Policy Tracker

The DPL Policy Tracker keeps tabs on federal policy proposals that address US drug pricing issues. To begin, select filter options.

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Accountability and Oversight

Allow government to regulate/require disclosure of patient assistance

[Improving Access to Affordable Prescription Drugs Act; Introduced 03/29/2017] Require independent charity assistance programs to disclose to the IRS the total amount of patient assistance provided to patients who are prescribed drugs manufactured by any contributor to the independent charity assistance program.

[Fair Care Act of 2020; Introduced 10/05/2020] Allow the Secretary of HHS to establish a mechanism to regulate drug manufacturers' financial contributions to patient out-of-pocket costs, such as copays.

Ensure 340B program is providing care for the low-income patients it is intended to serve

[U.S. Budget FY 2019; Introduced 02/12/2018] Modify the 340B drug discount program to reward hospitals that provide significant charity care and reducing payment through the program to hospitals that provide little charity care.

[Fair Care Act of 2020; Introduced 10/05/2020] Require DSH hopsital covered entities to report on low-income utilization rates of outpatient hospital services under 340B.

[Closing Loopholes for Orphan Drugs Act; Introduced 02/04/2021] Revise the 340B drug discount program to exclude discounting orphan drugs that are not being used to treat rare conditions.

Ensure biosimilars cannot be paid more than their reference biologic product

[Lower Costs, More Cures Act of 2019; Introduced 12/09/2019] Ensure biosimilars cannot be paid more than their reference product during the initial period.

[Lower Costs, More Cures Act of 2021; Introduced 04/21/2021] Limit the payment amount for biosimilars during the initial period.

Establish drug pricing review board/committee

[Prescription Drug and Medical Device Price Review Board Act of 2018; Introduced 05/09/2018] Establish an Interagency Drug and Device Price Review Board to collect data on drug and device prices and manufacturing costs, and if necessary, take enforcement action against manufacturers that charge consumers excessive prices.

[Prescription Drug and Medical Device Price Review Board Act of 2018; Introduced 05/09/2018] Establish a Medical Device Price Review Board under the Department of Health and Human Services to regulate the prices of qualifying prescription drugs and medical devices. The Board will require manufacturers to report the price charged and the costs to produce and market the drug and the board can prescribe a formula to determine whether the average manufacturer price is an excessive price and the manufacturer will be prohibited against charging that excessive price.

[We Protect American Investment in Drugs Act; Introduced 07/31/2019] Establish contract with National Academy of Medicine to study drug manufacturers' justifications for drug prices and develop framework for determining fairness of prices. Establish nonprofit corporation known as the Drug Affordability and Access Committee.

[Prescription Drug Affordability and Access Act; Introduced 01/08/2020] Establish an independent bureau within HHS devoted to obtaining lower prescription drug costs for patients, decrease government spending on such drugs, and ensure adequate access. Bureau will regularly conduct reviews of prescription drug prices including certain price increases.

Establish evidence based measures of quality

[Prescription Drug Pricing Reduction Act of 2020; Introduced 07/02/2020] Establish evidence-based measures of pharmacy quality to ensure that the incentive payments or price concessions that are paid by a pharmacy to a PDP sponsor for covered part D drugs focus on aspects of patient health outcomes that the pharmacy has an impact on.

[Lower Costs, More Cures Act of 2021; Introduced 04/21/2021] Establish pharmacy quality measures under part D.

[Elijah E. Cummings Lower Drug Costs Now Act; Introduced 04/22/2021] Establish pharmacy quality measures under part D.

[Medicare Prescription Drug Savings and Choice Act of 2019; Introduced 10/21/2019] Establish role of AHRQ to assess the clinical benefit of covered Part D drugs and make recommendations to the Secretary regarding negotiated prices of covered drugs.

Health Plan Transparency

[PBM Transparency in Prescription Drug Costs Act; Introduced 12/04/2019] Amend title XXVII of the Public Health Service Act to require health plan oversight. Prohibit a group health plan or PBM from entering into a contract with a manufacturer, distributor, wholesaler, or any other third party that limits the disclosure of information for production of reports that increase transparency.

[Prescription Drug Pricing Reduction Act of 2020; Introduced 07/02/2020] Requires the reporting of any potential fraud, waste, and abuse to the Secretary of Health and Human Services by Prescription Drug or Medicare Advantage Prescription Drug plans.

[A bill to increase transparency and access to group health plan and health insurance issuer reporting, and for other purposes.; Introduced 12/21/2020] Require all group insurance plans or insurers (excluding Church Plans) to report information on the past year's pharmacy benefits and drug costs to the Secretary of Labor and the Secretary of the Treasury.

[Lower Costs, More Cures Act of 2021; Introduced 04/21/2021] Require PDPs and MA-PD plans to report fraud, waste, and abuse to HHS.

Limit influence of branded manufacturers on patient decision-making

[Responsibility in Drug Advertising Act of 2016; Introduced 02/12/2016] Amend the Federal Food, Drug, and Cosmetic Act to restrict direct-to-consumer drug advertising.

[Protecting Americans from Drug Marketing Act; Introduced 03/03/2016] Amend the Internal Revenue Code to deny a tax deduction for the cost of direct-to-consumer advertising of prescription drugs.

Manufacturer Transparency

[Prescription Drug Affordability Act of 2015; Introduced 09/10/2015] Require drug companies to report not only the price information charged to federal payers, but also requires companies to submit prices, profits, and sale information in other countries in which those products are sold.

[Prescription Drug Affordability Act of 2015; Introduced 09/10/2015] Require pharmaceutical companies to publicly report information that affects drug pricing, including the total costs incurred for research and development and clinical trials, as well as the portion of drug development expenses offset by tax credits or paid by federal grants.

[Fair Accountability and Innovative Research Drug Pricing Act of 2017; Introduced 05/16/2017] Require manufacturers to notify HHS and submit a report 30 days before raising price of certain products by more than 10%. The report should contain justification and costs for manufacturing, R&D, along with net profits, and marketing and advertising.

[Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017; Introduced 06/13/2017] Amend title XI of the Social Security Act to require drug manufacturers to submit justification of drug price increases within 60 days of determination of applicability of rule.

[Improving Access To Affordable Prescription Drugs Act; Introduced 03/29/2017] Require the HHS Office of the Inspector General (HHS OIG) to monitor changes in drug prices and take steps to prevent drug manufacturers from engaging in price gouging. If price of a drug increases beyond medical inflation, the manufacturer would be subject to a graduated excise tax that depends on the size of the price increase, with prior assessment of the extent to which the price increase was due to changes in a drug’s supply chain or for other justifiable reasons.

[Improving Access To Affordable Prescription Drugs Act; Introduced 03/29/2017] Require drug manufacturers to disclose costs of research, development, manufacturing, marketing, and acquisitions, as well as federal investments, revenues and sales, and other factors that influence drug prices, by product, to the Secretary of the Department of Health and Human Services (HHS), to be made publicly available in a searchable format.

[Preserve Access to Affordable Generics Act; Introduced 01/12/2017] Require brand name manufacturers and generic manufacturers to submit to the Federal Trade Commission any other agreements the parties enter into within 30 days of entering into an agreement related to the manufacturing, marketing, sale, or exclusivity period of a drug.

[U.S. Budget FY 2019; Introduced 02/12/2018] Require manufacturers to better report ASP for accurate payment rates.

[CURE High Drug Prices Act; 12/13/2018] Allows the Secretary of HHS to notify a manufacturer of its potential price gouging and require a justification of the increase.

[Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019; Introduced 02/13/2019] Amend title XI of the Social Security Act to require drug manufacturers that increase their wholesale cost beyond a certain threshold to submit a written justification of that increase to CMS. This justification will be summarized and published on the CMS website. Manufacturers that do not abide by this bill will be fined.

[Right Rebate Act of 2019; Introduced 01/24/2019] Amend the Social Security Act to stop the misclassifications of drugs that are a part of the Medicaid drug rebate program.

[Affordable Medications Act; Introduced 09/05/2018] Propose to increase transparency by requiring drug manufacturers to submit reports outlining the revenue and incurred cost of a drug.

[Drug-price Transparency in Communications (DTC) Act; Introduced 05/13/2019] Amend title XI of the Social Security Act to require direct-to-consumer advertisements for prescription drugs and biologicals to include truthful and non-misleading pricing information.

[More Efficient Tools to Realize Information for Consumers Act; Introduced 04/12/2019] Amend Title III of the Public Health Service Act to require manufacturers to justify certain drug price increases. Report for justification required when qualifying drug increases 10 percent or more within a single calendar year or 25 percent or more within three consecutive calendar years.

[More Efficient Tools to Realize Information for Consumers Act; Introduced 04/12/2019] Amend the Social Security Act to require prescription drug marketing sample information reported by manufacturers to be available to oversight agencies, researchers, and payers.

[Prescription Drug Price Reporting Act; Introduced 05/23/2019] Require manufacturers to report a prescription drug price's wholesale acquisition cost, average net price, and rebates to health insurance plans or PBMs with respect to covered individuals.

[Prescription Drug STAR Act; Introduced 04/08/2019] Amend titles XI and XVIII of the Social Security Act to require manufacturers to justify certain drug price increases. Publicly disclose discounts and price concessions passed through to plan sponsors on the HHS website. Require certain manufacturers to report drug pricing information related to drugs covered under the Medicare program.

