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
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
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:
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.
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.
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:
- CMS' intentions of considering CED should be noted as early as the initiation of the national coverage analysis (NCA).
- 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.
- 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.
- The final NCD should name the final steering committee, interim coverage policy, and provide a clear timeline for next steps for appropriate CED implementation.
- 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.
CED should not be issued by local Medicare contractors.
Further detail on these recommendations is provided below. We appreciate your consideration
of these comments.
I. 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
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
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
ICDs: Need for a Clear Designation of Key Research Questions Before Implementation
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
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.
LVAD Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS):
Need for Clear and Fairly Distributed Financing for Data Collection Efforts
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.
Cochlear Implantations: Need for a Clear Timeline for Data Collection
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.
Additional Challenges Observed
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.
II. CMS Should Only Apply CED Rarely in NCDs and Only in Circumstances Where the
Alternative is Non-Coverage
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.
III. 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
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.
a) CMS' intentions of considering CED should be noted as early as the initiation of the NCA
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.
b) A value of information (VOI) analysis or at least 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.
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:
- Specific research question(s) that CMS believes CED will address;
- Gap analysis of public and private evidence generation activities; and
- 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.
c) Draft NCD should propose the membership of a CED implementation steering committee and
state an interim coverage policy
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.
d) Final NCD should name the final steering committee, interim coverage policy, and provide a
clear timeline for next steps for appropriate 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
e) Steering committee would work with CMS to ensure all questions are clearly answered for
appropriate implementation of CED
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
- 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
IV. CED Should Not Be Implemented by Local Medicare Contractors
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 email@example.com if you have any questions or wish to discuss our comments in further detail.
Vice President, Health Policy and Payment