Off-label procedures with drug-eluting stents, atrial fibrillation ablation and minimally invasive bariatric surgery are among topics CMS is considering for future national coverage policy determinations, the agency said July 30.

CMS ¹ posted 20 potential topics on its Web site and asked for public comment on whether each warranted review for reconsideration of Medicare's coverage policies.

The agency has never before issued such advance information on its specific thinking for future national coverage determinations. It follows from a commitment to post potential NCD topics made in the 2006 guidance on "Factors CMS Considers in Opening a National Coverage Decision" (² Also see "CMS Issues Two Of Three Final Guidances On The National Coverage Process" - Medtech Insight, 17 April, 2006., p. 4).

More Than Half Of The Topics Include Devices

Of the 20 topics CMS posted, 13 have implications for manufacturers of medical devices or combination products.

"Many of the items on the list are hot button concerns [for] companies and investors," write Stanford Group analysts David Blaszczak and Jan D. Wald in a July 31 bulletin. "A company's ability to market its products will be directly impacted by any decision CMS makes, whichever way it goes, and so we believe companies will take this list very seriously."

There was some discussion of CMS plans to limit coverage of drug-eluting stents for certain indications in 2006 when the products' potential to cause late-stent thrombosis - particularly in the majority of treated patients who presented with non-FDA-approved indications - was under serious scrutiny (³ Also see "CMS Contemplates Role Of Responding To Device Safety Concerns" - Medtech Insight, 6 November, 2006., p. 5).

Since then, a decline in some off-label procedures and new data have somewhat tempered concerns in the medical community about drug-eluting stents, but in the July 30 posting CMS cites limited data on the off-label use of these stents and questions whether there is adequate evidence to specify groups that do and do not benefit from the products.

CMS' posting also suggests the agency could at some point consider additional limitations on coverage for minimally invasive methods for bariatric surgery, which include Roux-en-Y gastric bypass and gastric banding.

National Medicare coverage was established in 2006 for these procedures for certain morbidly obese patients (⁴ Also see "Seniors Covered In New Medicare Policy For Bariatric Surgery" - Medtech Insight, 27 February, 2006., p. 9). The July 30 document questions whether evidence is sufficient to demonstrate "that it results in improved health outcomes for morbidly obese patients."

Catheter ablation is already a common off-label treatment for atrial fibrillation, and several firms are investing heavily in trials to gain FDA-approved labeling for the indication (⁵ Also see "Drug Rhythm-Control Failure Widens Opening For Ablation, Say Cardiologists" - Medtech Insight, 23 June, 2008., p. 21). In its posting, CMS floats the idea of an NCD to assess the evidence so far.

Among other topics on the list are proton radiation therapy for prostate cancer; peripheral artery stenting; artificial cervical discs; hip resurfacing; lumbar fusion; vertebroplasty and kyphoplasty; bone morphogenetic proteins; genomic and pharmacogenetic testing; and biologic therapies for chronic wounds (see chart: " ⁶ Potential National Coverage Determination Topics ").

"For many items on the list, it seems to us that sufficient evidence has not been demonstrated to justify coverage, including fusion, discs and peripheral stenting," note the Stanford analysts.

In any case, they say, "companies' antennae are likely to be raised, and because final decisions are a ways out, we may begin to see more attention paid to generating data to support positive outcomes."

The agency is requesting comments by September 28 "on whether a review should or should not proceed prior to the formal decision to open an NCD."

To vet topics and generate the candidate NCD list, CMS considered the number of inquiries it received on the topic, new evidence on procedures, conflicting local coverage policies, the extent of recent clinical or technological advances and uncertainty over a procedure's health benefits in certain patient populations.

- Monica Hogan (m.hogan@elsevier.com)

CMS Floats Topics For Possible National Coverage Determinations

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