[Empowering States to Address Drug Costs Act; Introduced 07/24/2019] Amend title XIX of the Social Security Act to review AMP, best price, and rebate calculation data to establish State all-payer prescription drug rate setting entities or State multi-payer purchasing tools.

[The Prescription Drug Pricing Reduction Act (PDPRA) of
2019; Introduced 07/25/2019] Require manufacturers that do not have a Medicaid drug rebate agreement to report ASP information to the HHS to help establish Medicare payment rates.

[The Prescription Drug Pricing Reduction Act (PDPRA) of
2019; Introduced 07/25/2019] Amend the Social Security Act to require manufacturers to report to HHS information and supporting documentation needed to justify price increases for prescription drugs and biological products as measured by wholesale acquisition cost (WAC) or changes in WAC that exceed certain thresholds.

[The Prescription Drug Pricing Reduction Act (PDPRA) of
2019; Introduced 07/25/2019] Amend the Social Security Act to require HHS Secretary to audit price and drug product information reported by manufacturers to ensure accuracy and timeliness. Allow Secretary to impose civil monetary penalties on wholesalers, manufacturers, or direct sellers if entities refuse to provide pricing information.

[CURE High Drug Prices Act; Introduced 08/02/2019] Allow the Secretary of HHS to notify a manufacturer of its potential price gouging and require a justification of the increase.

[Prescription Drug Price Reporting Act; Introduced 11/21/2019] Require manufacturers to report on each drug marketed in the U.S. their current wholesale acquisition cost, average wholesale acquisition cost during the previous calendar year, average net price, as well as total rebates during the previous calendar year or time that the drug has been marketed. Require manufacturers to report increases or decreases in wholesale acquisition cost of a prescription drug no later than 30 days before the price change takes effect.

[Lower Costs, More Cures Act of 2019; Introduced 12/09/2019] Require manufacturers to report drug pricing information with respect to drugs under Medicare. Require HHS to report on accuracy of ASP information submitted by manufacturers to Congress.

[Lower Costs, More Cures Act of 2019; Introduced 12/09/2019] Ensure the accuracy of the manufacturer price and product information under Medicaid by conducting audits and surveys.

[Lower Costs, More Cures Act of 2019; Introduced 12/09/2019] Require manufacturers to justify certain drug price increases.

[Prescription Drug Pricing Reduction Act of 2020; Introduced 07/02/2020] Improvement of manufacturer reporting of ASP in order to set more accurate payment rates.

[Matt's Act; Introduced 07/29/2021] Require manufacturers of insulin drugs to publish the average net price of each insulin product on a quarterly basis.

[Prescription Drug Pricing Reduction Act of 2020; Introduced 07/02/2020] Require drug manufacturer price transparency for drugs with a large price increase, high spending, or high launch price (for new drugs).

[Fair Accountability and Innovative Research Drug Pricing Act of 2021; Introduced 03/23/2021] Require manufacturers to report on justification for certain drug price increases.

[Lower Costs, More Cures Act of 2021, Introduced 04/21/2021] Require manufacturers to report on justification of certain drug price increases.

[Lower Costs, More Cures Act of 2021, Introduced 04/21/2021] Make prescription drug marketing sample information available to oversight agencies, researchers, payers, and the public.

[Lower Costs, More Cures Act of 2021, Introduced 04/21/2021] Conduct audits and surveys of manufacturer price and drug product information under the Medicaid Drug Rebate Program.

[Elijah E. Cummings Lower Drug Costs Now Act; Introduced 04/22/2021] Require manufacturers to justify to HHS certain drug price increases.

PBM Transparency

[Prescription Drug Price Transparency Act; Introduced 02/07/2019] Establish standards for pharmacy benefits manager under the Medicare prescription drug program and Medicare Advantage program to further transparency of payment methodologies to pharmacies, and for other purposes.

[More Efficient Tools to Realize Information for Consumers Act; Introduced 04/12/2019] Amend the Social Security Act to make publicly available PBMs' ability to negotiate rebates, discounts, remuneration fees, administrative fees, and price concessions as well as the amounts passed on to plan sponsors.

[Public Disclosure of Drug Discounts and Real-Time Beneficiary Drug Cost Act; Introduced 04/08/2019] Amend titIes XI and XVIII of the Social Security Act to require public disclosure of rebates, discounts, remuneration fees, administrative fees, and price concessions and the amounts passed through to plan sponsors.

[Creating Transparency to Have Drug Rebates Unlocked (C–THRU) Act of 2019; Introduced 02/13/2019] Amend titles XI and XVIII of the Social Security Act to increase transparency of discounts provided by drug manufacturers by publicly disclosing PBMs' ability to negotiate rebates, discounts, and price concessions and the amounts passed through to plan sponsors.

[Phair Relief Act of 2019; Introduced 07/24/2019] Amend titles XI and XVIII of the Social Security Act to make PBMs' ability to negotiate rebates, discounts, and price concessions as well as their amounts publicly available through the HHS website.

[The Prescription Drug Pricing Reduction Act (PDPRA) of
2019; Introduced 07/25/2019] Require HHS to publicly report information on aggregate price concessions, difference between what insurer pays PBM and what PBM pays pharmacies, and number of prescriptions dispensed while still preventing disclosure of price concessions for specific plans or drugs. Require Part D insurers to conduct financial audits of data related to their PBM contracts. Require Part D insurers to report to pharmacies' post-point-of-sales adjustments for price concessions or incentive payments for covered Part D drugs. Require Part D insurers to report actual and projected direct and indirect remuneration amounts in bids for Part D coverage.

[Prescription Drug Pricing Reduction Act of 2020; Introduced 07/02/2020] Establishes audits of PBM managers and data

[Prescription Drug Pricing Reduction Act of 2020; Introduced 07/02/2020] Strengthen pharmacy benefit managers’ transparency requirements. 

[Prescription Drug Pricing Reduction Act of 2020; Introduced 07/02/2020] Requires disclosure of pharmacy price concessions for covered part D drugs

Provide evidence of clinical superiority to receive financial rewards

[Improving Access To Affordable Prescription Drugs Act; Introduced 03/29/2017] Add a requirement that products awarded the 3-year New Clinical Investigation Exclusivity must show significant clinical benefit over existing therapies manufactured by the applicant in the 5-year period preceding the submission of the application.

[Lower Costs, More Cures Act of 2019; Introduced 12/09/2019] Clarify that in order to get new exclusivities, all orphan drugs must prove clinical superiority to a previous version of the drug already on the market.

Provider Transparency

[Ensuring the Value of the 340B Program Act of 2018; Introduced 02/27/2018] Require hospitals to provide information of drug acquisition costs for 340B drugs along with information on the hospital's revenues received for such drugs.

[Prescription Drug Pricing Reduction Act of 2020; Introduced 07/02/2020] Improving claims data that is provided to prescription drug plans to encourage appropriate use of medications and improve health outcomes.

Foster Competition

Drug importation for noncompetitive markets

[Pharmaceutical Supply and Value Enhancement Act; 09/28/2016] Allow for the expedited approval and temporary importation of generic prescription drugs in the case of noncompetitive drug markets (fewer than five holders of approved applications for brand or generic versions of the drug, drug has been approved for at least 10 years, or patents on the active ingredient of a drug have expired).

[Short on Competition Act; Introduced 01/20/2017] Allow for the expedited approval and temporary importation of generic prescription drugs in the case of noncompetitive drug markets (fewer than five holders of approved applications for brand or generic versions of the drug, drug has been approved for at least 10 years, or patents on the active ingredient of a drug have expired).

[Pharmaceutical Supply and Value Enhancement Act; Introduced 09/28/2016] Allow for importation of prescription drugs in the case of noncompetitive drug markets or drug shortages.

[Executive Order on Increasing Drug Importation to Lower Prices for American Patients; Introduced 07/24/2020] Permitting the importation of prescription drugs from other countries in order to create more competition in domestic pricing and lower the cost of prescription drugs for Americans.

Ensure competitive access to drug samples

[FAST Generics Act of 2017; Introduced 04/06/2017] Amend the Federal Food, Drug, and Cosmetic Act to ensure that eligible product developers have competitive access to approved drugs and licensed biological products.

[FAST Generics Act of 2015; Introduced 06/18/2015] Amend the Federal Food, Drug, and Cosmetic Act to ensure that eligible product developers have competitive access to approved drugs and licensed biological products, so as to enable eligible product developers to develop and test new products, and for other purposes.

Incentivize generic and biosimilar entry

[Making Pharmaceutical Markets More Competitive Act; Introduced 05/11/2017] Prioritize the review of, and act within 240 calendar days of the date of the submission of, an original abbreviated new drug application submitted for review under this subsection, or on a supplement to such an application, that is for a drug for which there are not more than 3 approved drugs listed.

[Pharmaceutical Supply and Value Enhancement Act; Introduced 09/28/2016] Allow for the expedited approval and temporary importation of generic prescription drugs in the case of noncompetitive drug markets (fewer than five holders of approved applications for brand or generic versions of the drug, drug has been approved for at least 10 years, or patents on the active ingredient of a drug have expired).

[Improving Access To Affordable Prescription Drugs Act; Introduced 03/29/2017] Modify the New Chemical Entity (NCE) exclusivity period to allow generic drug application for the branded product after three years rather than five, but maintain market exclusivity for five years.

