```

[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 5459 Introduced in Senate (IS)]

<DOC>

118th CONGRESS
  2d Session
                                S. 5459

 To amend title XI of the Social Security Act to alter when biosimilar 
   biological products are eligible for price negotiations under the 
                           Medicare program.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                            December 9, 2024

Mrs. Blackburn introduced the following bill; which was read twice and 
                  referred to the Committee on Finance

_______________________________________________________________________

                                 A BILL

 
 To amend title XI of the Social Security Act to alter when biosimilar 
   biological products are eligible for price negotiations under the 
                           Medicare program.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Biosimilars Access and Affordability 
Act''.

SEC. 2. CHANGE OF WHEN BIOSIMILARS ARE ELIGIBLE FOR PRICE NEGOTIATIONS.

    (a) In General.--Section 1192 of the Social Security Act (42 U.S.C. 
1320f-1) is amended--
            (1) in subsection (c)--
                    (A) in paragraph (1), in the matter before 
                subparagraph (A), by striking ``beginning before the 
                first year that begins at least 9 months after the date 
                on which'' and inserting ``during the price 
                applicability period, except that a drug shall no 
                longer be a selected drug for a particular year if, 
                before the first day of such year,'';
                    (B) in paragraph (2)--
                            (i) in subparagraph (b), by inserting ``or 
                        after the end of such negotiation period but 
                        before the first day of the initial price 
                        applicability year'' after ``such initial price 
                        applicability year''; and
                            (ii) in the flush matter following 
                        subparagraph (B), by inserting ``or any future 
                        publication of the maximum fair price under 
                        section 1195 or any application of such price'' 
                        after ``such negotiation period'';
            (2) in subsection (f)--
                    (A) in paragraph (1)--
                            (i) in subparagraph (A)--
                                    (I) by striking ``an extended 
                                monopoly drug (as defined in section 
                                1194(c)(4)''; and
                                    (II) by striking ``before the 
                                date'' and inserting ``on or before 
                                December 31 of the year'';
                            (ii) in subparagraph (B)--
                                    (I) in the heading, by striking 
                                ``Request required'' and inserting 
                                ``Procedures'';
                                    (II) by redesignating clauses (i) 
                                and (ii) as clauses (ii) and (iii) 
                                respectively;
                                    (III) by inserting before clause 
                                (ii) (as so redesignated) the 
                                following:
                            ``(i) Automatic delay.--The Secretary shall 
                        apply, with respect to a biological product 
                        described in subparagraph (A), the rules 
                        described in subparagraph (A) of paragraph (2) 
                        (subject to subparagraphs (B) and (C) of such 
                        paragraph) if, 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 paragraph 
                        (2)(A), the manufacturer of a biosimilar 
                        biological product for which such biological 
                        product will be the reference product has 
                        publicly disclosed in a press release or other 
                        communication, or the Secretary determines from 
                        information from any other source--
                                    ``(I) that such manufacturer's 
                                application for licensure under section 
                                351(k) of the Public Health Service Act 
                                for the biosimilar biological product 
                                was accepted for review or approved by 
                                the Food and Drug Administration;
                                    ``(II) that such manufacturer's 
                                clinical study of the biosimilar 
                                biological product as described in 
                                section 351(k)(2)(A)(i)(I)(cc) of the 
                                Public Health Service Act was initiated 
                                and remains ongoing; or
                                    ``(III) such manufacturer expects 
                                that the biosimilar biological product 
                                will be marketed on or before December 
                                31 of the year that is 2 years after 
                                the selected drug publication date with 
                                respect to such initial price 
                                applicability year.'';
                                    (IV) in clause (ii) (as so 
                                redesignated)--
                                            (aa) by striking subclause 
                                        (II);
                                            (bb) by striking ``In 
                                        general'' and all that follows 
                                        through ``unless'' and 
                                        inserting ``Delay upon 
                                        request.-- The Secretary shall 
                                        provide for a delay under 
                                        paragraph (2)(A) if''; and
                                            (cc) by striking 
                                        ``subparagraph (2)(A) or;'' and 
                                        inserting ``paragraph (2)(A), 
                                        provided that a determination 
                                        of high likelihood is made 
                                        under paragraph (3).''; and
                                    (V) in clause (iii) (as so 
                                redesignated)--
                                            (aa) in the heading, by 
                                        inserting ``for a delay upon 
                                        request'' after ``documents'';
                                            (bb) in subclause (I), in 
                                        the matter before item (aa), by 
                                        striking ``clause (i)'' and 
                                        inserting ``clause (ii)''; and
                                            (cc) in subclause 
                                        (III)(bb), by striking ``year 
                                        (or the 2 years, as 
                                        applicable)'' and inserting 
                                        ``applicable period''; and
                            (iii) in subparagraph (C)(i), by striking 
                        ``paragraph (2)(D)(iv)'' and inserting 
                        ``paragraph (2)(C)(iii)'';
                    (B) in paragraph (2)--
                            (i) in subparagraph (A)--
                                    (I) in the heading, by striking ``1 
                                year'' and inserting ``2 years'';
                                    (II) by inserting ``or paragraph 
                                (1)(B)(i) applies'' after ``under 
                                paragraph (3)''; and
                                    (III) by striking ``1 year'' and 
                                inserting ``2 years'';
                            (ii) by striking subparagraph (B) and 
                        inserting the following:
                    ``(B) If not licensed and marketed during the 
                delay.--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 2 years 
                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)(ii) (and for which the Secretary previously made 
                a high likelihood determination under paragraph (3)) 
                has not been licensed and marketed under section 351(k) 
                of the Public Health Service Act--
