42 U.S.C. § 1320f–1 — Selection of negotiation-eligible drugs as selected drugs
submitted 91 years ago by Pub. L. 117-169 to r/title-42-THE-PUBLIC-HEALTH-AND-WELFARE · 5,137 words · no verdicts yet
The Secretary selects and publishes Medicare drugs subject to maximum-fair-price negotiation. The section sets the selection order, eligibility rules, exclusions, and limited delays for certain biologics when a biosimilar is likely to enter.
(a) In general. By the required publication date, the Secretary* must publish a list of 10 qualifying high-spending Part D drugs for 2026, 15 qualifying high-spending Part D drugs for 2027, 15 qualifying high-spending Part B or Part D drugs for 2028, and 20 qualifying high-spending Part B or Part D drugs for 2029 and each later year. If fewer drugs qualify, the Secretary lists all of them. Subject to the exceptions in this section and section 1320f–3(f)(5), every listed drug* is subject to negotiation for that initial year and, when applicable, renegotiation in later years.
(b) Selection of drugs.
(1) For each initial year, the Secretary must rank all negotiation-eligible drugs by their total Medicare Part B and Part D spending during the latest available 12-month period before the publication date. The highest-spending drugs rank first. The Secretary selects the highest-ranked drugs needed under subsection (a). A biological product whose listing was delayed under paragraph (2) of subsection (f) must be removed before the ranking and selection.
(2) For 2026 and 2027, the Secretary applies that process only to Part D high-spending drugs and uses Part D spending rather than combined Part B and Part D spending.
(3) The Secretary must include on the list the biological products required by subsection (f)(2)(B)(ii)(I) and (C)(i). Those products count toward the number required by subsection (a)(1).
(c) Selected drug.
(1) A negotiation-eligible drug on the list is a “selected drug” for that initial year and each later year before the first year beginning at least nine months after the Secretary determines that at least one generic drug approved under section 355(j), using the drug as the listed drug, or at least one biosimilar, using it as the reference product*, is licensed under section 262(k) and marketed.
(2) If the Secretary makes that determination before or during the negotiation period*, the drug is not negotiated for that period. It still counts as a selected drug for the number listed for that initial year.
(d) Negotiation-eligible drug.
(1) The term means a qualifying single-source drug that, for the publication date, is among the 50 qualifying single-source drugs with the highest Part D spending, or among the 50 with the highest Part B spending. For 2026 and 2027, only the Part D group is used.
(2) Small-biotech exception. For 2026, 2027, and 2028, a qualifying single-source drug is excluded if its 2021 Part D spending was no more than 1 percent of all covered Part D drug spending and at least 80 percent of the spending on that manufacturer’s covered Part D drugs with the required manufacturer* agreement, or if the corresponding Part B tests are met: no more than 1 percent of spending on all qualifying single-source Part B drugs and at least 80 percent of spending on that manufacturer’s qualifying single-source Part B drugs. Related persons treated as one employer under Internal Revenue Code section 52 are one manufacturer. The exception does not apply after a post-2021 acquisition by a manufacturer that is not a specified manufacturer, effective at the start of the next plan year, or January 1, 2025, for an acquisition before 2025. A new formulation, such as extended release, is not treated as a qualifying drug described by this exception.
(3) In applying the top-50 tests, the Secretary must leave out drugs already selected and, for 2026 through 2028, drugs covered by the small-biotech exception. Spending data must be combined across all dosage forms and strengths, including new formulations, and cannot be limited to a particular formulation, package size, or package type.
(e) Qualifying single-source drug.
(1) The term means a covered Part D drug, or a Part B-payable drug or biological product, that meets one of these descriptions. (A) A drug is approved under section 355(c), marketed under that approval, has been approved for at least seven years by the publication date, and is not the listed drug for a drug approved and marketed under section 355(j). (B) A biological product is licensed under section 262(a), marketed under section 262, has been licensed for at least 11 years by that date, and is not the reference product for a biological product licensed and marketed under section 262(k).
(2) An authorized generic and its listed drug are treated as the same qualifying single-source drug. “Authorized generic drug” means a drug meeting section 355(t)(3), or, for a biological product, a product licensed under section 262(a) and marketed, sold, or distributed to retail customers under different labeling, packaging (other than institutional repackaging), product or labeler code, trade name, or trademark.
