The Centers for Medicare & Medicare Services (CMS) is expanding national coverage for implantable automatic defibrillators by including new indications.

A. General

The implantable automatic defibrillator is an electronic device designed to detect and treat life-threatening tachyarrhythmias. The device consists of a pulse generator and electrodes for sensing and defibrillating.

All Medicare providers billing either a Medicare carrier or Fiscal Intermediary (FI) for Implantable Automatic Defibrillators for Medicare beneficiaries who are members of Medicare Advantage plans, will be affected.

Be aware that CMS is expanding the set of medical indications for the use of implantable automatic defibrillators and this instruction discusses the impact of this change for beneficiaries who are members of a MA plan and receive these services.

B. Covered Indications

1. Documented episode of cardiac arrest due to ventricular fibrillation (VF), not due to a transient or reversible cause (effective July 1, 1991)
2. Documented sustained ventricular tachyarrhythmia (VT), either spontaneous or induced by an electrophysiology (EP) study, not associated with an acute myocardial infarction (MI) and not due to a transient or reversible cause (effective July 1, 1999).
3. Documented familial or inherited conditions with a high risk of life-threatening VT, such as long QT syndrome or hypertrophic cardiomyopathy (effective July 1, 1999).

Additional indications effective for services performed on or after October 1, 2003:

4. Coronary artery disease with a documented prior MI, a measured left ventricular ejection fraction (LVEF) < 0.35, and inducible, sustained VT or VF at EP study. (The MI must have occurred more than 40 days prior to defibrillator insertion. The EP test must be performed more than 4 weeks after the qualifying MI.)
5. Documented prior MI and a measured LVEF < 0.30 and a QRS duration of >120 milliseconds (the QRS restriction does not apply to services performed on or after January 27, 2005). Patients must not have:
• a) New York Heart Association (NYHC) classification IV;
• b) Cardiogenic shock or symptomatic hypotension while in a stable baseline rhythm
• c) Had a coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within past 3 months;
• d) Had an enzyme positive MI within past month (Effective for services on or after January 27, 2005, patients must not have an acute MI in the past 40 days);
• e) Clinical symptoms or findings that would make them a candidate for coronary revascularization; or
• f) Any disease, other than cardiac disease (e.g., cancer, uremia, liver failure), associated with a likelihood of survival less than 1 year.

All indications effective for services performed on or after January 27, 2005:
6. Patients with ischemic dilated cardiomyopathy (IDCM), documented prior MI, NYHA Class II and III heart failure, and measured LVEF <35%.
7. Patients with non-ischemic dilated cardiomyopathy (NIDCM) >9 months, NYHA Class II and III heart failure, and measured LVEF <35%;
8. Patients who meet all current Centers for Medicare & Medicaid Services (CMS) coverage requirements for a cardiac resynchronization therapy (CRT) device and have NYHA Class IV heart failure;

All indications must meet the following criteria:
• a) Patients must not have irreversible brain damage from preexisting cerebral disease;
• b) MIs must be documented and defined according to the consensus documented of the Joint European Society of Cardiology/American College of Cardiology Committee for the Redefinition of Myocardial Infarction;

Indications 3 - 8 (primary prevention of sudden cardiac death) must also meet the following criteria:

• a) Patients must be able to give informed consent;

Patients must not have:
• Cardiogenic shock or symptomatic hypotension while in a stable baseline rhythm;
• Had a CABG or PTCA within the past 3 months;
• Had an acute MI within the past 3 months;
• Had an acute MI within the past 40 days;
• Clinical symptoms or findings that would make them a candidate for coronary revascularization;
• Any disease, other than cardiac disease (e.g., cancer, uremia, liver failure), associated with a likelihood of survival less than 1 year;
• c) Ejection fractions must be measured by angiography, radionuclide scanning, or echocardiography;
• d) The beneficiary receiving the defibrillator implantation for primary prevention is enrolled in either a Food and Drug Administration (FDA)-approved category B investigational device exemption (IDE) clinical trial (42 CFR §405.201), a trial under the CMS Clinical Trial Policy (National Coverage Determination (NCD) Manual §310.01) or a qualifying data collection system including approved clinical trials and registries. Initially, an implantable cardiac defibrillator (ICD) database will be maintained using a data submission mechanism that is already in use by Medicare participating hospitals to submit data to the Iowa Foundation for Medical Care (IFMC)-a Quality Improvement Organization (QIO) contractor-for determination of reasonable and necessary and quality improvement. Initial hypothesis and data elements are specified in this decision (Appendix VI) and are the minimum necessary to ensure that the device is reasonable and necessary. Data collection will be completed using the ICDA (ICD Abstraction Tool) and transmitted via QNet (Quality Network Exchange) to the IFMC who will collect and maintain the database. Additional stakeholder-developed data collection systems to augment or replace the initial QNet system, adddressing at a minimum the hypotheses specified in this decision, must meet the following basic criteria:· Written protocol on file;· Institutional review board review and approval;· Scientific review and approval by two or more qualified individuals who are not part of the research team;· Certification that investigators have not been disqualified.For purposes of this coverage decision, CMS will determine whether specific registries or clinical trials meet these criteria.
• e) Providers must be able to justify the medical necessity of devices other than single lead devices. This justification should be available in the patient's medical record.
9. Patients with NIDCM >3 months, NYHA Class II or III heart failure, and measured LVEF < 35%, only if the following additional criteria are also met: a) Patients must be able to give informed concent;b) Patients must not have:· Cardiogenic shock or symptomatic hypotension while in a stable baseline rhythm;· Had a CABG or PTCA within the past 3 months;· Had an acute MI within the past 40 days;· Clinical symptoms or findings that would make them a candidate for coronary revascularization;· Irreversible brain damage from preexisting cerebral disease;· Any disease, other than cardiac disease (e.g. cancer, uremia, liver failure), associated with a likelihood of survival less than 1 year;
   c) Ejection fractions must be measured by angiography, radionuclide scanning, or echocardiography;d) MIs must be documented and defined according to the consensus document of the Joint European Society of Cardiology/American College of Cardiology Committee for the Redefinition of Myocardial Infarction;e) The beneficiary receiving the defibrillator implantation for this indication is enrolled in either an FDA-approved category B IDE clinical trial (42 CFR §405.201), a trial under the CMS Clinical Trial Policy (NCD Manual §310.1), or a prospective data collection system meeting the following basic criteria:· Written protocol on file;· Institutional Review Board review and approval;· Scientific review and approval by two or more qualified individuals who are not part of the research team;· Certification that investigators have not been disqualified.