[Increasing Competition in Pharmaceuticals Act; Introduced 02/02/2017] Create a new “generic priority review voucher” that would be awarded to the sponsor of a successful application for a medical shortage or sole-source drug that makes it to market.

[SAVINGS Act; Introduced 09/22/2016] Require the FDA to expedite the review of second generics and make a final decision within 150 days of receiving these Priority Review Abbreviated New Drug Applications.

[Lower Drug Costs through Competition Act; Introduced 01/30/2017] Revise provisions for the FDA to prioritize review of generic drug applications allowing for expedited inspection.

[U.S. Budget FY 2019; Introduced 02/12/2018] Give FDA greater ability to bring generic drugs to market quicker by granting power to approve a subsequently filed generic application for 180-day exclusivity when the first-to-file is not yet approved due to deficiencies.

[President's Blueprint; Introduced 05/01/2018] Allow the FDA to publish a list of drug names that have no competitors to encourage generic competitors to enter the market and bring prices down.

[CREATES Act of 2019; Introduced 02/05/2019] Promote the competition in the drug market by facilitating the entry of lower-cost generic and biosimilar versions of drugs.

[Fair Care Act of 2019; Introduced 02/25/2019] Expedite development and priority review for generic complex drug products.

[Competition Prescription Act of 2019; Introduced 07/24/2019] Expedite development and priority review for complex generic drugs.

[BIOSIM Act; Introduced 09/20/2019] Amend title XVIII of the Social Security Act to temporarily increase payment under Medicare program for certain biosimilars to incentivize biosimilar development.

[Lower Costs, More Cures Act of 2019; Introduced 12/09/2019] Change the conditions of first generic exclusivity to spur access and competition.

[Lower Costs, More Cures Act of 2019; Introduced 12/09/2019] Streamline biosimilars approval process by providing clarity for applicants that they can include information in their application showing the proposed conditions of use have been previously approved for the reference product.

[Lower Costs, More Cures Act of 2019; Introduced 12/09/2019] Require prescription drug marketing sample information reported by manufacturers to be available to certain individuals and entities.

[Fair Care Act of 2020; Introduced 10/05/2020] Expedite development and priority review for generic complex drugs.

[Short on Competition Act; Introduced 03/23/2021] Allow for the expedited approval and temporary importation of generic prescription drugs in the case of noncompetitive drug markets (fewer than five holders of approved applications for brand or generic versions of the drug, drug has been approved for at least 10 years, or patents on the active ingredient of a drug have expired).

Incentivize use of biosimilars and generics

[FAST Generics Act of 2019; Introduced 02/05/2019] Amend the Federal Food, Drug, and Cosmetic Act to allow sponsors interested in developing generic drugs and biosimilars to have competitive access to currently approved drugs and licensed biological products.

[The Prescription Drug Pricing Reduction Act (PDPRA) of
2019; Introduced 07/05/2019] Increase add-on payment for a biosimilar under Medicare Part B from 6% of reference product's ASP to 8% for a period of five years.

[Star Rating for Biosimilars Act; Introduced 10/08/2019] Amend title XVIII of the Social Security Act to implement new set of measures in the 5-star rating system under the Medicare Advantage program to encourage increased access to biosimilar products. Measures include coverage on plan formularies, tier placement, utilization management tools, and utilization relative to the reference biological product.

[Prescription Drug Pricing Reduction Act of 2020; Introduced 07/02/2020] A temporary increase in Medicare Part B payments for biosimilars.

Limit anticompetitive behaviors by manufacturers

[FAIR Generics Act; Introduced 01/08/2015] Disqualify from being a “first applicant” (which grants 180 days of market exclusivity) any ANDA applicant (for a generic drug) that has entered into a “pay for delay” agreement.

[Preserve Access to Affordable Generics Act; Introduced 01/12/2017] Prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market.

[EPI Act; Introduced 09/28/2016] Prohibit a company that holds the patent for a brand-name pharmaceutical product from also introducing an authorized generic.

[Improving Access To Affordable Prescription Drugs Act; Introduced 03/29/2017] Make it illegal for brand-name and generic drug manufacturers to enter into agreements in which the brand-name drug manufacturer pays the generic manufacturer to keep more affordable generic equivalents off the market. Take away 180 day exclusivity period for generic manufacturers entering into such an agreement.

[Prescription Drug Affordability Act of 2015; Introduced 09/10/2015] Prohibit anti-competitive arrangements between brand and generic drug makers where the brand name drug manufacturers pays the generic manufacturer to delay bringing their generic alternative to market.

[Preserve Access to Affordable Generics Act; Introduced 01/12/2017] Authorize the Federal Trade Commission to initiate proceedings against parties to any agreement that resolves or settles a patent infringement claim in connection with the sale of a drug.

[U.S. Budget FY 2019; Introduced 02/12/2018] Discourage generic manufacturers use of their 180-day exclusivity as the first generic to prevent other generic manufacturers from entering the market. Propose to start a drug company's 180-day exclusivity clock in cases when another generic application is waiting for approval, but is blocked by the first applicant's 180-day exclusivity.

[Preserve Access to Affordable Generics and Biosimilars Act; Introduced 01/09/2019] Prohibits brand name drug companies from paying generic drug companies for delaying the entry of a generic drug in the market. Similarly, prohibits biological product manufacturers from paying biosimilar companies to delay entry of biosimilar products

[Affordable Medications Act; Introduced 09/05/2018] Introduce measures to block unfair and anticompetitive drug monopoly practices to allow for generic competitors to come to market

[Prescription Drug Price Relief Act of 2019; Introduced 01/10/2019] End government-granted monopolies for drug manufacturers who charge prices that are higher than the median price charged in other countries.

[Affordable Prescriptions for Patients Act of 2019; Introduced 05/09/2019] Amend the Federal Trade Commission Act to prohibit anticompetitive behaviors by drug manufacturers, including "product hopping."

[PACED Act; Introduced 02/12/2019] Amend title 35 to prohibit patent owners from asserting sovereign immunity as a defense before the U.S. Patent & Trademark Office to prevent the production of generics.

[Stop STALLING Act; Introduced 04/29/2019] Deter the filing of sham citizen petitions that attempt to interfere with the approval of a competing generic drug or biosimilar.

[Affordable Prescriptions for Patients Through Promoting Competition Act of 2019; Introduced 09/19/2019] Amend the Federal Trade Commission Act to prohibit anticompetitive behaviors by drug manufacturers, including "product hopping."

[Lower Costs, More Cures Act of 2019; Introduced 12/09/2019] Allow for actions against bad actors who delay generics and biosimilars coming to market by withholding drug samples.

[Lower Costs, More Cures Act of 2019; Introduced 12/09/2019] Prevent manufacturers from gaming the system by receiving additional exclusivity periods once they are deemed biologics.

[Further Consolidated Appropriations Act, 2020; Introduced 03/25/2019] Promote competition by applying limitations on branded biologic exclusivity and not granting additional exclusivity through deeming. Prevent drug manufacturers from abusing REMS and restricting generic and biosimilar competition.

[Lowering Prescription Drug Prices for America’s Seniors and Families Act of 2020; Introduced 03/03/2020] Preserve access to affordable generics and biosimilars by allowing the Commission to initiate a proceeding against agreements presumed to have anticompetitive effects.

[Fair Care Act of 2020; Introduced 10/05/2020] Prohibit agreements that would prevent generic applicants from commercial marketing upon approval.

[Fair Care Act of 2020; Introduced 10/05/2020] Prohibit civil petitions with the intent of delaying generic entry.

[Protecting Consumer Access to Generic Drugs Act of 2021; Introduced 01/04/2021] Prohibit branded manufacturers from compensating generic manufacturers for delaying the entry of a generic drug into the market, and prohibit biologic manufacturers from compensating biosimilar and interchangeable product manufacturers for delaying entry of a biosimilar or interchangeable product.

[Lower Costs, More Cures Act of 2021; Introduced 04/21/2021] Prohibit pay-for-delay agreements.

Reduce market monopoly

[Improving Access To Affordable Prescription Drugs Act; Introduced 03/29/2017] Reduce the biological product exclusivity from 12 years to 7 years.

[Improving Access To Affordable Prescription Drugs Act; Introduced 03/29/2017] Reduce the biological product exclusivity from 12 years to 7 years.

[PRICED Act; Introduced 06/23/2016] Amend the Public Health Service Act to shorten the exclusivity period for brand name biological products from 12 to 7 years.

[PRICED Act; Introduced 07/26/2018] Amend the Public Health Service Act to shorten the exclusivity period for brand name biological products from 12 to 7 years.

[Prescription Drug Price Relief Act of 2019; Introduced 01/10/2019] End government-granted monopolies in regards to manufacturers who price drugs higher than the median in other countries

[Fair Care Act of 2019; Introduced 02/25/2019] Limit exclusivity periods for drugs that treat rare diseases and conditions.

[Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act; Introduced 05/14/2019] Incentivize low-cost drug options by changing the conditions of first-filer generic exclusivity to encourage competition.

[PRICED Act; Introduced 06/20/2019] Amend the Public Health Service Act to shorten exclusivity period for brand name biological products from 12 to 5 years.

[Lower Costs, More Cures Act of 2019; Introduced 12/09/2019] Limit potential for "evergreening" by restricting manufacturers from obtaining new exclusivities on previously approved clinical entities.