(3) The term excludes a drug designated for only one rare disease or condition when its only approved indication is that disease or condition; a drug or biological product whose combined Part B and D spending is below the specified threshold ($200 million for 2026, adjusted as stated for later years); and a biological product derived from human whole blood or plasma.
(f) Special rule delaying biologics for biosimilar entry.
(1) If a biological product would otherwise be an extended-monopoly drug* selected for an initial year, the Secretary applies paragraph (2) when there is a high likelihood that its biosimilar reference product will be licensed and marketed under section 262(k) before two years after publication. The Secretary may delay only when the biosimilar manufacturer requests it before the applicable publication date. The request must use the Secretary’s form and timing, include needed information and documents and all agreements filed with the Federal Trade Commission or Assistant Attorney General under the 2003 Medicare Modernization Act, and include available FDA manufacturing schedules and SEC or comparable private-company disclosures about investment, expected revenue, and planned marketing. The Secretary may demand more information. Related persons treated as one employer under section 52, and specified partnerships, count as one manufacturer.
(2) (A) After a high-likelihood finding, the Secretary delays selection and negotiation for one year. (B) If the biosimilar was not licensed and marketed during that delay, the Secretary, on request, reevaluates the likelihood of entry and whether clear and convincing evidence shows substantial progress toward licensure and marketing. If either finding fails, the Secretary selects the reference biological product for the next year and its manufacturer owes the rebate in paragraph (4) for the year that was delayed. If both findings are made, the Secretary may delay selection for a second year. (C) If the biosimilar still is not licensed and marketed during that second delay, the Secretary selects the biological product for that second year and its manufacturer owes rebates for each delayed year. (D) A delay can never exceed two years. A product that would have become a long-monopoly drug* cannot receive the second delay. No delay is allowed if more than one year has passed since biosimilar licensure without marketing, or if the biosimilar manufacturer is the reference-product manufacturer, treated as the same manufacturer, or has an agreement that caused the request or restricts the amount sold in the United States*.
(3) “High likelihood” requires that FDA has accepted or approved the biosimilar application and that the manufacturer’s submitted information gives clear and convincing evidence that it will be marketed within the applicable time.
(4) A manufacturer whose biological product was delayed and later negotiated must pay a rebate at the Secretary’s time and in the Secretary’s manner. For a Part D product, the estimated rebate is the sum for each delayed quarter of 75 percent of the amount by which the reported average manufacturer price exceeds the negotiated maximum fair price* (with the required inflation increase after a second delay), multiplied by Part D units dispensed. For a Part B product, it is the sum of 80 percent of the amount by which the Part B payment amount exceeds that maximum fair price, multiplied by separately payable units administered or furnished. For a delayed product that is a long-monopoly drug, the comparison amount is instead 65 percent of its 2021 average non-Federal average manufacturer price*, or the first full post-market year if no 2021 amount exists, increased by the stated CPI change. Rebates for Part B products go to the Federal Supplementary Medical Insurance Trust Fund; rebates for Part D products go to the Medicare Prescription Drug Account in that fund.
(5) “Biosimilar biological product” has the meaning given in section 1395w–3a(c)(6).
Not later than the selected drug publication date* with respect to an initial price applicability year*, in accordance with subsection (b), the Secretary* shall select and publish a list of—
with respect to the initial price applicability year 2026, 10 negotiation-eligible drugs described in subparagraph (A) of subsection (d)(1), but not subparagraph (B) of such subsection, with respect to such year (or, all (if such number is less than 10) such negotiation-eligible drugs with respect to such year);
with respect to the initial price applicability year 2027, 15 negotiation-eligible drugs described in subparagraph (A) of subsection (d)(1), but not subparagraph (B) of such subsection, with respect to such year (or, all (if such number is less than 15) such negotiation-eligible drugs with respect to such year);
with respect to the initial price applicability year 2028, 15 negotiation-eligible drugs described in subparagraph (A) or (B) of subsection (d)(1) with respect to such year (or, all (if such number is less than 15) such negotiation-eligible drugs with respect to such year); and
with respect to the initial price applicability year 2029 or a subsequent year, 20 negotiation-eligible drugs described in subparagraph (A) or (B) of subsection (d)(1), with respect to such year (or, all (if such number is less than 20) such negotiation-eligible drugs with respect to such year).
