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The FDA is beginning to get into the regulation of single lab tests. They already deem tests sold to multiple parties are medical devices and come under their scrutiny. The tests are complex and usually involve genes or proteins. The problem is the tests run by one company and sold directly to the consumer may be priced out of the market by FDA fees. If not priced out of the market, the fees to the patients will go up in order to pay the FDA fees. An example of one of the tests is Genomic's Oncotype DX which helps decide the efficacy of chemotherapy on breast cancer. It now costs $3500 and it potentially could go up another thousand or more per test to pay for the FDA requirements. Top
California is now investigating the University of California Irvine's heads of the anesthesia program. There are multiple tensions in the department and the staff physicians are complaining about patient safety. Some of the professors are considering a petition to protest the conditions of the anesthesiology department. The have been formal complaints that consents have not been signed prior to surgery and nurses signatures have been forged later. The vice chair of the department has already resigned her position but remains on the staff.
Dr. Reddy Reganti of Great River Medical Center in West Burlington, Iowa along with his wife and another radiation oncologist were accused of using too much radiation on patients. The physician had to pay a $10,000 fine and undergo a competency evaluation as well as having his work reviewed by another physician. The other radiation oncologist surrendered his license and went back to India. Top
Not all is well in the People's Republic of Massachusetts. The insurers in the state are finished asking and are now pleading with the state to give them guidance for the new low cost plans. They are supposed to come on line next year but can't without lead time to figure out what is covered and how much it will cost. The people who are being targeted for the new plan don't know about it. The State is now focusing on the October 1 deadline for very low income people to go to Medicaid HMOs. After that they will go on to the people without insurance who make over 300% of the poverty limit. There also need to be technical corrections to the bill that effect the insurance industry. The plan is to be able to start selling the insurance products by April first so the people will not be penalized as is in the law if they don't have insurance by July 1.
California's Democratic legislature has passed a bill for a state run Universal Health Care. This has been vetoed by the Governor and the legislature does not have the votes to override. The bill is supported by the last bastion of unionism in the country and would cost billions of dollars in new taxes. The actual cost was not in the bill and would have to be put in along with the financing by 2009. This plan has already been rejected once by the California voters in 2004. Top
Britain's Human Tissue Act
Britain has passed a law that state a person's wishes regarding transplant organs supercede those of the relatives if they have a signed donor card. Prior, families could prevent tissue from being used for transplants if they did not want it done no matter what the deceased intended. The new law it will be an offence to remove and store tissue without consent. It will also be illegal to remove and test genetic material without consent.
California is now looking into the failed execution of a murderer due to the refusal of two anesthesiologists to take part. The backup anesthesiologist "A2" was only told he was supposed to be in the room with the murderer an hour prior to the time of execution. He balked. The killer's attorney may attempt to call the two anesthesiologists to testify over the objection of the State.
The federal law states that if you want funds for treating undocumented aliens you must get certain information. Most hospitals are forgoing that money and are refusing to ask the questions. The money hungry Maricopa Integrated Health System is asking at have received $2.5 million in the federal funds.
Providence Health Systems of Washington has done it's usual stonewalling. The system which does not enjoy a good reputation in the physician community for its harsh treatment of its physicians, has now been forced to pay for credit checks to its patients who want it for 12 months. This is because of a stolen computer that wasn't reported for several weeks. They also paid $95,700 to Oregon to cover investigation costs. The System must also do certain things for the future such as put in a written program for information security. Of course, the System admitted no wrongdoing but they were wrong. Top
Finally, Drew/King got what it deserves. The nation's worst hospital lost its Medicare and Medicaid funding. This will force the Board of Stupes to do something with the hospital. They will have to give it to someone to run since they are incapable or close it. In the last inspection the hospital failed nine of 23 conditions. This was the worst inspection report in the past three years. There is no appeal. This may be the end to the incompetent Board that oversees the hospital. The incompetent Board met the day the notice arrived and did nothing. They voiced their frustration but accomplished nothing except posturing. The community "leaders" staged the usual ineffectual march to have the Board appeal an unappealable decision.
The LA Board of Stupes are now leaning to allow Harbor-UCLA Medical Center to run the Drew/King hospital. Harbor is located 10 miles away from Drew/King. The major problem with this solution is that the inept Board of Supervisors will still have control. California will not offer any funds to the hospital. It will be interesting to see what happens to the Drew University part of the program with UCLA becoming in charge.
California has sent inquiry letters to four hospitals regarding their transplant programs. The University of Southern California received on regarding their liver program. They have lower survival rate in their Medicaid population than the standards allow. The University of California-Davis received one for their liver program which had 1.5 times as many deaths as expected. The California Pacific Medical Center heart program received one for having one year survivals lower than standards. Finally Sutter Memorial's heart program got one for not performing enough to maintain competency. Plans are due back to the state by September 29. San Diego's Sharp became the third transplant center ever as well as the third California hospital to have its transplant program put on probation. Sharp had its pancreas program placed on probation since it had done one in over one year but continued to add to its list. This effects all of Sharp's transplants programs until the pancreas program is back on track.
It is hard to believe the government will not cut off funding for the inept Kaiser Renal Services. It is probably because if they did it would have meant the end not only to the ill fated transplant program but to the dialysis program as well treated in San Francisco.
If you don't do community benefit and you are a non profit hospital, you lose. Provena Health Care lost their property tax exemption at their Champaign, Illinois, facility because they used too much force to collect money from the uninsured. Provena is a Catholic organizations and like other of the same ilk does not practice what it preaches. At the time of the original order in 2001 the hospital in Champaign was only providing 1% of its net patient revenues on charity care. That doesn't cut it. Top
The Joint has a new sentinel event that all hospitals that are still stupid enough to be accredited by the organization must comply with. The new one is under emergency management and states that there must be a certain number of of generator tests. The idea is good but the forcing is bad. Top
The political DEA has finally buckled to pressure by the physician community to undo their prior illegal rule that required physicians to have patients come in to the office for unnecessary visits every month to get a narcotic prescription. Now the DEA has said that a physician can write three one month prescriptions for the narcotic and post date two of them. They continue to state that physicians have nothing to worry about from the organization as long as they continue to practice as the organization sees fit. They recently lost a huge case against a pain physician that is making them eat some crow. That case forced the organization to put up and then takedown and disavow its FAQs. This is not an organization that one can turn one's back to or you will get a knife. Top
The OIG has stated its priorities for 2007. They are CMS' oversight of patient safety, payments for diagnostic x-rays, hospital admissions, outpatient department outliers and unbundling of hospital services. Top
The Governor has signed legislation that allows the Department of Health to pay either a per diem or bundled monies for pharmacies that provide home infusion services. Another bill signed will create a hospital infectious disease control program. Now all nursing home residents will enjoy the same rights as was originally only for federal funded residents. The people of California may now have electronic end of life directives. The State's pharmacists will now have to inform customers of their rights in obtaining treatments or devices if a pharmacist declines to fill a prescription for personal reasons.
The Governor also vetoed the bill that would give universal healthcare. Also vetoed was a bill that would have required health insurers to provide hearing aids for all under 18 years of age. The physicians of California that wish to care for Medicaid patients will have to undergo the same enrollment as always and not be allowed to have expedited processing. Top
DISCLAIMER: Although this article is updated periodically, it reflects the author's point of view at the time of publication. Nothing in this article constitutes legal advice. Readers should consult with their own legal counsel before acting on any of the information presented.