116 HR 4629 IH: Star Rating for Biosimilars Act U.S. House of Representatives 2019-10-08 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

I116th CONGRESS1st SessionH. R. 4629IN THE HOUSE OF REPRESENTATIVESOctober 8, 2019Mr. 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 concernedA BILLTo 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.

1.

Short title

This Act may be cited as the Star Rating for Biosimilars Act.

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).