American College of Physicians: Internal Medicine — Doctors for Adults ®

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In the News for the Week of 7-19-05

Clinical news in the headlines

FDA update

  • FDA orders painkiller Palladone off shelves over safety concerns

Medicare news

  • Many seniors could face coverage gap in first year of drug benefit

Managed care

Health care costs

College news


Clinical news in the headlines

Highlights of Annals of Internal Medicine

The following articles appear in the July 19 issue of Annals of Internal Medicine. Full text is available to College members and subscribers online.

  • Survey shows adults took vitamin E despite possible risks. Results from a 1999-2000 national survey found that 12% of U.S. adults, or 24 million people, consumed high doses (at least 400 IU daily) of vitamin E supplements, despite evidence that those supplements are ineffective and possibly harmful.

    Researchers refer to several recent clinical trials showing that high doses of vitamin E are associated with increased risk for premature death. An accompanying editorial points to other recent studies, showing that high doses of vitamin E do not prevent or lower risk for heart disease, cancer, Alzheimer's disease or amyotrophic lateral sclerosis. Based on this research, the editorial advises people to avoid high doses of Vitamin E.

  • Test results pending after hospital discharge often languish. A study of hospitalist services at two hospitals found that more than 40% of 2,644 discharged patients had pending laboratory and radiological test results. Of those, 9%—about 191 patients—had results indicating the need for urgent clinical action, such as starting or changing antibiotic therapy.

    Of 105 hospital physicians who responded to a survey, 65 were unaware of those results and 31 didn't know the tests had been ordered. Researchers say that despite the small numbers in the study, findings suggest the need for a highly reliable system of ensuring follow-up of hospital test results.

  • Study: Medicare would save money, improve care, by paying full cost of ACE inhibitors for diabetics. A new cost-effectiveness study finds that Medicare would save money and improve patient outcomes by covering 100% of the costs of ACE inhibitors for people with diabetes.

    ACE inhibitors are underused by elderly diabetic patients, with some studies finding that these patients cut use of essential drugs as their out-of-pocket drug costs rise.

    Currently, fee-for-service Medicare does not pay for medications. Researchers used a computer model to compare three scenarios: current practice (no Medicare coverage of medications); coverage under the new Medicare drug benefit to be implemented in 2006 (shared costs); and full coverage of ACE inhibitors for patients with diabetes. They found that if full coverage increased ACE inhibitor use by just 7.2%, it would save Medicare money and improve outcomes for diabetic patients.

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FDA update

Painkiller shelved after study reveals serious risks

The FDA last week ordered the makers of hydromorphone hydrochloride to remove the narcotic painkiller from the market after determining that the extended release tablets could be fatal when combined with alcohol.

Studies by manufacturer Purdue Pharma L.P., which markets the extended release tablets as Palladone, revealed that people who took the drug and also consumed alcohol were at risk for serious and potentially fatal adverse reactions, a July 13 FDA news release reported. New data show that the extended release mechanism is damaged when the pills are taken with alcohol, the FDA said. That can cause dose-dumping, a rapid release of the active ingredient into the blood stream that is potentially fatal even at the lowest marketed dose of 12 mg.

The 24-hour extended release pill was the first of its kind when the FDA approved it last September to treat chronic pain, said the July 14 Washington Post. While there have been no reports of serious problems, the FDA release said, the agency was concerned that safety problems would emerge as more people started taking the drug.

The action comes amid concerns about abuse of other prescription narcotics such as oxycodone hydrochloride (Purdue Pharma’s Oxycontin), the Washington Post noted. Controversy has arisen on how to control the abuse of these drugs while still making sure they are available to patients who need them.

Purdue Pharma said it informed the FDA about the potential danger in November 2004, two months after it had been approved, but the drug didn't go on the market until February 2005, said the Washington Post. The company has plans to reformulate the drug and reintroduce it, pending further talks with the FDA.

The FDA news release is online.

The Washington Post is online.

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Medicare news

Many seniors will hit coverage gap in first year of new drug benefit

A study released last week reported that almost 40% of enrollees in Medicare’s new drug benefit starting next year will face significant gaps in prescription drug coverage.

The Commonwealth Fund-sponsored study found that in the first year of the benefit, 38% of enrollees in Medicare’s Part D prescription drug plan will be subject to the “doughnut hole,” a July 12 Commonwealth Fund news release reported. That is the term used for a coverage gap in which enrollees must pay all drug costs themselves. The study appears in the July/August issue of Health Affairs.

Under the new benefit that will start in 2006, Medicare will pay 75% of the cost of enrollees' drugs, subject to a $250 deductible, up to a limit of $2,250. Enrollees then enter a no-coverage gap during which they pay 100% of drug costs up to a catastrophic limit of $5,100, after which Medicare assumes 95% of costs.

Over three years, enrollees’ out-of-pocket costs will reach 44% of their total drug spending, on average, the release said. Those who spend the most on drugs could be required to pay up to 67% of their costs.

While about 20% of enrollees will be eligible for low-income subsidies, according to the release, many beneficiaries will not have the option of buying additional coverage to bridge that coverage gap. The report noted that new Medigap policies will not offer drug benefits, and other private coverage will not count toward reaching the catastrophic limit.

The Health Affairs abstract is online.

The Commonwealth Fund news release is online.

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Managed care

Physicians applaud WellPoint settlement over billing dispute

WellPoint Inc. agreed last week to a $198 million settlement with physicians and medical societies to resolve disputes over billing practices, a deal that may result in significant changes in the way managed care companies pay medical claims.

