View Public Comments for CED Public Solicitation

January 20, 2012

VIA ELECTRONIC DELIVERY

Louis B. Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
Mail Stop S3-02-01
7500 Security Blvd
Baltimore, MD 21244

Re: Centers for Medicare & Medicaid Services’ (CMS) public solicitation for comments on Coverage with Evidence Development (CED)

Dear Dr. Jacques:

The following comments on the CED Public Solicitation¹ are submitted on behalf of Eli Lilly and Company (“Lilly”). Lilly is one of the country’s leading innovation-driven, research-based pharmaceutical and biotechnology corporations. Our company is devoted to seeking answers for some of the world's most urgent medical needs through discovery and development of breakthrough medicines and technologies and through the health information we offer. Ultimately, our goal is to develop products that save and improve patients’ lives.

Lilly appreciates CMS’ attempt to improve the CED process, and build on the principles governing CED that were established in the 2006 guidance document. We believe that these principles are sound and should continue to be the foundation for any improved CED process. We urge the agency to include these core principles in any revised CED guidance that may be issued. The eight principles governing CED, as outlined in the 2006 guidance, are as follows:

1. National Coverage Determinations (NCDs) requiring CED will occur within the NCD processes, which is transparent and open to public comment.
2. CED will not be used when other forms of coverage are justified by the available evidence.
3. CED will in general expand access to technologies and treatments for Medicare beneficiaries.
4. CMS expects to use CED infrequently.
5. CED will lead to the production of evidence complementary to existing medical evidence.
6. CED will not duplicate or replace the FDA’s authority in assuring the safety, efficacy, and security of drugs, biological products, and devices.
7. CED will not assume the NIH’s role in fostering, managing, or prioritizing clinical trials.
8. Any application of CED will be consistent with federal laws, regulations, and patient protections.³

Lilly supports these principles as they protect and improve beneficiary access to important technologies and focus on the development of useful clinical evidence that is complimentary to existing evidence.

Lilly is concerned with CMS’ broad statement that “many new technologies are developed with insufficient attention to addressing the needs of the Medicare beneficiary population.”⁴ Although this may be true for some medical technologies, it is rarely true for drugs and biologics used by the Medicare population. These therapies are subject to a rigorous FDA approval process, and their approved prescribing information clearly indicates the population for which each therapy is approved based on data supporting that approval. Consistent with CMS’ 2006 CED principles, CMS should not duplicate or replace the FDA’s authority by requiring additional evidence of a drug or biological for its approved indications. CED is rarely, if ever, appropriate for the FDA-approved uses of drugs and biologics that are approved for use in the Medicare population based on FDA and often advisory panel review of data reflecting outcomes in the Medicare population.

Lilly believes CED is not necessary if an FDA Risk Evaluation and Mitigation Strategy (REMS) registry is in place. At most, when CMS believes CED is warranted, CED should simply integrate necessary data requirements into and extract relevant analyses from the REMS registry. This would allow requestors to implement CED efficiently in those situations where the FDA has required post-approval data collection. This process would provide coverage to beneficiaries while the evidence is being collected, thus avoiding duplicative and wasteful efforts for purpose of CED.

Additionally, CMS should proactively remove any pre-existing broad national non-coverage exclusionary policies, such as the current Positron Emission Tomography (PET) coverage policy (220.6), which explicitly non-covers new, innovative agents never reviewed by CMS from coverage. These exclusionary policies inappropriately render immediate non-coverage decisions on any new FDA-approved technology. In effect, such policies constitute an affirmative position that the imaging agent has failed to meet statutory criteria for medical necessity, even though the agent has undergone no review by Medicare. Exclusionary coverage policies create barriers to medical innovation that can discourage future investments in research and development.

New diagnostic radiopharmaceuticals will undergo the full rigors of the FDA-approval process. Furthermore, new proprietary agents are supported by manufacturers who invest in post-approval studies to broaden the evidence base and provide training and education on the appropriate use of the new technology. For these reasons, Lilly believes new diagnostic radiopharmaceuticals should be available to Medicare beneficiaries upon FDA approval and that the current exclusionary language is not appropriate. CED should be applied rarely to new radiopharmaceuticals. Lilly requests that CMS make these policy changes which will avoid denying important access to new innovations which will benefit the Medicare population.

We provide specific comments on each of the three areas specifically requested by CMS below.

1. Implementation of CED through the NCD or other avenues under Part A and Part B.

CMS has expressed interest in expanding application of CED beyond the NCD process. Lilly supports the first principle published in the 2006 guidance: “NCDs requiring CED will occur within the NCD processes, which is transparent and open to public comment.” Any application of CED must be developed in a clear and predictable manner, with opportunity for public comment, to ensure that CMS reaches an appropriate decision. The NCD process is designed to provide for this, whereas other processes might not.

In the rare situations when CMS chooses to apply CED, CMS can, however, substantially accelerate the launch of CED. When the manufacturer is in agreement, Lilly urges CMS to move directly to CED through a streamlined NCA/NCD process starting with a proposed coverage decision. This process, which would work under CMS’ existing framework, will eliminate inefficiency and waste and make new technologies with agreed upon evidence gaps available to beneficiaries within 90 days of FDA approval. CMS can propose an NCD in this manner, because § 1862(l)(3) of the Social Security Act requires only a single thirty-day comment period which occurs after posting a proposed decision memorandum. CMS has proposed NCDs in this way in cases where an initial six month analysis opened by public comment would serve no useful purpose (for example, in a reconsideration of the Clinical Trial Policy and in a requested NCD for home sleep testing for obstructive sleep apnea. ⁵) CMS would receive little difference in the way of public comment by announcing it intends to open CED on a specific therapy and indication, versus simply presenting the public the proposal for CED, in the form of an initial NCA.

When CED is warranted by CMS, we urge CMS to work with key stakeholders including the relevant clinical societies and the manufacturer prior to opening an NCD to design a CED process that will clearly define a pathway to begin and end CED on a technology after the appropriate amount of evidence has been collected. These parties should work together to develop, design and implement the study/registry protocols.

