Vice President, Health Policy
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.
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.
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.
Vice President, Global Health Policy
CMS' Principles Governing the Application of CED1
- 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
1 CMS Guidance Document, National Coverage Determinations with Data Collection as a Condition of Coverage: Coverage with Evidence Development, Issued on July 12 , 2006