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 271 people sickened in 16 states in a still-growing outbreak that has killed 21.
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.
In response, a department spokesman says Congress needs to provide the FDA with stronger powers.
The meningitis outbreak has called attention to the role of compounding pharmacies in supplying medications routinely used by hospitals and doctors to treat patients.
Regulated primarily by states, the pharmacies specialize in customizing doses for individual patients who have allergies to ingredients in an FDA-approved drug, or who might need a smaller dosage than what’s available commercially. But some pharmacies have pushed into full-scale manufacturing.
Medicare has long been aware of the risks.
“By compounding drugs on a large scale, a company may be operating as a drug manufacturer within the meaning of (federal law), without complying with requirements of that law,” Medicare’s coverage manual, a reference for contractors that handle payments, says in a section dealing with compounded drugs.
That situation, adds the manual, fails Medicare’s basic standard, that treatments must be “reasonable and necessary” in order to be covered.
“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.”
Medicare officials are looking into whether the program paid for drugs that have sickened patients.
FDA records show that in 2006 the agency issued a warning letter to the New England Compounding Center for producing anesthetic creams, but officials were unable to say if Medicare was alerted.
In a separate case, Medicare seems to have taken sweeping action on its own without much prodding from the FDA. In 2007, Medicare stopped coverage for compounded inhalation drugs used to treat lung disease.
