Amid meningitis crisis, critics say Medicare may promote risky drug
for drugs produced in that facility. But because the FDA's authority over compounding pharmacies is severely limited, we urge Congress to strengthen FDA's authority to ensure these kinds of outbreaks do not happen again.
In a letter to Medicare on Monday, Senators Debbie Stabenow, Al Franken, Dianne Feinstein and Blumenthal - all Democrats - also raised concerns about how compounded drugs are reimbursed at the state and federal level.
The senators cited a section of Medicare's policy manual which explains how the program can deny payment for compounded drugs. In addition, they asked how Medicare works with the FDA to determine which companies have received violations for mass compounding of drugs.
Medicare pays for compounded medications mostly under what is called Part B, which covers drugs that patients cannot administer themselves, such as spinal injections and intravenous cancer drugs. These medications are vital and often life-sustaining and should be covered in full, said David Ball, a spokesman for the International Academy of Compounding Pharmacists.
Also weighing in on compounding on Monday, the Senate Committee on Health, Education, Labor, and Pensions asked all 50 state boards of pharmacy - which, rather than federal regulators, oversee compounding pharmacies - for information on actions you have taken to address this meningitis outbreak.
Specifically, the committee asked the boards whether they had reported problems with drugs from New England Compounding Center, the company that produced the tainted steroids, to the FDA, and whether they require compounding pharmacies to report whether they produce large volumes
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