The regulation of drug prices has received significant recent bipartisan support in Congress. Democrats and Republicans in both houses have proposed approximately eighty bills relating to drug pricing over the past two years. The charts below summarize the key provisions of representative bills.[i]

Although the proposed price-regulating mechanisms differ from bill to bill, the bills do not indicate a clear difference in the parties’ goals when viewed at a high level. Many of the proposed bills focus on price transparency as well as reporting to the Department of Health and Human Services (HHS). Certain bills would require pharmaceutical manufacturers to provide data on, and justifications for, the pricing of certain drugs that would exceed specified price increase limits. These bills usually include penalties for reporting failures; however, they usually do not provide a procedure to lower a price that triggers the reporting provisions. Instead, they often establish or enhance public databases for the reported information, and some go as far as requiring pharmacists to communicate this information to the patient at the point of sale.

Other proposed bills would set caps on drug pricing, albeit through different approaches. Certain bills would require HHS to negotiate drug prices with the manufacturers of covered drugs, for example, and some of these bills grant HHS the power to establish a price if an agreement is not reached.

Although many bills on this topic have been proposed throughout the current legislative session, most are stalled in committee, often since their day of introduction.

There is one notable exception: on December 12, 2019, H.R. 3 passed the House, albeit almost entirely along party lines. If enacted in its current form, it would directly regulate drug prices by creating a price ceiling based on drug price averages in designated reference countries. H.R. 3 would also give the Centers for Medicare/Medicaid Services (CMS) the authority to promulgate rules relating to drug price disclosures in pharmaceutical advertisements (such as the Trump Administration’s recently-defeated Disclosure Rule) and would require CMS to negotiate drug prices. As a Democrat-sponsored bill, however, its fate in the current Senate is uncertain.

Regardless of the outcome of the November 2020 election, the bipartisan push for drug pricing regulation may foreshadow the passage of such legislation in the near future. We will continue to monitor Congress’s efforts to regulate in this area and provide updates.

[i] The charts below summarize selected drug pricing bills put forth in the 116th Congress. Although these lists are not exhaustive, they provide examples of the types of price-regulating measures under consideration. These bills were identified by searching congress.gov for the terms “drug pricing” and “drug price.”

Senate Bills

Bill No. Introduced Status Summary of Selected Key Points
S. 3384

 

Lowering Prescription Drug Prices for America’s Seniors and Families Act of 2020

03/03/2020

 

Sen. Martha McSally (R-AZ)

03/03/2020 Referred to Committee on Finance
  • Allows HHS to negotiate prices for certain Medicare Part D drugs.
  • Allows individuals to import drugs from Canada.
S. 3166

 

Prescription Drug Affordability and Access Act

01/08/2020

 

Sen. Cory Booker (D-NJ)

01/08/2020 Referred to Committee on Health, Education, Labor, and Pensions
  • Establishes the Bureau of Prescription Drug Affordability and Access.
  • Puts limits on price increases of drugs and otherwise regulates drug prices.
  • If a manufacturer intends to increase the WAC by more than the percentage by which the Consumer Price Index for All Urban Consumers for that year exceeds the index for the preceding year, then the manufacturer must submit information about the price increase to the Bureau 60 days before the increase is to take effect.
  • In determining whether the price increase is appropriate, the Bureau will consider several factors, including the size of the patient population, benefit of the drug, impact of price on drug access, costs of drug development, revenue, and the price of the drug in other countries.
  • If the price is not appropriate, the Bureau shall direct the manufacturer to lower the WAC to an appropriate price, and the Bureau will determine a rebate process for patients impacted by the inappropriate price.
S. 3129

 

Lower Costs, More Cures Act of 2019

12/19/2019

 

Sen. Mike Crapo (R-ID)