Lilly believes this approach is a much better mechanism to allow streamlined NCD than allowing CED through local Medicare contractors. Allowing CED to occur under a local coverage determination introduces additional complexity, duplication, and cost for all stakeholders involved. There are a number of substantial drawbacks to offering CED through local contractors, and they would be very difficult to remedy. Only by implementing CED at the national level can CMS bypass a number of drawbacks related to small study sample sizes, limited agency resources and duplicative clinical trials with incompatible endpoints. Furthermore, CED at the local level would be unreasonably burdensome for sponsors who may be required to work with as many as fifteen different Medicare Administrative Contractors (MACs), potentially leading to poor study enrollment and inconsistent access for Medicare beneficiaries. CMS has stated that CED should be used infrequently and not to duplicate or replace the FDA’s authority, but these principles will be difficult to enforce across a wide diversity of contractors and with local medical directors who have widely variable levels of topic-specific expertise. In general, as noted earlier, CED will not be necessary for FDA-approved drugs and biologicals, and should a potential exception arise, it should best be reviewed by experienced CMS staff and with the opportunity for national comment. Unlike surgical procedures or physical therapies, which require manual expertise, the efficacy of drugs does not vary locally.

2. Potential impact of CED on the Medicare program and its beneficiaries.

The principles established in the 2006 guidance document can help ensure that CED improves appropriate beneficiary access to innovation. As Lilly has requested, CMS should use the 2006 CED principles as the foundation for an improved CED policy that seeks to develop additional evidence to expand access to technologies in those rare instances where available evidence is insufficient.

Absent these principles, CED could create undue burden on beneficiaries, healthcare providers, and manufacturers. For Medicare beneficiaries, local CED likely would result in confusion and inefficiencies while generating a much smaller base of additional evidence. Patient access to life-saving technologies could be delayed with implementation of local CED which may result in lower health outcomes and additional cost to the healthcare system through potential use of less effective treatment. In addition, local CED could lead to regional access disparities resulting in discrimination against beneficiaries in certain region and/or rural geographies.

3. Suggested approaches to CED to maximize benefit to Medicare beneficiaries

We summarize our comments by stating four key principles. First, as stated above, we believe that maximizing CED benefit to Medicare beneficiaries will occur only if the principles established in the 2006 guidance document form the basis of any revision to the CED. CMS should apply CED rarely, especially in the case of drugs and biologics. In addition to the existing 2006 CED principles, Lilly urges CMS, when CMS believes CED is warranted and the manufacturer is in agreement, to move directly to CED through a streamlined NCA/NCD process starting with a proposed coverage decision. This process, which would work under CMS’ existing framework, will eliminate inefficiency and waste and make new technologies with agreed upon evidence gaps available to beneficiaries with 90 days of FDA approval. Local CED should not be pursued at this time.

Second, Lilly recommends that CED agreements should be in coordination with interested stakeholders, and expressly include the manufacturers and any involved professional/clinical societies. Manufacturers and/or key stakeholders should work directly with CMS to develop, design and implement the study. Agreements should allow for confidentiality provisions as agreed to by all parties, including appropriate distinctions for both financial and scientific information. CMS should allow industry sponsors (such as a device, diagnostic or pharmaceutical/biologic manufacturer) to conduct a CED study directly, in addition to funding the development and conduct of the study. Manufacturers and other stakeholders should be given blinded access to the final data set for their own analyses.

Third, CED should only be applied when the supposed data uncertainty is specific and feasible to define, and when the additional evidence required is obtainable in a reasonable and cost-effective manner, including the cost of time for program management by physicians, pharmacists, patients, and other stakeholders. The evidence gap as well as the design and methods of evaluation must be clearly stated in advance of the collection of new evidence. Sponsors and decision makers must be in agreement on the decision points and the quality of the evidence to be obtained before the program is implemented. Evidence must fit the purpose of CED, which means it should be relevant, narrowly defined, and timely. The timing for reporting results should be evaluated on a case-by-case basis and should include consideration of the impact of future treatments. CED should have a clearly defined beginning and end.

Fourth, and finally, Lilly feels strongly that CED should not delay access and at minimum, CMS coverage under the CED agreement should be consistent with product’s FDA label. While a technology is being evaluated under CED, we encourage CMS to make coverage available to all Medicare beneficiaries, not just those beneficiaries who are participating in the CED- sponsored registry or trial. Lilly believes that the important evidence being collected under CED should not have the negative consequence of denying beneficiaries who do not have access to the CED registry or trial the potential benefit of the innovative technology during the CED process. CMS should proactively remove existing non-coverage policies, such the current Positron Emission Tomography (PET) coverage policy, which explicitly excludes new agents from coverage. Forward-looking CED agreements can be in place prior to the date of FDA approval to facilitate access to beneficiaries upon FDA approval. Once a product's indication is determined by FDA approval, the product’s label should be taken as the definitive view of the product's characteristics for the purpose of CED design.

Lilly appreciates the opportunity to comment on the future of CED. We look forward to continuing to work with CMS to improve access to breakthrough medicines and technologies that improve Medicare beneficiaries’ lives. Please feel free to contact Derek Asay at 908-268-8720 if you have any questions or need any additional information. Thank you for your attention to this very important matter.

Sincerely,

/S/
Derek L. Asay
Director, Government Strategy, Federal
Accounts and Quality

/S/
Sean P. Donohue
Senior Director, Federal Affairs

January 20, 2012

Louis Jacques, M.D.
Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Mail Stop S3-02-01
7500 Security Boulevard
Baltimore, MD 21244

Re: Coverage with Evidence Development Public Solicitation

Dear Dr. Jacques:

On behalf of Johnson & Johnson (J&J), we are providing the following comments and recommendations in response to the public solicitation by the Centers for Medicare and Medicaid Services (CMS) for comments Coverage with Evidence Development (CED), issued on November 7, 2011.

Johnson & Johnson (J&J) is the world's most comprehensive and broadly-based manufacturer of health care products for the consumer, pharmaceutical and medical devices and diagnostics markets. For 125 years, J&J Companies have supplied hospitals with a broad range of products and have led the way in innovation, beginning with the first antiseptic bandages and sutures.

We appreciate CMS' past and present efforts to solicit public input as part of its CED policy development. J&J submitted comments during the development of the current CED Guidance document, and we believe the final policy was appropriate. We recognize that questions linger about the implementation of the policy and whether there are other potential approaches that could achieve CMS' twin objectives to improve access to innovative technologies and better inform the agency's decisions.

The November 7 solicitation identified three topics for which CMS sought public input:

• Implementation of CED through the national coverage determination (NCD) process or other avenues under Part A and Part B;
• Potential impact of CED on the Medicare program and its beneficiaries; and
• Suggested approaches to CED to maximize benefit to Medicare beneficiaries.

