CMS Gets Pushback For Playing Doctor In Renal Stenting Coverage Proposal

Stent manufacturers are urging CMS to finalize its draft coverage decision for renal stenting, though one aspect of the proposal has some wondering whether the agency is going too far in controlling physicians' interactions with patients.

Despite concerns from some stakeholders that CMS planned to restrict national coverage for renal stenting because of lackluster evidence of benefit, the agency's draft decision, released Nov. 20, proposes to maintain the status quo (¹ (Also see "Renal Stenting Surprise: CMS Proposes To Keep Coverage Status Quo" - Medtech Insight, 26 Nov, 2007.), p. 7).

Angioplasty in the renal arteries is covered for patients that do not respond to drug therapy, and stenting is left to the discretion of local Medicare contractors.

Stent makers Boston Scientific, Medtronic and Johnson & Johnson/Cordis voiced their strong support for the proposal, as did several professional societies.

However, one piece of the proposal has generated some pushback.

Because renal stenting has in many practices become the standard of care despite inconclusive evidence that it is better than medical management, CMS emphasizes in its proposal the importance of adequately informed, patient consent.

The agency specifically recommends that for all renal artery revascularization procedures, doctors disclose to Medicare patients:

the May 2004 Class I recall of Cordis' Precise RX biliary stent, in which FDA noted the danger of using stents off-label for vascular indications (² 'The Gray Sheet' May 10, 2004, In Brief);

the July 2007 Medicare Evidence Development and Coverage Advisory Committee meeting that revealed overall uncertainty about the procedure and its applicability to Medicare patients (³ (Also see "Medicare Coverage Advisers Split On Renal Artery Stenting" - Medtech Insight, 23 Jul, 2007.), p. 18);

and the availability of CMS's coverage decision memorandum discussing available evidence.

While CMS frames the consent issue as a "recommendation," the idea is meeting resistance from stakeholders who say the agency is reaching beyond its purview.

"We do not feel that it is within the scope of CMS' mandate to instruct physicians regarding how to explain renal artery revascularization or other procedures," Boston Scientific's Parashar Patel, VP of health economics and reimbursement, writes in Dec. 20 comments.

The Society of Interventional Radiology calls the recommendations "an unnecessary intrusion into the physician-patient relationship," and the Society for Cardiovascular Angiography and Intervention likewise asks CMS to remove that section from the coverage decision.

CMS told "The Gray Sheet" that it has included specific informed consent requirements in other national coverage policies, including those for bariatric surgery and ventricular assist devices. The requirements in those cases are part of criteria facilities performing the procedures must meet.

Firms Pursue Renal Indication For Vascular Stents

According to Boston Scientific, approximately 18,000 renal stenting procedures are performed in the United States each year.

Almost all physicians stenting the renal arteries use biliary stents outside of their approved indication. Although two stents were FDA-approved for a renal indication in 2002 (Cordis' Palmaz and Medtronic's Bridge ), neither are currently on the market.

Boston Scientific is seeking PMA approval for its Express SD to become the only renal stent available in the United States. The firm announced in May the submission to FDA of two-year follow-up data from the device's pivotal trial.

Abbott is among other biliary stent manufacturers seeking a renal indication. The firm began a pivotal trial for its RX Herculink Elite renal stent in September (⁴ 'The Gray Sheet' Oct. 1, 2007, In Brief).

- Chloe Taft ([email protected])