Policy Tracker

The DPL Policy Tracker keeps tabs on federal policy proposals that address US drug pricing issues. To begin, select filter options. For a complete archive and continued updated to the tracker, please see the Methods/FAQ.

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Accountability and Oversight

Allow government to regulate/require disclosure of patient assistance

[Reduced Costs and Continued Cures Act of 2021; Introduced 09/10/2021] Require the inclusion of manufacturer cost-sharing coupons in the determination of Average Sales Price for drugs and biologics reimbursed under Medicare Part B.

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

[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.

[PROTECT 340B Act of 2021; Introduced 07/09/2021] Ensure that entities covered by the 340B drug discount program are using the discount to properly benefit low income patients.

[Vital Medication Affordability Act; Introduced 09/23/2021] Require centers that participates in the 340B program to establish written practices to make insulin and injectable epinephrine available to low-income patients at or below the discounted 340B price paid by the center.

[Drug Price Transparency and Accountability Act; Introduced 09/30/2021] Enhance of reporting and transparency requirements for the 340B Drug Pricing Program.

Ensure biosimilars cannot be paid more than their reference biologic product

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

[Reduced Costs and Continued Cures Act of 2021; Introduced 09/10/2021] Require Medicare payment for biosimilar products during the initial period be equal to or less than the price of the reference biologic product.

Establish evidence based measures of quality

[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.

[Reduced Costs and Continued Cures Act of 2021; Introduced 09/10/2021] Establish pharmacy quality measures under Medicare Part D.

Health Plan Transparency

[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.

[Pharmacy DIR Reform to Reduce Senior Drug Costs Act; Introduced 05/25/2021] Require prescription drug plans to report price concessions or incentive payments that are made after payment for covered drugs at the point of sale, including by contracted intermediaries, to the pharmacy at least annually.

[Reduced Costs and Continued Cures Act of 2021; Introduced 09/10/2021] Require prescription drug plans and Medicare Advantage prescription drug plans to report potential fraud, waste, and abuse to HHS.

Manufacturer Transparency

[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.

[Affordable Medications Act; Introduced 05/27/2021] Require drug manufacturers to submit an annual report with data on approved drugs with respect to the previous calendar year, including the wholesale acquisition cost, net average price realized by pharmacy benefit managers, and net price of the drug charged to purchasers.

[Affordable Medications Act; Introduced 05/27/2021] Require pharmaceutical companies to submit pricing and sales information to the Inspector General on a quarterly basis to identify prescription drug price hikes.

[Affordable Medications Act; Introduced 05/27/2021] Require drug manufacturers to disclose the wholesale acquisition cost for a 30-day supply of the drug whenever a manufacturer communicates with a health care practitioner about a drug they manufacture.

[SPIKE Act; Introduced 07/13/2021] Require CMS to determine at least annually whether certain covered drugs under Medicare were subject to a price increase that exceeded specified thresholds. Drug manufacturers must submit justifications for such price increases to the CMS, subject to civil penalties.

[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.

[Medicare Negotiation and Competitive Licensing Act of 2021; Introduced 07/29/2021] Require pharmaceutical companies to submit pricing and sales information to the Inspector General on a quarterly basis.

[Reduced Cost and Continued Cures Act of 2021; Introduced 09/10/2021] Require drug manufacturers to submit justification for drug prices if the drug has a larger increase in price, high spending under Medicare and Medicaid, or a high launch price.

[Reduced Cost and Continued Cures Act of 2021; Introduced 09/10/2021] Require audits of drug pricing and product information reported to the Medicaid Drug Rebate Program by drug manufacturers.

PBM Transparency

[Improving Transparency to Lower Drug Costs Act of 2021; Introduced 06/01/2021] Require CMS to publish certain payment information regarding pharmacy benefit managers (PBMs) and prescription drugs, including generic dispensing rates, drug discounts and rebates, and payments between PBMs, health plans, and pharmacies.

[Reduced Costs and Continued Cures Act of 2021; Introduce 09/10/2021] Require HHS to publicly report on PBMs' ability to negotiate rebates, discounts, and price concessions and the amount of these rebates, discounts, and price concessions that are passed on to plan sponsors.

[Reduced Costs and Continued Cures Act of 2021; Introduce 09/10/2021] Expand PBM transparency requirements including, but not limited to, the reporting of bona fide service fees that PBMs receive from PDP sponsors, health benefit plans, managed care entities, and drug manufacturers.

[Reduced Costs and Continued Cures Act of 2021; Introduce 09/10/2021] Prohibit contracts between health plans and PBMs unless PBMs submit periodic quality reports to health plan sponsors. Reports include, but are not limited to, information on the dispensing of covered drugs, total gross drug spending, and the amount received from drug manufacturers.