The settlement by WellPoint, the nation’s largest health insurer with almost 29 million members, was hailed as a victory for doctors who have struggled to have more say over treatment decisions, according to the July 12 Washington Post. The agreement also allows for small back payments to about 700,000 physicians.

The agreement, filed last week in U.S. District Court in Miami, is the fifth to come out of a larger class-action suit filed in 2000 against 10 managed care companies by physicians and state medical societies, the Washington Post said. Together, WellPoint, Aetna, Cigna, Prudential and HealthNet have agreed to settlements totaling $590 million in cash, with an additional $40 million dedicated to nonprofit groups that work on quality improvement.

The agreement creates an independent appeal process for denied claims; requires insurers to notify doctors of reimbursement rates for specific procedures; and eliminates “downcoding,” where insurers downgrade billed procedures and pay claims at a lower rate, said the Washington Post. All five settlements have the effect of returning more decision power to physicians, the article claimed, who can decide which treatments are medically necessary.

Some analysts interviewed predicted that WellPoint will increase premiums to cover the cost of legal fees, payments and new billing systems, estimated at $450 million over several years. WellPoint, which recently merged with Anthem Inc., has BlueCross/Blue Shield subsidiaries in 13 states.

The Washington Post is online.

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Health care costs

State study cites high cost of hospital infections

A first-of-its-kind report released last week on the impact of hospital infections found that infections significantly increased hospital stays, deaths and the cost of care.

The report by the Pennsylvania Health Care Cost Containment Council, an independent state agency, found that 11,688 hospital patients in the state acquired infections during their treatments in 2004, resulting in a combined 205,000 extra days in the hospital, said the July 13 Philadelphia Inquirer. The report, which looked at more than 1.5 million admissions, also found that 1,793 patients who acquired infections died—about 1,500 more than expected.

The report, which was the first public analysis of hospital-reported infections by any state, found that complications related to infections added almost $350 million to the cost of care last year, the Philadelphia Inquirer reported. The council based its analysis on hospital reports of surgical site infections for orthopedic procedures, neurosurgery and cardiovascular surgery, as well as on reports of urinary catheter, ventilator and bloodstream infections. Pennsylvania is one of only a few states that require hospitals to report infections.

The report also pointed to problems with the accuracy of hospital reporting, noting that 16 hospitals reported no infections, said the Philadelphia Inquirer. The state hospital association responded by citing problems with the report, noting that some infections and deaths may have been the result of cancer treatments, for example, that would make a patient more susceptible to infection.

The Pennsylvania Health Care Cost Containment news release is online.

The Philadelphia Inquirer is online.

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Expensive drugs, services driving high cost of U.S. health care

Higher prices for health services—not malpractice costs or access to care—are the main culprits contributing to the high cost of health care in the United States, according to a report released last week.

According to findings, the United States spent $5,267 per capita on health care in 2002, 53% more than in Switzerland, the next highest spender, and 140% more than the median per capita cost among the 30 countries in the Organization for Economic Cooperation and Development, according to a July 12 Commonwealth Fund news release. The report was sponsored by the nonprofit Commonwealth Fund.

The study concluded that higher prices for prescription drugs, hospital stays and physician visits were the main reasons for higher U.S. costs, the release said. The authors rejected commonly-held explanations for the difference in spending here vs. in other countries. Rejected explanations include the argument that other countries achieve lower spending by restricting supply, which leads to waiting lists, and that the greater threat of litigation here drives up premiums and forces doctors to practice defensive medicine.

The new study builds on a 2003 Commonwealth Fund-sponsored paper, said the July 12 Los Angeles Times. That study reported that the average cost of a one-day stay in a U.S. hospital was $2,434 in 2002, compared with $807 in Canada.

Other findings from the latest survey indicate that Americans are not getting better care for all the money being spent, the Los Angeles Times reported. For example, the average number of CT scanners per capita was lower here than elsewhere, as was the number of hospital beds, physicians and nurses per capita. The study appears in the July/August issue of Health Affairs.

The Health Affairs abstract is online.

A Commonwealth Fund news release is online.

The Los Angeles Times is online.

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College news

ACP to HHS: Consider small practice needs in proposals for information technology

The College has asked the HHS Secretary to ensure that medical societies will have a prominent role in helping determine national health information technology standards. The College also asked the HHS to give more consideration to the needs of small and medium-sized practices when selecting bidders for proposals to build a national health information technology network.

In a letter dated July 5 and sent to the HHS secretary, the College noted recent requests for proposals issued by the HHS to develop standards of interoperability for information technology. Among several items requested, the College wants bidders for those contracts to ensure that physician membership associations can help define and set priorities on national interoperability standards.

The letter was signed by the American Academy of Family Physicians, the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists, as well as by ACP. The four organizations represent 300,000 physicians and medical students.

The letter also noted that winning contract bids should make sure that interoperability standards reflect the needs of internists. Physician experts in information technology must help identify specific clinical scenarios that need to be addressed through standards that facilitate, collect, manage and secure transmission of patient data, the letter said.

The letter also asked the HHS to ensure that all stakeholders monitor, review and comment upon all project levels, once contracts have been awarded. Transparency in the process is the best way to encourage physicians to move ahead with purchasing these technologies, the letter said.

The HHS plans to award several contracts for developing and maintaining standards this fall and another next year.

The letter is online.

More information about the requests for proposals is online.

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