                            ``(i) 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 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 subparagraph (A); and
                            ``(ii) if such biosimilar biological 
                        product has not been licensed and marketed 
                        under section 351(k) of the Public Health 
                        Service Act on or before December 31 of the 
                        year that is 2 years after 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), 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 subparagraph (A).'';
                            (iii) by striking subparagraph (C);
                            (iv) by redesignating subparagraph (D) as 
                        subparagraph (C); and
                            (v) in subparagraph (C) (as so 
                        redesignated)--
                                    (I) by striking clause (ii);
                                    (II) by redesignating clauses (iii) 
                                and (iv) as clauses (ii) and (iii), 
                                respectively;
                                    (III) in clause (ii) (as so 
                                redesignated)--
                                            (aa) in the heading, by 
                                        striking ``1 year'' and 
                                        inserting ``2 years''; and
                                            (bb) by striking ``1 year 
                                        has'' and inserting ``2 years 
                                        have''; and
                                    (IV) in clause (iii)(II) (as so 
                                redesignated), by striking ``paragraph 
                                (1)(B)(ii)(I)(bb)'' and inserting 
                                ``paragraph (1)(B)(iii)(I)(bb)'';
                    (C) by striking paragraph (3) and inserting the 
                following:
            ``(3) High likelihood.--For purposes of this subsection, 
        there is a high likelihood described in paragraph (1) or 
        paragraph (2), as applicable, if the Secretary finds that 
        information from items described in subclauses (I)(bb) and 
        (III) of paragraph (1)(B)(iii) submitted to the Secretary by 
        the manufacturer requesting a delay under such paragraph or 
        information submitted to the Secretary by any other party or 
        otherwise available to the Secretary from any other source 
        provides clear and convincing evidence that such biosimilar 
        biological product will, within the time period specified under 
        paragraph (1)(A) be marketed.''; and
                    (D) in paragraph (4)--
                            (i) in subparagraph (A)--
                                    (I) by striking ``subparagraphs 
                                (B)(ii)(II) and (C)(ii) of paragraph 
                                (2)'' and inserting ``paragraph 
                                (2)(B)(ii)''; and
                                    (II) by inserting ``not earlier 
                                than January 1 of the year that is 3 
                                years after the selected drug 
                                publication date of the list on which 
                                the biological product would have been 
                                included as a selected drug but for a 
                                delay under paragraph (2)(A)'' after 
                                ``at such time''; and
                            (ii) in subparagraph (B)--
                                    (I) in clause (i), by striking 
                                subclause (I) and inserting the 
                                following:
                                    ``(I) 75 percent of the amount by 
                                which the average manufacturer price, 
                                as reported by the manufacturer of such 
                                covered part D drug under section 1927 
                                (or, if not reported by such 
                                manufacturer under section 1927, as 
                                reported by such manufacturer to the 
                                Secretary pursuant to the agreement 
                                under section 1193(a)) 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--
                                            ``(aa) for the initial 
                                        price applicability year that 
                                        would have applied but for a 
                                        delay under paragraph (2)(A), 
                                        the maximum fair price 
                                        negotiated under section 1194 
                                        for such biological product 
                                        under such agreement; or
                                            ``(bb) for the second year 
                                        of such delay and the remaining 
                                        period of such delay ending on 
                                        December 31 of the year that is 
                                        2 years after the selected drug 
                                        publication date of the list on 
                                        which the biological product 
                                        would have been included as a 
                                        selected drug but for a delay 
                                        under paragraph (2)(A), such 
                                        maximum fair price, increased 
                                        as described in section 
                                        1195(b)(1)(A); and''; and
                                    (II) in clause (ii), by striking 
                                subclause (I) and inserting the 
                                following:
                                    ``(I) 80 percent of the amount by 
                                which the payment amount for such 
                                biological product under section 
                                1847A(b), with respect to each of the 
                                calendar quarters of the price 
                                applicability period that would have 
                                applied but for this subsection; 
                                exceeds--
                                            ``(aa) for the initial 
                                        price applicability year that 
                                        would have applied but for a 
                                        delay under paragraph (2)(A), 
                                        the maximum fair price 
                                        negotiated under section 1194 
                                        for such biological product 
                                        under such agreement; or
                                            ``(bb) for the second year 
                                        of such delay and the remaining 
                                        period of such delay ending on 
                                        December 31 of the year that is 
                                        2 years after the selected drug 
                                        publication date of the list on 
                                        which the biological product 
                                        would have been included as a 
                                        selected drug but for a delay 
                                        under paragraph (2)(A), such 
                                        maximum fair price, increased 
                                        as described in section 
                                        1195(b)(1)(A); and''; and
            (3) by adding at the end the following new subsection:
    ``(g) Definition of Market.--In this section, the term `market' 
means to introduce or deliver a drug or biological product (including a 
biosimilar biological product) for introduction into interstate 
commerce.''.
    (b) Conforming and Technical Amendments.--Such Act is amended--
            (1) in section 1192(b)(3) (42 U.S.C. 1320f-1(b)(3)), by 
        striking ``subparagraphs (B)(ii)(I) and (C)(i) of subsection 
        (f)(2)'' and inserting ``subsection (f)(2)(B)(ii)''; and
            (2) in section 1198(2) (42 U.S.C. 1320f-7(2)), by striking 
        ``1192(f),'' and inserting ``1192(f)''.
    (c) Effective Date.--The amendments made by this section shall 
apply with respect to initial price applicability years beginning with 
initial price applicability year 2027.
                                 <all>
```