services if such services are furnished—
(A)
by a
critical access hospital
(as defined in
section 1395x(mm)(1) of this title
), or
(B)
by an entity that is owned and operated by a
critical access hospital
but only if the
critical access hospital
or entity is the only provider or
supplier
of ambulance services that is located within a 35-mile drive of such
critical access hospital.
(9)
Transitional assistance for rural providers
In the case of ground ambulance services furnished on or after
July 1, 2001
, and before
January 1, 2004
, for which the transportation originates in a
rural area
(as defined in
section 1395ww(d)(2)(D) of this title
) or in a rural census tract of a metropolitan statistical area (as determined under the most recent modification of the Goldsmith Modification, originally published in the Federal Register on
February 27, 1992
(57 Fed. Reg.
6725
)), the fee schedule established under this subsection shall provide that, with respect to the payment rate for mileage for a trip above 17 miles, and up to 50 miles, the rate otherwise established shall be increased by not less than ½ of the additional payment per mile established for the first 17 miles of such a trip originating in a
rural area.
(10)
Phase-in providing floor using blend of fee schedule and regional fee schedules
In carrying out the phase-in under paragraph (2)(E) for each level of ground service furnished in a year, the portion of the payment amount that is based on the fee schedule shall be the greater of the amount determined under such fee schedule (without regard to this paragraph) or the following blended rate of the fee schedule under paragraph (1) and of a regional fee schedule for the region involved:
(A)
For 2004 (for services furnished on or after
July 1, 2004
), the blended rate shall be based 20 percent on the fee schedule under paragraph (1) and 80 percent on the regional fee schedule.
(B)
For 2005, the blended rate shall be based 40 percent on the fee schedule under paragraph (1) and 60 percent on the regional fee schedule.
(C)
For 2006, the blended rate shall be based 60 percent on the fee schedule under paragraph (1) and 40 percent on the regional fee schedule.
(D)
For 2007, 2008, and 2009, the blended rate shall be based 80 percent on the fee schedule under paragraph (1) and 20 percent on the regional fee schedule.
(E)
For 2010 and each succeeding year, the blended rate shall be based 100 percent on the fee schedule under paragraph (1).
For purposes of this paragraph, the
Secretary
shall establish a regional fee schedule for each of the nine census divisions (referred to in
section 1395ww(d)(2) of this title
) using the methodology (used in establishing the fee schedule under paragraph (1)) to calculate a regional conversion factor and a regional mileage payment rate and using the same payment adjustments and the same relative value units as used in the fee schedule under such paragraph.
(11)
Adjustment in payment for certain long trips
In the case of ground ambulance services furnished on or after
July 1, 2004
, and before
January 1, 2009
, regardless of where the transportation originates, the fee schedule established under this subsection shall provide that, with respect to the payment rate for mileage for a trip above 50 miles the per mile rate otherwise established shall be increased by ¼ of the payment per mile otherwise applicable to miles in excess of 50 miles in such trip.
(12)
Assistance for rural providers furnishing services in low population density areas
(A)
In general
In the case of ground ambulance services furnished on or after
July 1, 2004
, and before
January 1, 2028
, for which the transportation originates in a qualified
rural area
(identified under subparagraph (B)(iii)), the
Secretary
shall provide for a percent increase in the base rate of the fee schedule for a trip established under this subsection. In establishing such percent increase, the
Secretary
shall estimate the average cost per trip for such services (not taking into account mileage) in the lowest quartile as compared to the average cost per trip for such services (not taking into account mileage) in the highest quartile of all rural county populations.
(B)
Identification of qualified rural areas
(i)
Determination of population density in area
Based upon data from the
United States
decennial census for the year 2000, the
Secretary
shall determine, for each
rural area
, the population density for that area.
(ii)
Ranking of areas
The
Secretary
shall rank each such area based on such population density.
(iii)
Identification of qualified rural areas
The
Secretary
shall identify those areas (in subparagraph (A) referred to as “qualified
rural areas
”) with the lowest population densities that represent, if each such area were weighted by the population of such area (as used in computing such population densities), an aggregate total of 25 percent of the total of the population of all such areas.
(iv)
Rural area
For purposes of this paragraph, the term “
rural area
” has the meaning given such term in
section 1395ww(d)(2)(D) of this title
. If feasible, the
Secretary
shall treat a rural census tract of a metropolitan statistical area (as determined under the most recent modification of the Goldsmith Modification, originally published in the Federal Register on
February 27, 1992
(57 Fed. Reg.
6725
) as a
rural area
for purposes of this paragraph.
(v)
Judicial review
There shall be no administrative or judicial review under section
1395ff
1395oo
of this title, or otherwise, respecting the identification of an area under this subparagraph.
(13)
Temporary increase for ground ambulance services
(A)
In general
After computing the rates with respect to ground ambulance services under the other applicable provisions of this subsection, in the case of such services furnished on or after
July 1, 2004
, and before
January 1, 2007
, and for such services furnished on or after
July 1, 2008
, and before
January 1, 2028
,,
for which the transportation originates in—
(i)
rural area
described in paragraph (9) or in a rural census tract described in such paragraph, the fee schedule established under this section shall provide that the rate for the service otherwise established, after the application of any increase under paragraphs (11) and (12), shall be increased by 2 percent (or 3 percent if such service is furnished on or after
July 1, 2008
, and before
January 1, 2028
); and
(ii)
an area not described in clause (i), the fee schedule established under this subsection shall provide that the rate for the service otherwise established, after the application of any increase under paragraph (11), shall be increased by 1 percent (or 2 percent if such service is furnished on or after
July 1, 2008
, and before
January 1, 2028
).
(B)
Application of increased payments after applicable period
The increased payments under subparagraph (A) shall not be taken into account in calculating payments for services furnished after the
applicable period
specified in such subparagraph.
(14)
Providing appropriate coverage of rural air ambulance services
(A)
In general
The
regulations
described in
section 1395x(s)(7) of this title
shall provide, to the extent that any ambulance services (whether ground or air) may be covered under such section, that a
rural air ambulance service
(as defined in subparagraph (C)) is reimbursed under this subsection at the air ambulance rate if the air ambulance service—
(i)
is reasonable and necessary based on the health condition of the individual being transported at or immediately prior to the time of the transport; and
(ii)
complies with equipment and crew requirements established by the
Secretary
(B)
Satisfaction of requirement of medically necessary
The requirement of subparagraph (A)(i) is deemed to be met for a
rural air ambulance service
if—
(i)
subject to subparagraph (D), such service is requested by a
physician
or other qualified medical personnel (as specified by the
Secretary)
who certifies or reasonably determines that the individual’s condition is such that the time needed to transport the individual by land or the instability of transportation by land poses a threat to the individual’s survival or seriously endangers the individual’s health; or
(ii)
such service is furnished pursuant to a protocol that is established by a
State
or regional emergency medical service (EMS) agency and recognized or approved by the
Secretary
under which the use of an air ambulance is recommended, if such agency does not have an ownership interest in the entity furnishing such service.
(C)
Rural air ambulance service defined
For purposes of this paragraph, the term “
rural air ambulance service
” means fixed wing and rotary wing air ambulance service in which the point of pick up of the individual occurs in a
rural area
(as defined in
section 1395ww(d)(2)(D) of this title
) or in a rural census tract of a metropolitan statistical area (as determined under the most recent modification of the Goldsmith Modification, originally published in the Federal Register on
February 27, 1992
(57 Fed. Reg.
6725
)).
(D)
Limitation
(i)
In general
Subparagraph (B)(i) shall not apply if there is a financial or employment relationship between the
person
requesting the
rural air ambulance service
and the entity furnishing the ambulance service, or an entity under common ownership with the entity furnishing the air ambulance service, or a financial relationship between an immediate family member of such requester and such an entity.
(ii)
Exception
Where a
hospital
and the entity furnishing
rural air ambulance services
are under common ownership, clause (i) shall not apply to remuneration (through employment or other relationship) by the
hospital
of the requester or immediate family member if the remuneration is for provider-based
physician
services furnished in a
hospital
(as described in
section 1395xx of this title
) which are reimbursed under part A and the amount of the remuneration is unrelated directly or indirectly to the provision of
rural air ambulance services.
(15)
Payment adjustment for non-emergency ambulance transports for ESRD beneficiaries
The fee schedule amount otherwise applicable under the preceding provisions of this subsection shall be reduced by 10 percent for ambulance services furnished during the period beginning on
October 1, 2013
, and ending on
September 30, 2018
, and by 23 percent for such services furnished on or after
October 1, 2018
, consisting of non-emergency basic life support services involving transport of an individual with end-stage renal disease for renal dialysis services (as described in
section 1395rr(b)(14)(B) of this title
) furnished other than on an emergency basis by a provider of services or a renal dialysis facility.
(16)
Prior authorization for repetitive scheduled non-emergent ambulance transports
(A)
In general
Beginning
January 1, 2017
, if the expansion to all
States
of the model of prior authorization described in paragraph (2) of section 515(a) of the
Medicare
Access and CHIP Reauthorization Act of 2015 meets the requirements described in paragraphs (1) through (3) of
section 1315a(c) of this title
, then the
Secretary
shall expand such model to all
States.
(B)
Funding
The
Secretary
shall use funds made available under
section 1395ddd(h)(10) of this title
to carry out this paragraph.
(C)
Clarification regarding budget neutrality
Nothing in this paragraph may be construed to limit or modify the application of
section 1315a(b)(3)(B) of this title
to models described in such section, including with respect to the model described in subparagraph (A) and expanded beginning on
January 1, 2017
, under such subparagraph.
(17)
Submission of cost and other information
(A)
Development of data collection system
The
Secretary
shall develop a data collection system (which may include use of a cost survey) to collect cost, revenue, utilization, and other information determined
appropriate
by the
Secretary
with respect to providers of services (in this paragraph referred to as “providers”) and
suppliers
of ground ambulance services. Such system shall be designed to collect information—
(i)
needed to evaluate the extent to which reported costs relate to payment rates under this subsection;
(ii)
on the utilization of capital equipment and ambulance capacity, including information consistent with the type of information described in
section 1320a(a) of this title
; and
(iii)
on different types of ground ambulance services furnished in different geographic locations, including
rural areas
and low population density areas described in paragraph (12).
(B)
Specification of data collection system
(i)
In general
The
Secretary
shall—
(I)
not later than
December 31, 2019
, specify the data collection system under subparagraph (A); and
(II)
identify the providers and
suppliers
of ground ambulance services that would be required to submit information under such data collection system, including the representative sample described in clause (ii).
(ii)
Determination of representative sample
(I)
In general
Not later than
December 31, 2019
, with respect to the data collection for the first year under such system, and for each subsequent year through 2024, the
Secretary
shall determine a representative sample to submit information under the data collection system.
(II)
Requirements
The sample under subclause (I) shall be representative of the different types of providers and
suppliers
of ground ambulance services (such as those providers and
suppliers
that are part of an emergency service or part of a government organization) and the geographic locations in which ground ambulance services are furnished (such as urban, rural, and low population density areas).
(III)
Limitation
The
Secretary
shall not include an individual provider or
supplier
of ground ambulance services in the sample under subclause (I) in 2 consecutive years, to the extent practicable.
(C)
Reporting of cost information
For each year, a provider or
supplier
of ground ambulance services identified by the
Secretary
under subparagraph (B)(i)(II) as being required to submit information under the data collection system with respect to a period for the year shall submit to the
Secretary
information specified under the system. Such information shall be submitted in a form and manner, and at a time, specified by the
Secretary
for purposes of this subparagraph.
(D)
Payment reduction for failure to report
(i)
In general
Beginning
January 1, 2022
, subject to clause (ii), a 10 percent reduction to payments under this subsection shall be made for the
applicable period
(as defined in clause (ii)) to a provider or
supplier
of ground ambulance services that—
(I)
is required to submit information under the data collection system with respect to a period under subparagraph (C); and
(II)
does not sufficiently submit such information, as determined by the
Secretary
(ii)
Applicable period defined
For purposes of clause (i), the term “
applicable period
” means, with respect to a provider or
supplier
of ground ambulance services, a year specified by the
Secretary
not more than 2 years after the end of the period with respect to which the
Secretary
has made a determination under clause (i)(II) that the provider or
supplier
of ground ambulance services failed to sufficiently submit information under the data collection system.
(iii)
Hardship exemption
The
Secretary
may exempt a provider or
supplier
from the payment reduction under clause (i) with respect to an
applicable period
in the event of significant hardship, such as a natural disaster, bankruptcy, or other similar situation that the
Secretary
determines interfered with the ability of the provider or
supplier
of ground ambulance services to submit such information in a timely manner for the specified period.
(iv)
Informal review
The
Secretary
shall establish a process under which a provider or
supplier
of ground ambulance services may seek an informal review of a determination that the provider or
supplier
is subject to the payment reduction under clause (i).
(E)
Ongoing data collection
(i)
Revision of data collection system
The
Secretary
may, as the
Secretary
determines
appropriate
and, if available, taking into consideration the report (or reports) under subparagraph (F), revise the data collection system under subparagraph (A).
(ii)
Subsequent data collection
In order to continue to evaluate the extent to which reported costs relate to payment rates under this subsection and for other purposes the
Secretary
deems
appropriate
, the
Secretary
shall require providers and
suppliers
of ground ambulance services to submit information for years after 2024 as the
Secretary
determines
appropriate,
but in no case less often than once every 3 years.
(F)
Ground ambulance data collection system study
(i)
In general
Not later than the second June 15th following the date on which the
Secretary
transmits data for the first representative sample of providers and
suppliers
of ground ambulance services to the
Medicare
Payment Advisory Commission, and as determined necessary by such Commission thereafter,,
such Commission shall assess, and submit to
Congress
a report on, information submitted by providers and
suppliers
of ground ambulance services through the data collection system under subparagraph (A), the adequacy of payments for ground ambulance services under this subsection, and geographic variations in the cost of furnishing such services.
(ii)
Contents
A report under clause (i) shall contain the following:
(I)
An analysis of information submitted through the data collection system.
(II)
An analysis of any burden on providers and
suppliers
of ground ambulance services associated with the data collection system.
(III)
A recommendation as to whether information should continue to be submitted through such data collection system or if such system should be revised under subparagraph (E)(i).
(IV)
Other information determined
appropriate
by the Commission.
(G)
Public availability
The
Secretary
shall post information on the results of the data collection under this paragraph on the Internet website of the Centers for
Medicare
& Medicaid Services, as determined
appropriate
by the
Secretary.
(H)
Implementation
The
Secretary
shall implement this paragraph through notice and comment rulemaking.
(I)
Administration
Chapter 35 of title 44 shall not apply to the collection of information required under this subsection.
(J)
Limitations on review
There shall be no administrative or judicial review under
section 1395ff of this title
, section 1395oo of this title, or otherwise of the data collection system or identification of respondents under this paragraph.
(K)
Funding for implementation
For purposes of carrying out subparagraph (A), the
Secretary
shall provide for the transfer, from the Federal Supplementary Medical Insurance Trust Fund under
section 1395t of this title
, of $15,000,000 to the Centers for
Medicare
& Medicaid Services Program Management Account for fiscal year 2018. Amounts transferred under this subparagraph shall remain available until expended.
(m)
Payment for telehealth services
(1)
In general
Subject to paragraphs (8) and (9), the
Secretary
shall pay for
telehealth services
that are furnished via a
telecommunications system
by a
physician
(as defined in
section 1395x(r) of this title
) or a
practitioner
(as defined in paragraph (4)(E)) to an
eligible telehealth individual
enrolled under this part notwithstanding that the individual
physician
or
practitioner
providing the
telehealth service
is not at the same location as the beneficiary. For purposes of the preceding sentence, in the case of any Federal telemedicine demonstration program conducted in Alaska or Hawaii, the term
“telecommunications system”
includes store-and-forward technologies that provide for the asynchronous transmission of health care information in single or multimedia formats.
(2)
Payment amount
(A)
Distant site
Subject to paragraph (8), the
Secretary
shall pay to a
physician
or
practitioner
located at a
distant site
that furnishes a
telehealth service
to an
eligible telehealth individual
an amount equal to the amount that such
physician
or
practitioner
would have been paid under this subchapter had such service been furnished without the use of a
telecommunications system.
(B)
Facility fee for originating site
(i)
In general
Subject to clauses (ii) and (iii) and paragraph (6)(C), with respect to a
telehealth service
, subject to section 1395
(a)(1)(U) of this title, there shall be paid to the
originating site
a facility fee equal to—
(I)
for the period beginning on
October 1, 2001
, and ending on
December 31, 2001
, and for 2002, $20; and
(II)
for a subsequent year, the facility fee specified in subclause (I) or this subclause for the preceding year increased by the
percentage increase in the MEI
(as defined in
section 1395u(i)(3) of this title
) for such subsequent year.
(ii)
No facility fee if originating site is the home
No facility fee shall be paid under this subparagraph to an
originating site
described in paragraph (4)(C)(ii)(X).
(iii)
No facility fee for new sites
In the case that the emergency period described in
section 1320b–5(g)(1)(B) of this title
ends before
December 31, 2024
, with respect to
telehealth services
identified in paragraph (4)(F)(i) as of
March 15, 2022
, that are furnished during the period beginning on the first day after the end of such emergency period and ending
December 31, 2027
, a facility fee shall only be paid under this subparagraph to an
originating site
that is described in paragraph (4)(C)(ii) (other than subclause (X) of such paragraph).
(C)
Telepresenter not required
Nothing in this subsection shall be construed as requiring an
eligible telehealth individual
to be presented by a
physician
or
practitioner
at the
originating site
for the furnishing of a service via a
telecommunications system,
unless it is medically necessary (as determined by the
physician
or
practitioner
at the
distant site)
(3)
Limitation on beneficiary charges
(A)
Physician and practitioner
The provisions of
section 1395w–4(g) of this title
and subparagraphs (A) and (B) of
section 1395u(b)(18) of this title
shall apply to a
physician
or
practitioner
receiving payment under this subsection in the same manner as they apply to
physicians
or
practitioners
under such sections.
(B)
Originating site
The provisions of
section 1395u(b)(18) of this title
shall apply to
originating sites
receiving a facility fee in the same manner as they apply to
practitioners
under such section.
(4)
Definitions
For purposes of this subsection:
(A)
Distant site
Subject to paragraph (8), the term “
distant site
” means the site at which the
physician
or
practitioner
is located at the time the service is provided via a
telecommunications system.
(B)
Eligible telehealth individual
The term “
eligible telehealth individual
” means an individual enrolled under this part who receives a
telehealth service
furnished at an
originating site.
(C)
Originating site
(i)
In general
Except as provided in clause (iii) and paragraphs (5), (6), and (7), the term “
originating site
” means only those sites described in clause (ii) at which the
eligible telehealth individual
is located at the time the service is furnished via a
telecommunications system
and only if such site is located—
(I)
in an area that is designated as a rural health professional shortage area under
section 254e(a)(1)(A) of this title
(II)
in a county that is not included in a Metropolitan Statistical Area; or
(III)
from an entity that participates in a Federal telemedicine demonstration project that has been approved by (or receives funding from) the
Secretary
of Health and Human Services as of
December 31, 2000
(ii)
Sites described
The sites referred to in clause (i) are the following sites:
(I)
The office of a
physician
or
practitioner
(II)
critical access hospital
(as defined in
section 1395x(mm)(1) of this title
).
(III)
rural health clinic
(as defined in
section 1395x(aa)(2) of this title
).
(IV)
Federally qualified health center
(as defined in
section 1395x(aa)(4) of this title
).
(V)
hospital
(as defined in
section 1395x(e) of this title
).
(VI)
hospital
-based or
critical access hospital
-based renal dialysis center (including satellites).
(VII)
skilled nursing facility
(as defined in
section 1395i–3(a) of this title
).
(VIII)
A community mental health center (as defined in
section 1395x(ff)(3)(B) of this title
).
(IX)
A renal dialysis facility, but only for purposes of
section 1395rr(b)(3)(B) of this title
(X)
The home of an individual, but only for purposes of
section 1395rr(b)(3)(B) of this title
or
telehealth services
described in paragraph (7).
(XI)
rural emergency hospital
(as defined in
section 1395x(kkk)(2) of this title
).
(iii)
Expanding access to telehealth services
In the case that the emergency period described in
section 1320b–5(g)(1)(B) of this title
ends before
December 31, 2024
, with respect to
telehealth services
identified in subparagraph (F)(i) as of
March 15, 2022
, that are furnished during the period beginning on the first day after the end of such emergency period and ending on
December 31, 2027
, the term
“originating site”
means any site in the
United States
at which the
eligible telehealth individual
is located at the time the service is furnished via a
telecommunications system,
including the home of an individual.
(D)
Physician
The term “
physician
” has the meaning given that term in
section 1395x(r) of this title
(E)
Practitioner
The term “
practitioner
” has the meaning given that term in
section 1395u(b)(18)(C) of this title
and, in the case that the emergency period described in
section 1320b–5(g)(1)(B) of this title
ends before
December 31, 2024
, for the period beginning on the first day after the end of such emergency period and ending on
December 31, 2027
, shall include a qualified occupational therapist (as such term is used in
section 1395x(g) of this title
), a qualified physical therapist (as such term is used in
section 1395x(p) of this title
), a qualified speech-language pathologist (as defined in section 1395x(ll)(4)(A) of this title), and a qualified audiologist (as defined in section 1395x(ll)(4)(B) of this title).
(F)
Telehealth service
(i)
In general
Subject to paragraph (8), the term “
telehealth service
” means professional consultations, office visits, and office psychiatry services (identified as of
July 1, 2000
, by HCPCS codes 99241–99275, 99201–99215, 90804–90809, and 90862 (and as subsequently modified by the
Secretary)
), and any additional service specified by the
Secretary.
(ii)
Yearly update
The
Secretary
shall establish a process that provides, on an annual basis, for the addition or deletion of services (and HCPCS codes), as
appropriate
, to those specified in clause (i) for authorized payment under paragraph (1).
(5)
Treatment of home dialysis monthly ESRD-related visit
The geographic requirements described in paragraph (4)(C)(i) shall not apply with respect to
telehealth services
furnished on or after
January 1, 2019
, for purposes of
section 1395rr(b)(3)(B) of this title
, at an
originating site
described in subclause (VI), (IX), or (X) of paragraph (4)(C)(ii).
(6)
Treatment of stroke telehealth services
(A)
Non-application of originating site requirements
The requirements described in paragraph (4)(C) shall not apply with respect to
telehealth services
furnished on or after
January 1, 2019
, for purposes of diagnosis, evaluation, or
treatment
of symptoms of an acute stroke, as determined by the
Secretary.
(B)
Inclusion of certain sites
With respect to
telehealth services
described in subparagraph (A), the term
“originating site”
shall include any
hospital
(as defined in
section 1395x(e) of this title
) or
critical access hospital
(as defined in
section 1395x(mm)(1) of this title
), any mobile stroke unit (as defined by the
Secretary)
, or any other site determined
appropriate
by the
Secretary,
at which the
eligible telehealth individual
is located at the time the service is furnished via a
telecommunications system.
(C)
No originating site facility fee for new sites
No facility fee shall be paid under paragraph (2)(B) to an
originating site
with respect to a
telehealth service
described in subparagraph (A) if the
originating site
does not otherwise meet the requirements for an
originating site
under paragraph (4)(C).
(7)
Treatment of substance use disorder services and mental health services furnished through telehealth
(A)
In general
The geographic requirements described in paragraph (4)(C)(i) shall not apply with respect to
telehealth services
furnished on or after
July 1, 2019
, to an
eligible telehealth individual
with a substance use disorder diagnosis for purposes of
treatment
of such disorder or co-occurring mental health disorder, as determined by the
Secretary,
or, on or after the first day after the end of the emergency period described in
section 1320b–5(g)(1)(B) of this title
, subject to subparagraph (B), to an
eligible telehealth individual
for purposes of diagnosis, evaluation, or
treatment
of a mental health disorder, as determined by the
Secretary,
at an
originating site
described in paragraph (4)(C)(ii) (other than an
originating site
described in subclause (IX) of such paragraph) or, for the period for which clause (iii) of paragraph (4)(C) applies, at any site described in such clause.
(B)
Requirements for mental health services furnished through telehealth
(i)
In general
Payment may not be made under this paragraph for
telehealth services
furnished on or after
January 1, 2028
, by a
physician
or
practitioner
to an
eligible telehealth individual
for purposes of diagnosis, evaluation, or
treatment
of a mental health disorder unless such
physician
or
practitioner
furnishes an item or service in
person,
without the use of telehealth, for which payment is made under this subchapter (or would have been made under this subchapter if such individual were entitled to, or enrolled for, benefits under this subchapter at the time such item or service is furnished)—
(I)
within the 6-month period prior to the first time such
physician
or
practitioner
furnishes such a
telehealth service
to the
eligible telehealth individual
; and
(II)
during subsequent periods in which such
physician
or
practitioner
furnishes such
telehealth services
to the
eligible telehealth individual
, at such times as the
Secretary
determines
appropriate.
(ii)
Clarification
This subparagraph shall not apply if payment would otherwise be allowed—
(I)
under this paragraph (with respect to
telehealth services
furnished to an
eligible telehealth individual
with a substance use disorder diagnosis for purposes of
treatment
of such disorder or co-occurring mental health disorder); or
(II)
under this subsection without application of this paragraph.
(8)
Enhancing telehealth services for Federally qualified health centers and rural health clinics
(A)
In general
During the emergency period described in
section 1320b–5(g)(1)(B) of this title
and, in the case that such emergency period ends before
December 31, 2024
, during the period beginning on the first day after the end of such emergency period and ending on
December 31, 2027
(i)
the
Secretary
shall pay for
telehealth services
that are furnished via a
telecommunications system
by a
Federally qualified health center
or a
rural health clinic
to an
eligible telehealth individual
enrolled under this part notwithstanding that the
Federally qualified health center
or rural clinic providing the
telehealth service
is not at the same location as the beneficiary;
(ii)
the amount of payment to a
Federally qualified health center
or
rural health clinic
that serves as a
distant site
for such a
telehealth service
shall be determined under subparagraph (B); and
(iii)
for purposes of this subsection—
(I)
the term “
distant site
” includes a
Federally qualified health center
or
rural health clinic
that furnishes a
telehealth service
to an
eligible telehealth individual
; and
(II)
the term “
telehealth services
” includes a
rural health clinic
service or
Federally qualified health center
service that is furnished using telehealth to the extent that payment codes corresponding to services identified by the
Secretary
under clause (i) or (ii) of paragraph (4)(F) are listed on the corresponding claim for such
rural health clinic
service or
Federally qualified health center
service.
(B)
Special payment rule
(i)
In general
The
Secretary
shall develop and implement payment methods that apply under this subsection to a
Federally qualified health center
or
rural health clinic
that serves as a
distant site
that furnishes a
telehealth service
to an
eligible telehealth individual
during the periods for which subparagraph (A) applies. Such payment methods shall be based on payment rates that are similar to the national average payment rates for comparable
telehealth services
under the
physician
fee schedule under
section 1395w–4 of this title
. Notwithstanding any other provision of law, the
Secretary
may implement such payment methods through program instruction or otherwise.
(ii)
Exclusion from FQHC PPS calculation and RHC air calculation
Costs associated with
telehealth services
shall not be used to determine the amount of payment for
Federally qualified health center services
under the prospective payment system under subsection (o) or for
rural health clinic services
under the methodology for all-inclusive rates (established by the
Secretary)
under
section 1395l(a)(3) of this title
(9)
Treatment of telehealth services furnished using audio-only telecommunications technology
In the case that the emergency period described in
section 1320b–5(g)(1)(B) of this title
ends before
December 31, 2024
, the
Secretary
shall continue to provide coverage and payment under this part for
telehealth services
identified in paragraph (4)(F)(i) as of
March 15, 2022
, that are furnished via an audio-only communications system during the period beginning on the first day after the end of such emergency period and ending on
December 31, 2027
. For purposes of the previous sentence, the term
“telehealth service”
means a
telehealth service
identified as of
March 15, 2022
, by a HCPCS code (and any succeeding codes) for which the
Secretary
has not applied the requirements of paragraph (1) and the first sentence of section
410.78(a)(3)
of title 42, Code of Federal Regulations, during such emergency period.
(10)
Required use of modifiers in certain instances
Not later than
January 1, 2027
, the
Secretary
shall establish requirements to include one or more codes or modifiers, as determined
appropriate
by the
Secretary,
in the case of—
(A)
claims for
telehealth services
under this subsection that are furnished through a telehealth virtual platform—
(i)
by a
physician
or
practitioner
that contracts with an entity that owns such virtual platform; or
(ii)
for which a
physician
or
practitioner
has a payment arrangement with an entity for use of such virtual platform; and
(B)
claims for
telehealth services
under this subsection that are furnished incident to a
physician’
s or
practitioner’
s professional service.
(n)
Authority to modify or eliminate coverage of certain preventive services
Notwithstanding any other provision of this subchapter, effective beginning on
January 1, 2010
, if the
Secretary
determines
appropriate,
the
Secretary
may—
(1)
modify—
(A)
the coverage of any preventive service described in subparagraph (A) of
section 1395x(ddd)(3) of this title
to the extent that such modification is consistent with the recommendations of the United States
Preventive Services
Task Force; and
(B)
the services included in the
initial preventive physical examination
described in subparagraph (B) of such section; and
(2)
provide that no payment shall be made under this subchapter for a preventive service described in subparagraph (A) of such section that has not received a grade of A, B, C, or I by such Task Force.
(o)
Development and implementation of prospective payment system
(1)
Development
(A)
In general
The
Secretary
shall develop a prospective payment system for payment for
Federally qualified health center services
furnished by
Federally qualified health centers
under this subchapter. Such system shall include a process for appropriately describing the services furnished by
Federally qualified health centers
and shall establish payment rates for specific payment codes based on such
appropriate
descriptions of services. Such system shall be established to take into account the type, intensity, and duration of services furnished by
Federally qualified health centers.
Such system may include adjustments, including geographic adjustments, determined
appropriate
by the
Secretary.
(B)
Collection of data and evaluation
By not later than
January 1, 2011
, the
Secretary
shall require
Federally qualified health centers
to submit to the
Secretary
such information as the
Secretary
may require in order to develop and implement the prospective payment system under this subsection, including the reporting of services using HCPCS codes.
(2)
Implementation
(A)
In general
Notwithstanding
section 1395l(a)(3)(A) of this title
, the
Secretary
shall provide, for cost reporting periods beginning on or after
October 1, 2014
, for payments of prospective payment rates for
Federally qualified health center services
furnished by
Federally qualified health centers
under this subchapter in accordance with the prospective payment system developed by the
Secretary
under paragraph (1).
(B)
Payments
(i)
Initial payments
The
Secretary
shall implement such prospective payment system so that the estimated aggregate amount of prospective payment rates (determined prior to the application of
section 1395l(a)(1)(Z) of this title
) under this subchapter for
Federally qualified health center services
in the first year that such system is implemented is equal to 100 percent of the estimated amount of reasonable costs (determined without the application of a per visit payment limit or productivity screen and prior to the application of
section 1395cc(a)(2)(A)(ii) of this title
) that would have occurred for such services under this subchapter in such year if the system had not been implemented.
(ii)
Payments in subsequent years
Payment rates in years after the year of implementation of such system shall be the payment rates in the previous year increased—
(I)
in the first year after implementation of such system, by the
percentage increase in the MEI
(as defined in
section 1395u(i)(3) of this title
) for the year involved; and
(II)
in subsequent years, by the percentage increase in a market basket of
Federally qualified health center
goods and services as promulgated through
regulations,
or if such an index is not available, by the
percentage increase in the MEI
(as defined in
section 1395u(i)(3) of this title
) for the year involved.
(C)
Preparation for PPS implementation
Notwithstanding any other provision of law, the
Secretary
may establish and implement by program instruction or otherwise the payment codes to be used under the prospective payment system under this section.
(3)
Additional payments for certain FQHCS with physicians or other practitioners receiving data 2000 waivers
(A)
In general
In the case of a
Federally qualified health center
with respect to which, beginning on or after
January 1, 2019
Federally qualified health center services
(as defined in
section 1395x(aa)(3) of this title
) are furnished for the
treatment
of opioid use disorder by a
physician
or
practitioner
who meets the requirements described in subparagraph (C), the
Secretary
shall, subject to availability of funds under subparagraph (D), make a payment (at such time and in such manner as specified by the
Secretary)
to such
Federally qualified health center
after receiving and approving an application submitted by such
Federally qualified health center
under subparagraph (B). Such a payment shall be in an amount determined by the
Secretary,
based on an estimate of the average costs of training for purposes of receiving a waiver described in subparagraph (C)(ii). Such a payment may be made only one time with respect to each such
physician
or
practitioner.
(B)
Application
In order to receive a payment described in subparagraph (A), a
Federally qualified health center
shall submit to the
Secretary
an application for such a payment at such time, in such manner, and containing such information as specified by the
Secretary.
