Compounding of Inhalation Drugs

Date: Oct. 13, 2006
Location: Washington, DC
Issues: Drugs


Compounding of Inhalation Drugs

Earlier this month, Sen. Chuck Grassley received a response from the Food and Drug Administration to a letter he sent in July asking for the drug safety agency to respond to inappropriate compounding of inhalation drugs. The Food and Drug Administration said in its letter that the agency shared Sen. Grassley's concerns and highlighted recent enforcement
actions. The agency official wrote that Medicare reimbursement policies "may inadvertently create an incentive for the inappropriate compounding of these drugs." Accordingly, the Food and Drug Administration has sent proposed policy revisions to the Centers for Medicare and Medicaid Services.

Sen. Grassley had also written in July to the Centers for Medicare and Medicaid Services regarding inappropriate compounding of inhalation drugs. In a response to this letter from Sen. Grassley, Medicare officials said they would be revising reimbursement policies. Sen. Grassley has asked for more information on the agency's plans on coding and payment for compounded
inhalation drugs.

Here is a comment from Sen. Grassley regarding the situation today.

"Both government agencies with responsibility are finally taking matters seriously when it comes to compounded inhalation drugs. When pharmacies or durable medical equipment suppliers inappropriately provide compounded drugs to patients and the taxpayer foots the bill, it's time for Uncle Sam to tackle the problem head on. The Food and Drug Administration needs
more authority to track down the bad actors in the compounding industry and help put them out of business. Medicare program officials need to get a handle on how many compounded inhalation drugs taxpayers have been paying for."

The Oct. 2 letter from the Food and Drug Administration to Sen. Grassley is posted at http://finance.senate.gov.

The August 22 letter from the Centers for Medicare and Medicaid Services to Sen. Grassley is also posted at http://finance.senate.gov.

http://finance.senate.gov/sitepages/grassley.htm

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