Letter originally transmitted via e-mail August 31, 2007

Herb Kuhn, Acting Deputy Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
7500 Security Boulevard,
Baltimore, MD 21244-1850

Re: File Code CMS-1385-P

Dear Deputy Administrator Kuhn:

The Heart Rhythm Society (HRS) appreciates the opportunity to comment on the proposed rule entitled “Medicare Program; Proposed Revisions to Payment Policies Under the Physician Fee Schedule, and Other Part B Payment Policies for CY 2008; Proposed Revisions to the Payment Policies of Ambulance Services Under the Ambulance Fee Schedule for CY 2008; and the Proposed Elimination of the E-Prescribing Exemption for Computer-Generated Facsimile Transmissions” published in the July 12, 2007 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 4,500 specialists in cardiac pacing and electrophysiology, consisting of physicians, scientists and their support personnel. HRS’ members perform electrophysiology studies and curative catheter ablations to diagnose, treat and prevent cardiac arrhythmias. Electrophysiologists also implant pacemakers and 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.

MEDICARE PHYSICIAN PAYMENT RATE FOR 2008
The proposed rule confirms that a 9.9% decrease in Medicare payments will occur under the Sustainable Growth Rate (SGR) formula in CY 2008, unless Congress intervenes to avert the cut. The SGR formula clearly is not producing reasonable reimbursement rates. Physician payments are essentially the same as they were six years ago and additional cuts totaling almost 40% are projected over the next eight years. Yet, during this same time period, the Medicare Economic Index (MEI), which measures increases in medical practice costs, is expected to increase approximately 20%. Continued reductions in the physician fee schedule will not be sustainable. Physicians are the foundation of our nation’s health care system, and thus a stable payment environment for their services is critical. HRS recommends that CMS work with Congress to remedy this problem and ensure the physician payment update for 2008 and subsequent years accurately reflect increases in medical practice costs.

RECALLS AND REPLACEMENT DEVICES
HRS is strongly opposed to the correlation CMS is drawing between hospital-related recall and replacement devices (pacemakers and ICD’s), and physician monitoring services provided for patients affected by a recall action. While we understand the rationale for reduced payment when hospitals acquire a device at no cost or with partial credit, there is no compelling reason to reduce payment under the physician fee schedule. The proposed rule purports to seek public input on how best to identify additional Medicare expenditures associated with device recalls and replacements; however, there is major concern that the outcome will result in a payment decrease for physician services, which will threaten continued patient access to care.

HRS is very concerned that CMS’ effort to mitigate greater costs to the Medicare program will impose a financial penalty on the physician. To penalize the physician who bears no fault for device manufacturer product defects would be unjustified. As such, any solution to offset Medicare expenditures associated with device recalls and replacements should not intrude upon the ability of patients affected by the recall to continue to receive the highest quality care available, nor should the physician be punished when a manufacturer initiates a recall advisory to more closely monitor patients for potential problems.

It is our belief that adoption of a policy that would restrict access to patient care or reduce physician reimbursement would be very disruptive and will not result in significant savings to the Medicare program. In fact, Medicare may wind up paying higher costs for more catastrophic care than what would have been expended to monitor patients.

Due to the significant burden that a policy change would place on access to patient care and physician reimbursement, HRS requests that CMS defer development of any provisions until the potential outcomes have been thoroughly vetted through the appropriate stakeholders with a vested interest in pacemaker and ICD patient care.

The HRS Task Force on Device Performance Policies and Guidelines recently developed comprehensive recommendations for the surveillance, analysis and performance reporting of pacemakers and ICDs. These recommendations have been shared with the FDA’s new Risk Communication Advisory Committee to prevent confusion surrounding recalls of implantable devices. The FDA is one of the first Federal agencies to systematically turn to experts to successfully communicate the risks and benefits associated with FDA-regulated products to help consumers and health care professionals make informed decisions.

HRS would welcome the opportunity to work with CMS, in a manner similar to the FDA, to assemble an advisory panel of experts to develop recommendations for appropriate follow-up care that will accurately capture clinically relevant events applicable to certain pacemakers and ICD’s. This approach would ensure the objectives of the agency are met and protect the best interest of Medicare beneficiaries, as well as maintain the role of the physician.

