CMS' requirement that additional data be collected as a condition of expanded ICD coverage should not be repeated in future national coverage decisions, according to AdvaMed.

The trade association takes issue with CMS' draft guidance proposal to extend coverage-with-evidence-development requirements to cases where "a particular medical intervention has been demonstrated to improve health outcomes in a broad population of patients," to determine how specific patients respond to treatment.

"When available evidence is 'demonstrated to improve health outcomes in a broad population of patients' and FDA has given market clearance and approval, the evidence supporting the item or service intervention should be considered adequate for coverage," ¹ AdvaMed's June 6 comments state. Coverage with evidence development (CED) "should not be applied."

Earlier this year, CMS issued a national coverage decision that required patients who received defibrillators under the expanded policy to be enrolled in registries.

While the trial supporting expanded coverage showed that ICDs reduce mortality by about 30% in the patient population studied, most patients enrolled in the trial never needed their ICDs. Consequently, the agency hopes the registry will help determine specific sub-groups most likely to benefit from the technology (² Also see "ICD Registry Is Only First Step To Risk-Stratification – CMS’ Phurrough" - Medtech Insight, 9 May, 2005., p. 8).

After implementing the ICD policy and several other national coverage decisions that required additional evidence, the agency issued an April draft guidance attempting to codify factors leading CMS to issue coverage decisions requiring evidence development (³ Also see "CMS Issues “Coverage With Evidence Development” Draft Guidance" - Medtech Insight, 11 April, 2005., p. 9).

In June 6 comments, the Medical Device Manufacturers Association urges CMS to identify the criteria it will use to determine if additional data are needed.

Furthermore, MDMA argues that Medicare beneficiaries could face "additional access requirements" for technologies that are FDA-approved and available to the non-Medicare population. "CMS should reconsider applying CED in this circumstance to avoid imposing barriers to care that is available to non-Medicare patients," ⁴ MDMA's comments state.

AdvaMed urges CMS to issue a revised draft guidance with another comment period.

CMS' Definition Of "Reasonable And Necessary"

At the center of AdvaMed's concerns with the draft guidance is its belief that CMS is altering the interpretation of the "reasonable and necessary" criteria that the agency uses to determine whether an item or service should be covered under Medicare.

AdvaMed claims that the phrase has been interpreted to mean that the item or service prescribed for that patient must be 'reasonable and necessary' for that patient" (emphasis AdvaMed's). However, the trade association contends that the draft guidance is now equating "'reasonable and necessary' with the quality of evidence on improvement in health outcomes."

"We contend that it is inappropriate to base an individual patient care decision on the quality of available evidence pertaining to a population," AdvaMed states. Consequently, CMS should not use CED requirements for technologies such as ICDs that have been shown to improve health outcomes in a broad population of patients, according to AdvaMed.

NEMA, AdvaMed Weigh In On CED For Diagnostics

The guidance document also clarifies that coverage with evidence development will be undertaken when an intervention "has yet to conclusively demonstrate an improvement in health outcomes," although existing evidence suggests it may provide benefit. CMS pursued such policies for positron emission tomography to diagnose Alzheimer's disease and for brain, ovarian, pancreatic and small-cell lung cancer diagnoses.

In June 1 comments, the National Electrical Manufacturers Association calls the national coverage policy on PET for Alzheimer's a "sound approach that may prove to be a useful model for other imaging technologies."

"However, we want to raise a cautionary flag that the data gathered will typically not connect the technology in a casual way to health outcomes," NEMA continues.

The organization and AdvaMed contend that methodological problems, including the difficulty of accounting for multiple intervening steps between accurate diagnostic findings and improved health outcomes, prevent such linkage. Consequently, the guidance document should be modified to state that the goal of data collection in these instances should be "tailored to endpoints appropriate to the technology."

For diagnostic imaging, NEMA contends that "the appropriate endpoints may involve changes in patient management, rather than demonstrated direct relationship to improvements in health outcomes."

CMS Should "Elevate" Local Coverage - MDMA

One of MDMA's paramount concerns with the draft guidance is that the agency does not adequately discuss ways local coverage can be used "as a tool for further evidence development and for diffusing innovative technologies more slowly among the beneficiary community."

MDMA points out that the guidance states that CED questions are "best addressed in actual medical practice, where actual conditions of use and patient characteristics may differ significantly from those in a pre-market trial."

"This statement argues strongly for deferring to the local coverage process rather than engaging the technology in national coverage review and applying CED," MDMA states.

The association adds that the current language "contributes to the perception that CED may become a vehicle that eventually trumps the local coverage process." Consequently, MDMA urges CMS to "elevate the importance of the local coverage process."

Small manufacturers, in particular, depend on the local coverage process to obtain reimbursement while gathering evidence to support their products. In the event where evidence is insufficient to make a national coverage decision, NEMA urges CMS to allow stakeholders to use the local coverage process.

In June 3 comments, the Indiana Medical Device Manufacturers Council contends that CED requirements could act as a "barrier to innovation" for small companies. Small firms could initially find it "impractical to bear the evidence-gathering costs necessary to introduce" a new product and ultimately lose their incentive to innovate, the group says.

Safety, Cost Concerns Exceed CMS' Jurisdiction

AdvaMed and MDMA fault the draft guidance for stating the agency may pursue a CED policy in cases where the technology is likely to benefit, but significant safety concerns or potential side effects are insufficiently described in the literature.

The draft also states that "support for post-coverage evidence development to achieve a reasonable and necessary determination may help address important questions of safety and effectiveness that otherwise would be very difficult to address in the pre-market setting or in the post-market setting without CMS' support."

"The evaluation of safety is clearly within the purview of the FDA and should not be linked to coverage decisions for Medicare," AdvaMed contends.

In cases where patient outcomes from extensive studies undertaken for FDA approval are not transferable to the Medicare population, AdvaMed concedes that CED may be appropriate.

"However, even where existing safety data are not yet established...CMS should be required to show why FDA post-marketing surveillance or other existing data are insufficient for capturing such safety data before requiring CED to obtain such data," AdvaMed opines.

In addition, the groups take umbrage with the draft guidance's proposal to initiate CED policy when there is an absence of cost data. "Assessment of a technology's economic impact reaches beyond CMS' reasonable and necessary authority," MDMA states.

Industry Wants A Seat At The Table For CED Studies

To obtain public input in deciding when and how to apply CED, AdvaMed suggests that CMS follow FDA's workshop approach and offer manufacturers chances to meet informally with the agency.

The association also contends that an "independent, qualified body" should be tasked with determining a study design framework for assessing whether a trial to inform a coverage decision should be undertaken. The body should address "relative strengths and weaknesses; ability to address particular types of evidence questions; tradeoffs involving internal and external validity, costs, [and] duration," AdvaMed states.

The trade group also stresses that any proposed study design should prospectively determine tailored questions to inform coverage needs, rather than "starting with a study design and then determining what types of questions it might answer."

Trade Groups Vet CMS’ Coverage-With-Evidence Development Guidance

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