12/19/2019 Referred to Committee on Finance.
  • Increases drug price transparency and requires drug price information in advertisements, including a requirement that if the price of a qualifying drug is increased by 10% or more in a single calendar year, or 25% or more within three consecutive calendar years, then the manufacturer must submit a report to HHS with information certain information on the drug and a description of the price increase.
  • Gives HHS the authority to implement the recently defeated Disclosure Rule.
S. 2543

 

Prescription Drug Pricing Reduction Act of 2019

09/25/2019

 

Sen. Chuck Grassley (R-IA)

09/25/2019 Legislative Calendar under General Orders (Calendar No. 225)

 

S. 4199 (introduced 07/02/2020) reintroduces S. 2543

  • Requires manufacturers to provide a justification to HHS for a price increase of 100% more than the price in the previous 12 months, or greater percentages over longer periods of time.  If the drug is in the top 50th percentile of net spending under Title XVIII or XIX of the Social Security Act during any 12 month period in the previous 60 months, a justification is required if there is a 15% increase over the price in the previous year, or greater percentages over longer periods.
  • Drug manufacturers must issue rebates to CMS for certain covered drugs, including those for which the average manufacturer price increases faster than inflation.
S. 1987

 

End Price Gouging for Medications Act

06/26/2019

 

Sen. Jeff Merkley (D-OR)

06/26/2019 Referred to Committee on Health, Education, Labor, and Pensions
  • HHS must establish annual reference prices based on the median retail list price in Japan, Germany, the United Kingdom, France, Italy, Canada, Australia, Spain, the Netherlands, Switzerland, and Sweden.
  • If information is not available in at least 3 reference countries, then the reference price will be determined by HHS based on factors including the therapeutic effect, value, patient access, costs, and other appropriate factors.
  • Drugs covered under federal health programs may not exceed the reference prices.
  • Drugs must be available to uninsured people on private health insurance at this price.
S. 1664

 

Prescription Drug Price Reporting Act

05/23/2019

 

Sen. Rick Scott (R-FL)

05/23/2019 Referred to Committee on Health, Education, Labor, and Pensions
  • Requires manufacturers to submit information to HHS about drugs marketed in the U.S., including information about cost, pricing, and rebates.
  • Manufacturers must submit notice of price changes 30 days in advance.
  • HHS must establish a database allowing consumers to subscribe to price change notifications.
S. 1437

 

Drug-price Transparency in Communications (DTC) Act

05/13/2019

 

Sen. Richard J. Durbin (D-IL)

05/13/2019 Referred to Committee on Finance
  • Requires direct to consumer advertising for prescription drugs covered by Medicare and Medicaid to include “truthful and non-misleading pricing information,” giving statutory authority for the recently-defeated Disclosure Rule.
S. 1391

 

Fair Accountability and Innovative Research Drug Pricing Act of 2019

05/09/2019

 

Sen. Tammy Baldwin (D-WI)

05/09/2019 Referred to the Committee on Health, Education, Labor, and Pensions
  • Establishes reporting requirements for drug prices and price changes.
  • Requires HHS to make these reports public after 30 days.
S. 977

 

Transparent Drug Pricing Act of 2019

04/01/2019

 

Sen. Rick Scott (R-FL)

04/01/2019

Referred to Committee on Health, Education, Labor, and Pensions

  • At the point of sale, pharmacists must disclose out-of-pocket costs and the price without insurance.
  • Health insurers must publish the co-payment amount for each covered prescription drug prior to the annual open-enrollment period.
  • Retail list price is temporarily prohibited from exceeding the lowest retail list prices in Canada, France, the United Kingdom, Japan, and Germany.
S. 709

 

Prescription Drug Pricing Dashboard Act

03/07/2019

 

Sen. Robert P. Casey, Jr. (D-PA)

03/07/2019 Referred to Committee on Health, Education, Labor, and Pensions
  • HHS must establish an online dashboard with specific information on pricing and utilization of drugs in federal programs.
S. 637

 

CURE High Drug Prices Act

02/28/2019

 

Sponsor: Sen. Richard Blumenthal (D-CT)

 

