**

B. Nationally Covered Indications

**

Effective January 18, 2017, the Centers for Medicare & Medicaid Services (CMS)
covers leadless pacemakers through Coverage with Evidence Development (CED).
CMS covers leadless pacemakers when procedures are performed in Food and Drug
Administration (FDA) approved studies. CMS also covers, in prospective
longitudinal studies, leadless pacemakers that are used in accordance with the
FDA approved label for devices that have either:

  * an associated ongoing FDA approved post-approval study; or
  * completed an FDA post-approval study.

Each study must be approved by CMS and as a fully-described, written part of
its protocol, must address the following research questions:

  * What are the peri-procedural and post-procedural complications of leadless pacemakers?
  * What are the long term outcomes of leadless pacemakers?
  * What are the effects of patient characteristics (age, gender, comorbidities) on the use and health effects of leadless pacemakers?

CMS will review studies to determine if they meet the 13 criteria listed
below. If CMS determines that they meet these criteria, the study will be
posted on CMS CED website (<https://www.cms.gov/Medicare/Coverage/Coverage-
with-Evidence-Development/index.html>).

  1. The principal purpose of the study is to test whether the item or service meaningfully improves health outcomes of affected beneficiaries who are represented by the enrolled subjects.
  2. The rationale for the study is well supported by available scientific and medical evidence.
  3. The study results are not anticipated to unjustifiably duplicate existing knowledge.
  4. The study design is methodologically appropriate and the anticipated number of enrolled subjects is sufficient to answer the research question(s) being asked in the National Coverage Determination.
  5. The study is sponsored by an organization or individual capable of completing it successfully.
  6. The research study is in compliance with all applicable Federal regulations concerning the protection of human subjects found in the Code of Federal Regulations (CFR) at 45 CFR Part 46. If a study is regulated by the Food and Drug Administration (FDA), it is also in compliance with 21 CFR Parts 50 and 56. In addition, to further enhance the protection of human subjects in studies conducted under CED, the study must provide and obtain meaningful informed consent from patients regarding the risks associated with the study items and/or services, and the use and eventual disposition of the collected data.
  7. All aspects of the study are conducted according to appropriate standards of scientific integrity.
  8. The study has a written protocol that clearly demonstrates adherence to the standards listed here as Medicare requirements.
  9. The study is not designed to exclusively test toxicity or disease pathophysiology in healthy individuals. Such studies may meet this requirement only if the disease or condition being studied is life threatening as defined in 21 CFR 312.81(a) and the patient has no other viable treatment options.
  10. The clinical research studies and registries are registered on the www.ClinicalTrials.gov website by the principal sponsor/investigator prior to the enrollment of the first study subject. Registries are also registered in the Agency for Healthcare Research and Quality (AHRQ) Registry of Patient Registries (RoPR).
  11. The research study protocol specifies the method and timing of public release of all prespecified outcomes to be measured including release of outcomes if outcomes are negative or study is terminated early. The results must be made public within 12 months of the studys primary completion date, which is the date the final subject had final data collection for the primary endpoint, even if the trial does not achieve its primary aim. The results must include number started/completed, summary results for primary and secondary outcome measures, statistical analyses, and adverse events. Final results must be reported in a publicly accessibly manner; either in a peer-reviewed scientific journal (in print or on-line), in an on-line publicly accessible registry dedicated to the dissemination of clinical trial information such as ClinicalTrials.gov, or in journals willing to publish in abbreviated format (e.g., for studies with negative or incomplete results).
  12. The study protocol must explicitly discuss beneficiary subpopulations affected by the item or service under investigation, particularly traditionally underrepresented groups in clinical studies, how the inclusion and exclusion criteria effect enrollment of these populations, and a plan for the retention and reporting of said populations in the trial. If the inclusion and exclusion criteria are expected to have a negative effect on the recruitment or retention of underrepresented populations, the protocol must discuss why these criteria are necessary.
  13. The study protocol explicitly discusses how the results are or are not expected to be generalizable to affected beneficiary subpopulations. Separate discussions in the protocol may be necessary for populations eligible for Medicare due to age, disability or Medicaid eligibility.

Consistent with section 1142 of the Act, the Agency for Healthcare Research
and Quality (AHRQ) supports clinical research studies that CMS determines meet
the above-listed standards and address the above-listed research questions.

All clinical research study protocols must be reviewed and approved by CMS.
The principal investigator must submit the complete study protocol, identify
the relevant CMS research question(s) that will be addressed and cite the
location of the detailed analysis plan for those questions in the protocol,
plus provide a statement addressing how the study satisfies each of the
standards of scientific integrity (a. through m. listed above), as well as the
investigators contact information, to the address below. The information will
be reviewed, and approved studies will be identified on the CMS website.

Director, Coverage and Analysis Group  
Re: Leadless Pacemakers CED  
Centers for Medicare & Medicaid Services (CMS)  
7500 Security Blvd., Mail Stop S3-02-01  
Baltimore, MD 21244-1850  
Email address for protocol submissions:
[clinicalstudynotification@cms.hhs.gov](mailto:clinicalstudynotification@cms.hhs.gov)  
Email subject line: CED [NCD topic (i.e. Leadless Pacemakers)] [name of
sponsor/primary investigator]

**

C. Nationally Non-Covered Indications

**

Leadless pacemakers are non-covered when furnished outside of a CMS approved
CED study.

**

D. Other

**

NA

(This NCD last reviewed January 2017.)