The Centers for Medicare & Medicaid Services (CMS) is proposing to update coverage decisions for implantable cardioverter defibrillators (ICDs). CMS recently issued a proposed decision memo for implantable cardioverter defibrillators (CAG-00157R4). CMS has compiled evidence to support the conclusion that the use of ICDs is reasonable and necessary for the treatment of illness or injury and is reasonable and necessary to improve the functioning of a malformed body member. Based on this finding, the payment for ICDs would be permitted under Medicare Part A or B coverage. Section 1832(a)(1)(A) of the Social Security Act states: “Notwithstanding any other provision of this title, no payment may be made under Part A or Part B for any expenses incurred for items or services, which, except for items and services described in a succeeding subparagraph, are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member …”

An ICD is a battery-powered device placed under the skin that keeps track of a person's heart rate. Thin wires connect the ICD to the heart. If an abnormal heart rhythm is detected, the device will deliver an electric shock to restore a normal heartbeat if the heart is beating chaotically and too fast. ICDs have been very useful in preventing sudden death in patients with known, sustained ventricular tachycardia or fibrillation. Studies have shown that ICDs may have a role in preventing cardiac arrest in high-risk patients who have not had, but are at risk for, life-threatening ventricular arrhythmias. An ICD is relatively expensive, on average, costing $30,000. Currently, providers must submit data sets to CMS that provide more information about the safety and effectiveness of ICDs in order to receive a Medicare reimbursement.

CMS's proposed changes are the first suggested update to ICD Medicare coverage since 2005. Many in the industry agree it was long overdue. The proposed changes address three alterations to the current status of the CMS regulations:

Patient Criteria:

• Adding cardiac MRI to the list of diagnostic imaging studies that can evaluate left ventricular ejection fraction (LVEF);
• Requiring patients who have severe ischemic and/or nonischemic dilated cardiomyopathy but no prior personal history to have been on optimal medical therapy for at least three months;
• Requiring a patient shared decision-making (SDM) interaction prior to ICD implantation for certain patients; and
• Removing the Class IV heart failure requirement for CRT. Exceptions to Waiting Periods: |
  • Adding an exception for patient meeting CMS coverage requirements for cardiac pacemakers, and who meet the criteria for an ICD.
  • Adding an exception for patients with an existing ICD and qualifying replacement. Registry Requirement: |
    • Ending the data collection requirement.

CMS's proposal includes a requirement that patients and their physicians participate a decision-making discussion before an ICD is implanted for those patients who have a history of cardiac arrest or those with an existing ICD who qualify for a replacement. During these joint discussions, the doctor and patient discuss risks and benefits, patient preferences, and other important factors. These discussions allow for the doctor and patient to share responsibility in the decision making process.

Additionally, the proposal would permit certain patients to bypass the mandatory 40-day waiting period before receiving an ICD. The 40-day waiting period would be waived for patients who have recently had a heart attack, undergone a coronary revascularization procedure, or who need a new ICD due to a dead or malfunctioning battery.

Lastly, since industry groups and hospitals have been collecting data on the clinical use of ICDs for over a decade, CMS's proposal seeks to end the data collection requirement for patients who could benefit from having ICDs. Research has shown that it is medically necessary to provide coverage for implantations of ICDs. By removing the data collection requirement, health care providers would have a lessened burden which would allow providers to focus on quality improvement, safety, and appropriate use verification. In 2005, CMS had some questions about the evidence. Based on its concerns at the time, CMS required additional data to be collected via a Registry. CMS believes that additional data collection is no longer needed.

They were satisfied that the below 10 hypotheses have been answered.

• The clinical characteristics of the patients receiving ICDs are similar to those of patients involved in the primary prevention randomized clinical trials.
• The indications for ICD implantation in patients are similar to those in the primary prevention randomized clinical trials.
• The in-hospital procedure related complications for patients are similar to those in the primary prevention randomized clinical trials.
• Certified providers competent in ICD implantation are implanting ICD devices in patients.
• Patients who receive an ICD represent patients for which current clinical guidelines and the evidence base recommend implantation.
• The clinical characteristics and indications for ICD implantation do not differ significantly among facilities.
• The clinical characteristics and indications for ICD implantations do not differ significantly among providers.
• The in-hospital procedure related complications for ICD implantation do not differ significantly among facilities.
• The in-hospital procedure related complications for ICD implantation do not differ significantly among providers.
• The in-hospital procedure related complications for ICD implantation do not differ significantly among device manufacturer types, and programming.”

CMS was satisfied that real world studies have provided support for implementation of this technology outside the controlled trial environment. The initial data collection requirement served to generate and improve the evidence base for the use of ICDs in certain Medicare beneficiaries. The input of a number of professional societies and contribution of manufacturers in this positive collaborative effort over the past decade was acknowledged by CMS. CMS believes it has served its purpose and are proposing to end the registry data collection requirement.

Based on the evidence, CMS proposes to reduce provider burdens and documentation through discontinuation of the registry data collection requirement.

To read CMS's Proposed Decision Memorandum, visit: http://src.bna.com/utc.

—Katherine E. LaDow, an associate with Lamb McErlane, contributed to this article.

Vasilios “Bill” J. Kalogredis is chairman of Lamb McErlane's health law department. He represents many medical and dental groups and thousands of individual physicians and dentists.