Medicare Continues To Impose Conditions When Covering New Technologies

Main Category: Medicare / Medicaid / SCHIP
Also Included In: Medical Devices / Diagnostics
Article Date: 27 Feb 2011 – 0:00 PST

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The Centers for Medicare and Medicaid Services (CMS), the government agency that administers the Medicare program, made 11 National Coverage Determinations (NCDs) for medical technologies and procedures in 2010. NCDs permit or prohibit Medicare coverage for new technologies on a nationwide basis. Since Medicare is the largest single purchaser of healthcare in the country, these decisions have far-ranging effects, influencing health coverage by private plans and the development of medical technologies.

Medicare demands supporting clinical evidence of effectiveness before considering coverage approval. In 2010, only two of the eleven NCDs were unrestricted positive coverage decisions.[1] The remainder were either restricted in some manner, requiring the satisfaction of additional criteria (five), deferred to the discretion of regional Medicare contractors (two), covered in order to comply with an updated statute (one) or not covered (one, Collagen Meniscus Implant).

A study by researchers at Tufts Medical Center and the Center for Medical Technology Policy (CMTP), published in the New England Journal of Medicine last year, shows that CMS has been frequently citing the lack of evidence of improved health outcomes in its decisions about whether to provide coverage for new technologies. The data indicate that CMS is relying heavily on clinical trials that prove the effectiveness of the procedures, in order to ensure that public funds are exclusively delegated to technologies with proven positive health benefits. According to the analysis, the agency is beginning its assessments with the presumption that NCDs won’t be covered, unless strong documented evidence is provided that the procedure is both reasonable and necessary for the diagnosis or treatment of illness or injury.

“The data show that Medicare is continuing its move towards evidence-based medicine,” said Peter J. Neumann, ScD, Director of Tufts Medical Center’s Center for the Evaluation of Risk in Health (CEVR). “It is covering medical technologies only where the evidence is strongest. This trend will continue, especially with Medicare’s need to reduce its spending growth.”

CMS has a long history of covering medical interventions with restrictions. Data from the Tufts Medicare NCD Database, which details all aspects of NCDs, reveal that 84 (55 percent) of the 152 NCDs since 1999, resulted in coverage for only those Medicare beneficiaries that met specified conditions. These restrictions typically pertained to a Medicare beneficiary’s health status, the prior failure of other treatment options, the performance of a procedure restricted to certain treatment facilities, or to a “coverage with evidence development” (CED) policy, the granting of provisional coverage while generating additional evidence to establish whether unconditional or expanded coverage is warranted. The trend is critical, as medical interventions subject to NCDs affect a significant number of Medicare beneficiaries and are expected to have a major impact on the future of the Medicare program.

The Tufts Medicare NCD Database includes detailed information on all complete NCDs from 1999-2010, providing a thorough and independent review, summary, characterization and categorization of CMS decisions by Tufts Medical Center researchers. The database offers unique analyses of the NCDs, in terms of trends in CMS policies, review times and use of evidence for a variety of drugs, devices, diagnostics, and procedures.

Summary of 2010 Medicare National Coverage Determinations

Title of NCD – CMS’ final decision – Conditions on coverage

Positron Emission Tomography (NaF-18) to Identify Bone Metastasis of Cancer – Coverage with conditions – Only approved within CED data collection process

Dermal injections for the treatment of facial lipodystrophy syndrome (FLS) – Coverage with conditions – Restricted to certain population subgroups

Collagen Meniscus Implant – Non-coverage – NA

Magnetic Resonance Angiography (MRA) – Coverage decision referred to local contractors – NA

Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) for Myelodysplastic Syndrome – Coverage with conditions – Only approved within CED data collection process

Positron Emission Tomography for Initial Treatment Strategy in Solid Tumors and Myeloma – Coverage decision referred to local contractors – NA

Intensive Cardiac Rehabilitation (ICR) Program – Dr. Ornish’s Program for Reversing Heart Disease – Coverage – NA

Intensive Cardiac Rehabilitation (ICR) Program – Pritikin Program – Coverage – NA

Counseling to Prevent Tobacco Use – Coverage with conditions – Restricted to certain population subgroups; Treatment restriction applied

Ventricular Assist Devices as Destination Therapy – Coverage with conditions – Restricted to certain population subgroups; Restricted to patients receiving care in specific care settings

Cardiac Rehabilitation Programs – Update to ensure consistency with statute – NA


Tufts Medical Center

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