October 10, 2006

Leslie Norwalk
Interim Administrator
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Attention: CMS-1506-P
P.O. Box 8011
Baltimore, MD 21244-1850

Dear Ms. Norwalk:

The Heart Rhythm Society (HRS) welcomes the opportunity to comment on proposed rule CMS 1506-P entitled Medicare Program: Hospital Outpatient Prospective Payment System and CY 2007 Payment Rates; CY 2007 Update to the Ambulatory Surgical Center Covered Procedures List; Ambulatory Surgical Center Payment System and CY 2008 Payment Rates published in the August 23, 2006 Federal Register.

HRS is the international leader in science, education and advocacy for cardiac arrhythmia professionals and patients, and the primary information resource on heart rhythm disorders. Founded in 1979, HRS is the preeminent professional group representing more than 3,700 specialists in cardiac pacing and electrophysiology, known as electrophysiologists or heart rhythm specialists. HRS’ members perform electrophysiology (EP) studies and curative catheter ablations to diagnose, treat and prevent cardiac arrhythmias. Electrophysiologists also implant pacemakers and implantable cardioverter defibrillators (ICDs) in patients who have indications for these life-saving devices. After device implantation, heart rhythm specialists then monitor these patients and their implanted devices.

Device-Dependent APCs

HRS appreciates CMS’ efforts to ensure accurate and appropriate payment for replacement medical devices that are implanted at no or reduced cost to the hospital. However, we are concerned about the proposal to automatically reduce hospital payments for devices that have failed or have been recalled by their manufacturers. CMS is proposing that if a hospital receives a device that is replaced as a result of a warranty, field action, voluntary recall, involuntary recall, or is free of charge, the payment reduction would be triggered. In such cases, the reduced payment would cover only the procedural costs, not any device-related costs.

It is important to recognize that each device recall is a unique situation and should be reimbursed appropriately based on the costs that a hospital incurs. Therefore, HRS urges careful consideration of this issue as there needs to be acknowledgment that in many cases, the cost of replacing recalled devices is pro-rated. In these instances, hospitals have costs based on the device’s service life as compared with its projected longevity. Therefore, there is a cost, albeit reduced, for hospitals. HRS supports calculating payments on a pro-rated basis to accurately account for costs. Additionally, many device manufacturers have warranty policies under which hospitals continue to bear some of the costs of recalled devices.

In the rule, CMS proposes usage of the –FB modifier to indicate a payment adjustment. However, the current descriptor for the –FB modifier is not appropriate to use in situations involving device upgrades. Therefore, HRS recommends creation of a new modifier to accurately account for all situations requiring a payment adjustment.

HRS supports appropriate payment for replacement devices and we urge CMS to work with us as well as with device manufacturers to address payment for devices that are no-cost as well as those that are full-cost and reduced-cost.

Device Performance

ICD and pacemaker device performance is a fundamental issue for the members of the Heart Rhythm Society. Our members are on the ‘front lines’ taking care of patient with these life-saving devices. Over the past year, the Heart Rhythm Society spearheaded a Task Force to establish recommendations to provide patients and physicians with clearer, timelier and more consistent information about device performance of pacemakers and ICDs. HRS released these recommendations to the public on September 28^th and can be found at: http://www.hrsonline.org/uploadDocs/HRSTaskForceRecsFull.pdf

The recommendations offer specific guidanceto physicians, industry, the Food and Drug Administration and Congress about performance issues and the critical role of post market surveillance for implanted cardiac devices. The report calls for greater transparency in the post-market surveillance, analysis, reporting and communication of device information and recommends the following:

• The global scope of device performance issues requires enhanced cooperation among industry, physicians, government authorities (HHS, CMS, FDA, and AHRQ) and national health care systems to reduce the risk of injuries and deaths due to device malfunctions.
• The Heart Rhythm Society recommends that the National Cardiovascular Data Registry (NCDR) ICD Registry ™ , administered by the Heart Rhythm Society and the American College of Cardiology be modified to:
• Collect detailed device-specific performance data including a report of device performance at the time of device replacement or death; and
• Collect data regarding adverse device events, date of the event, and the outcome of the event or cause of each patient’s death.

This adjunctive information can assist in tracking device performance and the consequences of malfunctions. Implementation of this recommendation will require additional funding and resources from the federal government, private payers, device manufacturers, and hospitals.

