117 HR 5237 IH: Reduced Costs and Continued Cures Act of 2021 U.S. House of Representatives 2021-09-10 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.

I117th CONGRESS1st SessionH. R. 5237IN THE HOUSE OF REPRESENTATIVESSeptember 10, 2021Mr. Peters (for himself, Mr. Schrader, Miss Rice of New York, Mrs. Murphy of Florida, and Mr. Correa) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and the Judiciary, 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 titles XI, XVIII, and XIX of the Social Security Act to lower prescription drug prices in the Medicare and Medicaid programs, to improve transparency related to pharmaceutical prices and transactions, to lower patients’ out-of-pocket costs, and to ensure accountability to taxpayers, and for other purposes.

1.

Short title; table of contents

(a)

Short title

This Act may be cited as the Reduced Costs and Continued Cures Act of 2021.(b)

Table of contents

The table of contents of this Act is as follows:Sec. 1. Short title; table of contents.Title I—Establishment of part B payment rules for negotiation-eligible drugs and biologicalsSec. 101. Establishment of part B payment rules for negotiation-eligible drugs and biologicals.Title II—MedicareSubtitle A—Part BSec. 201. Inclusion of value of coupons in determination of average sales price for drugs and biologicals under Medicare part B.Sec. 202. Payment for biosimilar biological products during initial period.Sec. 203. Temporary increase in Medicare part B payment for biosimilar biological products.Sec. 204. Medicare part B rebate by manufacturers.Sec. 205. Requiring manufacturers of certain single-dose container or single-use package drugs payable under part B of the Medicare program to provide refunds with respect to discarded amounts of such drugs.Sec. 206. Establishment of maximum add-on payment for drugs and biologicals.Sec. 207. Treatment of drug administration services furnished by certain excepted off-campus outpatient departments of a provider.Sec. 208. GAO study and report on average sales price.Sec. 209. Authority to use alternative payment for drugs and biologicals to prevent potential drug shortages.Subtitle B—Part DSec. 221. Medicare part D modernization redesign.Sec. 222. Monthly out-of-pocket cost sharing maximum for enrollees who incur a significant portion of costs towards annual out-of-pocket threshold.Sec. 223. Public disclosure of drug discounts and other pharmacy benefit manager (PBM) provisions.Sec. 224. Public disclosure of direct and indirect remuneration review and audit results.Sec. 225. Improvements to provision of parts A and B claims data to prescription drug plans.Sec. 226. Medicare part D rebate by manufacturers.Sec. 227. Prohibiting branding on part D benefit cards.Sec. 228. Requiring prescription drug plans and MA–PD plans to report potential fraud, waste, and abuse to the Secretary of HHS.Sec. 229. Establishment of pharmacy quality measures under Medicare part D.Sec. 230. Addition of new measures based on access to biosimilar biological products to the 5-star rating system under Medicare Advantage.Sec. 231. HHS study and report on the influence of pharmaceutical manufacturer third-party reimbursement hubs on health care providers who prescribe their drugs and biologicals.Sec. 232. Definition of strength for the purposes of determining interchangeability of biologic and biosimilar products.Subtitle C—MiscellaneousSec. 233. Drug manufacturer price transparency.Sec. 234. Strengthening and expanding pharmacy benefit managers transparency requirements.Sec. 235. Prescription drug pricing dashboards.Sec. 236. Improving coordination between the Food and Drug Administration and the Centers for Medicare & Medicaid Services.Sec. 237. Patient consultation in Medicare national and local coverage determinations in order to mitigate barriers to inclusion of such perspectives.Sec. 238. GAO study on increases to Medicare and Medicaid spending due to copayment coupons and other patient assistance programs.Sec. 239. MedPAC report on shifting coverage of certain Medicare part B drugs to Medicare part D.Sec. 240. Taking steps to fulfill treaty obligations to Tribal communities.Sec. 241. Establishing a monthly cap on beneficiary incurred costs for insulin products and supplies under a prescription drug plan or MA–PD plan.Title III—MedicaidSec. 301. Medicaid pharmacy and therapeutics committee improvements.Sec. 302. Improving reporting requirements and developing standards for the use of drug use review boards in State Medicaid programs.Sec. 303. GAO report on conflicts of interest in State Medicaid program drug use review boards and pharmacy and therapeutics (P&T) committees.Sec. 304. Ensuring the accuracy of manufacturer price and drug product information under the Medicaid drug rebate program.Sec. 305. T–MSIS drug data analytics reports.Sec. 306. Risk-sharing value-based payment agreements for covered outpatient drugs under Medicaid.Sec. 307. Modification of maximum rebate amount under Medicaid drug rebate program.Sec. 308. Applying Medicaid drug rebate requirement to drugs provided as part of outpatient hospital services.Title IV—Addressing Intermediaries and Drug CompetitionSec. 401. Health plan oversight of pharmacy benefit manager services.Sec. 402. Study of pharmaceutical supply chain intermediaries and merger activity.Sec. 403. Requirement that direct-to-consumer advertisements for prescription drugs and biological products include truthful and non-misleading pricing information.Sec. 404. Change conditions of first generic exclusivity to spur access and competition.Sec. 405. Ending the practice preventing market competition known as Pay-for-Delay.Sec. 406. Empowering the FTC to prevent product hopping.Sec. 407. Promoting competition by limiting patent thickets.Title V—Beneficiary cost sharing fairnessSec. 501. Repealing of rule by the Department of Health and Human Services.Sec. 502. Defining cost under prescription drug plans under part D of Medicare.