Prescription Drugs
US Congress 116th Congress
Empowering Beneficiaries, Ensuring Access, and Strengthening Accountability Act of 2019 [HB-3253]
Extends several health care programs and requirements and revises certain Medicare drug payment methodologies. (Sec. 2) The bill temporarily extends the Medicaid demonstration program for certified community behavioral health clinics. (Sec. 3) The bill also temporarily extends the applicability of Medicaid eligibility criteria that protect against spousal impoverishment for recipients of home- and community-based services. (Sec. 4) The bill increases appropriations for FY2019 for the Money Follows the Person Rebalancing Demonstration Program. (Under
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Humanitarian Standards for Individuals in Customs and Border Protection Custody Act [HB-3239]
Imposes requirements and standards related to the care of aliens in U.S. Customs and Border Protection (CBP) custody. CBP shall conduct an initial health screening of each alien in custody to identify those with acute conditions and high-risk vulnerabilities and to provide appropriate healthcare. CBP shall conduct the screening within 12 hours of each alien's arrival at a CBP facility, and within 6 hours for certain priority individuals such as children, pregnant women, and those with disabilities. The bill imposes various requirements related to
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Pharmacy Benefit Manager Accountability Study Act of 2019 [HB-3223]
Requires the Government Accountability Office to study the role of pharmacy benefit managers (PBMs) with respect to federally facilitated exchanges, including the role of PBMs in pharmaceutical supply chains, the competition among PBMs, and the use of rebates and fees by PBMs in such exchanges.
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Pharmacy Benefit Manager Accountability Study Act of 2019 [HB-3223]
Requires the Government Accountability Office to study the role of pharmacy benefit managers (PBMs) with respect to federally facilitated exchanges, including the role of PBMs in pharmaceutical supply chains, the competition among PBMs, and the use of rebates and fees by PBMs in such exchanges.
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Affordable Medications Act [S.1801]
Revises and expands various requirements relating to prescription-drug pricing and affordability. Specifically, the bill expands financial reporting requirements for drug manufacturers and establishes corresponding civil penalties for noncompliance; adds reporting requirements for certain nonprofit patient-assistance programs; requires the Centers for Medicare & Medicaid Services (CMS) to negotiate prices for certain prescription drugs under Medicare; requires the Centers for Medicare and Medicaid Innovation within the CMS to test specified models
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Territories Health Equity Act of 2019 [S.1773]
Alters provisions under Medicaid, Medicare, and Medicare Advantage relating to U.S. territories, and generally modifies and establishes programs to expand health insurance coverage for residents. Among other things, the bill eliminates Medicaid funding limitations for U.S. territories beginning in FY2020, repeals provisions that exclude residents of Puerto Rico from a certain automatic enrollment process for Medicare medical services, establishes minimum criteria for certain elements used in Medicare Advantage payment calculations for areas within
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Term Act of 2019 Terminating the Extension of Rights Misappropriated Act of 2019 [HB-3199]
Addresses double patenting with respect to drug-related patents. Specifically, the bill requires an owner of drug-related patents, if the owner lists more than one patent as covering a particular drug, to prove in certain proceedings that each patent covers a distinct invention. If the patent owner fails to do so, then the owner shall have disclaimed patent protection from all the listed patents after the first patent expires. This requirement shall apply to various proceedings challenging the validity of drug-related patents, as well as to infringement
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Fair AMP Act Fair and Accurate Medicaid Pricing Act of 2019 [S.1785]
Alters certain requirements and definitions under the Medicaid Drug Rebate Program relating to rebate calculations. Specifically, the bill repeals the requirement that drug manufacturers include the prices of certain authorized generic drugs when determining the average manufacturer price (AMP) of brand-name drugs (also known as a "blended AMP"), and excludes manufacturers from the definition of "wholesalers" for purposes of rebate calculations.
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Safe Disposal of Opioids Act of 2019 [HB-3171]
Directs the Department of Justice to award grants to establish or maintain disposal sites for unwanted prescription medications. Additionally, the bill imposes a fee on the sale of an active opioid by the manufacturer, producer, or importer. The Department of Health and Human Services must establish a mechanism to provide discounts to patients to ensure that they do not pay the fee.
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RIDE Act of 2019 Reinforcing Impaired Driving Education Act of 2019 [HB-3159]
Requires the National Highway Traffic Safety Administration to establish a two-year pilot program to create and study the effects of a public marketing campaign to raise awareness on driving while under the influence of prescription and over-the-counter medications. The program shall be implemented in states or territories that are most affected by the opioid epidemic.
