Medical Device Daily Washington Editor

The Centers for Medicare & Medicaid Services released its final decision memo for transcatheter aortic valve replacement a day early, and made a few impressive changes to its requirements for the procedure. The agency held on to the requirement that patients be enrolled in a registry as part of a coverage-with-evidence-development requirement as was the case with the proposed decision memo, but CMS dropped the requirement that the trial demonstrate superiority to a comparator treatment, and dropped the period of follow-up from five years to one.

The news is a major boost for the fortunes of patients and industry alike, given the concerns expressed about the superiority requirement at CRT 2012, during which Michael Mack, MD, of the Baylor Health System (Dallas) remarked, "I can't believe that's right," while an industry representative on the panel opined that such an approach "would be very damaging for a start-up company" (Medical Device Daily, Feb. 8, 2012). Edwards Lifesciences (Irvine, California), the manufacturer of the Sapien aortic valve also weighed in on the superiority trial mandate in a March 5 statement, arguing that such a requirement "undermines efforts to promote continued U.S.-based clinical research for Medicare patients" (MDD, March 6, 2012).

Acting CMS administrator Tavenner said in a May 1 CMS statement that the decision "is particularly important as it highlights cooperative efforts" between CMS, FDA, and the Agency for Healthcare Research and Quality, but Tavenner also cited cooperation by "medical specialty societies, and the medical device industry." Tavenner also noted that the firm invoked parallel review in the Sapien application, noting that the coverage determination "is one of the first . . . completed under a mutual memorandum of understanding between CMS and the FDA, a joint effort aimed at getting sometimes lifesaving, new technology to patients sooner."

CMS rewrote other sections of the proposed decision memo as well, initially proposing that a clinical trial measure major stroke as an outcome, but the final memo cites only "stroke." All-cause mortality appears in both documents, as does transient ischemic attack. Both memos cite a requirement that a trial "consecutively enrolls TAVR patients," but the final memo states that a participating hospital must also "accept all manufactured devices," possibly a nod to Medtronic (Minneapolis), which is still working through the pivotal trial for the CoreValve.

CMS had proposed to require that two cardiac surgeons have "evaluated the patient's suitability for open valve replacement surgery" per the pivotal trial protocol, but the final memo requires that two cardiac surgeons "have independently examined the patient face-to-face and evaluated the patient's suitability for open aortic valve replacement (AVR) surgery." Both surgeons will have to document the rationale for that recommendation and make that explanation "available to the heart team."

In a statement e-mailed to Medical Device Daily, Edwards said it was "currently reviewing the NCD," adding that due to "the comprehensive nature of the document, we expect to issue a comment [only] when we have completed our analysis."

In a May 1 memo released before the CMS decision memo, Larry Biegelsen of Wells Fargo Securities (San Francisco) said the CMS memo should be "no worse than the draft NCD" and would likely "help clarify the reimbursement confusion" in place since the draft was released. Biegelsen projected an earnings-per-share for Edwards of $3.58 for fiscal 2013, a boost over the earnings of $2.68 for fiscal 2012.

GAO: providers skimping on EHR mandates

Establishing the meaningful use standard for providers trying to qualify for Medicare payments for electronic health records (EHRs) was complicated enough, but the Government Accountability Office posted a report recently indicating that some providers are basing their meaningful use numbers on data drawn from as few as seven patients. Another troublesome finding by GAO is that the measure most commonly claimed as an exemption by providers of all stripes was the requirement that doctors and hospitals provide patients with an electronic copy of their health information, a development which suggests that the U.S. healthcare economy and the Information Age are still separated by a wide gulf.

The problem with the small patient basis for establishing meaningful use is conspicuous with physician practices according to GAO, which provided a chart indicating that roughly 41% of practices base their meaningful use qualifications on a relatively small number of patients, but hospitals beat doctors handily in this measure, with nearly 87% basing their reports on a small sample of patients.

GAO also noted that the regulations for drawing grants through the program allow Medicare providers to opt out of one measure, but that providers must demonstrate that the measure in question is "not relevant to their patients or practices." The body of the report notes that roughly 72% of doctors claimed one exemption from the meaningful use set of measures, while nearly 80% of hospitals exercised the option. The document states that about 66% of the nearly 9,600 physicians described as generalists claimed an exemption, but that specialists were more likely to opt out of at least one measure. According to GAO, each of the 14 dentists in the program claimed at least one exemption, while 99% of chiropractors did so.

Rural hospitals were somewhat more likely than their urban counterparts to claim at least one exemption (81% to 78.8%), but 78.8% of government-owned hospitals claimed exemption from at least one measure whereas 78.1% of non-profit hospitals did so. Both were beat handily by "proprietary" hospitals, 84.6% of which took an exemption.

GAO had four recommendations for CMS, including that the latter establish "time frames for expeditiously implementing" an evaluation of the audit strategy for the Medicare part of the program, but GAO also urged CMS to rethink its approach to deciding when to verify a Medicare provider's compliance prior to making payments. CMS is said to have agreed to both these suggestions, as well as the suggestion to "collect the additional information from Medicare providers during attestation that CMS suggested states collect from Medicaid providers." However, CMS was not willing to go along with the proposal to offer states the option of having CMS collect meaningful use attestations from Medicaid providers.

CMS's objections to the last recommendation centered around the notion that the states do not have very high hurdles to overcome where attestation is concerned, principally because CMS lent the states a helping hand in designing attestation tools and because the agency had "approved designs developed by vendors that the states can use" for attestation. CMS is also said to be of the view that providers would have to provide data to multiple authorities should the agency get into Medicaid attestation, and that the additional requirements could "result in confusion and payment delays."

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