In comments submitted today in response to the bipartisan Senate request for information on the 340B program, PhRMA outlines how Congress can address problems in a program that is plagued with misaligned incentives and a lack of benefit for patients.
Our recommendations shared with the Senate fall into three buckets:
Make Sure 340B Reaches Low-income, Vulnerable Patients
- Congress needs to clarify who is an eligible “patient” to help ensure the benefits of the program are reaching those patients and strengthen program integrity.
- All hospitals in the program and their contract pharmacies should be required to pass through 340B discounts to lower the cost of medicines for vulnerable patients.
Ensure True Safety-Net Entities Are Participating in the Program
- Hospitals participating in the program should be required to provide charity care to uninsured, low-income and other vulnerable patients. These hospitals should also be prohibited from engaging in aggressive medical debt collection with respect to these patients. These requirements should also apply to hospitals’ offsite outpatient facilities.
- Contract pharmacy policies should only be considered as part of comprehensive changes that address patient affordability and program integrity concerns. There should also be limits on how contract pharmacies are able to profit from the program.
- Congress should prohibit for-profit corporations, like pharmacy benefit managers and for-profit chain pharmacies, from profiting off the program.
Institute Stronger Accountability Measures
- Congress should require covered entities to report basic information and make that information public, including how much charity care is provided at each 340B hospital and each of their offsite facilities.
- Creation of a clearinghouse for claims-level data to help ensure 340B discounts are being properly claimed, that all stakeholders are operating in a compliant manner and that low-income and vulnerable patients are benefiting.
- Congress should require HRSA to issue revised audit guidelines and provide necessary data that enable manufacturers to conduct appropriate covered entity oversight.
The 340B program of today is unrecognizable in both character and size when compared to the program Congress originally created. Congress needs to take meaningful action to get 340B back on track for vulnerable patients.
Read our full comments.