Policy Tracker

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

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340B Purchasing

Improve targeting of 340B

[U.S. Budget FY 2019; Introduced 2/2018] 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.

[U.S. Budget FY 2019; Introduced 2/2018] Require hospitals to provide information for drug acquisition costs of 340B drugs along with information on the hospital's revenues received for such drugs.

Importation / Reimportation

Enable reimportation (made in USA) or importation (made overseas)

[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.

[Improving Access To Affordable Prescription Drugs Act; Introduced 03/29/2017] Allow individuals, pharmacists, and wholesalers to import prescription drugs from licensed Canadian pharmacies.

[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. FDA-certified foreign sellers must comply with criteria including requiring a valid prescription for sale to individuals and a requirement to transmit product tracing and transaction history information to U.S. importers. The Secretary and GAO must report on the implementation of the Act.

[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.

[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.

[Safe Importation Act Plan; Introduced 7/2019] 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.

[Executive Order on Increasing Drug Importation to Lower Prices for American Patients; Introduced 7/24/2020] 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.

[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.

[Securing America’s Medical Supply Chain and Advancing the Production of Life Saving Medicines Act; Introduced 06/11/2020] Establishment of a Chief Pharmaceutical and Medical Supply Chain Negotiator in the Office of the United States Trade Representative. The position's responsibilities include conducting trade negotiations and enforcing trade agreements to ensure that the United States is appropriately rewarded for its pharmaceutical innovation and to ensure that the United States medical supply chain does not rely on foreign governments.

Unbranded Competition

Develop reciprocity

[Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2015; Introduced 12/10/2015] 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.

Remove barriers and create incentives for generic entry

[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.

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

[Fair Access for Safe and Timely 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.

[Price Relief, Innovation, and Competition for Essential Drugs 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.

[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.

[Short on Competition Act; Introduced 01/20/2017] Allow for the expedited approval of generic prescription drugs and temporary importation of prescription drugs in the case of noncompetitive drug markets and drug shortages.

[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.

[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.

[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.

[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 2/2018] 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.

[Price Relief, Innovation, and Competition for Essential Drugs 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.

[American Patients First; Introduced 5/2018] 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.

[Price Relief, Innovation, and Competition for Essential Drugs Act; Introduced 06/23/2016] Amend the Public Health Service Act to shorten the exclusivity period for brand name biological products from 12 years to 5 years.

[Prescription Drug Pricing Reduction Act of 2019; Introduced 07/25/2019] Increase add-on payment for a biosimilar under Medicare Part B from 6% of the reference product's ASP to 8% for a period of five years.

[Bolstering Innovative Options to Save Immediately on Medicines 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.

Modify IP environment

[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 (Prescription Drug Affordability Act).

[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. 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. Reduce the biological product exclusivity from 12 years to 7 years. Direct GAO to conduct a study on orphan drug development, awarding of exclusivities, and revenues generated from orphan drugs.

[Fair And Immediate Release of Generic Drugs Act; Introduced 01/08/2015] Disqualify from being a "first applicant" (which grants 180 days of market exclusivity) any applicant that has entered into a "pay-for-delay" agreement.

[Fair And Immediate Release of Generic Drugs Act; Introduced 01/08/2015] Prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market.

[Innovation Act; Introduced 02/05/2015] Direct courts to apply additional legal requirements as part of the patent infringement process.

[U.S. Budget FY 2019; Introduced 2/2018] 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.

[Prescription Drug Pricing Reduction Act of 2020; Introduced 07/02/2020] Limiting the payable amount for biosimilars during the initial period.

Bolster supply of drugs at risk of shortage

[Improving Access To Affordable Prescription Drugs Act; Introduced 03/29/2017] Require the HHS Secretary to maintain a public, up-to date list of generic drugs and their manufacturers (including distributors, labelers, and compounders) to more quickly identify drugs at risk of shortage or drugs with a limited number of competitors.

[Increasing Competition in Pharmaceuticals Act; Introduced 03/01/2016] 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.

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

Ensure access to samples for generic development

[Fair Access for Safe and Timely 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.

[Creating and Restoring Equal Access to Equivalent Samples Act of 2018; Introduced 04/27/2017] Allow the sponsor of an ANDA, a 505(b)(2) NDA, or a biosimilar application to bring an action in federal court to obtain from the brand-name sponsor of a drug or biological product subject to restricted distribution (and that is not in shortage) - either under an ETASU REMS or under a self-imposed restricted distribution system - the sample it needs to conduct testing to seek approval of a generic drug or biosimilar biological product.

