National Coverage Analyses
Percutaneous Left Atrial Appendage (LAA) Closure Therapy
Posted proposed decision memo
http://www.cms.gov/medicare-
Posted proposed decision memo
http://www.cms.gov/medicare-
A. The Centers for Medicare & Medicaid Services (CMS) proposes that the evidence is sufficient to determine percutaneous left atrial appendage closure (LAAC) therapy using an implanted device is not reasonable and necessary to diagnose or treat an illness or injury or to improve the functioning of a malformed body member and, therefore, is not covered under § 1862(a)(1)(A) of the Social Security Act.
B. In order to support evidence development for technologies likely to show benefit for the Medicare population, CMS proposes to cover items or services that are reasonable and necessary for research under §1862(a)(1)(E) of the Social Security Act using the Coverage with Evidence Development (CED) paradigm. We propose that coverage would be limited to items and services in clinical studies that meet the conditions specified below:
Percutaneous LAAC therapy is covered for patients with non-valvular atrial fibrillation only, when all of the following conditions 1-7 are met.
- The device is FDA approved for patients with non-valvular atrial fibrillation.
- The patient has:
- A high CHADS2 (Congestive heart failure, Hypertension, Age >75, Diabetes, Stroke/transient ischemia attack/thromboembolism) or CHA2DS2-VASc score (Congestive heart failure, Hypertension, Age ≥ 65, Diabetes, Stroke/transient ischemia attack/thromboembolism, Vascular disease, Sex category); and
- A high HAS-BLED score (Hypertension, Abnormal renal function and/or liver function, Stroke, prior Bleeding, Labile anticoagulation range, Elderly age>65, Drug therapy such as antiplatelet drugs), and
- A contraindication to warfarin.
- The procedure is furnished in a hospital that meets the following institutional requirements:
- Cardiac catheterization lab or electrophysiology (EP) lab with fluoroscopy capability
- Non-invasive imaging (i.e. transesophageal echocardiography) with dedicated echocardiography support
- Anesthesiology support for administration of general anesthesia specific to this procedure
- Cath lab, operating room (if required), post anesthesia recovery, intensive care and step down unit space to accommodate cases with and without complications
- On-site emergency cardiac surgery services
- The procedure is performed by physicians with the following qualifications and experience:
- The primary implanting physician has performed ≥ 25 interventional cardiac procedures involving a trans-septal puncture (TSP) in their total experience, with at least 10 TSP procedures performed over the past 12 month period.
- The primary implanting physician(s) must be an interventional cardiologist and/or an electrophysiologist. They may jointly participate in intra-procedural aspects of the implant or perform the implant procedure individually.
- The interventional cardiologist(s) and electrophysiologist(s) must receive the training prescribed by the manufacturer on the safe and effective use of the device prior to performing implant procedures. Training should also include a physician who already has experience implanting the device, but who is not a representative of the manufacturer, as well as a minimum of two supervised and two observed cases.
- The patient is enrolled in, and the treating physician team is participating in a prospective national registry that consecutively enrolls LAAC patients and tracks the following annual outcomes at the patient data level for a period of at least five years from the time of the LAAC procedure.
- Operator-specific complications
- Device-specific complications including device thromboses
- Stroke, adjudicated, by type
- TIA
- Systemic embolism
- Death
- Major bleeding, by site and severity
The registry must be designed to permit identification and analysis of patient, practitioner and facility level factors that predict patient risk for these outcomes. The registry must include contemporaneous patients followed on oral anticoagulant (OAC) therapy to serve as non-interventional controls. CMS will review the qualifications of candidate registries to ensure that the approved registry follows standard data collection practices and collects data necessary to evaluate the patient outcomes specified above.
The registry must collect all data necessary to conduct multivariable adjusted analyses and have a written executable analysis plan in place to address the following questions:
In a prospective, clinical study, when percutaneous LAAC therapy using an implanted device is performed outside a randomized, controlled clinical trial, compared to non-interventional controls followed on oral anticoagulant (OAC) therapy:
- How do the outcomes listed above compare to outcomes in the pivotal clinical trials in the short term (<12 months) and in the long term (≥ 5 years)?
- How do the outcomes listed above differ from outcomes in comparable concurrent OAC controls in the short term (<12 months) and in the long term (>5 years)?
- What is the long term (≥ 5 year) durability of the device?
- What are the short term (<12 months) and the long term (>5 years) device-specific complications including device thromboses?
- A formal shared decision-making interaction between the patient and provider using an evidence-based decision tool on anticoagulation in patients with NVAF must occur prior to LAAC, must be documented in the medical records, must include a discussion of the benefits and harms, must document an appropriate rationale to seek a non-pharmacologic alternative to anticoagulants, taking into account the safety and effectiveness of the device compared to anticoagulants, and have, after being informed of the reported risks of LAAC and reasonable alternative management strategies, given informed consent.
All CMS-approved clinical studies and registries must adhere to the following standards of scientific integrity and relevance to the Medicare population:
- 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 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 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).
- 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.
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 other indications are nationally non-covered.
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: LAAC Therapy CED
Centers for Medicare & Medicaid Services (CMS)
7500 Security Blvd., Mail Stop S3-02-01
Baltimore, MD 21244-1850
Re: LAAC Therapy CED
Centers for Medicare & Medicaid Services (CMS)
7500 Security Blvd., Mail Stop S3-02-01
Baltimore, MD 21244-1850
We are requesting public comments on this proposed determination pursuant to section 1862(l) of the Social Security Act. We are specifically interested in public comments on the use of CED in this decision. After considering the public comments, we will make a final determination and issue a final decision memorandum.
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