September 28, 2008

Steve Phurrough, MD, MPA
Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Mailstop: C1-13-18
7500 Security Blvd.
Baltimore, MD 21244

Re: Potential NCD Topics

Dear Dr. Phurrough:

The Medical Imaging and Technology Alliance (MITA), a division of the National Electrical Manufacturers Association (NEMA), appreciates this opportunity to comment on the Center for Medicare and Medicaid Services’(CMS) Potential National Coverage Determination (NCD) Topics for the third quarter of 2008 (Potential Topics).¹ As the leading trade association representing companies whose sales comprise over ninety five percent of the global market for medical imaging and radiotherapy, we have an in-depth understanding of the significant benefits to the health of Medicare beneficiaries that medical imaging, radiotherapy and proton therapy provides. MITA looks forward to working with you to continue to improve the healthcare of Medicare beneficiaries through appropriate use of these technologies for the early detection, diagnosis, staging, therapy monitoring, and surveillance of many diseases.

Medical imaging encompasses X-ray imaging, computed tomography (CT) scans, radiation therapy, diagnostic ultrasound, and nuclear medical imaging (including (PET)), and magnetic resonance imaging (MRI). Medical imaging is used to diagnose patients with disease, often reducing the need for costly medical services and invasive surgical procedures.² In addition, medical imaging equipment is often used to facilitate effective treatment, for example, by guiding physicians as they carry out a medical or surgical intervention, to ensure high-quality clinical results for the patient.³

Radiotherapy is a cancer treatment method that involves killing cancerous cells by exposing them to non-invasive, high-intensity waves. Advances in radiotherapy equipment have resulted in better outcomes for cancer patients in which the linear accelerators, the devices used to administer radiotherapy, target a specific cluster of cells without resulting in excessive damage to healthy tissues. This form of cancer treatment reduces the occurrence of negative side effects that can accompany less targeted treatments while also enabling the delivery of a higher level of high intensity waves to the cancerous cells, helping to increase the chances of eliminating the cancer entirely.

The Potential Topics list a broad range of items and services that are important to Medicare beneficiaries. MITA appreciates that CMS issued the Potential Topic list for public comment before initiating a NCD on any of the items or services. We believe it is crucial for the NCD process to be transparent, predicable, and open to public input and that listing potential topics is a critical step to attaining these goals. MITA is concerned, however, that CMS did not comply with its own guidance document on the factors the agency considers in opening a NCD.

In CMS’s guidance document entitled, “Factors CMS Considers in Opening a National Coverage Determination” (Guidance Document), CMS describes seven factors that may prompt the agency to generate a NCD on an existing technology.⁴ For each topic on the Potential Topics list, CMS provides a brief description of the item or service under consideration with another brief description as to the potential focus of a NCD. MITA believes that these brief descriptions are inconsistent with the agency’s Guidance Document. The circumstances that CMS stated in its Guidance Document for opening a NCD are when: (1) providers, patients or other members of the public have raised significant questions that are supported by data about the health benefits of the item or service; (2) changes may be warranted in light of the interpretation of new evidence or the re-interpretation of previous evidence; (3) local coverage policies are inconsistent or conflict with each other; or (4) program integrity concerns exist. The Guidance Document further states that a NCD can be generated in circumstances where there have been substantial clinical advances; the technology could have substantial impact on Medicare; or significant uncertainty about the health benefits, patient selection, or appropriate facility and staffing requirements for the new technology exists.

MITA greatly appreciates that CMS detailed these seven factors that it considers in opening a NCD. Unfortunately, in the Potential Topics, CMS’s brief description of each topic and the potential focus of the NCD are not clearly supported by any of the seven factors that the agency details in its Guidance Document. MITA, therefore, urges the agency to specifically link each Potential Topic to one or more of the factors stated in the Guidance Document. By clearly linking each Potential Topic to one or more factors, CMS will provide the detail necessary for the public to provide targeted comments on whether a NCD is warranted for the reasons CMS suggests.

In addition, MITA believes that it is critical to maintain the local coverage process because it works well for many new technologies. It often is more flexible to react to new clinical evidence and an evolving standard of care. Use of this process currently ensures patients have access to cutting-edge care. In any event, CMS should clarify that local coverage policies remain in effect while a national coverage analysis (NCA) is being conducted. The agency also should consult with stakeholders to identify when local coverage policy variation harms rather than helps patient access to new technologies.