[To amend the Biologics Price Competition and Innovation Act of 2009 to make improvements with respect to the transition of biological products, and for other purposes.; Introduced 03/09/2020] Amend the Biologics Price Competition and Innovation Act of 2009 by listing certain insulin products as interchangeable biosimilars.

[Fair Care Act of 2020; Introduced 10/05/2020] Consolidate exclusivity periods for drugs treating rare diseases by not allowing the Secretary to approve a different applicant or issue a license for the same drug for the same disease until the original exclusivity period expires.

[Fair Care Act of 2020; Introduced 10/05/2020] Protect access to biologics by limiting additional exclusivities.

Incentivize innovation

Direct financial incentives

[Affordable Medications Act; Introduced 09/05/2018] Encourage innovation by setting aside a prize fund for the development new antibiotics and drugs

Establish a new FDA approval pathway

[Promising Pathway Act; Introduced 05/13/2021] Establishment of an approval pathway for drugs and biologics for the treatment of serious diseases and conditions. Approval pathway would provide early, short-term approval for drugs and biologics that provide substantial evidence of safety and positive therapeutic benefit. Expands the evidence requirements to allow for use of "scientifically-substantially-surrogates" or surrogate endpoints to predict clinical benefit.

[Promising Pathway Act; Introduced 05/13/2021] Provisional approval granted under the Promising Pathway can be up to a maximum of 2 years, renewable every 2 years, for up to 6 years. Full approval is granted when the drug or biologic has at least a 15% improvement in an important endpoint as compared to other therapies.

Increase price awareness throughout the supply chain

Disclosure of pricing information to beneficiaries at decision-making

[Know the Lowest Price Act of 2018; Introduced 03/14/2018] Amend the Social Security Act to ensure that health plans and pharmacy benefit managers cannot restrict pharmacies from providing individuals information on the differential price of the drug under the plan and without health-insurance coverage.

[COST Act; Introduced 07/31/2018] Amend the Public Health Service Act and Social Security Act to prevent health insurers, group health plans, Medicare Advantage organizations and prescription drug plan sponsors from restricting drug pricing information given to consumer.

[More Efficient Tools to Realize Information for Consumers Act; Introduced 04/12/2019] Amend the Social Security Act to require prescription drug plan sponsors to include real-time benefit information as part of the sponsor's electronic prescription program under Medicare. Information should include clinically-appropriate alternatives to drugs in formulary, cost-sharing information, and applicable utilization management requirements.

[Public Disclosure of Drug Discounts and Real-Time Beneficiary Drug Cost Act; Introduced 04/08/2019] Require prescription drug plan sponsors to include real-time benefit information as part of sponsor's electronic prescription program under Medicare.

[Transparent Drug Pricing Act of 2019; Introduced 04/01/2019] Amend the Social Security Act to require disclosure of drug prices at point of sale, including customer's out-of-pocket cost in context of current health plan a well as cost without using any health plan. HHS required to make this information publicly available through a database that allows consumers to subscribe to price change notifications for prescription drugs.

[The Prescription Drug Pricing Reduction Act (PDPRA) of
2019; Introduced 07/25/2019] Modify transparency tool provision to require comparable information for services that can also be furnished in a physician office.

[The Prescription Drug Pricing Reduction Act (PDPRA) of
2019; Introduced 07/25/2019] Require Part D insurers to provide for a "real-time benefit tool (RTBT)" that enables electronic transmission formulary and benefit information to each enrollee's prescribing clinician.

[Lower Costs, More Cures Act of 2019; Introduced 12/09/2019] Require prescription drug plan sponsors to include real-time benefit information as part of sponsor's electronic prescription program under Medicare.

[Lowest Price for Patients Act; Introduced 12/16/2019] Amend title XXVII of the Public Health Service Act and title XVIII of the Social Security Act to require pharmacies to disclose any differential between the cost of a prescription drug based on whether certain individuals use prescription drug coverage to acquire the drug.

[Prescription Drug Pricing Reduction Act of 2020; Introduced 07/02/2020] Requiring Medicare Advantage Organizations and Prescription Drug Plans to increase the use of real-time benefit information and tools for prescribers by incorporating such tools into electronic health record systems.

Public disclosure of pricing information

[Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017; Introduced 03/15/2017] Amend titles XI and XVIII of the Social Security Act to provide public disclosure of information on rebates, discounts, and price concessions with respect to an individual drug or an individual plan on the HHS website. To allow patients and employers to compare PBMs negotiating capacity.

[Improving Access To Affordable Prescription Drugs Act; Introduced 03/29/2017] Require drug manufacturers to disclose costs of research, development, manufacturing, marketing, and acquisitions, as well as federal investments, revenues and sales, and other factors that influence drug prices, by product, to the Secretary of the Department of Health and Human Services (HHS), to be made publicly available in a searchable format.

[Drug-Price Transparency in Communications Act; Introduced 11/16/2017] Require drug manufacturers to disclose the prices of prescription drugs in any direct-to-consumer advertising and marketing to practitioners of a drug.

[Transparent Health Care Pricing Act of 2018; Introduced 01/16/2018] Require entities that offer or furnish health care related products or services to the public to disclose the price for those products and services at the point of purchase or on the internet. The entities must disclose all prices, including wholesale, retail and discounted prices that are accepted as payment in full for products and services furnished to individual consumers.

[Drug-Price Transparency in Communications Act; Introduced 07/26/2018] Require drug manufacturers to include prescription drug prices on any DTC advertising and any marketing to practitioners of a drug.

[Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017; Introduced 03/15/2017] Allow patients and employers to compare PBMs' ability to negotiate rebates, discounts, and price concessions passed through to plan sponsors by making this information publicly available on the internet.

[Lower Costs, More Cures Act of 2019; Introduced 12/09/2019] Require public disclosure of drug discounts on the internet in order to allow comparison of PBMs' ability to negotiate rebates, discounts, remuneration fees, concessions, etc.

[Lower Costs, More Cures Act of 2019; Introduced 12/09/2019] Codify recent HHS regulations to require pharmaceutical companies to list prices of their prescription drugs in direct-to-consumer advertisements.

[Transparency in Prescription Drug Advertising Act; Introduced 02/13/2020] Urge the Secretary of HHS to require the list prices of drugs to be included in advertisements.

[Transparency and Accountability in Health Care Costs and Prices Act of 2020; Introduced 02/27/2020] Amend title XXVII of the Public Health Service Act to require the Secretary of Health and Human Services to establish a grant program facilitating State efforts to establish or maintain an all-payer claims databases (APCD) in order to increase transparency. APCD data allows for users to track trends in health care prices, check price and quality, and aid employers and health plans in making informed decisions when developing health plans.

[Prescription Drug Pricing Reduction Act of 2020; Introduced 07/02/2020] Make PBM provisions and drug discounts available on the internet in order to allow patients and employers to compare PBMs' ability to negotiate rebates, discounts concessions, etc.

[Prescription Drug Pricing Reduction Act of 2020; Introduced 07/02/2020] Establish prescription drug pricing dashboards to be publicly available on the internet for beneficiaries, clinicians, researchers, and the public to view information on utilization and spending on prescription drugs and biologics covered under Medicare parts B, D, and Medicaid. 

[Prescription Drug Pricing Reduction Act of 2020; Introduced 07/02/2020] Increasing the transparency of the Medicare website by expanding the information published to include the amount paid to the physician for an item or service and the estimated amount of that the beneficiary pays for the item or service.

[Prescription Drug Pricing Reduction Act of 2020; Introduced 07/02/2020] Requires that the results of remuneration reports be disclosed to the public online for all prescription drug plans.

[Lower Costs, More Cures Act of 2021; Introduced 04/21/2020] Require public disclosure of drug discounts to allow comparison of PBMS' ability to negotiate rebates, discounts, remuneration fees, etc.

[Lower Costs, More Cures Act of 2021; Introduced 04/21/2020] Require that DTC advertisements for drugs and biologics include truthful pricing information.

Limit Price Inflation

Adjusting payments for inflation

[Competition Prescription Act of 2019; Introduced 07/24/2019] Allow Secretary of HHS to alter payments for prescription drugs provided through Medicare Part B by paying rates that are adjusted for inflation.

Implement inflation cap

[U.S. Budget FY 2019; Introduced 02/12/2018] Propose an inflation limit for reimbursement of Medicare Part B drugs.

[CURE High Drug Prices Act; Introduced 12/13/2018] Prohibit the gouging of drug prices by setting limit in drug price increase of a certain percent or more within a time period.

Impose a financial disincentive on manufacturers for drug prices that are increasing faster than inflation. Examples include excise taxes and rebates.

[Stop Price Gouging Act; Introduced 02/07/2019] Impose an excise tax on pharmaceutical companies that sell prescription drugs subject to price spikes that exceed rates of inflation.

[Protecting Medicare from Excessive Price Increases Act of 2018; Introduced 03/01/2018] Amends the Social Security Act to require drug manufacturers to pay a Medicare part B rebate for qualifying drugs if the price of the drug increases faster than inflation.

[CURE High Drug Prices Act; Introduced 12/13/2018] In the event that drug prices increase beyond the listed percentage or more within a certain time period, the Secretary has the power to restore any excessive amount paid from the price increase to the consumer.

[Stop Price Gouging Act; Introduced 02/07/2019] Subject pharmaceutical companies to an excise tax if drug prices exceed the annual percentage increase in the Chained Consumer Price Index.