• The use of standard definitions and terminology and the establishment of new systems to identify malfunctioning devices more quickly
• Standard industry notification and communication to physicians and patients from the manufacturer when a device malfunction is identified
• Post market surveillance needs to be prioritized by the FDA and recognized by Congress as needing more targeted resources
• Physicians are advised to return all devices to the manufacturer for analysis whether the replacement is routine or because of malfunction
• Physicians are urged to consider the risk of device removal and re-implantation when making clinical decisions regarding patients who may have a malfunctioning device. Consideration should be given to alternatives to re-implantation that may mitigate the consequences of device malfunction and decrease patient risk.

The recommendations have been officially endorsed by the American College of Cardiology Foundation and the American Heart Association.

The Heart Rhythm Society is committed to advocating for these changes as recommended in this Report. We look forward to working with CMS and our diverse partners throughout the next few months to initiate reforms that will, most importantly, increase patient safety and promote confidence in these life-saving devices.

HRS appreciates the recognition in the proposed rule of the American College of Cardiology – National Cardiovascular Data Registry (ACC-NCDR) for Implantable Cardioverter Defibrillators (ICD Registry^TM). However, HRS requests that in the future CMS accurately describe the ICD Registry™ as a partnership of the ACC and the Heart Rhythm Society. The Heart Rhythm Society is a partner of the ACC in the ICD Registry™ effort to collect data and maintain the ICD Registry^TM. HRS strongly believes that data from registries will help further the development of high quality, evidence-based clinical practice guidelines for the care of patients who may receive device-intensive procedures. Therefore, we request that CMS amend statements in the proposed rule to read as follows:

“Presently, the American College of Cardiology – National Cardiovascular Data Registry (ACC-NCDR) in partnership with the Heart Rhythm Society collects these data and maintains the registry.”

HRS agrees with CMS’ statement to “encourage the medical community to work to develop additional registries for implantable devices, so that timely and comprehensive information is available regarding devices, recipients of those devices, and their health status and outcomes.” To that end, HRS currently spearheads the ICD Registry Working Group, which includes representatives from CMS, other government agencies, the ACC, other physician association groups, payers, and members-at-large to develop a new and separate longitudinal registry to focus on device firing therapy for a subset of patients in the ICD Registry^TM.

HRS appreciates CMS involvement on this new endeavor, which will inform clinical thinking on the long-term outcomes associated with ICD implants. We believe that data collected and analyzed through this effort has a direct connection with the Coverage With Evidence Development questions (i.e., “Group B” Questions). The importance of this effort is underscored by our recently released final “Recommendations from the Heart Rhythm Society Task Force on Device Performance Policies and Guidelines.” HRS submits these recommendations to CMS and requests the agency to consider them in their final rule-making.

HRS urges CMS to consider government funding sources to continue funding the existing ICD Registry^TM and also provide financial resources to launch the longitudinal registry effort which has the potential to produce additional mechanisms for “early intervention to mitigate harm and improve the quality and efficiency of health care services.” We believe that participants have funded registry participation through increased personnel and time to collect and submit data. We believe most participating hospitals are willing to submit data on all their ICD patients, instead of the minimum requirement of Medicare primary patient population as stated in the national coverage decision. To sustain this high level of participation over time, HRS believes that further funding for this necessary additional data collection should be funded by government sources as indicated in the recent Institute of Medicine’s report on “Pathways to Quality Healthcare: Rewarding Provider Performance.”  Specifically, the Society supports the report’s recommendation:

“Recommendation 6: Because public reporting of performance measures should be an integral component of a pay-for-performance program for Medicare, the Secretary of DHHS should offer incentives to providers for the submission of performance data, and ensure that information pertaining to provider performance is transparent and made public in ways that are both meaningful and understandable to consumers.”[1]

As discussed above, HRS supports efforts to address device performance issues and we look forward to continuing to work with CMS on these issues. As part of these efforts, HRS has been a partner in the ICD Registry™ and we encourage CMS to recognize our involvement in future publications.

HRS appreciates the opportunity to provide input on Medicare payment policy and thanks CMS for your consideration of our comments. We look forward to continuing to work together to maintain access to medical services for Medicare beneficiaries. If you have any questions about HRS’ comments, please contact Lisa Miller, Director, Reimbursement and Regulatory Affairs, at lmiller@hrsonline.org or 202.464.3433.

Sincerely,

Dwight Reynolds, MD, FHRS
President
Heart Rhythm Society

[1] Institute of Medicine “Pathways to Quality Healthcare: Rewarding Provider Performance,” p. 82