Foster Competition

Incentivize generic and biosimilar entry

[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).

[BLOCKING Act of 2021; Introduced 04/26/2021] Authorize the FDA to approve a subsequent generic drug application prior to a first applicant's first date of commercial marketing if (1) the subsequent application is ready for full approval, (2) a first applicant's application has been pending for at least 30 months, and (3) the approval of a first applicant's application is not precluded by patent infringement claims asserted against that first applicant.

[STOP GAMES Act of 2021; Introduced 04/26/2021] Clarify the process for denying certain petitions whose primary purpose is to delay the approval of an pending new or generic drug application. If the FDA finds that delay is the primary purpose of the petition, it must refer the matter to the Federal Trade Commission.

[Protecting Access to Affordable Medicines Act of 2021; Introduced 04/28/2021] Limit additional rebates for non-innovator multiple-source drugs (i.e., generics) in the Medicaid program when the average manufacturer price is less than $1 to exempt low-cost generic drugs from inflation penalties under the 2015 Bipartisan Budget Act.

[Simplifying the Generic Drug Application Process Act; Introduced 04/29/2021] Remove requirement for a generic drug maker to petition the FDA before seeking market approval for a generic drug that has a different dosage or strength form than an already-approved drug.

[Affordable Medications Act; Introduced 05/27/2021] Modify Bipartisan Congressional Trade Priorities and Accountability Act of 2015 to ensure trade agreements do not require a party to provide biological product exclusivity of more than 7 years.

[Affordable Medications Act; Introduced 05/27/2021] Includes a 180-day exclusivity period for the generic applicants with first application status.

[Expanding Access to Affordable Prescription Drugs and Medical Devices Act; Introduced 06/24/2021] Allow the Secretary to provide cooperative agreements and low interest revolving loans to nonprofit generic and essential medicines and device manufacturers.

Incentivize use of biosimilars and generics

[BIOSIM Act; Introduced 04/22/2021] Provide a 5-year payment increase under the Medicare Part B program for biosimilar biological products for which the average sales price and wholesale acquisition cost is less than that of the reference biological product.

[Ensuring Access to Lower-Cost Medicines for Seniors Act of 2021; Introduced 04/26/2021] Require Medicare Part D prescription drug plans that use a formulary to include certain generic drugs and biosimilar biological products on such formulary.

[Star Rating for Biosimilars Act; Introduced 04/26/2021] Require CMS to establish quality measures regarding biosimilar biological products under the five-star performance rating system for Medicare Advantage plans. The measures must assess the level of access that plans provide to covered biosimilars, including with respect to formularies, cost-sharing, and utilization management.

[Reduced Cost and Continued Cures Act of 2021; Introduced 09/10/2021] 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.

[Reduced Cost and Continued Cures Act of 2021; Introduced 09/10/2021] Including a new measure of the 5-star rating system under Medicare Advantage that focuses on beneficiary access to biosimilars.

Limit anticompetitive behaviors by manufacturers

[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.

[Stop STALLING ACT; Introduced 04/28/2021] Authorize the Federal Trade Commission to sue an individual or entity that submits an objectively baseless petition to the FDA in an attempt to interfere with a competitor's application for market approval of a drug.

[Preserve Access to Affordable Generics and Biosimilars Act; Introduced 04/28/2021] Prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar and interchangeable biological products.

[Affordable Prescriptions for Patients Act of 2021; Introduced 04/28/2021] Prohibit product hopping.

[Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act; Introduced 04/28/2021] Set limits in certain instances to the number of patents that the manufacturer of a biologic drug can assert in a lawsuit against a company seeking to sell a biosimilar version of that drug.

[Affordable Medications Act; Introduced 05/27/2021] Prohibit compensation for the delay of affordable generics and biosimilars in the form of anything of value or an agreement to limit or forego research, development, manufacturing, marketing, or sales of a generic or biosimilar.

[Affordable Medications Act; Introduced 05/27/2021] Disqualify generic applicants from first application status if applicant agrees not to seek approval of its application or not to begin commercial marketing of its drug until a date that is after the expiration of the 180-day exclusivity period awarded to another applicant with respect to such drug.

[Reduced Costs and Continued Cures Act of 2021; Introduced 09/10/2021] Establish rules and regulations to end 'pay-for-delay' in which brand name drug manufacturers pay generic manufacturers to delay launch of generic products.

[Reduced Costs and Continued Cures Act of 2021; Introduced 09/10/2021] Creation of pathway for the Federal Trade Commission to prevent manufacturers from "product hopping."

[Reduced Costs and Continued Cures Act of 2021; Introduced 09/10/2021] Amendment of Section 271 (e) of title 35 of the U.S.C. to further limit patent thickets.

Reduce market monopoly

[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

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.

