On February 16, Janssen Pharmaceutica Products announced that it is recalling a single manufacturing lot of its 75 mcg per hour strength of Duragesic patches (fentanyl transdermal system CII), which are used to treat moderate to severe chronic pain, because some patches may leak medication along one edge. The manufacturing lot being recalled is control number 0327192. The control number appears on both the outer carton and on each foil pouch that contains a patch.

The Bureau of Controlled Substances recommends that facilities licensed and certified by the Department of Health check all Duragesic 75 mcg. patches that have been dispensed to their patients pursuant to a prescription. The Drug Enforcement Administration (DEA) and Bureau of Controlled Substances recommend that facilities contact the dispensing pharmacy to arrange for the return of unused patches bearing control number 0327192.

The replacement of such unused patches does not require a new prescription from a physician.The Department of Health recommends that pharmacists make every reasonable effort to contact all patients who have been dispensed Duragesic 75 mcg per hour patch since December 15, 2003 to help ensure all patients are aware of this recall.

DEA and the Bureau of Controlled Substances recommend the return of such patches to the manufacturer or a licensed distributor, pursuant to a DEA 222 form and required record-keeping. Inquiries regarding the return or recall of Duragesic patches should be directed to Janssen Pharmaceutica at 1-800-526-7736. The company estimates that significantly fewer than 19,000 patches, or less than 5% of this lot, are affected by this problem. The affected lot was shipped to distributors in the US between mid-December 2003 and early January 2004.

On March 3, CMS informed the AMA that it will encourage physicians and other providers to submit HIPAA-compliant claims by July 1, 2004. Beginning July 1, carriers and intermediaries will not process non-compliant HIPAA electronic claims until the 27th day after receipt. This effectively would be a two week delay in the processing of such claims. CMS will continue to process HIPAA-compliant electronic claims in 14 days.

This four-month advance notice of the policy is intended to encourage those submitting electronic claims to become HIPAA-compliant if they have not done so already. CMS data indicates that about 68% of all claims that Medicare receives are already HIPAA compliant. Should physicians not make the conversion by July 1, their “legacy” claims would continue to be accepted, but they would take longer to process.

An FDA advisory panel voted 16-8 to recommend mandatory enrollment in a central registry system for all patients taking the acne drug Accutane. This is an effort to prevent pregnancies among women taking the drug, which is known to cause severe birth defects. Studies have shown that Accutane, which the FDA approved in 1982 to treat severe cases of acne, can cause severe side effects in pregnant women, such as birth defects and fetal death, and also might cause depression and suicide. Earlier this month, the FDA released data showing that strict measures enacted to reduce the number of birth defects related to Accutane, known generically as isotretinoin, have had little effect on the number of women who take the drug while pregnant. In April 2002, Accutane maker Roche started a program that requires doctors to place a yellow sticker on prescriptions to verify that female patients of childbearing age who were prescribed the drug had taken a pregnancy test and received a negative result. Pharmacists are not supposed to fill the prescription without the sticker. Makers of generic Accutane, which was first approved in November 2002, started similar initiatives. FDA found that in 2003, seven pregnant women were prescribed Accutane and another 120 women became pregnant after they started taking Accutane or a generic equivalent. Of those women, 48 elected to have an abortion, six had miscarriages and two gave birth to infants with Accutane-related birth defects. The registry system also would require that pharmacists not fill an Accutane prescription for a woman without a negative pregnancy test result and that they advise women to use two forms of contraception while taking the drug. In addition, doctors who prescribe Accutane and pharmacies that dispense the drug must be registered. Pharmacies also would be required to double-check that women are “properly cleared” before dispensing the drug.

On March 9, the New York Times looked at the “national surge in Medicare managed care” stimulated by the new Medicare law’s plan to pay an estimated $46 billion to HMOs over the next decade.

The federal government anticipates that Medicare managed care membership will triple during the next three years to 14.7 million people and that HMOs will cover more than one-third of seniors. According to the Times, the increase would represent “a drastic reversal” from the last few years in which managed care companies closed 411 local plans – dropping more than 2.4 million Medicare beneficiaries – because of complaints that they were “losing money at the government’s old reimbursement rates.” The new Medicare law’s “sharp rise” in payments to HMOs is prompting some managed care companies to expand, the Times reports. According to CMS, plans are “using about half the windfall from Congress to reduce premiums or add benefits,” the Times reports.

For example, in Hernando County, FL, Humana began offering again a Medicare HMO plan in the area on March 1, 2004, after eliminating a similar plan in December 2000. Executives at Humana, said that they are “confident” enrollees will “overcome bitter memories” with the company’s recruitment of 17 primary doctors and 75 specialists, brand name drug coverage and free health club memberships, the Times reports. HMO's will retain 0.6%, or about $200 million, of the additional money they receive from the Medicare legislation in 2004.

Charles Boorady, an analyst at Smith Barney, predicted an after-tax profit of between 2% and 5% of Medicare payments for publicly-held health insurers. However, he warned that after the presidential election, investors might start to “focus on the possibility for cuts in Medicare reimbursement, because of budget concerns” and some senior HMO enrollees might “switch back to traditional Medicare if the new prescription drug benefit looks attractive.”

