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Old 07-11-2006, 04:41 PM
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Harrison Harrison is offline
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Mark Leahey, Esq., is the Executive Director of the Medical Device Manufacturers Association (MDMA), a national trade association that represents independent manufacturers of medical devices, diagnostic products and health care information systems.

His responsibilities include advocating on behalf of the entrepreneurial sector of the medical device industry to Congress, the Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS), and other federal and state agencies. Mr. Leahey currently sits on the Editorial Advisory Board of Medical Product Outsourcing and on the Medical Devices Committee for the Food and Drug Law Institute (FDLI). He has testified before Congress and appeared on multiple national news programs. Mark is a member of the Massachusetts Bar and a graduate of Georgetown University and the Georgetown Law Center.

Mark was kind enough to answer some questions we had on reimbursement issues – offering a unique “behind the scenes” perspective.

ADRSupport: Mark, thanks for taking the time for the patient community. As you know, thousands of patients in the U.S. have been seriously affected by policymakers’ decisions regarding non-coverage of artificial disc replacement. What’s the “big picture” on this complicated maze of politicking? And who are the major players in the formulation of policy coverage?

Mark Leahey: A complicated maze is an understatement. However, as patients, you have the incredible opportunity to influence the process. Ultimately, the federal government, specifically, the Centers for Medicare and Medicaid Services (CMS) is where the most attention should be given. Although private insurers are important, they usually follow the direction of CMS.

Dr. Mark B. McClellan, Administrator of CMS, has shown an interest in expanding coverage in certain areas, but has made it clear that these decisions must be based on sound, scientific evidence.

Dr. Steve Phurrough is another important player. He is the Director of the Coverage and Analysis Group at CMS.

ADRSupport: Do you see any favorable changes in any of the Medicare, Worker’s Compensation or Private Health Insurance carriers in the coming year? That is, changes that favor coverage for the patient? As we speak, there are thousands of suffering patients praying for favorable changes…

Mark Leahey: I certainly hope so, but it will require patients, physicians, industry and others making the case that denying coverage will ultimately cost more in the long run. The value of new medical technology is something that is not always realized in Washington. Rather than focusing on the initial cost of the device or procedure, policy makers and payers should focus on the long-term benefits that result from the use of the technology.

ADRSupport: So what’s up with the recent Medicare changes? Specifically, the Centers for Medicare and Medicaid Services, in its final decision, reversed a national non-coverage determination for the artificial disk – why? Did they possibly include clinical data that they did not previously have?

Mark Leahey: CMS in its final decision found that lumbar artificial disc replacement (LADR) is not reasonable and necessary for the over 60 Medicare population and therefore issued a national noncoverage determination for that group of beneficiaries. However, for Medicare beneficiaries 60 years of age and under (this of course is a small part of the Medicare population who usually qualify for Medicare due to disability), CMS made no national coverage determination, leaving such determinations to be handled on a local basis. Evidently, CMS must have felt that there was evidence that the procedure potentially could be beneficial to younger patients.

ADRSupport: To what extent is the Medicare decision influential for private insurance carriers?

Mark Leahey: Private insurance carriers watch Medicare’s decision-making process VERY closely. That is why so many medical technology companies are interested in CMS’s coverage determinations.

ADRSupport: Some companies like Aetna cover ADR and most others do not. Some patients are forced to mortgage their houses, put off surgery or even opt for a non-arthroplasty option. So, what data are insurance companies using to support their coverage decisions? Why are there so many inconstancies across carriers?

Mark Leahey: That is a great question. I think the insurers are in a better position to answer that question specifically about ADR. In general, individual private payers make decisions on both national and local levels and there are inconsistencies, because there are differing levels of expertise in different parts of the country. If there is a center of excellence in an area where the local payer feels there is sufficient expertise coupled with their review of the available peer-reviewed literature, that payer may cover the technology under specific circumstances. Others may not. Most payers follow an evidence-based technology assessment driven approach but different payers have their own processes. Local coverage reflects local standards of care so inconsistency is typical because some areas are exposed to new treatments before others.

ADRSupport: Later this year, ADRSupport aims to construct a statistically sound patient survey, asking ADR patients’ questions regarding their post surgery outcomes. If executed correctly, could this data be helpful to policymakers – on both sides of the fence? What data would be most helpful to the bean counters?

Mark Leahey: Evidence-based medicine is a prevailing theme when it comes to coverage decisions. In fact, CMS is in the process of issuing its second draft guidance document related to coverage with evidence development. This would provide conditional coverage of certain procedures so long as additional evidence was gathered on the procedure. Based on the data generated, the coverage would stand, expand or be eliminated in the future.

ADRSupport: Thanks so much for your time. We hope to hear from you again this year!

Mark Leahey: Thank you so much for the opportunity to interact with the patient community. I cannot stress enough the importance and impact an active patient coalition can have in changing the dynamic in Washington. Keep spreading the word about the importance of covering these important devices. Together we can make a difference.

Referring links:

Medicare Will Pay for J.& J Spinal Disk

United States: CMS Proposes Major Reforms of Medicare Inpatient Hospital Payment System and Changes for Long-Term Care Hospital Payments
"Harrison" - info (at)
Fell on my ***winter 2003, Canceled fusion April 6 2004
Reborn June 25th, 2004, L5-S1 ADR Charite in Boston
Founder & moderator of ADRSupport - 2004
Founder Arthroplasty Patient Foundation a 501(c)(3) - 2006
Creator & producer, Why Am I Still Sick? - 2012
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