Medical Device Daily Washington Editor

WASHINGTON — Sean Tunis, MD, chief medical officer at 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 Medical Device Daily. “That's just the way the timing worked out.“

In the past few weeks, CMS has released important coverage decisions on implantable cardioverter defibrillators (ICDs), positron emission tomography scans, additional “off-label“ uses in selected clinical studies for new cancer drugs, and 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.

“The registry requirement is not exactly brand new, but I think it is an important extension of an approach we are hoping to expand significantly in the future,“ Tunis said. “We are trying to strike a balance between making technology available and making decisions quickly, but at the same time making sure that we have mechanisms in place to learn more as we go along.“

Tunis and McClellan recently authored an article in the New England Journal of Medicine that outlined the change in methodology in terms of the ICD decision and how CMS will apply the same process to other decision-making.

“It will hopefully be a platform to now go forward and figure how we are going to apply that approach more systematically,“ he said.

When asked about how much the additional ICD coverage would cost CMS, Tunis said he has seen a “range of figures.“

“I used to think I knew, and I have seen a lot of variation of estimates, but I think it is safe to say we'll be spending north of $1 billion or $2 billion a year in the near future on defibrillators for prophylactic use,“ he said. “I suspect that number may be too low, but, regardless, it does not affect the decision of whether or not to cover it.“

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