For purposes of this coverage decision, CMS will determine whether specific registries or clinical trials meet these criteria.f) Providers must be able to justify the medical necessity of devices other than single lead devices. This justification should be available in the patient's medical record.C. Other IndicationsAll other indications for implantable automatic defibrillators not currently covered in accordance with this decision will continue to be covered under Category B IDE trials (42 CFR §405.201) and the CMS routine clinical trials policy (NCD §310.1).(This NCD last reviewed February 2005)

CMS Website LINK to NCD

www.cms.hhs.gov/medlearn/matters/mmarticles/2005/mm3604.pdf

Effective Date

January 27, 2005

Effective for services performed on or after December 17, 2004, a positive fasting beta cell autoantibody test is added as an adequate diagnostic criterion as an alternative to insulinopenia per the updated C-peptide testing requirement. Insulinopenia is defined as a fasting C-peptide level that is less than or equal to 110% of the lower limit of normal of the laboratory's measurement method.

Alternatively, for patients with renal insufficiency and creatinine clearance (actual or calculated from age, gender, weight, and serum creatinine) < 50 ml/minute, insulinopenia is defined as a fasting C-peptide level that is less than or equal to 200% of the lower limit of normal of the laboratory's measurement method. Fasting C-peptide levels will only be considered valid with a concurrently obtained fasting glucose < 225 ng/dL. Levels only need to be documented once in the medical records.

The CMS nationally covers the use of electrocardiographic (EKG) services under specific criteria described in § 20.15, Pub. 100-03, National Coverage Determinations (NCD) Manual. In addition, EKG technologies are now organized into an updated framework to aid in making reasonable and necessary coverage determinations as they pertain to EKG technology.

Medicare will cover PTA of the carotid artery concurrent with placement of an FDA-approved carotid stent for an FDA approved indication when furnished in accordance with FDA approved protocols governing post-approval studies. CMS determines that coverage of PTA of the carotid artery is considered reasonable and necessary under these circumstances.

Performance of PTA of the carotid artery concurrent with carotid stent placement when furnished outside of FDA approved protocols governing both FDA required post-approval studies and FDA Category B IDE clinical trials remains noncovered.

Pancreas transplantation is performed to induce the insulin-independent, euglycemic state in diabetic patients. The procedure is generally limited to those patients with severe secondary complications of diabetes, including kidney failure. However, pancreas transplantation is sometimes performed on patients with labile diabetes and hypoglycemic unawareness.

CMS determines that whole organ pancreas transplantation will be nationally covered by Medicare only when performed simultaneous with or after a kidney transplant. If the pancreas transplant occurs after the kidney transplant, immunosuppressive therapy will begin with the date of discharge from the hospital stay for the pancreas transplant.

CMS determines that the following procedures are not considered reasonable and necessary:

1. Pancreas transplantation for diabetic patients who have not experienced end-stage renal failure secondary to diabetes.
2. Transplantation of partial pancreatic tissue or islet cells (except in the context of a clinical trial).

Medicare will pay for the routine costs, as well as the transplantation and appropriate related items and services for Medicare beneficiaries participating in a National Institutes of Health (NIH)-sponsored clinical trial(s).

Specifically, Medicare will cover transplantation of pancreatic islet cells, the insulin producing cells of the pancreas. Coverage will include the costs of acquisition and delivery of the pancreatic islet cells, as well as clinically necessary inpatient and outpatient medical care and immunosuppressants.

Partial pancreatic tissue transplantation or islet cell transplantation performed outside the context of a clinical trial continue to be non-covered.

CMS revised it coverage policy language to address coverage of particular care and services rather than definition of illness. Language change did not directly affect current Medicare coverage.

Services are covered only when an integral and necessary part of a course of treatment for medical condition. Treatment unrelated to such medical condition remains non-covered.