[Stop Drug Companies from Overcharging Seniors in Medicare Part B Act of 2019; Introduced 07/10/2019] Amend title XVIII of the Social Security Act to require manufacturers to provide rebates for drugs covered under Medicare Part B if growth in average sales price exceeds inflation.

[The Prescription Drug Pricing Reduction Act (PDPRA) of
2019; Introduced 07/25/2019] Require drug manufacturers to pay a rebate to Medicare for the amount their Part B drugs increase above the rate of inflation.

[The Prescription Drug Pricing Reduction Act (PDPRA) of
2019; Introduced 07/25/2019] Establish a mandatory rebate if a pharmaceutical manufacturer increases their list price for certain covered Part D drugs above inflation.

[CURE High Drug Prices Act; Introduced 08/02/2019] Grant the Secretary the power to also restore any excessive amount paid from the price increase to the consumer or the payer.

[Elijah E. Cummings Lower Drug Costs Now Act; Introduced 04/22/2021] Enact inflation rebate if drug company has raised the price of a drug in Medicare Part B or D above rate of inflation since 2016.

[Pharmaceutical REPAI Act; Introduced 10/08/2019] Amend title XVIII of the Social Security Act to require drug manufacturers to pay a Medicare Part D rebate for certain drugs if the price increases above the rate of inflation.

[Prescription Drug Pricing Reduction Act of 2020; Introduced 07/02/2020] Establishment of Medicare Part B rebates for drugs and biologics with prices that are increasing faster than inflation.

[Prescription Drug Pricing Reduction Act of 2020; Introduced 07/02/2020] Amendment to the Social Security Act that requires manufacturer rebates for Medicare Part D drugs with prices that are increasing faster than inflation.

[Elijah E. Cummings Lower Drug Costs Now Act; Introduced 04/22/2021] Enact Medicare part B rebate for drugs with prices increasing faster than the rate of inflation.

[Elijah E. Cummings Lower Drug Costs Now Act; Introduced 04/22/2021] Enact Medicare part D rebate for drugs with prices increasing faster than the rate of inflation.

[Prescription Drug Affordability Act of 2015; Introduced 09/10/2015] Require generic drug manufacturers to pay an additional rebate to Medicaid if their drug prices rise faster than inflation, mirroring the current requirements for brand name drug makers.

Reduce period of exclusivity

[FLAT Prices Act; Introduced 02/06/2019] Reduce the period of exclusivity of prescription drugs if there is an increase in the wholesale acquisition cost beyond a set threshold.

Reduce costs and improve access for patients

Allow for the importation of FDA-approved drugs from other countries

[Improving Access To Affordable Prescription Drugs Act; Introduced 03/29/2017] Allow wholesalers, licensed U.S. pharmacies, and individuals to import qualifying prescription drugs manufactured at FDA-inspected facilities from licensed Canadian sellers and, after two years, from OECD countries that meet standards comparable to U.S. standards. Imported drugs must have the same active ingredient, route of administration, and strength as drugs approved in the U.S., and the Secretary has suspension authority when sellers do not meet standards.

[Prescription Drug Affordability Act of 2015; Introduced 09/10/2015] Allow individuals, pharmacists, and wholesalers to import prescription drugs from licensed Canadian pharmacies.

[Safe and Affordable Drugs from Canada Act of 2017; Introduced 01/09/2017] Amend the Federal Food, Drug, and Cosmetic Act to allow personal importation of safe and affordable drugs from approved pharmacies in Canada.

[Affordable and Safe Prescription Drug Importation Act; Introduced 02/28/2017] Introduce regulation that allows wholesalers, pharmacies, and individuals to import prescription drugs from a list of certified foreign sellers, published on a dedicated website, and permit importation from OECD countries with standards for approval and sale of prescription drugs comparable to those in the United States.

[Affordable and Safe Prescription Drug Importation Act; Introduced 02/28/2017] Allow individual importation of qualifying prescription drugs from Canada or another licensed foreign pharmacy.

[Personal Drug Importation Fairness Act of 2017; Introduced 02/07/2017] Allow importation by persons other than a drug's manufacturer if the drug has the same active ingredients, route of administration, and strength as an approved drug, is imported or re-imported from a qualified country in which it is lawfully marketed, is dispensed by a licensed pharmacist, is shipped directly to, or is imported by, the ultimate consumer, in quantities that do not exceed a 90-day supply, is accompanied by a copy of a valid prescription, and is not a controlled substance.

[Affordable Medications Act; Introduced 09/05/2018] Allow wholesale distributors, pharmacies, and individuals to import cheaper drugs from other countries.

[Affordable and Safe Prescription Drug Importation Act; Introduced 01/10/2019] Amend the Federal Food, Drug, and Cosmetic Act for the importation of safe drugs.

[Safe Importation Action Plan; Introduced 07/31/2019] Lay the foundation for the safe importation of certain drugs from foreign countries by: 1) authorizing demonstration projects allowing for the importation of drugs from Canada and 2) allowing manufacturers to import versions of FDA-approved drugs they sell in foreign markets.

[Lowering Prescription Drug Prices for America’s Seniors and Families Act of 2020; Introduced 03/03/2020] Allow individuals to import prescription drugs from Canada. Individuals may purchase drugs for personal use from approved Canadian pharmacies using a valid prescription issues by a physician licensed to practice in the United States.

[Affordable and Safe Prescription Drug Importation Act; Introduced 03/23/2021] Allow for the importation of affordable and safe drugs by wholesalers, pharmacies, and individuals.

Alternative payment plans

[Lower Costs, More Cures Act of 2019; Introduced 12/19/2019] Allow certain enrollees of prescription drug plans and MA-PD plans under Medicare to spread out cost-sharing.

[Lower Costs, More Cures Act of 2021; Introduced 04/21/2021] Allow certain enrollees of Medicare PDP and MA-PD plans to spread out payment of coinsurance into monthly installments under certain circumstances.

[Elijah E. Cummings Lower Drug Costs Now Act; Introduced 04/22/2021] Allow certain enrollees under part D to spread out their coinsurance payments over periodic installments.

Establish pricing requirements for drugs developed with federal support

[A bill to require persons who undertake Federally funded research and development of drugs to enter into reasonable pricing agreements with the Secretary of Health and Human Services.; Introduced 07/31/2017] Require persons who undertake federally funded research and development of drugs to enter into reasonable pricing agreements with the Secretary of Health and Human Services.

Incentivize physician prescribing of lower cost drugs

[Lower Costs, More Cures Act of 2019; Introduced 12/09/2019] Vary payment for certain drugs covered under Medicare Part B to incentivize providers to utilize lower cost drugs.

Include price concessions in point-of-sale (POS) for patients enrolled in Medicare/Medicaid

[Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017; Introduced 03/15/2017] Require PDP sponsors to provide enrollees with the negotiated price for covered drugs at point-of-sale.

[U.S. Budget FY 2019; Introduced 02/12/2018] Require plans to share at the point-of-sale portions of the rebate received from manufacturers.

[Phair Pricing Act of 2019; Introduced 02/07/2019] Amend the Social Security Act to require that pharmacy-negotiated price concessions are factored into the negotiated prices at point-of-sale for Medicare Part D program.

[Creating Transparency to Have Drug Rebates Unlocked (C–THRU) Act of 2019; Introduced 02/13/2019] Require negotiated prices for Part D covered drugs to be provided at point-of-sale.

[Prescription Drug Pricing Reduction Act of 2020; Introduced 07/02/2020] Requires pharmacy negotiated price concessions, payments, and fees to be included in the negotiating price at point-of-sale under Medicare part D.

[Lower Costs, More Cures Act of 2019; Introduced 12/09/2019] Include incentives to provide a share of rebates at the point-of-sale.

Increase beneficiary choices under Medicare

[Keeping Health Insurance Affordable Act of 2019; Introduced 01/03/2019] Amend the Social Security Act to ensure that each Part D eligible individual has a choice of at least three plans in the area in which the individual resides.

Increasing manufacturer rebates to government programs

[Keeping Health Insurance Affordable Act of 2019; Introduced 01/03/2019] Require manufacturers to provide rebates to CMS for drugs administered to low-income patients.

[Prescription Drug Pricing Reduction Act of 2020; Introduced 07/02/2020] Inclusion of discounts to purchasers and individuals in the calculation of average sales price for drugs and biologics included in Medicare Part B, excluding in-kind donations to low income patients.

Lower (out-of-pocket (OOP) costs

[Prescription Drug Affordability Act of 2015; Introduced 09/10/2015] Close the Medicare Part D donut hole for brand and generic drugs by 2017, three years earlier than under current law.

[Improving Access To Affordable Prescription Drugs Act; Introduced 03/29/2017] Close the Medicare Part D prescription coverage gap in 2018, two years earlier than under current law to expedite financial relief for seniors, and require drug manufacturers to pay a larger share of the costs during the coverage gap.

[Improving Access To Affordable Prescription Drugs Act; Introduced 03/29/2017] For plan years beginning in 2019 and later, cap prescription drug cost sharing at $250 per month for individuals and $500 a month for families enrolled in Qualified Health Plans and employer-based plans.

[RxCAP Act of 2019; Introduced 02/13/2019] Prevent catastrophic out-of-pocket spending on prescription drugs for seniors and individuals with disabilities, capping spending at $7,500 for Part D beneficiaries.