Encourage uptake of generics and biosimilars

[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.

Prevent single-source generic monopolies

[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.

Branded monopolies

Encourage branded competition

[Prescription Drug Affordability Act of 2015; Introduced 09/10/2015] Terminate any period of exclusivity granted to a person convicted of, or settling for, fraud or violation including off-label promotion, kickbacks, or anti-competitive practices.

Out of Pocket Costs

Lower out of pocket costs

[U.S. Budget FY 2019; Introduced 2/2018] Eliminate cost-sharing for generic drugs for beneficiaries who receive low-income subsidy.

[U.S. Budget FY 2019; Introduced 2/2018] 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 2/2018] 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.

[Phair Relief Act of 2019; Introduced 7/24/2019] 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. Help to ensure patients receive the maximum benefit of the discounts or concessions negotiated.

[Executive Order on Access to Affordable Life-saving Medications; Introduced 7/24/2020] Improving the financial availability of insulin and injectable epinephrine by allowing the sale of such drugs at FQHC purchase price for eligible individuals.

[Lowering Prescription Drug Prices for America's Seniors and Families Act of 2020; Introduced 3/3/2020] Reduce beneficiary coinsurance under Medicare part D.

[Lowering Prescription Drug Prices for America's Seniors and Families Act of 2020; Introduced 3/3/2020] 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.

Cap out of pocket costs

[Reducing Existing Costs Associated with Pharmaceuticals for Seniors (Rx CAP) Act; Introduced 4/27/2016] Prevent catastrophic out-of-pocket spending on prescription drugs for seniors and individuals with disabilities, capping spending at $7,500 for Part D beneficiaries.

[Improving Access to Affordable Prescription Drugs Act; Introduced 3/29/2017] 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.

[Capping Prescription Costs Act of 2018; Introduced 7/11/2018] 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.

[H.R.3 - Elijah E. Cummings Lower Drug Costs Now Act; Introduced in 9/19/2019] Cap seniors' out of pocket drug expenses at $2,000 annually.

[H.R.3 - Elijah E. Cummings Lower Drug Costs Now Act; Introduced 9/19/2019] Reduce beneficiary coinsurance under Medicare part D.

[Lowering Prescription Drug Prices for America's Seniors and Families Act of 2020; Introduced 3/3/2020] 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 3/26/2020] Cap seniors' insulin costs at $35 a month per type of insulin under Medicare part D.

[Prescription Drug Pricing Reduction Act of 2020; Introduced 7/2/2020] Establishment of add-on payment maximums from drugs and biologics beginning on January 1, 2022.

[Prescription Drug Pricing Reduction Act of 2020; Introduced 7/2/2020] Establishes a maximum monthly cap on cost-sharing payments under both prescription drug plans and Medicare advantage prescription drug plans.

[Matt's Act; Introduced 7/22/2020] 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.

Close Medicare Part D coverage gap

[Improving Access to Affordable Prescription Drugs Act; Introduced 3/29/2017] 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.

[Prescription Drug Affordability Act of 2015; Introduced 9/10/2015] Close the Medicare Part D donut hole for brand and generic drugs by 2017, three years earlier than under current law.

Establish medical-pharmacy cost parity

[Cancer Drug Parity Act of 2017; Introduced 3/17/2017] 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.

Share POS rebates

[C-THRU Act of 2017; Introduced 3/15/2017] Provide negotiated prices for covered Part D drugs, including all negotiations, at the point-of-sale of the covered Part D drug.

[Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen; Introduced 7/24/2020] 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 7/2/2020] Requires pharmacy negotiated price concessions, payments, and fees to be included in the negotiating price at point-of-sale under Medicare part D.

[Phair Pricing Act of 2019; Introduced 2/7/2019] Amend the Social Security Act to require that pharmacy-negotiated price concessions are factored into the negotiated prices at point-of-sale under Medicare part D.

DTC advertising

Ban DTC advertising

[Responsibility in Drug Advertising Act; Introduced 2/19/2016] Amend the Federal Food, Drug, and Cosmetic Act to restrict direct-to-consumer drug advertising.

Eliminate tax incentives for DTC advertising

[Protecting Americans from Drug Marketing Act; Introduced 3/3/2016] Amend the Internal Revenue Code to deny a tax deduction for the cost of direct-to-consumer advertising of prescription drugs.

