Congress of course remains on the campaign trail until next month. Congress now has one more issue to add to its lame duck session’s agenda — federal regulation of compounding pharmacies. The recent deadly outbreak of fungal meningitis has been traced to a large scale compounding pharmacy in Framingham, Massachusetts called the New England Compounding Center. The FEHBlog was bowled over yesterday when he read a New York Times article explaining that

some doctors and clinics have turned away from major drug manufacturers and have taken their business to so-called compounding pharmacies, like New England Compounding, which mix up batches of drugs on their own, often for much lower prices than major manufacturers charge — and with little of the federal oversight of drug safety and quality that is routine for the big companies. “The Food and Drug Administration has more regulatory authority over a drug factory in China than over a compounding pharmacy in Massachusetts,” said Kevin Outterson, an associate professor of law at Boston University.

The federal Food and Drug Act contemplates that state regulated pharmacies may occasionally combine ingredients into compounds. However, some companies like the New England Compounding Center have engaged in large scale compounding which should but doesn’t currently fall under FDA oversight. Regrettably, the New England Contaminating Center allegedly distributed impure injectable steroids across the country. The company now has recalled all of its compounds, and according to the Hill, Sen. Richard Blumenthal (D Conn.) is asking the FDA for its legislative recommendations.

The Affordable Care Act created accountable care organizations (“ACOs”) within the Medicare Program. Healthcare.gov defines an ACO as “a group of health care providers who give coordinated care, chronic disease management, and thereby improve the quality of care patients get. The organization’s payment is tied to achieving health care quality goals and outcomes that result in cost savings.”  Medpage Today is reporting on a Health Affairs reported simulation of an ACA that successfully treats Medicare eligible patients with diabetes 2.  The simulation found that a 10% clinical improvement would create just 1.22% in savings for Medicare Parts A and B — well below the level needed to trigger savings sharing. That’s bad news for those hoping to reap some revenues from ACO’s.” On the bright side, insurers also are developing ACOs which will offer providers much more flexible contractual rather than legally mandated compensation structures.

In other cheery news, the AMA News is reporting on a silent exodus of doctors from the medical profession. That’s not good news as we are only 15 months away from the great influs of new patients that the ACA subsidized health insurance exchanges are expected to produce.