[Cancer Drug Parity Act of 2017; Introduced 03/07/2017] Amend the Public Health Service Act to require group and individual health insurance coverage and group health plans to provide for cost sharing for oral anticancer drugs on terms no less favorable than the cost sharing provided for anticancer medications administered by a health care provider.

[U.S. Budget FY 2019; Introduced 02/12/2018] Create a new Part D out-of-pocket spending cap.

[U.S. Budget FY 2019; Introduced 02/12/2018] Create a new Part D out-of-pocket spending cap.

[Capping Prescription Costs Act of 2018; Introduced 07/11/2018] For plan years beginning in 2020, requires that all cost-sharing under a health plan pertaining to prescription drugs will not exceed $250 per month for each enrolled individual or $500 for each family. For plan years after 2020, the limitation will be be increase by an amount equal to the product of that amount and the medical care component of the consumer price index for all urban consumers for that year.

[U.S. Budget FY 2019; Introduced 02/12/2018] Propose to exclude manufacturer discounts in calculation of beneficiary out-of-pocket costs in the coverage gap and establish an out-of-pocket cost maximum in the catastrophic phase. This policy is intended to have plans take more responsibility to negotiate with manufacturers to lower prices for high-cost drugs.

[U.S. Budget FY 2019; Introduced 02/12/2018] Propose to remove cost-sharing for generic drugs for low-income beneficiaries and require plans to apply a majority of the rebates at the point of sale.

[CLAY Act; Introduced 05/15/2019] Amend title XVIII of the Social Security Act to reduce cost-sharing for low-income individuals covered under Medicare Part D.

[Prescription Drug Rebate Reform Act of 2019; Introduced 05/09/2019] Amend the Public Health Service Act to require a group health plan or insurer to set coinsurance for a prescription drug based on the drug's net price instead of the list price.

[The Prescription Drug Pricing Reduction Act (PDPRA) of
2019; Introduced 07/25/2019] Change the structure of the part D benefit to change enrollee cost-sharing in the initial coverage limit and coverage gap, cap enrollee cost sharing above the catastrophic threshold, and change the amount of annual out-of-pocket spending needed to reach catastrophic coverage.

[Elijah E. Cummings Lower Drug Costs Now Act; Introduced 09/19/2019] Cap seniors' out of pocket drug expenses at $2,000 annually.

[Lower Costs, More Cures Act of 2019; Introduced 12/09/2019] Establish a monthly $50 post-deductible cap for insulin and insulin supplies for seniors starting in 2022.

[Lower Costs, More Cures Act of 2019; Introduced 12/09/2019] Restructure Medicare Part D benefit to institute $3,100 annual out-of-pocket cap for beneficiaries and add 10% manufacturer responsibility throughout the benefit.

[Lower Costs, More Cures Act of 2019; Introduced 12/09/2019] Provide a safe harbor for plans without a deductible for insulin by treating such plans as high deductible plans.

[Affordable Insulin for All Act; Introduced 02/04/2020] Amend title XI of the Social Security Act to establish the American Insulin Program to require manufacturers to provide applicable individuals access to Medicaid prices for their insulin drugs. Cap out-of-pocket costs at not more than $10 for each one-month period of coverage for insulin drugs. Include provisions that require pass-through pricing in contracts between the State and a Pharmacy Benefit Manager or managed care entity.

[Lowering Prescription Drug Prices for America’s Seniors and Families Act of 2020; Introduced 03/03/2020] Reduce beneficiary coinsurance under Medicare part D.

[Lowering Prescription Drug Prices for America’s Seniors and Families Act of 2020; Introduced 03/03/2020] Establish a manufacturer discount program where the Secretary of Health and Human Services enters into agreements with manufacturers to provide applicable beneficiaries access to discounted prices for applicable drugs under Medicare part D.

[Part D Senior Savings Model; Introduced 03/26/2020] Cap seniors' insulin costs at $35 a month per type of insulin under Medicare part D.

[Legalizing Drug Discounts for Seniors Act of 2020; Introduced 07/22/2020] Amend the Social Security Act to exclude discounts for covered part D drugs from the anti-kickback prohibition.

[Matt's Act; Introduced 07/29/2021] Limit the price of insulin drugs for participants, beneficiaries, and enrollees enrolled in group or individual health insurance coverage and group health plans as well as uninsured individuals who have diabetes.

[Executive Order on Access to Affordable Life-saving Medications; Introduced 07/24/2020] Improving the financial availability of insulin and injectable epinephrine by allowing the sale of such drugs at FQHC purchase price for eligible individuals.

[Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen; Introduced 07/24/2020] Eliminating rebates to middlemen and passing those price discounts on to patients by creating new safe harbors that allow for patient directed discounts at point of sale.

[Prescription Drug Pricing Reduction Act of 2020; Introduced 07/02/2020] Reduce the part D premium.

[Prescription Drug Pricing Reduction Act of 2020; Introduced 07/02/2020] Establishes a maximum monthly cap on cost-sharing payments under both prescription drug plans and Medicare advantage prescription drug plans.

[Lower Costs, More Cures Act of 2021; Introduced 04/21/2021] Eliminate the part D benefit coverage gap and lower the out-of-pocket threshold to $3,100 beginning in 2022.

[Lower Costs, More Cures Act of 2021; Introduced 04/21/2021] Sunset the current part D manufacturer discount program and establish a new manufacturer discount program where manufacturers are required to provide beneficiaries who have met their deductible with a 10% discount off the negotiated price at point of sale.

[Lower Costs, More Cures Act of 2021; Introduced 04/21/2021] Establish a monthly out-of-pocket cap for insulin products and supplies under a PDP or MA-PD plan.

[Elijah E. Cummings Lower Drug Costs Now Act; Introduced 04/22/2021] Eliminate the part D benefit coverage gap by lowering the out-of-pocket threshold to $2,000 beginning in 2024.

[Elijah E. Cummings Lower Drug Costs Now Act; Introduced 04/22/2021] Sunset the current manufacturer coverage gap discount program and introduce a new manufacturer drug discount program. Require manufacturers to provide a discounted price to applicable beneficiaries of 10% of the part D negotiated price for spending below the $2,000 threshold, and a discounted price of 30% of the negotiated price for spending above the threshold.

Streamline FDA review for drugs that have already been approved in other countries

[Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019; Introduced 07/18/2019] Require the Food and Drug Administration (FDA) to quickly review drug, device, and biologic applications from sponsors who have products approved and sold in developed and trustworthy countries.

[Competition Prescription Act of 2019; Introduced 07/24/2019] Expedite licensing process for biologics that have been authorized or marketed by the European Medicines Agency.

Strengthen payer negotiating power by removing legal barriers

[U.S. Budget FY 2019; Introduced 02/12/2018] Propose a change in Part D formulary standards by requiring a minimum of one drug per class rather than two in order to strengthen Part D plans' negotiating power with drug manufacturers.

[State-Based, Market-Oriented, Prescription Drug Negotiations Act of 2019; Introduced 04/02/2019] Create an exemption in antitrust laws for private health insurers to jointly negotiate wholesale acquisition costs of prescription drugs from manufacturers.

[Competition Prescription Act of 2019; Introduced 07/24/2019] Create exemption in antitrust laws to allow health insurance issuers to jointly negotiate WAC prices of a prescription drug with a manufacturer, so long as no WAC price is jointly determined between insurance issuers.

[Fair Care Act of 2020; Introduced 10/05/2020] Create an antitrust exemption for private health insurers to jointly negotiate WAC prices of prescription drugs.

Utilize international reference pricing

[End Price Gouging for Medications Act; Introduced 06/26/2019] Establish annual reference prices for each prescription drug based on specific reference countries or distinct set of factors if drug pricing information not available in other countries. Require the retail list price for a drug not exceed the corresponding reference price.

Reduce costs for government health programs

Allow the Medicare program to negotiate with manufacturers

[Improving Access To Affordable Prescription Drugs Act; Introduced 03/29/2017] Allow the Secretary of HHS to negotiate with drug companies to lower prescription drug prices, and direct the Secretary to prioritize negotiations on specialty and other high-priced drugs. If, after a year, the Secretary and drug manufacturers fail to successfully negotiate a fair price, the Secretary will use the price that the Department of Veterans Affairs or other federal agencies that purchase prescription drugs use.

[Medicare Fair Drug Pricing Act of 2015; Introduced 12/09/2015] Require the Secretary of HHS to negotiate for the price of drugs covered by Medicare Part D that are either sole source drugs or biologics and are not manufactured by more than two drug manufacturers.

[Medicare Prescription Drug Price Negotiation Act of 2017; Introduced 01/05/2017] Amend part D of title XVIII of the Social Security Act to require the Secretary of Health and Human Services to negotiate covered part D drug prices on behalf of Medicare beneficiaries.

[Prescription Drug Affordability Act of 2015; Introduced 09/10/2015] Instruct the Secretary of HHS to negotiate drug prices under the Medicare Part D prescription drug program.

[Prescription Drug and Health Improvement Act of 2017; Introduced 02/09/2017] Amend title XVIII of the Social Security Act to require the Secretary of Health and Human Services to negotiate lower covered part D drug prices on behalf of Medicare beneficiaries.

[Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017; Introduced 08/01/2017] Allow the Secretary of Health and Human Services to negotiate prescription drug prices under Part D of the Medicare program by striking the subsection of the Social Security Act that prohibits interference by the Secretary in negotiations between manufacturers, pharmacies, and plan sponsors, as well as requirements for a particular formulary or price structure for reimbursing Part D drugs.

[Medicare Drug Price Negotiation Act; Introduced 10/25/2017] Amend Social Security Act to provide for negotiation of lower covered part D drug prices on behalf of Medicare beneficiaries and the establishment and application of a formulary by the Secretary of Health and Human Services under Medicare part D and for other purposes.

[Medicare Fair Drug Pricing Act of 2018; Introduced 07/26/2018] Require the Secretary of HHS to negotiate prices of certain drugs with the manufacturer. In the case that there is a failure to negotiate the price, the Secretary will set the price based on criteria set forth by the bill.

[Medicare Negotiation and Competitive Licensing Act of 2018; Introduced 07/25/2018] Amend the Social Security Act and require the Secretary of HHS to negotiate prices of prescription drugs under Medicare Part D. The Secretary will use clinical and cost effectiveness, budgetary impact, number of similarly effective drugs, associated patient financial burden, unmet patient need for the drug and total global revenue obtained by the manufacturer in order to negotiate such prices.

[Medicare Prescription Drug Savings and Choice Act of 2018; Introduced 07/26/2018] Allow the Secretary to enter into negotiations with pharmaceutical manufacturers to minimize the cost of Part D drugs for eligible individuals who are enroll in the plan.

[Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019; Introduced 01/09/2019] Allow the Secretary of Health and Human Services to negotiate prescription drug prices under Part D of the Medicare program by striking the subsection of the Social Security Act that prohibits interference by the Secretary in negotiations between manufacturers, pharmacies, and plan sponsors, as well as requirements for a particular formulary or price structure for reimbursing Part D drugs.

[Affordable Medications Act; Introduced 09/05/2018] Improve access and affordability by allowing Medicare to negotiate prescription drugs prices, charging drug companies that raise drug prices substantially.

[Medicare Drug Price Negotiation Act; Introduced 01/10/2019] Amend the Social Security Act to allow for the Secretary of HHS to negotiate part D drugs prices and the creation of a formulary for Medicare part D.

[Medicare Negotiation and Competitive Licensing Act of 2019; Introduced 02/07/2019] Amend the Social Security Act to require the Secretary of HHS to negotiate drugs under the Medicare Part D program.

[Medicare Prescription Drug Price Negotiation Act of 2019; Introduced 01/08/2019] Allow CMS to negotiate prices for covered drugs directly with pharmaceutical companies

[Elijah E. Cummings Lower Drug Costs Now Act; Introduced 09/19/2019] Allow Medicare to negotiate prices on 25-250 of the most expensive drugs that do not face market competition per year. Minimum number of drugs negotiated increases to 30 between 2028-2032 and then increases to 35 in 2033. Apply discounts (negotiated by Medicare) to private health plans as well. Enact penalty if manufacturers refuse to participate in negotiations, starting at 65% of gross sales of drug in question.

[Medicare Prescription Drug Savings and Choice Act of 2019; Introduced 10/21/2019] Amend title XVIII of the Social Security Act to allow Medicare to negotiate prescription drug prices under Part D.

[Life-Sustaining Prescription Drug Price Relief Act of 2019; Introduced 11/12/2019] Limit prices of life-sustaining prescription drugs by allowing the Secretary of Health and Human Services to negotiate prices under Medicare Part D. Total payment for a drug may not exceed 110 percent of the average price charged in 5 reference countries.

[Lowering Prescription Drug Prices for America’s Seniors and Families Act of 2020; Introduced 03/03/2020] Allow for the negotiation of prices for certain covered Medicare part D drugs following period of exclusivity. If Secretary is unable to reach an agreement, use Medicaid best price.

[Health Care Improvement Act of 2021; Introduced 02/22/2021] Grant Medicare the authority to negotiate prescription drugs.

[Medicare-X Choice Act of 2021; Introduced 02/23/2021] Grant Medicare the authority to negotiate prescription drugs.

[Medicare Prescription Drug Price Negotiation Act of 2021; Introduced 03/18/2021] Require the Secretary of HHS to negotiate prices for covered drugs under part D.

[Empowering Medicare Seniors to Negotiate Drug Prices Act of 2021; Introduced 03/18/2021] Allow the Secretary of HHS to negotiate fair prescription drug prices under part D.

[Medicare Drug Price Negotiation Act; Introduced 03/23/2021] Grant Medicare the authority to negotiation part D drug prices and establish and apply a formulary by the Secretary of HHS under part D.

[Elijah E. Cummings Lower Drug Costs Now Act; Introduced 09/19/2019] Establish a Fair Price Negotiation Program where the Secretary enters into agreements with the manufacturers of selected drugs to negotiate for lower prices. Negotiated price may not exceed 120% of the price in six other reference countries.

[Keeping Health Insurance Affordable Act of 2019; Introduced 01/03/2019] Allow Medicare to negotiate drug prices with manufacturers.

Alter payment rates

[To amend part B of title XVIII of the Social Security Act to exclude customary prompt pay discounts from manufacturers to wholesalers from the average sales price for drugs and biologicals under Medicare, and for other purposes; Introduced 04/05/2017] Amend part B of title XVIII of the Social Security Act to exclude customary prompt pay discounts from manufacturers to wholesalers from the ASP for drugs and biologicals under Medicare, and for other purposes.

[The Prescription Drug Pricing Reduction Act (PDPRA) of
2019; Introduced 07/25/2019] Narrow the definition of "bona fide service fees," which do not have to be included by manufacturers as a concession when calculating and reporting a drug's ASP. This would effectively expand the fees that manufacturers pay to wholesalers and GPOs that must be treated as price concessions and included in the ASP.

[The Prescription Drug Pricing Reduction Act (PDPRA) of
2019; Introduced 07/25/2019] Remove exception for "grandfathered" off-campus HOPDs, thus establishing PFS payment rate rather than the higher OPPS payment rate. Reduced payments would lower spending and beneficiary cost-sharing.

[The Prescription Drug Pricing Reduction Act (PDPRA) of
2019; Introduced 07/25/2019] Sunset the current coverage gap discount program where manufacturers pay 70% of drug costs and establish a new manufacturer discount program where manufacturers provide discounts for drugs and biologics utilized during catastrophic coverage. Manufacturers that choose to have their drugs covered would enter into agreements with HHS to provide 20% off negotiated prices during catastrophic coverage.

[The Prescription Drug Pricing Reduction Act (PDPRA) of
2019; Introduced 07/25/2019] Require prescription manufacturers to exclude the value of coupons provided to privately insured individuals from each drug's ASP as reported to HHS.

[The Prescription Drug Pricing Reduction Act (PDPRA) of
2019; Introduced 07/25/2019] Require payment to pharmacy benefit manager for administrative services to be limited to a reasonable administrative fee under Medicaid, including under managed care.

[The Prescription Drug Pricing Reduction Act (PDPRA) of
2019; Introduced 07/25/2019] Amend the Social Security Act to provide, at the option of a state, that the term "covered outpatient drug" include any drug, biological product, or insulin as part of a bundled payment if provided on an outpatient basis and in same setting as physicians' services or outpatient hospital services.

[Prescription Drug Pricing Reduction Act of 2020; Introduced 07/02/2020] Establishes that the payment amount for a covered drug administration service be the same and will apply if the drug administration service is provided by an off-campus outpatient department of the provider.

[Lower Costs, More Cures Act of 2019; Introduced 12/09/2019] Require site-neutral payment for the administration of drugs under Medicare Part B at the lower physician fee schedule rate rather than the rate paid to hospitals.

Expand 340B program to cover more drugs

[Closing Loopholes for Orphan Drugs Act; Introduced 06/13/2017] Amend the 340B Drug Pricing Program, which currently requires drug manufacturers to discount orphan drugs (drugs for rare conditions), to expand the discount to orphan drugs not being used to treat rare diseases.

Implement pass-through pricing requirement to plan sponsors associated with government health programs

[Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017; Introduced 03/15/2017] Establish a minimum percent of aggregate amount of rebates, discounts or price concessions that a PBM negotiates that is attributable to patient utilization under the plan to be passed through to the plan sponsor.

[Creating Transparency to Have Drug Rebates Unlocked (C–THRU) Act of 2019; Introduced 02/13/2019] Require PBMs that manage prescription drug coverage under contract with a PDP sponsor or MA organization to pass through to the plan sponsor a minimum percent of the rebates, discounts, or price concessions that the PBM negotiates.

[The Prescription Drug Pricing Reduction Act (PDPRA) of
2019; Introduced 07/25/2019] Amend the Social Security Act to require pass-through pricing to the state for covered outpatient drugs under Medicaid, including under managed care.

[Phair Relief Act of 2019; Introduced 07/24/2019] Require a pharmacy benefit manager (PBM) that manages prescription drug coverage under a contract with a PDP sponsor or MA organization to pass through to the plan sponsor a minimum percent of the aggregate amount of the rebates, discounts, or price concessions the PBM negotiates.

[Drug Price Transparency in Medicaid Act of 2019; Introduced 12/03/2019] In any contract between the State and a PBM, require pass-through pricing for covered outpatient drugs.

[Lower Costs, More Cures Act of 2019; Introduced 12/09/2019] Improve transparency and prevent the use of abusive spread pricing in Medicaid by requiring pass-through pricing and conducting survey of retail prices.

