Embryo 'Adoption' Called Misleading
Using the term adoption rather than donation of embryos is misleading, inaccurate, and potentially harmful to infertile patients, according to a new report from the ethics committee of the American Society for Reproductive Medicine. While embryos should be given “elevated moral status,” compared with other human tissues, they should not be equated with persons, the committee said. Currently, the Food and Drug Administration regulates embryo donation the same way it does other human-tissue donations. Were the process regulated more like the adoption of a child, it would probably entail home visits, legal fees, and judicial review. The committee determined that such requirements are unethical burdens on infertile patients seeking embryos. “We have long had guidelines on embryo donation that address the clinical aspects of the process,” Dr. William Gibbons, the society's president, said in a statement. “This report simply clarifies that embryo donation is in fact a clinical process and should be treated as such.” The report was published in the December issue of Fertility and Sterility (Fertil. Steril. 2009;92:1818-9).
NIH Approves New Stem Cell Lines
Officials at the National Institutes of Health have approved 13 additional human embryonic stem cell lines eligible for federal funding, the first since the Obama administration liberalized the government's stem cell policy last July. Children's Hospital Boston developed 11 of the approved stem cell lines. The other two are from Rockefeller University, New York. Approved lines are listed on the NIH Human Embryonic Stem Cell Registry and may be used in NIH-funded research. Under the new policy, researchers can use stem cells derived from embryos that were created through in-vitro fertilization for reproductive purposes and then donated for research. However, researchers can not offer payments for donation and they must obtain informed consent at the time a donors release the embryos. More lines are under review, and NIH is expected to continue to expand its list. The human stem cell research guidelines are available online at
http://stemcells.nih.gov/policy/2009guidelines.htm
Mastectomy Costs Rising Quickly
The costs for mastectomy in the United States rose 24% between 2004 and 2007, to $660 million, making it one of the 10 procedures experiencing the most rapid cost increases during that time, according to the Agency for Healthcare Research and Quality. Agency researchers also found that hospital stays for mastectomies increased only 3.6% during those years. The main driver of the cost increase is the growth in the mean cost per stay for the procedure, according to the agency's report. The other procedures experiencing the most rapid cost increases were bone marrow transplant; open prostatectomy; aortic resection, replacement, or anastomosis; cancer chemotherapy; spinal fusion; lobectomy or pneumonectomy; incision and drainage of skin and other tissues; knee arthroplasty; and nephrotomy and nephrostomy.
Medicare Covers HIV Screening
Medicare patients will now be able to get HIV screening tests as covered benefits. In December, the Centers for Medicare and Medicaid Services added HIV testing to the approved list of preventive services. “Every adult should know their HIV status,” Dr. Howard K. Koh, assistant secretary for health at the Department of Health and Human Services, said in a statement. Under the Medicare Improvements for Patients and Provider Act, passed in 2008, a preventive service must have been recommended by the U.S. Preventive Services Task Force to make Medicare's coverage list.
Adverse Event Reports Go Unused
The Food and Drug Administration's Center for Devices and Radiological Health fails to use adverse event reports in a systematic manner to detect and address medical device safety problems, a report from the HHS Office of the Inspector General found. Manufacturers and medical facilities are required to promptly submit reports to the FDA center following adverse events, which can include deaths, serious injuries, and device malfunctions. But the center has no documentation of following up on these events, and it fails to read most reports in a timely fashion, according to the report. Meanwhile, reports of problems with medical devices are increasing, the Inspector General's office found: The FDA center received about 73,000 adverse event reports in 2003 but more than 150,000 in 2007. The Inspector General recommended that the center develop better protocols for reviewing and tracking the reports.
Provider Fraud Most Common
By far, most health care fraud (80%) involves providers' systematically overcharging public or private insurers, according to a report from researchers at George Washington University, Washington, and the National Academy for State Health Policy. The study found that these schemes disproportionately target demographic groups who are likely to be enrolled in Medicare and Medicaid. However, the study found that fraud information on the public programs is frequently confused with payment-error data. The authors recommended stronger laws governing insurance marketing, enrollment, claims payments, and antifraud procedures.