Medtronic announced February 8 FDA approval of the Revo MRI SureScan pacing system, described as “the first and only pacemaker in the U.S. specifically designed for use in an Magnetic Resonance Imaging (MRI) environment.” In describing the impact of the new device, Medtronic estimated that 200,000 patients annually had to forego otherwise clinically appropriate MRIs because of the presence of a pacemaker.
The presence of a pacemaker, or any implanted device containing ferromagnetic components, has long been a contraindication for the use of MRI as a diagnostic tool. Subjecting such devices to the MRI’s magnetic field creates the risk of device malfunction as well as the potential for injury caused by moving or heating the device. The “shadow” of an implanted device may also obscure clinically relevant image content. Consequently, Medicare and most private payers have had non-coverage policies in place for use of MRI in conjunction with pacemakers and such other implantables as ICDs, LVADs, etc.
Less than three weeks after FDA approval of the Revo, Medicare issued a revision of its national coverage policy for MRI testing, retaining the general non-coverage policy but allowing coverage of MRIs for pacemaker patients in the context of clinical trials that conform to detailed requirements described in the revised policy. Industry news letters trumpeted that the agency was raining — hard — on Medtronic’s parade. The dominant conclusion in business and policy sources was that Medicare had decided “not to fund MRIs for patients with new MRI-safe pacemakers.” The first sentences of Medicare’s Decision Memo announcing and explaining the revised MRI coverage rule seemed clear:
The Centers for Medicare & Medicaid Services (CMS) determines that the evidence is not adequate to conclude that the use of magnetic resonance imaging (MRI) improves health outcomes for Medicare beneficiaries with implanted permanent pacemakers (PMs) or implantable cardioverter defibrillators (ICDs), and thus we determine that it is not reasonable and necessary under ß1862(a)(1)(A) of the Social Security Act (the Act). Therefore, subject to one exception, we will to retain the current general contraindications at Chapter 1, Section 220.2.C.1 in the NCD Manual.
Medicare, the analysis ran, was saying a loud “No” to coverage for the Revo system, denying patients with pacemakers characterized as MRI-safe by FDA access to MRI testing. Cynics weren’t surprised. Medicare has for several years clearly expressed deep concern about increasing utilization of so-called “advanced imaging” modalities, including MRI, and has instituted policies to reduce payment for those modalities. Was the new coverage policy revision an escalation of those cost-control efforts? Should industry be concerned that CMS had opened a new — coverage policy — front in the fight against advanced imaging costs?
No … and no. The MRI coverage policy revision actually had nothing at all to do with the Revo system, and certainly does not constitute a judgment about whether Medicare should pay for MRIs for patients with Revos. But you’d need to read past the first paragraph of the Decision Memo, to the detailed explication of the request that prompted the review, the timeline of the review process, and the evidence and other inputs available to CMS to inform the review in order to put the policy revision into perspective. There are lessons here about CMS coverage determination processes, and therefore about reimbursement strategies for innovative technologies entering the market in the context of prior non-coverage determinations. There are questions that might be asked about the effectiveness of Medtronic’s efforts to assure the earliest possible favorable revision of Medicare’s exclusion of MRI coverage for pacemaker patients. But there is nothing here to suggest that Medicare is negatively disposed with regard to coverage of MRIs for patients with MRI-safe pacemakers. The whole story actually isn’t all the complicated, and is clearly told in the February 24 Decision Memo. The essential facts are these:
- The MRI coverage policy reconsideration was prompted by a June 2010 request from an individual physician that Medicare re-assess MRI coverage policy for patients with pacemakers and ICDs “if (1) a clinically-indicated MRI is performed as part of a prospective clinical study designed to determine the risk of the procedure, and (2) the study is conducted after an IDE has been approved by FDA for a device involved in the proposed research.” This request reflects the fact that there are a number of potential methods for protecting pacemaker patients from MRI-related adverse events, but that those methods have not been studied in well designed clinical trials.
- Medicare opened the reconsideration, accepted public comments for 30 days, conducted an internal review of all available data and other relevant materials, as well as the submitted comments, and posted a Proposed Decision Memo in December 2010; after receiving and reviewing comments in response to the Proposed Decision Memo, Medicare issued the February 24 Final Decision Memo.
- The February 24 Decision Memo clearly states: “FDA approved the first pacemaker (Medtronic Revo MRI SureScanTM Pacing System) for use during certain MRI exams on February 8, 2011. This approval came after the public comment period, required by section 1862(l) of the Act, and was too late for CMS to adequately review the evidence to address coverage for MRI for patients that may obtain this device” (emphasis added).
In other words, the Feb. 28 MRI coverage policy revision was issued after FDA approval of Medtronic’s MRI-safe pacemaker, but was not informed by any consideration of that device. It tells us nothing about how Medicare is likely to decide concerning MRI coverage for Revo patients. We’ll get a definitive answer to that question later this year, because on February 25 — the day after promulgation of the policy revision in response to the July request – Medtronic formally asked Medicare to consider MRI coverage for patients with Revo pacemakers.
The curious thing about this story is that it played out with full knowledge on the part of all parties that FDA approval of the Revo was coming. An FDA Advisory Panel had unanimously recommended approval in March of 2010 — four months before the request for a policy review for traditional pacemakers, and 11 months before FDA’s formal action and Medicare’s release of the policy revision allowing coverage in clinical trials. Such Advisory Panel reviews entail substantial clinical data and analysis of those data by expert clinicians. Advisory Panel meetings are public events, and Medicare staff members are welcome, and frequently present, as observers. Yet Medicare was unable to review Revo data until after FDA approval. Can that be?
FDA does not — cannot — routinely share regulatory submission information with CMS. One reason for this is that FDA has a clear legal obligation, and well developed and effective mechanisms, to protect confidential proprietary information included in submissions; CMS does not. Another reason is that many in industry have opposed efforts to remedy this imbalance, and to allow better sharing of data between the agencies, out of fears that such sharing would facilitate a blurring of the lines between the legitimate missions and responsibilities of the two agencies; this is why some in industry have voiced opposition to the recent proposal to create a formal procedure to allow FDA-CMS “concurrent review””.
But even today a company can give FDA permission to share data with CMS, and can specify what data can be shared. Many companies preparing for future coverage policy reviews meet with CMS to educate the staff about their technology and give them a projected timeline for clinical trials, FDA submission, and possible market clearance. At such meetings, CMS staff often ask if the company will authorize FDA to share information. Many companies give such authorization, as it allows CMS to begin a review earlier and shorten the time between FDA approval and a coverage or payment decision. If CMS did not have information about the Revo MRI-safe pacemaker until after formal FDA approval, it is because Medtronic didn’t want the agency to have it or failed to convince the agency to look at it.
I haven’t spoken to anyone at Medtronic about this — not that they’d be likely to share … — and cannot be certain as to what the company did or didn’t do to attempt to secure consideration of the Revo pacemaker system in the recently completed MRI coverage policy review. It is possible that Medtronic did everything right, and CMS simply wouldn’t pay attention. But the February coverage decision, the delay in securing the coverage policy change that would make MRI testing readily available to patients with Revo pacemakers, and the inappropriately negative public perception around what CMS actually decided, looks like a failure of reimbursement strategy and advocacy.
Edward Berger is a senior healthcare executive with more than 25 years of experience in medical device reimbursement analysis, planning and advocacy. He’s the founder of Larchmont Strategic Advisors and the vice president of the Medical Development Group. Check him out at Larchmont Strategic Advisors.