January 20, 2012
Centers for Medicare and Medicaid Services
Department of Health and Human Services
7500 Security Blvd.
Baltimore, MD 21244
RE: CED Public Solicitation
Dear Administrator Tavenner:
The Medical Imaging and Technology Alliance (MITA) appreciates this opportunity to respond to the Coverage with Evidence Development (CED) Public Solicitation for comment. As the leading trade association representing medical imaging, radiotherapy technology, and radiopharmaceutical manufacturers, we have an in-depth understanding of the significant benefits to the health of Medicare beneficiaries that medical imaging, radiotherapy and proton therapy provide. MITA is pleased to work with the Centers for Medicare & Medicaid Services (CMS) to ensure appropriate use of and access to these life-saving technologies.
Medical imaging encompasses X-ray imaging, computed tomography (CT), radiation therapy, related image acquisitions, diagnostic ultrasound, nuclear medicine (including positron emission tomography (PET and PET/CT)), 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.1 In addition, medical imaging is often used to select, guide and facilitate effective treatment, for example, by using image guidance for surgical or radiotherapeutic interventions.2 MITA's members also develop and manufacture innovative radiotherapy equipment used in cancer treatment as well as radiopharmaceuticals.
Thank you for the opportunity to comment on CED. MITA believes that CMS should apply CED sparingly and judiciously to protect access to care and avoid unnecessary duplication of research efforts. Below we outline our recommendations for CED in PET imaging ("PET IMAGING") and for screening applications ("DEVICES USED FOR SCREENING PURPOSES"). Our recommendations in Part I may be applicable to the potential application of CED to other technologies, as well.
PART I: PET IMAGING
Our members have extensive experience with CED through the national coverage determinations (NCDs) on PET using the radioisotope F-18 fluorodeoxyglucose (FDG). Through those NCDs, CMS worked with stakeholders to establish the National Oncologic PET Registry (NOPR) to collect data on use of FDG PET/CT for specific indications, including the initial and subsequent treatment strategies for brain, cervical, ovarian, pancreatic, small cell lung, and testicular cancers. These NCDs expanded access to care while data were collected, and based on those data, CMS later revised its NCDs to cover some of those uses of PET (FDG) without requiring further data collection. MITA members have appreciated the opportunity to work with CMS on these NCDs and we look forward to continuing to assist CMS in developing coverage policies that provide appropriate access to imaging technologies.
MITA believes that imaging technologies are essential to providing correct diagnoses and effective treatments to Medicare beneficiaries. Imaging procedures and related diagnostic tools, such as radiopharmaceuticals, should receive CMS coverage for labeled indications upon Food and Drug Administration (FDA) approval. In this regard, CMS coverage for these technologies would be consistent with other FDA-approved technologies, including drugs and biologicals, which generally are covered for their labeled indications upon FDA approval. During the FDA approval process, these technologies undergo extensive and rigorous well-controlled clinical trials to provide substantial clinical evidence to inform appropriate use. While further testing under a CED framework may be a useful mechanism for gathering data on off-label indications, CED should only be required for those uses in which the data are insufficient to support FDA approval but suggestive that the agent may be reasonable and necessary. Such discernment would avoid denying access for the Medicare population to the health benefits of an imaging technology, while allowing access to innovative new technologies under a doctor's care within the practice of medicine.
To further protect access to innovative technologies, we recommend that CMS remove provisions in its NCDs that deny coverage for any items and services not listed in the NCD. These provisions deny coverage for all new technologies, regardless of the strength of evidence supporting their approval and use, until CMS completes a national coverage analysis on each technology. One such example is the exclusionary language in the PET NCD.3 MITA formally requested the removal of this exclusionary clause on January 17, 2012. Removal of the national non-coverage policy for additional PET agents and other technologies would permit local coverage, as is the case for all other diagnostic and therapeutic options, absent an NCD, and protect timely access to new diagnostic and therapeutic options.
When CED is justified, we offer the following recommendations to improve its use:
- CMS should use CED sparingly and judiciously to protect access to care and avoid unnecessary duplication of research efforts.
- CMS should streamline the NCD process by working with relevant stakeholders to develop agreements on CED prior to issuing a proposed decision memorandum on a technology.