Subject to subsection (c)(2) and section 1320f–3(f)(5) of this title, each drug* published on the list pursuant to the previous sentence and subsection (b)(3) shall be subject to the negotiation process under section 1320f–3 of this title for the negotiation period* with respect to such initial price applicability year (and the renegotiation process under such section as applicable for any subsequent year during the applicable price applicability period*).
In carrying out subsection (a), subject to paragraph (2), the Secretary shall, with respect to an initial price applicability year, do the following:
Rank negotiation-eligible drugs described in subsection (d)(1) according to the total expenditures* for such drugs under parts B and D of subchapter XVIII, as determined by the Secretary, during the most recent period of 12 months prior to the selected drug publication date (but ending not later than October 31 of the year prior to the year of such drug publication date), with respect to such year, for which data are available, with the negotiation-eligible drugs with the highest total expenditures being ranked the highest.
Select from such ranked drugs with respect to such year the negotiation-eligible drugs with the highest such rankings.
In the case of a biological product for which the inclusion of the biological product as a selected drug on a list published under subsection (a) has been delayed under subsection (f)(2), remove such biological product from the rankings under subparagraph (A) before making the selections under subparagraph (B).
With respect to the initial price applicability year 2026 and with respect to the initial price applicability year 2027, the Secretary shall apply paragraph (1) as if the reference to “negotiation-eligible drugs described in subsection (d)(1)” were a reference to “negotiation-eligible drugs described in subsection (d)(1)(A)” and as if the reference to “total expenditures for such drugs under parts B and D of subchapter XVIII” were a reference to “total expenditures for such drugs under part D of subchapter XVIII”.
Pursuant to subparagraphs (B)(ii)(I) and (C)(i) of subsection (f)(2), the Secretary shall select and include on the list published under subsection (a) the biological products described in such subparagraphs. Such biological products shall count towards the required number of drugs to be selected under subsection (a)(1).
For purposes of this part, in accordance with subsection (e)(2) and subject to paragraph (2), each negotiation-eligible drug included on the list published under subsection (a) with respect to an initial price applicability year shall be referred to as a “selected drug” with respect to such year and each subsequent year beginning before the first year that begins at least 9 months after the date on which the Secretary determines at least one drug or biological product—
is approved or licensed (as applicable)—
under section 355(j) of title 21 using such drug as the listed drug; or
under section 262(k) of this title using such drug as the reference product*; and
is marketed pursuant to such approval or licensure.
A negotiation-eligible drug—
that is included on the list published under subsection (a) with respect to an initial price applicability year; and
for which the Secretary makes a determination described in paragraph (1) before or during the negotiation period with respect to such initial price applicability year;
shall not be subject to the negotiation process under section 1320f–3 of this title with respect to such negotiation period and shall continue to be considered a selected drug under this part with respect to the number of negotiation-eligible drugs published on the list under subsection (a) with respect to such initial price applicability year.
For purposes of this part, subject to paragraph (2), the term “negotiation-eligible drug” means, with respect to the selected drug publication date with respect to an initial price applicability year, a qualifying single source drug, as defined in subsection (e), that is described in either of the following subparagraphs (or, with respect to the initial price applicability year 2026 or 2027, that is described in subparagraph (A)):
The qualifying single source drug is, determined in accordance with subsection (e)(2), among the 50 qualifying single source drugs with the highest total expenditures under part D of subchapter XVIII, as determined by the Secretary in accordance with paragraph (3), during the most recent 12-month period for which data are available prior to such selected drug publication date (but ending no later than October 31 of the year prior to the year of such drug publication date).
The qualifying single source drug is, determined in accordance with subsection (e)(2), among the 50 qualifying single source drugs with the highest total expenditures under part B of subchapter XVIII, as determined by the Secretary in accordance with paragraph (3), during such most recent 12-month period, as described in subparagraph (A).
Subject to subparagraph (C), the term “negotiation-eligible drug” shall not include, with respect to the initial price applicability years 2026, 2027, and 2028, a qualifying single source drug that meets either of the following:
The total expenditures for the qualifying single source drug under part D of subchapter XVIII, as determined by the Secretary in accordance with paragraph (3)(B), during 2021—
are equal to or less than 1 percent of the total expenditures under such part D, as so determined, for all covered part D drugs (as defined in section 1395w–102(e) of this title) during such year; and
are equal to at least 80 percent of the total expenditures under such part D, as so determined, for all covered part D drugs for which the manufacturer* of the drug has an agreement in effect under section 1395w–114a of this title during such year.