Our comments primarily address the implementation of CED, although we agree the goal of CED should be to maximize benefit to Medicare beneficiaries. That is, CED should be used in a way that enhances access, and not to discourage or hamper the development and provision of innovative treatments that provide health benefits to Medicare beneficiaries and others.

Implementing CED

While we understand CMS' interest in encouraging new thoughts about the best way to utilize CED, we believe the 2006 guidance was carefully crafted with public input and does provide an appropriate framework. In particular, adherence to the eight principles (attached) enunciated in the guidance should continue with respect to CED use within the NCD process. It should also be used to help guide discussions regarding the use of CED outside of the NCD process

We also believe it is important that CMS continue to proceed in an open and consultative manner. We trust the agency will follow its 2005 precedent to accept public input as it proceeds with any policy changes. Especially given the broad nature of the November 7 solicitation, we look forward to additional opportunities for an ongoing dialogue with CMS in this area.

Our comments here pertain to clarifying and improving the current CED process. In particular, we believe CMS should use this opportunity to develop a more detailed process for defining CEDs, including the direct involvement of all stakeholders associated with the service or technology to be studied. We also discuss some specific thoughts on potential approaches to supplement the available evidence apart from the NCD process.

• Improved Clarity is Needed Regarding the Timetable and Endpoints for CED CMS should identify the process and timetable for implementing a CED and for using data upon completion of a CED to reassure patients, physicians, and industry that the process does not create an additional barrier to entry or delay access to new treatments. We encourage CMS to develop a more detailed process for establishing the timetable and endpoints for each CED. Explicit criteria for any CED should be to collect only the minimal amount of data necessary to answer the coverage question at hand. CMS should consider creating a "study design oversight" external group that can provide input on the validity of study designs prior to any analysis of data or results.
• Engage a Full Range of Stakeholders in Setting Parameters for the CED Data Collection Effort The CED process should identify and involve outside stakeholders to develop the implementation details. For example, patient groups, the product manufacturer, and practicing physicians should be included in the design of the CED implementation and evaluation. This should help to assure less burdensome data collection that is more relevant to the coverage concern and reduce duplication with other studies underway. These types of data collection efforts are expensive and should be designed carefully to avoid unnecessary costs.
• Conditional Coverage At times it may be appropriate to specify conditions associated with coverage rather than CED. This may be the case where there is concern that particular treatments should be provided in certain settings such as Centers of Excellence. This may occasionally be a less burdensome solution than CED. We would request that, as part of any further clarification of its CED policy, CMS provide additional guidance on the factors it considers when applying conditional coverage policies as opposed to CED.
• Clarify the Legal Basis for CED We understand that CMS is currently reviewing the legal basis for the CED program. CMS views CED as a method for covering certain technologies and procedures on a conditional basis, but previous CED guidance documents have not fully explained the legal basis. We therefore ask that the revised CED guidance document include a complete analysis of the legal basis for this program. It is critical for stakeholders to have a thorough understanding of CMS' position as to the legal foundation for this program.

Additional Issues: Greater Collaboration With Stakeholders and Local CED

We are concerned that expanded use of CED could lead to targeting a narrower and narrower group of patients, rather than making important treatments more widely available. If the agency proceeds too quickly with CED, without clarity about the selection criteria, the use of data , industry's and physicians' responsibilities in data oversight, coordination with FDA, and other key issues, the CED effort could create problems with access to important new treatments for beneficiaries and opposition by stakeholders.

However, there may be situations where CMS perceives gaps in the evidence for a procedure or technology in terms of the benefits to the Medicare-age population, but the manufacturer or other stakeholders believe issuance of an NCD is premature. Similarly, additional evidence could help CMS address questions in other areas (e.g., sites of service, reimbursement) that may be addressed through additional evidence.

Under the current CED process, CMS could only proceed with opening an NCD to establish CED in this situation. This places what may be an unnecessary burden on the agency to go through the NCD process when the objective was not to limit coverage but only to generate more evidence. The current CED process also generates uncertainty surrounding the use of the procedure or technology with regard to the potential for a noncoverage decision at the end of the NCD process.

CMS could consider establishing a framework for open and collaborative discussions about any perceived evidence gaps, and explore ways to fill those gaps outside of the NCD process. We would be happy to work with CMS to explore whether this concept could be workable and how it can be accomplished.

Since the issuance of the solicitation for comments, CMS has mentioned the possibility that CED could be used by its Medicare Administrative Contractors (MAC) in conjunction with their local coverage determinations (LCD). An example cited by CMS where such a process may be appropriate was the situation where all of the processing for a specific diagnostic test is performed by a single reference laboratory, and the payment claims go to a single MAC. CMS noted that, in this case, any applicable LCD would serve as an NCD.

In general, we do not believe that CED should be an option for LCDs. The potential for inconsistent evidence requirements across the various MACs, and the potential for a great expansion in the volume of CED and an exponential growth in the costs of studies, are two significant concerns with this approach. While it may potentially be appropriate to allow CED for situations where all of the Medicare claims are processed by a single MAC, analysis of the legal authority for such use of CED and further discussion with stakeholders regarding development of this idea is needed.

Conclusion

We support CMS' efforts to continue to explore ways to improve the CED process. We believe our comments above are consistent with ensuring the CED process leads to faster access to new treatments and technologies for patients, reducing the risk of noncoverage that currently exists from lack of data. Any expansion of CED should not create a hurdle to coverage that will reduce access to important treatments that can be beneficial to Medicare beneficiaries. We also continue to believe that CED should be used selectively, where it can provide the greatest benefit, and CMS should be very cognizant of minimizing the cost of the methods used and reporting burden.

We appreciate the opportunity to comment on this important issue and look forward to working with CMS to assure that the promise of better patient care and information about new treatments is fulfilled. If you would like to discuss our comments, please do not hesitate to call me at 202/589-1000.

Sincerely,

/s/
Kathy Buto
Vice President, Global Health Policy

• Principle 1. NCDs requiring CED will occur within the NCD processes, which is transparent and open to public comment.
• Principle 2. CED will not be used when other forms of coverage are justified by the available evidence.
• Principle 3. CED will in general expand access to technologies and treatments for Medicare beneficiaries.
• Principle 4. CMS expects to use CED infrequently.
• Principle 5. CED will lead to the production of evidence complementary to existing medical evidence.
• Principle 6. CED will not duplicate or replace the FDA's authority in assuring the safety, efficacy, and security of drugs, biological products, and devices.
• Principle 7. CED will not assume the NIH's role in fostering, managing, or prioritizing clinical trials.
• Principle 8. Any application of CED will be consistent with federal laws, regulations, and patient protections

January 20, 2012

Louis Jacques, M.D.
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
Office of Clinical Standards and Quality
7500 Security Blvd.
Mail stop: C1-09-06
Baltimore, MD 21244

RE: Request for Comments on CMS' Coverage with Evidence Development Policy

Dear Dr. Jacques:

On behalf of Medtronic, Inc., I am pleased to respond to the Centers for Medicare & Medicaid Services' (CMS') request for public comment on its coverage with evidence development (CED) policy.¹ Medtronic is one of the world's leading medical technology companies, specializing in implantable and interventional therapies that alleviate pain, restore health, and extend life. We are committed to the continual research and development necessary to produce high-quality products and to support innovative therapies that improve patient and health care system outcomes.

