Dear Heart Rhythm Society Member,

As many of you know, the Centers for Medicare and Medicaid Services (CMS) will be publishing in the next few days a final National Coverage Decision (NCD) related to Medicare coverage for heart failure patients receiving an ICD for primary prevention as described in SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial). The Heart Rhythm Society has been advocating these past 9 months for coverage of ischemic or non ischemic heart failure patients with an ejection fraction of <=35% based on the trial results. http://www.hrsonline.org/pdf_files/ICDCoveragetoCMSFinal.pdf

We are extremely pleased CMS is poised to make a positive coverage decision and expand the number of heart failure patients eligible for ICD therapy. This is a landmark coverage decision that will allow Medicare beneficiaries access to the appropriate care they deserve.

As a condition of Medicare coverage for these primary prevention patients, CMS will be requiring hospitals to enter specific clinical data elements related to the ICD implant into the hospital QualityNet Exchange system (QNET). Hospitals will not be in compliance with Medicare regulations and payment for the ICD will be considered fraudulent unless the ICD QNET data is entered for the appropriate primary prevention Medicare patients.

This QNET requirement applies only to Medicare beneficiaries receiving ICDs for primary prevention. It does not apply to ICD replacements, non-Medicare patients, patients with a secondary prevention indication (a diagnosis of VT or VF ( ICD–9 CM diagnosis codes 427.1, 427.41, 427.42, 427.5, 427.9) or if a patient is participating in an FDA regulated study, NIH clinical trial or a qualifying post market study.

In a future Washington Report we will outline the purpose of the registry and how the information will be used to test the following ICD Registry Hypothesis published by CMS:

http://www.cms.hhs.gov/coverage/download/id139b.pdf

What will this mean for the heart rhythm specialist?

This will mean that the following data elements will either have to be clearly accessible from the patients medical record for the QNET abstractor tool to work OR the heart rhythm specialist can use the following form in hard copy format to attach to the patient's medical record. Use of this form may help ensure compliance with this new hospital requirement, however, use of this form is NOT mandatory. Use of this form will help clearly differentiate which patient's data are required to be entered into the QNET system and which are not. For example, data from non-Medicare patients, ICD replacements, patients with a secondary prevention indication (a diagnosis of VT or VF ( ICD–9 CM diagnosis codes 427.1, 427.41, 427.42, 427.5, 427.9) or if a patient is participating in an FDA regulated study does not need to be entered into the QNET system (see bolded section above). The use of this form will help heart rhythm specialists easily document in the patient record which patients will be in the QNET ICD Registry and which patients the registry requirement does not exist. Although the QNET abstractor tool will be capable of extracting much of this data, the use of this data form may help ensure better accuracy of the QNET data and will help capture all of the required data fields. Ultimately, it will be your hospital's responsibility for QNET abstraction and data submission, however, it is the implanting physician's responsibility that all relevant information be available in the chart and/or indicated on the form below. The Heart Rhythm Society recommends that the EP physician identify your institution's QNET administrator and work closely with them to remain compliant with this new requirement.

IMPORTANT: Medicare Part B claims for primary prevention ICDs are required to include a QR modifier to signify that the patient is enrolled in a registry.

The Heart Rhythm Society has been advocating to CMS that this Registry should include the collection of provider certification information. CMS has listened to our concerns about the need to collect this information and this will be a required data field. This data collection effort will assist the Society to communicate the need for physicians to be certified as competent in ICD implantation.

CLICK HERE FOR FORM:

What is QNET? https://qnetexchange.org/qnet/

The QualityNet Exchange, known as QNET, is the only approved method for electronic transmission of quality measures to the QIO Clinical Data Warehouse. This is the information repository for the clinical data measures collected and submitted by hospitals. Established by CMS, QNet Exchange is the only CMS-approved site for secure communications and data exchange between Quality Improvement Organizations http://www.medqic.org/content/qio/qio.jsp, Hospitals, Performance Measurement System Vendors and Clinical Data Abstraction Centers. In the short-term, approximately 6 months, CMS has chosen to utilize the QNET system to begin collecting post-coverage data on ICD implants.

CMS has released an Implantable Cardioverter Defibrillator Abstraction (ICDA) tool to facilitate the collection of registry information related to ICDs. The tool is available for your QNET administrator's use at: http://www.qnetexchange.org/icda

All hospitals have been notified that data must be entered into the QNET system for Medicare beneficiaries receiving an ICD for primary prevention. These patients can be identified through the absence of ICD-9 diagnosis codes for secondary prevention from the claim. A patient claim for which at least one of the following codes does not appear for secondary prevention could signify that the patient should be enrolled in the QNET registry. Medicare Part B claims that fit this description should include a QR modifier to signify that the patient is enrolled in a registry. Although CMS does not have a coding mechanism for Part A claims that is similar to the function of modifier QR on Part B claims, CMS will have the ability to match inpatient claims to identify and review registry participation through other mechanisms. The following codes identify patients with previous arrhythmias (secondary prevention):

These ICD-9 codes are not used in patients receiving the ICD for primary prevention indications.

The ICDA tool allows for on-line collection of registry information, including patient identifiers, history and clinical characteristics, medications, ICD indications, device information, complications, and facility and provider information. Your hospital QNET Administrator can access software and associated documents from the "Tools" option available from the ICDA Overview page at: http://www.qnetexchange.org/icda

What's in store for the future?

CMS has indicated that this QNET requirement is not a permanent long term solution to data collection related to ICDs. The Heart Rhythm Society is working with the American College of Cardiology on a joint venture to develop the CMS required ICD Registry that will be focused on ICD data collection as a tool for measuring and improving the quality of care provided to patients receiving an ICD. As progress develops on this ACC/HRS ICD Registry, information will be shared with the membership. Additionally, a summary and analysis of the final coverage decision will be sent out once it has been published.

If you have any questions, please contact Amy Melnick, Vice President, Health Policy amelnick@hrsonline.org or 202-464-3434 or Brian Outland, Manager, Regulatory and Reimbursement Affairs, at boutland@hrsonline.org or 202-464-3433.

Sincerely,

Stephen C. Hammill, MD
President
Heart Rhythm Society