End Price Gouging for Medications Act
The End Price Gouging for Medications Act would require the Secretary of Health and Human Services (HHS) to establish an annual reference price for every prescription drug for purposes of Federal health programs (like Medicare, Medicaid, CHIP, TRICARE, Veterans Affairs, Federal Employees Health Benefits, and certain Indian Health Service programs). For Federal programs, the drug’s retail list price would not be allowed to exceed this reference price. The reference price would be set either by using the lowest available retail list price among a specified set of reference countries (if pricing data is available for at least 3 of them) or, if data are insufficient, by considering factors such as therapeutic effect, drug value, patient access, and research and development costs. The Act would require drug manufacturers to offer the reference price to all purchasers, including the uninsured and those with private insurance, with the insured’s obligation limited to the sum of coverage plus cost-sharing not exceeding the reference price. Violations would incur civil penalties paid to NIH for drug research and development, and the penalties would be calculated as five times the difference between what the manufacturer earned under Federal programs and what they would have earned had they complied. The reference price would apply to both brand-name and generic drugs approved under the FDA or Public Health Service Act.
Key Points
- 1Establishment of annual reference prices for prescription drugs the federal government covers through major health programs.
- 2Method for setting reference prices:
- 3- If data exist for at least 3 reference countries (Australia, Austria, Belgium, Canada, France, Germany, Italy, Japan, the Netherlands, Sweden, Switzerland, and the United Kingdom), the reference price is the lowest retail list price among those countries.
- 4- If fewer than 3 countries have data, the Secretary may set the price based on factors such as added therapeutic effect, drug value, patient access, R&D costs, and other relevant considerations.
- 5Federal health programs covered by the reference price: Medicare, Medicaid, CHIP, TRICARE, VA hospital care/services, Federal Employees Health Benefits Program, and certain Indian Health Service programs.
- 6Manufacturer obligation and consumer access: drug manufacturers must offer the reference price to all buyers (including uninsured and those with private insurance); for privately insured individuals, coverage plus cost-sharing must not exceed the reference price.
- 7Enforcement and funding: civil penalties for noncompliance, calculated as five times the difference between what the manufacturer earned under federal programs and what they would have earned at the reference price; penalties go to the NIH to fund drug research and development.