por Brendon Nafziger
, DOTmed News Associate Editor | December 27, 2011
From the December 2011 issue of HealthCare Business News magazine
Many doctors are hoping that Congress finally delivers the fatal blow to the sustainable growth rate (SGR) formula next year. Last week, after some last-minute political wrangling, Congress passed a bill that includes a two-month freeze on the 27 percent Medicare reimbursement cut to physicians that was scheduled to go in effect in January, courtesy of the SGR. But come March, these cuts will loom again.
Congress has kicked this billion dollar can (fully repealing the SGR is thought to cost about $300 billion) down the road so many times in the past that maybe it's unreasonable to expect anything to change in the next 12 months.
However, politicians have made some moves indicating that they might (might!) be serious this time. For instance, last week, Democrats appointed Rep. Allyson Schwartz, from Pennsylvania, to a House-Senate committee that among other problems will look at how to fix the SGR, The Hill newspaper reports. And Schwartz is the author of an SGR fix, which she proposed to the ill-fated "super committee" earlier in the fall.
True, the American Medical Association didn't much like her ideas. And it's unclear what doctors can expect to come out of a largely gridlocked Washington in the near future. But whatever happens with the SGR, 2012 promises a number of fairly big policy decisions for health care. We've come up with a list of three to keep an eye on:
1. Health reform's fate
Is the Affordable Care Act, the signature domestic policy victory of the Obama administration, constitutional? It depends who you ask. In November, a D.C. appeals court upheld the law. But earlier this year, an Atlanta appeals court struck down part of it. The fault line for many is the individual mandate, which requires citizens to get health insurance by 2014 or face penalties. But judges also disagree on whether the law can even be ruled on yet: another appeals court, in Cincinnati, said because the mandate was, in effect, a tax, for legal reasons nothing could be decided until it first takes effect in 2014. With appeals courts split, it's now time for the Supreme Court to weigh in. The court said it has set aside three days to hear arguments at the end of March; a ruling is expected over the summer. Stay tuned: This could be the most divisive judgment since 2001's Bush vs. Gore.
2. How the FDA will regulate mobile devices
The future of health care is becomingly increasingly mobile, so the Food and Drug Administration now has to reckon with a lot of new gadgets falling under its purview. This summer, the agency released draft guidance on how it plans to regulate mobile devices, like smartphone health care apps. Mostly, the FDA says it intends to focus on only a small fraction of devices and programs cluttering the App Store: those that function as an accessory to something already regulated, such as an app that lets radiologists access a PACS server to see images to make a diagnosis; and those that turn the product into a real medical device, such as a smartphone that takes ECG readings. However, the mobile health industry has some worries. In a slew of comments sent to the agency this fall, stakeholders have fretted about a number of points. For one, they worry the language the regulations are written in is too jargon-filled for developers who tend not have a lot of experience with the FDA's technical prose. Also, they're afraid the FDA's proposals lack proper risk analysis so the regulations only concentrate on the most potentially harmful applications. We'll see how the FDA deals with the feedback soon, as final rules are expected next year.
3. A new way to understand Alzheimer's
There is a gold standard for diagnosing Alzheimer's disease, but the problem is that it first requires the patient to be dead. Doctors can't exactly cut open your brain to check for beta-amyloid plaques and tangles while you're still alive. This is partly why there's so much excitement around a handful of in-the-works PET imaging agents that can measure, non-invasively, your brain's plaque load. Now, they can't "diagnose" Alzheimer's, but they could, at least, help rule it out and add another useful weapon to a doctor's diagnostic arsenal. Of the PET agents in development, Eli Lilly's florbetapir F18, also called Amyvid, is probably the furthest along, regulatory-wise. Lilly has already filed with the Food and Drug Administration. However, the first go around for Lilly's product didn't end so well -- this spring, the agency rejected the drug because of concerns over user training. But Lilly says they've made some corrections and have re-filed, and expect some sort of response from the FDA by the middle of next year. No one can say for sure it will be positive, but Lilly's not alone in this game. GE is also said to be working through plans with its agent, flutemetamol, and they expect to seek FDA approval by the end of this year -- meaning they, too, could expect some news in 2012.
A version of this article appeared in the November issue of DOTmed Business News