U.S Code last checked for updates: Nov 22, 2024
All TitlesTitle 42Chapter 7Subchapter XVIIIPart B
§ 1395m.
Special payment rules for particular items and services
(a)
Payment for durable medical equipment
(1)
General rule for payment
(A)
In general
(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
(D)
Reduction in fee schedules for certain items
(E)
Clinical conditions for coverage
(i)
In general
(ii)
Requirements
(iii)
Priority of establishment of standards
(iv)
Standards for power wheelchairs
(v)
Limitation on payment for covered items
(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
(ii)
Date described
(I)
Treatment of vacuum erection systems
(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
(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
(5)
Payment for oxygen and oxygen equipment
(A)
In general
(B)
Add-on 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
(E)
Recertification for patients receiving home oxygen therapy
(F)
Rental cap
(i)
In general
(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)
(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
(II)
Payment amount
(III)
Special rule for power-driven wheelchairs
(ii)
Ownership after rental
(iii)
Purchase agreement option for complex, rehabilitative power-driven wheelchairs
(iv)
Maintenance and servicing
(B)
Range for rental amounts
(i)
For 1989
(ii)
For 1990
(C)
Replacement of items
(i)
Establishment of reasonable useful lifetime
(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
(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
1
 So in original. The semicolon probably should be a comma.
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
(ii)
Budget neutrality
(10)
Exceptions and adjustments
(A)
Areas outside continental United States
(B)
Adjustment for inherent reasonableness
(C)
Transcutaneous electrical nerve stimulator (TENS)
(11)
Improper billing and requirement of physician order
(A)
Improper billing for certain rental items
(B)
Requirement of physician order
(i)
In general
(ii)
Requirement for face to face encounter
(12)
Regional carriers
(13)
“Covered item” defined
(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
(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
A 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
A 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
(C)
Exclusion from program for suppliers engaging in pattern of unsolicited contacts
(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
(C)
Notice
(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
(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
(C)
Quality 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
(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
(C)
Application of update to special payment amount
(22)
Special payment rule for diabetic supplies
(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
(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
(B)
Initial savings
(C)
1990 fee schedules
(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
(ii)
Reduced national weighted average
(iii)
Computation of 1990 locality index relative to national average
(iv)
Adjusted conversion factor
(v)
Locally-adjusted amount
(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
(E)
Rule for certain scanning services
(F)
Subsequent updating
(G)
Nonparticipating physicians and suppliers
(5)
Limiting charges of nonparticipating physicians and suppliers
(A)
In general
(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
(6)
“Radiologist services” defined
For the purposes of this subsection and section 1395l(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
(ii)
Revision of frequency
(d)
Frequency limits and payment for colorectal cancer screening tests
(1)
Screening fecal-occult blood tests
(A)
Payment amount
(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
(B)
Payment limit
(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 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 1395l(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
(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
(B)
Payment limit
(C)
Facility payment limit
(i)
In general
(ii)
Limitation on coinsurance
Subject to section 1395l(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
(E)
Frequency limit
(e)
Accreditation requirement for advanced diagnostic imaging services
(1)
In general
(A)
In general
(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
(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) 2 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
(C)
Review and modification of list of accreditation organizations
(i)
In general
(ii)
Special rule for accreditations done prior to removal from list of designated accreditation organizations
(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
(f)
Reduction in payments for physician pathology services during 1991
(1)
In general
(2)
Limitation
(g)
Payment for outpatient critical access hospital services
(1)
In general
(2)
Election of cost-based hospital outpatient service payment plus fee schedule for professional services
A 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
(B)
Fee schedule for professional services
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
(4)
Treatment of clinical diagnostic laboratory services
(5)
Coverage of costs for certain emergency room on-call providers
(h)
Payment for prosthetic devices and orthotics and prosthetics
(1)
General rule for payment
(A)
In general
(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
(D)
Exclusive payment rule
(E)
Exception for certain items
(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
(II)
List of items
(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
(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;
(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
(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
4
 So in original.