Federally qualified health center
may apply for such a payment for each
physician
or
practitioner
described in subparagraph (A) furnishing services described in such subparagraph at such center.
(C)
Requirements
For purposes of subparagraph (A), the requirements described in this subparagraph, with respect to a
physician
or
practitioner
, are the following:
(i)
The
physician
or
practitioner
is employed by or working under contract with a
Federally qualified health center
described in subparagraph (A) that submits an application under subparagraph (B).
(ii)
The
physician
or
practitioner
first begins prescribing narcotic
drugs
in schedule III, IV, or V of
section 812 of title 21
for the purpose of maintenance or detoxification
treatment
on or after
January 1, 2021
(D)
Funding
For purposes of making payments under this paragraph, there are appropriated, out of amounts in the Treasury not otherwise appropriated, $6,000,000, which shall remain available until expended.
(4)
Payment for certain services furnished by Federally qualified health centers
(A)
Attending physician services for hospice patients
In the case of services described in
section 1395d(d)(2)(A)(ii) of this title
furnished on or after
January 1, 2022
, by an attending
physician
(as defined in
section 1395x(dd)(3)(B) of this title
, other than a
physician
or
practitioner
who is employed by a
hospice program)
who is employed by or working under contract with a
Federally qualified health center,
Federally qualified health center
shall be paid for such services under the prospective payment system under this subsection.
(B)
Mental health visits furnished via telecommunications technology
In the case of mental health visits furnished via interactive, real-time, audio and video telecommunications technology or audio-only interactions, the in-
person
mental health visit requirements established under section
405.2463(b)(3)
of title 42 of the Code of Federal Regulations (or a successor regulation) shall not apply prior to
January 1, 2028
(5)
Special payment rule for intensive outpatient services
(A)
In general
In the case of
intensive outpatient services
furnished by a
Federally qualified health center
, the payment amount for such services shall be equal to the amount that would have been paid under this subchapter for such services had such services been covered OPD services furnished by a
hospital.
(B)
Exclusion
Costs associated with
intensive outpatient services
shall not be used to determine the amount of payment for
Federally qualified health center services
under the prospective payment system under this subsection.
(p)
Quality incentives to promote patient safety and public health in computed tomography
(1)
Quality incentives
In the case of an
applicable computed tomography service
(as defined in paragraph (2)) for which payment is made under an
applicable payment system
(as defined in paragraph (3)) and that is furnished on or after
January 1, 2016
, using equipment that is
not consistent with the CT equipment standard
(described in paragraph (4)), the payment amount for such service shall be reduced by the
applicable percentage
(as defined in paragraph (5)).
(2)
Applicable computed tomography services defined
In this subsection, the term “
applicable computed tomography service
” means a service billed using diagnostic radiological imaging codes for computed tomography (identified as of
January 1, 2014
, by HCPCS codes 70450–70498, 71250–71275, 72125–72133, 72191–72194, 73200–73206, 73700–73706, 74150–74178, 74261–74263, and 75571–75574 (and any succeeding codes).
[6]
(3)
Applicable payment system defined
In this subsection, the term “
applicable payment system
” means the following:
(A)
The technical component and the technical component of the global fee under the fee schedule established under
section 1395w–4(b) of this title
(B)
The prospective payment system for
hospital
outpatient department services under
section 1395l(t) of this title
(4)
Consistency with CT equipment standard
In this subsection, the term “
not consistent with the CT equipment standard
” means, with respect to an
applicable computed tomography service,
that the service was furnished using equipment that does not meet each of the attributes of the National Electrical Manufacturers Association (NEMA) Standard XR–29–2013, entitled “Standard Attributes on CT Equipment Related to Dose Optimization and Management”. Through rulemaking, the
Secretary
may apply successor standards.
(5)
Applicable percentage defined
In this subsection, the term “
applicable percentage
” means—
(A)
for 2016, 5 percent; and
(B)
for 2017 and subsequent years, 15 percent.
(6)
Implementation
(A)
Information
The
Secretary
shall require that information be provided and attested to by a
supplier
and a
hospital
outpatient department that indicates whether an
applicable computed tomography service
was furnished that was
not consistent with the CT equipment standard
(described in paragraph (4)). Such information may be included on a claim and may be a modifier. Such information shall be verified, as
appropriate,
as part of the periodic accreditation of
suppliers
under subsection (e) and
hospitals
under
section 1395bb(a) of this title
(B)
Administration
Chapter 35 of title 44 shall not apply to information described in subparagraph (A).
(q)
Recognizing appropriate use criteria for certain imaging services
(1)
Program established
(A)
In general
The
Secretary
shall establish a program to promote the use of
appropriate use criteria
(as defined in subparagraph (B)) for
applicable imaging services
(as defined in subparagraph (C)) furnished in an
applicable setting
(as defined in subparagraph (D)) by
ordering professionals
and
furnishing professionals
(as defined in subparagraphs (E) and (F), respectively).
(B)
Appropriate use criteria defined
In this subsection, the term “
appropriate use criteria
” means criteria, only developed or endorsed by national professional medical specialty societies or other provider-led entities, to assist
ordering professionals
and
furnishing professionals
in making the most appropriate
treatment
decision for a specific clinical condition for an individual. To the extent feasible, such criteria shall be evidence-based.
(C)
Applicable imaging service defined
In this subsection, the term “
applicable imaging service
” means an advanced diagnostic imaging service (as defined in subsection (e)(1)(B)) for which the
Secretary
determines—
(i)
one or more applicable
appropriate use criteria
specified under paragraph (2) apply;
(ii)
there are one or more qualified clinical decision support mechanisms listed under paragraph (3)(C); and
(iii)
one or more of such mechanisms is available free of charge.
(D)
Applicable setting defined
In this subsection, the term “
applicable setting
” means a
physician’
s office, a
hospital
outpatient department (including an emergency department), an ambulatory surgical center, and any other provider-led outpatient setting determined
appropriate
by the
Secretary.
(E)
Ordering professional defined
In this subsection, the term “
ordering professional
” means a
physician
(as defined in
section 1395x(r) of this title
) or a
practitioner
described in
section 1395u(b)(18)(C) of this title
who orders an
applicable imaging service.
(F)
Furnishing professional defined
In this subsection, the term “
furnishing professional
” means a
physician
(as defined in
section 1395x(r) of this title
) or a
practitioner
described in
section 1395u(b)(18)(C) of this title
who furnishes an
applicable imaging service.
(2)
Establishment of applicable appropriate use criteria
(A)
In general
Not later than
November 15, 2015
, the
Secretary
shall through rulemaking, and in consultation with
physicians,
practitioners,
and other stakeholders, specify applicable
appropriate use criteria
for
applicable imaging services
only from among
appropriate use criteria
developed or endorsed by national professional medical specialty societies or other provider-led entities.
(B)
Considerations
In specifying applicable
appropriate use criteria
under subparagraph (A), the
Secretary
shall take into account whether the criteria—
(i)
have stakeholder consensus;
(ii)
are scientifically valid and evidence based; and
(iii)
are based on studies that are published and reviewable by stakeholders.
(C)
Revisions
The
Secretary
shall review, on an annual basis, the specified applicable
appropriate use criteria
to determine if there is a need to update or revise (as
appropriate)
such specification of applicable
appropriate use criteria
and make such updates or revisions through rulemaking.
(D)
Treatment of multiple applicable appropriate use criteria
In the case where the
Secretary
determines that more than one
appropriate
use criterion applies with respect to an
applicable imaging service
, the
Secretary
shall apply one or more applicable
appropriate use criteria
under this paragraph for the service.
(3)
Mechanisms for consultation with applicable appropriate use criteria
(A)
Identification of mechanisms to consult with applicable appropriate use criteria
(i)
In general
The
Secretary
shall specify qualified clinical decision support mechanisms that could be used by
ordering professionals
to consult with applicable
appropriate use criteria
for
applicable imaging services
(ii)
Consultation
The
Secretary
shall consult with
physicians
practitioners
, health care technology experts, and other stakeholders in specifying mechanisms under this paragraph.
(iii)
Inclusion of certain mechanisms
Mechanisms specified under this paragraph may include any or all of the following that meet the requirements described in subparagraph (B)(ii):
(I)
Use of clinical decision support modules in certified EHR technology (as defined in
section 1395w–4(o)(4) of this title
).
(II)
Use of private sector clinical decision support mechanisms that are independent from certified EHR technology, which may include use of clinical decision support mechanisms available from medical specialty organizations.
(III)
Use of a clinical decision support mechanism established by the
Secretary
(B)
Qualified clinical decision support mechanisms
(i)
In general
For purposes of this subsection, a qualified clinical decision support mechanism is a mechanism that the
Secretary
determines meets the requirements described in clause (ii).
(ii)
Requirements
The requirements described in this clause are the following:
(I)
The mechanism makes available to the
ordering professional
applicable
appropriate use criteria
specified under paragraph (2) and the supporting documentation for the
applicable imaging service
ordered.
(II)
In the case where there is more than one applicable
appropriate
use criterion specified under such paragraph for an
applicable imaging service
, the mechanism indicates the criteria that it uses for the service.
(III)
The mechanism determines the extent to which an
applicable imaging service
ordered is consistent with the applicable
appropriate use criteria
so specified.
(IV)
The mechanism generates and provides to the
ordering professional
a certification or documentation that documents that the qualified clinical decision support mechanism was consulted by the
ordering professional
(V)
The mechanism is updated on a timely basis to reflect revisions to the specification of applicable
appropriate use criteria
under such paragraph.
(VI)
The mechanism meets privacy and security standards under applicable provisions of law.
(VII)
The mechanism performs such other functions as specified by the
Secretary
, which may include a requirement to provide aggregate feedback to the
ordering professional
(C)
List of mechanisms for consultation with applicable appropriate use criteria
(i)
Initial list
Not later than
April 1, 2016
, the
Secretary
shall publish a list of mechanisms specified under this paragraph.
(ii)
Periodic updating of list
The
Secretary
shall identify on an annual basis the list of qualified clinical decision support mechanisms specified under this paragraph.
(4)
Consultation with applicable appropriate use criteria
(A)
Consultation by ordering professional
Beginning with
January 1, 2017
, subject to subparagraph (C), with respect to an
applicable imaging service
ordered by an
ordering professional
that would be furnished in an
applicable setting
and paid for under an
applicable payment system
(as defined in subparagraph (D)), an
ordering professional
shall—
(i)
consult with a qualified decision support mechanism listed under paragraph (3)(C); and
(ii)
provide to the
furnishing professional
the information described in clauses (i) through (iii) of subparagraph (B).
(B)
Reporting by furnishing professional
Beginning with
January 1, 2017
, subject to subparagraph (C), with respect to an
applicable imaging service
furnished in an
applicable setting
and paid for under an
applicable payment system
(as defined in subparagraph (D)), payment for such service may only be made if the claim for the service includes the following:
(i)
Information about which qualified clinical decision support mechanism was consulted by the
ordering professional
for the service.
(ii)
Information regarding—
(I)
whether the service ordered would adhere to the applicable
appropriate use criteria
specified under paragraph (2);
(II)
whether the service ordered would not adhere to such criteria; or
(III)
whether such criteria was not applicable to the service ordered.
(iii)
The national provider identifier of the
ordering professional
(if different from the
furnishing professional
).
(C)
Exceptions
The provisions of subparagraphs (A) and (B) and paragraph (6)(A) shall not apply to the following:
(i)
Emergency services
An
applicable imaging service
ordered for an individual with an emergency medical condition (as defined in
section 1395dd(e)(1) of this title
).
(ii)
Inpatient services
An
applicable imaging service
ordered for an inpatient and for which payment is made under part A.
(iii)
Significant hardship
An
applicable imaging service
ordered by an
ordering professional
who the
Secretary
may, on a case-by-case basis, exempt from the application of such provisions if the
Secretary
determines, subject to annual renewal, that consultation with applicable
appropriate use criteria
would result in a significant hardship, such as in the case of a professional who practices in a
rural area
without sufficient Internet access.
(D)
Applicable payment system defined
In this subsection, the term “
applicable payment system
” means the following:
(i)
The
physician
fee schedule established under
section 1395w–4(b) of this title
(ii)
The prospective payment system for
hospital
outpatient department services under
section 1395l(t) of this title
(iii)
The ambulatory surgical center payment systems under
section 1395l(i) of this title
(5)
Identification of outlier ordering professionals
(A)
In general
With respect to
applicable imaging services
furnished beginning with 2017, the
Secretary
shall determine, on an annual basis, no more than five percent of the total number of
ordering professionals
who are outlier
ordering professionals.
(B)
Outlier ordering professionals
The determination of an outlier
ordering professional
shall—
(i)
be based on low adherence to applicable
appropriate use criteria
specified under paragraph (2), which may be based on comparison to other
ordering professionals;
and
(ii)
include data for
ordering professionals
for whom prior authorization under paragraph (6)(A) applies.
(C)
Use of two years of data
The
Secretary
shall use two years of data to identify outlier
ordering professionals
under this paragraph.
(D)
Process
The
Secretary
shall establish a process for determining when an outlier
ordering professional
is no longer an outlier
ordering professional
(E)
Consultation with stakeholders
The
Secretary
shall consult with
physicians
practitioners
and other stakeholders in developing methods to identify outlier
ordering professionals
under this paragraph.
(6)
Prior authorization for ordering professionals who are outliers
(A)
In general
Beginning
January 1, 2020
, subject to paragraph (4)(C), with respect to services furnished during a year, the
Secretary
shall, for a period determined
appropriate
by the
Secretary,
apply prior authorization for
applicable imaging services
that are ordered by an outlier
ordering professional
identified under paragraph (5).
(B)
Appropriate use criteria in prior authorization
In applying prior authorization under subparagraph (A), the
Secretary
shall utilize only the applicable
appropriate use criteria
specified under this subsection.
(C)
Funding
For purposes of carrying out this paragraph, the
Secretary
shall provide for the transfer, from the Federal Supplementary Medical Insurance Trust Fund under
section 1395t of this title
, of $5,000,000 to the Centers for
Medicare
& Medicaid Services Program Management Account for each of fiscal years 2019 through 2021. Amounts transferred under the preceding sentence shall remain available until expended.
(7)
Construction
Nothing in this subsection shall be construed as granting the
Secretary
the authority to develop or initiate the development of clinical practice guidelines or
appropriate use criteria
(r)
Payment for renal dialysis services for individuals with acute kidney injury
(1)
Payment rate
In the case of renal dialysis services (as defined in subparagraph (B) of
section 1395rr(b)(14) of this title
) furnished under this part by a renal dialysis facility or provider of services paid under such section during a year (beginning with 2017) to an
individual with acute kidney injury
(as defined in paragraph (2)), the amount of payment under this part for such services shall be the base rate for renal dialysis services determined for such year under such section, as adjusted by any applicable geographic adjustment factor applied under subparagraph (D)(iv)(II) of such section and may be adjusted by the
Secretary
(on a budget neutral basis for payments under this paragraph) by any other adjustment factor under subparagraph (D) of such section.
(2)
Individual with acute kidney injury defined
In this subsection, the term “
individual with acute kidney injury
” means an individual who has acute loss of renal function and does not receive renal dialysis services for which payment is made under
section 1395rr(b)(14) of this title
(s)
Payment for applicable disposable devices
(1)
Separate payment
The
Secretary
shall make a payment (separate from the payments otherwise made under
section 1395fff of this title
) in the amount established under paragraph (3) to a
home health agency
for an applicable disposable device (as defined in paragraph (2)) when furnished on or after
January 1, 2017
, to an individual who receives
home health services
for which payment is made under
section 1395fff(b) of this title
(2)
Applicable disposable device
In this subsection, the term applicable disposable device means a disposable device that, as determined by the
Secretary
, is—
(A)
a disposable negative pressure wound therapy device that is an integrated system comprised of a non-manual vacuum pump, a receptacle for collecting exudate, and dressings for the purposes of wound therapy; and
(B)
a substitute for, and used in lieu of, a negative pressure wound therapy
durable medical equipment
item that is an integrated system of a negative pressure vacuum pump, a separate exudate collection canister, and dressings that would otherwise be covered for individuals for such wound therapy.
(3)
Payment
(A)
In general
The separate payment amount established under this paragraph for an applicable disposable device for a year shall be equal to—
(i)
for a year before 2024, the amount of the payment that would be made under
section 1395l(t) of this title
(relating to payment for covered OPD services) for the year for the Level I Healthcare Common Procedure Coding System (HCPCS) code for which the description for a professional service includes the furnishing of such device;
(ii)
for 2024, the supply price used to determine the relative value for the service under the fee schedule under
section 1395w–4 of this title
(as of
January 1, 2022
) for the applicable disposable device, updated by the specified adjustment described in subparagraph (B) for such year; and
(iii)
for 2025 and each subsequent year, the payment amount established under this paragraph for such device for the previous year, updated by the specified adjustment described in subparagraph (B) for such year.
(B)
Specified adjustment
(i)
In general
For purposes of subparagraph (A), the specified adjustment described in this subparagraph for a year is equal to—
(I)
the percentage increase in the consumer price index for all urban consumers (
United States
city average) for the 12-month period ending in June of the previous year; minus
(II)
the productivity adjustment described in
section 1395ww(b)(3)(B)(xi)(II) of this title
for such year.
(ii)
Clarification on application of the productivity adjustment
The application of clause (i)(II) may result in a specified adjustment of less than 0.0 for a year, and may result in the separate payment amount under this subsection for an applicable device for a year being less than such separate payment amount for such device for the preceding year.
(C)
Exclusion of nursing and therapy services from separate payment
With respect to applicable devices furnished on or after
January 1, 2024
, the separate payment amount determined under this paragraph shall not include payment for nursing or therapy services described in
section 1395x(m) of this title
. Payment for such nursing or therapy services shall be made under the prospective payment system established under
section 1395fff of this title
and shall not be separately billable.
(4)
Implementation
As part of submitting claims for the separate payment established under this subsection, beginning with 2024, the
Secretary
shall accept and process claims submitted using the type of bill that is most commonly used by home health agencies to bill services under a home health plan of care.
(t)
Site-of-service price transparency
(1)
In general
In order to facilitate price transparency with respect to items and services for which payment may be made either to a
hospital
outpatient department or to an ambulatory surgical center under this subchapter, the
Secretary
shall, for 2018 and each year thereafter, make available to the public via a searchable Internet website, with respect to an
appropriate
number of such items and services—
(A)
the estimated payment amount for the item or service under the outpatient department fee schedule under subsection (t) of
section 1395l of this title
and the ambulatory surgical center payment system under subsection (i) of such section; and
(B)
the estimated amount of beneficiary liability applicable to the item or service.
(2)
Calculation of estimated beneficiary liability
For purposes of paragraph (1)(B), the estimated amount of beneficiary liability, with respect to an item or service, is the amount for such item or service for which an individual who does not have coverage under a
Medicare
supplemental policy certified under
section 1395ss of this title
or any other supplemental insurance coverage is responsible.
(3)
Implementation
In carrying out this subsection, the
Secretary
(A)
shall include in the notice described in
section 1395b–2(a) of this title
a notification of the availability of the estimated amounts made available under paragraph (1); and
(B)
may utilize mechanisms in existence on
December 13, 2016
, such as the portion of the Internet website of the Centers for
Medicare
& Medicaid Services on which information comparing
physician
performance is posted (commonly referred to as the
Physician
Compare Internet website), to make available such estimated amounts under such paragraph.
(4)
Funding
For purposes of implementing this subsection, the
Secretary
shall provide for the transfer, from the Federal Supplementary Medical Insurance Trust Fund under
section 1395t of this title
to the Centers for
Medicare
& Medicaid Services Program Management Account, of $6,000,000 for fiscal year 2017, to remain available until expended.
(u)
Payment and related requirements for home infusion therapy
(1)
Payment
(A)
Single payment
(i)
In general
Subject to clause (iii) and subparagraphs (B) and (C), the
Secretary
shall implement a payment system under which a single payment is made under this subchapter to a qualified
home infusion therapy
supplier
for items and services described in subparagraphs (A) and (B) of
section 1395x(iii)(2)
[7]
of this title furnished by a qualified home infusion therapy
supplier
(as defined in
section 1395x(iii)(3)(D) of this title
) in coordination with the furnishing of home infusion
drugs
(as defined in
section 1395x(iii)(3)(C) of this title
) under this part.
(ii)
Unit of single payment
A unit of single payment under the payment system implemented under this subparagraph is for each infusion drug
administration
calendar day in the individual’s home. The
Secretary
shall, as
appropriate
, establish single payment amounts for types of infusion therapy, including to take into account variation in utilization of nursing services by therapy type.
(iii)
Limitation
The single payment amount determined under this subparagraph after application of subparagraph (B) and paragraph (3) shall not exceed the amount determined under the fee schedule under
section 1395w–4 of this title
for infusion therapy services furnished in a calendar day if furnished in a
physician
office setting, except such single payment shall not reflect more than 5 hours of infusion for a particular therapy in a calendar day.
(B)
Required adjustments
The
Secretary
shall adjust the single payment amount determined under subparagraph (A) for
home infusion therapy
services under
section 1395x(iii)(1) of this title
to reflect other factors such as—
(i)
a geographic wage index and other costs that may vary by region; and
(ii)
patient acuity and complexity of drug
administration
(C)
Discretionary adjustments
(i)
In general
Subject to clause (ii), the
Secretary
may adjust the single payment amount determined under subparagraph (A) (after application of subparagraph (B)) to reflect outlier situations and other factors as the
Secretary
determines
appropriate
(ii)
Requirement of budget neutrality
Any adjustment under this subparagraph shall be made in a budget neutral manner.
(2)
Considerations
In developing the payment system under this subsection, the
Secretary
may consider the costs of furnishing infusion therapy in the home, consult with
home infusion therapy
suppliers
, consider payment amounts for similar items and services under this part and part A, and consider payment amounts established by
Medicare
Advantage plans under part C and in the private insurance market for
home infusion therapy
(including average per
treatment
day payment amounts by type of
home infusion therapy)
(3)
Annual updates
(A)
In general
Subject to subparagraph (B), the
Secretary
shall update the single payment amount under this subsection from year to year beginning in 2022 by increasing the single payment amount from the prior year by the percentage increase in the Consumer Price Index for all urban consumers (
United States
city average) for the 12-month period ending with June of the preceding year.
(B)
Adjustment
For each year, the
Secretary
shall reduce the percentage increase described in subparagraph (A) by the productivity adjustment described in
section 1395ww(b)(3)(B)(xi)(II) of this title
. The application of the preceding sentence may result in a percentage being less than 0.0 for a year, and may result in payment being less than such payment rates for the preceding year.
(4)
Authority to apply prior authorization
The
Secretary
may, as determined
appropriate
by the
Secretary,
apply prior authorization for
home infusion therapy
services under
section 1395x(iii)(1) of this title
(5)
Accreditation of qualified home infusion therapy suppliers
(A)
Factors for designation of accreditation organizations
The
Secretary
shall consider the following factors in designating accreditation organizations under subparagraph (B) and in reviewing and modifying the list of accreditation organizations designated pursuant to subparagraph (C):
(i)
The ability of the organization to conduct timely reviews of accreditation applications.
(ii)
The ability of the organization to take into account the capacities of
suppliers
located in a
rural area
(as defined in
section 1395ww(d)(2)(D) of this title
).
(iii)
Whether the organization has established reasonable fees to be charged to
suppliers
applying for accreditation.
(iv)
Such other factors as the
Secretary
determines
appropriate
(B)
Designation
Not later than
January 1, 2021
, the
Secretary
shall designate organizations to accredit
suppliers
furnishing
home infusion therapy.
The list of accreditation organizations so designated may be modified pursuant to subparagraph (C).
(C)
Review and modification of list of accreditation organizations
(i)
In general
The
Secretary
shall review the list of accreditation organizations designated under subparagraph (B) taking into account the factors under subparagraph (A). Taking into account the results of such review, the
Secretary
may, by regulation, modify the list of accreditation organizations designated under subparagraph (B).
(ii)
Special rule for accreditations done prior to removal from list of designated accreditation organizations
In the case where the
Secretary
removes an organization from the list of accreditation organizations designated under subparagraph (B), any
supplier
that is accredited by the organization during the period beginning on the date on which the organization is designated as an accreditation organization under subparagraph (B) and ending on the date on which the organization is removed from such list shall be considered to have been accredited by an organization designated by the
Secretary
under subparagraph (B) for the remaining period such accreditation is in effect.
(D)
Rule for accreditations made prior to designation
In the case of a
supplier
that is accredited before
January 1, 2021
, by an accreditation organization designated by the
Secretary
under subparagraph (B) as of
January 1, 2019
, such
supplier
shall be considered to have been accredited by an organization designated by the
Secretary
under such paragraph as of
January 1, 2023
, for the remaining period such accreditation is in effect.
(6)
Notification of infusion therapy options available prior to furnishing home infusion therapy
Prior to the furnishing of
home infusion therapy
to an individual, the
physician
who establishes the plan described in
section 1395x(iii)(1) of this title
for the individual shall provide notification (in a form, manner, and frequency determined
appropriate
by the
Secretary)
of the options available (such as home,
physician’
s office,
hospital
outpatient department) for the furnishing of infusion therapy under this part.
(7)
Home infusion therapy services temporary transitional payment
(A)
Temporary transitional payment
(i)
In general
The
Secretary
shall, in accordance with the payment methodology described in subparagraph (B) and subject to the provisions of this paragraph, provide a
home infusion therapy
services temporary transitional payment under this part to an
eligible home infusion supplier
(as defined in subparagraph (F)) for items and services described in subparagraphs (A) and (B) of
section 1395x(iii)(2)
of this title furnished during the period specified in clause (ii) by such
supplier
in coordination with the furnishing of
transitional home infusion drugs
(as defined in clause (iii)).
(ii)
Period specified
For purposes of clause (i), the period specified in this clause is the period beginning on
January 1, 2019
, and ending on the day before the date of the implementation of the payment system under paragraph (1)(A).
(iii)
Transitional home infusion drug defined
For purposes of this paragraph, the term “
transitional home infusion drug
” has the meaning given to the term “home infusion drug” under
section 1395x(iii)(3)(C)
of this title, except that clause (ii) of such section shall not apply if a drug described in such clause is identified in clauses (i), (ii), (iii) or (iv) of subparagraph (C) as of
February 9, 2018
(B)
Payment methodology
For purposes of this paragraph, the
Secretary
shall establish a payment methodology, with respect to items and services described in subparagraph (A)(i). Under such payment methodology the
Secretary
shall—
(i)
create the three payment categories described in clauses (i), (ii), and (iii) of subparagraph (C);
(ii)
assign
drugs
to such categories, in accordance with such clauses;
(iii)
assign
appropriate
Healthcare Common Procedure Coding System (HCPCS) codes to each payment category; and
(iv)
establish a single payment amount for each such payment category, in accordance with subparagraph (D), for each infusion drug
administration
calendar day in the individual’s home for
drugs
assigned to such category.
(C)
Payment categories
(i)
Payment category 1
The
Secretary
shall create a payment category 1 and assign to such category
drugs
which are covered under the Local Coverage Determination on External Infusion Pumps (LCD number L33794) and billed with the following HCPCS codes (as identified as of
January 1, 2018
, and as subsequently modified by the
Secretary)
: J0133, J0285, J0287, J0288, J0289, J0895, J1170, J1250, J1265, J1325, J1455, J1457, J1570, J2175, J2260, J2270, J2274, J2278, J3010, or J3285.
(ii)
Payment category 2
The
Secretary
shall create a payment category 2 and assign to such category
drugs
which are covered under such local coverage determination and billed with the following HCPCS codes (as identified as of
January 1, 2018
, and as subsequently modified by the
Secretary)
: J1555 JB, J1559 JB, J1561 JB, J1562 JB, J1569 JB, or J1575 JB.
(iii)
Payment category 3
The
Secretary
shall create a payment category 3 and assign to such category
drugs
which are covered under such local coverage determination and billed with the following HCPCS codes (as identified as of
January 1, 2018
, and as subsequently modified by the
Secretary)
: J9000, J9039, J9040, J9065, J9100, J9190, J9200, J9360, or J9370.
(iv)
Infusion drugs not otherwise included
With respect to
drugs
that are not included in payment category 1, 2, or 3 under clause (i), (ii), or (iii), respectively, the
Secretary
shall assign to the most
appropriate
of such categories, as determined by the
Secretary,
drugs
which are—
(I)
covered under such local coverage determination and billed under HCPCS codes J7799 or J7999 (as identified as of
July 1, 2017
, and as subsequently modified by the
Secretary)
; or
(II)
billed under any code that is implemented after
February 9, 2018
, and included in such local coverage determination or included in subregulatory guidance as a home infusion drug described in subparagraph (A)(i).
(D)
Payment amounts
(i)
In general
Under the payment methodology, the
Secretary
shall pay
eligible home infusion suppliers
, with respect to items and services described in subparagraph (A)(i) furnished during the period described in subparagraph (A)(ii) by such
supplier
to an individual, at amounts equal to the amounts determined under the
physician
fee schedule established under
section 1395w–4 of this title
for services furnished during the year for codes and units of such codes described in clauses (ii), (iii), and (iv) with respect to
drugs
included in the payment category under subparagraph (C) specified in the respective clause, determined without application of the geographic adjustment under subsection (e) of such section.
(ii)
Payment amount for category 1
For purposes of clause (i), the codes and units described in this clause, with respect to
drugs
included in payment category 1 described in subparagraph (C)(i), are one unit of HCPCS code 96365 plus three units of HCPCS code 96366 (as identified as of
January 1, 2018
, and as subsequently modified by the
Secretary)
(iii)
Payment amount for category 2
For purposes of clause (i), the codes and units described in this clause, with respect to
drugs
included in payment category 2 described in subparagraph (C)(i), are one unit of HCPCS code 96369 plus three units of HCPCS code 96370 (as identified as of
January 1, 2018
, and as subsequently modified by the
Secretary)
(iv)
Payment amount for category 3
For purposes of clause (i), the codes and units described in this clause, with respect to
drugs
included in payment category 3 described in subparagraph (C)(i), are one unit of HCPCS code 96413 plus three units of HCPCS code 96415 (as identified as of
January 1, 2018
, and as subsequently modified by the
Secretary)
(E)
Clarifications
(i)
Infusion drug administration day
For purposes of this subsection, with respect to the furnishing of
transitional home infusion drugs
or home infusion
drugs
to an individual by an
eligible home infusion supplier
or a qualified home infusion therapy
supplier,
a reference to payment to such
supplier
for an infusion drug
administration
calendar day in the individual’s home shall refer to payment only for the date on which professional services (as described in
section 1395x(iii)(2)(A) of this title
) were furnished to administer such
drugs
to such individual. For purposes of the previous sentence, an infusion drug
administration
calendar day shall include all such
drugs
administered to such individual on such day.
(ii)
Treatment of multiple drugs administered on same infusion drug administration day
In the case that an
eligible home infusion supplier
, with respect to an infusion drug
administration
calendar day in an individual’s home, furnishes to such individual
transitional home infusion drugs
which are not all assigned to the same payment category under subparagraph (C), payment to such
supplier
for such infusion drug
administration
calendar day in the individual’s home shall be a single payment equal to the amount of payment under this paragraph for the drug, among all such
drugs
so furnished to such individual during such calendar day, for which the highest payment would be made under this paragraph.
(F)
Eligible home infusion suppliers
In this paragraph, the term “
eligible home infusion supplier
” means a
supplier
that is enrolled under this part as a pharmacy that provides external infusion pumps and external infusion pump supplies and that maintains all pharmacy licensure requirements in the
State
in which the applicable infusion
drugs
are administered.
(G)
Implementation
Notwithstanding any other provision of law, the
Secretary
may implement this paragraph by program instruction or otherwise.
(v)
Payment for outpatient physical therapy services and outpatient occupational therapy services furnished by a therapy assistant
(1)
In general
In the case of an outpatient physical therapy service or outpatient occupational therapy service furnished on or after
January 1, 2022
, for which payment is made under
section 1395w–4 of this title
or subsection (k), that is furnished in whole or in part by a therapy assistant (as defined by the
Secretary)
, the amount of payment for such service shall be an amount equal to 85 percent of the amount of payment otherwise applicable for the service under this part. Nothing in the preceding sentence shall be construed to change applicable requirements with respect to such services.
(2)
Use of modifier
(A)
Establishment
Not later than
January 1, 2019
, the
Secretary
shall establish a modifier to indicate (in a form and manner specified by the
Secretary)
, in the case of an outpatient physical therapy service or outpatient occupational therapy service furnished in whole or in part by a therapy assistant (as so defined), that the service was furnished by a therapy assistant.
(B)
Required use
Each request for payment, or bill submitted, for an outpatient physical therapy service or outpatient occupational therapy service furnished in whole or in part by a therapy assistant (as so defined) on or after
January 1, 2020
, shall include the modifier established under subparagraph (A) for each such service.