- CED should be applied with clearly defined endpoints and evidentiary standards appropriate to the item or service.
- The CED pathway should be deployed as an element of NCDs in most cases and not local coverage determinations (LCDs).
- All relevant stakeholders should participate in the setting of conditions and parameters under which CED would be applied.
Our comments discuss each of these recommendations in detail.
1. CMS should use CED sparingly and judiciously to protect access to care and avoid unnecessary duplication of research efforts.
Although CED can be a practical way to obtain evidence and speed collection of much-needed data on risks and benefits in specific population groups, we feel that it should be used only when Medicare coverage otherwise would be denied, and thus should be used exclusively to expand, rather than limit, access to promising technologies. Typically, when a new technology or procedure is evaluated by CMS for coverage, it already has been tested through extensive clinical trials by manufacturers and the medical community. We urge CMS to use the CED process sparingly and only in those cases in which the collection of additional data would address a specific and identifiable research gap that must be addressed before CMS can make a coverage determination. CED should not delay access to new medical imaging technologies for Medicare beneficiaries.
2. CMS should streamline the NCD process by working with relevant stakeholders to develop agreements on CED prior to issuing a proposed decision memorandum on a technology.
CED is most effective when all stakeholders agree on the need for CED and the data collection method to be used. To improve the success of any application of CED, we recommend that an agreement for each potential application of CED be developed among the technology's sponsor, CMS and any relevant and mutually agreeable professional societies. These parties should work together to determine whether CED is appropriate and to develop, design and implement research protocols. If there is agreement that a new product should be covered through CED at the national level, for example, when there are obvious indications adjacent to the proposed labeling, then MITA recommends a streamlined national coverage analysis process that begins with release for public comment of a proposed decision memorandum describing the application of CED, rather than a tracking sheet, thereby reducing the current 270 day process to 90 days.
3. CED should be applied with clearly defined endpoints and evidentiary standards appropriate to the item or service.
The feasibility of CED is affected by study infrastructure and duration but even more significantly by evidentiary standards, including numbers of patients and the endpoint, or "outcome." Outcomes of diagnostic interventions differ from those for therapeutics; diagnostic interventions are intended to resolve diagnostic dilemmas or stratify and monitor patients for the purpose of making treatment decisions. Diagnostics should not be held to therapeutic outcomes, but instead must be measured against their intended use, such as the ability to diagnose a condition, measure disease progression, or help determine a treatment plan. Additionally, if endpoints are too distant or difficult to gather, or the clinical protocol and evidence gathering too cumbersome, the participating sites will not be representative of "community practice" and any conclusions would be biased.
Such evidence should not be unreasonably difficult or costly, including financial and non-financial costs such as data collection and program management by physicians, pharmacists, patients, and other stakeholders. The evidence gap, the design, and the methods of evaluation must be clearly agreed to in advance of the collection of new evidence by all relevant stakeholders, including manufacturers and providers. In addition, the timing for reporting CED results and ending data collection should be clearly specified prior to the initiation of the CED decision. Whether for CED or routine NCD coverage, the evidentiary standard for any given procedure or drug should take into account the circumstances of intended use, e.g., different standards might be required of products and services which have a large impact on a large population.4
4. The CED pathway should be deployed as an element of NCDs in most cases and not LCDs.
Applications of CED should be made through NCDs to maximize the likelihood of successful data collection with minimal burden to stakeholders. For example, the NOPR enjoyed success because of the large body of consistent clinical evidence accumulated through national participation in a unified program of data collection. CED applied through LCDs would be unreasonably burdensome for sponsors who may be required to work with as many as fifteen different Medicare Administrative Contractors (MACs) and as many different protocol designs, could result in poor study enrollment unlikely to generate sufficient clinical evidence and may lead to unequal access for Medicare beneficiaries. CED provisions in an LCD may be reasonable in limited situations, however, e.g., for items or services for which all claims are processed within one MAC, as is common with some other non-imaging diagnostic tests, or if all MACs applying CED agree to a common data collection and claims processing methodology supported by the relevant stakeholders.