02/28/2019 Referred to Committee on Health, Education, Labor, and Pensions
  • Prohibits price gouging by manufacturers of prescription drugs covered by a federal health care program.
  • Price gouging is presumed if the manufacturer increases the price: (1) 10% or more within the previous 12-month period; (2) 20% or more in the previous 36-month period; (3) 30% or more within the previous 60-month period.
  • If HHS has reason to believe that an increase constitutes price gouging, it will notify the manufacturer who must submit a justification for the price increase.
S. 474

 

Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019

02/13/2019

 

Sen. Ron Wyden (D-OR)

02/13/2019 Referred to Committee on Finance
  • Requires manufacturers to submit to CMS written justification for price increases of certain percentages.
S. 378

 

Stop Price Gouging Act

02/07/2019

 

Sen. Sherrod Brown (D-OH)

02/07/2019 Referred to Committee on Finance
  • When there is a price spike, this bill imposes an excise tax ranging from 50%-100% of the price spike revenue received by the company.
  • A price spike occurs when the price is increased by more than the price increase allowance, which is the percentage by which the Chained Consumer Price Index for All Urban Consumers (C-CPI-U) for that year exceeds the C-CPI-U for the previous year.
  • HHS can exempt drugs from the excise tax if (1) a for-cause price increase exemption should apply, or (2) the drug has an average manufacturer price of not greater than $10 for a 30-day supply and is marketed by at least 3 other holders of FDA-approved applications.
  • Pharmaceutical companies must submit data about drug prices and revenue to HHS, and HHS must submit an assessment of the data to the IRS.
S. 102

 

Prescription Drug Price Relief Act of 2019

01/10/2019

 

Sen. Bernard Sanders (I-VT)

01/10/2019 Referred to Committee on Health, Education, Labor, and Pensions
  • Establishes oversight and disclosure requirements to HHS relating to prices of brand-name drugs.
  • Requires HHS to conduct annual review for excessive pricing of drugs.
  • Prices are considered excessive if the domestic average manufacturing price exceeds the median price of the drug in Canada, the United Kingdom, Germany, France, and Japan.  If the price does not exceed this average, or if data is unavailable in at least three of these countries, the price can still be considered excessive depending on several factors, including cost, revenue, the value of drug to patients, and the size of the affected patient population.
S. 99

 

Medicare Drug Price Negotiation Act

 

01/10/2019

 

Sen. Bernard Sanders (I-VT)

01/10/2019 Referred to Committee on Finance
  • Similar to H.R. 275, requires CMS to negotiate prices of covered drugs.
S. 62

 

Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019

 

01/09/2019

 

Sen. Amy Klobuchar (D-MN)

01/09/2019 Referred to Committee on Finance
  • Similar to other legislation, requires CMS to negotiate prices of Medicare drugs and institute a price structure for reimbursement of covered drugs.

 

House Bills

Bill No. Introduced Status Summary of Selected Key Points
H.R. 5281

 

Drug Price Transparency in Medicaid Act of 2019

12/03/2019

 

Rep. Earl L. Carter (R-GA-1)

 

12/04/2019 Referred to the Subcommittee on Health
  • Requires pass-through pricing.
H.R. 5239

 

Prescription Drug Price Reporting Act

11/21/2019

 

Rep. David P. Joyce (R-OH-14)

11/22/2019 Referred to the Subcommittee on Health
  • Manufacturers must submit to HHS any price changes to prescription drugs 30 days in advance, as well as information about drug cost, pricing, and rebates.
  • Requires HHS to maintain a public database with this information (including prices).
H.R. 5039

 

Life-Sustaining Prescription Drug Price Relief Act of 2019

11/12/2019

 

Rep. Daniel Lipinski (D-IL-3)

11/13/2019 Referred to Subcommittee on Health.
  • Places restrictions on prices of “life-sustaining prescription drugs.”  Specifically, the domestic average manufacturing price cannot exceed 110% of the average price for the drug in Canada, the United Kingdom, Germany, France, and Japan.
  • Allows HHS to negotiate drug prices for drugs covered by Medicare Part D.
  • Requires HHS to maintain a drug price database.
H.R. 4640

