Title: Star Rating for Biosimilars Act
Policy area: Health

Summary:
Star Rating for Biosimilars Act
This bill requires the Centers for Medicare & Medicaid Services (CMS) to establish quality measures regarding biosimilar biological products under the five-star performance rating system for Medicare Advantage plans. The measures must assess the level of access that plans provide to covered biosimilars, including with respect to formularies, cost-sharing, and utilization management.
The CMS must also incorporate such measures into similar rating systems for plans under the Medicare prescription drug benefit.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4629 Introduced in House (IH)]

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116th CONGRESS
  1st Session
                                H. R. 4629

    To amend title XVIII of the Social Security Act to require the 
Secretary of Health and Human Services to add a new set of measures to 
the 5-star rating system under the Medicare Advantage program in order 
    to encourage increased access to biosimilar biological products.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            October 8, 2019

 Mr. Tonko (for himself and Mr. Gibbs) introduced the following bill; 
  which was referred to the Committee on Energy and Commerce, and in 
    addition to the Committee on Ways and Means, for a period to be 
subsequently determined by the Speaker, in each case for consideration 
  of such provisions as fall within the jurisdiction of the committee 
                               concerned

_______________________________________________________________________

                                 A BILL


 
    To amend title XVIII of the Social Security Act to require the 
Secretary of Health and Human Services to add a new set of measures to 
the 5-star rating system under the Medicare Advantage program in order 
    to encourage increased access to biosimilar biological products.

    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 ``Star Rating for Biosimilars Act''.

SEC. 2. ADDITION OF NEW MEASURES BASED ON ACCESS TO BIOSIMILAR 
              BIOLOGICAL PRODUCTS TO THE 5-STAR RATING SYSTEM UNDER 
              MEDICARE ADVANTAGE.

    (a) In General.--Section 1853(o)(4) of the Social Security Act (42 
U.S.C. 1395w-23(o)(4)) is amended by adding at the end the following 
new subparagraph:
                    ``(E) Addition of new measures based on access to 
                biosimilar biological products.--
                            ``(i) In general.--For 2021 and subsequent 
                        years, the Secretary shall add a new set of 
                        measures to the 5-star rating system based on 
                        access to biosimilar biological products 
                        covered under part B and, in the case of MA-PD 
                        plans, such products that are covered part D 
                        drugs. Such measures shall assess the impact a 
                        plan's benefit structure may have on enrollees' 
                        utilization of or ability to access biosimilar 
                        biological products, including in comparison to 
                        the reference biological product, and shall 
                        include measures, as applicable, with respect 
                        to the following:
                                    ``(I) Coverage.--Assessing whether 
                                a biosimilar biological product is on 
                                the plan formulary in lieu of or in 
                                addition to the reference biological 
                                product.
                                    ``(II) Preferencing.--Assessing 
                                tier placement or cost sharing for a 
                                biosimilar biological product relative 
                                to the reference biological product.
                                    ``(III) Utilization management 
                                tools.--Assessing whether and how 
                                utilization management tools are used 
                                with respect to a biosimilar biological 
                                product relative to the reference 
                                biological product.
                                    ``(IV) Utilization.--Assessing the 
                                percentage of enrollees prescribed the 
                                biosimilar biological product when the 
                                reference biological product is also 
                                available.
                            ``(ii) Definitions.--In this subparagraph, 
                        the terms `biosimilar biological product' and 
                        `reference biological product' have the meaning 
                        given those terms in section 1847A(c)(6).
                            ``(iii) Protecting patient interests.--In 
                        developing such measures, the Secretary shall 
                        ensure that each measure developed to address 
                        coverage, preferencing, or utilization 
                        management is constructed such that patients 
                        retain equal access to appropriate therapeutic 
                        options without undue administrative burden.''.
    (b) Clarification Regarding Application to Prescription Drug 
Plans.--To the extent the Secretary of Health and Human Services 
applies the 5-star rating system under section 1853(o)(4) of the Social 
Security Act (42 U.S.C. 1395w-23(o)(4)), or a similar system, to 
prescription drug plans under part D of title XVIII of such Act, the 
provisions of subparagraph (E) of such section, as added by subsection 
(a) of this section, shall apply under the system with respect to such 
plans in the same manner as such provisions apply to the 5-star rating 
system under such section 1853(o)(4).
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