The drug industry has announced it wants Congress to reopen the original 340B law to give the Health Resources and Services Administration additional rule- making authority to regulate the program. [ms-protect-content id=”2799″]
The move comes on the heels of the agency’s announcement last week that it would withdraw the so-called “mega-reg” from consideration at the Office of Management and Budget. Instead, HRSA will issue regulations early next year in areas where it has clear legislative authority, such as civil monetary penalties for manufacturers, the administrative dispute resolution process, and the calculation of 340B ceiling prices. In areas where it does not believe it has that power, the agency will issue interpretive guidance.
The drug industry wants more than that. “While we look forward to the guidance to be issued by HRSA, we believe that the fundamental problems of the program still need to be addressed by Congress,” PhRMA Executive Vice President Lori Reilly said in a statement.
The industry’s AIR340B lobby group was even more direct in an interview with Congressional Quarterly: “Opening the statute is an important opportunity not only to give HRSA the additional authority they seek, but also to make the programmatic reforms to 340B that vulnerable and underserved patients deserve,” said Stephanie Silverman, spokeswoman for the Alliance for Integrity and Reform of 340B.
Advocates for the program are deeply concerned that drug companies will push highly restrictive new language if the statute is reopened.
“The pharmaceutical industry wants to limit the program to the uninsured only,” said Ted Slafsky, President and Chief Executive Officer of Safety Net Hospitals for Pharmaceutical Access. “Most safety-net hospitals would drop out because it is costly to administer and there would no longer be any savings realized to help pay for vital clinical services for the needy.”
Hospitals are also concerned that the drug industry is pushing for other possible changes they believe would undermine the program, including requiring hospitals to pass their entire Medicare Part B savings to the government and dramatically limiting the number of hospitals that qualify for 340B. [/ms-protect-content]