Title: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2020
Policy area: Health

Summary:
Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2020 or the ACCESS for Biosimilars Act of 2020
This bill temporarily eliminates cost-sharing for biosimilar biological products for certain qualifying beneficiaries under Medicare medical services. Specifically, the bill eliminates cost-sharing for beneficiaries whose coverage under private health insurance, a federal program (other than Medicare), a Medicare supplemental policy, or Medicare Advantage does not already do so. The Centers for Medicare & Medicaid Services must establish a process for determining a beneficiary's eligibility and notifying Medicare Advantage organizations of such determinations.
The bill's provisions apply to products that are furnished during the five-year period beginning on January 1, 2021, or the date on which the product is first marketed, whichever is later.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 3466 Introduced in Senate (IS)]

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116th CONGRESS
  2d Session
                                S. 3466

   To amend title XVIII of the Social Security Act to eliminate cost 
 sharing for biosimilar biological products furnished under part B of 
    the Medicare program during the first 5 years such products are 
                               marketed.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             March 12, 2020

Ms. McSally (for herself and Mr. Jones) introduced the following bill; 
     which was read twice and referred to the Committee on Finance

_______________________________________________________________________

                                 A BILL


 
   To amend title XVIII of the Social Security Act to eliminate cost 
 sharing for biosimilar biological products furnished under part B of 
    the Medicare program during the first 5 years such products are 
                               marketed.

    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 ``Acting to Cancel Copays and Ensure 
Substantial Savings for Biosimilars Act of 2020'' or the ``ACCESS for 
Biosimilars Act of 2020''.

SEC. 2. ELIMINATING COST SHARING FOR BIOSIMILAR BIOLOGICAL PRODUCTS 
              FURNISHED UNDER PART B OF THE MEDICARE PROGRAM.

    Section 1833 of the Social Security Act (42 U.S.C. 1395l) is 
amended--
            (1) in subsection (a)(1)(S), by inserting ``(or, in the 
        case of such a biological that is a specified biosimilar 
        biological product (as defined in subsection (cc)) furnished 
        during a year (beginning with 2021) to an individual who is a 
        cost-sharing reduction eligible individual (as defined in such 
        subsection) with respect to such year, 100 percent)'' after 
        ``80 percent''; and
            (2) by adding at the end the following new subsection:
    ``(cc) Specified Biosimilar Biological Product Reduced Cost-Sharing 
Provisions.--
            ``(1) Definitions.--
                    ``(A) Cost-sharing reduction eligible individual 
                defined.--For purposes of subsection (a)(1)(S) and with 
                respect to a year, the term `cost-sharing reduction 
                eligible individual' means an individual who, as of 
                January 1 of such year--
                            ``(i) is enrolled under this part; and
                            ``(ii) does not have qualifying coverage 
                        (as defined in subparagraph (B)).
                    ``(B) Qualifying coverage.--
                            ``(i) In general.--For purposes of 
                        subparagraph (A), the term `qualifying 
                        coverage' means, with respect to an individual, 
                        coverage--
                                    ``(I) under--
                                            ``(aa) a group health plan 
                                        or health insurance coverage 
                                        (as such terms are defined in 
                                        section 2791 of the Public 
                                        Health Service Act);
                                            ``(bb) a Federal health 
                                        care program (as defined in 
                                        section 1128B(f)), other than 
                                        the program established under 
                                        this title;
                                            ``(cc) the health insurance 
                                        program under chapter 89 of 
                                        title 5, United States Code;
                                            ``(dd) a medicare 
                                        supplemental policy under 
                                        section 1882; or
                                            ``(ee) an MA or MA-PD plan; 
                                        and
                                    ``(II) that meets--
                                            ``(aa) in the case of 
                                        coverage described in any of 
                                        items (aa) through (dd) of 
                                        subclause (I), the condition 
                                        described in clause (ii); and
                                            ``(bb) in the case of 
                                        coverage described in item (ee) 
                                        of subclause (I), the condition 
                                        described in clause (iii).
                            ``(ii) Condition for coverage other than 
                        part c coverage.--For purposes of clause 
                        (i)(II)(aa), the condition described in this 
                        clause, with respect to an individual enrolled 
                        in coverage described in any of items (aa) 
                        through (dd) of clause (i)(I) during a year, is 
                        that such coverage provides for the payment of 
                        all cost sharing owed by such individual under 
                        this part (or, if applicable, under an MA or 
                        MA-PD plan) with respect to a specified 
                        biosimilar biological product (as defined in 
                        subparagraph (C)) furnished under this part 
                        (or, if applicable, under an MA or MA-PD plan) 
                        during such year, not taking into account the 
                        application of any deductible under such 
                        coverage.
                            ``(iii) Condition for part c coverage.--For 
                        purposes of clause (i)(II)(bb), the condition 
                        described in this clause, with respect to an 
                        individual enrolled in an MA or MA-PD plan 
                        during a year, is that such plan provides for 
                        no cost sharing for such individual with 
                        respect to a specified biological biosimilar 
                        product (as defined in subparagraph (C)) 
                        furnished under such plan during such year.
                    ``(C) Specified biosimilar biological product.--For 
                purposes of subsection (a)(1)(S), the term `specified 
                biosimilar biological product' means a biosimilar 
                biological product (as defined in subsection (c)(6) of 
                section 1847A)--
                            ``(i) for which the payment amount 
                        determined under subsection (b)(8) of such 
                        section for such product is less than the 
                        payment amount determined under subsection 
                        (b)(4) of such section for the reference 
                        biological product (as defined in subsection 
                        (c)(6) of such section); and
                            ``(ii) that is furnished during the 5-year 
                        period beginning on the later of--
                                    ``(I) January 1, 2021; or
                                    ``(II) the date on which the 
                                biosimilar biological product is first 
                                marketed.
            ``(2) Determinations.--The Secretary shall establish a 
        process--
                    ``(A) for determining whether an individual is a 
                cost-sharing reduction eligible individual for a year; 
                and
                    ``(B) for notifying MA organizations of such a 
                determination made with respect to an individual 
                enrolled under an MA plan or MA-PD plan offered by such 
                organization during such year.''.
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