The total expenditures for the qualifying single source drug under part B of subchapter XVIII, as determined by the Secretary in accordance with paragraph (3)(B), during 2021—
are equal to or less than 1 percent of the total expenditures under such part B, as so determined, for all qualifying single source drugs for which payment may be made under such part B during such year; and
are equal to at least 80 percent of the total expenditures under such part B, as so determined, for all qualifying single source drugs of the manufacturer for which payment may be made under such part B during such year.
All persons treated as a single employer under subsection (a) or (b) of section 52 of the Internal Revenue Code of 1986 shall be treated as one manufacturer for purposes of this paragraph.
A drug shall not be considered to be a qualifying single source drug described in clause (i) or (ii) of subparagraph (A) if the manufacturer of such drug is acquired after 2021 by another manufacturer that does not meet the definition of a specified manufacturer under section 1395w–114c(g)(4)(B)(ii) of this title, effective at the beginning of the plan year immediately following such acquisition or, in the case of an acquisition before 2025, effective January 1, 2025.
A new formulation, such as an extended release formulation, of a qualifying single source drug shall not be considered a qualifying single source drug described in subparagraph (A).
In applying subparagraphs (A) and (B) of paragraph (1), the Secretary shall not consider or count—
drugs that are already selected drugs; and
for initial price applicability years 2026, 2027, and 2028, qualifying single source drugs described in paragraph (2)(A).
In determining whether a qualifying single source drug satisfies any of the criteria described in paragraph (1) or (2), the Secretary shall use data that is aggregated across dosage forms and strengths of the drug, including new formulations of the drug, such as an extended release formulation, and not based on the specific formulation or package size or package type of the drug.
For purposes of this part, the term “qualifying single source drug” means, with respect to an initial price applicability year, subject to paragraphs (2) and (3), a covered part D drug (as defined in section 1395w–102(e) of this title) that is described in any of the following or a drug or biological product for which payment may be made under part B of subchapter XVIII that is described in any of the following:
A drug—
that is approved under section 355(c) of title 21 and is marketed pursuant to such approval;
for which, as of the selected drug publication date with respect to such initial price applicability year, at least 7 years will have elapsed since the date of such approval; and
that is not the listed drug for any drug that is approved and marketed under section 355(j) of such title.
A biological product—
that is licensed under section 262(a) of this title and is marketed under section 262 of this title;
for which, as of the selected drug publication date with respect to such initial price applicability year, at least 11 years will have elapsed since the date of such licensure; and
that is not the reference product for any biological product that is licensed and marketed under section 262(k) of this title.
In the case of a qualifying single source drug described in subparagraph (A) or (B) of paragraph (1) that is the listed drug (as such term is used in section 355(j) of title 21) or a product described in clause (ii) of subparagraph (B), with respect to an authorized generic drug, in applying the provisions of this part, such authorized generic drug and such listed drug or such product shall be treated as the same qualifying single source drug.
For purposes of this paragraph, the term “authorized generic drug” means—
in the case of a drug, an authorized generic drug (as such term is defined in section 355(t)(3) of title 21); and
in the case of a biological product, a product that—
has been licensed under section 262(a) of this title; 1 and
is marketed, sold, or distributed directly or indirectly to retail class of trade under a different labeling, packaging (other than repackaging as the reference product in blister packs, unit* doses, or similar packaging for use in institutions), product code, labeler code, trade name, or trade mark than the reference product.
In this part, the term “qualifying single source drug” does not include any of the following:
A drug that is designated as a drug for only one rare disease or condition under section 360bb of title 21 and for which the only approved indication (or indications) is for such disease or condition.
A drug or biological product with respect to which the total expenditures under parts B and D of subchapter XVIII, as determined by the Secretary in accordance with subsection (d)(3)(B)—
with respect to initial price applicability year 2026, is less than, during the period beginning on June 1, 2022, and ending on May 31, 2023, $200,000,000;
with respect to initial price applicability year 2027, is less than, during the most recent 12-month period applicable under subparagraphs (A) and (B) of subsection (d)(1) for such year, the dollar amount specified in clause (i) increased by the annual percentage increase in the consumer price index for all urban consumers (all items; United States* city average) for the period beginning on June 1, 2023, and ending on September 30, 2024; or
with respect to a subsequent initial price applicability year, is less than, during the most recent 12-month period applicable under subparagraphs (A) and (B) of subsection (d)(1) for such year, the dollar amount specified in this subparagraph for the previous initial price applicability year increased by the annual percentage increase in such consumer price index for the 12-month period ending on September 30 of the year prior to the year of the selected drug publication date with respect to such subsequent initial price applicability year.
