Evidence report questions for each Medicare Coverage Advisory Committee panel meeting will be made public much earlier in the review process under guidelines updated by the MCAC Executive Committee at a Feb. 22 meeting in Baltimore.

For each issue before an MCAC panel, HCFA collaborates with the panel chair to develop questions to be analyzed in a technology assessment. The questions will be posted on the Internet at the same time that they are issued to the contractor HCFA has selected to perform the assessment.

The panel chairs and HCFA will determine whether questions should be changed or augmented based on public comments. The evidence report generally forms the basis of the subsequent panel review.

Up until now, the questions addressed by the evidence reports and its panels have been hidden from public view. At the Medical and Surgical Procedures Panel review of biofeedback and pelvic floor stimulation devices, stakeholders complained that they had limited time to review the panel questions prior to the meeting.

Particularly in the case of biofeedback, med/surg panel members complained that HCFA's questions in the evidence report did not address the bulk of scientific evidence (¹ Also see "MCAC Panel Finds Evidence Insufficient To Evaluate Pelvic Stim, Biofeedback" - Medtech Insight, 17 April, 2000.).

The changes approved by the EC should prevent that situation from occurring again. "HCFA should post in draft form the key questions that the evidence report will address on the MCAC website and provide a means for members of the public to transmit their comments on the key questions," the EC recommends.

The guidelines also create more panel oversight of the evidence reports. "What we are potentially proposing here...is that the Executive Committee get involved much earlier in this process to give us some guidance," HCFA Coverage and Analysis Group Director Sean Tunis, MD, commented at the meeting. The EC is primarily composed of the chairs and vice-chairs of each of the individual MCAC panels.

Up until now, the panel chairs have had little involvement framing the questions for the evidence report. The panel chair, in preparing for a meeting, could decide that the panel should address a different set of questions from the evidence report, rendering the report less valuable for the meeting.

"We formulate the key questions and the analytic framework well after the evidence report was submitted but in time to organize a meeting," Medical Devices and Prosthetics Panel Chair Hal Sox, MD Dartmouth-Hitchcock Medical Center, said of the panel's Feb. 21 meeting on ambulatory blood pressure monitors. The panel arrived at a positive conclusion for ABPMs, despite the Blue Cross/Blue Shield evidence report's finding that evidence was inadequate (² Also see "MCAC Panel Takes "Clinical Common Sense" Approach To Coverage Review" - Medtech Insight, 26 February, 2001.).

The posting of the questions will also give outside groups a chance to forward relevant information to the contractor performing the evidence report. HCFA has several outlets for contracting assessments, including Agency for Healthcare Research and Quality evidence based practice centers. HCFA has independently contracted the BC/BS Technology Evaluation Center to perform several evidence reports for MCAC reviews.

EC panel members discussed whether information that is not public, either because it is being reviewed but has not been accepted by a medical journal or because it is proprietary, should be included in the evidence report evaluation. The committee adopted an amendment to the guidelines stating that "evidence that cannot be released to the public at the time the evidence report is posted may not be considered."

"If it will remain proprietary, I think we have lost nothing by excluding it from the process," Alan Garber, MD/PhD, Stanford University Medical School, maintained. The BC/BS process considers proprietary information, but it has never "swayed the decision" of the group, he explained.

The guidelines recommend that the evidence report be made public two weeks prior to the related MCAC panel meeting. However, representatives from Empi, a pelvic floor stimulator manufacturer, questioned whether two weeks would be sufficient for companies to assemble physicians to testify at MCAC panels.

"It appears to me that we have a dilemma that on the one hand we take too much time...on the other hand, we're not giving the petitioners enough time," EC panel member Robert Murray, PhD, Lutheran General Hospital, Park Ridge, Illinois commented. "I don't know how we can answer both of those complaints at the same time."

But manufacturers' concerns about lengthy delays during the MCAC process appear to outweigh any other gripes at the moment. "My most serious concern...is that none of these procedures have any timelines whatsoever," industry rep Randel Richner, Boston Scientific remarked.

A provision in Medicare, Medicaid and SCHIP Benefits Improvement and Protection Act (BIPA) of 2000 will shorten the MCAC process greatly by removing the requirement that MCAC panel recommendations be ratified by the MCAC EC. The provision will go into effect in October.

With the its ratification authority removed, the EC will focus its attention on overarching themes related to the MCAC, such as updating the panel process, Tunis explained. If the EC disagreed with a panel finding, it could vote for "a contrary view or suggest that HCFA send something back to a panel with some advice."

"One part of our function would be to set the scope of work for the next year," Sox added. Tunis said that HCFA may also ask the EC to recommend an appropriate scope for a specific panel meeting, such as the meeting scheduled this spring on PET (³ Also see "HCFA Hints At Expanded PET Review, While Hill Seeks Hands-Off Approach" - Medtech Insight, 5 March, 2001.).

The EC also made a significant change to the ways the standard procedure for panels' evaluations of evidence by allowing panels to make further recommendations even if they determine that evidence is inadequate to draw formal conclusions.

In the past, EC guidelines recommended that panels close their review if they determined that evidence supporting a technology was inadequate. The policy led to an overly rigid dependence on scientific data, critics argued, with not enough flexibility to deal with treatments that were rare, inexpensive, or not conducive to randomized or controlled trials.

Under the new guidelines, panels may determine for a particular procedure that "definitive studies are not feasible" or that "studies are possible but have not been performed" due to extenuating circumstances. The panel may also find that a technology is "promising," even if evidence is still inadequate.

"HCFA could deal with the problem of 'inadequately studied' but 'promising' technologies in several ways," the document notes. It could "encourage or directly support studies," or it could cover the technology "on a provisional basis," such as a clinical trial or for limited time until a future review. For rare conditions, HCFA might issue coverage decisions for promising treatments, the guidelines note.

MCAC Amendments Open Up Panel Process, Broaden Scope Of Reviews

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