Federal News

Congress stands in recess until September 5.

HCFA has determined that heart, liver and lung transplant centers may qualify for coverage of transplants after a year's experience compared to the previous two-year waiting period under a new national coverage decision. Recently published research convinced HCFA that the number of transplants performed by a center is a better predictor of outcomes than the number of years of experience. Transplant centers must still meet the other Medicare criteria for approval such as standards for patient selection policies, patient management protocols, and minimum volume and survival rates.

The ACC recently submitted its recommendations to HCFA on the June 2000 proposed guidelines for evaluation and management services. The ACC addressed the importance of physician immunity from monetary penalties during the pilot-testing phase and for six months after implementation and recommended suspension of all routine audits under the current guidelines. The ACC indicated its support of the vignette system to assist with medical decision making and examinations as an alternative to counting elements. The ACC stated that only vignettes demonstrating a high level of inter-reviewer reliability should be accepted. The pilot-testing should also utilize a peer review approach using physicians in the same specialty and geographic region. The ACC also offered its assistance in developing vignettes for comprehensive single system exams and high levels of complexity.

Contact Anne Bicha at abicha@acc.org or 1-800-435-9203 if you would like a copy of the letter to HCFA.

The Food and Drug Administration (FDA) has released a draft guidance document providing general principles for the clinical evaluation of new antihypertensive drugs. The guidance document is a consensus draft which has been agreed to by the International Conference on Harmonisation Expert Working Group. Written comments on the draft guidance, available on the FDA's Web site, will be accepted through November 7, 2000.

The Department of Health and Human Services generally met its fiscal year 1999 goals directly related to less waste, fraud, and error in Medicare, according to a Government Accounting Office (GAO) report. The report further states that the Health Care Financing Administration is working to develop specific error rates for contractors, providers, and beneficiary services which would better enable it to monitor the overall effectiveness of its program integrity activities. Contact ACC staff Alan Yount (ayount@acc.org) if you would like a copy of the GAO's report.

Medtronic, Inc. has received approval from the Food and Drug Administration (FDA) for its Mosaic porcine bioprosthetic heart valve. The Mosaic valve, is a reduced-profile valve that incorporates a flexible stent. Medtronic announced that the Mosaic valve will be commercially launched later this year. Medtronic's press release is available on their website.

On August 1, the National Institutes of Health (NIH) updated its 1994 policy mandating the inclusion of women and minorities as subjects in clinical trials. NIH reported that, although appropriate inclusion has been achieved, the results of Phase III clinical trials need to be more consistently reported. The updated policy provides further guidance on planning, conducting, and reporting the analysis of sex/gender or race/ethnicity differences in the intervention effect of NIH Phase III clinical trials. The updated policy is available on NIH's Web site.

The National Committee for Quality Assurance (NCQA) has launched a Preferred Provider Organization (PPO) Plan Accreditation program. Five PPOs covering more than eight million Americans have committed to participating in the program. NCQA's PPO program incorporates some of the same requirements as its managed care organization (MCO) accreditation program. Accreditation requirements will focus on appeal processes, customer service, physician credentialing, and utilization management. PPOs nationwide cover approximately 100 million lives.