A biological product that is derived from human whole blood or plasma.
Subject to subparagraph (B), in the case of a biological product that would (but for this subsection) be an extended-monopoly drug* (as defined in section 1320f–3(c)(4) of this title) included as a selected drug on the list published under subsection (a) with respect to an initial price applicability year, the rules described in paragraph (2) shall apply if the Secretary determines that there is a high likelihood (as described in paragraph (3)) that a biosimilar biological product (for which such biological product will be the reference product) will be licensed and marketed under section 262(k) of this title before the date that is 2 years after the selected drug publication date with respect to such initial price applicability year.
The Secretary shall not provide for a delay under—
paragraph (2)(A) unless a request is made for such a delay by a manufacturer of a biosimilar biological product prior to the selected drug publication date for the list published under subsection (a) with respect to the initial price applicability year for which the biological product may have been included as a selected drug on such list but for subparagraph (2)(A); or
paragraph (2)(B)(iii) unless a request is made for such a delay by such a manufacturer prior to the selected drug publication date for the list published under subsection (a) with respect to the initial price applicability year that is 1 year after the initial price applicability year for which the biological product described in subsection (a) would have been included as a selected drug on such list but for paragraph (2)(A).
A request made under clause (i) shall be submitted to the Secretary by such manufacturer at a time and in a form and manner specified by the Secretary, and contain—
information and documents necessary for the Secretary to make determinations under this subsection, as specified by the Secretary and including, to the extent available, items described in subclause (III); and
all agreements related to the biosimilar biological product filed with the Federal Trade Commission or the Assistant Attorney General pursuant to subsections (a) and (c) of section 1112 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003.
After the Secretary has reviewed the request and materials submitted under subclause (I), the manufacturer shall submit any additional information and documents requested by the Secretary necessary to make determinations under this subsection.
The items described in this clause are the following:
The manufacturing schedule for such biosimilar biological product submitted to the Food and Drug Administration* during its review of the application under such section 262(k) of this title.
Disclosures (in filings by the manufacturer of such biosimilar biological product with the Securities and Exchange Commission required under section 78l(b), 78l(g), 78m(a), or 78o(d) of title 15 about capital investment, revenue expectations, and actions taken by the manufacturer that are typical of the normal course of business in the year (or the 2 years, as applicable) before marketing of a biosimilar biological product) that pertain to the marketing of such biosimilar biological product, or comparable documentation that is distributed to the shareholders of privately held companies.
All persons treated as a single employer under subsection (a) or (b) of section 52 of the Internal Revenue Code of 1986, or in a partnership, shall be treated as one manufacturer for purposes of paragraph (2)(D)(iv).
In clause (i), the term “partnership” means a syndicate, group, pool, joint venture, or other organization through or by means of which any business, financial operation, or venture is carried on by the manufacturer of the biological product and the manufacturer of the biosimilar biological product.
The rules described in this paragraph are the following:
If a determination of high likelihood is made under paragraph (3), the Secretary shall delay the inclusion of the biological product as a selected drug on the list published under subsection (a) until such list is published with respect to the initial price applicability year that is 1 year after the initial price applicability year for which the biological product would have been included as a selected drug on such list.
If, during the time period between the selected drug publication date on which the biological product would have been included on the list as a selected drug pursuant to subsection (a) but for subparagraph (A) and the selected drug publication date with respect to the initial price applicability year that is 1 year after the initial price applicability year for which such biological product would have been included as a selected drug on such list, the Secretary determines that the biosimilar biological product for which the manufacturer submitted the request under paragraph (1)(B)(i)(II) (and for which the Secretary previously made a high likelihood determination under paragraph (3)) has not been licensed and marketed under section 262(k) of this title, the Secretary shall, at the request of such manufacturer—
reevaluate whether there is a high likelihood (as described in paragraph (3)) that such biosimilar biological product will be licensed and marketed under such section 262(k) before the date that is 2 years after the selected drug publication date for which such biological product would have been included as a selected drug on such list published but for subparagraph (A); and
evaluate whether, on the basis of clear and convincing evidence, the manufacturer of such biosimilar biological product has made a significant amount of progress (as determined by the Secretary) towards both such licensure and the marketing of such biosimilar biological product (based on information from items described in subclauses (I)(bb) and (II) of paragraph (1)(B)(ii)) since the receipt by the Secretary of the request made by such manufacturer under paragraph (1)(B)(i)(I).
