Diagnostics & Imaging Week Washington Editor

WASHINGTON Sean Tunis, MD, chief medical officer for the Centers for Medicare & Medicaid Services (CMS; Baltimore), said there was no conscious decision to "hit the ground running" in 2005, but acknowledged that the agency has been pretty busy lately.

"We put out three or four major coverage decisions and three regs within two days last week, and nobody I know of would have thought it was a good idea to plan it that way," Tunis told Diagnostics & Imaging Week. "That's just the way the timing worked out.

In the past few weeks, CMS has released important coverage decisions on positron emission tomography (PET) scans, implantable cardioverter defibrillators (ICDs) and additional "off-label" uses in selected clinical studies for new cancer drugs, and also proposed a rule that would modernize the end-stage renal disease conditions for coverage by promoting higher-quality care in dialysis facilities that want to participate in Medicare.

Add to that the rollout of a new program to pay physician groups based on performance to test financial incentives to reduce cost and improve quality of care, a proposed rule that would increase the Medicare payment rates for long-term care hospitals, and proposed regulations that will support electronic prescriptions for Medicare when the prescription drug benefit takes effect in January 2006, and you've got a full plate.

Tunis joked that it is CMS Administrator Mark McClellan's hyperactive nature that was really responsible for driving the wheels of productivity within the agency.

"Seriously, I must say that Mark is a very focused and energetic individual, and he has remarkable capacity to energize folks," he said. "Mark clearly had a hand in pushing the physician group practice demo along to fruition, and the fact the e-prescribing reg got done nine months before it was scheduled to had a lot to with him, too."

Tunis said that the national coverage decisions (NCDs) such as the expanded ICD decision were just part of meeting targets set out in the Medicare Modernization Act of 2003 (MMA).

"The national coverage decisions are on an MMA regimented timeframe and we have been endeavoring to meet every milestone," he explained. "Since the MMA went into effect in January 2004, we have hit every NCD milestone or beat it in some cases."

With ICDs, Tunis said the agency was waiting for more data. After the results of the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) study were recently released and ICD manufacturer Medtronic (Minneapolis) submitted a request for CMS to reconsider coverage, CMS had enough data to move ahead with the expanded coverage decision.

Tunis also said that the ICD coverage decision was one of the most important actions CMS has taken recently, both in terms of benefit to patients and in the establishment of multiple registries to follow patients prior to treatment and post-implant.

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