(3)
Implementation
The
Secretary
shall implement this subsection through notice and comment rulemaking.
(w)
Opioid use disorder treatment services
(1)
In general
The
Secretary
shall pay to an opioid
treatment
program (as defined in paragraph (2) of
section 1395x(jjj) of this title
) an amount that is equal to 100 percent of a bundled payment under this part for opioid use disorder
treatment
services (as defined in paragraph (1) of such section) that are furnished by such program to an individual during an episode of care (as defined by the
Secretary)
beginning on or after
January 1, 2020
. The
Secretary
shall ensure, as determined
appropriate
by the
Secretary,
that no duplicative payments are made under this part or part D for items and services furnished by an opioid
treatment
program.
(2)
Considerations
The
Secretary
may implement this subsection through one or more bundles based on the type of medication provided (such as buprenorphine, methadone, naltrexone, or a new innovative drug), the frequency of services, the scope of services furnished, characteristics of the individuals furnished such services, or other factors as the
Secretary
determine
[8]
appropriate.
In developing such bundles, the
Secretary
may consider payment rates paid to opioid
treatment
programs for comparable services under
State
plans under subchapter XIX or under the TRICARE program under chapter 55 of title 10.
(3)
Annual updates
The
Secretary
shall provide an update each year to the bundled payment amounts under this subsection.
(x)
Payment rules relating to rural emergency hospitals
(1)
Payment for rural emergency hospital services
In the case of
rural emergency hospital services
(as defined in
section 1395x(kkk)(1) of this title
), furnished by a
rural emergency hospital
(as defined in
section 1395x(kkk)(2) of this title
) on or after
January 1, 2023
, the amount of payment for such services shall be equal to the amount of payment that would otherwise apply under
section 1395l(t) of this title
for covered OPD services (as defined in
section 1395l(t)(1)(B) of this title
(other than clause (ii) of such section)), increased by 5 percent to reflect the higher costs incurred by such
hospitals,
and shall include the application of any copayment amount determined under
section 1395l(t)(8) of this title
as if such increase had not occurred.
(2)
Additional facility payment
(A)
In general
The
Secretary
shall make monthly payments to a
rural emergency hospital
in an amount that is equal to
12
of the annual additional facility payment specified in subparagraph (B).
(B)
Annual additional facility payment amount
The annual additional facility payment amount specified in this subparagraph is—
(i)
for 2023, a
Medicare
subsidy amount determined under subparagraph (C); and
(ii)
for 2024 and each subsequent year, the amount determined under this subparagraph for the preceding year, increased by the
hospital
market basket percentage increase.
(C)
Determination of
medicare
subsidy amount
For purposes of subparagraph (B)(i), the
Medicare
subsidy amount determined under this subparagraph is an amount equal to—
(i)
the excess (if any) of—
(I)
the total amount that the
Secretary
determines was paid under this subchapter to all
critical access hospitals
in 2019; over
(II)
the estimated total amount that the
Secretary
determines would have been paid under this subchapter to such
hospitals
in 2019 if payment were made for inpatient
hospital
, outpatient
hospital
, and
skilled nursing facility
services under the applicable prospective payment systems for such services during such year; divided by
(ii)
the total number of such
hospitals
in 2019.
(D)
Reporting on use of the additional facility payment
rural emergency hospital
receiving the additional facility payment under this paragraph shall maintain detailed information as specified by the
Secretary
as to how the facility has used the additional facility payments. Such information shall be made available to the
Secretary
upon request.
(3)
Payment for ambulance services
For provisions relating to payment for ambulance services furnished by an entity owned and operated by a
rural emergency hospital
, see subsection (l).
(4)
Payment for post-hospital extended care services
For provisions relating to payment for
post-hospital extended care services
furnished by a
rural emergency hospital
that has a unit that is a distinct part licensed as a
skilled nursing facility,
see
section 1395yy(e) of this title
(5)
Source of payments
(A)
In general
Except as provided in subparagraph (B), payments under this subsection shall be made from the Federal Supplementary Medical Insurance Trust Fund under
section 1395t of this title
(B)
Additional facility payment and post-hospital extended care services
Payments under paragraph (2) shall be made from the Federal
Hospital
Insurance Trust Fund under
section 1395i of this title
(y)
Payment for certain services furnished by rural health clinics
(1)
Attending physician services for hospice patients
In the case of services described in
section 1395d(d)(2)(A)(ii) of this title
furnished on or after
January 1, 2022
, by an attending
physician
(as defined in
section 1395x(dd)(3)(B) of this title
, other than a
physician
or
practitioner
who is employed by a
hospice program)
who is employed by or working under contract with a
rural health clinic,
rural health clinic
shall be paid for such services under the methodology for all-inclusive rates (established by the
Secretary)
under section 1395l(a)(3) of this title, subject to the limits described in section 1395l(f) of this title.
(2)
Mental health visits furnished via telecommunications technology
In the case of mental health visits furnished via interactive, real-time, audio and video telecommunications technology or audio-only interactions, the in-
person
mental health visit requirements established under section
405.2463(b)(3)
of title 42 of the Code of Federal Regulations (or a successor regulation) shall not apply prior to
January 1, 2028
(3)
Special payment rule for intensive outpatient services
(A)
In general
In the case of
intensive outpatient services
furnished by a
rural health clinic,
the payment amount for such services shall be equal to the amount that would have been paid under this subchapter for such services had such services been covered OPD services furnished by a
hospital.
(B)
Exclusion
Costs associated with
intensive outpatient services
shall not be used to determine the amount of payment for
rural health clinic services
under the methodology for all-inclusive rates (established by the
Secretary)
under
section 1395l(a)(3) of this title
(z)
Payment for lymphedema compression treatment items
(1)
In general
The
Secretary
shall determine an
appropriate
payment basis for lymphedema compression
treatment
items (as defined in
section 1395x(mmm) of this title
). In making such a determination, the
Secretary
may take into account payment rates for such items under
State
plans (or waivers of such plans) under subchapter XIX, the Veterans Health
Administration,
and group health plans and health insurance coverage (as such terms are defined in
section 300gg–91 of this title
), and such other information as the
Secretary
determines
appropriate.
(2)
Frequency limitation
No payment may be made under this part for lymphedema compression
treatment
items furnished other than at such frequency as the
Secretary
may establish.
(3)
Application of competitive acquisition
In the case of lymphedema compression
treatment
items that are included in a competitive acquisition program in a competitive acquisition area under
section 1395w–3(a) of this title
(A)
the payment basis under this subsection for such items furnished in such area shall be the payment basis determined under such competitive acquisition program; and
(B)
the
Secretary
may use information on the payment determined under such competitive acquisition programs to adjust the payment amount otherwise determined under this subsection for an area that is not a competitive acquisition area under
section 1395w–3 of this title
, and in the case of such adjustment, paragraphs (8) and (9) of
section 1395u(b) of this title
shall not be applied.
(aa)
Payment and standards for multi-cancer early detection screening tests
(1)
Payment amount
The payment amount for a
multi-cancer early detection screening test
(as defined in
section 1395x(nnn) of this title
) is—
(A)
with respect to such a test furnished before
January 1, 2031
, equal to the payment amount in effect on
February 3, 2026
, for a multi-target stool screening DNA test covered pursuant to
section 1395x(pp)(1)(D) of this title
; and
(B)
with respect to such a test furnished on or after
January 1, 2031
, equal to the lesser of—
(i)
the amount described in subparagraph (A); or
(ii)
the payment amount determined for such test under
section 1395m–1 of this title
(2)
Limitations
(A)
In general
No payment may be made under this part for a
multi-cancer early detection screening test
furnished during a year to an individual if—
(i)
such individual—
(I)
is under 50 years of age; or
(II)
as of January 1 of such year, has attained the age specified in subparagraph (B) for such year; or
(ii)
such a test was furnished to the individual during the previous 11 months.
(B)
Age specified
For purposes of subparagraph (A)(i)(II), the age specified in this subparagraph is—
(i)
for 2029, 65 years of age; and
(ii)
for a succeeding year, the age specified in this subparagraph for the preceding year, increased by 1 year.
(C)
Standards following USPSTF rating of A or B
In the case of a
multi-cancer early detection screening test
that is recommended with a grade of A or B by the United States
Preventive Services
Task Force, beginning on the date on which coverage for such test is provided pursuant to
section 1395x(ddd)(1) of this title
, the preceding provisions of this paragraph shall not apply.
(Aug. 14, 1935, ch. 531, title XVIII, § 1834, as added and amended
Pub. L. 100–203, title IV
, §§ 4049(a)(2), 4062(b),
Dec. 22, 1987
101 Stat. 1330–91
, 1330–100;
Pub. L. 100–360, title II
, §§ 202(b)(4), 203(c)(1)(F), 204(b), title IV, § 411(a)(3)(A), (B)(ii), (C)(ii), (f)(8)(A), (B)(ii), (D), (g)(1)(A), (B),
July 1, 1988
102 Stat. 704
, 722, 726, 768, 779, 781;
Pub. L. 100–485, title VI, § 608(d)(21)(C)
, (22)(A),
Oct. 13, 1988
102 Stat. 2420
Pub. L. 101–234, title II, § 201(a)
, title III, § 301(b)(1), (c)(1),
Dec. 13, 1989
103 Stat. 1981
, 1985;
Pub. L. 101–239, title VI
, §§ 6102(f)(1), 6105(a), 6112(a), (c), (d)(1), (e)(2), 6116(b)(2), 6140,
Dec. 19, 1989
103 Stat. 2188
, 2210, 2214–2216, 2220, 2224;
Pub. L. 101–508, title IV
, §§ 4102(a), (d), (f), 4104(a), 4152(a)(1), (b), (c)(1)–(4)(B)(i), (e), (f)(1), (g)(1), 4153(a)(1), (2)(D), 4163(b),
Nov. 5, 1990
104 Stat. 1388–55
, 1388–57, 1388–59, 1388–74, 1388–77 to 1388–81, 1388–83, 1388–97;
Pub. L. 103–66, title XIII
, §§ 13542(a), 13543(a), (b), 13544(a)(1), (2), (b)(1), 13545(a), 13546,
Aug. 10, 1993
107 Stat. 587
, 589, 590;
Pub. L. 103–432, title I
, §§ 102(e), 126(b)(1), (2), (4), (5), (g)(1), (10)(B), 131(a), 132(a), (b), 133(a)(1), 134(a)(1), 135(a)(1), (b)(1), (3), (d)(1), (e)(2)–(5), 145(a), 156(a)(2)(C),
Oct. 31, 1994
108 Stat. 4403
, 4414–4416, 4419, 4421–4424, 4427, 4440;
Pub. L. 105–33, title IV
, §§ 4101(a), (c), 4104(b)(1), 4105(b)(2), 4201(c)(5), 4312(a), (c), 4316(b), 4531(b)(2), 4541(a)(2), 4551(a), (c)(1), 4552(a), (b),
Aug. 5, 1997
111 Stat. 360
, 363, 367, 374, 386, 387, 392, 451, 455, 457–459;
Pub. L. 106–113, div. B, § 1000(a)(6) [title II, § 201(e)(2), title III, § 321(k)(3), title IV, § 403(d)(1)]
Nov. 29, 1999
113 Stat. 1536
, 1501A–340, 1501A–366, 1501A–371;
Pub. L. 106–554, § 1(a)(6) [title I, §§ 103(b), 104(b), title II, §§ 201(a), 202(a), 204(a), 205(a), 221(a), 223(b), title IV, §§ 423(a)(1), (b)(1), 425(a), 426(a), 427(a), 428(a)]
Dec. 21, 2000
114 Stat. 2763
, 2763A–468, 2763A–469, 2763A–481, 2763A–482, 2763A–486, 2763A–487, 2763A–518 to 2763A–520, 2763A–522;
Pub. L. 108–173, title III, § 302(a)
, (c)(1)(A), (2), (3), (d)(1), (2), title IV, §§ 405(a)(1), (b)(1), (d)(1), 414(a)–(c)(1), (d), 415(a), title VI, § 627(b)(1), title VII, § 736(b)(4), (5),
Dec. 8, 2003
117 Stat. 2223
, 2230–2232, 2266, 2267, 2278–2281, 2321, 2356;
Pub. L. 109–171, title V
, §§ 5101(a)(1), (b)(1), 5113(b),
Feb. 8, 2006
120 Stat. 37
, 38, 44;
Pub. L. 110–275, title I
, §§ 125(b)(5), 135(a)(1), 144(b)(1), 146(a), (b)(2)(A), 148(a), 149(a), 154(a)(2)(A), (3), (4), (b)(1)(A), (d)(2),
July 15, 2008
122 Stat. 2519
, 2532, 2547–2549, 2563, 2564, 2567;
Pub. L. 111–72, § 1(a)
Oct. 13, 2009
123 Stat. 2059
Pub. L. 111–148, title III
, §§ 3105(a), (c), 3109(a), 3128(a), 3136(a), (b), 3401(j), (m), (n), title IV, § 4105(a), title V, §§ 5501(a)(2), (b)(2), 5502(b), title VI, §§ 6402(g)(1), 6405(a), 6407(b), 6410(b), title X, §§ 10311(a), (c), 10501(i)(1), (3)(A),
Mar. 23, 2010
124 Stat. 417
, 418, 426, 437, 438, 486, 487, 558, 653, 654, 759, 768, 770, 773, 942, 943, 997;
Pub. L. 111–309, title I, § 106(a)
, (c),
Dec. 15, 2010
124 Stat. 3287
Pub. L. 112–78, title III, § 306(a)
, (c),
Dec. 23, 2011
125 Stat. 1285
Pub. L. 112–96, title III, § 3007(a)
, (c),
Feb. 22, 2012
126 Stat. 190
Pub. L. 112–240, title VI
, §§ 604(a), (c), 633(b), 636, 637,
Jan. 2, 2013
126 Stat. 2347
, 2348, 2355–2357;
Pub. L. 113–67, div. B, title I, § 1104
Dec. 26, 2013
127 Stat. 1196
Pub. L. 113–93, title I, § 104
, title II, § 218(a)(1), (b)(1),
Apr. 1, 2014
128 Stat. 1042
, 1063, 1065;
Pub. L. 113–295, div. B, title II, § 203
Dec. 19, 2014
128 Stat. 4065
Pub. L. 114–10, title II, § 203
, title V, §§ 504(a), 515(b),
Apr. 16, 2015
129 Stat. 144
, 165, 174;
Pub. L. 114–27, title VIII, § 808(b)
June 29, 2015
129 Stat. 418
Pub. L. 114–40, § 3
July 30, 2015
129 Stat. 441
Pub. L. 114–113, div. O, title V, § 504(a)
Dec. 18, 2015
129 Stat. 3021
Pub. L. 114–255, div. A, title IV, § 4011
, title V, § 5012(b), div. C, title XVI, § 16008(a), (b)(1),
Dec. 13, 2016
130 Stat. 1186
, 1199, 1329;
Pub. L. 115–123, div. E, title II, § 50203
, title III, §§ 50302(b), 50325, title IV, §§ 50401(a), 50402, 50411, title XII, §§ 53107, 53108,
Feb. 9, 2018
132 Stat. 178
, 191, 205, 214, 217, 220, 303;
Pub. L. 115–271, title II
, §§ 2001(a), 2005(c)(2), title VI, § 6083(a),
Oct. 24, 2018
132 Stat. 3924
, 3929, 3994;
Pub. L. 116–136, div. A, title III, § 3704
Mar. 27, 2020
134 Stat. 416
Pub. L. 116–260, div. CC, title I
, §§ 121(a), (b)(1), 122(c), 123(a), 125(a)(2)(B), (c), 132,
Dec. 27, 2020
134 Stat. 2955
, 2956, 2964, 2966, 2976;
Pub. L. 117–103, div. P, title III
, §§ 301–305, 311,
Mar. 15, 2022
136 Stat. 804–806
, 808;
Pub. L. 117–215, title I, § 103(b)(4)(B)
Dec. 2, 2022
136 Stat. 2263
Pub. L. 117–328, div. FF, title I, § 1262(b)(6)
, title IV, §§ 4103, 4113(a)–(e), 4124(c), 4133(a)(2)(B), (b), 4134(c), 4136(a),
Dec. 29, 2022
136 Stat. 5682
, 5896, 5898, 5899, 5909, 5919–5921, 5924;
Pub. L. 118–158, div. C, title II
, §§ 3203, 3207(a)–(e),
Dec. 21, 2024
138 Stat. 1765
, 1766;
Pub. L. 119–4, div. B, title II
, §§ 2203, 2207(a)–(e),
Mar. 15, 2025
139 Stat. 43
, 44;
Pub. L. 119–26, § 4(2)(B)(vi)
July 16, 2025
139 Stat. 417
Pub. L. 119–37, div. F, title II
, §§ 6206, 6208(a)–(e),
Nov. 12, 2025
139 Stat. 632
, 633;
Pub. L. 119–75, div. J, title II
, §§ 6203, 6209(a)–(e), (g), 6212(a), 6221(b)(1),
Feb. 3, 2026
140 Stat. 646
, 648, 649, 652, 662.)
[1]
So in original. The semicolon probably should be a comma.
[2]
So in original. Subpar. (B) of par. (2) does not contain clauses.
[3]
So in original. Probably should be “a”.
[4]
So in original.
[5]
So in original. Two subpars. (G) have been enacted.
[6]
So in original. The period probably should be preceded by another closing parenthesis.
[7]
So in original. The second closing parenthesis probably should not appear.
[8]
So in original. Probably should be “determines”.
Editorial Notes
References in Text
Section 302(c)(1)(B) of the
Medicare
Prescription Drug, Improvement, and Modernization Act of 2003, referred to in subsec. (a)(14)(H)(i), is
section 302(c)(1)(B) of Pub. L. 108–173
, which is set out as a note under this section.
Section 4531(a) of the
Balanced Budget Act of 1997
, referred to in subsec. (l)(3)(A), is
section 4531(a) of Pub. L. 105–33
, which amended sections 1395u and 1395x of this title.
Section 515(a) of the
Medicare
Access and CHIP Reauthorization Act of 2015, referred to in subsec. (l)(16)(A), is
section 515(a) of Pub. L. 114–10
, title V,
Apr. 16, 2015
129 Stat. 174
, which relates to the initial expansion of prior authorization model for repetitive scheduled non-emergent ambulance transports and is not classified to the Code.
Codification
Amendment of subsec. (a)(4) by
Pub. L. 101–508, § 4152(c)(4)(B)(i)
, did not become effective pursuant to
Pub. L. 101–508, § 4152(c)(4)(B)(ii)
, because of action of
Secretary
in developing specific criteria for the
treatment
of wheelchairs as customized items for purposes of subsec. (a)(4). See Effective Date of 1990 Amendment note below.
Prior Provisions
A prior section 1395m, act Aug. 14, 1935, ch. 531, title XVIII, § 1834, as added
July 30, 1965
Pub. L. 89–97, title I, § 102(a)
79 Stat. 303
, prescribed limitations on payments for
home health services,
prior to repeal by
Pub. L. 96–499, title IX, § 930(i)
Dec. 5, 1980
94 Stat. 2631
, effective with respect to services furnished on or after
July 1, 1981
Amendments
2026—Subsec. (a)(23).
Pub. L. 119–75, § 6212(a)(1)
, added par. (23).
Subsec. (h)(3).
Pub. L. 119–75, § 6212(a)(2)
, inserted “, and paragraph (23) of subsection (a) shall apply to
prosthetic devices,
orthotics, and prosthetics in the same manner as such provision applies to items for which payment may be made under such subsection” before period at end.
Subsec. (l)(12)(A).
Pub. L. 119–75, § 6203(1)
, substituted “
January 1, 2028
” for “
January 31, 2026
”.
Subsec. (l)(13)(A).
Pub. L. 119–75, § 6203(2)
, substituted “
January 1, 2028
” for “
January 31, 2026
” wherever appearing.
Subsec. (m)(2)(B)(iii).
Pub. L. 119–75, § 6209(a)(1)
, substituted “ending
December 31, 2027
” for “ending
January 30, 2026
”.
Subsec. (m)(4)(C)(iii).
Pub. L. 119–75, § 6209(a)(2)
, substituted “ending on
December 31, 2027
” for “ending on
January 30, 2026
”.
Subsec. (m)(4)(E).
Pub. L. 119–75, § 6209(b)
, substituted “ending on
December 31, 2027
” for “ending on
January 30, 2026
”.
Subsec. (m)(7)(B)(i).
Pub. L. 119–75, § 6209(d)(1)
, substituted “on or after
January 1, 2028
” for “on or after
January 31, 2026
” in introductory provisions.
Subsec. (m)(8)(A).
Pub. L. 119–75, § 6209(c)
, substituted “ending on
December 31, 2027
” for “ending on
January 30, 2026
” in introductory provisions.
Subsec. (m)(9).
Pub. L. 119–75, § 6209(e)
, substituted “ending on
December 31, 2027
” for “ending on
January 30, 2026
”.
Subsec. (m)(10).
Pub. L. 119–75, § 6209(g)
, added par. (10).
Subsec. (o)(4)(B).
Pub. L. 119–75, § 6209(d)(3)
, substituted “
January 1, 2028
” for “
January 31, 2026
”.
Subsec. (y)(2).
Pub. L. 119–75, § 6209(d)(2)
, substituted “
January 1, 2028
” for “
January 31, 2026
”.
Subsec. (aa).
Pub. L. 119–75, § 6221(b)(1)
, added subsec. (aa).
2025—Subsec. (l)(12)(A).
Pub. L. 119–37, § 6206(1)
, substituted “
January 31, 2026
” for “
October 1, 2025
”.
Pub. L. 119–4, § 2203(1)
, substituted “
October 1, 2025
” for “
April 1, 2025
”.
Subsec. (l)(13)(A).
Pub. L. 119–37, § 6206(2)
, substituted “
January 31, 2026
” for “
October 1, 2025
” wherever appearing.
Pub. L. 119–4, § 2203(2)
, substituted “
October 1, 2025
” for “
April 1, 2025
” wherever appearing.
Subsec. (m)(2)(B)(iii).
Pub. L. 119–37, § 6208(a)(1)
, substituted “ending
January 30, 2026
” for “ending
September 30, 2025
”.
Pub. L. 119–4, § 2207(a)(1)
, substituted “ending
September 30, 2025
” for “ending
March 31, 2025
”.
Subsec. (m)(4)(C)(iii).
Pub. L. 119–37, § 6208(a)(2)
, substituted “ending on
January 30, 2026
” for “ending on
September 30, 2025
”.
Pub. L. 119–4, § 2207(a)(2)
, substituted “ending on
September 30, 2025
” for “ending on
March 31, 2025
”.
Subsec. (m)(4)(E).
Pub. L. 119–37, § 6208(b)
, substituted “ending on
January 30, 2026
” for “ending on
September 30, 2025
”.
Pub. L. 119–4, § 2207(b)
, substituted “ending on
September 30, 2025
” for “ending on
March 31, 2025
”.
Subsec. (m)(7)(B)(i).
Pub. L. 119–37, § 6208(d)(1)
, substituted “on or after
January 31, 2026
” for “on or after
October 1, 2025
” in introductory provisions.
Pub. L. 119–4, § 2207(d)(1)
, substituted “on or after
October 1, 2025
,” for “on or after
April 1, 2025
” in introductory provisions.
Subsec. (m)(8)(A).
Pub. L. 119–37, § 6208(c)
, substituted “ending on
January 30, 2026
” for “ending on
September 30, 2025
” in introductory provisions.
Pub. L. 119–4, § 2207(c)
, substituted “ending on
September 30, 2025
” for “ending on
March 31, 2025
” in introductory provisions.
Subsec. (m)(9).
Pub. L. 119–37, § 6208(e)
, substituted “ending on
January 30, 2026
” for “ending on
September 30, 2025
”.
Pub. L. 119–4, § 2207(e)
, substituted “ending on
September 30, 2025
” for “ending on
March 31, 2025
”.
Subsec. (o)(3)(C)(ii).
Pub. L. 119–26, § 4(2)(B)(vi)
, amended
Pub. L. 117–328, § 1262(b)(6)
. See 2022 Amendment note below.
Subsec. (o)(4)(B).
Pub. L. 119–37, § 6208(d)(3)
, substituted “
January 31, 2026
” for “
October 1, 2025
”.
Pub. L. 119–4, § 2207(d)(3)
, substituted “
October 1, 2025
” for “
April 1, 2025
”.
Subsec. (y)(2).
Pub. L. 119–37, § 6208(d)(2)
, substituted “
January 31, 2026
” for “
October 1, 2025
”.
Pub. L. 119–4, § 2207(d)(2)
, substituted “
October 1, 2025
” for “
April 1, 2025
”.
2024—Subsec. (l)(12)(A).
Pub. L. 118–158, § 3203(1)
, substituted “
April 1, 2025
” for “
January 1, 2025
”.
Subsec. (l)(13)(A).
Pub. L. 118–158, § 3203(2)
, substituted “
April 1, 2025
” for “
January 1, 2025
” wherever appearing.
Subsec. (m)(2)(B)(iii).
Pub. L. 118–158, § 3207(a)(1)
, substituted “ending
March 31, 2025
” for “ending
December 31, 2024
”.
Subsec. (m)(4)(C)(iii).
Pub. L. 118–158, § 3207(a)(2)
, substituted “ending on
March 31, 2025
” for “ending on
December 31, 2024
”.
Subsec. (m)(4)(E).
Pub. L. 118–158, § 3207(b)
, substituted “ending on
March 31, 2025
” for “ending on
December 31, 2024
”.
Subsec. (m)(7)(B)(i).
Pub. L. 118–158, § 3207(d)(1)
, substituted “on or after
April 1, 2025
” for “on or after
January 1, 2025
(or, if later, the first day after the end of the emergency period described in
section 1320b–5(g)(1)(B) of this title
)” in introductory provisions.
Subsec. (m)(8)(A).
Pub. L. 118–158, § 3207(c)
, substituted “ending on
March 31, 2025
” for “ending on
December 31, 2024
”.
Subsec. (m)(9).
Pub. L. 118–158, § 3207(e)
, substituted “ending on
March 31, 2025
” for “ending on
December 31, 2024
”.
Subsec. (o)(4)(B).
Pub. L. 118–158, § 3207(d)(3)
, substituted “
April 1, 2025
.” for “
January 1, 2025
(or, if later, the first day after the end of the emergency period described in
section 1320b–5(g)(1)(B) of this title
).”
Subsec. (y)(2).
Pub. L. 118–158, § 3207(d)(2)
, substituted “
April 1, 2025
.” for “
January 1, 2025
(or, if later, the first day after the end of the emergency period described in
section 1320b–5(g)(1)(B) of this title
).”
2022—Subsec. (a)(20)(D)(iv).
Pub. L. 117–328, § 4133(b)(1)
, added cl. (iv).
Subsec. (j)(5)(E).
Pub. L. 117–328, § 4134(c)(2)
, added subpar. (E), relating to items and services related to the
administration
of
intravenous immune globulin
furnished on or after
January 1, 2024
, after subpar. (D). Former subpar. (E), added by
Pub. L. 117–328, § 4133(b)(2)(B)
, redesignated (F). See note below.
Pub. L. 117–328, § 4133(b)(2)(B)
, added subpar. (E), relating to lymphedema compression
treatment
items, after subpar. (D). Former subpar. (E) redesignated (F).
Subsec. (j)(5)(F).
Pub. L. 117–328, § 4134(c)(1)
, redesignated subpar. (E), added by
Pub. L. 117–328, § 4133(b)(2)(B)
, relating to lymphedema compression
treatment
items, as (F). Former subpar. (F), as previously redesignated by
Pub. L. 117–328, § 4133(b)(2)(A)
, redesignated (G).
Pub. L. 117–328, § 4133(b)(2)(A)
, redesignated subpar. (E) as (F). Former subpar. (F) redesignated (G).
Subpar. (j)(5)(G).
Pub. L. 117–328, § 4134(c)(1)
, redesignated subpar. (F), as previously redesignated by
Pub. L. 117–328, § 4133(b)(2)(A)
, as (G).
Pub. L. 117–328, § 4133(b)(2)(A)
, redesignated subpar. (F) as (G).
Subsec. (l)(12)(A).
Pub. L. 117–328, § 4103(1)
, substituted “
January 1, 2025
” for “
January 1, 2023
”.
Subsec. (l)(13)(A).
Pub. L. 117–328, § 4103(2)
, substituted “
January 1, 2025
” for “
January 1, 2023
” wherever appearing.
Subsec. (l)(17)(F)(i).
Pub. L. 117–103, § 311
, substituted “Not later than the second June 15th following the date on which the
Secretary
transmits data for the first representative sample of providers and
suppliers
of ground ambulance services to the
Medicare
Payment Advisory Commission, and as determined necessary by such Commission thereafter,” for “Not later than
March 15, 2023
, and as determined necessary by the
Medicare
Payment Advisory Commission thereafter”.
Subsec. (m)(1).
Pub. L. 117–103
, §§ 302(1), 305(1), substituted “paragraphs (8) and (9)” for “paragraph (8)” and “(as defined in paragraph (4)(E))” for “(described in
section 1395u(b)(18)(C) of this title
)”.
Subsec. (m)(2)(B)(i).
Pub. L. 117–103, § 301(b)(1)
, substituted “clauses (ii) and (iii)” for “clause (ii)” in introductory provisions.
Subsec. (m)(2)(B)(iii).
Pub. L. 117–328, § 4113(a)(1)
, substituted “In the case that the emergency period described in
section 1320b–5(g)(1)(B) of this title
ends before
December 31, 2024
, with” for “With” and “that are furnished during the period beginning on the first day after the end of such emergency period and ending
December 31, 2024
” for “that are furnished during the 151-day period beginning on the first day after the end of the emergency period described in
section 1320b–5(g)(1)(B) of this title
”.
Pub. L. 117–103, § 301(b)(2)
, added cl. (iii).
Subsec. (m)(4)(C)(i).
Pub. L. 117–103, § 301(a)(1)(A)
, inserted “clause (iii) and” after “Except as provided in” in introductory provisions.
Subsec. (m)(4)(C)(iii).
Pub. L. 117–328, § 4113(a)(2)
, substituted “In the case that the emergency period described in
section 1320b–5(g)(1)(B) of this title
ends before
December 31, 2024
, with” for “With” and “that are furnished during the period beginning on the first day after the end of such emergency period and ending on
December 31, 2024
” for “that are furnished during the 151-day period beginning on the first day after the end of the emergency period described in
section 1320b–5(g)(1)(B) of this title
”.
Pub. L. 117–103, § 301(a)(1)(B)
, added cl. (iii).
Subsec. (m)(4)(E).
Pub. L. 117–328, § 4113(b)
, substituted “and, in the case that the emergency period described in
section 1320b–5(g)(1)(B) of this title
ends before
December 31, 2024
, for the period beginning on the first day after the end of such emergency period and ending on
December 31, 2024
” for “and, for the 151-day period beginning on the first day after the end of the emergency period described in
section 1320b–5(g)(1)(B) of this title
”.
Pub. L. 117–103, § 302(2)
, inserted before period at end: “and, for the 151-day period beginning on the first day after the end of the emergency period described in
section 1320b–5(g)(1)(B) of this title
, shall include a qualified occupational therapist (as such term is used in
section 1395x(g) of this title
), a qualified physical therapist (as such term is used in
section 1395x(p) of this title
), a qualified speech-language pathologist (as defined in section 1395x(ll)(4)(A) of this title), and a qualified audiologist (as defined in section 1395x(ll)(4)(B) of this title)”.
Subsec. (m)(7)(A).
Pub. L. 117–103, § 301(a)(2)
, inserted “or, for the period for which clause (iii) of paragraph (4)(C) applies, at any site described in such clause” before period at end.
Subsec. (m)(7)(B)(i).
Pub. L. 117–328, § 4113(d)(1)
, which directed the substitution of “on or after
January 1, 2025
(or, if later, the first day after the end of the emergency period described in
section 1320b–5(g)(1)(B) of this title
)” for “on or after the day that is the 152nd day after the end of the period at the end of the emergency sentence described in
section 1320b–5(g)(1)(B) of this title
)” in introductory provisions, was executed by making the substitution for “on or after the day that is the 152nd day after the end of the emergency period described in
section 1320b–5(g)(1)(B) of this title
)”, to reflect the probable intent of
Congress
Pub. L. 117–103, § 304(a)
, inserted “on or after the day that is the 152nd day after the end of the emergency period described in
section 1320b–5(g)(1)(B) of this title
)” after
“telehealth services
furnished” in introductory provisions.
Subsec. (m)(8).
Pub. L. 117–103, § 303(1)
, struck out “during emergency period” after “clinics” in heading.
Subsec. (m)(8)(A).