We appreciate the opportunity to comment on the CED policy, building on our past work with CMS on the national coverage process and on coverage determinations for many Medtronic therapies, including CED for implantable cardioverter defibrillators (ICDs). We have appended our 2005 comment letter to the agency's initial solicitation for public input on factors to consider when making a determination of CED.² Medtronic appreciates the value of evidence-based approaches to generate real-world evidence and create data sources to track real-world outcomes of interest to Medicare and its beneficiaries. We have and continue to engage with CMS and the FDA to generate these data and continue to make significant investments on our own to refine the use of our products, better define appropriate indications, and expand the evidence base for our therapies.

Medtronic supports CMS' overarching goal to ensure that Medicare beneficiaries receive appropriate, high-quality health care, including access to life-saving and life-enhancing medical advancements. Medtronic also supports CMS' goal to improve physician and patient decisionmaking. In that regard, it is up to all of us as the stewards of limited clinical research dollars to ensure that the data generated through the CED approach would create meaningful, actionable clinical evidence and would not duplicate existing public and private efforts outside the agency. It is also important that CED be conducted in a manner that is efficient and considers the financial and administrative burdens placed on all parties involved.

To that end, we put forward the following recommendations for the agency's consideration:

1. CMS should publicly issue an evaluation of the successes and challenges of its existing CED policies and host a public meeting to engage stakeholders in ways to improve and mature CED.

2. CMS should limit the use of CED as an outcome of the NCD process. More specifically, CED should be applied rarely in NCDs and only in circumstances where the alternative is non-coverage. In these instances, CED should be used to generate specific evidence that will address, in a timely fashion, the open questions related to whether the technology is reasonable and necessary. These questions should be identified prior to the implementation of CED.

3. In light of past challenges with CED, Medtronic recommends that CMS consider the following refinements to the existing NCD process to ensure appropriate implementation of CED:

   1. CMS' intentions of considering CED should be noted as early as the initiation of the national coverage analysis (NCA).
   2. A value of information (VOI) analysis or at minimum an informal analysis of the return on investment from CED should be conducted before the draft decision; the results of this analysis should be included in the draft guidance.
   3. The draft NCD should propose the membership of a CED implementation steering committee with representation from all appropriate stakeholders and state an interim coverage policy to ensure beneficiary access to the therapy before the data collection mechanism is operational.
   4. The final NCD should name the final steering committee, interim coverage policy, and provide a clear timeline for next steps for appropriate CED implementation.
   5. While the billing and coding instructions are being written, the steering committee would work with CMS to ensure all questions are clearly answered for appropriate implementation of CED.

4. CED should not be issued by local Medicare contractors.

Further detail on these recommendations is provided below. We appreciate your consideration of these comments.

Medtronic appreciates the agency's efforts of considering internal lessons learned to better align CED with the rapidly evolving changes in our healthcare system. We believe that a formal evaluation of the lessons learned from all prior applications of CED is an important step to refine the overall effort and prove the value of additional data collection. We recommend that the agency publicly post its lessons learned and incorporate these lessons in a revised policy framework for CED. Moreover, we recommend that CMS establish a permanent mechanism to evaluate the effectiveness of CED in providing additional evidence to bolster physician and patient decision-making.

For example, as recommended by stakeholders in response to the 2005 draft CED guidance, each year in CMS' report to Congress on the NCD process, the agency's Office of Research, Development, and Information could conduct an internal evaluation of CED initiatives. Alternatively, CMS could contract with an independent entity to review CED policies on an ongoing basis to assess their implementation. The agency should monitor and evaluate beneficiary access to care after the implementation of all NCDs that issued CED to verify that these decisions have expanded access to these therapies and that the data collection efforts have minimized the burden and have resulted in useful and actionable data. CMS should publicly post these reports evaluating the CED initiatives at least every three years.

In considering lessons learned, Medtronic believes it is helpful to draw from three illustrative specific cases of CED to improve future efforts: ICD, left ventricular assist device (LVAD), and cochlear implantation.

In 2005, CMS implemented an NCD on implantable automatic defibrillators, which expanded coverage for ICDs by requiring the systematic collection of implant data via an ICD registry.³ While this registry has served to aggregate data on ICD implantations, several challenges have been observed in its implementation. Particularly, even after the establishment of the registry, there was no formal agreement between CMS and the National ICD Registry Working Group on a protocol with well-defined research questions or a timeline for the duration of data collection. As a result, the study population was not targeted and the collected data was not necessarily relevant to the CED policy.⁴

At the start of the ICD CED registry, it was acknowledged that certain data elements were absent and there were no specific plans on how to obtain the necessary follow-up data for ICD firing, complications that occur after discharge, such as infection and lead dislodgement, and long-term survival data. This is a problematic approach to robust clinical research. Mayo Clinic clinician Dr. Stephen Hammill noted that the ability of the original ICD Registry to address specific areas identified as research gaps in the coverage decision remained uncertain: "some were skeptical whether data from this registry would ever be useful in refining coverage decisions; with little/no history of using observational data to affect coverage and with no control group, some view using such data to change coverage as unlikely, especially after nearly a half-decade of established use."⁵ In April 2010, version 2.0 of the registry was launched to meet many of these limitations.

Registries provide a useful vehicle for real world utilization and safety surveillance observations. But their role and ability to efficiently and effectively answer CED questions have not yet been demonstrated in the example of ICDs. There have been no publications or advancement of the CED discussion based on the ICD CED registry data. There are no specific terms or dates that provide process transparency to the use of the registry to answer definitively the CED questions. We are now seven years in to answering the CED question but there is no clear path forward in terms of process and decision making.