[PBM Transparency in Prescription Drug Costs Act; Introduced 12/04/2019] Require 100% of rebates, fees, and discounts Pharmacy Benefit Managers receive from manufacturers to be passed through to plan sponsor.

[Prescription Drug Pricing Reduction Act of 2020; Introduced 07/02/2020] Require pass-through pricing in contracts between the State and a PBM or managed care entity under Medicaid. 

[Lower Costs, More Cures Act of 2021; Introduced 04/21/2021] Require pass-through pricing under Medicaid.

Incentivize physician prescribing of lower cost drugs

[Lower Costs, More Cures Act of 2021; Introduced 04/21/2021] Vary payments for certain part B drugs based on percentile ranking of per beneficiary allowed charges. Per beneficiary charge equals the total part B payment divided by the number of drug beneficiaries. Higher percentile ranking drugs would have a lower ASP percentage markup. Percentage markup would vary between 4-10%.

Increasing manufacturer rebates to government programs

[Improving Access To Affordable Prescription Drugs Act; Introduced 03/29/2017] Restore prescription drug rebates from manufacturers to Medicare for seniors dually eligible for Medicare and Medicaid and extends these rebates to other Medicare patients in Medicare low-income subsidy (LIS) plans.

[Medicare Drug Savings Act of 2015; Introduced 04/23/2015] Require drug makers to provide Medicare the same rebates as Medicaid for low-income individuals.

[Medicare Drug Savings Act of 2017; Introduced 02/01/2017] Amend title XVIII of the Social Security Act to require drug manufacturers to provide rebates for drugs dispensed to low-income individuals under the Medicare prescription drug benefit program.

[Prescription Drug Affordability Act of 2015; Introduced 09/10/2015] Restore minimum rebate on drugs covered under Medicare Part D for low income Medicare beneficiaries, previously eliminated in the creation of Part D.

[To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs.; Introduced 01/03/2019] Sunset the limit on the maximum rebate amount under Medicaid.

[The Prescription Drug Pricing Reduction Act (PDPRA) of
2019; Introduced 07/25/2019] Amend the Social Security Act to exclude authorized generics from AMP calculation for purposes of the Medicaid drug rebate program. Amend statutory definition of wholesaler to exclude COD manufacturers.

[The Prescription Drug Pricing Reduction Act (PDPRA) of
2019; Introduced 07/25/2019] Revise the Social Security Act to increase maximum allowable Medicaid rebate permissible in a rebate period from 100% of a covered outpatient drug's AMP to 125% starting fiscal year 2022.

[Continuing Appropriations Act, 2020, and Health Extenders Act of 2019; Introduced 09/18/2019] Amend the Social Security Act to exclude authorized generics from AMP calculations for Medicaid Drug Rebate purposes.

[Lower Costs, More Cures Act of 2019; Introduced 12/09/2019] Sunset the limit on the maximum rebate amounts for single source and innovator multiple source drugs.

[Prescription Drug Pricing Reduction Act of 2020; Introduced 07/02/2020] Apply Medicaid drug rebate requirements to drugs provided as a part of outpatient hospital services. 

[Prescription Drug Pricing Reduction Act of 2020; Introduced 07/02/2020] Sunset limit on maximum rebate amount for single source drugs and innovator multiple source drugs under Medicaid.

[Prescription Drug Pricing Reduction Act of 2020; Introduced 07/02/2020] Exclude authorized generics from the calculation of AMP under the Medicaid Drug Rebate Program.

[Fair Drug Prices for Kids Act; Introduced 10/06/2020] Apply requirements of Medicaid Drug Rebate Program to cover outpatient, Part D drugs under CHIP.

[Lower Costs, More Cures Act of 2021, Introduced 04/21/2021] Apply Medicaid drug rebate requirements to drugs provided as part of outpatient hospital services.

[Medicare Drug Price Negotiation Act; Introduced 03/23/2021] Require manufacturers to provide rebates for drugs dispensed to low-income individuals.

Limiting add-on payments to providers

[U.S. Budget FY 2019; Introduced 02/12/2018] Reduce WAC-based payment amounts (to providers for new drugs during the initial period) if ASP is unavailable.

[Sustaining Excellence in Medicaid Act of 2019; Introduced 06/13/2019] Amend the Medicaid Program to reduce the WAC add-on payment for new drugs or biologics from 6% to 3% when ASP is unavailable.

[The Prescription Drug Pricing Reduction Act (PDPRA) of
2019; Introduced 07/05/2019] Establish a WAC add-on payment no greater than 3% when ASP is unavailable for new drugs.

[The Prescription Drug Pricing Reduction Act (PDPRA) of
2019; Introduced 07/05/2019] Establish payment rate for initial period that is the lesser of the biosimilar's WAC plus 3% or ASP plus 6% of the reference biological product's ASP.

[The Prescription Drug Pricing Reduction Act (PDPRA) of
2019; Introduced 07/05/2019] Establish $1,000 as maximum add-on amount that a provider can be paid for a drug.

[Lower Costs, More Cures Act of 2019; Introduced 12/19/2019] Create maximum add-on payments for certain drugs and biologicals ($1,000 for most drugs and $2,000 for certain immunotherapies) to reduce out-of-pocket costs.

[Prescription Drug Pricing Reduction Act of 2020; Introduced 07/02/2020] Limit the add-on payment amount to providers and hospitals for biosimilars during the initial period.

[Prescription Drug Pricing Reduction Act of 2020; Introduced 07/02/2020] Establishment of add on payment maximums from drugs and biologics beginning on January 1, 2022.

[Lower Costs, More Cures Act of 2021; Introduced 04/21/2021] Establish a maximum add-on payment for drugs and biologics.

Require rebates for amount of drug discarded for medicines packaged in single-dose vials

[REFUND Act of 2019; Introduced 02/25/2019] Require manufacturers of certain single-dose vial drugs covered under Medicare Part B to provide rebates with respect to amounts of drug discarded.

[The Prescription Drug Pricing Reduction Act (PDPRA) of
2019; Introduced 07/25/2019] Require manufacturer to refund the amount of payment made to providers for unused amounts of certain single-use vials under Medicare Part B.

[Lower Costs, More Cures Act of 2019; Introduced 12/09/2019] Require manufacturers of certain single-dose containers or single-use package drugs under Medicare Part B to provide refunds with respect to discarded amounts of these drugs.

[Prescription Drug Pricing Reduction Act of 2020; Introduced 07/02/2020] Requires that manufacturers of drugs under Medicare Part B that have single dose packaging provide refunds for the amount of the drug that is discarded.

[Lower Costs, More Cures Act of 2021, Introduced 04/21/2021] Require manufacturers of certain single-dose container or single-use package drugs under part B to provide refunds for amounts of discarded drugs.

Share risk between payers and manufacturers

[The Prescription Drug Pricing Reduction Act (PDPRA) of
2019; Introduced 07/25/2019] Allow states to pay for certain covered outpatient drugs in the Medicaid Drug Rebate Program through risk-sharing, value-based agreements. Enable states to use this for covered outpatient drugs that are potentially curative treatments.

[Lower Costs, More Cures Act of 2019; Introduced 12/09/2019] Add an option for states to pay for certain covered outpatient drugs through risk-sharing value-based agreements beginning January 1, 2022.

[GENE Therapy Payment Act; Introduced 02/12/2020] Provide States with the option to pay for certain covered outpatient drugs under Medicaid by entering into risk-sharing value-based agreements with manufacturers.

[Prescription Drug Pricing Reduction Act of 2020; Introduced 07/02/2020] Provide states with the option to pay for covered outpatient drugs that are potentially curative treatments intended for one-time use to enter into risk-sharing value-based agreements with drug manufacturers. 

[Lower Costs, More Cures Act of 2021; Introduced 04/21/2021] Allow the option for states to pay for risk-sharing value-based payment agreements for covered outpatient drugs under Medicaid.

Utilize international reference pricing

[Low Drug Prices Act; Introduced 11/29/2018] Require the Secretary of HHS to create annual reference prices for prescription drugs for Federal health programs. The annual reference prices will be determined by the median price for the same drug in reference countries.

[Elijah E. Cummings Lower Drug Costs Now Act; Introduced 09/19/2019] Enact international pricing index by capping U.S. drug payments for Medicare at an average of foreign prices. Negotiated prices cannot be above 120% of drug costs in six foreign markets.

[Life-Sustaining Prescription Drug Price Relief Act of 2019; Introduced 11/12/2019] Limit prices of life-sustaining prescription drugs by allowing the Secretary of Health and Human Services to negotiate prices under Medicare Part D. Total payment for a drug may not exceed 110 percent of the average price charged in 5 reference countries.

[Prescription Drug Price Relief Act of 2021; Introduced 03/23/2021] End government-granted monopolies for manufacturers that charge drug prices higher than the median prices for drugs in other countries.

[End Price Gouging for Medications Act; Introduced 04/22/2021] Require the Secretary of HHS to establish reference prices for drugs under Federal health programs.

[Elijah E. Cummings Lower Drug Costs Now Act; Introduced 04/22/2021] Establish a Fair Price Negotiation Program where the Secretary enters into agreements with the manufacturers of selected drugs to negotiate for lower prices. Negotiated price may not exceed 120% of the price in six other reference countries.