For two of the proposed topics, CMS refers to cost in its description of the technology. Specifically, the agency notes that ESAs are a large cost in current ESRD treatment strategies and that proton beam facilities have a very high upfront cost to build. MITA does not believe that cost is an appropriate consideration for any NCA, and we urge CMS to act consistently with its previous statements in the Guidance Document. The Guidance Document states that “the cost of a particular technology is not relevant in the determination of whether the technology improves health outcomes or should be covered for the Medicare population through an NCD.”⁵ MITA agrees with the Guidance Document that cost should not factor into coverage decisions.

MITA also is concerned that CMS already has moved forward with a NCA for one of the potential topics before the agency has been able to consider comments on the list. One of the potential topics is pharmacogenomic testing, and the description includes testing patients for certain variants in VKORC1 and CYP2C9 genes to permit more accurate calibration of warfarin dosing. CMS already issued a draft NCD on pharmacogenomic testing on this issue on August 4, 2008, only five days after the Potential Topics list was released.⁶ We do not believe it was appropriate to open this NCA until the agency considered comments to the Potential Topics.

Finally, MITA urges CMS to provide greater detail as to the timing and likelihood that NCAs will be opened for other items and services included on the Potential Topics list. This information is critical for the process truly to be transparent and predictable. CMS states that these topics are for the third quarter of 2008. Does that mean that CMS plans to release similar lists each quarter? How do items get considered, added, modified, or removed from the Potential Topics list? Is the selection process influenced by other CMS initiatives or communications, and, if so, which of these provide higher influence? For example, MITA has followed CMS’s efforts to develop the “Medicare Evidentiary Priorities.” How does the potential NCD topics list relate to the “Medicare Evidentiary Priorities” list posted on the CMS website? To what extent do multi-stakeholder initiatives, such as the proposed CTA-CARE registry, influence whether an item or service is included on the Potential Topics list? Moreover, how does coverage with evidence development (CED) and CMS’s recent experience with it through the National Oncology PET Registry (NOPR) interface with the Potential Topics list? Specifically, we are interested in CMS’s insights with respect to measuring changes in treatment decisions versus direct ties to patient outcomes. Will NCAs likely be opened for listed items and services shortly after the comment period on the Potential Topics closes and probably by the end of the year? How will these topics be prioritized and by what criteria? How will CMS determine whether opening a NCA is warranted? Will NCAs be opened on only a few of the listed topics or on most of them? CMS’s answers to these questions are critical to us.

MITA looks forward to working with you to establish coverage policies that appropriately balance the benefits and risks of new technologies. We appreciate this opportunity to submit these comments and urge CMS to provide greater detail as to why it chose these items and services as well as the potential timing and likelihood of the opening of related NCAs. If you have any questions or would like to discuss these matters further, please contact me at 703-703-841-3250. Thank you for consideration of these comments.

Respectfully submitted,

/s/

Maureen Zilly
Director, Government Relations

¹ Potential Topics is available at: http://www.cms.hhs.gov/mcd/ncpc_view_document.asp?id=19.

² Multidetector-Row Computed Tomography in Suspected Pulmonary Embolism," Perrier, et. al., New England Journal of Medicine, Vol 352, No 17; pp1760-1768, April 28, 2005. Further, in reviewing the clinical literature, MITA recommends that CMS consider the positive findings on the cost-effectiveness of PET in the diagnosis of lung cancer. Muller A., Stratmann-Schone D, Klose T, Leidl, Overview of Economic Evaluation of Positron-Emission Tomograpy. Eur J Health Econ 3:59-65 2002.

³ Jelinek, JS et al. "Diagnosis of Primary Bone Tumors with Image-Guided Percutaneous Biopsy: Experience with 110 Tumors." Radiology. 223 (2002): 731-737.

⁴ Guidance Document is available at: http://www.cms.hhs.gov/mcd/ncpc_view_document.asp?id=6

⁵ Guidance Document at page 5 (emphasis added). ⁶ The NCA tracking sheet for Pharmacogenomic Testing for Warfarin Response is available at: http://www.cms.hhs.gov/mcd/viewtrackingsheet.asp?id=224