CMS Pub. 100-03, ch. 1, § 20.8.4

A. General

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 eliminate 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.

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).

a. 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.

b. The rationale for the study is well supported by available scientific and medical

evidence.

c. The study results are not anticipated to unjustifiably duplicate existing

knowledge.

d. 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.

e. The study is sponsored by an organization or individual capable of completing it

successfully.

f. 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.

g. All aspects of the study are conducted according to appropriate standards of

scientific integrity.

h. The study has a written protocol that clearly demonstrates adherence to the

standards listed here as Medicare requirements.

i. 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.

j. 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).

k. 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 study’s 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).

l. 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.

m. 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 investigator’s 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

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.)