On February 15, 2018, CMS released a final policy decision updating the national coverage determination (NCD) governing implantable cardioverter defibrillator (ICD) implantation for Medicare fee-for-service patients. In this reconsideration of the NCD, CMS did not eliminate the two waiting periods during which there is no coverage for an ICD implant for primary prevention: (i) a myocardial infarction within the past 40 days or (ii) a coronary artery bypass graft surgery or a percutaneous coronary intervention within the past three months of the ICD implant. However, the updated NCD creates two exceptions to the waiting period requirements for patients who otherwise meet the ICD requirements: (i) patients meeting CMS coverage requirements for cardiac pacemakers, and (ii) patients with an existing ICD who qualify for an ICD replacement, such as end-of-battery life. The NCD’s waiting period requirements were the subject of two settlements in 2015 and 2016 between hundreds of hospitals and the U.S. Department of Justice (DOJ). Additionally, under the updated NCD, providers will no longer be required to collect and transmit data regarding the procedure, but will be required to document a shared decision making encounter prior to the procedure for some patients. CMS also eliminated the ICD indication that provided coverage for patients who have New York Heart Association (NYHA) Class IV heart failure and meet coverage requirements for a cardiac resynchronization (CRT) device (there is no NCD for CRT devices). Under the new NCD, it appears that there is now no coverage for primary prevention ICD placement in a patient with Class IV heart failure.

An ICD is an electronic device placed in the chest, and connected to the heart by leads. The device monitors the heart’s electrical activity, detects the onset of life-threatening tachyarrhythmias (ventricular tachycardia and ventricular fibrillation), and then terminates the arrhythmia with an electric shock to the heart.

CMS’s revised NCD for ICDs is at Section 20.4 of the NCD Manual. The NCD was last reconsidered by CMS in 2005. The 2005 NCD established waiting period requirements for ICDs that were implanted for “primary prevention” indications, such that the ICD had to be implanted at least 40 days after a heart attack and at least three months after bypass surgery or angioplasty. CMS also concluded that Medicare coverage for ICDs for primary prevention was appropriate only when providers reported certain data to be collected via a registry. In 2005, CMS stated its concerns with ICD implantations and posed ten “initial hypotheses” regarding the procedure, which the agency hoped would be addressed by future evidence, including the evidence collected via the National Cardiovascular Data Registry.

In 2010, the DOJ began sending out Civil Investigative Demands to hospitals, requesting medical records for Medicare beneficiaries who underwent ICD implantation. The focus of the DOJ’s investigation was primarily compliance with the waiting period requirements for patients implanted with ICDs for primary prevention. The DOJ alleged that hospitals implanted ICDs during the periods prohibited by the NCD and submitted the claims for Medicare reimbursement in violation of the False Claims Act. The hospitals and cardiology professional societies argued that the NCD was inflexible, out of date, and conflicted with other medical guidelines. Ultimately, in 2015 and 2016, around 500 hospitals entered into two settlements with the DOJ, and agreed to pay around $273 million in total. The DOJ press release regarding the 2015 settlement is available here. The DOJ press release regarding the 2016 settlement is available here.

On May 30, 2017, CMS announced the opening of a new national coverage analysis to reconsider coverage indications for ICDs in view of scientific evidence published since 2005. After receiving comments and publishing a proposed decision memorandum in November 2017, the agency issued its final decision, creating the two exceptions to the waiting period requirement before an implantation, and citing recent research in support of its decision. In addition, the criteria for coverage have been simplified from nine criteria to six criteria: one for secondary prevention, four for primary prevention, and one for patients who require an ICD replacement for end of battery life, elective replacement indication alert, or device/lead malfunction.

CMS also concluded that peer-reviewed publications published since 2005 addressed CMS’s ten hypotheses, and that the data collected via the registry has served its purpose such that it is no longer necessary to support CMS coverage. CMS encouraged providers to continue reporting data voluntarily.

Finally, CMS also made changes to the patient criteria, by—

• Removing the indication for Class IV heart failure in the presence of cardiac resynchronization therapy;
• Adding cardiac magnetic resonance imaging to the list of diagnostic imaging studies that can evaluate left ventricular ejection fraction;
• Requiring patients who have severe non-ischemic dilated cardiomyopathy but no personal history of sustained ventricular tachyarrhythmia or cardiac arrest due to ventricular fibrillation to have been on optimal medical therapy for at least three months; and
• Requiring a patient shared decision making (SDM) interaction prior to ICD implantation for all indications for primary prevention. The SDM, which may occur as a separate visit, must be a formal SDM encounter between the patient and a physician or a qualified non-physicians practitioner using an evidence-based decision tool on ICDs.

CMS’s current NCD Decision Memorandum is available here.