President Bush Signs Bill to Increase FDA's Regulatory Oversight
New legislation will give the U.S. Food and Drug Administration (FDA) increased regulatory oversight, especially over products already on the market. The FDA will receive additional resources and authority to monitor approved drugs and medical devices, provide the public with online access to research about medical products, and limit distribution and alter labels for approved products that pose health risks. The measure aims to help ensure patient safety; this comes after widely used products have been shown to cause life-threatening illnesses in recent years. Consumer advocacy groups argue, however, that the bill does not go far enough to guarantee that the FDA's priority remains patient safety and not the organization's relationship with pharmaceutical companies. These groups had hoped for legislation allowing the FDA to monitor direct-to-consumer advertising. Those in the pharmaceutical industry counter that the measure is a good bipartisan compromise that will benefit health care consumers. For more information, visithttps://www.aafp.org/news-now/government-medicine/20071001fdaoversight.html.
AAFP Congress Debates Health Care Issues, Focuses on Children's Health
The American Academy of Family Physicians' (AAFP's) Congress of Delegates made children's health a top priority last month at its 2007 Scientific Assembly in Chicago, Ill. Two youth-related resolutions were introduced urging the academy to endorse school-based fitness and health programs, although it was determined that further study was needed on the topic. The delegates also voted to support an expanded Tar Wars program aimed at curbing tobacco use, including making the program more visible to policy makers. Other important issues for debate included retail health services and rural health care. The delegates passed resolutions to confirm that the academy does not endorse retail health clinics and to establish a working group on rural health care. Although there was some disagreement about the Family Smoking Prevention and Control Act, which gives the FDA authority to regulate tobacco products, the delegates ultimately called on AAFP to support measures that allow the FDA to use any means to help stop and prevent tobacco use. The delegates also expressed the need for change in insurance payment practices, specifically improvement in mental and women's health coverage. For more information, visithttps://www.aafp.org/news-now/annual-assembly/20071005tarwarscod.printerview.html,https://www.aafp.org/news-now/annual-assembly/20071005codretailruraltobacc.html, andhttps://www.aafp.org/news-now/annual-assembly/20071004congressonhealth.printerview.html.
Senate Proposal Would Call for Expansion of Medical Home Project
The Senate Finance Committee is expected to introduce a proposal to expand the Medical Home Demonstration grant program, overseen by TransforMED. The program helps physicians transition to a new model of care that focuses on the patient-centered medical home. Representatives from the AAFP, American College of Physicians, and American Osteopathic Association met with committee members to discuss the proposal. At AAFP's 2007 Scientific Assembly, TransforMED announced that initial data show that the Medical Home Demonstration grant program has a positive impact on patients and physicians, although barriers to change remain a challenge. According to TransforMED, aspects that are important for a successful transition to the new model of care include: meaningful outcome analyses; participation from everyone in the practice (e.g., administrative staff, nurses, laboratory technicians); and preparation for change. For more information, visit:https://www.aafp.org/news-now/government-medicine/20071002medhomedemo.html andhttps://www.aafp.org/news-now/annual-assembly/20071008transformeddemo.html.
Senate Passes Bill to Ensure Parity for Mental Health Coverage
A bill (S.B. 558) recently passed in the Senate would require insurers to cover mental and physical illnesses equally, including parity for deductibles, copayments, annual and lifetime expenditure limits, and treatment limitations. The bill would only affect companies that already provide mental health coverage and have at least 50 employees. State mental health parity laws would take precedence, and the new legislation allows for exemptions if mental health and substance abuse costs exceed a certain limit. Although the bill would not require insurers to provide mental health coverage, it would ensure that those who do provide the coverage are not more restrictive with mental health coverage than with medical or surgical coverage. Proponents of the bill contend that it would improve coverage for more than 100 million Americans. The House passed a similar bill (H.R. 1424), although it addresses a broader range of health conditions and out-of-network benefits. For more information, visithttps://www.aafp.org/news-now/government-medicine/20070926mentalhealthbill.html.