If the Secretary determines that there is not a high likelihood that such biosimilar biological product will be licensed and marketed as described in clause (i)(I) or there has not been a significant amount of progress as described in clause (i)(II)—
the Secretary shall include the biological product as a selected drug on the list published under subsection (a) with respect to the initial price applicability year that is 1 year after the initial price applicability year for which such biological product would have been included as a selected drug on such list but for subparagraph (A); and
the manufacturer of such biological product shall pay a rebate under paragraph (4) with respect to the year for which such manufacturer would have provided access to a maximum fair price* for such biological product but for subparagraph (A).
If the Secretary determines that there is a high likelihood that such biosimilar biological product will be licensed and marketed (as described in clause (i)(I)) and a significant amount of progress has been made by the manufacturer of such biosimilar biological product towards such licensure and marketing (as described in clause (i)(II)), the Secretary shall delay the inclusion of the biological product as a selected drug on the list published under subsection (a) until the selected drug publication date of such list with respect to the initial price applicability year that is 2 years after the initial price applicability year for which such biological product would have been included as a selected drug on such list but for this subsection.
If, during the time period between the selected drug publication date of the list for which the biological product would have been included as a selected drug but for subparagraph (B)(iii) and the selected drug publication date with respect to the initial price applicability year that is 2 years after the initial price applicability year for which such biological product would have been included as a selected drug on such list but for this subsection, the Secretary determines that such biosimilar biological product has not been licensed and marketed—
the Secretary shall include such biological product as a selected drug on such list with respect to the initial price applicability year that is 2 years after the initial price applicability year for which such biological product would have been included as a selected drug on such list; and
the manufacturer of such biological product shall pay a rebate under paragraph (4) with respect to the years for which such manufacturer would have provided access to a maximum fair price for such biological product but for this subsection.
In no case shall the Secretary delay the inclusion of a biological product on the list published under subsection (a) for more than 2 years.
In the case of a biological product for which the inclusion on the list published pursuant to subsection (a) was delayed by 1 year under subparagraph (A) and for which there would have been a change in status to a long-monopoly drug (as defined in section 1320f–3(c)(5) of this title) if such biological product had been a selected drug, in no case may the Secretary provide for a second 1-year delay under subparagraph (B)(iii).
In no case shall the Secretary delay the inclusion of a biological product on the list published under subsection (a) if more than 1 year has elapsed since the biosimilar biological product has been licensed under section 262(k) of this title and marketing has not commenced for such biosimilar biological product.
In no case shall the Secretary delay the inclusion of a biological product as a selected drug on the list published under subsection (a) if Secretary determined that the manufacturer of the biosimilar biological product described in paragraph (1)(A)—
is the same as the manufacturer of the reference product described in such paragraph or is treated as being the same pursuant to paragraph (1)(C); or
has, based on information from items described in paragraph (1)(B)(ii)(I)(bb), entered into any agreement described in such paragraph with the manufacturer of the reference product described in paragraph (1)(A) that—
requires or incentivizes the manufacturer of the biosimilar biological product to submit a request described in paragraph (1)(B); or
restricts the quantity (either directly or indirectly) of the biosimilar biological product that may be sold in the United States over a specified period of time.
For purposes of this subsection, there is a high likelihood described in paragraph (1) or paragraph (2), as applicable, if the Secretary finds that—
an application for licensure under section 262(k) of this title for the biosimilar biological product has been accepted for review or approved by the Food and Drug Administration; and
information from items described in sub clauses 2 (I)(bb) and (III) of paragraph (1)(B)(ii) submitted to the Secretary by the manufacturer requesting a delay under such paragraph provides clear and convincing evidence that such biosimilar biological product will, within the time period specified under paragraph (1)(A) or (2)(B)(i)(I), be marketed.
