You don't have to be genetically inclined to be smarter than average to know that Path Genomics announcement that their affordable genetic test kit would be sold at Walgreens across the country may have been a little too soon. After a strongly-worded letter from the Food & Drug Administration questioning the legality of Pathway and their products, Walgreens has reversed its decision to carry the kits for the time being. Now, Pathway has 15 days to respond to the FDA's request for information regarding the home test kit and the methods they use to provide results.

The reason the FDA is up in arms about the test is that it is considered a "medical device" as defined by the Federal Food & Drug and Cosmetic Act, according to FDA Deputy Director for Patient Safety & Patient Quality James Woods. The test kit is essentially a vial to spit in and a shipping envelop ($30) to send to a Pathway Genomics laboratory. The results (another $240 to access) are then posted online. That alone should raise some red flags from medical privacy proponents, but the lack of medical consultation also has physicians concerned that the information provided could be misunderstood. Pathway is defending their decision, saying that their labs are federally certified and state-licensed. They have also offered the genetic health report for the past year without FDA interference.

Four years ago, the Association of American Medical Colleges tried to make plans to cut off a physician shortage by boosting first-year med school enrollment. Based on 2002's enrollment numbers, the AAMC's goal was to increase that 30% by 2015. However, in an enrollment survey based on 2009's demographics, it looks like they're going to miss that goal by a few years. The new projection for 2015 is an increase of 23%. However, if one counts both normal med schools and osteopathic medical schools, 2015 will see an increase of over 36%.

The problem with the increase in med school graduates is that the number of residency slots aren't growing exponentially. In fact, the number of residency positions has been growing at a pace of less than 1%. While the addition new schools and expansion of other schools has had a slight boom over the past two years, the number of residency slots, particularly in primary care specialties, are still no where near where they need to be.

Last week's post about genetic testing become more readily available may actually be coming a lot sooner than expected. In fact, one company wants to sell "spit and check" test kits at your local drug store. Pathway Genomics already sells a "health report" test kit that  looks for over 70 indicators for disease and drug response for $400, but is in talks with Walgreens to sell the kit and service for under $300 in over 6,000 stores nationwide.

As one can expect, the Food & Drug Administration may have a problem with that. According to the Washington Post, the FDA is trying to decided whether or not the over-the-counter genetic test falls under their authority and requires approval. Critics are calling the test irresponsible and too vague to price useful health guidance, while supporters say that cheaper tests that are readily available will spawn a new era in biomedical sciences.

Healthcare reform is not going to be very pretty for insurance companies and employers who provide health insurance for their employees, but one provision in the Patient Protection & Affordable Care Act may relieve some of the pressure from both groups. Under the new law, existing health insurance plans will not have to adopt all of the changes required by the bill. In fact, most current healthcare plans may only see changes to lifetime insurance limits and banning the act of rescission. Grandfathering also means that current health plans may not see a change in co-pays for preventative care or a cap on out-of-pocket costs.

That's according to Kaiser Health news, who point out that if the grandfather provision is defined too broadly, that will give insurance companies the wiggle room they need to sidestep consumer protection laws. While the Obama administration is still developing regulatory rules that will determine the extent of grandfather provisions,  organizations like the U.S. Chamber of Commerce and America's Health Insurance Plans are pushing for a loose interpretation of the law that will allow businesses and insurance companies to make changes to current policies while still being protected from regulation. Consumer advocacy groups, as one can imagine, fear that a loose interpretation would allow insurers and employers to sidestep consumer protection provisions in the reform law. An official proclamation of policy is needed by this summer, as employers need to develop their health benefits for the next year.