Prescription Drugs
US Congress 116th Congress
Protecting Access to Biosimilars Act of 2019 [HB-2011]
To amend the Public Health Service Act with respect to the treatment under section 351(k)(7) of such Act (relating to exclusivity for reference products) of certain products deemed to have a biologics license pursuant to section 7002 of the Biologics Price Competition and Innovation Act of 2009.
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More Efficient Tools to Realize Information for Consumers Act [HB-2296]
To require reporting regarding certain drug price increases, and for other purposes.
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US Congress 116th Congress
Protecting Jessica Grubb’s Legacy Act [S.1012]
More closely aligns the federal privacy standards for substance use disorder (SUD) patient records with the standards under the Health Insurance Portability and Accountability Act (HIPAA). Specifically, the bill authorizes the disclosure of SUD patient records without a patient's written consent to: (1) a covered entity for the purposes of treatment, payment, and health care operations, as long as the disclosure is made in accordance with HIPAA; and (2) a public health authority, as long as the content of the disclosure meets HIPAA standards regarding
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Ensuring Timely Access to Generics Act of 2019 [S.1169]
A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions.
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REMEDY Act Reforming Evergreening and Manipulation that Extends Drug Years Act [S.1209]
A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to approval of abbreviated new drug applications.
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Protecting Access to Biosimilars Act of 2019 [S.1140]
Excludes biological products that were initially licensed under the Federal Food, Drug, and Cosmetic Act (FD&C Act) (e.g., insulin) from the exclusivity protections that delay the licensure of biosimilar products under the Public Health Service Act (PHS Act). (The Biologics Price Competition and Innovation Act of 2009 generally requires that biological products approved under the FD&C Act are treated as though they were approved under the PHS Act through March 23, 2020.)
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Consumer Health Insurance Protection Act of 2019 [S.1213]
A bill to provide health insurance reform, and for other purposes.
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Improving Transparency and Accuracy in Medicare Part D Spending Act [S.988]
Prohibits Medicare prescription drug plan sponsors from retroactively reducing payment on clean claims submitted by pharmacies. (A clean claim is a Medicare claim that is free of defects such as incomplete documentation.)
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Medicare-X Choice Act of 2019 [S.981]
Establishes and funds the Medicare Exchange health plan, which allows individuals who are not otherwise eligible for Medicare to enroll in a government-administered health insurance plan. The Centers for Medicare & Medicaid Services (CMS) must offer such plan in certain individual health insurance exchanges beginning plan year 2021 and offer it in all individual health insurance exchanges beginning plan year 2024. CMS must offer the plan in the small group market in all geographic areas for plan year 2025. The plan must meet the same requirements,
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Medicare for All Act of 2019 [S.1129]
Establishes a national health insurance program that is administered by the Department of Health and Human Services (HHS). Among other requirements, the program must (1) cover all U.S. residents; (2) provide for automatic enrollment of individuals upon birth or residency in the United States; and (3) cover items and services that are medically necessary or appropriate to maintain health or to diagnose, treat, or rehabilitate a health condition, including hospital services, prescription drugs, mental health and substance abuse treatment, dental and
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Safe Step Act [HB-2279]
Requires a group health plan to establish an exception to medication step-therapy protocol in specified cases. A medication step-therapy protocol establishes a specific sequence in which prescription drugs are covered by a group health plan or a health insurance issuer. A request for such an exception to the protocol must be granted if (1) the treatment is expected to be ineffective, (2) the treatment will cause or is likely to cause an adverse reaction to the individual, (3) the treatment is expected to decrease the individual's ability either
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A resolution authorizing the use of the atrium in the Philip A. Hart Senate Office Building for the National Prescription Drug Take Back Day, a semiannual event of the Drug Enforcement Administration. [SR-158]
This resolution authorizes the use of the atrium in the Philip A. Hart Senate Office Building on April 24, 2019, for the National Prescription Drug Take Back Day, a semiannual event of the Drug Enforcement Administration.
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Fentanyl Sanctions Act [HB-2226]
Establishes programs to address illicit opioid trafficking and imposes sanctions on foreign individuals and entities involved in such activities. The President shall impose sanctions on foreign individuals and entities identified as opioid traffickers or those that own, control, or supply opioid precursors. The sanctions include bans on (1) receiving loans, (2) foreign exchange transactions, (3) property transactions, and (4) certain investments that fall under U.S. jurisdiction. The President may waive sanctions on certain parties for national
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Fixing Global Freeloading Act [HB-2209]
Establishes the position of Chief Pharmaceutical Negotiator in the Office of the U.S. Trade Representative. The Chief Pharmaceutical Negotiator must conduct trade negotiations and enforce trade agreements related to pharmaceutical products and services.
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Transparent Drug Pricing Act of 2019 [S.977]
Establishes several requirements relating to the prices of prescription drugs. For example, state Medicaid drug-use review programs must require pharmacists to disclose an individual's out-of-pocket cost for a prescription drug, and the price without health insurance, at the point-of-sale. Additionally, health insurers must publish the co-payment amount for each covered prescription drug prior to the annual open-enrollment period. The bill also temporarily prohibits the retail list price of drugs and biologics from exceeding the lowest retail list
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US Congress 116th Congress
Transparent Drug Pricing Act of 2019 [S.977]
Establishes several requirements relating to the prices of prescription drugs. For example, state Medicaid drug-use review programs must require pharmacists to disclose an individual's out-of-pocket cost for a prescription drug, and the price without health insurance, at the point-of-sale. Additionally, health insurers must publish the co-payment amount for each covered prescription drug prior to the annual open-enrollment period. The bill also temporarily prohibits the retail list price of drugs and biologics from exceeding the lowest retail list
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US Congress 116th Congress
Gluten in Medicine Disclosure Act of 2019 [HB-2074]
To amend the Federal Food, Drug, and Cosmetic Act to require the label of a drug that is intended for human use and contains an ingredient that is derived directly or indirectly from a gluten-containing grain to identify each such ingredient, and for other purposes.
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To amend title XIX of the Social Security Act to remove the matching requirement for a territory to use specially allocated Federal funds for Medicare covered part D drugs for low-income individuals. [HB-2172]
Establishes a Federal Medical Assistance Percentage of 100% with respect to a U.S. territory's use of specified federal funds to provide covered drugs to low-income individuals who are eligible for the Medicare prescription drug benefit.
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Restoring Access to Medication Act of 2019 [S.1089]
Repeals provisions of the Internal Revenue Code, as added by the Patient Protection and Affordable Care Act, that limit payments for medications from health savings accounts, medical savings accounts, and health flexible spending arrangements to only prescription drugs or insulin (thus allowing distributions from such accounts for over-the-counter drugs).
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SPIKE Act Stopping the Pharmaceutical Industry from Keeping drugs Expensive Act [HB-2069]
Requires the Centers for Medicare & Medicaid Services (CMS) to determine at least annually whether certain covered drugs under Medicare were subject to a price increase that exceeded specified thresholds. Drug manufacturers must submit justifications for such price increases to the CMS, subject to civil penalties. The bill's requirements do not apply to low-cost drugs, as identified by the CMS.