Compliance and Coding Lessons
Rheumatologists should try to issue an advanced beneficiary notice (ABN) to their Medicare patients before providing any services that they believe could be denied by Medicare, Resaee Freeman of the American College of Rheumatology said during an ACR-sponsored audioconference on compliance and coding. This written notice, which needs to be signed and dated by the patient, can safeguard the medical practice if Medicare does not cover the service, she said. ACR coding experts who participated in the audioconference also reminded physicians to be careful of upcoding and downcoding. One common upcoding mistake is to code a new patient visit incorrectly as a consultation. “Documentation is the key,” said Ms. Freeman. Rheumatologists also should be careful when waiving fees for patients. Under the Office of Inspector General's compliance guide, a complete waiver of fees is allowed for an entire group—such as low-income patients—as long as that group is not related to the referring of patients. It's important to have a written notice explaining the policy of waiving fees, she said. The ACR coding audioconference was supported by Abbott Laboratories, Amgen Inc., Genentech Inc., Biogen Idec, UCB Inc., and Wyeth.
Musculoskeletal Exam Planned
The National Board of Medical Examiners is in the process of testing a new exam that will focus specifically on musculoskeletal subject matter. The U.S. Bone and Joint Decade, an initiative focused on raising awareness of musculoskeletal diseases, approached the national board about initiating the project. As of press time, the exam had been tested among undergraduate medical students at Washington University, St. Louis. In the meantime, several other medical schools are reviewing the exam and planning testing for later this semester, according to Judith Miller, a program officer at the National Board of Medical Examiners. The exam, which is Web-based, includes 75 basic and clinical science elements. Once pilot testing is completed, the National Board of Medical Examiners will post the exam content online on its Web site (
Doctors Say FDA Moves Too Slowly
More than three-quarters of orthopedic surgeons polled in a recent survey said that the Food and Drug Administration is too slow in approving new drugs and medical devices. Commissioned by the Competitive Enterprise Institute, a Washington-based think tank that favors deregulation and limited government, the online survey included responses from 175 orthopedic surgeons from around the country. The majority of respondents (60%) also agreed that, on balance, FDA regulations hinder rather than help them in using new drugs or medical devices to treat their patients. About 80% of respondents also said that if it were up to them, they would make Vioxx available again as a prescription drug.
FDA's $2 Billion Budget
The Bush administration is requesting $2.1 billion for the Food and Drug Administration in fiscal 2008, a 5% increase from the previous year's request. The agency still has not received its final appropriation for fiscal 2007, so the exact amount it will receive for that year is not yet known. The budget includes $444 million in user fees from industry, including a new program to charge generic drug makers fees to review their products. The agency estimates that generic companies will contribute $16 million in fiscal 2008. In a statement, Generic Pharmaceutical Association CEO Kathleen Jaeger said the decision to seek user fees “will not bring generic medicines to consumers faster as long as brand companies are still permitted to use tactics that delay market entry.” The budget also includes $11 million for improving drug safety—this does not include user fee funds that will also go to that effort—and $7 million to boost medical device safety and to speed up device review. The agency also is requesting $13 million to move about 1,300 employees of the Center for Devices and Radiological Health to offices at the FDA's new White Oak, Md., campus. The FDA has been gradually moving its operations to the new facilities. The Washington-based consumer-, patient- and industry-supported Coalition for a Stronger FDA said the budget did not go far enough. It is seeking at least $175 million more, including greater increases for food, drug, and medical device safety.
Disclosing Financial Conflicts
Experts from Johns Hopkins University, Baltimore, Duke University, Durham, N.C., and Wake Forest University, Winston-Salem, N.C., have designed model language aimed at helping researchers disclose their financial conflicts to medical research participants in a meaningful way. The model language was published in the January/February issue of IRB: Ethics and Human Research. Included is a standard disclosure for situations in which there is a financial interest that does not represent a measurable risk to patients. The model also includes language that researchers can use to describe salary support, money received outside of a study, per capita payments, and unrestricted finders' fees, among other conflicts. “This is language that can help these institutions craft better written materials. It can also serve as a model for how to accurately phrase disclosure in discussions with potential research subjects,” Dr. Jeremy Sugarman, the lead author and professor at Johns Hopkins University, said in a statement. “It could also be expanded and presented in other formats, such as stand-alone pamphlets or videos about clinical research.”