Wednesday, April 30, 2014

DeLauro Statement on Inspector General Report on Compounded Drugs

Issued By
April 30, 2014
Urges Centers for Medicare & Medicaid Services to Implement Recommendations WASHINGTON, DC-Congresswoman Rosa DeLauro (D-CT) released the following statement today on a new report from the Health and Human Services (HHS) Inspector General, Compounded Drugs Under Medicare Part B: Payment and Oversight. DeLauro is the senior Democrat on the subcommittee responsible for funding HHS and is the former chairwoman of the subcommittee responsible for funding the Food and Drug Administration (FDA), which has responsibility for overseeing compounded drugs.
"As the tragic outbreak of 2012-2013 demonstrated, our current system of tracking and ensuring the safety of compounded drugs is systemically flawed.  The Inspector General's recommendations make clear that we need to do far more to track compounded drugs, particularly in the Medicare program as seniors are more susceptible to becoming seriously ill or dying from an infection than the general public. I am disturbed that we could be wasting millions of taxpayer dollars on unsafe drugs, with no way of knowing for sure. While I introduced legislation which would have made FDA registration mandatory for companies that mass produce compounded drugs, the bill signed into law unfortunately made that registration only voluntary.  The current system still leaves our seniors and general population vulnerable and we need to change it. HHS should use the IG recommendations to take step to better protect our seniors from potentially dangerous compounded drugs."                                           
The Inspector General issued three recommendations:
·         Establish a method to identify Medicare Part B claims for compounded drugs
·         Explore the possibility of requiring providers to identify the pharmacy that produced the compounded drug on the Medicare Part B claim
·         Explore the possibility of conducting descriptive analyses of Medicare Part B claims for compounded drugs. Such analyses could include calculating how much Medicare Part B is paying for compounded drugs, determining where compounded drugs are being produced and determining which compounded drugs are being billed for.

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