Bill Reducing Long-Term Student Debt to Benefit Medical Residents
A new bill (H.R. 2669) that makes important additions to the Higher Education Act will reduce medical school loans. Although it is unclear how the bill will affect current medical students nearing their residencies, the final legislation, signed by President Bush, introduces two initiatives to reduce long-term debt: an income-based repayment program and a loan-forgiveness program for direct loans and loan consolidation. The repayment program caps required monthly payments based on income, substantially decreasing what a student owes each month. Although the current economic hardship program allows students to defer loan payments, more medical residents will qualify for the income-based repayment program and will be able to begin paying off loans immediately after graduation. The loan-forgiveness program allows for partial government forgiveness or repayment if the student has been making loan payments for 10 years while working in the public service, public health, or nonprofit arena. For more information, visithttps://www.aafp.org/news-now/resident-student-focus/20071002debtrelief.html.
AAFP Launches Strategic Plan Reaffirming Commitment to Advocacy
A redesigned seal and a two-year, $5 million advertising campaign launched the AAFP's strategic plan. The plan focuses on championing initiatives on behalf of physicians and reaching legislators, insurers, employers, and health care consumers. The plan's launch comes after members expressed the increasing need for advocacy. The advertisements, which highlight the importance of family medicine, its role in health care reform, and the need for a patient-centered approach to health care, will run in several national media outlets, including USA Today, The Wall Street Journal, The Washington Post, Forbes, Fortune, public radio, and online news sources such as CNN.com and ABCNews.com. Other initiatives under the new plan include a medical home symposium for policy makers, purchasers, and employers; research on the effects of the new practice model; and an online action center to get health care consumers involved in family medicine advocacy. For more information, visithttps://www.aafp.org/news-now/annual-assembly/20071004adcampaign.html andhttps://www.aafp.org/news-now/annual-assembly/20071003newbrand.html.
Manufacturers Send Unclear Message About Hepatitis A Vaccine Availability
Although Merck has temporarily halted taking orders for its hepatitis A vaccine, GlaxoSmithKline, the only other manufacturer of the vaccine in the United States, says they have a good supply of their hepatits A vaccine for children and adults and their hepatitis A/hepatitis B combination vaccine for adults, and will be able to meet the demand for these products. Merck announced in August that the company was experiencing production delays for its hepatitis A vaccines for children and adults, resulting in backorders for these products; however, officials with the company estimate that they will resume providing the hepatitis A vaccine late in the first quarter of 2008. The Centers for Disease Control and Prevention (CDC) notes that changes in recommendations for hepatitis A vaccination are not currently needed. For more information, visit:https://www.aafp.org/news-now/clinical-care-research/20071002hepavacc.html or the CDC's Current Vaccine Shortages & Immunizations Web page,http://www.cdc.gov/vaccines/vac-gen/shortages/default.htm.
CCHIT Offers Guide to Ambulatory EHR Software Certification
The Certification Commission for Health Information Technology (CCHIT), the official certification body for electronic health record (EHR) products, has released a revised list of criteria for certification. An online guide, “2007 Physician's Guide to Certification for Ambulatory Electronic Health Records,” is available to inform physicians of the nearly 100 additions to the criteria and to highlight the benefits of EHR certification (http://www.cchit.org). The criteria ensure that products meet basic requirements for functionality, interoperability, and security. EHR products that are certified using the new criteria must provide an electronic prescription refill option and a standard format for laboratory results, facilitate identification of drug interactions, and offer strong security protection for patient records. Although some companies claim to be “CCHIT-compliant,” only products with the CCHIT-certified seal have been certified by the commission. For more information, visithttps://www.aafp.org/news-now/practice-management/20070925cchitcertguide.html.
—AFP and AAFP NEWS NOW staff
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