Congressional Bills
H.R. 19 (Introduced in House)
72 sections
- PreambleTo provide for certain reforms with respect to the Medicare program under title XVIII of the Social Security Act, the...
- Sec. 1Short title
- Sec. 2Table of contents
- Sec. 101Improvements to Medicare site-of-service transparency
- Sec. 102Requiring 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. 103Providing for variation in payment for certain drugs covered under part B of the Medicare program
- Sec. 104Establishment of maximum add-on payment for drugs and biologicals
- Sec. 105Treatment of drug administration services furnished by certain excepted off-campus outpatient departments of a provider
- Sec. 111Reporting on explanation for drug price increases
- Sec. 112Public disclosure of drug discounts
- Sec. 113Study of pharmaceutical supply chain intermediaries and merger activity
- Sec. 114Requiring certain manufacturers to report drug pricing information with respect to drugs under the Medicare program
- Sec. 115Making prescription drug marketing sample information reported by manufacturers available to certain individuals and entities
- Sec. 116Requiring prescription drug plan sponsors to include real-time benefit information as part of such sponsor’s electronic prescription program under the Medicare program
- Sec. 117Sense of Congress regarding the need to expand commercially available drug pricing comparison platforms
- Sec. 118Technical corrections
- Sec. 121Medicare part D benefit redesign
- Sec. 131Transitional coverage and retroactive Medicare part D coverage for certain low-income beneficiaries
- Sec. 132Allowing the offering of additional prescription drug plans under Medicare part D
- Sec. 133Allowing certain enrollees of prescription drugs plans and MA–PD plans under Medicare program to spread out cost-sharing under certain circumstances
- Sec. 134Establishing a monthly cap on beneficiary incurred costs for insulin products and supplies under a prescription drug plan or MA–PD plan
- Sec. 135Growth rate of Medicare part D out-of-pocket cost threshold
- Sec. 141Providing the Medicare Payment Advisory Commission and Medicaid and CHIP Payment and Access Commission with access to certain drug payment information, including certain rebate information
- Sec. 201Sunset of limit on maximum rebate amount for single source drugs and innovator multiple source drugs
- Sec. 202Medicaid pharmacy and therapeutics committee improvements
- Sec. 203GAO report on conflicts of interest in State Medicaid program drug use review boards and pharmacy and therapeutics (P&T) committees
- Sec. 204Ensuring the accuracy of manufacturer price and drug product information under the Medicaid drug rebate program
- Sec. 205Improving transparency and preventing the use of abusive spread pricing and related practices in Medicaid
- Sec. 206T–MSIS drug data analytics reports
- Sec. 207Risk-sharing value-based payment agreements for covered outpatient drugs under Medicaid
- Sec. 208Applying Medicaid drug rebate requirement to drugs provided as part of outpatient hospital services
- Sec. 301Actions for delays of generic drugs and biosimilar biological products
- Sec. 302REMS approval process for subsequent filers
- Sec. 303Rule of construction
- Sec. 311Unlawful agreements
- Sec. 312Notice and certification of agreements
- Sec. 313Forfeiture of 180-day exclusivity period
- Sec. 314Commission litigation authority
- Sec. 315Statute of limitations
- Sec. 321Change conditions of first generic exclusivity to spur access and competition
- Sec. 331Public listing
- Sec. 332Review and report on types of information to be listed
- Sec. 341Orange Book
- Sec. 342GAO report to Congress
- Sec. 351Education on biological products
- Sec. 361Streamlining the transition of biological products
- Sec. 370Short title; references in subtitle
- Sec. 371Regulation of certain nonprescription drugs that are marketed without an approved drug application
- Sec. 372Misbranding
- Sec. 373Drugs excluded from the over-the-counter drug review
- Sec. 374Treatment of Sunscreen Innovation Act
- Sec. 375Annual update to Congress on appropriate pediatric indication for certain OTC cough and cold drugs
- Sec. 376Technical corrections
- Sec. 381Short title; finding
- Sec. 382Fees relating to over-the-counter drugs
- Sec. 391Protecting access to biological products
- Sec. 392Orphan drug clarification
- Sec. 393Conditions of use for biosimilar biological products
- Sec. 394Clarifying the meaning of new chemical entity
- Sec. 401Permanent extension of reduction in medical expense deduction floor
- Sec. 402Safe harbor for high deductible health plans without deductible for insulin
- Sec. 403Inclusion of certain over-the-counter medical products as qualified medical expenses
- Sec. 501Payment for biosimilar biological products during initial period
- Sec. 502GAO study and report on average sales price
- Sec. 503Requiring prescription drug plans and MA–PD plans to report potential fraud, waste, and abuse to the Secretary of HHS
- Sec. 504Establishment of pharmacy quality measures under Medicare part D
- Sec. 505Improving coordination between the Food and Drug Administration and the Centers for Medicare & Medicaid Services
- Sec. 506Patient consultation in Medicare national and local coverage determinations in order to mitigate barriers to inclusion of such perspectives
- Sec. 507MedPAC report on shifting coverage of certain Medicare part B drugs to Medicare part D
- Sec. 508Requirement that direct-to-consumer advertisements for prescription drugs and biological products include truthful and non-misleading pricing information
- Sec. 509Chief Pharmaceutical Negotiator at the Office of the United States Trade Representative
- Sec. 510Waiving Medicare coinsurance for colorectal cancer screening tests