We note that even when a specific CED requirement is applied, alternative studies may be conducted that answer questions intended to be addressed by the CED requirement. This has been the case with ICDs, where Medtronic initiated the OMNI study to prove further the outcome benefit of ICD in relation to the CED questions. The results of OMNI have been shared with CMS and publications are pending. We believe CMS should carefully consider alternative public and private study resources such as OMNI when addressing CED questions, and should take into consideration results of such studies in determining whether and when a CED requirement should conclude.

In 2007, CMS released a reconsideration of its final decision on ventricular assist devices (VAD) as destination therapy, which established INTERMACS as the registry that satisfies CMS' reporting requirements for coverage.⁶ The INTERMACS case demonstrates that establishing a sustainable and fairly distributed funding program is a difficult endeavor that needs to be carefully considered within a clearly defined process. Established in 2005, the registry was initially funded by the NIH and the U.S. Department of Health and Human Services (DHHS). In this case, the burden of third parties (e.g., medical technology companies and hospitals) to provide financial support has steadily increased. Starting in 2010, the NIH contract renewal requires INTERMACS to become mostly self-funded by 2015. As of April 2011, the registry is now funded 38% by NIH, 38% by hospitals, and 22% by industry.⁷ As a result, each hospital participating in INTERMACS will pay $10,000 per year and industry will pay an increasing rate, starting at $500 per patient enrolled to cover the costs of the registry.⁸ Due to these increasing costs, hospitals may choose to stop participating in the registry, which would ultimately impede Medicare beneficiaries' access to the procedure.

In order to ensure there is a sustainable funding mechanism that does not unduly burden providers and other relevant stakeholders, Medtronic suggests that CMS should identify appropriate stakeholders to jointly establish a framework for funding the collection and analysis of the data. If CMS envisions a cost-sharing model that includes the private sector, there should be a process to establish who will convene the various parties when there are multiple stakeholders and product sponsors as well as how decisions will be made concerning who will pay what share and for how long. These funding consultations should also include consideration of reimbursement for providers who will bear an additional data collection and reporting burden. Medtronic encourages CMS to provide reimbursement mechanisms for physicians and other healthcare professionals participating in CED data collection, such as implementing special coding for reimbursement directly to providers for the additional efforts required to collect meaningful and relevant data.

In 2005, CMS published an NCD for cochlear implantations, which specified that cochlear implantations may be covered only in the context of a clinical trial approved by CMS, among other criteria.⁹ However, according to the Medicare Evidence Development and Coverage Advisory Committee's (MEDCAC's) review of this topic in 2011, there have not been any clinical trials established to satisfy the terms of the coverage decision, since the final NCD was published in 2005.¹⁰ As a result, cochlear implantations have remained non-covered for the specified patient population, thus preventing beneficiary access to this treatment.¹¹ This case illustrates the importance of a clear framework outlining the appropriate timeline, data elements, and responsibilities for data collection before the implementation of CED. Moreover, it also shows the need to determine interim coverage of the item or service until the data collection vehicle is operational. The need is particularly acute with respect to items or services whose pre- CED coverage status is non-coverage.

In its 2010 Report to Congress, the Medicare Payment Advisory Commission (MedPAC) cites operational challenges to implementing CED that should be addressed as the agency updates its guidance. Identified challenges include the need to develop: (1) a mechanism to identify potential CED candidates, (2) a timeframe for the consideration and re-consideration of a particular service under CED, and (3) a clear financial and management plan for data collection efforts.¹² Medtronic agrees with MedPAC that CMS needs to develop a clear and predictable decision-making process for applying CED, implementing CED, and reconsidering the evidence generated by CED. In addition, CMS should also put forth a process for concluding CED requirements after the research questions have been sufficiently resolved. CMS should consider the development of such processes in draft form before they are finalized, giving stakeholders an opportunity to comment on the processes before implementation.

Medtronic believes that the next iteration of the CED guidance document should clearly articulate a framework for the appropriate application of CED, developed and vetted in a public forum. We recommend that this guidance be issued in draft form before it is finalized, giving stakeholders an opportunity to comment on the new policy before it takes effect. The previously issued CED guidance was too broad and provided little predictability in understanding how CED would be applied in the evaluation of valuable health technologies.

Moreover, while the agency has publicly stated that CED will be applied rarely, the agency has applied its CED policy at an increasing rate. Before the finalization of the CED guidance, CED policy was applied in fewer than 10% of NCDs from 2000 to 2007.13 In comparison, since the guideline was finalized in 2006, CMS issued 38 NCDs, 21% of which have resulted in CED.14 Therefore, it is imperative for the agency to clearly articulate a defined framework for the appropriate application of CED.

To provide further clarity and predictability to the CED process, Medtronic believes the situations in which CED may be applied should be clearly outlined and identified by CMS. We believe the following circumstances are most appropriate:

• Since the primary goal of CED is to increase access to medical advancements for Medicare beneficiaries, as previously stated by the agency, Medtronic believes that CED should only be applied when the alternative to the policy is national non-coverage or significant noncoverage at the local level because of limited evidence of clinical benefit.

• CED should only be used to answer essential questions of "reasonable and necessary" affecting the health of Medicare beneficiaries. In these instances, CED should be used to generate specific evidence that will address the open questions regarding coverage of the item or service under review that are within the jurisdiction of CMS.

• CED should not be used to generate evidence to address research questions that have already been confirmed by RCTs.

• Moreover, CED should not be applied in situations where the outstanding questions are related to safety, as the mechanism to answer these questions is the responsibility of the FDA and generally should not be addressed through CED. The FDA routinely requires manufacturers to conduct post-approval studies for the purposes of detecting adverse events, estimating adverse event frequencies, evaluating product performance, and identifying groups at risk. The manufacturer is already legally obligated to fulfill these requirements and, therefore, CED is not necessary.

• Lastly, CED should also not be implemented in a way that creates geographic disparities in Medicare beneficiary access or unnecessarily disadvantages providers who may not be financially capable of meeting the data collection requirements or reduces coverage available under the existing local process.

Medtronic believes the implementation of CED would benefit from a more structured approach within the national coverage process. Several of the concerns raised above about previous CEDs resulted from the lack of a systematic and transparent approach to conceptualizing and developing the specific details of the proposed CED. We believe this has occurred because the NCD timeframes and comment periods ¡V which otherwise are quite useful and appropriate ¡V do not provide sufficient time or flexibility to address the myriad questions and issues that must be taken into consideration in developing a suitable approach for individual CEDs. We therefore recommend a series of steps that would clarify and improve the process for establishing CEDs when the need for CED is determined to be appropriate.