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
(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
(B)
Standards for possessing a supplier number
A 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
(D)
Prohibition against multiple supplier numbers
(E)
Prohibition against delegation of supplier determinations
(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
(iii)
Penalty
(B)
“Certificate of medical necessity” defined
(3)
Coverage and review criteria
(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
(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
5
 So in original. Two subpars. (G) have been enacted.
such other items as the Secretary may determine; and
(G)
 5 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 1395l(a)(8) or 1395l(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
(4)
Adjusted reasonable costs
(5)
Uniform coding
(6)
Restraint on billing
(7)
Adjustment in discount for certain multiple therapy services
(l)
Establishment of fee schedule for ambulance services
(1)
In general
(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
(5)
Limitation on review
(6)
Restraint on billing
(7)
Coding system
(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
(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
(12)
Assistance for rural providers furnishing services in low population density areas
(A)
In general
(B)
Identification of qualified rural areas
(i)
Determination of population density in area
(ii)
Ranking of areas
(iii)
Identification of qualified rural areas
(iv)
Rural area
(v)
Judicial review
(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, 2025,,4 for which the transportation originates in—
(i)
a 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, 2025); 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, 2025).
(B)
Application of increased payments after applicable period
(14)
Providing appropriate coverage of rural air ambulance services
(A)
In general
The regulations described in section 1395x(s)(7) of this title
(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
(D)
Limitation
(i)
In general
(ii)
Exception
(15)
Payment adjustment for non-emergency ambulance transports for ESRD beneficiaries
(16)
Prior authorization for repetitive scheduled non-emergent ambulance transports
(A)
In general
(B)
Funding
(C)
Clarification regarding budget neutrality
(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
(II)
Requirements
(III)
Limitation
(C)
Reporting of cost information
(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
(iii)
Hardship exemption
(iv)
Informal review
(E)
Ongoing data collection
(i)
Revision of data collection system
(ii)
Subsequent data collection
(F)
Ground ambulance data collection system study
(i)
In general
(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
(H)
Implementation
(I)
Administration
(J)
Limitations on review
(K)
Funding for implementation
(m)
Payment for telehealth services
(1)
In general
(2)
Payment amount
(A)
Distant site
(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 1395l(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
(iii)
No facility fee for new sites
(C)
Telepresenter not required
(3)
Limitation on beneficiary charges
(A)
Physician and practitioner
(B)
Originating site
(4)
Definitions
(A)
Distant site
(B)
Eligible telehealth individual
(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)
A critical access hospital (as defined in section 1395x(mm)(1) of this title).
(III)
A rural health clinic (as defined in section 1395x(aa)(2) of this title).
(IV)
A Federally qualified health center (as defined in section 1395x(aa)(4) of this title).
(V)
A hospital (as defined in section 1395x(e) of this title).
(VI)
A hospital-based or critical access hospital-based renal dialysis center (including satellites).
(VII)
A 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)
A rural emergency hospital (as defined in section 1395x(kkk)(2) of this title).
