More MS news articles for January 2001

Device Makers Ask HCFA to Scrap 'clandestine' Policymaking Process

NEW YORK (Reuters Health) Jan 04 - A national trade group of small-to-midsize device makers has asked federal health officials to disband the local "workgroups" whose decisions about Medicare coverage policy are being made "absent public scrutiny and accountability."

The Medical Device Manufacturers Association (MDMA) charges that the workgroups are "passing judgment in secret on important medical procedures and technologies" and are "effectively accountable to no one."

The MDMA's January 2 letter to Acting HCFA Administrator Dr. Robert A. Berenson claims that the workgroups, comprised of the medical directors of HCFA's Medicare contractors, are not specifically authorized by law or regulation and lack any mandate to disclose their deliberations or justify their decisions.

Yet according to MDMA Executive Director Stephen J. Northrup, determinations made by the contractor medical director (CMD) workgroups serve as the basis for hundreds of local medical review policies that determine what procedures and technologies will be paid for by the Medicare Part B program.

In an interview with Reuters Health, Dr. Northrup said that little is really known about how many workgroups exist, although it is believed every major specialty, including cardiology, has one.

But it is inappropriate, Dr. Northrup said, for the CMD workgroups' template policies to serve as the basis for national Medicare coverage policy.

"If there's an issue that needs to be addressed nationally, [it] should be addressed centrally by HCFA's national office in Baltimore," he added. "There should not be a de facto national process ... to develop local medical review policy."

MDMA said that it isn't the only organization concerned about the actions of the CMD workgroups. The association cites a 1998 letter to HCFA from the American College of Surgeons, which raises similar concerns about the power wielded by the workgroups.

A HCFA official said that the agency could not comment because it had not received the MDMA's letter.

Dr. Northrup said the issue particularly affects his 140 members, mostly smaller entrepreneurial companies that lack the resources to hire their own consultants to guide them through the technology approval process.

A spokesman for the Advanced Medical Technology Association, which represents many large device makers, had no specific comment on the MDMA proposal, but told Reuters Health that the group supports greater "transparency" of Medicare policy decisions as part of a larger examination of the local coverage process.