Medtronic believes that the agency should announce its consideration of CED at the initiation of the NCA to promptly begin a transparent process of ensuring appropriate application and implementation of CED. During this process, CMS should work with all appropriate stakeholders in the development of the CED requirement and framework for data collection.

Following the agency's initial announcement of considering CED at the initiation of the NCA, Medtronic believes that a thorough VOI analysis should be commissioned.¹⁵ Such an analysis would assist CMS in determining whether the additional information collected as part of a CED requirement represents a worthwhile investment relative to the burden it places on stakeholders and restrictions imposed on beneficiary access. This analysis should be completed before the draft decision and the results should be included in the draft guidance.

In order to properly conduct this VOI, CMS should work with the stakeholder community to clearly identify the key questions that, if addressed with sufficient evidence, would allow the agency to make a determination that the item or service is "reasonable and necessary." Moreover, we urge CMS to acknowledge initiatives, such as ongoing private sector and FDAmandated post-market studies, when considering the need for an additional governmentmandated data collection as a condition for Medicare coverage and conduct a gap analysis of ongoing or planned public and private evidence generation activities to ensure that the proposed CED is not duplicative.

We believe the draft decision memorandum should address the following:

1. Specific research question(s) that CMS believes CED will address;
2. Gap analysis of public and private evidence generation activities; and
3. Impact of additional burden of data collection (i.e., time, financial, administrative) on key stakeholders (e.g., geographic inequality in beneficiary access to treatment)

Before the draft decision is published, Medtronic recommends that the agency publicly discuss and vet the VOI analysis findings in an open forum, such as a MEDCAC. Such discussions will help ensure that CED is appropriately applied and that future data collection efforts through CED will not be duplicative or burdensome.

In order to ensure that following an NCD, CED will advance the common goals of all stakeholders, Medtronic recommends establishing a steering committee with broad stakeholder representation, including all relevant stakeholders, such as patient representatives, hospitals, professional societies, and medical technology companies. The draft decision memo should propose key members for the steering committee designed to develop a clear framework for data collection, addressing outstanding factors, such as timeline, data elements, access and ownership to data, and funding of data collection. The public should have the opportunity to nominate members of this committee via public comments after NCA initiation and comment on the proposed members for this committee following the release of the draft decision.

Additionally, it will be important for the agency to include a draft interim coverage policy as a safeguard for beneficiaries between the final NCD and CED implementation.

Medtronic believes that the final NCD should clearly outline the steps required for appropriate and effective implementation of CED. The final NCD should include a final interim coverage policy, a final list of members for the steering committee, and a clear timeline for the committee to develop a framework for data collection. Clearly outlined next steps will ensure appropriate data collection through CED, while granting Medicare beneficiaries access to promising medical advancements.

Following the final NCD, the steering committee would work with the Coverage and Analysis Group to develop a clear framework for data collection under CED. As such, the committee would aim to answer the following questions:

• What is the appropriate study design to specifically answer the CED questions?
• What is the expected duration that patients will be followed in the study?
• What data elements will be collected and how do they specifically contribute to the CED research questions?
• How should the evidence be collected to ensure analyses can be done on specific subpopulations?
• Who will have access to the data?
• Who will have ownership of the data?
• Who will fund the data collection and analysis of the data?
• Who will conduct the analysis of the data?
• What will be the time intervals of this analysis and review by CMS?

The answer to each of these questions has important implications for the success and scientific character of data collection through CED and should be considered in an open and transparent manner, led by the steering committee. The agency should not move forward without further clarification on these questions. Moreover, the answers to these questions should be posted on the tracking sheet of the decision. Failure to articulate these issues in any NCD with a CED requirement will put an undue burden on beneficiaries, providers, and other stakeholders, and ultimately, decrease the potential for any meaningful data collection to lead to improved decision-making.

CMS should continue to implement CED within the NCD process. Medtronic does not believe that CED should be implemented by local Medicare contractors due to challenges with executing the policy at this level, such as limited sample size to adequately power studies and the potential for duplicative studies with potentially conflicting outcomes across contractors. Moreover, since a CED decision impacts entire populations of Medicare beneficiaries in need of specific classes of products, it is also important that such decisions are made at the national level to ensure that all relevant stakeholders have the opportunity to engage in the decision-making process. The NCD process, with its statutorily defined public comment periods and process requirements, provides stakeholders with the opportunity to monitor and weigh in on CED decisions that impact them.

Medtronic appreciates this opportunity to provide comments to CMS on the CED policy. We appreciate your consideration and are happy to provide further information or assist with any additional questions. Please feel free to contact me at (202)442-3633 or jeff.a.farkas@medtronic.com if you have any questions or wish to discuss our comments in further detail.

Sincerely

Jeff Farkas
Vice President, Health Policy and Payment
Medtronic, Inc.

January 20, 2012

Marilyn Tavenner
Acting Administrator
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Mailstop: C1-09-06
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:

1. CMS should use CED sparingly and judiciously to protect access to care and avoid unnecessary duplication of research efforts.
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.
3. CED should be applied with clearly defined endpoints and evidentiary standards appropriate to the item or service.
4. The CED pathway should be deployed as an element of NCDs in most cases and not local coverage determinations (LCDs).
5. 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.

Conclusion

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.

Respectfully submitted,

January 17, 2012

VIA EMAIL CAGinquiries@cms.hhs.gov

Louis Jacques, M.D.
Director, Coverage Analysis Group
Office of Clinical Standards & Quality
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Mail Stop S3-02-01
Baltimore, MD 21224

Re: CED Public Solicitation: Comments on Guidance Document for National Coverage with Evidence Development

Dear Dr. Jacques:

Regenesis Biomedical, Inc. (“Regenesis”) appreciates this opportunity to present its comments to the Centers for Medicare & Medicaid Services (“CMS”) on the National Coverage with Evidence Development (“CED”) Guidance Document solicitation. Regenesis supports the use of CED as a way to improve health outcomes through timely adoption of new technologies. In particular, our comments address some of the unique circumstances facing small companies offering promising new technologies. Our comments also address suggestions for establishing a CED guidance document that takes into account how stakeholders of all sizes can partner with CMS to develop needed evidence for Medicare coverage, as well as the importance to the Medicare population of improving quality of life in the home setting. In addition, we would suggest that CMS continue to work with stakeholders in refining the CED process to reduce barriers to innovation.

