Five U.S. senators asked the Inspector General of the Department of Health and Human Services to open an investigation into physician-owned distributorships, middleman entities that allow surgeons to profit from the medical devices they use on their patients, to determine whether they are legal. The senators' request was accompanied by the release of a Senate Finance Committee report compiled by the office of Utah Sen. Orrin Hatch, the top Republican on the committee, on the proliferation of such entities in spine and orthopedic surgery. Physician-owned distributorships, or PODs, now exist in at least 20 states, with more than 40 operating in California alone, according to the report. By creating "financial incentives for physician investors to use those devices that give them the greatest financial return," they may violate an anti-kickback statute and other federal fraud and abuse laws, the report warns. Distributorships act as links between medical-device makers and hospitals: In exchange for marketing and stocking the devices, they get a cut of each sale. When surgeons own a distributorship, that commission goes into their pockets.
A panel developing clinical and process measures for meaningful use endorsed the delay of stage 2 for one year until 2014. As a result, providers will have three years through 2013 in which to verify that they have met stage 1 meaningful use requirements. The delay is designed to avoid the train wreck that probably would result from the publication of the final rule for stage 2 requirements just several months before the provider reporting period would begin. The timing revision will only affect those providers who have attested to stage 1 in 2011. The delay is among the stage 2 recommendations that the Health IT Policy Committee approved at its meeting June 8 by an overwhelming vote of 12 to 5. The original 2013 timeframe does not give vendors enough time to design, develop, and test new functionality and providers to deploy it and report measures for one year, said Dr. Paul Tang, vice chair of the Health IT Policy Committee and chair of its meaningful use work group.
Pfizer Inc. is running the first U.S. clinical study in which patients participate by using mobile phones and the Internet, rather than repeatedly visiting a participating hospital. The study is a pilot project, approved by the Food and Drug Administration and known by the acronym REMOTE. The goal is to determine whether such "virtual" clinical studies can produce the same results as traditional ones that require patients to live near and regularly visit a hospital or clinic for an initial screening and multiple checkups. If it works, it could mean that patients all over America could participate in many future medical studies, allowing under-represented groups to take part, speeding up data collection and likely reducing costs and the rate of participants dropping out. FDA spokeswoman Karen Riley confirmed that this is the first such study in the country.
A proposed federal rule would require hospitals, doctors' offices and health insurers to tell patients of anyone who has accessed their electronic medical records, if requested.Under the rule proposed by the Department of Health and Human Services (HHS), health-care-related businesses must list everyone in their firms — from doctors to data-entry clerks — who has accessed a patient's electronic records and when."It is important to protect a person's right to know how their health information has been used or disclosed," said Rachel Seeger, spokeswoman for HHS' Office of Civil Rights. For example, in 2008, the UCLA Medical Center fired several employees who looked at Britney Spears' medical records without being directly involved in her care. Under the new rule, Spears could see who accessed her records.
The reaction to the 2009 U.S. Preventive Services Task Force recommendations that women in their 40s did not need routine mammograms was swift and furious. Using email, social networking sites and electronic bulletin boards, breast cancer survivors vented their outrage. Researchers say the magnitude of the reaction heralded a new era in the online exchange of health information -- one that's faster, fiercer and more powerful than before. The reaction to the task force's recommendations "was a great illustration of how two worlds collide," said Kristin K. Barker, a sociologist at Oregon State University, and lead author of a new study. "On the one hand, you had the science that was saying mammography for women in their 40s might not be as effective as we thought, and on the other hand, you had the personal experiences of the women who believed they were saved by having a mammogram."
An expert in tropical diseases will lead an elite team of researchers in establishing a unique center in Houston to study and develop vaccines for these afflictions, which affect millions of poor people worldwide. Peter Hotez, MD, who will join the staffs of Texas Children's Hospital and Baylor College of Medicine this summer, will serve as founding dean of a new, as yet unnamed, tropical disease research school at Baylor. It will be the only such institution in North or South America, said Hotez, who was in Houston for the announcement Wednesday. He is chairman of the Department of Microbiology, Immunology, and Tropical Medicine at George Washington University in Washington, D.C., and president of the nonprofit Sabin Vaccine Institute, named for polio vaccine developer Albert Sabin, MD. More than 20 researchers with the Sabin Institute's vaccine-development arm will come to Houston with Hotez. Other functions of the institute will remain in Washington.