Pub. L. 117–328, § 4113(c)
, substituted “in the case that such emergency period ends before
December 31, 2024
, during the period beginning on the first day after the end of such emergency period and ending on
December 31, 2024
” for “during the 151-day period beginning on the first day after the end of such emergency period” in introductory provisions.
Pub. L. 117–103, § 303(2)
, inserted “and, during the 151-day period beginning on the first day after the end of such emergency period” after “
section 1320b–5(g)(1)(B) of this title
” in introductory provisions.
Subsec. (m)(8)(B)(i).
Pub. L. 117–103, § 303(3)
, substituted “the periods for which subparagraph (A) applies” for “such emergency period”.
Subsec. (m)(9).
Pub. L. 117–328, § 4113(e)
, substituted “In the case that the emergency period described in
section 1320b–5(g)(1)(B) of this title
ends before
December 31, 2024
, the
Secretary
shall continue to provide coverage and payment under this part for
telehealth services
identified in paragraph (4)(F)(i) as of
March 15, 2022
, that are furnished via an audio-only communications system during the period beginning on the first day after the end of such emergency period and ending on
December 31, 2024
” for “The
Secretary
shall continue to provide coverage and payment under this part for
telehealth services
identified in paragraph (4)(F)(i) as of
March 15, 2022
, that are furnished via an audio-only
telecommunications system
during the 151-day period beginning on the first day after the end of the emergency period described in
section 1320b–5(g)(1)(B) of this title
”.
Pub. L. 117–103, § 305(2)
, added par. (9).
Subsec. (o)(3)(C)(ii).
Pub. L. 117–328, § 1262(b)(6)
, as amended by
Pub. L. 119–26, § 4(2)(B)(vi)
, substituted “first begins prescribing narcotic
drugs
in schedule III, IV, or V of
section 812 of title 21
for the purpose of maintenance or detoxification
treatment
on or after
January 1, 2021
” for “first receives a waiver under
section 823(h) of title 21
on or after
January 1, 2019
”.
Pub. L. 117–215
substituted “823(h)” for “823(g)”.
Subsec. (o)(4).
Pub. L. 117–328, § 4113(d)(3)(A)
, struck out “to hospice patients” after
“federally qualified health centers”
in heading.
Pub. L. 117–103, § 304(c)
, substituted “certain” for “attending
physician”
in par. heading, designated existing provisions as subpar. (A) and inserted heading, and added subpar. (B).
Subsec. (o)(4)(B).
Pub. L. 117–328, § 4113(d)(3)(B)
, substituted “prior to
January 1, 2025
(or, if later, the first day after the end of the emergency period described in
section 1320b–5(g)(1)(B) of this title
)” for “prior to the day that is the 152nd day after the end of the emergency period described in
section 1320b–5(g)(1)(B) of this title
)”.
Subsec. (o)(5).
Pub. L. 117–328, § 4124(c)(1)
, added par. (5).
Subsec. (s)(3).
Pub. L. 117–328, § 4136(a)(1)
, amended par. (3) generally. Prior to amendment, text read as follows: “The separate payment amount established under this paragraph for an applicable disposable device for a year shall be equal to the amount of the payment that would be made under section 1395l(t) of this title (relating to payment for covered OPD services) for the year for the Level I Healthcare Common Procedure Coding System (HCPCS) code for which the description for a professional service includes the furnishing of such device.”
Subsec. (s)(4).
Pub. L. 117–328, § 4136(a)(2)
, added par. (4).
Subsec. (y).
Pub. L. 117–328, § 4124(c)(2)(A)
, which directed amendment of subsec. (y) by striking out “to hospice patients” in heading, could not be executed in view of the intervening amendment by
Pub. L. 117–328, § 4113(d)(2)(A)
. See below.
Pub. L. 117–328, § 4113(d)(2)(A)
, struck out “to hospice patients” after
“rural health clinics”
in heading.
Pub. L. 117–103, § 304(b)
, substituted “certain” for “attending
physician”
in heading, designated existing provisions as par. (1) and inserted heading, and added par. (2).
Subsec. (y)(2).
Pub. L. 117–328, § 4113(d)(2)(B)
, substituted “prior to
January 1, 2025
(or, if later, the first day after the end of the emergency period described in
section 1320b–5(g)(1)(B) of this title
)” for “prior to the day that is the 152nd day after the end of the emergency period described in
section 1320b–5(g)(1)(B) of this title
)”.
Subsec. (y)(3).
Pub. L. 117–328, § 4124(c)(2)(B)
, added par. (3).
Subsec. (z).
Pub. L. 117–328, § 4133(a)(2)(B)
, added subsec. (z).
2020—Subsec. (a)(9)(D).
Pub. L. 116–260, § 121(b)(1)
, made technical correction to
Pub. L. 105–33, § 4552(b)
. See 1997 Amendment note below.
Subsec. (a)(9)(D)(ii).
Pub. L. 116–260, § 121(a)
, inserted at end “The requirement of the preceding sentence shall not apply beginning with the second calendar quarter beginning on or after
December 27, 2020
.”
Subsec. (d)(2)(C)(ii), (3)(C)(ii).
Pub. L. 116–260, § 122(c)(1)
, substituted “Subject to section 1395l(a)(1)(Y) of this title, but notwithstanding” for “Notwithstanding” in introductory provisions.
Subsec. (d)(2)(D), (3)(D).
Pub. L. 116–260, § 122(c)(2)
, substituted “Subject to section 1395l(a)(1)(Y) of this title, if during” for “If during”.
Subsec. (m)(1).
Pub. L. 116–136, § 3704(1)
, substituted “Subject to paragraph (8), the
Secretary”
for “The
Secretary”
Subsec. (m)(2)(A).
Pub. L. 116–136, § 3704(2)
, substituted “Subject to paragraph (8), the
Secretary”
for “The
Secretary”
Subsec. (m)(4)(A).
Pub. L. 116–136, § 3704(3)(A)
, substituted “Subject to paragraph (8), the term” for “The term”.
Subsec. (m)(4)(C)(ii)(XI).
Pub. L. 116–260, § 125(c)
, added subcl. (XI).
Subsec. (m)(4)(F)(i).
Pub. L. 116–136, § 3704(3)(B)
, substituted “Subject to paragraph (8), the term” for “The term”.
Subsec. (m)(7).
Pub. L. 116–260, § 123(a)
, substituted “disorder services and mental health services furnished through telehealth” for “disorder services furnished through telehealth” in heading, designated existing provisions as subpar. (A) and inserted heading, inserted “or, on or after the first day after the end of the emergency period described in
section 1320b–5(g)(1)(B) of this title
, subject to subparagraph (B), to an
eligible telehealth individual
for purposes of diagnosis, evaluation, or
treatment
of a mental health disorder, as determined by the
Secretary,
” after “as determined by the
Secretary,
”, and added subpar. (B).
Subsec. (m)(8).
Pub. L. 116–136, § 3704(4)
, added par. (8).
Subsec. (o)(4).
Pub. L. 116–260, § 132(1)
, added par. (4).
Subsec. (x).
Pub. L. 116–260, § 125(a)(2)(B)
, added subsec. (x).
Subsec. (y).
Pub. L. 116–260, § 132(2)
, added subsec. (y).
2018—Subsec. (a)(2)(A)(iv).
Pub. L. 115–123, § 50411
, struck out “and before
October 1, 2018
,” after “
October 1, 2015
,”.
Subsec. (h)(5).
Pub. L. 115–123, § 50402
, added par. (5).
Subsec. (l)(12)(A).
Pub. L. 115–123, § 50203(a)(2)
, substituted “2023” for “2018”.
Subsec. (l)(13)(A).
Pub. L. 115–123, § 50203(a)(1)
, substituted “2023” for “2018” wherever appearing.
Subsec. (l)(15).
Pub. L. 115–123, § 53108
, substituted “during the period beginning on
October 1, 2013
, and ending on
September 30, 2018
, and by 23 percent for such services furnished on or after
October 1, 2018
” for “on or after
October 1, 2013
”.
Subsec. (l)(17).
Pub. L. 115–123, § 50203(b)
, added par. (17).
Subsec. (m)(2)(B).
Pub. L. 115–123, § 50302(b)(2)
, redesignated existing provisions as cl. (i), inserted heading, substituted “Subject to clause (ii), with respect to” for “With respect to”, redesignated former cls. (i) and (ii) as subcls. (I) and (II), respectively, of cl. (i), substituted “subclause (I) or this subclause” for “clause (i) or this clause” in subcl. (II), and added cl. (ii).
Subsec. (m)(2)(B)(i).
Pub. L. 115–271, § 2001(a)(1)(A)
, substituted “clause (ii) and paragraph (6)(C)” for “clause (ii)” in introductory provisions.
Subsec. (m)(2)(B)(ii).
Pub. L. 115–271, § 2001(a)(1)(B)
, struck out “for home dialysis therapy” after “site” in heading.
Subsec. (m)(4)(C)(i).
Pub. L. 115–271, § 2001(a)(2)(A)
, substituted “paragraphs (5), (6), and (7)” for “paragraph (6)” in introductory provisions.
Pub. L. 115–123, § 50325(1)
, substituted “Except as provided in paragraph (6), the term” for “The term” in introductory provisions.
Subsec. (m)(4)(C)(ii)(IX).
Pub. L. 115–123, § 50302(b)(1)(A)
, added subcl. (IX).
Subsec. (m)(4)(C)(ii)(X).
Pub. L. 115–271, § 2001(a)(2)(B)
, inserted “or
telehealth services
described in paragraph (7)” before period at end.
Pub. L. 115–123, § 50302(b)(1)(A)
, added subcl. (X).
Subsec. (m)(5).
Pub. L. 115–123, § 50302(b)(1)(B)
, added par. (5).
Subsec. (m)(6).
Pub. L. 115–123, § 50325(2)
, added par. (6).
Subsec. (m)(7).
Pub. L. 115–271, § 2001(a)(3)
, added par. (7).
Subsec. (o)(3).
Pub. L. 115–271, § 6083(a)
, added par. (3).
Subsec. (u)(7).
Pub. L. 115–123, § 50401(a)
, added par. (7).
Subsec. (v).
Pub. L. 115–123, § 53107
, added subsec. (v).
Subsec. (w).
Pub. L. 115–271, § 2005(c)(2)
, added subsec. (w).
2016—Subsec. (a)(1)(G).
Pub. L. 114–255, § 16008(a)
, inserted at end “In the case of items and services furnished on or after
January 1, 2019
, in making any adjustments under clause (ii) or (iii) of subparagraph (F), under subsection (h)(1)(H)(ii), or under
section 1395u(s)(3)(B) of this title
, the
Secretary
shall—” and added cls. (i) and (ii).
Subsec. (h)(1)(H)(ii).
Pub. L. 114–255, § 16008(b)(1)
, substituted “subject to subsection (a)(1)(G), the
Secretary”
for “the
Secretary”
Subsec. (t).
Pub. L. 114–255, § 4011
, added subsec. (t).
Subsec. (u).
Pub. L. 114–255, § 5012(b)
, added subsec. (u).
2015—Subsec. (a)(2)(A)(iv).
Pub. L. 114–40
added cl. (iv).
Subsec. (a)(11)(B)(ii).
Pub. L. 114–10, § 504(a)
, struck out “the
physician
documenting that” after “written pursuant to” and substituted “documenting such
physician,
physician
assistant,
practitioner,
or specialist has had a face-to-face encounter” for “has had a face-to-face encounter”.
Subsec. (l)(12)(A).
Pub. L. 114–10, § 203(b)
, substituted “
January 1, 2018
” for “
April 1, 2015
”.
Subsec. (l)(13)(A).
Pub. L. 114–10, § 203(a)
, substituted “
January 1, 2018
” for “
April 1, 2015
” wherever appearing.
Subsec. (l)(16).
Pub. L. 114–10, § 515(b)
, added par. (16).
Subsec. (r).
Pub. L. 114–27
added subsec. (r).
Subsec. (s).
Pub. L. 114–113
added subsec. (s).
2014—Subsec. (a)(1)(I).
Pub. L. 113–295
added subpar. (I).
Subsec. (l)(12)(A).
Pub. L. 113–93, § 104(b)
, substituted “
April 1, 2015
” for “
April 1, 2014
”.
Subsec. (l)(13)(A).
Pub. L. 113–93, § 104(a)
, substituted “
April 1, 2015
” for “
April 1, 2014
” wherever appearing.
Subsec. (p).
Pub. L. 113–93, § 218(a)(1)
, added subsec. (p).
Subsec. (q).
Pub. L. 113–93, § 218(b)(1)
, added subsec. (q).
2013—Subsec. (a)(1)(F).
Pub. L. 112–240, § 636(a)(1)
, substituted “subparagraphs (G) and (H)” for “subparagraph (G)” in introductory provisions.
Subsec. (a)(1)(H).
Pub. L. 112–240, § 636(a)(2)
, added subpar. (H).
Subsec. (a)(22).
Pub. L. 112–240, § 636(b)
, added par. (22).
Subsec. (k)(7).
Pub. L. 112–240, § 633(b)
, added par. (7).
Subsec. (l)(12)(A).
Pub. L. 113–67, § 1104(b)
, substituted “
April 1, 2014
” for “
January 1, 2014
”.
Pub. L. 112–240, § 604(c)
, substituted “
January 1, 2014
” for “
January 1, 2013
”.
Subsec. (l)(13)(A).
Pub. L. 113–67, § 1104(a)
, substituted “
April 1, 2014
” for “
January 1, 2014
” wherever appearing.
Pub. L. 112–240, § 604(a)
, substituted “
January 1, 2014
” for “
January 1, 2013
” wherever appearing.
Subsec. (l)(15).
Pub. L. 112–240, § 637
, added par. (15).
2012—Subsec. (l)(12)(A).
Pub. L. 112–96, § 3007(c)
, substituted “
January 1, 2013
” for “
March 1, 2012
”.
Subsec. (l)(13)(A).
Pub. L. 112–96, § 3007(a)
, substituted “
January 1, 2013
” for “
March 1, 2012
” wherever appearing.
2011—Subsec. (l)(12)(A).
Pub. L. 112–78, § 306(c)
, substituted “
March 1, 2012
” for “
January 1, 2012
”.
Subsec. (l)(13)(A).
Pub. L. 112–78, § 306(a)
, substituted “
March 1, 2012
” for “
January 1, 2012
” wherever appearing.
2010—Subsec. (a)(1)(F)(ii).
Pub. L. 111–148, § 6410(b)(2)(A)
, inserted “(and, in the case of
covered items
furnished on or after
January 1, 2016
, subject to clause (iii), shall)” after “may”.
Subsec. (a)(1)(F)(iii).
Pub. L. 111–148, § 6410(b)(1)
, (2)(B), (3), added cl. (iii).
Subsec. (a)(7)(A)(i)(II).
Pub. L. 111–148, § 3136(a)(1)(A)
, inserted “subclause (III) and” after “Subject to”.
Subsec. (a)(7)(A)(i)(III).
Pub. L. 111–148, § 3136(a)(1)(B)
, added subcl. (III).
Subsec. (a)(7)(A)(iii).
Pub. L. 111–148, § 3136(a)(2)(B)
, inserted “complex, rehabilitative” after “case of a”.
Pub. L. 111–148, § 3136(a)(2)(A)
, inserted “complex, rehabilitative” after “option for” in heading.
Subsec. (a)(7)(C)(ii)(II).
Pub. L. 111–148, § 3136(b)
, struck out “(A)(ii) or” after “subparagraph”.
Subsec. (a)(11)(B).
Pub. L. 111–148, § 6407(b)(1)
, designated existing provisions as cl. (i) and inserted heading.
Pub. L. 111–148, § 6405(a)
, substituted
“physician
enrolled under
section 1395cc(j) of this title
or an eligible professional under
section 1395w–4(k)(3)(B) of this title
that is enrolled under
section 1395cc(j) of this title
” for
“physician”
Subsec. (a)(11)(B)(ii).
Pub. L. 111–148, § 6407(b)(2)
, added cl. (ii).
Subsec. (a)(14).
Pub. L. 111–148, § 3401(m)(3)
, inserted concluding provisions.
Subsec. (a)(14)(K).
Pub. L. 111–148, § 3401(m)(1)
, struck out “2011, 2012, and 2013,” after “2010,” and inserted “and” at the end.
Subsec. (a)(14)(L), (M).
Pub. L. 111–148, § 3401(m)(2)
, added subpar. (L) and struck out former subpars. (L) and (M) which read as follows:
“(L) for 2014—
“(i) in the case of items and services described in subparagraph (J)(i) for which a payment adjustment has not been made under subsection (a)(1)(F)(ii) in any previous year, the percentage increase in the consumer price index for all urban consumers (U.S. urban average) for the 12-month period ending with June 2013, plus 2.0 percentage points; or
“(ii) in the case of other items and services, the percentage increase in the consumer price index for all urban consumers (U.S. urban average) for the 12-month period ending with June 2013; and
“(M) for a subsequent year, the percentage increase in the consumer price index for all urban consumers (U.S. urban average) for the 12-month period ending with June of the previous year.”
Subsec. (a)(16)(B).
Pub. L. 111–148, § 6402(g)(1)
, inserted “that the
Secretary
determines is commensurate with the volume of the billing of the
supplier”
after “$50,000”.
Subsec. (a)(20)(F)(i).
Pub. L. 111–148, § 3109(a)(1)(B)
, which directed amendment by inserting “, except that the
Secretary
shall not require a pharmacy to have submitted to the
Secretary
such evidence of accreditation prior to
January 1, 2011
” before semicolon “at the end”, was executed by making the insertion before “; and” to reflect the probable intent of
Congress
Pub. L. 111–148, § 3109(a)(1)(A)
, inserted “and subparagraph (G)” after “clause (ii)”.
Subsec. (a)(20)(G).
Pub. L. 111–148, § 3109(a)(2)
, added subpar. (G).
Subsec. (g)(2)(A).
Pub. L. 111–148, § 3128(a)
, inserted “101 percent of” after “subparagraph (B),”.
Subsec. (g)(2)(B).
Pub. L. 111–148, § 5501(b)(2)
, substituted “Subsections (x) and (y) of section 1395l” for “Section 1395l(x)”.
Pub. L. 111–148, § 5501(a)(2)
, inserted at end “Section 1395l(x) of this title shall not be taken into account in determining the amounts that would otherwise be paid pursuant to the preceding sentence.”
Subsec. (h)(4)(A).
Pub. L. 111–148, § 3401(n)(1)(D)
, inserted concluding provisions.
Subsec. (h)(4)(A)(x).
Pub. L. 111–148, § 3401(n)(1)(B)(i)
, substituted “for each of 2007 through 2010” for “a subsequent year”.
Subsec. (h)(4)(A)(xi).
Pub. L. 111–148, § 3401(n)(1)(A)
, (B)(ii), (C), added cl. (xi).
Subsec. (l)(3).
Pub. L. 111–148, § 3401(j)(4)
, inserted concluding provisions.
Subsec. (l)(3)(B).
Pub. L. 111–148, § 3401(j)(2)(A)
, inserted “, subject to subparagraph (C) and the succeeding sentence of this paragraph,” after “increased”.
Subsec. (l)(3)(C).
Pub. L. 111–148, § 3401(j)(1)
, (2)(B), (3), added subpar. (C).
Subsec. (l)(8).
Pub. L. 111–148, § 3128(a)
, inserted “101 percent of” after “pay” in introductory provisions.
Subsec. (l)(12)(A).
Pub. L. 111–309, § 106(c)
, substituted “2012” for “2011”.
Pub. L. 111–148, § 10311(c)
, substituted “2011” for “2010, and on or after
April 1, 2010
, and before
January 1, 2011
”.
Pub. L. 111–148, § 3105(c)
, substituted “2010, and on or after
April 1, 2010
, and before
January 1, 2011
” for “2010”.
Subsec. (l)(13)(A).
Pub. L. 111–309, § 106(a)(1)
, substituted “2012,” for “2011” in introductory provisions.
Pub. L. 111–148, § 10311(a)(1)
, in introductory provisions, substituted “2007, and for” for “2007, for” and “2011” for “2010, and for such services furnished on or after
April 1, 2010
, and before
January 1, 2011
”.
Pub. L. 111–148, § 3105(a)(1)
, in introductory provisions, substituted “2007, for” for “2007, and for” and “2010, and for such services furnished on or after
April 1, 2010
, and before
January 1, 2011
,” for “2010”.
Subsec. (l)(13)(A)(i), (ii).
Pub. L. 111–309, § 106(a)(2)
, substituted “
January 1, 2012
” for “
January 1, 2011
”.
Pub. L. 111–148, § 10311(a)(2)(B)
, substituted “
January 1, 2011
” for “
January 1, 2010
”.
Pub. L. 111–148, § 10311(a)(2)(A)
, struck out “, and on or after
April 1, 2010
, and before
January 1, 2011
” after “
January 1, 2010
”.
Pub. L. 111–148, § 3105(a)(2)
, inserted “, and on or after
April 1, 2010
, and before
January 1, 2011
” after “
January 1, 2010
”.
Subsec. (n).
Pub. L. 111–148, § 5502(b)
, which directed the addition of subsec. (n) relating to development and implementation of prospective payment system, was repealed by
Pub. L. 111–148, § 10501(i)(1)
Pub. L. 111–148, § 4105(a)
, added subsec. (n) relating to authority to modify or eliminate coverage of certain
preventive services.
Subsec. (o).
Pub. L. 111–148, § 10501(i)(3)(A)
, added subsec. (o).
2009—Subsec. (a)(20)(F)(i).
Pub. L. 111–72
inserted “, except that the
Secretary
shall not require under this clause pharmacies to obtain such accreditation before
January 1, 2010
” before semicolon.
2008—Subsec. (a)(1)(E)(ii).
Pub. L. 110–275, § 154(d)(2)
, substituted “1395x(r)” for “1395x(r)(1)”.
Subsec. (a)(1)(F).
Pub. L. 110–275, § 154(a)(3)
, (4)(A)(i), in introductory provisions, substituted “
January 1, 2011
” for “
January 1, 2009
” and inserted “subject to subparagraph (G),” before “that are included”.
Subsec. (a)(1)(G).
Pub. L. 110–275, § 154(a)(4)(A)(ii)
, added subpar. (G).
Subsec. (a)(5)(F).
Pub. L. 110–275, § 144(b)(1)
, substituted “Rental cap” for “Ownership of equipment” in heading, added cl. (ii), and struck out former cl. (ii) which related to transfer of title to equipment and payments for oxygen and maintenance and servicing.
Subsec. (a)(14)(J) to (M).
Pub. L. 110–275, § 154(a)(2)(A)
, added subpars. (J) to (L) and redesignated former subpar. (J) as (M).
Subsec. (a)(20)(B).
Pub. L. 110–275, § 125(b)(5)
, substituted “section 1395bb(a)” for “section 1395bb(b)”.
Subsec. (a)(20)(E).
Pub. L. 110–275, § 154(b)(1)(A)(i)
, inserted “including subparagraph (F),” after “under this paragraph,”.
Subsec. (a)(20)(F).
Pub. L. 110–275, § 154(b)(1)(A)(ii)
, added subpar. (F).
Subsec. (e).
Pub. L. 110–275, § 135(a)(1)
, added subsec. (e).
Subsec. (g)(4).
Pub. L. 110–275, § 148(a)
, substituted
“Treatment
of” for “No beneficiary cost-sharing for” in heading and inserted at end “For purposes of the preceding sentence and
section 1395x(mm)(3) of this title
, clinical diagnostic laboratory services furnished by a
critical access hospital
shall be treated as being furnished as part of outpatient critical access services without regard to whether the individual with respect to whom such services are furnished is physically present in the
critical access hospital,
or in a
skilled nursing facility
or a clinic (including a
rural health clinic)
that is operated by a
critical access hospital,
at the time the specimen is collected.”
Subsec. (h)(1)(H).
Pub. L. 110–275, § 154(a)(3)
, (4)(B), in introductory provisions, substituted “
January 1, 2011
” for “
January 1, 2009
” and inserted “subject to subsection (a)(1)(G),” before “that are included”.
Subsec. (l)(13)(A).
Pub. L. 110–275, § 146(a)(1)
, inserted “and for such services furnished on or after
July 1, 2008
, and before
January 1, 2010
” after “2007,” in introductory provisions, “(or 3 percent if such service is furnished on or after
July 1, 2008
, and before
January 1, 2010
)” after “2 percent” in cl. (i), and “(or 2 percent if such service is furnished on or after
July 1, 2008
, and before
January 1, 2010
)” after “1 percent” in cl. (ii).
Subsec. (l)(13)(B).
Pub. L. 110–275, § 146(a)(2)
, substituted
“applicable period”
for “2006” in heading and inserted “applicable” before “period” in text.
Subsec. (l)(14)(B)(i).
Pub. L. 110–275, § 146(b)(2)(A)
, substituted “certifies or reasonably determines” for “reasonably determines or certifies”.
Subsec. (m)(4)(C)(ii)(VI) to (VIII).
Pub. L. 110–275, § 149(a)
, added subcls. (VI) to (VIII).
2006—Subsec. (a)(5)(A).
Pub. L. 109–171, § 5101(b)(1)(A)
, substituted “(E), and (F)” for “and (E)”.
Subsec. (a)(5)(F).
Pub. L. 109–171, § 5101(b)(1)(B)
, added subpar. (F).
Subsec. (a)(7)(A).
Pub. L. 109–171, § 5101(a)(1)
, amended heading and text of subpar. (A) generally, revising and restating as cls. (i) to (iv) provisions of former cls. (i) to (vi).
Subsec. (d)(2)(C)(ii).
Pub. L. 109–171, § 5113(b)
, struck out “deductible and” before “coinsurance” in heading and struck out “deductible or” before “copayment” and before “coinsurance” in subcl. (I).
Subsec. (d)(3)(C)(ii).
Pub. L. 109–171, § 5113(b)
, struck out “deductible and” before “coinsurance” in heading and struck out “deductible or” before “coinsurance” in two places in subcl. (I).
2003—Subsec. (a)(1)(B).
Pub. L. 108–173, § 302(d)(1)(A)
, substituted “Subject to subparagraph (F)(i), the payment basis” for “The payment basis” in introductory provisions.
Subsec. (a)(1)(C).
Pub. L. 108–173, § 302(d)(1)(B)
, substituted “Subject to subparagraph (F)(ii), this subsection” for “This subsection”.
Subsec. (a)(1)(E).
Pub. L. 108–173, § 302(a)(2)
, added subpar. (E).
Subsec. (a)(1)(F).
Pub. L. 108–173, § 302(d)(1)(C)
, added subpar. (F).
Subsec. (a)(10)(B).
Pub. L. 108–173, § 302(d)(1)(D)
, inserted “in an area and with respect to
covered items
and services for which the
Secretary
does not make a payment amount adjustment under paragraph (1)(F)” after “under this subsection”.
Subsec. (a)(14)(F).
Pub. L. 108–173, § 302(c)(1)(A)(ii)
, substituted “2003” for “a subsequent year” and “2002;” for “the previous year.”
Subsec. (a)(14)(G) to (J).
Pub. L. 108–173, § 302(c)(1)(A)(i)
, (iii), added subpars (G) to (J).
Subsec. (a)(17), (19).
Pub. L. 108–173, § 302(a)(1)(A)
, redesignated par. (17), relating to certain upgraded items, as (19) and transferred it to the end of subsec. (a).
Subsec. (a)(20).
Pub. L. 108–173, § 302(a)(1)(B)
, added par. (20).
Subsec. (a)(21).
Pub. L. 108–173, § 302(c)(2)
, added par. (21).
Subsec. (b)(4)(D)(iv).
Pub. L. 108–173, § 736(b)(4)
, substituted “clause (vi)” for “clauses (vi)”.
Subsec. (g)(1).
Pub. L. 108–173, § 405(a)(1)
, inserted “equal to 101 percent of” before “the reasonable costs”.
Subsec. (g)(2).
Pub. L. 108–173, § 405(d)(1)
, inserted concluding provisions.
Subsec. (g)(5).
Pub. L. 108–173, § 405(b)(1)
, in heading, inserted “certain” before “emergency” and substituted “providers” for
“physicians”
, and, in text, substituted
“physicians,
physician
assistants, nurse
practitioners,
and
clinical nurse specialists
who are on-call (as defined by the
Secretary)
to provide emergency services” for “emergency room
physicians
who are on-call (as defined by the
Secretary)
” and “services covered under this subchapter” for
“physicians’
services”.
Subsec. (h)(1)(B).
Pub. L. 108–173, § 302(d)(2)(A)
, substituted “, (E), and (H)(i)” for “and (E)” in introductory provisions.
Subsec. (h)(1)(D).
Pub. L. 108–173, § 302(d)(2)(B)
, substituted “Subject to subparagraph (H)(ii), this subsection” for “This subsection”.
Subsec. (h)(1)(H).
Pub. L. 108–173, § 302(d)(2)(C)
, added subpar. (H).
Subsec. (h)(4)(A)(viii).
Pub. L. 108–173, § 302(c)(3)(B)
, substituted “2003” for “a subsequent year”.
Subsec. (h)(4)(A)(ix), (x).
Pub. L. 108–173, § 302(c)(3)(A)
, (C), added cls. (ix) and (x).
Subsec. (h)(4)(C).
Pub. L. 108–173, § 627(b)(1)
, inserted “(and includes shoes described in
section 1395x(s)(12) of this title
)” after “in
section 1395x(s)(9) of this title
”.
Subsec. (l)(2)(E).
Pub. L. 108–173, § 414(a)(1)
, inserted “consistent with paragraph (11)” after “in an efficient and fair manner”.
Subsec. (l)(8), (9).
Pub. L. 108–173, § 414(a)(2)
, redesignated par. (8), relating to transitional assistance for rural providers, as (9).
Subsec. (l)(10).
Pub. L. 108–173, § 414(a)(3)
, added par. (10).
Subsec. (l)(11).
Pub. L. 108–173, § 414(b)
, added par. (11).
Subsec. (l)(12).
Pub. L. 108–173, § 414(c)(1)
, added par. (12).
Subsec. (l)(13).
Pub. L. 108–173, § 414(d)
, added par. (13).
Subsec. (l)(14).
Pub. L. 108–173, § 415(a)
, added par. (14).
Subsec. (m)(4)(C)(ii)(III).
Pub. L. 108–173, § 736(b)(5)
, substituted “1395x(aa)(2)” for “1395x(aa)(s)”.
2000—Subsec. (a)(14)(C).
Pub. L. 106–554, § 1(a)(6) [title IV, § 425(a)(2)]
, substituted “through 2000” for “through 2002” and struck out “and” at end.
Subsec. (a)(14)(D) to (F).
Pub. L. 106–554, § 1(a)(6) [title IV, § 425(a)(1), (3)]
, added subpars. (D) and (E) and redesignated former subpar. (D) as (F).
Subsec. (c).
Pub. L. 106–554, § 1(a)(6) [title I, § 104(b)]
, amended heading and text generally, substituting present provisions for provisions which had set forth similar standards for
screening mammography
but had provided for payment limited to 80 percent of the least of the actual charge, a statutory fee schedule, if applicable, or the indexed dollar limit described, and which had set forth provisions relating to reduction of indexed dollar limit, application of limit in a
hospital
outpatient setting, and limitation of charges of nonparticipating
physicians.
Subsec. (d)(2)(E)(ii).
Pub. L. 106–554, § 1(a)(6) [title I, § 103(b)(1)]
, inserted before period at end “or, in the case of an individual who is not at high risk for colorectal cancer, if the procedure is performed within the 119 months after a previous screening colonoscopy”.
Subsec. (d)(3).
Pub. L. 106–554, § 1(a)(6) [title I, § 103(b)(2)(A)]
, struck out “for individuals at high risk for colorectal cancer” after “colonoscopy” in heading.
Subsec. (d)(3)(A).
Pub. L. 106–554, § 1(a)(6) [title I, § 103(b)(2)(B)]
, struck out “for individuals at high risk for colorectal cancer (as defined in
section 1395x(pp)(2) of this title
)” after “screening colonoscopy”.
Subsec. (d)(3)(E).
Pub. L. 106–554, § 1(a)(6) [title I, § 103(b)(2)(C)]
, inserted before period at end “or for other individuals if the procedure is performed within the 119 months after a previous screening colonoscopy or within 47 months after a previous screening flexible sigmoidoscopy”.
Subsec. (g)(2)(B).
Pub. L. 106–554, § 1(a)(6) [title II, § 202(a)]
, inserted “115 percent of” before “such amounts”.
Subsec. (g)(4).
Pub. L. 106–554, § 1(a)(6) [title II, § 201(a)]
, added par. (4).
Subsec. (g)(5).
Pub. L. 106–554, § 1(a)(6) [title II, § 204(a)]
, added par. (5).
Subsec. (h)(1)(F).
Pub. L. 106–554, § 1(a)(6) [title IV, § 427(a)]
, added subpar. (F).
Subsec. (h)(1)(G).