Regenesis is a privately held medical technology company focused on developing and marketing noninvasive regenerative medicine products. Regenesis developed, patented, and now markets the Provant® Therapy System, cleared by the Food and Drug Administration for the palliative treatment of post-operative pain and edema in superficial soft tissue. We are particularly interested in CMS’s proposed refinements of the current CED process so that small companies can be included in any approach adopted by the Agency. Only through workable CED pathways to coverage can meaningful access and choices be made available to Medicare beneficiaries.

The CED Should Be Expanded and Should Consider the Resources Available to Small Manufacturers

Because the CED process remains important for early access to new technologies, we believe that CMS should retain this tool. Indeed, the use of the process should be expanded so that it plays a more prominent role in national coverage. This may be accomplished through avenues other than the national coverage determination process, including through local coverage. Even if its implementation remains within the context of the national coverage analysis procedures, however, the CED process should be sufficiently simplified and streamlined so that adoption of new technologies is encouraged, and barriers to innovation may be simultaneously reduced.

To promote the efficient implementation of the CED process, CMS should adopt a flexible approach that can tailor specific evidentiary requirements to the particular circumstances. Recognizing that high-level quality controls are a key to collecting meaningful data, going forward, CMS should consider how the process can become more practical, particularly given some of constraints on small manufacturers bringing new technologies to market. Perhaps the greatest challenge for manufacturers posed by the CED process is the amount of resources required to develop well-powered clinical trials and registries. We recognize that CMS and the Medicare population would be best served with clinical trials and registries that are developed and maintained by qualified entities. We believe that often manufacturers are experienced in coordinating registries and, therefore, would recommend that CMS consider the use of manufacturer registries. Further stakeholder collaboration should also be considered to help identify the specific criteria that would ensure appropriate safeguards are incorporated into software or other data collection tools for registries.

CMS should also consider developing more formalized partnerships with other government agencies and independent third parties. The coordination for CED evidence-gathering with agencies within the Department of Health and Human Services that have experience with research and data collections, including the National Institutes of Health and the Agency for Healthcare Research and Quality, may help to limit barriers.

In addition, to promote practical implementation—without compromising the integrity of data—consideration should be given to the expanded use of the electronic claim form for data collection activities. This would also help reduce burdens on providers. For example, information may be recorded for easy reviews by CMS using the claim form (e.g., the “NTE segment”) to relay information about progress and key observations from the use of a product under review. The electronic format could then streamline the ability of CMS to evaluate outcomes data.

As to evaluation of data, CMS should identify scheduled intervals—such as 18 to 24 months—after which time, the agency will assess whether there is sufficient information to make a final national coverage determination decision, or whether additional information should continue to be developed and gathered. For some technologies, CMS may determine that continuation of the data-gathering is appropriate, whereas for others the NCD process may come to a close.

The CED Process Should Reinforce the Use of New Technologies in the Home Setting

We also urge CMS to adopt the CED process for evaluating and collecting data to demonstrate how advances in technologies can be applied to alternative settings. As our population ages, technologies that permit individuals to remain at home become more critical. When patients can be cared for in the home or community setting, not only does the patient’s quality of life benefit, but also the Medicare program stands to achieve cost savings. Particularly for technologies that have already been recognized and accepted by Medicare in one setting—and for which there is a defined benefit category—CMS should consider using a streamlined CED process to obtain clinical evidence for home use. Extending coverage to this setting could proceed with the appropriate safeguards, adapted to the special circumstances associated with the specific technology and other applicable factors.

On behalf of Regenesis, thank you for your consideration of our comments. Should you have any questions or need additional information from us, we can be reached at [telephone #]

Sincerely,

January 17, 2012

Ms. Marilyn Tavenner, Acting Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
7500 Security Boulevard
Baltimore, MD 21244-1850

Re: CED Public Solicitation

Dear Ms. Tavenner:

DJO Global, Inc. (DJO) appreciates the opportunity to submit comments on the Centers for Medicare & Medicaid Services' (CMS) coverage with evidence development (CEO) policy.

DJO is a leading global developer, manufacturer, and distributor of high-quality medical devices that provide solutions for pain management, musculoskeletal health, and vascular health. Our products address the continuum of patient care, from injury prevention to rehabilitation, enabling people to regain or maintain their natural motion. With regard to medical technology, DJO is a leading designer, manufacturer, and distributor of orthopedic products and transcutaneous electrical nerve stimulation (TENS) products used for pain management.

DJO agrees with CMS that the goal of any CED policy should be "to accelerate Medicare beneficiaries' access to innovative items and services." We are concerned that as currently configured, CMS's CED policy is overly-cumbersome and can pose a barrier to coverage of effective technologies. CMS should ensure that any application of its CED policy does not hinder Medicare beneficiary access to safe, effective medical care. To that end, DJO recommends that:

1. Coverage with Study Participation should be used as an alternative to noncoverage for situations in which: (1) there are either demonstrated safety concerns associated with a new technology or with new uses of an existing technology, or (2) when there is reliable evidence that a new FDA-approved technology is not reasonable and necessary for use in the Medicare population or a Medicare subpopulation.

2. To the extent CMS seeks additional information about use of a technology, CMS should consider alternatives to the registry option provided under the Coverage with Appropriateness Determination mechanism. For instance, CMS could develop modifiers describing treatment parameters or other claims based reporting for additional data collection, or use beneficiary surveys to provide additional information to CMS and its contractors on how care is furnished.

These recommendations are discussed in greater detail below. We would also suggest that in light of potential changes to the CED policy, CMS should suspend new or pending coverage reviews under which CED is a stated coverage option (i.e., TENS for chronic low back pain) until the CED review process is completed.

I. CSP Option Should be Limited to New Technology with Safety Concerns

In the current CMS guidance on "National Coverage Determinations with Data Collection as a Condition of Coverage: Coverage with Evidence Develqpment," CMS sets forth the option of using CEO to permit Medicare coverage under certain circumstances when evidence is not adequate for coverage as reasonable and necessary under Section 1862{a){1)(E) of the Social Security Act.¹ CMS identifies two "arms· of CEO determinations: (1) Coverage with Study Participation (CSP), under which CMS will provide coverage only to patients enrolled in an approved clinical research study that meets certain rigorous standards; and (2) Coverage with Appropriateness Determination (CAD), under which additional clinical data must be submitted by the provider to a database or registry as a condition of the beneficiary's coverage.

We share CMS's view that it is valuable to have alternative mechanisms to expand Medicare beneficiary access to new medical technologies while clinical evidence is still emerging to demonstrate that a technology meets the statutory "reasonable and necessary" standard. We believe that situations justifying CSP as a condition of Medicare coverage would be very rare, however, since imposing new clinical trial requirements would effectively deny most beneficiaries access to an approved medical technology for many years.