5. MITA strongly recommends that all relevant stakeholders participate in the setting of conditions and parameters under which CED would be applied.
We welcome an opportunity to discuss CED in a public forum and MITA would be willing to participate in and/or convene a workshop during which researchers, academics, industry, the government, professional societies and patient advocacy groups collaborate to specify both the application of CED (conditions under which CED is appropriate) and the mechanism for how CED will be undertaken if deemed necessary (research and analytical methods, protocols, endpoints and study duration). Establishing these rules in advance of new applications of CED will facilitate the already productive relationship CMS enjoys with the imaging community and would create a level playing field for technology sponsors while streamlining and making more efficient the CED process.
PART II: DEVICES USED FOR SCREENING PURPOSES
CMS should reconsider its authority to use CED to expand access to preventive care.
We ask CMS to reconsider the potential use of CED to expand coverage of innovative preventive services. We understand that CMS has determined that CED is not applicable to screening procedures because these services would have been covered under an exception to Social Security Act (SSA) § 1862(a)(1)(A), not one of the two statutory provisions CMS identified as the basis for CED.5 We disagree with this conclusion and we recommend that CMS reconsider the potential application of CED to preventive services.
We believe that preventive services could be covered under either of the statutory bases CMS has identified for CED. In CMS's 2006 guidance document on CED,6 CMS identified two types of CED .Coverage with Study Participation (CSP) and Coverage with Appropriateness Determination (CAD) . based on two different statutory provisions. CSP is based on section 1862(a)(1)(E) of the SSA, which allows coverage of items and services that are "reasonable and necessary" to carry out the Agency for Healthcare Research and Quality's research on the "manner in which diseases, disorders, and other health conditions can most effectively and appropriately be prevented, diagnosed, treated, and managed clinically."7 This authority allows Medicare to cover a broad array of items or services, including preventive services, and CMS could use CED based on this authority to cover any of those services. Alternatively, CMS could apply CAD to preventive services. CAD is based on SSA § 1862(a)(1)(A). Although preventive services generally are covered under an exception to section 1862(a)(1)(A), CMS has applied this section's "reasonable and necessary" standard to coverage of preventive services. CMS similarly could extend CAD to apply to preventive services, as well.
In addition to reconsidering the authorities CMS previously identified for CED, CMS could expand application of CED to address benefits covered under provisions other than sections 1862(a)(1)(A) or (E), such as the specific benefit categories for preventive services. We ask CMS to reconsider the potential application of CED to preventive services, discuss any alternative approaches, and solicit public comments on them, in a new version of the CED guidance document.
Streamlining CED and specifying clear mechanisms for its application will ensure that CMS has access to the clinical evidence necessary to make informed decisions, enable access to new products and services with reasonable boundaries and encourage innovation in imaging technologies. We thank CMS for its interest in improving this process and for the opportunity to submit these comments. If you have any questions or would like to discuss these matters further, please contact me at 703-841-3279. Thank you for consideration of these comments.
Executive Director, MITA
Vice President, NEMA
1 See, e.g., 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.
2 See, e.g., Jelinek, JS et al. "Diagnosis of Primary Bone Tumors with Image-Guided Percutaneous Biopsy: Experience with 110 Tumors." Radiology. 223 (2002): 731 - 737.
3 NCD Manual § 220.6 et seq.
4 The Working Group on Comparative Effectiveness Research for Imaging (Gazelle SG, Kessler L, Lee DW, McGinn T, Menzin J, Neumann PJ, van Amerongen D, White L.). A framework for assessing the value of diagnostic imaging in the era of comparative effectiveness research. Radiology 2011; 261:692- 698.
5 See, e.g., Decision Memo for Screening Computed Tomography Colonography (CTC) for Colorectal Cancer (CAG-00396N), May 12, 2009.
6 Guidance for the Public, Industry, and CMS Staff: National Coverage Determinations with Data Collection as a Condition of Coverage: Coverage with Evidence Development, July 12, 2006, http://www.cms.hhs.gov/mcd/ncpc_view_document.asp?id=8 (hereinafter "CED Guidance Document").
7 SSA §1862(a)(1)(E), referring to SSA § 1142.