CMS Takes Another Stab at Updating its Medicare Clinical Trial Policy

After a highly anticipated revision of Medicare’s Clinical Trial Policy (“CTP”) that was issued in a July 9, 2007 Decision Memorandum (“Proposed Decision”) left many scratching their heads, the Centers for Medicare & Medicaid Services (“CMS”) issued a Proposed Decision Memorandum for Second Reconsideration of the CTP (“Second Reconsideration of the Proposed Decision”) on July 19, 2007.  A Proposed Decision Memorandum was issued on April 10, 2007 to clarify and expand Medicare coverage of items and services in clinical research.  The April 10, 2007 proposed policy generated many public comments from providers and industry.  Based in part on significant concerns raised in public comments, including the apparent confusion among Medicare contractors on interpretation of the CTP, CMS decided to “preserve the status quo” and made just two changes, including addition of Coverage with Evidence Development (“CED”) to Medicare clinical research policy.  CMS explained that based on several important issues raised in public comments on the Proposed Decision, the agency would reopen reconsideration of the CTP and issue a new proposed National Coverage Determination (“NCD”), which CMS did on July 19th.

The Second Reconsideration of the Proposed Decision is intended to clarify many of the issues that were identified in public comments on the Proposed Decision, renames the CTP to “Clinical Research Policy,” and expands the policy’s scope to cover a broad range of clinical research.  The Second Reconsideration of the Proposed Decision addresses many issues raised in comments on the Proposed Decision and defines new terms, including:

1. Explaining the scope of the policy by defining “clinical research” and renaming the overall NCD to clearly include all clinical research.
2. Replacing the requirements and other necessary characteristics for qualifying clinical trials under the CTP with scientific and technical standards for certified clinical research studies.
3. Preserving CMS authority to permit CED when appropriate.
4. Redefining coverage for qualifying clinical research studies or CED to avoid confusion with terms used in other contexts, using the term “usual patient care.”
5. Defining “routine clinical services” that are included in “usual patient care.”
6. Clarifying the extent to which “investigational clinical services” are included in “usual patient care.”
7. Clarifying that coverage does not include “administrative services” required to carry out studies but not required to furnish usual patient care.
8. Establishing a process that clinical research study sponsors/principal investigators must use to certify to CMS that their study meets the standards described in the policy, including registration with ClinicalTrials.gov.
9. Enumerating the types of clinical research studies that are excluded from the policy.
10. Clarifying the relationship between coverage under the policy and local coverage determinations.
11. No change in Medicare coverage policy for category A and B Investigational Device Exemptions (“IDEs”) (e.g., IDE category B devices remain eligible for coverage).
12. No change in contractor discretion to cover humanitarian use devices.
13. No effect on Medicare Part D policy.
14. No effect on any clinical research study that was covered under any previous policy that began enrollment prior to the effective date of the policy.

Medicare has covered routine costs incurred by Medicare beneficiaries in clinical trials since 2000.  However, CMS guidance on “routine costs” has been confusing and interpreted differently by various Medicare contractors.  CMS explained in the Proposed Decision that several comments showed there is significant confusion about the 2000 CTP, including the fact that Medicare contractors have been paying claims for items and services outside the terms of the CTP. 

The Proposed Decision added language intended to clarify when routine costs in clinical trials are covered.  Specifically, routine costs of a clinical trial include all items and services that are otherwise covered by Medicare that are provided in either the experimental or the control arms of a clinical trial, except the investigational item or service itself, unless otherwise covered outside of the clinical trial.  CMS added the phrase “unless otherwise covered outside of the clinical trial” to clarify that investigational items that are already covered by Medicare may also be covered when they are an investigational item in a clinical trial.

CMS also added to the CTP Medicare coverage of certain items and services under CED.  CMS uses CED to impose Medicare coverage with conditions — Medicare coverage is conditioned on the collection of additional evidence on appropriateness or effectiveness using either data submission to registries or data developed in further clinical research.  The CED policy was discussed in a December 13, 2006 meeting of the Medicare Coverage with Evidence Development & Coverage Advisory Committee and was supported by the committee.  Based on that support and the support of a federal panel convened by the Agency for Healthcare Research and Quality, CMS decided to adopt the policy as part of CTP coverage.  Although public comment highlighted the burden and additional expense that may be imposed on beneficiaries, providers, and sponsors/investigators under CED, CMS chose not provide funding for the additional data collection.  CMS explained that it appreciates the additional burden that further clinical research adds to patient care, but CED allows Medicare coverage for items and services that would not otherwise be covered.  Therefore, according to CMS, the benefits of covering additional items and services under CED outweigh the burden.  CMS includes the addition of CED policy in the Second Reconsideration of the Proposed Decision.

The Second Reconsideration of the Proposed Decision is intended to “[build] upon the input from the previous reconsideration.”  At the outset, CMS explains its authority for making coverage decisions under § 1862(a)(1)(A) of the Social Security Act when evaluating evidence to whether items and services meet the reasonable and necessary standard.  However, evidence-based review is not feasible for the broad range of items and services used in clinical research.  As a result, CMS relies on the integrity of clinical research protocols to gain assurance that research interventions are reasonable and necessary, expose participating beneficiaries to the least amount of risk, and maximize health outcomes.

In an apparent effort to clarify Medicare coverage policy on items and services already covered outside the clinical research context, CMS proposes Medicare coverage of “usual patient care” in qualified clinical research.  “Usual patient care” is defined as routine clinical services and investigational clinical services in clinical research when the investigational clinical services would be covered outside of the clinical research and the clinical research meets the standards for a clinical research study. 

CMS defines “clinical research,” and proposes standards that it believes exposes beneficiaries to the least amount of risk and maximizes the potential for improvement of health outcomes.  Clinical research is defined as “any systematic investigation involving human participants which is designed to contribute to generalizable knowledge and which involves a clinical intervention, care delivery strategy, or diagnostic technique designed to potentially improve predefined health outcomes.”  CMS identifies 13 scientific and technical standards for clinical research that would be required for providers, practitioners, or suppliers who request payment for usual patient care furnished to Medicare beneficiaries participating in clinical research. 

Medicare secondary payer concerns have been a lingering cloud of disquiet for sponsors and principal investigators.  The Second Reconsideration of the Proposed Decision appears to shed some light on these concerns by explaining that Medicare does not cover usual patient care when the care is provided free to the Medicare beneficiary, or when the study sponsor agreement with the investigator sites or the informed consent documents provided to the patient specify that the care will be provided free to participants.  In other words, if a study sponsor or agreement states that routine or investigation clinical services otherwise covered by Medicare are free, Medicare will not pay for the services.

Interested stakeholders have 30 days to comment on the Second Reconsideration of the Proposed Decision.

By Kirk L. Dobbins