CMS suggests that CSP could be used to "influence clinical practice and help Medicare beneficiaries and providers make the most appropriate diagnostic and therapeutic decisions." However, a general interest in additional Clinical information should be insufficient grounds to trigger a CSP coverage limitation. While additional evidence can help refine treatment practices for virtually any medical technology, there are very few circumstances that justify essentially revoking patient access to such technology while such additional evidence is gathered.

In particular, CSP should not serve as a barrier to widespread patient access to technology that has longstanding Medicare coverage and that is widely regarded by clinicians as a safe and effective treatment. For example, in opening up long-standing Medicare coverage policy for TENS for chronic low back pain, CMS requested comments on the applicability of "clinical studies falling under the Coverage with Evidence Development (CEO) paradigm." Clinical evidence clearly shows that TENS used for chronic low back pain meets the statutory criteria under § 1862{a)(1)(A), as there is ample evidence that TENS, when properly administered, is reasonable and necessary as an effective treatment for low back pain. It simply is unjustifiable to deny Medicare beneficiaries with chronic low back pain the documented, safe pain relief available through the proper use of TENS while any additional studies of this technology are conducted. Restricting access to this technology instead could necessitate greater use of potentially addictive narcotics and in some cases result in the need for surgical intervention.

We urge CMS to ensure that any application of its CEO policy does not hinder Medicare beneficiary access to safe, effective medical care, such as the use of TENS for chronic low back pain. Thus, we recommend that CMS limit the use of CSP as an alternative to noncoverage for situations in which: (1) there are demonstrated safety concerns associated with a new technology [or new uses of an existing technology], or (2) when there is reliable evidence that a new FDA-approved technology is not reasonable and necessary for use in the Medicare population or a Medicare subpopulation.

To the extent CMS seeks additional data about use of a technology. CMS should consider alternatives to the registry option currently provided under the CAD mechanism. The establishment of a registry is a lengthy. cumbersome process. and reporting to registries is burdensome to impacted providers. This results in many providers electing to "opt-ouf' of the registry process. leading to the potential for a two tier Medicare system: only the Medicare patients whose providers agree to participate in the process will be eligible to receive the benefit. Instead. to the extent that CMS requires additional information for Medicare coverage purposes. CMS should explore the use of claims modifiers or other claims-based reporting options that can provide additional details on the specific patient characteristic or treatment parameter of interest to CMS. Alternatively. CMS could consider whether beneficiary follow-up surveys would provide the requisite information. This information would be reported directly to CMS or its contractors. bypassing the need for a third party to collect. aggregate. and submit the data to CMS for further review. CMS also should set forth clear parameters for ending the collection. assessing the collected data. and applying the data to Medicare coverage policy.

More broadly, CMS should ensure that any data collection requirement seeks to furnish very specific information that is necessary to determine a specific Medicare coverage policy issue. It is not appropriate to impose such requirements on providers and other stakeholders simply to further general research goals.

We appreciate your consideration of our comments. We would be pleased to answer any questions you may have or to provide additional information.

Sincerely,

January 17, 2012

Louis Jacques, MD
Director
Coverage & Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: CED Public Solicitation

Dear Dr. Jacques:

The American College of Cardiology (ACC) appreciates this opportunity to comment on role of CED in the Medicare program. ACC is transforming cardiovascular care and improving heart health through continuous quality improvement, patient-centered care, payment innovation and professionalism. The College is a 40,000 member nonprofit medical society comprised of physicians, nurses, nurse practitioners, physician assistants, pharmacists and practice managers, and bestows credentials upon cardiovascular specialists who meet its stringent qualifications. The College is a leader in the formulation of health policy, standards and guidelines, and is a staunch supporter of cardiovascular research. The ACC provides professional education and operates national registries for the measurement and improvement of quality care. More information about the association is available online at http://www.cardiosource.org/ACC.

ACC supports the use of CED to provide Medicare beneficiaries with prompt access to new technologies/services when early evidence suggests, but does not yet convincingly demonstrate a net benefit for beneficiaries. We are familiar with this process through the use of ACC’s National Cardiovascular Data Registry (NCDR) for data collection as a condition of coverage for implanted cardioverter defibrillators (ICDs) for the purpose of primary prevention. Based on that experience, we feel several aspects of CED could be improved.

First, the largest shortcoming we perceive with CED is that it has been underutilized as a tool to diffuse and evaluate technologies/services more quickly and effectively. CED can be used to expand access to promising services for the collection of clinical data that addresses key questions of concern to CMS, clinician, and patients. We do not support CED when it is used primarily as a tool to limit access to technologies/services with the perceived potential for inappropriate use or overutilization.

Second, we have found it difficult to anticipate when CMS will consider CED. Additional guidance from CMS on circumstances when CED will be considered would be helpful. Such guidance could address the level of already existing evidence needed to qualify for CED, and the degree to which issues such as the availability of alternative treatments, risk of the service under consideration, and the likelihood of developing useful evidence within a reasonable timeframe might influence the agency’s decision to implement CED. Further exploration of the use of CED in unique circumstances where very limited evidence for a service/technology of great potential benefit exists would be helpful as well.

Third, CED policies often do not appear to incorporate a specific timeline or process for evaluating results and making subsequent coverage decisions. CED policies should include the following elements:

• Well-defined clinical questions formulated with input from clinical experts and the specialties most likely to provide the services in question.
• A reasonable timeframe for evaluation of data collected as part of the CED.
• Data analysis plans outlining how CMS will use data collected through CED.
• Evaluation criteria that describe how CMS will determine whether evidence collected through CED is sufficient to justify national coverage.
• A flexible mechanism for modifying data capture elements as knowledge evolves through ongoing analysis during the CED period.

Finally, CMS should encourage the use of existing research and data collection infrastructure. Registries such as NCDR provide a valuable, cost-effective infrastructure to meet CED requirements while also fostering improvements in the quality of care. By using national registries the resource burden to capture clinical data would be significantly minimized, since in many cases the same data are captured as part of a national registry. Additionally national registries offer data quality procedures that would benefit CMS by helping to improve the overall quality and completeness of the data.

Thank you for this opportunity to contribute to this review of CED. Please contact James Vavricek, Senior Specialist for Regulatory Affairs, at jvavricek@acc.org or 202-375-6421 if you need any further information.

Sincerely,