Inspector General Guidance on Patient Assistance Programs

Inspector General Guidance on Patient Assistance Programs

United States Senate Committee on Finance

Friday, June 30, 2006

Today the Inspector General for the Department of Health and Human Services issued and Advisory Opinion for a clinic in West Virginia regarding its practice of dispensing drugs on behalf of the patient assistance programs sponsored by drug manufacturers. The Inspector General said that the clinic's practice would not constitute grounds for civil monetary penalties
or administrative sanctions under federal anti-kickback statutes.

Statements from Sens. Chuck Grassley, Max Baucus and Jay Rockefeller are below.

These senators have been working to see that drug-company sponsored patient assistance programs continue alongside Medicare's new Part D prescription drug benefit. They have sought legal guidance from the Inspector General and personally urged drug makers to continue these valuable programs.

Comments -

"I appreciate the initiative demonstrated by the clinic in West Virginia in asking for this important opinion. The Inspector General's advisory should help everyone involved in this clinic's program to distribute medicines on behalf of patient assistance programs know that their work doesn't violate the federal anti-kickback statute. Patient assistance programs help millions
of Americans get the medicine they need. I also very much appreciate the Inspector General's continued diligent review of other similar requests regarding these valuable programs," said Sen. Chuck Grassley of Iowa, Chairman of the Senate Committee on Finance.

"Free clinics are a valuable way to get low-cost and no-cost drugs to Americans in need. This opinion from the Inspector General's office lets clinics know this service is not only laudable, but still legal under the new Medicare drug benefit. The Inspector General is working hard to harmonize patient assistance programs with the new Medicare law, and his opinion is a
good step toward keeping these programs going and keeping seniors well," said Sen. Max Baucus of Montana, Ranking Member of the Senate Committee on Finance.

"I applaud this most recent guidance from the HHS Inspector General regarding free clinic participation in pharmaceutical patient assistance programs. This opinion will allow West Virginia Health Right and other free clinics around the country to continue providing vital prescription assistance to people who need it, including individuals enrolled in the Medicare
prescription drug program," said Sen. John D. (Jay) Rockefeller IV of West Virginia, Ranking Member of the Senate Finance Subcommittee on Health.

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http://finance.senate.gov/press/Bpress/2005press/prb063006.pdf