Pub. L. 106–554, § 1(a)(6) [title IV, § 428(a)]
, added subpar. (G).
Subsec. (h)(4)(A)(v).
Pub. L. 106–554, § 1(a)(6) [title IV, § 426(a)(2)]
, substituted “through 2000” for “through 2002” and struck out “and” at end.
Subsec. (h)(4)(A)(vi) to (viii).
Pub. L. 106–554, § 1(a)(6) [title IV, § 426(a)(1), (3)]
, added cls. (vi) and (vii) and redesignated former cl. (vi) as (viii).
Subsec. (l)(2)(E).
Pub. L. 106–554, § 1(a)(6) [title IV, § 423(b)(1)]
, inserted before period at end “, except that such phase-in shall provide for full payment of any national mileage rate for ambulance services provided by
suppliers
that are paid by
carriers
in any of the 50
States
where payment by a
carrier
for such services for all such
suppliers
in such
State
did not, prior to the implementation of the fee schedule, include a separate amount for all mileage within the county from which the beneficiary is transported”.
Subsec. (l)(3)(A), (B).
Pub. L. 106–554, § 1(a)(6) [title IV, § 423(a)(1)]
, substituted “reduced in the case of 2002” for “reduced in the case of 2001 and 2002”.
Subsec. (l)(8).
Pub. L. 106–554, § 1(a)(6) [title II, § 221(a)]
, added par. (8) relating to transitional assistance for rural providers.
Pub. L. 106–554, § 1(a)(6) [title II, § 205(a)]
, added par. (8) relating to services furnished by
critical access hospitals.
Subsec. (m).
Pub. L. 106–554, § 1(a)(6) [title II, § 223(b)]
, added subsec. (m).
1999—Subsec. (a)(13).
Pub. L. 106–113, § 1000(a)(6) [title II, § 201(e)(2)(A)]
, substituted “1395x(m)(5) of this title, but not including implantable items for which payment may be made under section 1395l(t) of this title” for “1395x(m)(5) of this title)”.
Subsec. (g).
Pub. L. 106–113, § 1000(a)(6) [title IV, § 403(d)(1)]
, amended heading and text of subsec. (g) generally. Prior to amendment, text read as follows: “The amount of payment under this part for
outpatient critical access hospital services
is the reasonable costs of the
critical access hospital
in providing such services.”
Subsec. (h)(4)(A)(i).
Pub. L. 106–113, § 1000(a)(6) [title III, § 321(k)(3)(A)]
, substituted semicolon for comma at end.
Subsec. (h)(4)(A)(v).
Pub. L. 106–113, § 1000(a)(6) [title III, § 321(k)(3)(B)]
, substituted “; and” for “, and” at end.
Subsec. (h)(4)(B).
Pub. L. 106–113, § 1000(a)(6) [title II, § 201(e)(2)(B)]
, inserted “and does not include an implantable item for which payment may be made under section 1395l(t) of this title” before the semicolon.
1997—Subsec. (a)(2)(B)(iv).
Pub. L. 105–33, § 4105(b)(2)
, inserted before period at end “(reduced by 10 percent, in the case of a blood glucose testing strip furnished after 1997 for an individual with diabetes)”.
Subsec. (a)(9)(B)(iv).
Pub. L. 105–33, § 4552(a)(2)(A)
, substituted “1995, 1996, and 1997” for “each subsequent year”.
Subsec. (a)(9)(B)(v), (vi).
Pub. L. 105–33, § 4552(a)(1)
, (2)(B), (3), added cls. (v) and (vi).
Subsec. (a)(9)(D).
Pub. L. 105–33, § 4552(b)
, as amended by
Pub. L. 116–260, § 121(b)(1)
, added subpar. (D).
Subsec. (a)(10)(B).
Pub. L. 105–33, § 4316(b)
, substituted “The
Secretary”
for “For
covered items
furnished on or after
January 1, 1991
, the
Secretary”
and struck out “(other than subparagraph (D))” before “of
section 1395u(b) of this title
” and “as such provisions would otherwise apply to
physicians’
services and
physicians
and a reasonable charge under
section 1395u(b) of this title
but for the application of
section 1395w–4(i)(3) of this title
. In applying such provisions to payments for an item under this subsection, the
Secretary
shall make adjustments to the payment basis for the item described in paragraph (1)(B) if the
Secretary
determines (in accordance with such provisions and on the basis of prices and costs applicable at the time the item is furnished) that such payment basis is not inherently reasonable” before period at end.
Subsec. (a)(14)(B).
Pub. L. 105–33, § 4551(a)(1)(B)(i)
, substituted “1993, 1994, 1995, 1996, and 1997” for “a subsequent year”.
Subsec. (a)(14)(C), (D).
Pub. L. 105–33, § 4551(a)(1)(A)
, (B)(ii), (C), added subpars. (C) and (D).
Subsec. (a)(16).
Pub. L. 105–33, § 4312(c)
, inserted at end “The
Secretary,
at the
Secretary’
s discretion, may impose the requirements of the first sentence with respect to some or all providers of items or services under part A or some or all
suppliers
or other
persons
(other than
physicians
or other
practitioners,
as defined in
section 1395u(b)(18)(C) of this title
) who furnish items or services under this part.”
Pub. L. 105–33, § 4312(a)
, added par. (16).
Subsec. (a)(17).
Pub. L. 105–33, § 4551(c)(1)
, added par. (17) relating to certain upgraded items.
Subsec. (c)(1)(C).
Pub. L. 105–33, § 4101(c)
, in introductory provisions, struck out “, subject to the deductible established under section 1395l(b) of this title,” before “be equal to 80”.
Subsec. (c)(2)(A)(iii).
Pub. L. 105–33, § 4101(a)(1)
, amended cl. (iii) generally. Prior to amendment, cl. (iii) read as follows: “In the case of a woman over 39 years of age, but under 50 years of age, who—
“(I) is at a high risk of developing breast cancer (as determined pursuant to factors identified by the
Secretary
), payment may not be made under this part for a
screening mammography
performed within the 11 months following the month in which a previous
screening mammography
was performed, or
“(II) is not at a high risk of developing breast cancer, payment may not be made under this part for a
screening mammography
performed within the 23 months following the month in which a previous
screening mammography
was performed.”
Subsec. (c)(2)(A)(iv), (v).
Pub. L. 105–33, § 4101(a)(2)
, struck out cls. (iv) and (v), which read as follows:
“(iv) In the case of a woman over 49 years of age, but under 65 years of age, payment may not be made under this part for
screening mammography
performed within 11 months following the month in which a previous
screening mammography
was performed.
“(v) In the case of a woman over 64 years of age, payment may not be made for
screening mammography
performed within 23 months following the month in which a previous
screening mammography
was performed.”
Subsec. (d).
Pub. L. 105–33, § 4104(b)(1)
, added subsec. (d).
Subsec. (g).
Pub. L. 105–33, § 4201(c)(5)
, amended heading and text of subsec. (g) generally. Prior to amendment, text related to payment for outpatient rural primary care
hospital
services as determined, in par. (1), by either the cost-based facility fee plus professional charges method or the all-inclusive rate method and, in par. (2), by the prospective payment system.
Subsec. (h)(4)(A)(iv).
Pub. L. 105–33, § 4551(a)(2)(B)
, substituted “1996 and 1997” for “a subsequent year”.
Subsec. (h)(4)(A)(v), (vi).
Pub. L. 105–33, § 4551(a)(2)(A)
, (C), added cls. (v) and (vi).
Subsec. (k).
Pub. L. 105–33, § 4541(a)(2)
, added subsec. (k).
Subsec. (l).
Pub. L. 105–33, § 4531(b)(2)
, added subsec. (l).
1994—Subsec. (a)(3)(D).
Pub. L. 103–432, § 135(e)(5)
, struck out heading and text of subpar. (D). Text read as follows: “If the reasonable useful lifetime of such an item, as established under paragraph (7)(C), has been reached during a continuous period of medical need, or the
Secretary
determines on the basis of investigation by the
carrier
that the item is lost or irreparably damaged, payment for an item serving as a replacement for such item shall be made on a monthly basis for the rental of the replacement item in accordance with subparagraph (A).”
Subsec. (a)(5)(E).
Pub. L. 103–432, § 135(d)(1)
, substituted “pressure of 56” for “pressure of 55”.
Subsec. (a)(7).
Pub. L. 103–432, § 135(e)(2)
, made technical amendment to directory language of
Pub. L. 101–508, § 4152(c)(2)
. See 1990 Amendment note below.
Subsec. (a)(7)(A)(iii)(II).
Pub. L. 103–432, § 135(e)(3)
, substituted “clause (vi)” for “clause (v)”.
Subsec. (a)(7)(C)(i).
Pub. L. 103–432, § 135(e)(4)
, substituted “this paragraph” for “this paragraph or paragraph (3)”.
Subsec. (a)(10)(B).
Pub. L. 103–432, § 134(a)(1)
, inserted at end “In applying such provisions to payments for an item under this subsection, the
Secretary
shall make adjustments to the payment basis for the item described in paragraph (1)(B) if the
Secretary
determines (in accordance with such provisions and on the basis of prices and costs applicable at the time the item is furnished) that such payment basis is not inherently reasonable.”
Pub. L. 103–432, § 126(g)(10)(B)
, substituted “would otherwise apply to
physicians’
services” for “apply to
physicians’
services” and inserted before period at end “but for the application of
section 1395w–4(i)(3) of this title
”.
Subsec. (a)(14)(A).
Pub. L. 103–432, § 135(a)(1)
, amended subpar. (A) generally. Prior to amendment, subpar. (A) read as follows: “for 1991 and 1992, reduction of 1 percentage point; and”.
Subsec. (a)(15).
Pub. L. 103–432, § 135(b)(1)
, amended heading and text of par. (15) generally. Prior to amendment, text read as follows:
“(A)
Development of list of items by secretary
.—The
Secretary
shall develop and periodically update a list of items for which payment may be made under this subsection that the
Secretary
determines, on the basis of prior payment experience, are frequently subject to unnecessary utilization, and shall include in such list seat-lift mechanisms, transcutaneous electrical nerve stimulators, and motorized scooters.
“(B)
Determinations of coverage in advance
.—A
carrier
shall determine in advance whether payment for an item included on the list developed by the
Secretary
under subparagraph (A) may not be made because of the application of
section 1395y(a)(1) of this title
.”
Subsec. (a)(16).
Pub. L. 103–432, § 131(a)(2)
, struck out heading and text of par. (16). Text read as follows:
“(A)
In general
.—A
supplier
of a
covered item
under this subsection may not distribute to
physicians
or to individuals entitled to benefits under this part for commercial purposes any completed or partially completed forms or other documents required by the
Secretary
to be submitted to show that a
covered item
is reasonable and necessary for the diagnosis or
treatment
of illness or injury or to improve the functioning of a malformed body member.
“(B)
Penalty
.—Any
supplier
of a
covered item
who knowingly and willfully distributes a form or other document in violation of subparagraph (A) is subject to a civil money penalty in an amount not to exceed $1,000 for each such form or document so distributed. The provisions of
section 1320a–7a of this title
(other than subsections (a) and (b)) shall apply to civil money penalties under this subparagraph in the same manner as they apply to a penalty or proceeding under
section 1320a–7a(a) of this title
.”
Subsec. (a)(17), (18).
Pub. L. 103–432, § 132(a)(1)
, (2), added pars. (17) and (18).
Subsec. (b)(4)(D).
Pub. L. 103–432, § 126(b)(2)(A)
, in introductory provisions substituted “shall, subject to clause (vii), be reduced to the adjusted conversion factor for the locality determined as follows:” for “shall be determined as follows:”.
Subsec. (b)(4)(D)(iv).
Pub. L. 103–432, § 126(b)(2)(B)
, substituted “Adjusted conversion factor” for “Local adjustment” in heading and “The adjusted conversion factor for” for “Subject to clause (vii), the conversion factor to be applied to” in text.
Subsec. (b)(4)(D)(vii).
Pub. L. 103–432, § 126(b)(2)(C)
, (D), struck out “under this subparagraph” after “applied to a locality” and inserted “reduced under this subparagraph by” before “more than 9.5 percent”.
Subsec. (b)(4)(E).
Pub. L. 103–432, § 126(b)(5)
, inserted heading “Rule for certain scanning services”.
Pub. L. 103–432, § 126(b)(4)
, made technical amendment to directory language of
Pub. L. 101–508, § 4102(d)
. See 1990 Amendment note below.
Pub. L. 103–432, § 126(b)(1)
, redesignated subpar. (E), relating to subsequent updating, as (F).
Subsec. (b)(4)(F), (G).
Pub. L. 103–432, § 126(b)(1)
, redesignated subpars. (E), relating to subsequent updating, and (F) as (F) and (G), respectively.
Subsec. (c)(1)(B).
Pub. L. 103–432, § 145(a)(1)
, substituted “is conducted by a facility that has a certificate (or provisional certificate) issued under
section 263b of this title
” for “meets the quality standards established under paragraph (3)”.
Subsec. (c)(1)(C)(iii).
Pub. L. 103–432, § 145(a)(2)
, substituted “paragraph (3)” for “paragraph (4)”.
Subsec. (c)(3) to (5).
Pub. L. 103–432, § 145(a)(3)
, (4), redesignated pars. (4) and (5) as (3) and (4), respectively, and struck out former par. (3) which directed
Secretary
to establish standards to assure the safety and accuracy of
screening mammography
performed under this part.
Subsec. (f).
Pub. L. 103–432, § 126(g)(1)
, substituted “during 1991” for “during fiscal year 1991” in heading.
Subsec. (g)(1).
Pub. L. 103–432, § 102(e)(1)(A)
, (2), substituted in introductory provisions “during a year before the prospective payment system described in paragraph (2) is in effect” for “during a year before 1993” and inserted at end “The amount of payment shall be determined under either method without regard to the amount of the customary or other charge.”
Subsec. (g)(1)(B).
Pub. L. 103–432, § 156(a)(2)(C)
, struck out “and for items and services furnished in connection with obtaining a second opinion required under
section 1320c–13(c)(2) of this title
, or a third opinion, if the second opinion was in disagreement with the first opinion” after “
section 1395x(s)(10)(A) of this title
”.
Subsec. (g)(2).
Pub. L. 103–432, § 102(e)(1)(B)
, substituted “
January 1, 1996
” for “
January 1, 1993
”.
Subsec. (h)(3).
Pub. L. 103–432, § 135(b)(3)
, substituted “Paragraphs (12), (15), and (17)” for “Paragraphs (12) and (17)”.
Pub. L. 103–432, § 132(b)
, substituted “Paragraphs (12) and (17)” for “Paragraph (12)”.
Subsec. (j).
Pub. L. 103–432, § 131(a)(1)
, added subsec. (j).
Subsec. (j)(4), (5).
Pub. L. 103–432, § 133(a)(1)
, added par. (4) and redesignated former par. (4) as (5).
1993—Subsec. (a)(1)(D).
Pub. L. 103–66, § 13545(a)
, substituted “45 percent” for “15 percent” after “(as previously reduced) by”.
Subsec. (a)(2)(A)(iii).
Pub. L. 103–66, § 13543(b)
, added cl. (iii).
Subsec. (a)(2)(C).
Pub. L. 103–66, § 13542(a)(1)
, in cl. (i)(II), substituted “for 1992, 1993, and 1994” for “for 1992” and “update for the year” for “update for 1992”, and in cl. (ii), struck out “and” at end of subcl. (I), added subcls. (II) and (III), and redesignated former subcl. (II) as (IV).
Subsec. (a)(3)(A).
Pub. L. 103–66, § 13543(a)
, substituted “IPPB machines and ventilators, excluding ventilators that are either continuous airway pressure devices or
intermittent
assist devices with continuous airway pressure devices” for “ventilators, aspirators, IPPB machines, and nebulizers”.
Subsec. (a)(3)(C).
Pub. L. 103–66, § 13542(a)(1)
, in cl. (i)(II), substituted “for 1992, 1993, and 1994” for “for 1992” and “update for the year” for “update for 1992”, and in cl. (ii), struck out “and” at end of subcl. (I), added subcls. (II) and (III), and redesignated former subcl. (II) as (IV).
Subsec. (a)(8)(A)(ii)(III).
Pub. L. 103–66, § 13542(a)(2)(A)
, substituted “1992, 1993, and 1994” for “1992”.
Subsec. (a)(8)(B)(ii) to (iv).
Pub. L. 103–66, § 13542(a)(2)(B)
, added cls. (ii) and (iii) and redesignated former cl. (ii) as (iv).
Subsec. (a)(9)(A)(ii)(II).
Pub. L. 103–66, § 13542(a)(3)(A)
, substituted “1991, 1992, 1993, and 1994” for “1991 and 1992”.
Subsec. (a)(9)(B)(ii) to (iv).
Pub. L. 103–66, § 13542(a)(3)(B)
, added cls. (ii) and (iii) and redesignated former cl. (ii) as (iv).
Subsec. (h)(1)(B).
Pub. L. 103–66, § 13544(a)(2)
, substituted “subparagraphs (C) and (E)” for “subparagraph (C)” in introductory provisions.
Subsec. (h)(1)(E).
Pub. L. 103–66, § 13544(a)(1)
, added subpar. (E).
Subsec. (h)(4)(A).
Pub. L. 103–66, § 13546
, struck out “and” at end of cl. (i), substituted “1992 and 1993” for “a subsequent year” in cl. (ii), and added cls. (iii) and (iv).
Subsec. (i).
Pub. L. 103–66, § 13544(b)(1)
, added subsec. (i).
1990—Subsec. (a).
Pub. L. 101–508, § 4153(a)(2)(D)(i)
, struck out “,
prosthetic devices,
orthotics, and prosthetics” after “medical equipment” in heading.
Subsec. (a)(1)(D).
Pub. L. 101–508, § 4152(a)(1)
, inserted before period at end “, and, in the case of a transcutaneous electrical nerve stimulator furnished on or after
January 1, 1991
, the
Secretary
shall further reduce such payment amount (as previously reduced) by 15 percent”.
Subsec. (a)(2)(A).
Pub. L. 101–508, § 4153(a)(2)(D)(ii)
, substituted “(13)” for “(13)(A)”.
Pub. L. 101–508, § 4152(c)(4)(A)
, inserted “or” after “$150,” in cl. (i), struck out “or” after “purchase,” in cl. (ii), and struck out cl. (iii) which read as follows: “which is a power-driven wheelchair (other than a customized wheelchair that is classified as a customized item under paragraph (4) pursuant to criteria specified by the
Secretary)
,”.
Subsec. (a)(2)(B).
Pub. L. 101–508, § 4152(b)(1)(A)
, (B), struck out “or” after “1987;” in cl. (i), added cls. (ii) to (iv), and struck out former cl. (ii) which read as follows: “in a subsequent year, is the amount specified in this subparagraph for the preceding year increased by the percentage increase in the consumer price index for all urban consumers (U.S. city average) for the 12-month period ending with June of that preceding year.”
Subsec. (a)(2)(C).
Pub. L. 101–508, § 4152(b)(1)(C)
, added subpar. (C).
Subsec. (a)(3)(B).
Pub. L. 101–508, § 4152(b)(1)(A)
, (B), struck out “or” after “1987;” in cl. (i), added cls. (ii) to (iv), and struck out former cl. (ii) which read as follows: “in a subsequent year, is the amount specified in this subparagraph for the preceding year increased by the percentage increase in the consumer price index for all urban consumers (U.S. city average) for the 12-month period ending with June of that preceding year.”
Subsec. (a)(3)(C).
Pub. L. 101–508, § 4152(b)(1)(C)
, added subpar. (C).
Subsec. (a)(3)(D).
Pub. L. 101–508, § 4152(c)(3)
, added subpar. (D).
Subsec. (a)(4).
Pub. L. 101–508, § 4152(c)(4)(B)(i)
, directed amendment of par. (4) by inserting at end “In the case of a wheelchair furnished on or after
January 1, 1992
, the wheelchair shall be treated as a customized item for purposes of this paragraph if the wheelchair has been measured, fitted, or adapted in consideration of the patient’s body size, disability, period of need, or intended use, and has been assembled by a
supplier
or ordered from a manufacturer who makes available customized features, modifications, or components for wheelchairs that are intended for an individual patient’s use in accordance with instructions from the patient’s
physician.
” The amendment did not become effective pursuant to
Pub. L. 101–508, § 4152(c)(4)(B)(ii)
. See Effective Date of 1990 Amendment note below.
Subsec. (a)(5)(A).
Pub. L. 101–508, § 4152(g)(1)(A)
, substituted “(B), (C), and (E)” for “(B) and (C)”.
Subsec. (a)(5)(E).
Pub. L. 101–508, § 4152(g)(1)(B)
, added subpar. (E).
Subsec. (a)(7)(A)(i).
Pub. L. 101–508, § 4152(c)(2)(A)
, as amended by
Pub. L. 103–432, § 135(e)(2)
, substituted “15 months, or, in the case of an item for which a purchase agreement has been entered into under clause (iii), a period of continuous use of longer than 13 months” for “15 months”.
Pub. L. 101–508, § 4152(c)(1)
, substituted “for each of the first 3 months of such period” for “for each such month” and “, and for each of the remaining months of such period is 7.5 percent of such purchase price;” for semicolon at end.
Subsec. (a)(7)(A)(ii), (iii).
Pub. L. 101–508, § 4152(c)(2)(D)
, as amended by
Pub. L. 103–432, § 135(e)(2)
, added cls. (ii) and (iii). Former cls. (ii) and (iii) redesignated (iv) and (v), respectively.
Subsec. (a)(7)(A)(iv).
Pub. L. 101–508, § 4152(c)(2)(B)
, as amended by
Pub. L. 103–432, § 135(e)(2)
, redesignated cl. (ii) as (iv), substituted “in the case of an item for which a purchase agreement has not been entered into under clause (ii) or clause (iii), during the first 6-month period of medical need that follows the period of medical need during which payment is made under clause (i),” for “during the succeeding 6-month period of medical need,” and struck out “and” at end.
Subsec. (a)(7)(A)(v).
Pub. L. 101–508, § 4152(c)(2)(C)
, as amended by
Pub. L. 103–432, § 135(e)(2)
, redesignated cl. (iii) as (v), inserted at beginning “in the case of an item for which a purchase agreement has not been entered into under clause (ii) or clause (iii),”, and substituted “; and” for period at end.
Subsec. (a)(7)(A)(vi).
Pub. L. 101–508, § 4152(c)(2)(E)
, as amended by
Pub. L. 103–432, § 135(e)(2)
, added cl. (vi).
Subsec. (a)(7)(C).
Pub. L. 101–508, § 4152(c)(2)(F)
, as amended by
Pub. L. 103–432, § 135(e)(2)
, added subpar. (C).
Subsec. (a)(8)(A)(ii).
Pub. L. 101–508, § 4152(b)(2)(A)
, added subcl. (II), redesignated former subcl. (II) as (III), struck out “1991 or” before “1992”, and substituted “the
covered item update
for the year” for “the percentage increase in the consumer price index for all urban consumers (U.S. city average) for the 12-month period ending with June of the previous year”.
Subsec. (a)(8)(B).
Pub. L. 101–508, § 4152(b)(2)(B)
, amended subpar. (B) generally. Prior to amendment, subpar. (B) read as follows: “With respect to the furnishing of a particular item in each region (as defined by the
Secretary)
, the
Secretary
shall compute a regional purchase price—
“(i) for 1991 and for 1992, equal to the average (weighted by relative volume of all claims among
carriers
) of the local purchase prices for the
carriers
in the region computed under subparagraph (A)(ii)(II) for the year, and
“(ii) for each subsequent year, equal to the regional purchase price computed under this subparagraph for the previous year increased by the percentage increase in the consumer price index for all urban consumers (U.S. city average) for the 12-month period ending with June of the previous year.”
Subsec. (a)(8)(C).
Pub. L. 101–508, § 4152(b)(2)(C)(ii)
, struck out “and subject to subparagraph (D)” after “and (7)” in introductory provisions.
Subsec. (a)(8)(C)(ii).
Pub. L. 101–508, § 4152(b)(2)(C)(i)
, (iii), in subcl. (I) substituted “67 percent” for “75 percent” and in subcl. (II) substituted “33 percent” for “25 percent” and “national limited purchase price” for “regional purchase price”.
Subsec. (a)(8)(C)(iii).
Pub. L. 101–508, § 4152(b)(2)(C)(i)
, (iv), in subcl. (I) substituted “33 percent” for “50 percent” and “subparagraph (A)(ii)(III)” for “subparagraph (A)(ii)(II)” and in subcl. (II) substituted “67 percent” for “50 percent” and “national limited purchase price” for “regional purchase price”.
Subsec. (a)(8)(C)(iv).
Pub. L. 101–508, § 4152(b)(2)(C)(i)
, substituted “national limited purchase price” for “regional purchase price”.
Subsec. (a)(8)(D).
Pub. L. 101–508, § 4152(b)(2)(D)
, struck out subpar. (D) which read as follows: “The amount that is recognized under subparagraph (C) as the purchase price for an item furnished—
“(i) in 1991, may not exceed 125 percent, and may not be lower than 85 percent, of the average of the purchase prices recognized under such subparagraph for all the
carrier
service areas in the
United States
in that year; and
“(ii) in a subsequent year, may not exceed 120 percent, and may not be lower than 90 percent, of the average of the purchase prices recognized under such subparagraph for all the
carrier
service areas in the
United States
in that year.”
Subsec. (a)(9)(A)(ii)(II).
Pub. L. 101–508, § 4152(b)(3)(A)
, substituted “the
covered item
increase for the year” for “the percentage increase in the consumer price index for all urban consumers (U.S. city average) for the 12-month period ending with June of the previous year”.
Subsec. (a)(9)(B).
Pub. L. 101–508, § 4152(b)(3)(B)
, amended subpar. (B) generally. Prior to amendment, subpar. (B) read as follows: “With respect to the furnishing of an item in each region (as defined by the
Secretary)
, the
Secretary
shall compute a regional monthly payment rate—
“(i) for 1991 and 1992, equal to the average (weighted by relative volume of all claims among
carriers
) of the local monthly payment rates for the
carriers
in the region computed under subparagraph (A)(ii)(II) for the year, and
“(ii) for each subsequent year, equal to the regional monthly payment rates computed under this subparagraph for the previous year increased by the percentage increase in the consumer price index for all urban consumers (U.S. city average) for the 12-month period ending with June of the previous year.”
Subsec. (a)(9)(C)(ii).
Pub. L. 101–508, § 4152(b)(3)(C)(i)
, (ii), in subcl. (I) substituted “67 percent” for “75 percent” and in subcl. (II) substituted “33 percent” for “25 percent” and “national limited monthly payment rate” for “regional monthly payment rate”.
Subsec. (a)(9)(C)(iii).
Pub. L. 101–508, § 4152(b)(3)(C)(i)
, (iii), in subcl. (I) substituted “33 percent” for “50 percent” and in subcl. (II) substituted “67 percent” for “50 percent”, “national limited monthly payment rate” for “regional monthly payment rate”, and “subparagraph (B)(ii)” for “subparagraph (B)(i)”.
Subsec. (a)(9)(C)(iv).
Pub. L. 101–508, § 4152(b)(3)(C)(i)
, substituted “national limited monthly payment rate” for “regional monthly payment rate”.
Subsec. (a)(9)(D).
Pub. L. 101–508, § 4152(b)(3)(D)
, struck out subpar. (D) which read as follows: “The amount that is recognized under subparagraph (C) as the base monthly payment amount for an item furnished—
“(i) in 1991, may not exceed 125 percent, and may not be lower than 85 percent, of the average of the base monthly payment amounts recognized under such subparagraph for all the
carrier
service areas in the
United States
in that year; and
“(ii) in a subsequent year, may not exceed 120 percent, and may not be lower than 90 percent, of the average of the base monthly payment amounts recognized under such subparagraph for all the
carrier
service areas in the
United States
in that year.”
Subsec. (a)(12).
Pub. L. 101–508, § 4152(b)(5)
, struck out “defined for purposes of paragraphs (8)(B) and (9)(B)” after “one or more entire regions”.
Subsec. (a)(13).
Pub. L. 101–508, § 4153(a)(2)(D)(iii)
, substituted “means
durable medical equipment
(as defined in
section 1395x(n) of this title
), including such equipment described in
section 1395x(m)(5) of this title
).” for “means—
“(A)
durable medical equipment
(as defined in
section 1395x(n) of this title
), including such equipment described in
section 1395x(m)(5) of this title
“(B)
prosthetic devices
(described in
section 1395x(s)(8) of this title
), but not including parenteral and enteral nutrition nutrients, supplies, and equipment; and
“(C)
orthotics and prosthetics
(described in
section 1395x(s)(9) of this title
);
but does not include intraocular lenses or medical supplies (including catheters, catheter supplies, ostomy bags, and supplies related to ostomy care) furnished by a
home health agency
under
section 1395x(m)(5) of this title
.”
Subsec. (a)(14).
Pub. L. 101–508, § 4152(b)(4)
, added par. (14).
Subsec. (a)(15).
Pub. L. 101–508, § 4152(e)
, added par. (15).
Subsec. (a)(16).
Pub. L. 101–508, § 4152(f)(1)
, added par. (16).
Subsec. (b)(1)(B).
Pub. L. 101–508, § 4163(b)(1)
, inserted “and subject to subsection (c)(1)(A)” after “conversion factors”.
Pub. L. 101–508, § 4102(f)
, inserted “locality,” after “statewide,”.
Subsec. (b)(4)(D).
Pub. L. 101–508, § 4102(a)(2)
, added subpar. (D). Former subpar. (D) redesignated (E) relating to subsequent updating.
Subsec. (b)(4)(E).
Pub. L. 101–508, § 4102(d)
, as amended by
Pub. L. 103–432, § 126(b)(4)
, added subpar. (E) relating to rule for certain scanning services.
Pub. L. 101–508, § 4102(a)(1)
, redesignated subpar. (D), relating to subsequent updating, as (E). Former subpar. (E) redesignated (F).
Subsec. (b)(4)(F).
Pub. L. 101–508, § 4102(a)(1)
, redesignated subpar. (E) as (F).
Subsec. (c).
Pub. L. 101–508, § 4163(b)(2)
, added subsec. (c).
Subsec. (f).
Pub. L. 101–508, § 4104(a)
, amended subsec. (f) generally, substituting provisions relating to reduction in payments for
physician
pathology services during 1991 for provisions directing
Secretary
to provide for application of a fee schedule with respect to such services.
Subsec. (h).
Pub. L. 101–508, § 4153(a)(1)
, added subsec. (h).
1989—Subsec. (a)(1)(D).
Pub. L. 101–239, § 6112(c)
, added subpar. (D).
Subsec. (a)(2)(A)(iii).
Pub. L. 101–239, § 6112(d)(1)
, added cl. (iii).
Subsec. (a)(2)(B)(i), (3)(B)(i).
Pub. L. 101–239, § 6112(a)(1)
, inserted “and in 1990” after “1989”.
Subsec. (a)(7)(A)(i).
Pub. L. 101–239, § 6112(a)(4)(A)
, substituted “this clause” for “this subparagraph”.
Subsec. (a)(7)(B)(i).
Pub. L. 101–239, § 6112(a)(4)(B)
, inserted “in” after “rental of the item”.
Subsec. (a)(7)(B)(ii).
Pub. L. 101–239, § 6112(a)(4)(C)
, substituted “clause (i) shall apply in the same manner as it applies to items furnished during 1989” for “the payment amount recognized under subparagraph (A)(i) shall not be more than the maximum amount established under clause (i), and shall not be less than the minimum amount established under such clause, for 1989, each such amount increased by the percentage increase in the consumer price index for all urban consumers (U.S. city average) for the 12-month period ending with June 1989”.
Subsec. (a)(8)(A)(ii)(I).
Pub. L. 101–239, § 6112(a)(2)(A)
, inserted “and 1990” after “1989”.
Subsec. (a)(8)(A)(ii)(II).
Pub. L. 101–239, § 6112(a)(2)(B)
, substituted “1991 or 1992” for “1990, 1991, or 1992”.
Subsec. (a)(8)(D)(i).
Pub. L. 101–239, § 6140(1)
, substituted “1991, may not exceed 125 percent, and may not be lower than 85 percent” for “1991, may not exceed 130 percent, and may not be lower than 80 percent”.
Subsec. (a)(8)(D)(ii).
Pub. L. 101–239, § 6140(2)
, substituted “120 percent, and may not be lower than 90 percent” for “125 percent, and may not be lower than 85 percent”.
Subsec. (a)(9)(A)(ii)(I).
Pub. L. 101–239, § 6112(a)(3)(A)
, inserted “and 1990” after “1989”.
Subsec. (a)(9)(A)(ii)(II).
Pub. L. 101–239, § 6112(a)(3)(B)
, substituted “1991 and 1992” for “1990, 1991, and 1992”.
Subsec. (a)(9)(D)(i).