Enable oversight of DTC advertising

[Drug-Price Transparency in Communications Act; Introduced 7/26/2018] Require drug manufacturers to include prescription drug prices on any DTC advertising and any marketing to practitioners of a drug.

Transparency

Price and input transparency

[Improving Access to Affordable Prescription Drugs Act; Introduced 3/29/2017] 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.

[Prescription Drug Affordability Act of 2015; Introduced 9/10/2015] 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.

[Prescription Drug Affordability Act of 2015; Introduced 9/10/2015] 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.

[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 1/16/2018] 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.

[Medication Automated Quotation System, or MEDAQ, Act of 2018; Introduced 7/26/2018] Direct the Comptroller General of the United States to study the feasibility of creating and maintaining a searchable system that tracks the prescription drug prices in the United States. Data include the acquisition price per unit that any purchaser pays for a prescription drug and the effect that other entities, such as PBMS, have on prices.

[American Patients First; Introduced 5/2018] Require Part D sponsors to supplement the current Explanation of Benefits provided to members with further information on drug price increases and lower-cost alternatives.

[American Patients First; Introduced 5/2018] Forbid Part D plan contracts from issuing gag clauses that prevents pharmacists from informing patients when it costs less to pay out-of-pocket by not using insurance.

[More Efficient Tools to Realize Information for Consumers Act; Introduced 4/12/2019] 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.

[Prescription Drug STAR Act; Introduced 4/8/2019] 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.

[Prescription Drug Pricing Reduction Act of 2019; Introduced 9/25/2019] 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 biologics as measured by wholesale acquisition cost (WAC) or changes in WAC that exceed certain thresholds.

[Transparency and Accountability in Health Care Costs and Prices Act of 2020; Introduced 2/27/2020] 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 7/2/2020] Improvement of manufacturer reporting of ASP in order to set more accurate payment rates.

[Prescription Drug Pricing Reduction Act of 2020; Introduced 7/2/2020] 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.

[Transparency and Accountability in Health Care Costs and Prices Act of 2020; Introduced 2/27/2020] 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 7/2/2020] Improvement of manufacturer reporting of ASP in order to set more accurate payment rates.

Post-approval transparency

[Prescription Drug Pricing Reduction Act of 2020; Introduced 7/2/2020] Require the disclosure of pharmacy price concessions for covered part D drugs.

Encourage transparency to allow informed policy choices

[Fair Accountability and Innovative Research Drug Pricing Act of 2017; Introduced 5/16/2017] 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.

[Improving Access To Affordable Prescription Drugs Act; Introduced 3/29/2017] 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.

[Prescription Drug Price Transparency Act; Introduced 3/2/2017] Establish standards for pharmacy benefits managers under the Medicare prescription drug program and Medicare Advantage program to further transparency of payment methodologies to pharmacies, and for other purposes.

[Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017; Introduced 3/15/2017] 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.

[Prescription Drug and Medical Device Price Review Board Act of 2018; Introduced 5/9/2018] 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.

[More Efficient Tools to Realize Information for Consumers Act; Introduced 4/12/2019] Require the FTC to generate a report that studies pharmaceutical supply chain intermediaries and merger activity. Report should include legislative recommendations to improve transparency and competition, deter anticompetitive behavior, and ensure consumers benefit from mergers and consolidations.

[More Efficient Tools to Realize Information for Consumers Act; Introduced 4/12/2019] Require prescription drug marketing sample information reported by manufacturers to be available to oversight agencies, researchers, and payers.

[Prescription Drug Pricing Reduction Act of 2019; 7/25/2019] Require HHS to publicly report information on aggregate price concessions, difference between what insurer pays pharmacy benefit manager (PBM) and what PBM pays pharmacies, and number of prescriptions dispensed.

[Phair Relief Act of 2019; Introduced 7/24/2019] Amend titles XI and XVIII of the Social Security Act to make pharmacy benefit managers' ability to negotiate rebates, discounts, and price concessions as well as their amounts publicly available through the HHS website.

[Prescription Drug Pricing Reduction Act of 2020; Introduced 7/2/2020] Increases the Medicare Payment Advisory Commissions and Medicaid and CHIP Payment and Access Commissions access to certain rebate and payment data.

Educate consumers

[Know the Lowest Price Act of 2018; Introduced 3/14/2018] 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.

[More Efficient Tools to Realize Information for Consumers Act; Introduced 4/12/2019] 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.

