Friday, May 25, 2018

Meningitis outbreak raises questions for Medicare

WASHINGTON — Medicare is coming under scrutiny in the meningitis outbreak that has rekindled doubts about the safety of the nation's drug supply.

The giant health insurance program for seniors long ago flagged compounded drugs produced for the mass market without oversight from the Food and Drug Administration as safety risks. In 2007, Medicare revoked coverage of compounded inhaler drugs for lung disease.

But Medicare doesn't seem to have consistently used its own legal power to deny payment, and critics say that has enabled the compounding business to flourish.

Now program officials are scrambling to find out how many Medicare beneficiaries are among the more than 270 people sickened in 16 states in a still-growing outbreak that has claimed 21 lives.

The illnesses have been linked to an injectable steroid used to treat back pain, made by the New England Compounding Center, a Massachusetts specialty pharmacy. The medication was contaminated with a fungus.

A senior lawmaker and consumer advocates are raising questions about Medicare's role, including an apparent lack of coordination between Medicare and the FDA, the two most powerful agencies within the federal Health and Human Services Department.

"Medicare indicates in its own policy documents that it can cut off payments for compounded drugs produced under manufacturing-like conditions," said Sen. Charles Grassley, R-Iowa, who over the years has pushed for stronger government oversight of the pharmaceutical industry.

"Medicare should explain whether it uses this step, and if not, why not. Every avenue for explaining how this health crisis occurred and preventing others like it needs exploration," he added.

Medicare officials are looking into whether the program paid for drugs that have sickened patients.

"If the FDA determines a company is producing compounded drugs in violation of (federal law), Medicare will not reimburse for drugs produced in that facility," said HHS spokesman Tait Sye.

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