The United States Supreme Court, in a unanimous opinion written Justice Sotomayor, overturned an Eleventh Circuit Court of Appeals and Georgia District Court finding “state action” antitrust immunity in the case of FTC v. Phoebe Putney Health System, Inc. et al, No. 11-1160. Had they ruled otherwise there would have opened a huge whole in the FTC’s ability to regulate anticompetitive conduct by state sub-entities under a general grant of state authority. Georgia like many states has a hospital authorities law that permits counties and or municipalities to create quasi governmental entities with broad grants of powers to operate health care facilities.
The Obama Administration recently announced the formation of the “Brain Activity Map Project” to be funded by the National Institutes of Health and other public and private foundations and organizations to undertake a ten year study of the human brain. The effort, which is similar to the organized effort to map the human genome is expected to cost at least 300 million dollars a year over the ten years. It is anticipated by scientists that it will be much for complex and difficult to undertake than the genome project. The hope is to develop a complete model of brain activity and the process of neuron firings that lead to cognition.
The United States Supreme Court will decide the question of whether genes are patentable in the coming term. The decisions has broad implications for the biotechnology industry, for researchers and for patients. The case at hand is Association for Molecular Pathology v. Myriad Genetics, Inc. originally filed in the U.S. District Court for the Southern District of New York by the ACLU and the Public Patent Foundation. The object of the case is to challenge a number of patents granted to Myriad, a Utah biotechnology company, by the U.S. Patent and Trademark Office. The patents granted were on DNA isolated from two human genes that increase the risk to women for breast and ovarian cancer.
The Institute of Medicine and the National Research Counsel announced the pre-publication release of their report on their recent comparison of health care data between the U.S. and 16 other countries which crosses all age categories. The other countries include Canada, Japan, Australia, Germany, Austria, Denmark, Finland, Norway, Portugal, Sweden, Switzerland, the Netherlands, the United Kingdom and Spain. This is a fascinating read entitled U.S. Health in International Perspective: Shorter Lives, Poorer Health is currently available to read on line for free at the National Academies Press website. The U.S. generally finished near the bottom in most categories for the population under the age of 75. Our post 75 population, outscores their peers elsewhere.
160 Common U.S. Food and Drug Administration (“FDA”) approved drugs which are used for “off label” purposes represent approximately 21 percent of all prescriptions in the United states. Physicians may prescribe FDA approved drugs for any therapeutic use that is appropriate in their medical judgment. The FDA, however, prohibits pharmaceutical companies and their employees from promoting the use of FDA approved drugs for “off label” use. Although there is no express prohibition in the Food Drug and Cosmetic Act or its regulations prohibiting the promotion of drugs for off label use, the government uses a criminal statute which prohibits the introduction of “misbranded” drugs into interstate commerce ( 21 U.S.C. 331(a) and 333(a)(1) to prosecute pharmaceutical companies, their employees and sometimes physicians who are “promoting” the off-label use of drugs.
In holding with the minority liberal wing of the court that the Affordable Care Act is constitutional as a tax, Justice Roberts seems to have concluded that the wholesale sinking of the Act by the Supreme Court was “a bridge too far” for the conservative majority which stopped the vote recount in Florida before it was completed, effectively anointing George W. Bush President of the United States on legal grounds not used before or since. That of course brought us 2 middle east wars on a credit card that we are just beginning to pay and the worst financial crash since the Great Depression.
If the Supreme Court decides to tank the Affordable Care Act and returns us to the past system, James Carville may just be right that it will be a long term boon for Democrats. Health Care costs rose from 12% to 17% of GNP from the 1970s to the present. An estimated 45,000 uninsured die each year over inadequate health care. The uninsured population is approaching 50,000,000. People with pre-existing conditions will continue to be uninsurable. Insurance companies will continue to make money but denying coverage to keep their medical loss ratios low and their stock prices and bonuses high.
Cost shifting will continue to be the major financing vehicle for hospitals and physicians to cover deficits in service shortfalls in funding from Medicare, Medicaid and the uninsured care. Medical bankruptcy’s will continue to grow from the current 60% of bankruptcy’s. The cost of private insurance will continue to climb as the consolidation of hospitals exercise increasing leverage to cover their costs and gain a tidy profit. The number of uninsured will continue to rise as employers continue their effort to shift the cost increases to individual employees.
Modern biotechnology now makes possible issues that were not contemplated by Congress in the adoption of the Social Security Act. One of those issues is whether a child conceived by artificial insemination a year after her father’s death is a “child” of her father entitled to survivor benefits under the Social Security Act. The 9th U.S. Circuit Court of appeals earlier ruled “yes.” In the recent ruling in Beeler v. Astrue, the 8th U.S. Circuit Court of Appeals ruled “no”, overturning a lower, trial court decisions and affirming the final decision of the Commissioner of Social Security.
It seems counterintuitive and contrary to the overwhelming majority of articles and studies, but the New York Times today reported on a study recently appearing in Health Affairs that suggested that the switch to electronic medical records resulted in a 40 percent increase in tests, most of the MRI and CAT scan variety. The study, based upon the analysis of a 2008 survey by the National Center for Health Statistics, performed for an entirely different purpose, and has questionable design. The study followed 28,888 patient visits and 1100 physicians and claims to have a more National perspective. The authors of the study suggest that most earlier studies are based upon statistical models of expected savings like those undertaken by the RAND Corporation and the study of flagship integrated systems like Kaiser, rather than on national utilization data.
The Texas Sonogram abortion case returned to Judge Sam Sparks in the U.S. District Court last week after his finding that the Texas law requiring physicians performing abortions to show pre-abortion patients copies of sonogram images and to listen to fetal heartbeats 24 hours before performing the procedure was unconstitutional. The Fifth Circuit U.S. Court of Appeals overturned Judge Sparks in January. The case, Texas Physicians Providing Abortion Services v. David Lackey, M.D., built upon the U.S. Supreme Court decision in Planned Parenthood of Southeast Pennsylvania v. Casey,which upheld the right to abortion, but affirmed the state’s “informed consent” requirement that certain information be provided to the woman first.
