(a) Application
(1) In general Except as provided in paragraph (2), this section shall apply to payment for drugs and biologicals that are described in section
1395u (o)(1)(C) of this title and that are furnished on or after January 1, 2005.
(2) Election
This section shall not apply in the case of a physician who elects under subsection (a)(1)(A)(ii) of section 1395w–3b of this title for that section to apply instead of this section for the payment for drugs and biologicals.
(b) Payment amount
(1) In general Subject to paragraph (7) and subsections (d)(3)(C) and (e) of this section, the amount of payment determined under this section for the billing and payment code for a drug or biological (based on a minimum dosage unit) is, subject to applicable deductible and coinsurance
(A) in the case of a multiple source drug (as defined in subsection (c)(6)(C) of this section), 106 percent of the amount determined under paragraph (3) for a multiple source drug furnished before April 1, 2008, or 106 percent of the amount determined under paragraph (6) for a multiple source drug furnished on or after April 1, 2008; or
(B) in the case of a single source drug or biological (as defined in subsection (c)(6)(D) of this section), 106 percent of the amount determined under paragraph (4).
(2) Specification of unit
(A) Specification by manufacturer The manufacturer of a drug or biological shall specify the unit associated with each National Drug Code (including package size) as part of the submission of data under section
1396r–8 (b)(3)(A)(iii) of this title.
(B) Unit defined
In this section, the term unit means, with respect to each National Drug Code (including package size) associated with a drug or biological, the lowest identifiable quantity (such as a capsule or tablet, milligram of molecules, or grams) of the drug or biological that is dispensed, exclusive of any diluent without reference to volume measures pertaining to liquids. For years after 2004, the Secretary may establish the unit for a manufacturer to report and methods for counting units as the Secretary determines appropriate to implement this section.
(3) Multiple source drug For all drug products included within the same multiple source drug billing and payment code, the amount specified in this paragraph is the volume-weighted average of the average sales prices reported under section
1396r–8 (b)(3)(A)(iii) of this title determined by
(A) computing the sum of the products (for each National Drug Code assigned to such drug products) of
(i) the manufacturers average sales price (as defined in subsection (c) of this section); and
(ii) the total number of units specified under paragraph (2) sold; and
(B) dividing the sum determined under subparagraph (A) by the sum of the total number of units under subparagraph (A)(ii) for all National Drug Codes assigned to such drug products.
(4) Single source drug or biological The amount specified in this paragraph for a single source drug or biological is the lesser of the following:
(A) Average sales price
The average sales price as determined using the methodology applied under paragraph (3) for single source drugs and biologicals furnished before April 1, 2008, and using the methodology applied under paragraph (6) for single source drugs and biologicals furnished on or after April 1, 2008, for all National Drug Codes assigned to such drug or biological product.
(B) Wholesale acquisition cost (WAC)
The wholesale acquisition cost (as defined in subsection (c)(6)(B) of this section) using the methodology applied under paragraph (3) for single source drugs and biologicals furnished before April 1, 2008, and using the methodology applied under paragraph (6) for single source drugs and biologicals furnished on or after April 1, 2008, for all National Drug Codes assigned to such drug or biological product.
(5) Basis for payment amount
The payment amount shall be determined under this subsection based on information reported under subsection (f) of this section and without regard to any special packaging, labeling, or identifiers on the dosage form or product or package.
(6) Use of volume-weighted average sales prices in calculation of average sales price
(A) In general For all drug products included within the same multiple source drug billing and payment code, the amount specified in this paragraph is the volume-weighted average of the average sales prices reported under section
1396r–8 (b)(3)(A)(iii) of this title determined by
(i) computing the sum of the products (for each National Drug Code assigned to such drug products) of
(I) the manufacturers average sales price (as defined in subsection (c)), determined by the Secretary without dividing such price by the total number of billing units for the National Drug Code for the billing and payment code; and
(II) the total number of units specified under paragraph (2) sold; and
(ii) dividing the sum determined under clause (i) by the sum of the products (for each National Drug Code assigned to such drug products) of
(I) the total number of units specified under paragraph (2) sold; and
(II) the total number of billing units for the National Drug Code for the billing and payment code.
(B) Billing unit defined
For purposes of this subsection, the term billing unit means the identifiable quantity associated with a billing and payment code, as established by the Secretary.
(7) Special rule Beginning with April 1, 2008, the payment amount for
(A) each single source drug or biological described in section
1395u (o)(1)(G) of this title that is treated as a multiple source drug because of the application of subsection (c)(6)(C)(ii) is the lower of
(i) the payment amount that would be determined for such drug or biological applying such subsection; or
(ii) the payment amount that would have been determined for such drug or biological if such subsection were not applied; and
(B) a multiple source drug described in section
1395u (o)(1)(G) of this title (excluding a drug or biological that is treated as a multiple source drug because of the application of such subsection) is the lower of
(i) the payment amount that would be determined for such drug or biological taking into account the application of such subsection; or
(ii) the payment amount that would have been determined for such drug or biological if such subsection were not applied.
