(Medicare National Coverage Determinations Manual)

D. Other  A/B MACs will determine coverage under section 1862(a)(1)(A) of the Social Security Act for any other indications for the implantation and use of single chamber or dual chamber cardiac pa cemakers that are not specifically addressed in this national coverage determination.   (This NCD last reviewed August 2013.)   20.8.4  Leadless Pacemakers  (Rev.  201, Issued: 07- 28-17, Effective: 01 -18-18, Implementation: 08- 29-17- for MAC local edits; Jan uary 2, 2018 -  for MCS shared edits)   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 traditiona l 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 al so 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 r esults 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 Coverag e 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 F ederal 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 unde r 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) R egistry 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 resul ts 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).  l. The study protoc ol 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 Me dicare 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 a bove -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 cit e 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 Securit y 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.)   20.9 - Artificial Hearts and Related Devices (RETIRED)  (Rev. 11892; Issued: 03- 09-23; Effective: 04 -10-23; Implementation:04- 10-23)    This section has been removed from the NCD Manual and incorporated into NCD 20.9.1 effective December 1, 2020.  20.9.1 - Ventricular Assist Devices (VADs)  (Rev.10837; Issued: 06- 11-21; Effective: 12 -01-20; Implementation: 07 -27-21)  A. General   A ventricular assist device (VAD) is surgically attached to one or both intact ventricles and is used to assist or augment the ability of a damaged or weakened native heart to pump blood. Improvement in the performance of the native heart may allow the device to be removed.   Indications and Limitations of Coverage   B. Nationally Covered Indications  1. Post -cardiotomy ( effective for services performed on or after October 18, 1993)  Post-cardiotomy is the period following open- heart surgery. VADs used for support of blood circulation post -cardiotomy are covered only if they have received approval from the Food and Drug Administration (FDA) for that purpose, and the VADs are used according to the FDA -approved labeling instructions.  2. Left ventricular assist devices (LVADs) are covered if they are FDA approved for short -term (e.g., bridge -to-recovery and bridge -to-transpla nt) or long- term (e.g., destination therapy) mechanical circulatory support for heart failure patients who meet the following criteria:   Have New York Heart Association (NYHA) Class IV heart failure; and   Have a left ventricular ejection fraction (LVEF)  25%; and   Are inotrope dependent  OR have a Cardiac Index (CI) < 2.2 L/min/m2, while not on inotropes, and also meet one of the following:  o Are on optimal medical management (OMM), based on current heart failure practice guidelines for at least 45 out of the last 60 days and are failing to respond; or  o Have advanced heart failure for at least 14 days and are dependent on an intraaortic balloon  pump (IABP) or similar temporary mechanical circulatory support for at least 7 days.  Beneficiaries receiving a VAD must be managed by an explicitly identified, cohesive, multidisciplinary team of medical professionals with appropriate qualifications, tra ining, and experience.   The team embodies collaboration and dedication across medical specialties to offer optimal patient- centered care.   Collectively, the team must ensure that patients and caregivers have the knowledge and support necessary to participa te in informed decision making.  The team members must be based at the facility and must include individuals with experience working with patients before and after placement of a VAD.  The team must include, at a minimum:   At least one physician with cardiot horacic surgery privileges and individual experience implanting at least 10 durable, intracorporeal, left ventricular assist devices over the course of the previous 36 months with activity in the last year.   At least one cardiologist trained in advanced hea rt failure with clinical competence in medical - and device -based management including VADs, and clinical competence in the management of patients before and after placement of a VAD.   A VAD program coordinator.  A social worker.   A palliative care specialist.  Facilities must be credentialed by an organization approved by CMS.  The process for organizations to apply for CMS approval to be designated as a credentialing organization for LVAD facilities is posted on our web site along with a list of approved crede ntialing organizations, approved standard versions, and credentialed facilities: http://www.cms.gov/Medicare/Medicare -General -Information/MedicareApprovedFacilitie/VAD -Destination -Therapy -Facilities.html  C. Nationally Non -Covered Indications  All other indications for the use of VADs not otherwise listed remain non- covered, except in the context of Category B investigational device exemption clinical trials (42 CFR 405) or as a routine cost in clinical trials defined under section 310.1 of the National Coverage Determinations (NCD) Manual.  D. Other  This policy does not address coverage of VADs for right ventricular support, biventricular support, use in beneficiaries under the age of 18, use in beneficiaries with complex congenital heart diseas e, or use in beneficiaries with acute heart failure without a history of chronic heart failure. Coverage under section 1862(a)(1)(A) of the Act for VADs in these situations will be made by local Medicare Administrative Contractors within their respective jurisdictions.     Destination therapy (DT) is for patients that require mechanical cardiac support.  The VADs used for DT are covered only if they have received approval from the FDA for that purpose.   Patient Selection (effective November 9, 2010):   The VA Ds are covered for patients who have chronic end- stage heart failure (New York Heart Association Class IV end -stage left ventricular failure) who are not candidates for heart transplantation at the time of VAD implant, and meet the following conditions:    Have failed to respond to optimal medical management (including beta -blockers and ACE inhibitors if tolerated) for 45 of the last 60 days, or have been balloon pump-dependent for 7 days, or IV inotrope -dependent for 14 days; and,    Have a left ventricular ejection fraction (LVEF) <25%; and,    Have demonstrated functional limitation with a peak oxygen consumption of 14 ml/kg/min unless balloon pump-  or inotrope -dependent or physically unable to perform the test.   Facility Criteria (effective October 30, 2013) :