Pub. L. 101–239, § 6140(1)
, substituted “1991, may not exceed 125 percent, and may not be lower than 85 percent” for “1991, may not exceed 130 percent, and may not be lower than 80 percent”.
Subsec. (a)(9)(D)(ii).
Pub. L. 101–239, § 6140(2)
, substituted “120 percent, and may not be lower than 90 percent” for “125 percent, and may not be lower than 85 percent”.
Subsec. (a)(13).
Pub. L. 101–239, § 6112(e)(2)
, inserted before period at end “or medical supplies (including catheters, catheter supplies, ostomy bags, and supplies related to ostomy care) furnished by a
home health agency
under
section 1395x(m)(5) of this title
”.
Subsec. (b)(1)(B).
Pub. L. 101–234, § 201(a)
, repealed
Pub. L. 100–360, § 204(b)(1)
, and provided that the provisions of law amended or repealed by such section are restored or revived as if such section had not been enacted, see 1988 Amendment note below.
Subsec. (b)(4)(A).
Pub. L. 101–234, § 301(b)(1)
, (c)(1), amended subpar. (A) identically, substituting “coinsurance and deductibles under sections 1395l(a)(1)(J)” for “insurance and deductibles under section 1395n(a)(1)(I)”.
Subsec. (b)(4)(C) to (E).
Pub. L. 101–239, § 6105(a)
, added subpar. (C) and redesignated former subpars. (C) and (D) as (D) and (E), respectively.
Subsecs. (c) to (e).
Pub. L. 101–234, § 201(a)
, repealed
Pub. L. 100–360
, §§ 202(b)(4), 203(c)(1)(F), 204(b)(2), and provided that the provisions of law amended or repealed by such sections are restored or revived as if such sections had not been enacted, see 1988 Amendment notes below.
Subsec. (f).
Pub. L. 101–239, § 6102(f)(1)
, added subsec. (f).
Subsec. (g).
Pub. L. 101–239, § 6116(b)(2)
, added subsec. (g).
1988—
Pub. L. 100–360, § 411(g)(1)(A)
, inserted “items and” in section catchline.
Subsec. (a)(1)(C).
Pub. L. 100–360, § 411(g)(1)(B)(i)
, inserted “or under part A to a
home health agency”
before period at end.
Subsec. (a)(2)(A).
Pub. L. 100–360, § 411(g)(1)(B)(iii)
, struck out “rental” before “payments” in concluding provisions.
Subsec. (a)(2)(B)(i).
Pub. L. 100–360, § 411(g)(1)
(B)(iii), substituted “reasonable” for “allowed”.
Subsec. (a)(3)(A).
Pub. L. 100–360, § 411(g)(1)(B)(iv)
, struck out the extra space appearing in text of original act after “ventilators”.
Subsec. (a)(3)(B)(i).
Pub. L. 100–360, § 411(g)(1)
(B)(iii), substituted “reasonable” for “allowable”.
Subsec. (a)(4).
Pub. L. 100–360, § 411(g)(1)
(B)(v)–(vii), inserted “, and for that reason cannot be grouped with similar items for purposes of payment under this subchapter,” after “individual patient”, inserted cl. (A) and (B) designations, and in cl. (B), substituted “servicing” for “service” in two places.
Subsec. (a)(7)(A)(ii).
Pub. L. 100–360, § 411(g)(1)
(B)(vii), inserted “maintenance and” before “servicing”.
Subsec. (a)(7)(A)(iii).
Pub. L. 100–360, § 411(g)(1)
(B)(vii), (viii), substituted “maintenance and servicing” for “service and maintenance”, and in subcl. (I) substituted “fee or fees established by the
Secretary”
for “fee established by the
carrier”
Subsec. (a)(7)(B)(i).
Pub. L. 100–360, § 411(a)(3)(A)
, (C)(ii), provided that subsec. (a)(7)(B)(i) of this section, as inserted by
section 4062(b) of Pub. L. 100–203
, is deemed to have a reference to “1987” immediately after “December”.
Subsec. (a)(8)(A)(i)(I).
Pub. L. 100–360, § 411(g)(1)
(B)(iii), substituted “reasonable” for “allowable”.
Subsec. (a)(8)(B).
Pub. L. 100–360, § 411(g)(1)(B)(xi)
, as amended
Pub. L. 100–485, § 608(d)(22)(A)(i)
, substituted “(as defined by the
Secretary)
” for “(as defined in
section 1395ww(d)(2)(D) of this title
)”, and in cl. (i) struck out the comma after “1991”.
Subsec. (a)(9)(A)(ii)(I).
Pub. L. 100–360, § 411(g)(1)
(B)(ix), substituted “6-month” for “12-month”.
Subsec. (a)(9)(A)(ii)(II).
Pub. L. 100–360, § 411(g)(1)
(B)(x), substituted “, 1991, and 1992” for “and to 1991”.
Subsec. (a)(9)(B).
Pub. L. 100–360, § 411(g)(1)(B)(xi)
, as amended by
Pub. L. 100–485, § 608(d)(22)(A)(i)
, substituted “(as defined by the
Secretary)
” for “(as defined in
section 1395ww(d)(2)(D) of this title
)”, and in cl. (i) struck out the comma after “1991”.
Subsec. (a)(9)(C)(i).
Pub. L. 100–360, § 411(g)(1)
(B)(xii), substituted “subparagraph (A)(ii)” for “subparagraph (A)(ii)(I)”.
Subsec. (a)(10)(B).
Pub. L. 100–360, § 411(g)(1)
(B)(xiii), inserted before period at end “and payments under this subsection as such provisions apply to
physicians’
services and
physicians
and a reasonable charge under
section 1395u(b) of this title
”.
Subsec. (a)(11)(A).
Pub. L. 100–360, § 411(g)(1)
(B)(vii), (xiv), inserted “maintenance and” before “servicing” and substituted “
section 1395u(j)(2) of this title
” for “subsection (j)(2) of this section”.
Subsec. (a)(12).
Pub. L. 100–360, § 411(g)(1)(B)(xv)
, as amended by
Pub. L. 100–485, § 608(d)(22)(A)(ii)
, substituted “one or more entire regions defined for purposes of paragraphs (8)(B) and (9)(B)” for “each region (as defined in
section 1395ww(d)(2)(D) of this title
)”.
Subsec. (a)(14).
Pub. L. 100–360, § 411(g)(1)(B)(xvi)
, struck out par. (14) which read as follows: “In this subsection, any reference to the term
‘carrier’
includes a reference, with respect to
durable medical equipment
furnished by a
home health agency
as part of
home health services,
to a fiscal intermediary.”
Subsec. (b).
Pub. L. 100–360, § 411(a)(3)(A)
, (B)(ii), (f)(8)(B)(ii), amended
Pub. L. 100–203, § 4049(a)(2)
, see 1987 Amendment note below.
Subsec. (b)(1)(B).
Pub. L. 100–360, § 204(b)(1)
, inserted “and subject to subsection (e)(1)(A) of this section” after “conversion factors”.
Subsec. (b)(4)(C).
Pub. L. 100–360, § 411(f)(8)(D)(ii)
, as added by
Pub. L. 100–485, § 608(d)(21)(C)
, substituted “For radiologist” for “Radiologist” and “1395u(i)(3) of this title” for “1395u(b)(4)(E)(ii) of this title”.
Subsec. (b)(4)(D), (5).
Pub. L. 100–360, § 411(f)(8)(D)(i)
, inserted “and
suppliers”
after
“physicians”
in heading.
Subsec. (b)(5)(C).
Pub. L. 100–360, § 411(f)(8)(D)(iii)
, (iv), formerly (ii), (iii), as redesignated by
Pub. L. 100–485, § 608(d)(21)(C)
, substituted “bills” for “imposes a charge” and inserted “in the same manner as such sanctions may apply to a
physician”
before period at end.
Subsec. (b)(6).
Pub. L. 100–360, § 411(f)(8)(D)(v)
, formerly (iv), as redesignated by
Pub. L. 100–485, § 608(d)(21)(C)
, substituted “and section 1395l(a)(1)(J) of this title” for “, section 1395l(a)(1)(I) of this title, and
section 1395u(h)(1)(B) of this title
”.
Pub. L. 100–360, § 411(f)(8)(A)
, substituted “radiology” for “radiologic”.
Subsec. (b)(6)(B).
Pub. L. 100–360, § 411(f)(8)(D)(vi)
, formerly (v), as redesignated by
Pub. L. 100–485, § 608(d)(21)(C)
, substituted “the total amount of charges” for “billings”.
Pub. L. 100–360, § 411(f)(8)(A)
, substituted “radiology” for “radiologic”.
Subsec. (c).
Pub. L. 100–360, § 202(b)(4)
, added subsec. (c) relating to payment for covered outpatient
drugs.
Subsec. (d).
Pub. L. 100–360, § 203(c)(1)(F)
, added subsec. (d) relating to home intravenous drug therapy services.
Subsec. (e).
Pub. L. 100–360, § 204(b)(2)
, added subsec. (e) relating to payments and standards for
screening mammography.
1987—Subsec. (b).
Pub. L. 100–203, § 4049(a)(2)
, as amended by
Pub. L. 100–360, § 411(a)(3)(A)
, (B)(ii), (f)(8)(B)(ii), added subsec. (b).
Statutory Notes and Related Subsidiaries
Effective Date of 2025 Amendment
Pub. L. 119–26, § 4
July 16, 2025
139 Stat. 416
, provided that the amendment made by section 4(2)(B)(vi) is effective as if included in the enactment of
Pub. L. 117–328
Effective Date of 2022 Amendment
Amendment by
section 4124(c) of Pub. L. 117–328
applicable with respect to items and services furnished on or after
Jan. 1, 2024
, see
section 4124(d) of Pub. L. 117–328
, set out as a note under section 1395k of this section.
Effective Date of 2020 Amendment
Pub. L. 116–260, div. CC, title I, § 121(b)(2)
Dec. 27, 2020
134 Stat. 2955
, provided that:
“The amendment made by paragraph (1) [amending
Pub. L. 105–33
which amended this section] shall take effect as if included in the enactment of the
Balanced Budget Act of 1997
Public Law 105–33
).”
Amendment by section 125(a)(2)(B), (c) of
Pub. L. 116–260
applicable to items and services furnished on or after
Jan. 1, 2023
, see
section 125(g) of Pub. L. 116–260
, set out as a note under section 1395l of this title.
Effective Date of 2016 Amendment
Amendment by
section 5012(b) of Pub. L. 114–255
applicable to items and services furnished on or after
Jan. 1, 2021
, see
section 5012(d) of Pub. L. 114–255
, set out as a note under section 1395l of this title.
Effective Date of 2015 Amendment
Amendment by
Pub. L. 114–113
applicable to items furnished on or after
Jan. 1, 2017
, see
section 504(d) of Pub. L. 114–113
, set out as a note under section 1395l of this title.
Effective Date of 2010 Amendment
Pub. L. 111–148, title III, § 3128(b)
Mar. 23, 2010
124 Stat. 426
, provided that:
“The amendments made by subsection (a) [amending this section] shall take effect as if included in the enactment of section 405(a) of the
Medicare
Prescription Drug, Improvement, and Modernization Act of 2003 (
Public Law 108–173
117 Stat. 2266
).”
Pub. L. 111–148, title III, § 3136(c)
Mar. 23, 2010
124 Stat. 438
, provided that:
“(1)
In general.—
Subject to paragraph (2), the amendments made by subsection (a) [amending this section] shall take effect on
January 1, 2011
, and shall apply to power-driven wheelchairs furnished on or after such date.
“(2)
Application to competitive bidding.—
The amendments made by subsection (a) shall not apply to payment made for items and services furnished pursuant to contracts entered into under section 1847 of the
Social Security Act
42 U.S.C. 1395w–3
) prior to
January 1, 2011
, pursuant to the implementation of subsection (a)(1)(B)(i)(I) of such section 1847.”
Amendment by
section 6405(a) of Pub. L. 111–148
applicable to written orders and certifications made on or after
July 1, 2010
, see
section 6405(d) of Pub. L. 111–148
, set out as a note under
section 1395f of this title
Effective Date of 2008 Amendment
Amendment by
section 125(b)(5) of Pub. L. 110–275
applicable with respect to accreditations of
hospitals
granted on or after the date that is 24 months after
July 15, 2008
, with transition rule, see
section 125(d) of Pub. L. 110–275
, set out as an Effective Date of 2008 Amendment; Transition Rule note under
section 1395bb of this title
Pub. L. 110–275, title I, § 144(b)(2)
July 15, 2008
122 Stat. 2547
, provided that:
“The amendments made by paragraph (1) [amending this section] shall take effect on
January 1, 2009
.”
Pub. L. 110–275, title I, § 146(b)(2)(B)
July 15, 2008
122 Stat. 2548
, provided that:
“The amendment made by subparagraph (A) [amending this section] shall apply to services furnished on or after the date of the enactment of this Act [
July 15, 2008
].”
Pub. L. 110–275, title I, § 148(b)
July 15, 2008
122 Stat. 2549
, provided that:
“The amendments made by subsection (a) [amending this section] shall apply to services furnished on or after
July 1, 2009
.”
Pub. L. 110–275, title I, § 149(c)
July 15, 2008
122 Stat. 2549
, provided that:
“The amendments made by this section [amending this section and
section 1395yy of this title
] shall apply to services furnished on or after
January 1, 2009
.”
Pub. L. 110–275, title I, § 154(e)
July 15, 2008
122 Stat. 2568
, provided that:
“The amendments made by this section [amending this section, sections
1395u
and
1395w–3
of this title, and provisions set out as notes under
section 1395w–3 of this title
] shall take effect as of
June 30, 2008
.”
Effective Date of 2006 Amendment
Pub. L. 109–171, title V, § 5101(a)(2)
Feb. 8, 2006
120 Stat. 38
, provided that:
“The amendment made by paragraph (1) [amending this section] shall apply to items furnished for which the first rental month occurs on or after
January 1, 2006
.”
Pub. L. 109–171, title V, § 5101(b)(2)
Feb. 8, 2006
120 Stat. 39
, provided that:
“(A)
In general.—
The amendments made by paragraph (1) [amending this section] shall take effect on
January 1, 2006
“(B)
Application to certain individuals.—
In the case of an individual receiving oxygen equipment on
December 31, 2005
, for which payment is made under section 1834(a) of the
Social Security Act
42 U.S.C. 1395m(a)
), the 36-month period described in paragraph (5)(F)(i) of such section, as added by paragraph (1), shall begin on
January 1, 2006
.”
Amendment by
section 5113(b) of Pub. L. 109–171
applicable to services furnished on or after
Jan. 1, 2007
, see
section 5113(c) of Pub. L. 109–171
, set out as a note under section 1395l of this title.
Effective Date of 2003 Amendment
Amendment by
section 405(a)(1) of Pub. L. 108–173
applicable to payments for services furnished during cost reporting periods beginning on or after
Jan. 1, 2004
, see
section 405(a)(2) of Pub. L. 108–173
, set out as a note under
section 1395f of this title
Pub. L. 108–173, title IV, § 405(b)(2)
Dec. 8, 2003
117 Stat. 2266
, provided that:
“The amendments made by paragraph (1) [amending this section] shall apply with respect to costs incurred for services furnished on or after
January 1, 2005
.”
Pub. L. 108–173, title IV, § 405(d)(2)
Dec. 8, 2003
117 Stat. 2267
, provided that:
“(A)
In general.—
Except as provided in subparagraph (B), the amendment made by paragraph (1) [amending this section] shall apply to cost reporting periods beginning on or after
July 1, 2004
“(B)
Rule of application.—
In the case of a
critical access hospital
that made an election under section 1834(g)(2) of the
Social Security Act
42 U.S.C. 1395m(g)(2)
) before
November 1, 2003
, the amendment made by paragraph (1) shall apply to cost reporting periods beginning on or after
July 1, 2001
.”
Pub. L. 108–173, title IV, § 415(c)
Dec. 8, 2003
117 Stat. 2282
, provided that:
“The amendments made by this subsection [probably should be “this section”, amending this section and
section 1395x of this title
] shall apply to services furnished on or after
January 1, 2005
.”
Amendment by
section 627(b)(1) of Pub. L. 108–173
applicable to items furnished on or after
Jan. 1, 2005
, see
section 627(c) of Pub. L. 108–173
, set out as a note under section 1395l of this title.
Effective Date of 2000 Amendment
Pub. L. 106–554, § 1(a)(6) [title I, § 103(c)]
Dec. 21, 2000
114 Stat. 2763
, 2763A–469, provided that:
“The amendments made by this section [amending this section and
section 1395x of this title
] shall apply to colorectal cancer screening services provided on or after
July 1, 2001
.”
Pub. L. 106–554, § 1(a)(6) [title I, § 104(c)]
Dec. 21, 2000
114 Stat. 2763
, 2763A–470, provided that:
“The amendments made by subsections (a) and (b) [amending this section and
section 1395w–4 of this title
] shall apply with respect to screening mammographies furnished on or after
January 1, 2002
.”
Amendment by section 1(a)(6) [title II, § 201(a)] of
Pub. L. 106–554
applicable to services furnished on or after
Nov. 29, 1999
, see section 1(a)(6) [title II, § 201(c)] of
Pub. L. 106–554
, set out as a note under section 1395l of this title.
Pub. L. 106–554, § 1(a)(6) [title II, § 202(b)]
Dec. 21, 2000
114 Stat. 2763
, 2763A–481, provided that:
“The amendment made by subsection (a) [amending this section] shall apply with respect to items and services furnished on or after
July 1, 2001
.”
Pub. L. 106–554, § 1(a)(6) [title II, § 204(b)]
Dec. 21, 2000
114 Stat. 2763
, 2763A–482, provided that:
“The amendment made by subsection (a) [amending this section] shall apply to cost reporting periods beginning on or after
October 1, 2001
.”
Amendment by section 1(a)(6) [title II, § 205(a)] of
Pub. L. 106–554
applicable to services furnished on or after
Dec. 21, 2000
, see section 1(a)(6) [title II, § 205(c)] of
Pub. L. 106–554
, set out as a note under section 1395l of this title.
Pub. L. 106–554, § 1(a)(6) [title II, § 221(d)]
Dec. 21, 2000
114 Stat. 2763
, 2763A–487, provided that:
“The amendment made by subsection (a) [amending this section] shall apply to services furnished on or after
July 1, 2001
. In applying such amendment to services furnished on or after such date and before
January 1, 2002
, the amount of the rate increase provided under such amendment shall be equal to $1.25 per mile.”
Amendment by section 1(a)(6) [title II, § 223(b)] of
Pub. L. 106–554
effective for services furnished on or after
Oct. 1, 2001
, see section 1(a)(6) [title II, § 223(e)] of
Pub. L. 106–554
, set out as a note under section 1395l of this title.
Pub. L. 106–554, § 1(a)(6) [title IV, § 423(b)(2)]
Dec. 21, 2000
114 Stat. 2763
, 2763A–518, provided that:
“The amendment made by paragraph (1) [amending this section] shall apply to services furnished on or after
July 1, 2001
.”
Pub. L. 106–554, § 1(a)(6) [title IV, § 428(c)]
Dec. 21, 2000
114 Stat. 2763
, 2763A–522, provided that:
“The amendment made by subsection (a) [amending this section] shall apply to items replaced on or after
April 1, 2001
.”
Effective Date of 1999 Amendment
Amendment by section 1000(a)(6) [title II, § 201(e)(2)] of
Pub. L. 106–113
effective as if included in enactment of the
Balanced Budget Act of 1997
Pub. L. 105–33
, except as otherwise provided, see § 1000(a)(6) [title II, § 201(m)] of
Pub. L. 106–113
, set out as a note under section 1395l of this title.
Amendment by section 1000(a)(6) [title III, § 321(k)(3)] of
Pub. L. 106–113
effective as if included in the enactment of the
Balanced Budget Act of 1997
Pub. L. 105–33
, except as otherwise provided, see section 1000(a)(6) [title III, § 321(m)] of
Pub. L. 106–113
, set out as a note under
section 1395d of this title
Pub. L. 106–113, div. B, § 1000(a)(6) [title IV, § 403(d)(2)]
Nov. 29, 1999
113 Stat. 1536
, 1501A–371, as amended by
Pub. L. 106–554, § 1(a)(6) [title II, § 201(b)(2)]
Dec. 21, 2000
114 Stat. 2763
, 2763A–481, provided that:
“Paragraphs (1) through (3) of section 1834(g) of the
Social Security Act
42 U.S.C. 1395m(g)(1)
–(3)] (as amended by paragraph (1)) apply for cost reporting periods beginning on or after
October 1, 2000
.”
Effective Date of 1997 Amendment
Amendment by section 4101(a), (c) of
Pub. L. 105–33
applicable to items and services furnished on or after
Jan. 1, 1998
, see
section 4101(d) of Pub. L. 105–33
, set out as a note under section 1395l of this title.
Amendment by
section 4104(b)(1) of Pub. L. 105–33
applicable to items and services furnished on or after
Jan. 1, 1998
, see
section 4104(e) of Pub. L. 105–33
, set out as a note under section 1395l of this title.
Pub. L. 105–33, title IV, § 4105(d)
Aug. 5, 1997
111 Stat. 367
, provided that:
“(1)
In general.—
Except as provided in paragraph (2), the amendments made by this section [amending this section and sections
1395w–4
and
1395x
of this title] shall apply to items and services furnished on or after
July 1, 1998
“(2)
Testing strips.—
The amendment made by subsection (b)(2) [amending this section] shall apply with respect to blood glucose testing strips furnished on or after
January 1, 1998
.”
Amendment by
section 4201(c)(5) of Pub. L. 105–33
applicable to services furnished on or after
Oct. 1, 1997
, see
section 4201(d) of Pub. L. 105–33
, set out as a note under
section 1395f of this title
Pub. L. 105–33, title IV, § 4312(f)(1)
Aug. 5, 1997
111 Stat. 387
, provided that:
“The amendment made by subsection (a) [amending this section] shall apply to
suppliers
of
durable medical equipment
with respect to such equipment furnished on or after
January 1, 1998
.”
Pub. L. 105–33, title IV, § 4312(f)(3)
Aug. 5, 1997
111 Stat. 388
, provided that:
“The amendments made by subsections (c) through (e) [amending this section and
section 1395x of this title
] shall take effect on the date of the enactment of this Act [
Aug. 5, 1997
] and may be applied with respect to items and services furnished on or after
January 1, 1998
.”
Pub. L. 105–33, title IV, § 4316(c)
Aug. 5, 1997
111 Stat. 392
, provided that:
“The amendments made by this section [amending this section and
section 1395u of this title
] shall take effect on the date of the enactment of this Act [
Aug. 5, 1997
].”
Amendment by
section 4531(b)(2) of Pub. L. 105–33
applicable to services furnished on or after
Jan. 1, 2000
, see
section 4531(b)(3) of Pub. L. 105–33
, set out as a note under section 1395l of this title.
Amendment by
section 4541(a)(2) of Pub. L. 105–33
applicable to services furnished on or after
Jan. 1, 1998
, including portions of cost reporting periods occurring on or after such date, except that subsec. (k) of this section inapplicable to services described in
section 1395l(a)(8)(B) of this title
that are furnished during 1998, see
section 4541(e) of Pub. L. 105–33
, set out as a note under section 1395l of this title.
Pub. L. 105–33, title IV, § 4551(c)(2)
Aug. 5, 1997
111 Stat. 459
, provided that:
“The amendment made by paragraph (1) [amending this section] shall apply to purchases or rentals after the effective date of any
regulations
issued pursuant to such amendment.”
Pub. L. 105–33, title IV, § 4552(e)
Aug. 5, 1997
111 Stat. 459
, provided that:
“(1)
Oxygen.—
The amendments made by subsection (a) [amending this section] shall apply to items furnished on and after
January 1, 1998
“(2)
Other provisions.—
The amendments made by this section other than subsection (a) [amending this section] shall take effect on the date of the enactment of this Act [
Aug. 5, 1997
].”
Effective Date of 1994 Amendment
Pub. L. 103–432, title I, § 126(i)
Oct. 31, 1994
108 Stat. 4416
, provided that:
“Except as provided in subsection (h) [amending
section 1395u of this title
, enacting provisions set out as notes under sections 1395u and 1395w–4 of this title, and amending provisions set out as a note under
section 1395w–4 of this title
], the amendments made by this section and the provisions of this section [amending this section and sections 1395u, 1395w–1, and 1395w–4 of this title, enacting provisions set out as notes under sections 1395u and 1395w–4 of this title, and amending provisions set out as notes under this section and sections 1395u and 1395w–4 of this title] shall take effect as if included in the enactment of
OBRA
–1990 [
Pub. L. 101–508
].”
Pub. L. 103–432, title I, § 131(a)(2)
Oct. 31, 1994
108 Stat. 4419
, provided that the amendment made by that section is effective 60 days after
Oct. 31, 1994
Pub. L. 103–432, title I, § 132(c)
Oct. 31, 1994
108 Stat. 4421
, provided that:
“The amendments made by subsections (a) and (b) [amending this section] shall apply to items furnished after the expiration of the 60-day period that begins on the date of the enactment of this Act [
Oct. 31, 1994
].”
Pub. L. 103–432, title I, § 133(c)
Oct. 31, 1994
108 Stat. 4422
, provided that:
“The amendments made by this section [amending this section and sections
1395m
and
1395pp
of this title] shall apply to items or services furnished on or after
January 1, 1995
.”
Pub. L. 103–432, title I, § 134(a)(2)
Oct. 31, 1994
108 Stat. 4422
, provided that:
“The amendment made by paragraph (1) [amending this section] shall take effect on the date of the enactment of this Act [
Oct. 31, 1994
].”
Pub. L. 103–432, title I, § 135(a)(2)
Oct. 31, 1994
108 Stat. 4422
, provided that:
“The amendment made by paragraph (1) [amending this section] shall be effective on the date of the enactment of this Act [
Oct. 31, 1994
].”
Pub. L. 103–432, title I, § 135(b)(1)
Oct. 31, 1994
108 Stat. 4422
, provided that the amendment made by that section is effective
Oct. 31, 1994
Pub. L. 103–432, title I, § 135(b)(3)
Oct. 31, 1994
108 Stat. 4423
, provided that the amendment made by that section is effective
Oct. 31, 1994
Pub. L. 103–432, title I, § 135(d)(2)
Oct. 31, 1994
108 Stat. 4424
, provided that:
“The amendment made by paragraph (1) [amending this section] shall be effective on the date of the enactment of this Act [
Oct. 31, 1994
].”
Pub. L. 103–432, title I, § 135(e)(8)
Oct. 31, 1994
108 Stat. 4424
, provided that:
“The amendments made by this subsection [amending this section and provisions set out as notes under this section and
section 1395cc of this title
] shall take effect as if included in the enactment of
OBRA
–1990 [
Pub. L. 101–508
].”
Pub. L. 103–432, title I, § 145(d)
Oct. 31, 1994
108 Stat. 4428
, provided that:
“The amendments made by this section [amending this section and sections
1395x
to
1395bb
of this title] shall apply to mammography furnished by a facility on and after the first date that the certificate requirements of section 354(b) of the
Public Health Service Act
section 263b(b) of this title
] apply to such mammography conducted by such facility.”
Amendment by
section 156(a)(2)(C) of Pub. L. 103–432
applicable to services provided on or after
Oct. 31, 1994
, see
section 156(a)(3) of Pub. L. 103–432
, set out as a note under
section 1320c–3 of this title
Effective Date of 1993 Amendment
Pub. L. 103–66, title XIII, § 13542(b)
Aug. 10, 1993
107 Stat. 589
, provided that:
“The amendments made by this section [amending this section] shall apply to items furnished on or after
January 1, 1994
.”
Pub. L. 103–66, title XIII, § 13543(c)
Aug. 10, 1993
107 Stat. 589
, provided that:
“The amendments made by this section [amending this section] shall apply to items furnished on or after
January 1, 1994
.”
Pub. L. 103–66, title XIII, § 13544(a)(3)
Aug. 10, 1993
107 Stat. 589
, provided that:
“The amendments made by this subsection [amending this section] shall apply to items furnished on or after
January 1, 1994
.”
Amendment by
section 13544(b)(1) of Pub. L. 103–66
applicable to items furnished on or after
Jan. 1, 1994
, see
section 13544(b)(3) of Pub. L. 103–66
, set out as a note under section 1395l of this title.
Pub. L. 103–66, title XIII, § 13545(b)
Aug. 10, 1993
107 Stat. 590
, provided that:
“The amendment made by subsection (a) [amending this section] shall apply to items furnished on or after
January 1, 1994
.”
Effective Date of 1990 Amendment
Pub. L. 101–508, title IV, § 4102(i)
Nov. 5, 1990
104 Stat. 1388–58
, provided that:
“(1)
Except as otherwise provided, the amendments made by this section [amending this section,
section 1395w–4 of this title
, and provisions set out as a note below] shall apply to services furnished on or after
January 1, 1991
“(2)
The amendment made by subsection (f) [amending this section] shall be effective as if included in the enactment of the
Omnibus Budget Reconciliation Act of 1987
Pub. L. 100–203
].”
Amendment by
section 4104(a) of Pub. L. 101–508
applicable to services furnished on or after
Jan. 1, 1991
, see
section 4104(d) of Pub. L. 101–508
, set out as a note under section 1395l of this title.
Pub. L. 101–508, title IV, § 4152(a)(3)
Nov. 5, 1990
104 Stat. 1388–74
, as amended by
Pub. L. 103–432, title I, § 135(e)(1)
Oct. 31, 1994
108 Stat. 4424
, provided that:
“The amendments made by this subsection [amending this section and
section 1395x of this title
] shall apply to items furnished on or after
January 1, 1991
.”
Pub. L. 101–508, title IV, § 4152(c)(4)(B)(ii)
Nov. 5, 1990
104 Stat. 1388–79
, provided that:
“The amendment made by clause (i) [amending this section] shall apply to items furnished on or after
January 1, 1992
, unless the
Secretary
develops specific criteria before that date for the
treatment
of wheelchairs as customized items for purposes of section 1834(a)(4) of the
Social Security Act
[subsec. (a)(4) of this section] (in which case the amendment made by such clause shall not become effective).”
[Criteria established by
Secretary
Nov. 1, 1991
, see 56 F.R.
65995
Dec. 20, 1991
, 42 CFR §
414.224
.]
Pub. L. 101–508, title IV, § 4152(f)(2)
Nov. 5, 1990
104 Stat. 1388–80
, provided that:
“The amendment made by paragraph (1) [amending this section] shall apply to forms and documents distributed on or after
January 1, 1991
.”
Pub. L. 101–508, title IV, § 4152(g)(2)
Nov. 5, 1990
104 Stat. 1388–80
, provided that:
“The amendments made by paragraph (1) [amending this section] shall apply to patients who first receive home oxygen therapy services on or after
January 1, 1991
.”
Pub. L. 101–508, title IV, § 4152(i)
Nov. 5, 1990
104 Stat. 1388–81
, provided that:
“Except as otherwise provided, the amendments made by this section [amending this section,
section 1395x of this title
, and provisions set out as a note under
section 1395f of this title
] shall apply to items furnished on or after
January 1, 1991
.”
Amendment by section 4153(a)(1), (2)(D) of
Pub. L. 101–508
applicable to items furnished on or after
Jan. 1, 1991
, see
section 4153(a)(3) of Pub. L. 101–508
, set out as a note under
section 1395k of this title
Amendment by
section 4163(b) of Pub. L. 101–508
applicable to
screening mammography
performed on or after
Jan. 1, 1991
, see
section 4163(e) of Pub. L. 101–508
, set out as a note under section 1395l of this title.
Effective Date of 1989 Amendment
Amendment by
section 6102(f)(1) of Pub. L. 101–239
applicable to services furnished on or after
Jan. 1, 1991
, see
section 6102(f)(3) of Pub. L. 101–239
, set out as a note under section 1395l of this title.
Pub. L. 101–239, title VI, § 6112(e)(4)
Dec. 19, 1989
103 Stat. 2216
, provided that:
“The amendments made by this subsection [amending this section and sections
1395x
and
1395cc
of this title] shall apply with respect to items furnished on or after
January 1, 1990
.”