[More Efficient Tools to Realize Information for Consumers Act; Introduced 4/12/2019] Express sense of Congress that commercially available drug pricing comparison platforms should be made available to help patients find the lowest price for their medications at their local pharmacy.

[Prescription Drug Pricing Reduction Act of 2020; Introduced 7/2/2020] Increase the availability of PBM provisions and drug discounts to the public.

[Prescription Drug Pricing Reduction Act of 2020; Introduced 7/2/2020] Require that the results of remuneration reports be disclosed to the public online for all prescription drug plans.

[Prescription Drug Pricing Reduction Act of 2020; Introduced 7/2/2020] Increase 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 7/2/2020] Increase the availability of PBM provisions and drug discounts to the public.

[Prescription Drug Pricing Reduction Act of 2020; Introduced 7/2/2020] Require that the results of remuneration reports be disclosed to the public online for all prescription drug plans.

Post-approval monitoring

[Prescription Drug Pricing Reduction Act of 2020; Introduced 7/2/2020] Require drug manufacturer price transparency for drugs with a large price increase, high spending, or high launch price (for new drugs).

[Matt’s Act; Introduced 7/22/2020] 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 7/2/2020] Establish audits of PBM managers and data.

[Prescription Drug Pricing Reduction Act of 2020; Introduced 7/2/2020] Require drug manufacturer price transparency for drugs with a large price increase, high spending, or high launch price (for new drugs).

[Matt’s Act; Introduced 7/22/2020] Require manufacturers of insulin drugs to publish the average net price of each insulin product on a quarterly basis.

Evidence-based decision-making

Leverage comparative evidence and cost

[Promising Pathway Act; Introduced 6/3/2020] 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.

Inform clinical choice

[More Efficient Tools to Realize Information for Consumers Act; Introduced 4/12/2019] 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.

[Prescription Drug Pricing Reduction Act of 2020; Introduced 7/2/2020] Improve claims data that is provided to prescription drug plans to encourage appropriate use of medications and improve health outcomes.

[Promising Pathway Act; Introduced 6/3/2020] 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.

[Prescription Drug Pricing Reduction Act of 2020; Introduced 7/2/2020] Improving claims data that is provided to prescription drug plans to encourage appropriate use of medications and improve health outcomes.

Value-based payment

Enable value-based insurance design

[A Better Way: Our Vision for a Confident America; Introduced 6/22/2016] Allow for value-based insurance design throughout Medicare Advantage.

Develop pathways for value-based payment

[[U.S. Budget FY 2018; Introduced 5/23/2017] Clarify treatment of Value Based Purchasing initiatives.

[American Patients First; Introduced 5/2018] Direct Centers for Medicare & Medicaid Services (CMS) to develop demonstration projects to test innovative ways to encourage value-based care and lower drug prices.

[Prescription Drug Pricing Reduction Act of 2019; Introduced 7/25/2019] Amend the Social Security Act to 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.

[Prescription Drug Pricing Reduction Act of 2020; Introduced 7/2/2020] 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. 

Price Inflation Limiters

Implement inflation cap

[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.

[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.

[Stop Price Gouging Act; Introduced 06/15/2017] Establish an excise tax on certain prescription drugs which have been subject to a price spike.

[U.S. Budget FY 2019; Introduced 2/2018] Propose an inflation limit for reimbursement of Medicare Part B drugs, a reduction in WAC-based payment if Average Sales Price (ASP) is unavailable and have manufacturers better report Average Sales Prices for accurate payment rates.

[Combatting Unreasonable Rises and Excessively High Drug Prices Act; Introduced 08/02/2019] Prohibit the gouging of drug prices by setting limits on drug price increases within a certain time period. Allow the Secretary of Health and Human Services to notify a manufacturer of its potential price gouging and require a justification of the price increase. Grant the Secretary the power to restore any excessive amount paid from the price increase to the consumer or the payer.

[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.

[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.

Establish price review board

[Prescription Drug and Medical Device Price Review Board Act of 2016; Introduced 12/08/2016] 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.

Government as Purchaser

Allow Medicare Part D negotiation

[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.

[Fair Accountability and Innovative Research Drug Pricing Act of 2017; Introduced 05/16/2017] 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.

[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.

[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.

[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.

[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 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 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.

[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.

[American Patients First; Introduced 5/2018] Allow plans the full flexibility to manage high cost drugs that do not provide rebates to Part D plans, including protected classes.

[U.S. Budget FY 2019; Introduced 2/2018] 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.

[Keeping Health Insurance Affordable Act of 2019; Introduced 01/03/2019] Allow negotiation of Medicare Part D drugs.

