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ACP, AMA Back 'Partnership' Bill

States would get federal support to experiment with covering the uninsured and pursuing disease management strategies under the bipartisan Health Partnership Act (S. 2772). The bill was introduced last month and has the support of the American College of Physicians, the American Medical Association, and the National Association of Counties, and would establish a Health Care Expansion and Improvement Commission at the Health and Human Services department. The commission could approve a variety of options that states could pursue to expand access to health care, including tax credit expansions, expansions of Medicaid or State Children's Health Insurance Programs (SCHIP), creation of pooling arrangements, single-payer systems, and health savings accounts. If the legislation were enacted, it would allow states to do an “end run” around Washington's gridlock on covering the uninsured, said Robert B. Doherty, senior vice president, government affairs and public policy, for ACP. Like the physician's code of “first, do no harm,” the experiments could not result in diminished coverage for anyone, Mr. Doherty said.

More Employees Decline Coverage

More Americans are declining their employers' offer of health insurance as premiums continue to rise, according to a study by the Robert Wood Johnson Foundation. Approximately 3 million fewer workers who were eligible for employer-sponsored health insurance enrolled in 2003, compared with 1998. The national increase in individual premiums from 1998 to 2003 was $1,027, a 42% increase after adjustments for inflation. In 1998 dollars the amount was $2,454; with the adjustment it stood at $3,481 in 2003, the foundation said in a statement. States with the biggest percentage drops include New Jersey, −12%; Nebraska, −11%; Wisconsin, −9%; Colorado, −9%, and Iowa, −9%. The survey used trend data from 1998 to 2003 from the federal Medical Expenditure Panel Survey-Insurance Component, collected and distributed by the Agency for Healthcare Research and Quality (AHRQ).

Off-Label Scrips Common

More than one in five prescriptions (21%) for commonly used medications were written for off-label indications, according to a nationally representative study. Further, 15% of those off-label prescriptions lacked any scientific evidence of efficacy, David D. Radley of Dartmouth University, Hanover, N.H., and his colleagues wrote in the Archives of Internal Medicine. Off-label prescription was rare among medications for glycemic control in diabetes (less than 1%), infrequent among analgesics (6%), and in drugs to lower lipid levels (7%). Off-label prescription was most common among cardiac drugs (antianginals, 46%; antiarrhythmics, 39%; and anticoagulants, 46%) as well as anticonvulsants, 46%; and asthma drugs, 42%. “Off-label prescription with limited or no scientific support was more common than supported off-label use in all therapeutic classes except diabetes therapies,” the authors wrote. However, many of the off-label prescriptions “represent a logical extension of the FDA-approved indications.” Off-label prescribing can lead to innovative treatments, but “policy makers must begin to consider strategies for mandatory postapproval surveillance” to curtail dangerous or wasteful practices, the authors concluded. The study was supported by AHRQ.

Medicare Formulary Guidance

If officials at a Medicare Part D drug plan change the preferred or nonpreferred formulary drugs, remove dosage forms, or exchange therapeutic alternatives, they must allow beneficiaries currently taking the drug to be exempt from the changes for the rest of the year, according to guidance from the Centers for Medicare and Medicaid Services. Abby L. Block, director of the CMS Center for Beneficiary Choices issued a memo to Part D sponsors in April outlining policies for formulary changes made after a beneficiary has signed onto a plan at the beginning of the plan year. In addition, Part D plans can only change therapeutic categories and classes in a formulary at the beginning of each plan year, except to account for new therapeutic uses or newly approved drugs. CMS also noted that after March 1, Part D drug plans are only allowed to make “maintenance changes” to their formulary, such as replacing a brand name drugs with a new generic drug. All proposed formulary changes, except for expansions, must be submitted to CMS for review and approval, according to the memo. “Prescription drug therapies are constantly evolving, and new drug availability, new medical knowledge, and new opportunities for improving safety and quality in prescription drug use at a low cost will inevitably occur over the course of the year,” Ms. Block said in the memo to Part D sponsors.

Rare Disease Studies

Officials at the National Institutes of Health have launched the first clinical studies that are part of its Rare Diseases Clinical Research Network. The network has received a total of $71 million in 5-year funding awards to study rare diseases. In the next few months, more than 20 studies are expected to open in sites around the world. In one example, an investigator at the Johns Hopkins Vasculitis Center in Baltimore will conduct a study of giant cell arteritis. “By studying the genetic component of these rare diseases, we hope to be able to better predict the course of the illnesses and provide more effective, personalized treatments for those afflicted,” Dr. Elias A. Zerhouni, NIH director, said in a statement.

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