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Opioid Treatment Surge Act [HB-3105]
Requires the Department of Health and Human Services to assess market-share-based fees, for the next 10 years, on drug manufacturers that have produced opioid drugs since 1999. Opioid drugs manufactured to treat opioid addiction, cancer patients, or hospice patients are, however, exempt from this assessment. All assessed fees must be used for the substance abuse prevention and treatment block grant program.
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Improving Low-Income Access to Prescription Drugs Act of 2019 [HB-3029]
Requires the Centers for Medicare & Medicaid Services to establish a transition program under the Medicare prescription drug benefit for limited-income, newly eligible individuals (i.e., individuals who are eligible for subsidies and have not yet enrolled in, or whose coverage has not yet taken effect under, a Medicare or Medicare Advantage prescription drug plan). Such coverage must provide immediate access to covered drugs at the point of sale as soon as the individual becomes eligible for subsidies; coverage also applies retroactively for dual
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Advancing Education on Biosimilars Act of 2020 [S.1681]
A bill to educate health care providers and the public on biosimilar biological products, and for other purposes.
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Prescription Drug Price Reporting Act [S.1664]
Requires that all prescription drug manufacturers submit certain information for every drug marketed in the United States to the Department of Health and Human Services (HHS). Specifically, manufacturers must provide information about cost, pricing, and rebates. Manufacturers are also required to submit any price changes to a prescription drug at least 30 days in advance.HHS must make this information available through a public database that enables consumers to subscribe to price change notifications for different types of prescriptions drugs.
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Opioid Treatment Surge Act [S.1662]
Requires the Department of Health and Human Services to assess market-share-based fees, for the next 10 years, on drug manufacturers that have produced opioid drugs since 1999. Opioid drugs manufactured to treat opioid addiction, cancer patients, or hospice patients are, however, exempt from this assessment. All assessed fees must be used for the substance abuse prevention and treatment block grant program.
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Second Look at Drug Patents Act of 2019 [S.1617]
A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the listing of patents in the Orange Book.
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Opioid Crisis Accountability Act of 2019 [HB-2917]
Establishes a series of restrictions and requirements relating to opioid marketing and distribution practices. Specifically, the bill prohibits (1) knowingly making false advertising or marketing claims regarding the addictive nature of opioids; (2) knowingly supplying communities with quantities of opioids that are not medically reasonable; or (3) failing to report distribution orders, or patterns of orders, while knowing that the orders are not being dispensed in a medically reasonable manner. Employees of opioid manufacturers and distributors
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Respond NOW Act Respond to the Needs in the Opioid War Act [HB-2922]
Establishes the Opioid Epidemic Response Fund through FY2024 to fund programs and activities addressing the opioid and substance use epidemic, including Substance Abuse and Mental Health Services Administration demonstration grants; Centers for Disease Control and Prevention surveillance, prevention, and treatment programs; Food and Drug Administration support of innovation in non-opioid and nonaddictive medical products for pain treatment; National Institutes of Health research on creating longer-lasting or faster-acting antidotes for opioid overdoses;
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FORWARD Act of 2019 Finding Orphan-disease Remedies With Antifungal Research and Development Act of 2019 [S.1567]
Establishes programs to support the research of endemic fungal diseases and the development of antifungal drugs. (Endemic fungal diseases are fungal infections, e.g., Valley fever, that tend to to occur in specific geographic areas and affect particular at-risk populations, e.g., older adults.)Specifically, the bill establishes the Endemic Fungal Disease Working Group to review, coordinate, and make recommendations about the Department of Health and Human Services' (HHS) efforts to address endemic fungal diseases. The working group is comprised
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FORWARD Act of 2019 Finding Orphan-disease Remedies With Antifungal Research and Development Act of 2019 [HB-2858]
Establishes programs to support the research of endemic fungal diseases and the development of antifungal drugs. (Endemic fungal diseases are fungal infections, e.g., Valley fever, that tend to to occur in specific geographic areas and affect particular at-risk populations, e.g., older adults.)Specifically, the bill establishes the Endemic Fungal Disease Working Group to review, coordinate, and make recommendations about the Department of Health and Human Services' (HHS) efforts to address endemic fungal diseases. The working group is comprised
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