[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 then 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.

[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.

Improve government purchasing power

[Improving Access To Affordable Prescription Drugs Act; Introduced 03/29/2017] Authorize the federal government to enter into purchase contracts with generic drug manufacturers if the number of manufacturers for essential medicines, as defined by the World Health Organization or another similar entity, falls below two.

[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.

[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.

[Sustaining Excellence in Medicaid Act of 2019; Introduced 06/13/2019] Amend the Medicaid Program under title XIX of the Social Security Act to not allow the payable amount for a drug or biological product to exceed 103% of WAC.

[The Prescription Drug Pricing Reduction Act of 2019; Introduced 07/25/2019] Establish WAC add-on payment no greater than 3% when ASP is unavailable for new drugs.

[The Prescription Drug Pricing Reduction Act of 2019; Introduced 07/25/2019] 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 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 of 2019; Introduced 07/25/2019] Establish $1,000 as the maximum add-on amount that a provider can be paid for a drug.

[The Prescription Drug Pricing Reduction Act 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 the rate of inflation.

[The Prescription Drug Pricing Reduction Act of 2019; Introduced 07/25/2019] Amend the Social Security Act to require pass-through pricing for covered outpatient drugs in Medicaid, including under managed care. Require payment to pharmacy benefit manager for administrative services to be limited to a reasonable administrative fee. Require HHS Secretary to conduct a survey of retail drug prices to include national average drug acquisition cost. Require Secretary to report to Congress on specialty drug coverage and reimbursement under State Medicaid programs.

[Elijah E. Cummings Lower Drug Costs Now Act; Introduced 09/19/2019] Enact inflation rebate if a drug manufacturer has raised the price of a drug in Medicare Part B or D above rate of inflation since 2016.

Allow Medicaid formulary exclusion

[U.S. Budget FY 2019; Introduced 2/2018] Test Medicaid drug coverage and financing reforms to that take on private sector best practices, such as State determination of drug formularies.

[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.

Allow Medicaid to exclude drugs based on effectiveness. Health plans should have the ability to manage their own formularies.

ASP based reimbursement

[Prescription Drug Pricing Reduction Act 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.

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

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

Create reference prices for prescription drugs

[End Price Gouging for Medications Act; Introduced 06/26/2019] Establish annual reference prices for prescription drugs under Federal health programs 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.

[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.

Reinforce governmental price protections

[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.

[Medication Access Improves Lives Act; Introduced 04/17/2020] Increase in the Federal Medical Assistance Program for Medicaid by 1 percentage point in states that provide coverage for certain covered outpatient drugs. Additionally, those states must provide prescription fills or refills for up to a 90 day supply.

[Prescription Drug Pricing Reduction Act of 2020; Introduced 07/02/2020] In the event that a drug or biologic is placed on the drug shortage list, the Secretary is authorized to use the Wholesale Acquisition Cost for quarterly pricing until the number of drug manufacturers is sufficient and the drug or biologic is removed from the drug shortage list.

Wasteful Packaging

Packaging and vial sizes

[Prescription Drug Pricing Reduction Act of 2019; Introduced 07/25/2019] Require manufacturers to refund the amount of payment made to providers for unused amounts of certain single-use vials that exceed a minimum threshold.

[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.

[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.

Access to Treatment

Leverage federal action

[Make Medications Affordable by Preventing Pandemic Price gouging Act of 2020; Introduced 06/22/2020] Establishment of requirements for Covid-19 drugs that are developed with federal support in order to improve affordability and accessibility. This would be implemented through requirements for open-nonexclusive licensing, reasonable pricing, and reporting of manufacturer expenses. Establishment of pricing requirements for current treatments and vaccines during a Public Health Emergency.

Limit influence of international trade agreements on drug prices

[Prescription Drug Affordability Act of 2015; Introduced 09/10/2015] Direct the United States Trade Representative to reject provisions in trade agreements that would raise drug prices in the U.S., extend periods of patent exclusivity, or remove flexibilities in U.S. law regarding drug pricing.

Rebates

Increase Medicare and Medicaid rebates

[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.

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

[Prescription Drug Pricing Reduction Act 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.

[Prescription Drug Pricing Reduction Act 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.

Limit rebate amount on drug categories

[Prescription Drug Pricing Reduction Act of 2020; Introduced 07/02/2020] Modify the maximum rebate amount for drugs administered under the Medicaid Drug Rebate Program.