Amendment by
section 201(a) of Pub. L. 101–234
effective
Jan. 1, 1990
, see
section 201(c) of Pub. L. 101–234
, set out as a note under
section 1320a–7a of this title
Pub. L. 101–234, title III, § 301(b)(1)
, (c)(1),
Dec. 13, 1989
103 Stat. 1985
, provided that the amendments made by that section are effective as if included in the enactment of the
Omnibus Budget Reconciliation Act of 1987
Pub. L. 100–203
Effective Date of 1988 Amendment
Amendment by
Pub. L. 100–485
effective as if included in the enactment of the
Medicare Catastrophic Coverage Act of 1988
Pub. L. 100–360
, see
section 608(g)(1) of Pub. L. 100–485
, set out as a note under
section 704 of this title
Amendment by
section 202(b)(4) of Pub. L. 100–360
applicable to items dispensed on or after
Jan. 1, 1990
, see
section 202(m)(1) of Pub. L. 100–360
, set out as a note under
section 1395u of this title
Amendment by
section 203(c)(1)(F) of Pub. L. 100–360
applicable to items and services furnished on or after
Jan. 1, 1990
, see
section 203(g) of Pub. L. 100–360
, set out as a note under
section 1320c–3 of this title
Pub. L. 100–360, title II, § 204(e)
July 1, 1988
102 Stat. 729
, which provided that the amendments made by
section 204 of Pub. L. 100–360
[amending this section and sections 1395l, 1395x to 1395z, 1395aa, 1395bb, 1396a, and 1396n of this title] applied to
screening mammography
performed on or after
January 1, 1990
, and that subsec. (e)(5) of this section only applied until such time as the
Secretary
of Health and Human Services implemented the
physician
fee schedules based on relative value scale developed under
section 1395w–1(e) of this title
, was repealed by
Pub. L. 101–234, title II, § 201(a)
Dec. 13, 1989
103 Stat. 1981
Except as specifically provided in
section 411 of Pub. L. 100–360
, amendment by section 411(a)(3)(A), (B)(ii), (C)(ii), (f)(8)(A), (B)(ii), (D), (g)(1)(A) and (B) of
Pub. L. 100–360
, as it relates to a provision in the
Omnibus Budget Reconciliation Act of 1987
Pub. L. 100–203
, effective as if included in the enactment of that provision in
Pub. L. 100–203
, see
section 411(a) of Pub. L. 100–360
, set out as a Reference to
OBRA
; Effective Date note under
section 106 of Title 1
, General Provisions.
Effective Date of 1987 Amendment
Pub. L. 100–203, title IV, § 4049(b)(2)
Dec. 22, 1987
101 Stat. 1330–92
, as amended by
Pub. L. 101–239, title VI, § 6102(e)(6)(B)
Dec. 19, 1989
103 Stat. 2188
Pub. L. 101–508, title IV, § 4118(h)(2)
Nov. 5, 1990
104 Stat. 1388–70
, provided that:
“The amendments made by this section [amending this section and section 1395
of this title] shall apply to services performed on or after
April 1, 1989
.”
Pub. L. 101–508, title IV, § 4118(h)
Nov. 5, 1990
104 Stat. 1388–70
, provided that the amendment by that section to
section 4049(b)(2) of Pub. L. 100–203
, set out above, is effective as if included in enactment of
Omnibus Budget Reconciliation Act of 1987
Pub. L. 100–203
.]
Effective Date
Subsection (a) of this section applicable to
covered items
(other than oxygen and oxygen equipment) furnished on or after
Jan. 1, 1989
, and to oxygen and oxygen equipment furnished on or after
June 1, 1989
, see
section 4062(e) of Pub. L. 100–203
, set out as an Effective Date of 1987 Amendment note under
section 1395f of this title
Regulations
Pub. L. 106–554, § 1(a)(6) [title IV, § 427(b)]
Dec. 21, 2000
114 Stat. 2763
, 2763A–521, provided that:
“Not later than 1 year after the date of the enactment of this Act [
Dec. 21, 2000
], the
Secretary
of Health and Human Services shall promulgate revised
regulations
to carry out the amendment made by subsection (a) [amending this section] using a negotiated rulemaking process under subchapter III of chapter 5 of title
United States
Code.”
Construction of 2026 Amendment
Pub. L. 119–75, div. J, title II, § 6221(c)
Feb. 3, 2026
140 Stat. 663
, provided that:
“Nothing in this section [amending this section and sections 1395
, 1395x and 1395y of this title], including the amendments made by this section, shall be construed—
“(1)
in the case of an individual who undergoes a
multi-cancer early detection screening test
, to affect coverage under part B of title XVIII of the
Social Security Act
42 U.S.C. 1395j
et seq.] for other cancer screening tests covered under such title [
42 U.S.C. 1395
et seq.], such as screening tests for breast, cervical, colorectal, lung, or prostate cancer; or
“(2)
in the case of an individual who undergoes another cancer screening test, to affect coverage under such part for a
multi-cancer early detection screening test
or the use of such a test as a diagnostic or confirmatory test for a result of the other cancer screening test.”
Construction of 2010 Amendment
Pub. L. 111–148, title III, § 3109(c)
Mar. 23, 2010
124 Stat. 420
, provided that:
“Nothing in the provisions of or amendments made by this section [amending this section and enacting provisions set out as a note under this section] shall be construed as affecting the application of an accreditation requirement for pharmacies to qualify for bidding in a competitive acquisition area under section 1847 of the
Social Security Act
42 U.S.C. 1395w–3
).”
Pub. L. 111–148, title IV, § 4105(b)
Mar. 23, 2010
124 Stat. 559
, provided that:
“Nothing in the amendment made by paragraph (1) [probably means subsec. (a), amending this section] shall be construed to affect the coverage of diagnostic or
treatment
services under title XVIII of the
Social Security Act
42 U.S.C. 1395
et seq.].”
Construction of 2009 Amendment
Pub. L. 111–72, § 1(b)
Oct. 13, 2009
123 Stat. 2059
, provided that:
“Nothing in subsection (a) [amending this section] shall be construed as affecting the application of an accreditation requirement for pharmacies to qualify for bidding in a competitive acquisition area under section 1847 of the
Social Security Act
42 U.S.C. 1395w–3
).”
Construction of 2008 Amendment
Pub. L. 110–275, title I, § 154(b)(1)(B)
July 15, 2008
122 Stat. 2565
, provided that:
“Section 1834(a)(20)(F)(ii) of the
Social Security Act
42 U.S.C. 1395m(a)(20)(F)(ii)
], as added by subparagraph (A), shall not be construed as preventing the
Secretary
of Health and Human Services from implementing the first round of competition under section 1847 of such Act [
42 U.S.C. 1395w–3
] on a timely basis.”
Transfer of Functions
Physician Payment Review Commission (PPRC) was terminated and its assets and staff transferred to the
Medicare
Payment Advisory Commission (MedPAC) by section 4022(c)(2), (3) of
Pub. L. 105–33
, set out as a note under
section 1395b–6 of this title
. Section 4022(c)(2), (3) further provided that MedPAC was to be responsible for preparation and submission of reports required by law to be submitted by PPRC, and that, for that purpose, any reference in law to PPRC was to be deemed, after the appointment of MedPAC, to refer to MedPAC.
Implementation of Amendment by
Pub. L. 119–75
Pub. L. 119–75, div. J, title II, § 6209(h)
Feb. 3, 2026
140 Stat. 650
, provided that:
“Notwithstanding any other provision of law, the
Secretary
of Health and Human Services may implement the amendments made by this section [amending this section and
section 1395f of this title
] by program instruction or otherwise.”
Implementation of Amendment by
Pub. L. 119–37
Pub. L. 119–37, div. F, title II, § 6208(g)
Nov. 12, 2025
139 Stat. 633
, provided that:
“The
Secretary
of Health and Human Services may implement the amendments made by this section [amending this section and
section 1395f of this title
] through program instruction or otherwise.”
Implementation of Amendment by
Pub. L. 119–4
Pub. L. 119–4, div. B, title II, § 2207(g)
Mar. 15, 2025
139 Stat. 44
, provided that:
“The
Secretary
of Health and Human Services may implement the amendments made by this section [amending this section and
section 1395f of this title
] through program instruction or otherwise.”
Implementation of Amendment by
Pub. L. 118–158
Pub. L. 118–158, div. C, title II, § 3207(g)
Dec. 21, 2024
138 Stat. 1766
, provided that:
“The
Secretary
of Health and Human Services may implement the amendments made by this section [amending this section and
section 1395f of this title
] through program instruction or otherwise.”
Implementation of Amendment by
Pub. L. 117–328
Pub. L. 117–328, div. FF, title IV, § 4113(h)
Dec. 29, 2022
136 Stat. 5901
, provided that:
“Notwithstanding any other provision of law, the
Secretary
of Health and Human Services may implement the provisions of, including amendments made by, this section [amending this section and
section 1395f of this title
] through program instruction or otherwise.”
Implementation of Amendment by
Pub. L. 117–103
Pub. L. 117–103, div. P, title II, § 309
Mar. 15, 2022
136 Stat. 808
, provided that:
“Notwithstanding any other provision of law, the
Secretary
of Health and Human Services may implement the provisions of, including amendments made by, sections 301 through 306 [amending this section and
section 1395f of this title
] through program instruction or otherwise.”
Implementation of Amendment by
Pub. L. 116–260
Pub. L. 116–260, div. CC, title I, § 121(c)
Dec. 27, 2020
134 Stat. 2955
, provided that:
“Notwithstanding any other provision of law, the
Secretary
of Health and Human Services may implement the amendments made by this section [amending this section and amending
Pub. L. 105–33
which amended this section] by program instruction or otherwise.”
Pub. L. 116–260, div. CC, title I, § 123(b)
Dec. 27, 2020
134 Stat. 2957
, provided that:
“Notwithstanding any other provision of law, the
Secretary
may implement the provisions of, or amendments made by, this section [amending this section] by interim final rule, program instruction, or otherwise.”
Implementation of Amendment by
Pub. L. 115–271
Pub. L. 115–271, title II, § 2001(b)
Oct. 24, 2018
132 Stat. 3925
, provided that:
“The
Secretary
of Health and Human Services (in this section [amending this section] referred to as the ‘
Secretary
’) may implement the amendments made by this section by interim final rule.”
Implementation of Amendment by
Pub. L. 114–10
Pub. L. 114–10, title V, § 504(b)
Apr. 16, 2015
129 Stat. 166
, provided that:
“Notwithstanding any other provision of law, the
Secretary
of Health and Human Services may implement the amendments made by subsection (a) [amending this section] by program instruction or otherwise.”
Implementation of Amendment by
Pub. L. 111–148
Pub. L. 111–148, title III, § 3109(b)
Mar. 23, 2010
124 Stat. 419
, provided that:
“Notwithstanding any other provision of law, the
Secretary
may implement the amendments made by subsection (a) [amending this section] by program instruction or otherwise.”
Implementation of Amendment by
Pub. L. 108–173
Pub. L. 108–173, title IV, § 414(e)
Dec. 8, 2003
117 Stat. 2280
, provided that:
“The
Secretary
[of Health and Human Services] may implement the amendments made by this section [amending this section,
section 1395x of this title
, and provisions set out as a note under this section], and revise the conversion factor applicable under section 1834(
) of the
Social Security Act
42 U.S.C. 1395m
)) for purposes of implementing such amendments, on an interim final basis, or by program instruction.”
Inclusion of Virtual Diabetes Prevention Program Suppliers in MDPP Expanded Model
Pub. L. 119–75, div. J, title II, § 6214
Feb. 3, 2026
140 Stat. 654
, provided that:
“(a)
In General.—
For the period beginning on
January 1, 2026
, and ending on
December 31, 2029
“(1)
an entity may participate in the MDPP by offering only MDPP services via distance learning or online delivery modalities if such entity meets the conditions for enrollment as an MDPP
supplier
“(2)
if an entity participates in the MDPP in the manner described in paragraph (1), in the case of online MDPP services furnished by such entity to an MDPP beneficiary who was not located in the same
State
as the entity at the time such services were furnished, the entity shall not be prohibited from submitting a claim for payment for such services solely by reason of the location of such beneficiary at such time; and
“(3)
no limit is applied on the number of times an individual may enroll in the MDPP.
“(b)
Definitions.—
In this section:
“(1)
MDPP.—
The term ‘MDPP’ means the
Medicare
Diabetes Prevention Program (as such term is defined in section
410.79(b)
of title 42, Code of Federal Regulations).
“(2)
Regulatory terms.—
The terms ‘distance learning’, ‘MDPP beneficiary’, ‘MDPP services’, ‘MDPP
supplier
’, and ‘online’ [probably should be “online delivery”] have the meanings given such terms in section
410.79(b)
of title 42, Code of Federal Regulations.
“(3)
Secretary.—
The term ‘
Secretary
’ means the
Secretary
of Health and Human Services.
“(c)
Implementation.—
Notwithstanding any other provision of law, the
Secretary
may implement this section by program instruction or otherwise.”
Payment Rates for Durable Medical Equipment Under the
Medicare
Program
Pub. L. 117–328, div. FF, title IV, § 4139
Dec. 29, 2022
136 Stat. 5926
, provided that:
“(a)
Areas Other Than Rural and Noncontiguous Areas.—
The
Secretary
shall implement section
414.210(g)(9)(v)
of title 42, Code of Federal Regulations (or any successor regulation), to apply the transition rule described in the first sentence of such section to all
applicable items and services
furnished in areas other than rural or noncontiguous areas (as such terms are defined for purposes of such section) through the remainder of the duration of the emergency period described in section 1135(g)(1)(B) of the
Social Security Act
42 U.S.C. 1320b–5(g)(1)(B)
) or
December 31, 2023
, whichever is later.
“(b)
All Areas.—
The
Secretary
shall not implement section
414.210(g)(9)(vi)
of title 42, Code of Federal Regulations (or any successor regulation) until the date immediately following the last day of the emergency period described in section 1135(g)(1)(B) of the
Social Security Act
42 U.S.C. 1320b–5(g)(1)(B)
), or
January 1, 2024
, whichever is later.
“(c)
Implementation.—
Notwithstanding any other provision of law, the
Secretary
may implement the provisions of this section by program instruction or otherwise.”
Publication of Data
Pub. L. 117–103, div. P, title II, § 308(b)
Mar. 15, 2022
136 Stat. 808
, provided that:
“Beginning
July 1, 2022
, the
Secretary
of Health and Human Services shall post on the public website of the Centers for
Medicare
& Medicaid Services on a quarterly basis data with respect to
Medicare
claims for telemedicine services, including data on utilization and beneficiary characteristics.”
Encouraging Use of Telecommunications Systems for Home Health Services Furnished During Emergency Period
Pub. L. 116–136, div. A, title III, § 3707
Mar. 27, 2020
134 Stat. 418
, provided that:
“With respect to
home health services
(as defined in section 1861(m) of the
Social Security Act
42 U.S.C. 1395x(m)
) that are furnished during the emergency period described in section 1135(g)(1)(B) of such Act (
42 U.S.C. 1320b–5(g)(1)(B)
), the
Secretary
of Health and Human Services shall consider ways to encourage the use of
telecommunications systems,
including for remote patient monitoring as described in section
409.46(e)
of title 42, Code of Federal Regulations (or any successor
regulations)
and other communications or monitoring services, consistent with the plan of care for the individual, including by clarifying guidance and conducting outreach, as
appropriate.
Revising Payment Rates for Durable Medical Equipment Under the
Medicare
Program Through Duration of Emergency Period
Pub. L. 116–136, div. A, title III, § 3712
Mar. 27, 2020
134 Stat. 423
, provided that:
“(a)
Rural and Noncontiguous Areas.—
The
Secretary
of Health and Human Services shall implement section
414.210(g)(9)(iii)
of title 42, Code of Federal Regulations (or any successor regulation), to apply the transition rule described in such section to all
applicable items and services
furnished in
rural areas
and noncontiguous areas (as such terms are defined for purposes of such section) as planned through
December 31, 2020
, and through the duration of the emergency period described in section 1135(g)(1)(B) of the
Social Security Act
42 U.S.C. 1320b–5(g)(1)(B)
), if longer.
“(b)
Areas Other Than Rural and Noncontiguous Areas.—
With respect to items and services furnished on or after the date that is 30 days after the date of the enactment of this Act [
Mar. 27, 2020
], the
Secretary
of Health and Human Services shall apply section
414.210(g)(9)(iv)
of title 42, Code of Federal Regulations (or any successor regulation), as if the reference to ‘dates of service from
June 1, 2018
through
December 31, 2020
, based on the fee schedule amount for the area is equal to 100 percent of the adjusted payment amount established under this section’ were instead a reference to ‘dates of service from
March 6, 2020
, through the remainder of the duration of the emergency period described in section 1135(g)(1)(B) of the
Social Security Act
42 U.S.C. 1320b–5(g)(1)(B)
), based on the fee schedule amount for the area is equal to 75 percent of the adjusted payment amount established under this section and 25 percent of the unadjusted fee schedule amount’.”
Demonstration Project To Assess the Appropriate Use of Imaging Services
Pub. L. 110–275, title I, § 135(b)
July 15, 2008
122 Stat. 2535
, provided that:
“(1)
Conduct of demonstration project.—
“(A)
In general.—
The
Secretary
of Health and Human Services (in this section referred to as the ‘
Secretary
’) shall conduct a demonstration project using the models described in paragraph (2)(E) to collect data regarding
physician
compliance with appropriateness criteria selected under paragraph (2)(D) in order to determine the appropriateness of
advanced diagnostic imaging services
furnished to
Medicare
beneficiaries.
“(B)
Advanced diagnostic imaging services.—
In this subsection, the term ‘
advanced diagnostic imaging services
’ has the meaning given such term in section 1834(e)(1)(B) of the
Social Security Act
42 U.S.C. 1395m(e)(1)(B)
], as added by subsection (a).
“(C)
Authority to focus demonstration project.—
The
Secretary
may focus the demonstration project with respect to certain
advanced diagnostic imaging services
, such as services that account for a large amount of expenditures under the
Medicare
program, services that have recently experienced a high rate of growth, or services for which appropriateness criteria exists.
“(2)
Implementation and design of demonstration project.—
“(A)
Implementation and duration.—
“(i)
Implementation.—
The
Secretary
shall implement the demonstration project under this subsection not later than
January 1, 2010
“(ii)
Duration.—
The
Secretary
shall conduct the demonstration project under this subsection for a 2-year period.
“(B)
Application and selection of participating physicians.—
“(i)
Application.—
Each
physician
that desires to participate in the demonstration project under this subsection shall submit an application to the
Secretary
at such time, in such manner, and containing such information as the
Secretary
may require.
“(ii)
Selection.—
The
Secretary
shall select
physicians
to participate in the demonstration project under this subsection from among
physicians
submitting applications under clause (i). The
Secretary
shall ensure that the
physicians
selected—
“(I)
represent a wide range of geographic areas, demographic characteristics (such as urban, rural, and suburban), and practice settings (such as private and academic practices); and
“(II)
have the capability to submit data to the
Secretary
(or an entity under a subcontract with the
Secretary
) in an electronic format in accordance with standards established by the
Secretary
“(C)
Administrative costs and incentives.—
The
Secretary
shall—
“(i)
reimburse
physicians
for reasonable administrative costs incurred in participating in the demonstration project under this subsection; and
“(ii)
provide reasonable incentives to
physicians
to encourage participation in the demonstration project under this subsection.
“(D)
Use of appropriateness criteria.—
“(i)
In general.—
The
Secretary
, in consultation with medical specialty societies and other stakeholders, shall select criteria with respect to the clinical appropriateness of
advanced diagnostic imaging services
for use in the demonstration project under this subsection.
“(ii)
Criteria selected.—
Any criteria selected under clause (i) shall—
“(I)
be developed or endorsed by a medical specialty society; and
“(II)
be developed in adherence to appropriateness principles developed by a consensus organization, such as the AQA alliance.
“(E)
Models for collecting data regarding physician compliance with selected criteria.—
Subject to subparagraph (H), in carrying out the demonstration project under this subsection, the
Secretary
shall use each of the following models for collecting data regarding
physician
compliance with appropriateness criteria selected under subparagraph (D):
“(i)
A model described in subparagraph (F).
“(ii)
A model described in subparagraph (G).
“(iii)
Any other model that the
Secretary
determines to be useful in evaluating the use of appropriateness criteria for
advanced diagnostic imaging services
“(F)
Point of service model described.—
A model described in this subparagraph is a model that—
“(i)
uses an electronic or paper intake form that—
“(I)
contains a certification by the
physician
furnishing the imaging service that the data on the intake form was confirmed with the
Medicare
beneficiary before the service was furnished;
“(II)
contains standardized data elements for diagnosis, service ordered, service furnished, and such other information determined by the
Secretary
, in consultation with medical specialty societies and other stakeholders, to be germane to evaluating the effectiveness of the use of appropriateness criteria selected under subparagraph (D); and
“(III)
is accessible to
physicians
participating in the demonstration project under this subsection in a format that allows for the electronic submission of such form; and
“(ii)
provides for feedback reports in accordance with paragraph (3)(B).
“(G)
Point of order model described.—
A model described in this subparagraph is a model that—
“(i)
uses a computerized order-entry system that requires the transmittal of relevant supporting information at the time of referral for
advanced diagnostic imaging services
and provides automated decision-support feedback to the referring
physician
regarding the appropriateness of furnishing such imaging services; and
“(ii)
provides for feedback reports in accordance with paragraph (3)(B).
“(H)
Limitation.—
In no case may the
Secretary
use prior authorization—
“(i)
as a model for collecting data regarding
physician
compliance with appropriateness criteria selected under subparagraph (D) under the demonstration project under this subsection; or
“(ii)
under any model used for collecting such data under the demonstration project.
“(I)
Required contracts and performance standards for certain entities.—
“(i)
In general.—
The
Secretary
shall enter into contracts with entities to carry out the model described in subparagraph (G).
“(ii)
Performance standards.—
The
Secretary
shall establish and enforce performance standards for such entities under the contracts entered into under clause (i), including performance standards with respect to—
“(I)
the satisfaction of
Medicare
beneficiaries who are furnished
advanced diagnostic imaging services
by a
physician
participating in the demonstration project;
“(II)
the satisfaction of
physicians
participating in the demonstration project;
“(III)
if applicable, timelines for the provision of feedback reports under paragraph (3)(B); and
“(IV)
any other areas determined
appropriate
by the
Secretary.
“(3)
Comparison of utilization of advanced diagnostic imaging services and feedback reports.—
“(A)
Comparison of utilization of advanced diagnostic imaging services.—
The
Secretary
shall consult with medical specialty societies and other stakeholders to develop mechanisms for comparing the utilization of
advanced diagnostic imaging services
by
physicians
participating in the demonstration project under this subsection against—
“(i)
the appropriateness criteria selected under paragraph (2)(D); and
“(ii)
to the extent feasible, the utilization of such services by
physicians
not participating in the demonstration project.
“(B)
Feedback reports.—
The
Secretary
shall, in consultation with medical specialty societies and other stakeholders, develop mechanisms to provide feedback reports to
physicians
participating in the demonstration project under this subsection. Such feedback reports shall include—
“(i)
a profile of the rate of compliance by the
physician
with appropriateness criteria selected under paragraph (2)(D), including a comparison of—
“(I)
the rate of compliance by the
physician
with such criteria; and
“(II)
the rate of compliance by the
physician
’s peers (as defined by the
Secretary)
with such criteria; and
“(ii)
to the extent feasible, a comparison of—
“(I)
the rate of utilization of
advanced diagnostic imaging services
by the
physician;
and
“(II)
the rate of utilization of such services by the
physician
’s peers (as defined by the
Secretary)
who are not participating in the demonstration project.
“(4)
Conduct of demonstration project and waiver.—
“(A)
Conduct of demonstration project.—
Chapter
35
of title 44,
United States
Code, shall not apply to the conduct of the demonstration project under this subsection.
“(B)
Waiver.—
The
Secretary
may waive such provisions of titles XI and XVIII of the
Social Security Act
42 U.S.C. 1301
et seq.; 1395 et seq.) as may be necessary to carry out the demonstration project under this subsection.
“(5)
Evaluation and report.—
“(A)
Evaluation.—
The
Secretary
shall evaluate the demonstration project under this subsection to—
“(i)
assess the timeliness and efficacy of the demonstration project;
“(ii)
assess the performance of entities under a contract entered into under paragraph (2)(I)(i);
“(iii)
analyze data—
“(I)
on the rates of
appropriate
, uncertain, and inappropriate
advanced diagnostic imaging services
furnished by
physicians
participating in the demonstration project;
“(II)
on patterns and trends in the appropriateness and inappropriateness of such services furnished by such
physicians
“(III)
on patterns and trends in national and regional variations of care with respect to the furnishing of such services; and
“(IV)
on the correlation between the appropriateness of the services furnished and image results; and
“(iv)
address—
“(I)
the thresholds used under the demonstration project to identify acceptable and outlier levels of performance with respect to the appropriateness of
advanced diagnostic imaging services
furnished;
“(II)
whether prospective use of appropriateness criteria could have an effect on the volume of such services furnished;
“(III)
whether expansion of the use of appropriateness criteria with respect to such services to a broader population of
Medicare
beneficiaries would be advisable;
“(IV)
whether, under such an expansion,
physicians
who demonstrate consistent compliance with such appropriateness criteria should be exempted from certain requirements;
“(V)
the use of incident-specific versus practice-specific outlier information in formulating future recommendations with respect to the use of appropriateness criteria for such services under the
Medicare
program; and
“(VI)
the potential for using methods (including financial incentives), in addition to those used under the models under the demonstration project, to ensure compliance with such criteria.
“(B)
Report.—
Not later than 1 year after the completion of the demonstration project under this subsection, the
Secretary
shall submit to
Congress
a report containing the results of the evaluation of the demonstration project conducted under subparagraph (A), together with recommendations for such legislation and administrative action as the
Secretary
determines
appropriate.
“(6)
Funding.—
The
Secretary
shall provide for the transfer from the Federal Supplementary Medical Insurance Trust Fund established under section 1841 of the
Social Security Act
42 U.S.C. 1395t
) of $10,000,000, for carrying out the demonstration project under this subsection (including costs associated with administering the demonstration project, reimbursing
physicians
for administrative costs and providing incentives to encourage participation under paragraph (2)(C), entering into contracts under paragraph (2)(I), and evaluating the demonstration project under paragraph (5)).”
Air Ambulance Payment Improvements
Pub. L. 110–275, title I, § 146(b)(1)
July 15, 2008
122 Stat. 2548
, as amended by
Pub. L. 111–148, title III, § 3105(b)
, title X, § 10311(b),
Mar. 23, 2010
124 Stat. 417
, 943;
Pub. L. 111–309, title I, § 106(b)
Dec. 15, 2010
124 Stat. 3287
Pub. L. 112–78, title III, § 306(b)
Dec. 23, 2011
125 Stat. 1285
Pub. L. 112–96, title III, § 3007(b)
Feb. 22, 2012
126 Stat. 190
Pub. L. 112–240, title VI, § 604(b)
Jan. 2, 2013
126 Stat. 2348
, provided that:
“Notwithstanding any other provision of law, for purposes of making payments under section 1834(
) of the
Social Security Act
42 U.S.C. 1395m
)) for air ambulance services furnished during the period beginning on
July 1, 2008
, and ending on
June 30, 2013
, any area that was designated as a
rural area
for purposes of making payments under such section for air ambulance services furnished on
December 31, 2006
, shall be treated as a
rural area
for purposes of making payments under such section for air ambulance services furnished during such period.”
Evaluation of Certain Code
Pub. L. 110–275, title I, § 154(c)(3)
July 15, 2008
122 Stat. 2566
, provided that:
“The
Secretary
of Health and Human Services shall evaluate the existing Health Care Common Procedure Coding System (HCPCS) codes for negative pressure wound therapy to ensure accurate reporting and billing for items and services under such codes. In carrying out such evaluation, the
Secretary
shall use an existing process, administered by the
Durable Medical Equipment
Medicare
Administrative Contractors, for the consideration of coding changes and consider all relevant studies and information furnished pursuant to such process.”
GAO Report on Class III Medical Devices
Pub. L. 108–173, title III, § 302(c)(1)(B)
Dec. 8, 2003
117 Stat. 2231
, provided that:
“Not later than
March 1, 2006
, the Comptroller General of the
United States
shall submit to
Congress
, and transmit to the
Secretary
[of Health and Human Services], a report containing recommendations on the
appropriate
update percentage under section 1834(a)(14) of the
Social Security Act
42 U.S.C. 1395m(a)(14)
) for class III medical devices described in section 513(a)(1)(C) of the
Federal Food, Drug, and Cosmetic Act
21 U.S.C. 360(a)(1)(C)
[360c(a)(1)(C)]) furnished to
medicare
beneficiaries during 2007 and 2008.”
Use of Data
Pub. L. 108–173, title IV, § 414(c)(2)
Dec. 8, 2003
117 Stat. 2280
, provided that:
“In order to promptly implement section 1834(
)(12) of the
Social Security Act
42 U.S.C. 1395m
)(12)], as added by paragraph (1), the
Secretary
[of Health and Human Services] may use data furnished by the Comptroller General of the
United States.
GAO Report on Costs and Access
Pub. L. 108–173, title IV, § 414(f)
Dec. 8, 2003
117 Stat. 2280
, which required the Comptroller General of the
United States
to submit to
Congress
initial and final reports on how costs differ among the types of ambulance providers and on access, supply, and quality of ambulance services in those regions and
States
that have a reduction in payment under the
medicare
ambulance fee schedule under section 1395m(l) of this title, was repealed by
Pub. L. 111–68, div. A, title I, § 1501(e)(1)
Oct. 1, 2009
123 Stat. 2041
Report on Demonstration Project Permitting Skilled Nursing Facilities To Be Originating Telehealth Sites; Authority To Implement
Pub. L. 108–173, title IV, § 418
Dec. 8, 2003
117 Stat. 2283
, provided that:
“(a)
Evaluation.—
The
Secretary
[of Health and Human Services], acting through the Administrator of the
Health Resources and Services Administration
in consultation with the Administrator of the Centers for
Medicare
& Medicaid Services, shall evaluate demonstration projects conducted by the
Secretary
under which skilled nursing facilities (as defined in section 1819(a) of the
Social Security Act
42 U.S.C. 1395i–3(a)
)[)] are treated as
originating sites
for
telehealth services.
“(b)
Report.—
Not later than
January 1, 2005
, the
Secretary
shall submit to
Congress
a report on the evaluation conducted under subsection (a). Such report shall include recommendations on mechanisms to ensure that permitting a
skilled nursing facility
to serve as an
originating site
for the use of
telehealth services
or any other service delivered via a
telecommunications system
does not serve as a substitute for in
-person
visits furnished by a
physician,
or for in
-person
visits furnished by a
physician
assistant, nurse
practitioner
or
clinical nurse specialist,
as is otherwise required by the
Secretary.
“(c)
Authority To Expand Originating Telehealth Sites To Include Skilled Nursing Facilities.—
Insofar as the
Secretary
concludes in the report required under subsection (b) that it is advisable to permit a
skilled nursing facility
to be an
originating site
for
telehealth services
under section 1834(m) of the
Social Security Act
42 U.S.C. 1395m(m)
), and that the
Secretary
can establish the mechanisms to ensure such permission does not serve as a substitute for in
-person
visits furnished by a
physician,
or for in
-person
visits furnished by a
physician
assistant, nurse
practitioner
or
clinical nurse specialist,
the
Secretary
may deem a
skilled nursing facility
to be an
originating site
under paragraph (4)(C)(ii) of such section beginning on
January 1, 2006
.”
Payment for New Technologies
Pub. L. 106–554, § 1(a)(6) [title I, § 104(d)]
Dec. 21, 2000
114 Stat. 2763
, 2763A–470, as amended by
Pub. L. 108–173, title IX, § 900(e)(6)(H)
Dec. 8, 2003
117 Stat. 2374
, provided that:
“(1)
Tests furnished in 2001.—
“(A)
Screening.—
For a
screening mammography
(as defined in section 1861(jj) of the
Social Security Act
42 U.S.C. 1395x(jj)
)) furnished during the period beginning on
April 1, 2001
, and ending on
December 31, 2001
, that uses a new technology, payment for such
screening mammography
shall be made as follows:
“(i)
In the case of a technology which directly takes a digital image (without involving film), in an amount equal to 150 percent of the amount of payment under section 1848 of such Act (
42 U.S.C. 1395w–4
) for a bilateral diagnostic mammography (under HCPCS code 76091) for such year.
“(ii)
In the case of a technology which allows conversion of a standard film mammogram into a digital image and subsequently analyzes such resulting image with software to identify possible problem areas, in an amount equal to the limit that would otherwise be applied under section 1834(c)(3) of such Act (
42 U.S.C. 1395m(c)(3)
) for 2001, increased by $15.
“(B)
Bilateral diagnostic mammography.—
For a bilateral diagnostic mammography furnished during the period beginning on
April 1, 2001
, and ending on
December 31, 2001
, that uses a new technology described in subparagraph (A), payment for such mammography shall be the amount of payment provided for under such subparagraph.
“(C)
Allocation of amounts.—
The
Secretary
shall provide for an
appropriate
allocation of the amounts under subparagraphs (A) and (B) between the professional and technical components.
“(D)
Implementation of provision.—
The
Secretary
of Health and Human Services may implement the provisions of this paragraph by program memorandum or otherwise.