The Young Physicians Section annual meeting is on Saturday, March 20, 2004 from 10 am to 3 pm at MSSNY headquarters. Pat Clark, a communications expert for the AMA, hospital associations, the press and television, will give her popular workshop on how to communicate effectively and think clearly while speaking with the public, including tips on message development, posture, dress and voice. Lunch will be served. There is no fee for MSSNY young physician members; nonmembers pay $50 (refundable with membership).

For further information, contact Sandy Bennett at sbennett@mssny.org or 516-488-6100 extension 383.

The 43rd Annual Medallion Ball
honoring Burton Glass, MD will be held on May 1, 2004 at the
Westbury Manor.

Ad placement in the Medallion Ball Journal is March 15. For more information call 832-2300 x14.

In recognition of World Tuberculosis Day (March 24, 2004) the Nassau County Department of Health has announced that the number of tuberculosis (TB) cases has decreased in Nassau County last year to the lowest number ever reported in the County. In 2003, there were 56 confirmed cases, or a rate of 4.2 cases per 100,000 people. The rate is down 14% from 2002 which had 65 confirmed cases, or a rate of 4.9 cases per 100,000 people. In the past decade, the rate decreased 47% from 1994, which had 115 confirmed cases or a rate of 8.9 cases per 100,000 people.

TB remains a significant problem in Nassau County and is disproportionally high in the foreign born, in people living in poverty, and in minority populations. In 2003, 70% of the 56 cases were foreign born; 25% of the cases were residents of the identified poverty communities (although only 14% of the population resides in these areas); and 79% were in minority populations.

To eliminate TB, Nassau County has programs to provide education and testing for tuberculosis for the groups at greatest risk. The testing identifies people with latent TB infection and they can receive treatment to prevent the development of active TB disease.

In Nassau County, the Health Department provides a Directly Observed Therapy (DOT) program for patients with tuberculosis. This program ensures that patients take the proper medication at correct times by having Health Department Community Outreach Workers directly observe the patients taking medication. DOT reduces the spread of TB and protects the health of the county residents.

The World Health Organization estimates that one-third of the world’s population is infected with tuberculosis without having any active tuberculosis disease. Currently, worldwide, there are approximately 8,000,000 people diagnosed with tuberculosis disease and 2,000,000 die from tuberculosis annually. Only 50% ever receive any treatment.

Active TB Cases in Nassau County:

For additional information about TB, call the Nassau County Department of Health weekdays from 9:00 a.m. – 4:45 p.m. at (516) 571-2309.

By a unanimous vote, the Assembly Health committee favorably reported legislation authorizing physicians to collectively negotiate contract terms with HMOs and other insurers (A.1317-A) out of committee on March 16. The bill would grant an exemption from the federal antitrust laws (which the insurance industry already enjoys) to allow physicians to negotiate quality-of-care issues with managed care plans, such as the definition of medical necessity, the construct of the utilization review process, the internal appeals process for coverage denials and payment practices, under close state supervision.

The legislation is needed to counterbalance the monopoly-type power that the managed care industry has throughout the state. The legislation has now been referred to the Assembly Committee on Ways and Means. Similar legislation (S.1092) is awaiting consideration by the Senate Committee on Health. All physicians are urged to contact their State Legislators and urge the passage of collective negotiation.

To send a letter via e-mail to their own lawmakers on this issue physicians can log onto: http://capwiz.com/mssny/issues/alert.

Governor George Pataki and MSSNY have announced a new comprehensive training program for New York State Physicians. The new program includes multiple web-based modules on biological, chemical and radiological agents as well as a physician's education resource manual and a desktop reference card.

The new "on-line" website is www.bcnny.com and focuses on 16 different chemical and biological agents such as plague, smallpox, anthrax, ricin, sarin, and vx agents. New York State physicians who take the on-line modules may earn up to 16 free continuing medical education credits.

The comprehensive course provides New York's physicians with vital information of the various agents and potential patient conditions as well as the diagnostic tools and treatment methods available to physicians caring for patient who may have been exposed to one of these agents.

Governor Pataki, in making the announcement said, "We continue to fight the war against terror on every front and this new training program is another step in our comprehensive efforts to protect New Yorkers. This collaboration with the Medical Society builds on our efforts to prepare in every way possible for potential attacks and ensure that our medical professionals and emergency responders are prepared to meet any challenges that may arise. The physicians throughout New York State who are participating in these critical bioterrorism training initiatives are to be commended."

The MSSNY bioterrorism readiness training program was developed as part of a state and federal grant awarded to the Society in 2003. The MSSNY Task Force on Bioterrorism also reviewed and added to the course content.

The MSSNY worked with EM Technologies, LL (EMT) to develop the on-line web site, as well as a resource manual and reference card for physicians.

Physicians are reminded that any changes in the mandatory portion of the state physician profile must be reported within 30 days of the change. Optional information updates must be reported within 365 days of the change. New York State will soon be sending reminders to all physicians on this matter.