February 23, 2005

Dear Heart Rhythm Society Member:

On January 27, the Centers for Medicare and Medicaid Services (CMS) announced its expanded ICD coverage decision for primary prevention ICD therapy. Immediately, coverage for primary prevention was expanded to include most SCD-HeFT patients and an expanded MADIT II population. Along with this expanded coverage, CMS also implemented an ICD registry requirement. Details of this expanded coverage, including the QNET registry requirement have now become available.

Implementation of Expanded Implantable Defibrillator Coverage:

CMS has revised and expanded ICD coverage as indicated in the ICD national coverage determination. This expanded coverage is in addition to already indicated patients. A new ICD Registry through your hospitals QNET system has also been established. This ICD Registry requirement is for primary prevention ICD patients only as indicated below.

View the summary of coverage that includes the revised National Coverage Determination (NCD).

This revised expanded coverage in the January decision includes the following indications :

1. Documented episode of cardiac arrest due to ventricular fibrillation (VF), not due to a transient or reversible cause (effective July 1, 1991). (These patients are not required to be entered into the registry, secondary prevention)
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). (Not required to be entered into the registry, secondary prevention)
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). (REGISTRY REQUIREMENT)
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 4 weeks prior to defibrillator insertion. The EP test must be performed more than 4 weeks after the qualifying MI.) (MADIT I patients, REGISTRY REQUIREMENT)
5. Documented prior MI and a measured LVEF < 30%; (MADIT II patients, Class I, REGISTRY REQUIREMENT)
6. Patients with ischemic dilated cardiomyopathy (IDCM), documented prior myocardial infarction (MI), New York Heart Association (NYHA) Class II and III heart failure, and measured left ventricular ejection fraction (LVEF) < 35%; (SCD-HeFT patients, REGISTRY REQUIREMENT)
7. Patients with nonischemic dilated cardiomyopathy (NIDCM) > 9 months, NYHA Class II and III heart failure, and measured LVEF < 35%; (SCD-HeFT patients, REGISTRY REQUIREMENT)
8. Patients who meet all current CMS coverage requirements for a cardiac resynchronization therapy (CRT) device and have NYHA Class IV heart failure;(COMPANION patients, no national coverage decision exists for CRT, coverage may vary by Medicare carrier, REGISTRY REQUIREMENT)
9. Patients with NIDCM >3 months and < 9 months, NYHA Class II or III heart failure, and measured LVEF < 35% at this time are only covered by Medicare if these patients are 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¡±. These patients cannot be enrolled in the current ICD Registry through QNET. Therefore, these patients do not have a covered Medicare indication unless this patient is enrolled in a FDA-approved category B IDE clinical trial or an IRB clinical investigation . A subsequent ICD Registry is being developed that will enroll this subset of patients. The Heart Rhythm Society will notify HRS members as soon as this becomes available.

NOTE: The QRS duration is no longer a requirement for any patients receiving an ICD under the expanded coverage for ICD therapy. However, CRT therapy still requires a QRS of 120 MS or greater.

The following additional criteria for all of the above patients must also be met:

a. Patient must be able to give an informed consent;

b. Patient must not have:

• Cardiogenic shock or symptomatic hypotension while in a stable baseline rhythm;
• Had a coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within the past 3 months;
• Had an acute MI within the past 40 days; [NOTE: This requirement has changed from previous coverage which required an acute MI within the past month]
• 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 one year;

NOTE: All primary prevention ICD replacements for Medicare patients must also be included in the Registry.

Diagnosis Codes for ICD Patients

ICD-9 codes are important in this expanded coverage and determining which patients should and should not be included in the registry. A claim with a diagnosis of 427.1 ventricular tachycardia as secondary prevention, does not need to be included in the registry. However, a claim with this same diagnosis 427.1 ventricular tachycardia as primary prevention as in MADIT I or MUST patients (post-EP study) should be included in the registry. The important difference in these two claims is the determination that the patient is considered primary or secondary prevention. Other diagnosis codes that may identify patients with previous arrhythmias (secondary prevention) are:

• 427.1 Ventricular tachycardia
• 427.41 Ventricular fibrillation
• 427.42 Ventricular flutter
• 427.5 Cardiac arrest
• 427.9 Cardiac dysrhythmia, unspecified

Read more detailed information on diagnosis coding related to ICD patients.

QR Modifier ¨C What the Clinician Needs to Know

Beginning April 1^st 2005 the physician must include modifier QR on the primary procedure code for the ICD implant for patients receiving primary prevention therapy. Prior to April 1^st , claims should be submitted without the modifier.

ICD Registry Requirement ¨C Using the QNET System

The data collection requirement for patients with indications #3 - 8 above is met by your hospital submitting data through the ICD Abstraction Tool through QualityNet Exchange.

All of the resources necessary for your hospital to comply with this new requirement can be found on the QualityNet Exchange website.

For detailed information related to this new data collection requirement for ICDs, click here for an QNET ICD Q&A.

For any problems encountered with the use of the QualityNet Exchange web site, or questions/problems related to ICDA, please contact the QualityNet Help Desk for support.

Phone: 866-288-8912 ( 7 a.m. - 7 p.m. CT Monday through Friday)
Fax: 888-329-7377
Email: qnetsupport@ifmc.sdps.org

ICD Registry Worksheet/Required Data Elements

Some hospitals and EP labs find it useful to use the worksheet found here to use with every ICD implant. This worksheet is not a CMS requirement but is useful to determine which patient's medical record will need to be included in the ICD Registry and which does not. More importantly, this ICD Registry Worksheet/Data Elements Checklist also indicates to the implanting physician which data fields must be complete in the patient record for the ICD-QNET system to function properly. It is the physician's responsibility that these data elements on the attached worksheet be complete in the patient's record and/or that this data element checklist be completed and appended to the patient record.

Certification Status Information Will be Collected

During this past year, the Heart Rhythm Society encouraged CMS require providers be certified as competent in ICD implantation. The Heart Rhythm Society's goal was to ensure patient's access to this life saving therapy and access to qualified implanters. This new ICD Registry requirement through the QNET system will collect data on physician certification. CMS included the following statement in the final coverage decision .¡°As with any invasive procedure, physicians who insert ICDs must be appropriately trained and fully competent to perform the implantation. CMS strongly encourages credentialing and certification of physicians who insert ICDs by appropriate national organizations, such as the Heart Rhythm Society (HRS) or boards of medical specialties, to ensure the safety of Medicare beneficiaries. CMS also believes that provider credentialing and certification should be tracked and included in any and all registries and data collection systems. This information is valuable for informing patients as part of effective clinical decision-making and will provide useful data on procedural outcomes associated with different levels of provider training and expertise .¡±

The QNET system is collecting data on the certification status of physicians. At this time, physicians are being asked to indicate if they are certified in electrophysiology. According to the help screen provided in the ICDA QNET tool, electrophysiology certification includes physicians with board certification in Clinical Cardiac Electrophysiology by the American Board of Internal Medicine or physicians that are certified by passing NASPExAM .

In the second phase of the registry, definitions of certification and qualifications will be expanded and further defined. This data will need to be either present in the patient's medical record or indicated on the data element worksheet .

The Heart Rhythm Society will continue to provide information regarding ICD coverage and reimbursement to the membership as it becomes available. Please contact the Heart Rhythm Society (Amy Melnick or Brian Outland at 202.464.3400 or amelnick@hrsonline.org or boutland@hrsonline.org if you have questions regarding implementation of these new policies.

Sincerely,

Stephen C. Hammill, MD
President
Heart Rhythm Society