“(2)
Consideration of new hcpcs code for new technologies after 2001.—
The
Secretary
shall determine, for such mammographies performed after 2001, whether the assignment of a new HCPCS code is
appropriate
for mammography that uses a new technology. If the
Secretary
determines that a new code is
appropriate
for such mammography, the
Secretary
shall provide for such new code for such tests furnished after 2001.
“(3)
New technology described.—
For purposes of this subsection, a new technology with respect to a mammography is an advance in technology with respect to the test or equipment that results in the following:
“(A)
A significant increase or decrease in the resources used in the test or in the manufacture of the equipment.
“(B)
A significant improvement in the performance of the test or equipment.
“(C)
A significant advance in medical technology that is expected to significantly improve the
treatment
of
medicare
beneficiaries.
“(4)
HCPCS code defined.—
The term ‘HCPCS code’ means a code under the Health Care Common Procedure Coding System (HCPCS).”
MedPAC Study and Report on
Medicare
Coverage of Cardiac and Pulmonary Rehabilitation Therapy Services
Pub. L. 106–554, § 1(a)(6) [title I, § 127]
Dec. 21, 2000
114 Stat. 2763
, 2763A–479, provided that:
“(a)
Study.—
“(1)
In general.—
The
Medicare
Payment Advisory Commission shall conduct a study on coverage of cardiac and pulmonary rehabilitation therapy services under the
medicare
program under title XVIII of the
Social Security Act
[this subchapter].
“(2)
Focus.—
In conducting the study under paragraph (1), the Commission shall focus on the
appropriate
“(A)
qualifying diagnoses required for coverage of cardiac and pulmonary rehabilitation therapy services;
“(B)
level of
physician
direct involvement and supervision in furnishing such services; and
“(C)
level of reimbursement for such services.
“(b)
Report.—
Not later than 18 months after the date of the enactment of this Act [
Dec. 21, 2000
], the Commission shall submit to
Congress
a report on the study conducted under subsection (a) together with such recommendations for legislation and administrative action as the Commission determines
appropriate.
GAO Studies on Costs of Ambulance Services Furnished in Rural Areas
Pub. L. 106–554, § 1(a)(6) [title II, § 221(b)]
Dec. 21, 2000
114 Stat. 2763
, 2763A–486, provided that:
“(1)
Study.—
The Comptroller General of the
United States
shall conduct a study on each of the matters described in paragraph (2).
“(2)
Matters described.—
The matters referred to in paragraph (1) are the following:
“(A)
The cost of efficiently providing ambulance services for trips originating in
rural areas
, with special emphasis on collection of cost data from rural providers.
“(B)
The means by which
rural areas
with low population densities can be identified for the purpose of designating areas in which the cost of providing ambulance services would be expected to be higher than similar services provided in more heavily populated areas because of low usage. Such study shall also include an analysis of the additional costs of providing ambulance services in areas designated under the previous sentence.
“(3)
Report.—
Not later than
June 30, 2002
, the Comptroller General shall submit to
Congress
a report on the results of the studies conducted under paragraph (1) and shall include recommendations on steps that should be taken to assure access to ambulance services in
rural areas.
Adjustment in Rural Rates
Pub. L. 106–554, § 1(a)(6) [title II, § 221(c)]
Dec. 21, 2000
114 Stat. 2763
, 2763A–487, as amended by
Pub. L. 108–173, title IV, § 414(f)(1)
, formerly § 414(g)(1),
Dec. 8, 2003
117 Stat. 2281
, as renumbered by
Pub. L. 111–68, div. A, title I, § 1501(e)(2)
Oct. 1, 2009
123 Stat. 2041
, provided that:
“In providing for adjustments under subparagraph (D) of section 1834(
)(2) of the
Social Security Act
42 U.S.C. 1395m
)(2)) for years beginning with 2004, the
Secretary
of Health and Human Services shall take into consideration the recommendations contained in the report under subsection (b)(3) [set out above] and shall adjust the fee schedule payment rates under such section for ambulance services provided in low density
rural areas
based on the increased cost (if any) of providing such services in such areas.”
Study and Report on Additional Coverage for Telehealth Services
Pub. L. 106–554, § 1(a)(6) [title II, § 223(d)]
Dec. 21, 2000
114 Stat. 2763
, 2763A–489, provided that:
“(1)
Study.—
The
Secretary
of Health and Human Services shall conduct a study to identify—
“(A)
settings and sites for the provision of
telehealth services
that are in addition to those permitted under section 1834(m) of the
Social Security Act
42 U.S.C. 1395m(m)
], as added by subsection (b);
“(B)
practitioners
that may be reimbursed under such section for furnishing
telehealth services
that are in addition to the
practitioners
that may be reimbursed for such services under such section; and
“(C)
geographic areas in which
telehealth services
may be reimbursed that are in addition to the geographic areas where such services may be reimbursed under such section.
“(2)
Report.—
Not later than 2 years after the date of the enactment of this Act [
Dec. 21, 2000
], the
Secretary
shall submit to
Congress
a report on the study conducted under paragraph (1) together with such recommendations for legislation that the
Secretary
determines are
appropriate.
Special Rules for Payments for 2001
Pub. L. 106–554, § 1(a)(6) [title IV, § 423(a)(2)]
Dec. 21, 2000
114 Stat. 2763
, 2763A–518, provided that:
“Notwithstanding the amendment made by paragraph (1) [amending this section], for purposes of making payments for ambulance services under part B of title XVIII of the
Social Security Act
42 U.S.C. 1395j
et seq.], for services furnished during 2001, the ‘percentage increase in the consumer price index’ specified in section 1834(
)(3)(B) of such Act (
42 U.S.C. 1395m
)(3)(B))—
“(A)
for services furnished on or after
January 1, 2001
, and before
July 1, 2001
, shall be the percentage increase for 2001 as determined under the provisions of law in effect on the day before the date of the enactment of this Act [
Dec. 21, 2000
]; and
“(B)
for services furnished on or after
July 1, 2001
, and before
January 1, 2002
, shall be equal to 4.7 percent.”
Pub. L. 106–554, § 1(a)(6) [title IV, § 425(b)]
Dec. 21, 2000
114 Stat. 2763
, 2763A–519, provided that:
“Notwithstanding the amendments made by subsection (a) [amending this section], for purposes of making payments for
durable medical equipment
under section 1834(a) of the
Social Security Act
42 U.S.C. 1395m(a)
), other than for oxygen and oxygen equipment specified in paragraph (9) of such section, the payment basis recognized for 2001 under such section—
“(1)
for items furnished on or after
January 1, 2001
, and before
July 1, 2001
, shall be the payment basis for 2001 as determined under the provisions of law in effect on the day before the date of the enactment of this Act [
Dec. 21, 2000
] (including the application of section 228(a)(1) of BBRA [
Pub. L. 106–113, § 1000(a)(6) [title II, § 228(a)(1)]
, set out as a note below]); and
“(2)
for items furnished on or after
July 1, 2001
, and before
January 1, 2002
, shall be the payment basis that is determined under such section 1834(a) if such section 228(a)(1) did not apply and taking into account the amendment made by subsection (a), increased by a transitional percentage allowance equal to 3.28 percent (to account for the timing of implementation of the CPI update).”
Pub. L. 106–554, § 1(a)(6) [title IV, § 426(b)]
Dec. 21, 2000
114 Stat. 2763
, 2763A–520, provided that:
“Notwithstanding the amendments made by subsection (a) [amending this section], for purposes of making payments for
prosthetic devices
and
orthotics and prosthetics
(as defined in subparagraphs (B) and (C) of paragraph (4) of section 1834(h) of the
Social Security Act
42 U.S.C. 1395m(h)
) under such section, the payment basis recognized for 2001 under paragraph (2) of such section—
“(1)
for items furnished on or after
January 1, 2001
, and before
July 1, 2001
, shall be the payment basis for 2001 as determined under the provisions of law in effect on the day before the date of the enactment of this Act [
Dec. 21, 2000
]; and
“(2)
for items furnished on or after
July 1, 2001
, and before
January 1, 2002
, shall be the payment basis that is determined under such section taking into account the amendments made by subsection (a), increased by a transitional percentage allowance equal to 2.6 percent (to account for the timing of implementation of the CPI update).”
Preemption of Rule
Pub. L. 106–554, § 1(a)(6) [title IV, § 428(b)]
Dec. 21, 2000
114 Stat. 2763
, 2763A–522, provided that:
“The provisions of section 1834(h)(1)(G) [
42 U.S.C. 1395m(h)(1)(G)
] as added by subsection (a) shall supersede any rule that as of the date of the enactment of this Act [
Dec. 21, 2000
] may have applied a 5-year replacement rule with regard to
prosthetic devices.
GAO Study and Report on Costs of Emergency and Medical Transportation Services
Pub. L. 106–554, § 1(a)(6) [title IV, § 436]
Dec. 21, 2000
114 Stat. 2763
, 2763A–527, provided that:
“(a)
Study.—
The Comptroller General of the
United States
shall conduct a study on the costs of providing emergency and medical transportation services across the range of acuity levels of conditions for which such transportation services are provided.
“(b)
Report.—
Not later than 18 months after the date of the enactment of this Act [
Dec. 21, 2000
], the Comptroller General shall submit to
Congress
a report on the study conducted under subsection (a), together with recommendations for any changes in methodology or payment level necessary to fairly compensate
suppliers
of emergency and medical transportation services and to ensure the access of beneficiaries under the
medicare
program under title XVIII of the
Social Security Act
42 U.S.C. 1395
et seq.].”
Treatment of Temporary Payment Increases After Calendar Year 2001
Pub. L. 106–554, § 1(a)(6) [title V, § 547(d)]
Dec. 21, 2000
114 Stat. 2763
, 2763A–553, provided that:
“The payment increase provided under the following sections shall not apply after calendar year 2001 and shall not be taken into account in calculating the payment amounts applicable for items and services furnished after such year:
“(1)
Section 401(c)(2)
[set out as a note under
section 1395l of this title
] (relating to covered OPD services).
“(2)
Section 422(e)(2)
[set out as a note under
section 1395rr of this title
] (relating to renal dialysis services paid for on a composite rate basis).
“(3)
Section 423(a)(2)(B) [set out above] (relating to ambulance services).
“(4)
Section 425(b)(2) [set out above] (relating to
durable medical equipment
).
“(5)
Section 426(b)(2) [set out above] (relating to
prosthetic devices
and
orthotics and prosthetics
).”
Study of Delivery of Intravenous Immune Globulin (IVIG) Outside Hospitals and Physicians’ Offices
Pub. L. 106–113, div. B, § 1000(a)(6) [title II, § 201(n)]
Nov. 29, 1999
113 Stat. 1536
, 1501A–341, required the
Secretary
of Health and Human Services to conduct a study of the extent to which
intravenous immune globulin
could be delivered and reimbursed under the
medicare
program outside of a
hospital
or
physician’
s office and to submit a report on such study to
Congress
within 18 months after
Nov. 29, 1999
Temporary Increase in Payment Rates for Durable Medical Equipment and Oxygen
Pub. L. 106–113, div. B, § 1000(a)(6) [title II, § 228]
Nov. 29, 1999
113 Stat. 1536
, 1501A–356, provided that:
“(a)
In General.—
For purposes of payments under section 1834(a) of the
Social Security Act
42 U.S.C. 1395m(a)
) for
covered items
(as defined in paragraph (13) of that section) furnished during 2001 and 2002, the
Secretary
of Health and Human Services shall increase the payment amount in effect (but for this section) for such items for—
“(1)
2001 by 0.3 percent, and
“(2)
2002 by 0.6 percent.
“(b)
Limiting Application to Specified Years.—
The payment amount increase—
“(1)
under subsection (a)(1) shall not apply after 2001 and shall not be taken into account in calculating the payment amounts applicable for
covered items
furnished after such year; and
“(2)
under subsection (a)(2) shall not apply after 2002 and shall not be taken into account in calculating the payment amounts applicable for
covered items
furnished after such year.”
Demonstration of Coverage of Ambulance Services Under
Medicare
Through Contracts With Units of Local Government
Pub. L. 105–33, title IV, § 4532
Aug. 5, 1997
111 Stat. 453
, as amended by
Pub. L. 106–113, div. B, § 1000(a)(6) [title II, § 225]
Nov. 29, 1999
113 Stat. 1536
, 1501A–353, provided that:
“(a)
Demonstration Project Contracts with Local Governments.—
The
Secretary
of Health and Human Services shall establish up to 3 demonstration projects under which, at the request of a unit of local government, the
Secretary
enters into a contract with the unit of local government under which—
“(1)
the unit of local government furnishes (or arranges for the furnishing of) ambulance services for which payment may be made under part B of title XVIII of the
Social Security Act
42 U.S.C. 1395j
et seq.] for individuals residing in the unit of local government who are enrolled under such part, except that the unit of local government may not enter into the contract unless the contract covers at least 80 percent of the individuals residing in the unit of local government who are enrolled under such part but not in a
Medicare
+Choice plan;
“(2)
any individual or entity furnishing ambulance services under the contract meets the requirements otherwise applicable to individuals and entities furnishing such services under such part; and
“(3)
for each month during which the contract is in effect, the
Secretary
makes a capitated payment to the unit of local government in accordance with subsection (b).
The projects may extend over a period of not to exceed 3 years each. Not later than
July 1, 2000
, the
Secretary
shall publish a request for proposals for such projects.
“(b)
Amount of Payment.—
“(1)
In general.—
The amount of the monthly payment made for months occurring during a calendar year to a unit of local government under a demonstration project contract under subsection (a) shall be equal to the product of—
“(A)
the
Secretary
’s estimate of the number of individuals covered under the contract for the month; and
“(B)
12
of the capitated payment rate for the year established under paragraph (2).
“(2)
Capitated payment rate defined.—
In this subsection, the term ‘capitated payment rate’ means, with respect to a demonstration project—
“(A)
in its first year, a rate established for the project by the
Secretary
, using the most current available data, in a manner that ensures that aggregate payments under the project will not exceed the aggregate payment that would have been made for ambulance services under part B of title XVIII of the
Social Security Act
42 U.S.C. 1395j
et seq.] in the local area of government’s jurisdiction; and
“(B)
in a subsequent year, the capitated payment rate established for the previous year increased by an
appropriate
inflation adjustment factor.
“(c)
Other Terms of Contract.—
The
Secretary
and the unit of local government may include in a contract under this section such other terms as the parties consider
appropriate
, including—
“(1)
covering individuals residing in additional units of local government (under arrangements entered into between such units and the unit of local government involved);
“(2)
permitting the unit of local government to transport individuals to non-
hospital
providers if such providers are able to furnish quality services at a lower cost than
hospital
providers; or
“(3)
implementing such other innovations as the unit of local government may propose to improve the quality of ambulance services and control the costs of such services.
“(d)
Contract Payments in Lieu of Other Benefits.—
Payments under a contract to a unit of local government under this section shall be instead of the amounts which (in the absence of the contract) would otherwise be payable under part B of title XVIII of the
Social Security Act
42 U.S.C. 1395j
et seq.] for the services covered under the contract which are furnished to individuals who reside in the unit of local government.
“(e)
Report on Effects of Capitated Contracts.—
“(1)
Study.—
The
Secretary
shall evaluate the demonstration projects conducted under this section. Such evaluation shall include an analysis of the quality and cost-effectiveness of ambulance services furnished under the projects.
“(2)
Report.—
Not later than
January 1, 2000
, the
Secretary
shall submit a report to
Congress
on the study conducted under paragraph (1), and shall include in the report such recommendations as the
Secretary
considers
appropriate,
including recommendations regarding modifications to the methodology used to determine the amount of payments made under such contracts and extending or expanding such projects.”
[References to
Medicare
+Choice deemed to refer to
Medicare
Advantage, see
section 201(b) of Pub. L. 108–173
, set out as a note under
section 1395w–21 of this title
.]
Pub. L. 106–113, div. B, § 1000(a)(6) [title II, § 225]
Nov. 29, 1999
113 Stat. 1536
, 1501A–353, provided that the amendment made by that section to
section 4532 of Pub. L. 105–33
, set out above, is effective as if included in the enactment of the
Balanced Budget Act of 1997
Pub. L. 105–33
.]
Payment Freeze for Parenteral and Enteral Nutrients, Supplies, and Equipment
Pub. L. 105–33, title IV, § 4551(b)
Aug. 5, 1997
111 Stat. 458
, provided that:
“In determining the amount of payment under part B of title XVIII of the
Social Security Act
42 U.S.C. 1395j
et seq.] with respect to parenteral and enteral nutrients, supplies, and equipment during each of the years 1998 through 2002, the charges determined to be reasonable with respect to such nutrients, supplies, and equipment may not exceed the charges determined to be reasonable with respect to such nutrients, supplies, and equipment during 1995.”
Service Standards for Providers of Oxygen and Oxygen Equipment
Pub. L. 105–33, title IV, § 4552(c)
Aug. 5, 1997
111 Stat. 459
, provided that:
“The
Secretary
shall as soon as practicable establish service standards for
persons
seeking payment under part B of title XVIII of the
Social Security Act
42 U.S.C. 1395j
et seq.] for the providing of oxygen and oxygen equipment to beneficiaries within their homes.”
Access to Home Oxygen Equipment
Pub. L. 105–33, title IV, § 4552(d)
Aug. 5, 1997
111 Stat. 459
, provided that:
“(1)
Study.—
The Comptroller General of the
United States
shall study issues relating to access to home oxygen equipment and shall, within 18 months after the date of the enactment of this Act [
Aug. 5, 1997
], report to the Committees on Commerce and Ways and Means of the
House of Representatives
and the Committee on Finance of the
Senate
the results of the study, including recommendations (if any) for legislation.
“(2)
Peer review evaluation.—
The
Secretary
of Health and Human Services shall arrange for peer review [now “quality improvement”] organizations established under section 1154 of the
Social Security Act
42 U.S.C. 1320c–3
] to evaluate access to, and quality of, home oxygen equipment.”
Use of Covered Items by Disabled Beneficiaries
Pub. L. 103–432, title I, § 131(b)
Oct. 31, 1994
108 Stat. 4419
, provided that:
“(1)
In general.—
The
Secretary
of Health and Human Services, in consultation with representatives of
suppliers
of
durable medical equipment
under part B of the
medicare
program [
42 U.S.C. 1395j
et seq.] and individuals entitled to benefits under such program on the basis of disability, shall conduct a study of the effects of the methodology for determining payments for items of such equipment under such part on the ability of such individuals to obtain items of such equipment, including customized items.
“(2)
Report.—
Not later than one year after the date of the enactment of this Act [
Oct. 31, 1994
], the
Secretary
shall submit a report to
Congress
on the study conducted under paragraph (1), and shall include in the report such recommendations as the
Secretary
considers
appropriate
to assure that disabled
medicare
beneficiaries have access to items of
durable medical equipment.
Criteria for Treatment of Items as Prosthetic Devices or Orthotics and Prosthetics
Pub. L. 103–432, title I, § 131(c)
Oct. 31, 1994
108 Stat. 4419
, provided that not later than one year after
Oct. 31, 1994
Secretary
of Health and Human Services was to submit to
Congress
a report describing
prosthetic devices
or
orthotics and prosthetics
covered under this part that do not require individualized or custom fitting and adjustment to be used by a patient, including recommendations for
appropriate
methodology for determining amount of payment for such items.
Adjustment Required for Certain Items
Pub. L. 103–432, title I, § 134(b)
Oct. 31, 1994
108 Stat. 4422
, provided that:
“(1)
In general.—
In accordance with section 1834(a)(10)(B) of the
Social Security Act
42 U.S.C. 1395m(a)(10)(B)
] (as amended by subsection (a)), the
Secretary
of Health and Human Services shall determine whether the payment amounts for the items described in paragraph (2) are not inherently reasonable, and shall adjust such amounts in accordance with such section if the amounts are not inherently reasonable.
“(2)
Items described.—
The items referred to in paragraph (1) are decubitus care equipment, transcutaneous electrical nerve stimulators, and any other items considered
appropriate
by the
Secretary.
Limitation on Prevailing Charge for Physicians’ Radiology Services Furnished During 1991; Exceptions
Pub. L. 101–508, title IV, § 4102(c)
Nov. 5, 1990
104 Stat. 1388–57
, as amended by
Pub. L. 103–432, title I, § 126(b)(3)
Oct. 31, 1994
108 Stat. 4415
, provided that:
“(1)
In general.—
In applying part B of title XVIII of the
Social Security Act
42 U.S.C. 1395j
et seq.], the prevailing charge for
physicians’
services, furnished during 1991, which are radiology services may not exceed the fee schedule amount established under section 1834(b) of such Act [
42 U.S.C. 1395m(b)
] with respect to such services.
“(2)
Exception.—
Paragraph (1) shall not apply to nuclear medicine services.”
Limitation on Carrier Adjustments for Radiologist Services Furnished During 1991
Pub. L. 101–508, title IV, § 4102(e)
Nov. 5, 1990
104 Stat. 1388–57
, provided that:
“For
radiologist services
furnished during 1991 for which payment is made under section 1834(b) of the
Social Security Act
42 U.S.C. 1395m(b)
]—
“(1)
carrier
may not make any adjustment, under section 1842(b)(3)(B) of such Act [
42 U.S.C. 1395u(b)(3)(B)
], in the payment amount for the service under section 1834(b) on the basis that the payment amount is higher than the charge applicable, for a comparable service and under comparable circumstances, to the policyholders and subscribers of the
carrier,
“(2)
no payment adjustment may be made under section 1842(b)(8) of such Act, and
“(3)
section 1842(b)(9) of such Act shall not apply.”
Study of Payments for Prosthetic Devices, Orthotics, and Prosthetics
Pub. L. 101–508, title IV, § 4153(c)
Nov. 9, 1990
104 Stat. 1388–84
, as amended by
Pub. L. 103–432, title I, § 135(e)(6)
Oct. 31, 1994
108 Stat. 4424
, directed Comptroller General to conduct a study of feasibility and desirability of establishing a separate fee schedule for use in determining the amount of payments for
covered items
under subsec. (h) of this section with respect to
suppliers
of
prosthetic devices,
orthotics, and prosthetics who provide professional services that would take into account the costs to such providers of providing such services and, not later than 1 year after
Nov. 5, 1990
, submit a report on the study to Committees on Energy and Commerce and Ways and Means of
House of Representatives
and Committee on Finance of
Senate
, including any recommendations regarding payments for
prosthetic devices,
orthotics, and prosthetics under the
medicare
program.
Special Rule for Nuclear Medicine Physicians
Pub. L. 101–239, title VI, § 6105(b)
Dec. 19, 1989
103 Stat. 2210
, as amended by
Pub. L. 101–508, title IV, § 4102(g)(1)
Nov. 5, 1990
104 Stat. 1388–57
, provided that:
“In applying section 1834(b) of the
Social Security Act
42 U.S.C. 1395m(b)
] with respect to nuclear medicine services furnished by a
physician
for whom nuclear medicine services account for at least 80 percent of the total amount of charges made under part B of title XVIII of the
Social Security Act
42 U.S.C. 1395j
et seq.] beginning
April 1, 1990
, and ending
December 31, 1991
, there shall be substituted for the fee schedule otherwise applicable a fee schedule based ⅓ on the fee schedule computed under such section (without regard to this subsection) and ⅔ on 101 percent of the 1988 prevailing charge for such services.”
Special Rule for Interventional Radiologists; “Split Billing”
Pub. L. 101–239, title VI, § 6105(c)
Dec. 19, 1989
103 Stat. 2210
, as amended by
Pub. L. 101–508, title IV, § 4102(h)
Nov. 5, 1990
104 Stat. 1388–58
, provided that:
“In applying section 1834(b) of the
Social Security Act
42 U.S.C. 1395m(b)
] to
radiologist services
furnished in 1990 or 1991, the exception for ‘split billing’ set forth at section 5262J of the
Medicare
Carriers
Manual shall apply to services furnished in 1990 or 1991 in the same manner and to the same extent as the exception applied to services furnished in 1989.”
Rental Payments for Enteral and Parenteral Pumps
Pub. L. 101–239, title VI, § 6112(b)
Dec. 19, 1989
103 Stat. 2215
, provided that:
“(1)
In general.—
Except as provided in paragraph (2), the amount of any monthly rental payment under part B of title XVIII of the
Social Security Act
42 U.S.C. 1395j
et seq.] for an enteral or parenteral pump furnished on or after
April 1, 1990
, shall be determined in accordance with the methodology under which monthly rental payments for such pumps were determined during 1989.
“(2)
Cap on Rental Payments, Servicing, and Repairs.—
In the case of an enteral or parenteral pump described in paragraph (1) that is furnished on a rental basis during a period of medical need—
“(A)
monthly rental payments shall not be made under part B of title XVIII of the
Social Security Act
for more than 15 months during such period, and
“(B)
after monthly rental payments have been made for 15 months during such period, payment under such part shall be made for maintenance and servicing of the pump in such amounts as the
Secretary
of Health and Human Services determines to be reasonable and necessary to ensure the proper operation of the pump.”
Treatment of Power-Driven Wheelchairs as Customized Items
Pub. L. 101–239, title VI, § 6112(d)(2)
Dec. 19, 1989
103 Stat. 2215
, provided that:
“The
Secretary
of Health and Human Services shall by regulation specify criteria to be used by
carriers
in making determinations on a case-by-case basis as whether to classify power-driven wheelchairs as a customized item (as described in section 1834(a)(4) of the
Social Security Act
42 U.S.C. 1395m(a)(4)
]) for purposes of reimbursement under title XVIII of such Act [
42 U.S.C. 1395
et seq.].”
Study of Payment for Portable X-Ray Services
Pub. L. 101–239, title VI, § 6134
Dec. 19, 1989
103 Stat. 2222
, directed
Secretary
of Health and Human Services to conduct a study of costs of furnishing, and payments for, portable x-ray services under part B and, not later than 1 year after
Dec. 19, 1989
, report to
Congress
on results of such study including a recommendation respecting whether payment for such services should be made in the same manner as for radiologists’ services or on the basis of a separate fee schedule.
GAO Study of Standards for Use of and Payment for Items of Durable Medical Equipment
Pub. L. 101–239, title VI, § 6139
Dec. 19, 1989
103 Stat. 2224
, directed Comptroller General to conduct a study of
appropriate
uses of items of
durable medical equipment
and of
appropriate
criteria for making determinations of medical necessity under this subchapter for such items, with particular emphasis on items (including seat-lift chairs) that may be subject to abusive billing practices, such study to include an analysis of
appropriate
use of forms in making medical necessity determinations for items of
durable medical equipment
under such title, and procedures for identifying items of
durable medical equipment
that should no longer be covered under this subchapter, and to be conducted with a panel convened by the Comptroller General consisting of specialists in the disciplines of orthopedic medicine, rehabilitation, arthritis, and geriatric medicine, representatives of consumer organizations, and representatives of
carriers
under the
medicare
program, with the Comptroller General to submit not later than
Apr. 1, 1991
, a report to Committees on Ways and Means and Energy and Commerce of
House of Representatives
and Committee on Finance of
Senate
on the study including recommendations.
Reports on
Medicare
Beneficiary Drug Expenses
Pub. L. 100–360, title II, § 202(i)
July 1, 1988
102 Stat. 718
, directed
Secretary
of Health and Human Services, by not later than
Apr. 1, 1989
, to report to
Congress
on expenses incurred by
medicare
beneficiaries for outpatient prescription
drugs,
and to provide Director of
Congressional Budget Office
with such data from that Survey as Director might request to make required estimates, prior to repeal by
Pub. L. 101–234, title II, § 201(a)
Dec. 13, 1989
103 Stat. 1981
Additional Studies by Secretary or Comptroller General
Pub. L. 100–360, title II, § 202(k)
July 1, 1988
102 Stat. 719
, directed
Secretary
of Health and Human Services to conduct a study, and make a report to
Congress
by
Jan. 1, 1990
, on possibility of including
drugs
which have not yet been approved under section 355 or 357 of Title 21, Food and
Drugs,
and biological products which have not been licensed under
section 262 of this title
but which are commonly used in the
treatment
of cancer or in immunosuppressive therapy and other experimental
drugs
and biological products as covered outpatient
drugs
under
medicare
program, to conduct a study, and report to
Congress
by
Jan. 1, 1990
, evaluating potential to use mail service pharmacies to reduce costs to
medicare
program and to
medicare
beneficiaries, to conduct a study, and report to
Congress
by
Jan. 1, 1993
, on methods to improve utilization review of covered outpatient
drugs,
and to conduct a longitudinal study, and report to
Congress
by
Jan. 1, 1993
, on use of outpatient prescription
drugs
by
medicare
beneficiaries with respect to medical necessity, potential for adverse drug interactions, cost (including whether lower cost
drugs
could have been used), and patient stockpiling or wastage, and which further directed Comptroller General to conduct studies, and report to
Congress
by not later than
May 1, 1991
, on comparing average wholesale prices with actual pharmacy acquisition costs by type of pharmacy, on determining the overhead costs of retail pharmacies, and on discounts given by pharmacies to other third-party insurers, prior to repeal by
Pub. L. 101–234, title II, § 201(a)
Dec. 13, 1989
103 Stat. 1981
Development of Standard
Medicare
Claims Forms
Pub. L. 100–360, title II, § 202
(l),
July 1, 1988
102 Stat. 720
, directed
Secretary
of Health and Human Services to develop, in consultation with representatives of pharmacies and other interested individuals, a standard claims form (and a standard electronic claims format) to be used in requests for payment for covered outpatient
drugs
under
medicare
program and other third-party payors, prior to repeal by
Pub. L. 101–234, title II, § 201(a)
Dec. 13, 1989
103 Stat. 1981
Studies and Reports on Screening Mammography
Pub. L. 100–360, title II, § 204(f)
July 1, 1988
102 Stat. 729
, directed
Physician
Payment Review Commission to study and report, by
July 1, 1989
, to Committees on Ways and Means and Energy and Commerce of the
House of Representatives
and Committee on Finance of the
Senate
concerning the cost of providing
screening mammography
in a variety of settings and at different volume levels, prior to repeal by
Pub. L. 101–234, title II, § 201(a)
Dec. 13, 1989
103 Stat. 1981
Deadline for Establishment of Fee Schedules for Radiologist Services; Report to
Congress
Pub. L. 100–203, title IV, § 4049(b)(1)
Dec. 22, 1987
101 Stat. 1330–92
, as amended by
Pub. L. 100–360, title IV, § 411(f)(8)(E)
July 1, 1988
102 Stat. 780
Pub. L. 101–508, title IV, § 4118(g)(3)
Nov. 5, 1990
104 Stat. 1388–70
, directed
Secretary
of Health and Human Services to propose the relative value scale and fee schedules for
radiologist services
(under subsec. (b) of this section) by not later than
Aug. 1, 1988
Study and Evaluation
Pub. L. 100–203, title IV, § 4062(c)
Dec. 22, 1987
101 Stat. 1330–107
, as amended by
Pub. L. 100–360, title IV, § 411(g)(1)(C)
July 1, 1988
102 Stat. 782
, provided that:
“(1)
The
Secretary
of Health and Human Services shall monitor the impact of the amendments made by this section [enacting this section, amending sections
1395f
1395k
1395l
, and
1395cc
of this title, and repealing
section 1395zz of this title
] on the availability of
covered items
and shall evaluate the appropriateness of the volume adjustment for oxygen and oxygen equipment under section 1834(a)(5)(C) of the
Social Security Act
42 U.S.C. 1395m(a)(5)(C)
] (as amended by subsection (b) of this section). The
Secretary
shall report to
Congress
, by not later than
January 1, 1991
, on such impact and on the evaluation and shall include in such report recommendations for changes in payment methodology for
covered items
under section 1834(a) of such Act.
“(2)
Before
January 1, 1991
, the
Secretary
may not conduct any demonstration project respecting alternative methods of payment for
covered items
under title XVIII of the
Social Security Act
42 U.S.C. 1395
et seq.].
“(3)
In this subsection, the term ‘
covered item
’ has the meaning given such term in section 1834(a)(13) of the
Social Security Act
42 U.S.C. 1395m(a)(13)
] (as amended by subsection (b) of this section).
“(4)
The
Secretary
shall, upon written request and payment of a reasonable copying fee which the
Secretary
may establish, provide the data and information used in determining the payment amounts for
covered items
under section 1834(a) of the
Social Security Act
42 U.S.C. 1395m(a)
], but only in a form which does not permit identification of individual
suppliers.
“(5)
The Comptroller General shall conduct a study on the appropriateness of the level of payments allowed for
covered items
under the
medicare
program, and shall report to
Congress
on the results of such study (including recommendations on the transition to regional or national rates) by not later than
January 1, 1991
. Entities furnishing such items which fail to provide the Comptroller General with reasonable access to necessary records to carry out the study under this paragraph are subject to exclusion from the
medicare
program under section 1128(a) of the
Social Security Act
42 U.S.C. 1320a–7(a)
].”
CFR Title
Parts
42
41
410
413
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