[ADAPT Act; Introduced 05/13/2021] Authorize the FDA to create an accelerated approval pathway for drugs currently approved for sale in certain countries and that meet certain criteria, including the drug is safe and effective, all relevant U.S. patents or legal exclusivities have expired, and the United States has a public health or unmet medical need for the drug.

Increase price awareness throughout the supply chain

Disclosure of pricing information to beneficiaries at decision-making

[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.

[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.

[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.

[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

[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 04/21/2021] Require that DTC advertisements for drugs and biologics include truthful pricing information.

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

[Health Care PRICE Transparency Act; Introduced 04/29/2021] Require hospitals to publicly report the following pricing information for hospital items or services: a description of each item or service, the gross charge, any payer-specific negotiated charge clearly associated with the name of the third party payer and plan, the de-identified minimum and maximum negotiated charge, the discounted cash price, and any associated billing codes.

[Prescription Drug Pricing Dashboard Act; Introduced 05/20/2021] Require CMS to update the Medicare and Medicaid prescription drug pricing dashboards to include specified information, such as data on out-of-pocket costs and drugs with the highest total spending under each program.

[DTC Act of 2021; Introduced 06/24/2021] Require direct-to consumer advertisements for prescription drugs and biologics to include a clear and conspicuous disclosure of the wholesale acquisition cost (WAC) for a 30-day supply of the drug.

[Matt's Act; Introduced 07/29/2021] Require drug manufacturers to publish net prices on the internet on a quarterly basis.

[Reduced Costs and Continued Cures Act of 2021; Introduced 09/10/2021] Require HHS to publicly report on PBMs' ability to negotiate rebates, discounts, and price concessions and the amount of these rebates, discounts, and price concessions that are passed on to plan sponsors.

[Reduced Costs and Continued Cures Act of 2021; Introduced 09/10/2021] Publish direct and indirect remuneration (DIR) reports to CMS website that are submitted by prescription drug plan sponsors.

[Reduced Costs and Continued Cures Act of 2021; Introduced 09/10/2021] Amend the Social Security Act to require the establishment and annual updating of publicly available drug pricing dashboards including: the Medicare Part B Drug and Biologic Dashboard, the Medicare Covered Part D Drug Dashboard, and the Medicaid Covered Outpatient Drug Dashboard.

[Reduced Costs and Continued Cures Act of 2021; Introduced 09/10/2021] Require that direct-to-consumer advertisements for drugs and biologics provide 'truthful and non-misleading pricing information.'

[Build Back Better Act; Introduced 09/27/2021] Require the Secretary of HHS to publish the upper limit price, also known as the maximum fair price, for negotiations with drug manufacturers.

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.

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.

[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.

[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.

[Freedom from Price Gouging Act; Introduced 04/20/2021] Require drug manufacturers to pay a Medicare part B rebate for certain drugs if the price of such drugs increases faster than inflation.

[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.

[Reduced Costs and Continued Cures Act of 2021; Introduced 09/10/2021] Require drug manufacturers to provide rebates to Medicare Part B for single source drugs with prices increasing faster than inflation.

[Reduced Costs and Continued Cures Act of 2021; Introduced 09/10/2021] Requires drug manufacturers to provide rebates to Medicare Part D for drugs with prices increasing faster than inflation.

[Reduced Costs and Continued Cures Act of 2021; Introduced 09/10/2021] Remove the maximum Medicaid rebate amount in the case that a drug's average manufacturer price is increasing faster than the rate of inflation.

[Build Back Better Act; Introduced 09/27/2021] Require drug manufacturers to provide rebates to Medicare Parts B and D when drug prices are increasing faster than inflation.

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

[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.

[Affordable Medications Act; Introduced 05/27/2021] Permit the importation of qualifying prescription drugs into the United States by certified wholesale distributors, 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.

[Reduced Costs and Continued Cures Act of 2021; Introduced 09/10/2021] Allow beneficiaries enrolled in Medicare Part D and Medicare Advantage prescription drug plans who incur a significant portion of costs towards annual out-of-pocket threshold to have their monthly out-of-pocket cost-sharing capped and paid in monthly installments.

[Build Back Better Act; Introduced 09/27/2021] Allow beneficiaries enrolled in Medicare Part D and Medicare Advantage prescription drug plans who incur costs equal to or above the annual out-of-pocket threshold while dispensing the first fill of a covered Part D drug to spread cost-sharing and pay for such a drug in periodic installments.

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

[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.

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

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

[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.

[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.

[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.

[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.

[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.

[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.

[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.

[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.

[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.

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

[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

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

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

[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.

[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.

[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.

[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.

[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.

Alter payment rates

[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.

[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.

[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.

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

[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.

[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.

[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.

[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.

[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.

[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.

[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

[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.

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

[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.

Limiting add-on payments to providers

[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

[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.