For purposes of subparagraphs (B)(ii)(II) and (C)(ii) of paragraph (2), in the case of a biological product for which the inclusion on the list under subsection (a) was delayed under this subsection and for which the Secretary has negotiated and entered into an agreement under section 1320f–2 of this title with respect to such biological product, the manufacturer shall be required to pay a rebate to the Secretary at such time and in such manner as determined by the Secretary.
Subject to subparagraph (C), the amount of the rebate under subparagraph (A) with respect to a biological product shall be equal to the estimated amount—
in the case of a biological product that is a covered part D drug (as defined in section 1395w–102(e) of this title), that is the sum of the products of—
75 percent of the amount by which—
the average manufacturer price, as reported by the manufacturer of such covered part D drug under section 1396r–8 of this title (or, if not reported by such manufacturer under section 1396r–8 of this title, as reported by such manufacturer to the Secretary pursuant to the agreement under section 1320f–2(a) of this title) for such biological product, with respect to each of the calendar quarters of the price applicability period that would have applied but for this subsection; exceeds
in the initial price applicability year that would have applied but for a delay under—
paragraph (2)(A), the maximum fair price negotiated under section 1320f–3 of this title for such biological product under such agreement; or
paragraph (2)(B)(iii), such maximum fair price, increased as described in section 1320f–4(b)(1)(A) of this title; and
the number of units dispensed under part D of subchapter XVIII for such covered part D drug during each such calendar quarter of such price applicability period; and
in the case of a biological product for which payment may be made under part B of subchapter XVIII, that is the sum of the products of—
80 percent of the amount by which—
the payment amount for such biological product under section 1395w–3a(b) of this title, with respect to each of the calendar quarters of the price applicability period that would have applied but for this subsection; exceeds
in the initial price applicability year that would have applied but for a delay under—
paragraph (2)(A), the maximum fair price negotiated under section 1320f–3 of this title for such biological product under such agreement; or
paragraph (2)(B)(iii), such maximum fair price, increased as described in section 1320f–4(b)(1)(A) of this title; and
the number of units (excluding units that are packaged into the payment amount for an item or service and are not separately payable under such part B) of the billing and payment code of such biological product administered or furnished under such part B during each such calendar quarter of such price applicability period.
In the case of a biological product with respect to which a rebate is required to be paid under this paragraph, if such biological product qualifies as a long-monopoly drug (as defined in section 1320f–3(c)(5) of this title) at the time of its inclusion on the list published under subsection (a), in determining the amount of the rebate for such biological product under subparagraph (B), the amount described in clause (ii) shall be substituted for the maximum fair price described in clause (i)(I) or (ii)(I) of such subparagraph (B), as applicable.
The amount described in this clause is an amount equal to 65 percent of the average non-Federal average manufacturer price* for the biological product for 2021 (or, in the case that there is not an average non-Federal average manufacturer price available for such biological product for 2021, for the first full year following the market entry for such biological product), increased by the percentage increase in the consumer price index for all urban consumers (all items; United States city average) from September 2021 (or December of such first full year following the market entry), as applicable, to September of the year prior to the selected drug publication date with respect to the initial price applicability year that would have applied but for this subsection.
Amounts paid as rebates under this paragraph shall be deposited into—
in the case payment is made for such biological product under part B of subchapter XVIII, the Federal Supplementary Medical Insurance Trust Fund established under section 1395t of this title; and
in the case such biological product is a covered part D drug (as defined in section 1395w–102(e) of this title), the Medicare Prescription Drug Account under section 1395w–116 of this title in such Trust Fund.
In this subsection, the term “biosimilar biological product” has the meaning given such term in section 1395w–3a(c)(6) of this title.
Source credit: (Aug. 14, 1935, ch. 531, title XI, § 1192, as added and amended Pub. L. 117–169, title I, §§ 11001(a), 11002(a)(1), Aug. 16, 2022, 136 Stat. 1836, 1854; Pub. L. 119–21, title VII, § 71203(a), July 4, 2025, 139 Stat. 320.)
- 1935Enacted · Pub. L. 117-169 · 136 Stat. 1836, 1854
- 2025Amended · Pub. L. 119-21 · 139 Stat. 320
A history note hasn’t been published yet. The record shows enactment by Pub. L. 117-169 on 1935-08-14.
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