(iii)
Expanding access to telehealth services
(D)
Physician
(E)
Practitioner
(F)
Telehealth service
(i)
In general
(ii)
Yearly update
(5)
Treatment of home dialysis monthly ESRD-related visit
(6)
Treatment of stroke telehealth services
(A)
Non-application of originating site requirements
(B)
Inclusion of certain sites
(C)
No originating site facility fee for new sites
(7)
Treatment of substance use disorder services and mental health services furnished through telehealth
(A)
In general
(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, 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) 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, 2024—
(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
(ii)
Exclusion from FQHC PPS calculation and RHC air calculation
(9)
Treatment of telehealth services furnished using audio-only telecommunications technology
(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
(B)
Collection of data and evaluation
(2)
Implementation
(A)
In general
(B)
Payments
(i)
Initial payments
(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
(C)
Preparation for PPS implementation
(3)
Additional payments for certain FQHCS with physicians or other practitioners receiving data 2000 waivers
(A)
In general
(B)
Application
(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
(4)
Payment for certain services furnished by federally qualified health centers
(A)
Attending physician services for hospice patients
(B)
Mental health visits furnished via telecommunications technology
(5)
Special payment rule for intensive outpatient services
(A)
In general
(B)
Exclusion
(p)
Quality incentives to promote patient safety and public health in computed tomography
(1)
Quality incentives
(2)
Applicable computed tomography services defined
(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
(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
(B)
Administration
(q)
Recognizing appropriate use criteria for certain imaging services
(1)
Program established
(A)
In general
(B)
Appropriate use criteria defined
(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
(E)
Ordering professional defined
(F)
Furnishing professional defined
(2)
Establishment of applicable appropriate use criteria
(A)
In general
(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
(D)
Treatment of multiple applicable appropriate use criteria
(3)
Mechanisms for consultation with applicable appropriate use criteria
(A)
Identification of mechanisms to consult with applicable appropriate use criteria
(i)
In general
(ii)
Consultation
(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
(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
(ii)
Periodic updating of list
(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
(ii)
Inpatient services
(iii)
Significant hardship
(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
(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
(D)
Process
(E)
Consultation with stakeholders
(6)
Prior authorization for ordering professionals who are outliers
(A)
In general
(B)
Appropriate use criteria in prior authorization
(C)
Funding
(7)
Construction
(r)
Payment for renal dialysis services for individuals with acute kidney injury
(1)
Payment rate
(2)
Individual with acute kidney injury defined
(s)
Payment for applicable disposable devices
(1)
Separate payment
(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
(C)
Exclusion of nursing and therapy services from separate payment
(4)
Implementation
(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
(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
(u)
Payment and related requirements for home infusion therapy
(1)
Payment
(A)
Single payment
(i)
In general
(ii)
Unit of single payment
(iii)
Limitation
(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
(ii)
Requirement of budget neutrality
(2)
Considerations
(3)
Annual updates
(A)
In general
(B)
Adjustment
(4)
Authority to apply prior authorization
(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
(C)
Review and modification of list of accreditation organizations
(i)
In general
(ii)
Special rule for accreditations done prior to removal from list of designated accreditation organizations
(D)
Rule for accreditations made prior to designation
(6)
Notification of infusion therapy options available prior to furnishing home infusion therapy
(7)
Home infusion therapy services temporary transitional payment
(A)
Temporary transitional payment
(i)
In general
(ii)
Period specified
(iii)
Transitional home infusion drug defined
(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
(ii)
Payment category 2
(iii)
Payment category 3
(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
(ii)
Payment amount for category 1
(iii)
Payment amount for category 2
(iv)
Payment amount for category 3
(E)
Clarifications
(i)
Infusion drug administration day
(ii)
Treatment of multiple drugs administered on same infusion drug administration day
(F)
Eligible home infusion suppliers
(G)
Implementation
(v)
Payment for outpatient physical therapy services and outpatient occupational therapy services furnished by a therapy assistant
(1)
In general
(2)
Use of modifier
(A)
Establishment
(B)
Required use
(3)
Implementation
(w)
Opioid use disorder treatment services
(1)
In general
(2)
Considerations
(3)
Annual updates
(x)
Payment rules relating to rural emergency hospitals
(1)
Payment for rural emergency hospital services
(2)
Additional facility payment
(A)
In general
(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)
(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
(3)
Payment for ambulance services
(4)
Payment for post-hospital extended care services
(5)
Source of payments
(A)
In general
(B)
Additional facility payment and post-hospital extended care services
(y)
Payment for certain services furnished by rural health clinics
(1)
Attending physician services for hospice patients
(2)
Mental health visits furnished via telecommunications technology
(3)
Special payment rule for intensive outpatient services
(A)
In general
(B)
Exclusion
(z)
Payment for lymphedema compression treatment items
(1)
In general
(2)
Frequency limitation
(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.
(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.)
cite as: 42 USC 1395m
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