(c) Manufacturer’s average sales price
(1) In general For purposes of this section, subject to paragraphs (2) and (3), the manufacturers average sales price means, of a drug or biological for a National Drug Code for a calendar quarter for a manufacturer for a unit
(A) the manufacturers sales to all purchasers (excluding sales exempted in paragraph (2)) in the United States for such drug or biological in the calendar quarter; divided by
(B) the total number of such units of such drug or biological sold by the manufacturer in such quarter.
(2) Certain sales exempted from computation In calculating the manufacturers average sales price under this subsection, the following sales shall be excluded:
(A) Sales exempt from best price Sales exempt from the inclusion in the determination of best price under section
1396r–8 (c)(1)(C)(i) of this title.
(B) Sales at nominal charge Such other sales as the Secretary identifies as sales to an entity that are merely nominal in amount (as applied for purposes of section
1396r–8 (c)(1)(C)(ii)(III) of this title, except as the Secretary may otherwise provide).
(3) Sale price net of discounts In calculating the manufacturers average sales price under this subsection, such price shall include volume discounts, prompt pay discounts, cash discounts, free goods that are contingent on any purchase requirement, chargebacks, and rebates (other than rebates under section
1396r–8 of this title). For years after 2004, the Secretary may include in such price other price concessions, which may be based on recommendations of the Inspector General, that would result in a reduction of the cost to the purchaser.
(4) Payment methodology in cases where average sales price during first quarter of sales is unavailable In the case of a drug or biological during an initial period (not to exceed a full calendar quarter) in which data on the prices for sales for the drug or biological is not sufficiently available from the manufacturer to compute an average sales price for the drug or biological, the Secretary may determine the amount payable under this section for the drug or biological based on
(A) the wholesale acquisition cost; or
(B) the methodologies in effect under this part on November 1, 2003, to determine payment amounts for drugs or biologicals.
(5) Frequency of determinations
(A) In general on a quarterly basis
The manufacturers average sales price, for a drug or biological of a manufacturer, shall be calculated by such manufacturer under this subsection on a quarterly basis. In making such calculation insofar as there is a lag in the reporting of the information on rebates and chargebacks under paragraph (3) so that adequate data are not available on a timely basis, the manufacturer shall apply a methodology based on a 12-month rolling average for the manufacturer to estimate costs attributable to rebates and chargebacks. For years after 2004, the Secretary may establish a uniform methodology under this subparagraph to estimate and apply such costs.
(B) Updates in payment amounts
The payment amounts under subsection (b) of this section shall be updated by the Secretary on a quarterly basis and shall be applied based upon the manufacturers average sales price calculated for the most recent calendar quarter for which data is available.
(C) Use of contractors; implementation
The Secretary may contract with appropriate entities to calculate the payment amount under subsection (b) of this section. Notwithstanding any other provision of law, the Secretary may implement, by program instruction or otherwise, any of the provisions of this section.
(6) Definitions and other rules In this section:
(A) Manufacturer The term manufacturer means, with respect to a drug or biological, the manufacturer (as defined in section
1396r–8 (k)(5) of this title).
(B) Wholesale acquisition cost
The term wholesale acquisition cost means, with respect to a drug or biological, the manufacturers list price for the drug or biological to wholesalers or direct purchasers in the United States, not including prompt pay or other discounts, rebates or reductions in price, for the most recent month for which the information is available, as reported in wholesale price guides or other publications of drug or biological pricing data.
(C) Multiple source drug
(i) In general The term multiple source drug means, for a calendar quarter, a drug for which there are 2 or more drug products which
(I) are rated as therapeutically equivalent (under the Food and Drug Administrations most recent publication of Approved Drug Products with Therapeutic Equivalence Evaluations),
(II) except as provided in subparagraph (E), are pharmaceutically equivalent and bioequivalent, as determined under subparagraph (F) and as determined by the Food and Drug Administration, and
(III) are sold or marketed in the United States during the quarter.
(ii) Exception With respect to single source drugs or biologicals that are within the same billing and payment code as of October 1, 2003, the Secretary shall treat such single source drugs or biologicals as if the single source drugs or biologicals were multiple source drugs.
(D) Single source drug or biological The term single source drug or biological means
(i) a biological; or
(ii) a drug which is not a multiple source drug and which is produced or distributed under a new drug application approved by the Food and Drug Administration, including a drug product marketed by any cross-licensed producers or distributors operating under the new drug application.
(E) Exception from pharmaceutical equivalence and bioequivalence requirement
Subparagraph (C)(ii) shall not apply if the Food and Drug Administration changes by regulation the requirement that, for purposes of the publication described in subparagraph (C)(i), in order for drug products to be rated as therapeutically equivalent, they must be pharmaceutically equivalent and bioequivalent, as defined in subparagraph (F).