 

Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2019

10/11/2019

 

Rep. Peter A. DeFazio (D-OR-4)

10/14/2019 Referred to Subcommittee on Health
  • If federally funded healthcare research and development results in development of a drug, a patent for the drug will not be granted unless the entity receiving the patent agrees to a reasonable pricing agreement with HHS.
H.R. 3

 

Elijah E. Cummings Lower Drug Costs Now Act

09/19/2019

 

Rep. Frank Pallone, Jr. (D-NJ-6)

12/12/2019 Passed House

 

Senate – 09/08/2020 Placed on Legislative Calendar (General Orders, Calendar No. 521)

  • Drug price cannot exceed 120% of the average price in Australia, Canada, France, Germany, Japan, and the United Kingdom, or, if that information is not available, 85% of the average manufacturer price in the U.S.
  • Requires CMS to issue regulations requiring ads to display the price of a 30 day supply or the typical course of treatment.
  • Requires HHS to negotiate certain drug prices.
H.R. 3379

 

Price Relief, Innovation, and Competition for Essential Drugs Act

06/20/2019

 

Rep. Janice D. Schakowsky (D-IL-9)

06/21/2019 Referred to the Subcommittee on Health
  • Shortens the marketing-exclusivity period for biosimilars to five years after the reference drug is licensed.
H.R. 2115

 

Public Disclosure of Drug Discounts and Real-Time Beneficiary Drug Cost Act

04/08/2019

 

Rep. Abigail Davis Spanberger (D-VA-7)

10/28/2019 Passed House

 

Senate – 10/29/2019 Committee on Finance

  • Requires CMS to publish certain information regarding Pharmacy Benefit Managers (PBMs) and prescription drugs, including information related to generic dispensing rates, drug discounts and rebates, and payments between PBMs, health plans, and pharmacies.
H.R. 2087

 

Drug Price Transparency Act

04/04/2019

 

Rep. Lloyd Doggett (D-TX-35)

 

05/21/2019 Subcommittee hearings
  • Requires manufacturers of drugs without rebate agreements under the Medicaid Drug Rebate Program to report information to CMS, including average sales price, total units, and WAC.
H.R. 987

 

Strengthening Health Care and Lowering Prescription Drug Costs Act

02/06/2019

 

Rep. Lisa Blunt Rochester (D-DE-At Large)

05/16/2019 Passed House

 

Senate – 05/20/2019 Committee on Health, Education, Labor, and Pensions

 

 

  • Requires HHS to submit a report to Congress as to whether increases in prescription drug costs caused Medicare beneficiaries to forego recommended treatment.
H.R. 448

 

Medicare Drug Price Negotiation Act

01/10/2019

 

Rep. Elijah E. Cummings (D-MD-7)

09/25/2019 Subcommittee Hearings Held
  • Requires CMS to negotiate with drug manufacturers.  If CMS is unable to negotiate an appropriate drug price, then the price must be the lowest of the following: (1) the contract price pursuant to 38 U.S.C. § 8126; (2) the average price during the most recent 12 month period in Canada, the United Kingdom, Germany, France, and Japan; or (3) the best price determined under § 1927(c)(1)(C) for the most recent rebate period.
H.R. 275

 

Medicare Prescription Drug Price Negotiation Act of 2019

 

 

01/08/2019

 

Rep. Peter Welch (D-VT-At Large)

09/25/2019 Subcommittee Hearings Held
  • Requires CMS to negotiate with pharmaceutical companies regarding prices of drugs covered by Medicare.

 

[1] The charts above summarize selected drug pricing bills put forth in the 116th Congress.  Although these lists are not exhaustive, they provide examples of the types of price-regulating measures under consideration. These bills were identified by searching congress.gov for the terms “drug pricing” and “drug price.”