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The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. 
You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101. 
 
 
The rules say that the leadless pacemaker eliminates the need for a device pocket and insertion of a pacing lead 
which are integral elements of traditional pacing systems. The removal of these elements eliminates an 
important source of complications associated with traditional pacing systems while providing similar benefits. 
Leadless pacemakers are delivered via catheter to the heart, and function similarly to other transvenous single-
chamber ventricular pacemakers. 
 
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 ). 
 
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. 
The rationale for the study is well supported by available scientific and medical evidence. 
The study results are not anticipated to unjustifiably duplicate existing knowledge. 
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. 
The study is sponsored by an organization or individual capable of completing it successfully. 
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. 
All aspects of the study are conducted according to appropriate standards of scientific integrity. 
The study has a written protocol that clearly demonstrates adherence to the standards listed here as Medicare 
requirements. 
 
 
 
 
 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. 
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). 
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). 
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. 
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. 
Nationally Non-Covered Indications 
 
Leadless pacemakers are non-covered when furnished outside of a CMS approved CED study. 
 
You can find these rules in the National Coverage Determination (NCD) Leadless Pacemakers 20.8.4. 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com. 
 
The Plan contract says that the Plan covers items and services in accordance with Medicare rules.