(F) Determination of pharmaceutical equivalence and bioequivalence For purposes of this paragraph
(i) drug products are pharmaceutically equivalent if the products contain identical amounts of the same active drug ingredient in the same dosage form and meet compendial or other applicable standards of strength, quality, purity, and identity; and
(ii) drugs are bioequivalent if they do not present a known or potential bioequivalence problem, or, if they do present such a problem, they are shown to meet an appropriate standard of bioequivalence.
(G) Inclusion of vaccines In applying provisions of section
1396r–8 of this title under this section, other than a vaccine is deemed deleted from section
1396r–8 (k)(2)(B) of this title.
(d) Monitoring of market prices
(1) In general
The Inspector General of the Department of Health and Human Services shall conduct studies, which may include surveys, to determine the widely available market prices of drugs and biologicals to which this section applies, as the Inspector General, in consultation with the Secretary, determines to be appropriate.
(2) Comparison of prices Based upon such studies and other data for drugs and biologicals, the Inspector General shall compare the average sales price under this section for drugs and biologicals with
(A) the widely available market price for such drugs and biologicals (if any); and
(B) the average manufacturer price (as determined under section
1396r–8 (k)(1) of this title) for such drugs and biologicals.
(3) Limitation on average sales price
(A) In general
The Secretary may disregard the average sales price for a drug or biological that exceeds the widely available market price or the average manufacturer price for such drug or biological by the applicable threshold percentage (as defined in subparagraph (B)).
(B) Applicable threshold percentage defined In this paragraph, the term applicable threshold percentage means
(i) in 2005, in the case of an average sales price for a drug or biological that exceeds widely available market price or the average manufacturer price, 5 percent; and
(ii) in 2006 and subsequent years, the percentage applied under this subparagraph subject to such adjustment as the Secretary may specify for the widely available market price or the average manufacturer price, or both.
(C) Authority to adjust average sales price If the Inspector General finds that the average sales price for a drug or biological exceeds such widely available market price or average manufacturer price for such drug or biological by the applicable threshold percentage, the Inspector General shall inform the Secretary (at such times as the Secretary may specify to carry out this subparagraph) and the Secretary shall, effective as of the next quarter, substitute for the amount of payment otherwise determined under this section for such drug or biological the lesser of
(i) the widely available market price for the drug or biological (if any); or
(ii) 103 percent of the average manufacturer price (as determined under section
1396r–8 (k)(1) of this title) for the drug or biological.
(4) Civil money penalty
(A) In general
If the Secretary determines that a manufacturer has made a misrepresentation in the reporting of the manufacturers average sales price for a drug or biological, the Secretary may apply a civil money penalty in an amount of up to $10,000 for each such price misrepresentation and for each day in which such price misrepresentation was applied.
(B) Procedures The provisions of section
1320a–7a of this title (other than subsections (a) and (b)) shall apply to civil money penalties under subparagraph (B) in the same manner as they apply to a penalty or proceeding under section
1320a–7a (a) of this title.
(5) Widely available market price
(A) In general
In this subsection, the term widely available market price means the price that a prudent physician or supplier would pay for the drug or biological. In determining such price, the Inspector General shall take into account the discounts, rebates, and other price concessions routinely made available to such prudent physicians or suppliers for such drugs or biologicals.
(B) Considerations In determining the price under subparagraph (A), the Inspector General shall consider information from one or more of the following sources:
(i) Manufacturers.
(ii) Wholesalers.
(iii) Distributors.
(iv) Physician supply houses.
(v) Specialty pharmacies.
(vi) Group purchasing arrangements.
(vii) Surveys of physicians.
(viii) Surveys of suppliers.
(ix) Information on such market prices from insurers.
(x) Information on such market prices from private health plans.
(e) Authority to use alternative payment in response to public health emergency In the case of a public health emergency under section
247d of this title in which there is a documented inability to access drugs and biologicals, and a concomitant increase in the price,
of a drug or biological which is not reflected in the manufacturers average sales price for one or more quarters, the Secretary may use the wholesale acquisition cost (or other reasonable measure of drug or biological price) instead of the manufacturers average sales price for such quarters and for subsequent quarters until the price and availability of the drug or biological has stabilized and is substantially reflected in the applicable manufacturers average sales price.
(f) Quarterly report on average sales price For requirements for reporting the manufacturers average sales price (and, if required to make payment, the manufacturers wholesale acquisition cost) for the drug or biological under this section, see section
1396r–8 (b)(3) of this title.
(g) Judicial review There shall be no administrative or judicial review under section
1395ff of this title, section
1395oo of this title, or otherwise, of
(1) determinations of payment amounts under this section, including the assignment of National Drug Codes to billing and payment codes;
(2) the identification of units (and package size) under subsection (b)(2) of this section;
(3) the method to allocate rebates, chargebacks, and other price concessions to a quarter if specified by the Secretary;
(4) the manufacturers average sales price when it is used for the determination of a payment amount under this section; and
(5) the disclosure of the average manufacturer price by reason of an adjustment under subsection (d)(3)(C) or (e) of this section.
