My last post dealt with the misinterpretation by many industry news outlets of a CMS policy change for coverage of MRIs when the patient has an implanted pacemaker or ICD. The new policy was widely reported as a rejection of coverage for studies performed on patients with Medtronic’s newly approved MRI-safe pacemaker, when in fact CMS had very clearly stated that it had not evaluated coverage for that device and had not reviewed any data on that device because it had not yet been approved by FDA when the coverage policy analysis was performed. My main point was that Medtronic had taken an unwarranted PR hit. I noted that I hadn’t reached out to anyone at Medtronic to ask about the issue, or what the company had or had not done to secure inclusion of the MRI-safe device in the coverage policy review, and went on to speculate that there might have been a failure of either strategy or implementation.
About a week ago, Medtronic reached out to me (who knew the reach of a humble MassDevice blog?), and I now have a fuller story. And that story both eliminates any suspicion that Medtronic dropped the ball in any way in its dealings with CMS on the MRI policy issue and highlights some of the hurdles imposed on public agencies in achieving timely response to changing technologies.
Medtronic was on top of the CMS coverage policy review process all the way and made every possible effort to secure inclusion of the MRI-safe pacemaker in CMS’s coverage analysis, both by offering access to the clinical data under review at FDA and by seeking a delay in the ongoing review process until such data could be considered. There was no failure of strategy or advocacy by Medtronic on this issue.
What happened was that the company’s efforts ran up against CMS’ adherence to two different procedural standards:
- The need for FDA approval of a technology before initiation of a CMS coverage policy review and
- CMS’ commitment to complete coverage policy reviews, once begun, in a timely manner.
The first of these “rules", which has been generally but not universally applied for many years, serves a number of reasonable purposes, most notably to preclude commitment of scarce agency resources to the analysis of technologies that don’t ever get to market because they can’t secure FDA clearance. The fact that this requirement for serial review can delay Medicare coverage for important new technologies is widely recognized and is being addressed. FDA and CMS have a new memorandum of understanding for sharing of data, and a proposal to establish a formal (i.e. not arbitrary or ad hoc) “parallel review" process for the two agencies has been promulgated in an effort to allow CMS to begin coverage analysis for selected new technologies prior to final FDA approval. I’ve written about this initiative, and industry’s ambivalence about it, previously.
Nor should CMS be seriously faulted for keeping to its commitments with regard to time for completion of its review cycle for coverage determinations. The inability of agencies — FDA and CMS alike — to comply with such commitments is one of industry’s strongest and most justified complaints about the regulatory process. In the present case, CMS has a coverage review underway in response to a clear and well-defined request — to extend coverage (more precisely, to remove the contraindication for coverage) for MRI’s to patients with implanted devices in the context of clinical trials designed to assess the safety of such tests. Incorporating consideration of coverage for MRI-safe pacemakers in general clinical practice — the decision that would most benefit Medtronic — into that review would have required restating the question under review as well as delaying completion. CMS opted to complete the narrowly focused analysis and policy review in a timely manner, and to consider the broader question in a separate analysis when requested after FDA final action on Medtronic’s MRI-safe device. In doing so, it did two things that industry generally applauds, and avoided doing two things — diverging from standard and predictable processes and taking too long to make a decision – that industry generally criticizes. Of course, some in industry — when things don’t go the way they’d hoped — also criticize CMS, and other agencies, for rushing to decisions or for failing to be appropriately flexible in their procedures.
The situation today is that Medtronic is selling a pacemaker identified by FDA as MRI-safe, and CMS has a National Coverage Policy for MRI that excludes coverage for patients with pacemakers except when they are enrolled in appropriate clinical trials designed to determine the safety… Medtronic has requested a further MRI coverage policy reconsideration. CMS opened that reconsideration process on March 3, 2011, a proposed decision memo is due on September 3, 2011 — exactly 6 months from initiation of the process — and a final National Coverage Analysis is anticipated by December 2, 2011 — 3 months later. That timeline reflects CMS’ procedural commitment to industry. The MRI-safe pacemaker will be in Medicare coverage limbo for 9 months. Whether regional Medicare carriers can or will extend coverage during this time period — something that seems reasonable but which is technically improper – is problematic. But I now know that I can call Medtronic and (perhaps) find out.
Private insurers, by the way, can and likely will act more quickly. They can rewrite technical components of coverage policies as they like and without the procedural hindrances imposed on a public agency. If a private insurer concludes that covering MRIs for patients with the new Medtronic pacemaker is good and safe clinical practice, it can do so immediately. Industry generally applauds the decision making agility and flexibility of private insurers — except when coverage is abruptly withdrawn or restricted in response to new clinical findings or documented overutilization. Medicare doesn’t have that agility, and has to account for its decisions in a wholly transparent manner. Sometimes that’s a good thing, sometimes not.
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.