Sec. 2. Table of contents

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The table of contents for this Act is as follows: Sec. 1. Short title. Sec. 2. Table of contents. Title I—Medicare Parts B and D Subtitle A—Medicare Part B Provisions Sec. 101. Improvements to Medicare site-of-service transparency. Sec. 102. 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. 103. Providing for variation in payment for certain drugs covered under part B of the Medicare program.

Sec. 104. Establishment of maximum add-on payment for drugs and biologicals. Sec. 105. Treatment of drug administration services furnished by certain excepted off-campus outpatient departments of a provider. Subtitle B—Drug Price Transparency Sec. 111. Reporting on explanation for drug price increases. Sec. 112. Public disclosure of drug discounts. Sec. 113. Study of pharmaceutical supply chain intermediaries and merger activity. Sec. 114. Requiring certain manufacturers to report drug pricing information with respect to drugs under the Medicare program.

Sec. 115. Making prescription drug marketing sample information reported by manufacturers available to certain individuals and entities. Sec. 116. Requiring prescription drug plan sponsors to include real-time benefit information as part of such sponsor’s electronic prescription program under the Medicare program. Sec. 117. Sense of Congress regarding the need to expand commercially available drug pricing comparison platforms. Sec. 118. Technical corrections. Subtitle C—Medicare Part D Benefit Redesign Sec. 121.

Medicare part D benefit redesign. Subtitle D—Other Medicare Part D Provisions Sec. 131. Transitional coverage and retroactive Medicare part D coverage for certain low-income beneficiaries. Sec. 132. Allowing the offering of additional prescription drug plans under Medicare part D. Sec. 133. Allowing certain enrollees of prescription drugs plans and MA–PD plans under Medicare program to spread out cost-sharing under certain circumstances. Sec. 134. Establishing a monthly cap on beneficiary incurred costs for insulin products and supplies under a prescription drug plan or MA–PD plan.

Sec. 135. Growth rate of Medicare part D out-of-pocket cost threshold. Subtitle E—MedPAC Sec. 141. Providing the Medicare Payment Advisory Commission and Medicaid and CHIP Payment and Access Commission with access to certain drug payment information, including certain rebate information. Title II—Medicaid Sec. 201. Sunset of limit on maximum rebate amount for single source drugs and innovator multiple source drugs. Sec. 202. Medicaid pharmacy and therapeutics committee improvements.

Sec. 203. GAO report on conflicts of interest in State Medicaid program drug use review boards and pharmacy and therapeutics (P&T) committees. Sec. 204. Ensuring the accuracy of manufacturer price and drug product information under the Medicaid drug rebate program. Sec. 205. Improving transparency and preventing the use of abusive spread pricing and related practices in Medicaid. Sec. 206. T–MSIS drug data analytics reports. Sec. 207. Risk-sharing value-based payment agreements for covered outpatient drugs under Medicaid.

Sec. 208. Applying Medicaid drug rebate requirement to drugs provided as part of outpatient hospital services. Title III—Food and Drug Administration Subtitle A—CREATES Act Sec. 301. Actions for delays of generic drugs and biosimilar biological products. Sec. 302. REMS approval process for subsequent filers. Sec. 303. Rule of construction. Subtitle B—Pay-for-Delay Sec. 311. Unlawful agreements. Sec. 312. Notice and certification of agreements. Sec. 313. Forfeiture of 180-day exclusivity period.

Sec. 314. Commission litigation authority. Sec. 315. Statute of limitations. Subtitle C—BLOCKING Act Sec. 321. Change conditions of first generic exclusivity to spur access and competition. Subtitle D—Purple Book Sec. 331. Public listing. Sec. 332. Review and report on types of information to be listed. Subtitle E—Orange Book Sec. 341. Orange Book. Sec. 342. GAO report to Congress. Subtitle F—Advancing Education on Biosimilars Sec. 351. Education on biological products. Subtitle G—Streamlining Transition of Biological Products Sec. 361.

Streamlining the transition of biological products. Subtitle H—Over-the-Counter Monograph Safety, Innovation, and Reform Sec. 370. Short title; references in subtitle. Part 1—OTC Drug Review Sec. 371. Regulation of certain nonprescription drugs that are marketed without an approved drug application. Sec. 372. Misbranding. Sec. 373. Drugs excluded from the over-the-counter drug review. Sec. 374. Treatment of Sunscreen Innovation Act. Sec. 375. Annual update to Congress on appropriate pediatric indication for certain OTC cough and cold drugs.

Sec. 376. Technical corrections. Part 2—User Fees Sec. 381. Short title; finding. Sec. 382. Fees relating to over-the-counter drugs. Subtitle I—Other Provisions Sec. 391. Protecting access to biological products. Sec. 392. Orphan drug clarification. Sec. 393. Conditions of use for biosimilar biological products. Sec. 394. Clarifying the meaning of new chemical entity. Title IV—Revenue Provisions Sec. 401. Permanent extension of reduction in medical expense deduction floor. Sec. 402.

Safe harbor for high deductible health plans without deductible for insulin. Sec. 403. Inclusion of certain over-the-counter medical products as qualified medical expenses. Title V—Miscellaneous Sec. 501. Payment for biosimilar biological products during initial period. Sec. 502. GAO study and report on average sales price. Sec. 503. Requiring prescription drug plans and MA–PD plans to report potential fraud, waste, and abuse to the Secretary of HHS. Sec. 504. Establishment of pharmacy quality measures under Medicare part D.

Sec. 505. Improving coordination between the Food and Drug Administration and the Centers for Medicare & Medicaid Services. Sec. 506. Patient consultation in Medicare national and local coverage determinations in order to mitigate barriers to inclusion of such perspectives. Sec. 507. MedPAC report on shifting coverage of certain Medicare part B drugs to Medicare part D. Sec. 508. Requirement that direct-to-consumer advertisements for prescription drugs and biological products include truthful and non-misleading pricing information.

Sec. 509. Chief Pharmaceutical Negotiator at the Office of the United States Trade Representative. Sec. 510. Waiving Medicare coinsurance for colorectal cancer screening tests.