RESOURCE-BASED PE RVUs
Remote Cardiac Event Monitoring
HRS commends CMS for its willingness to continue working with the Remote Cardiac Services Provider Group to refine the interim direct Practice Expense (PE) inputs adopted for CY 2007 for remote cardiac monitoring services represented by CPT codes 93012, 93225, 93226, 93231, 93232, 93270, 93271, 93733 and 93736. As CMS has acknowledged, remote cardiac event monitoring services have substantial equipment-related costs that remain disproportionately valued as a result of the elimination of the zero physician work pool and use of the new “bottom-up” approach to calculate direct costs. We are particularly concerned about proposed reimbursement for holter monitoring codes (93232, 93226, 93231 and 93225), which will decrease by 50% once the PE values are fully implemented in 2010. The cardiac event monitoring codes (93271, 93012 and 93270) will also decrease 15% and 30%, respectively. The care rendered for remote cardiac monitoring services is heavily dependent on use of equipment and technology to collect, analyze and transmit vital medical data. Without adequate reimbursement for these services, Medicare beneficiaries will lose access to critical diagnostic services, which will result in undiagnosed life-threatening conditions, increased hospital, emergency room and physician services. HRS encourages CMS to continue working with the provider group to develop direct and indirect inputs that better align with the equipment, technology and operating expenses required to furnish remote cardiac monitoring services.

CODING—ADDITIONAL CODES FROM 5-YEAR REVIEW
HRS urges CMS to reconsider its proposal to bundle CPT code 93325 (Doppler echocardiography color flow velocity mapping (List separately in addition to codes for echocardiography) into CPT codes 76825, 76826, 76827, 76828, 93303, 93304, 93307, 93308, 93312, 93314, 93315, 93317 and 93350 for echocardiography services. The RUC recently discussed the inherent nature of providing the services described in CPT codes 93325, 93320 and 93307 during the same patient encounter and recommended that this issue be referred to the CPT Editorial Panel to determine the appropriateness of creating a single procedure code to reflect these services. The American College of Cardiology and the American Society of Echocardiography will present physician work and practice expense recommendations to support establishment of a new combined echocardiography code during the September 2007 RUC meeting. Once again, we urge CMS to reconsider its proposal to bundle 93325 and allow this issue to be addressed within the CPT and RUC processes to ensure that the practice expense and physician work involved in the performance and interpretation of color flow studies are appropriately allocated.

TRHCA—SECTION 101(b): PQRI
HRS aims to make it easier for physicians that provide quality care for patients to prove it. HRS promotes quality initiatives that have appropriate incentives that offset administrative costs to participate in such programs. HRS has an active quality committee of physicians and allied professionals engaged in performance measure development processes at the Physician Consortium, AQA, and CMS-levels. We actively collaborate with other physician organizations including the American College of Cardiology on finding new ways to work together to coordinate care, reduce inappropriate variation, increase adherence to evidence-based practices, develop new quality measures, and increase voluntary participation in quality programs. Overall, we believe that these partnerships are essential and have been a success.

HRS’ current effort resulted in five quality measures¹ for the 2007 Physician Quality Reporting Initiative (PQRI). HRS promotes 2007 PQRI on the HRSonline.org website with one-on-one support provided to our members who are voluntary participants. While larger practices with in-house billing services generally participate in the program, interested physicians in smaller practices who have third-party billing services indicate that new fees have been added to their existing billing services, which make participation in PQRI programs cost prohibitive. In other words, the billing service would charge a substantial surcharge for PQRI-reporting that would eliminate any profit to be made from participating. Most often, we have learned that physicians who are capable of proving that they provide quality care cannot participate since the incentive is too low. HRS urges CMS and Congress to provide appropriate levels of incentives that will exceed surcharges imposed by billing services and increase voluntary participation.

HRS believes the 2008 PQRI should continue to be voluntary with confidential reports provided back to participants. HRS agrees that physicians should be able to continue to self-select at least three measures most relevant to their practice. HRS aims to have up to three additional quality measures for atrial fibrillation endorsed by NQF by the November 15, 2007 deadline; however, we request that CMS extend the deadline in the preamble of the Final Rule through the end of December 2007 since: (1) quality measure implementation has been streamlined through experience gained in 2007 PQRI efforts, and (2) physicians who voluntarily participate will not be burdened to quickly adopt new quality measures that fit their practice. The outcome would expand participation since interested physicians not eligible for 2007 PQRI would be able to find the minimum quality measure set to participate in the program.

HRS strongly recommends that adequate federal funding be provided to the NQF to ensure that evidence-based quality measures are vetted and endorsed at a pace that meets physician demands and statutory deadlines. Federal funding will provide the resources to assure timely decisions occur and increase participation by specialty societies in those efforts. Annual costs to participate in NQF are prohibitive to many physician specialty societies who might otherwise want to provide their expertise.

HRS encourages CMS to adopt policies and positions to incorporate outcomes measures into the 2008 PQRI prior to incorporation of efficiency measures. Our current goal is to adopt process measures for new and existing procedures and work towards developing outcomes measures for procedures that have process measures. HRS strongly disagrees with current efforts by payers and other non-physician groups to develop efficiency measures without adequate outcomes measures. Such efforts would penalize physicians who provide quality care since they cannot be more efficient without knowing which outcomes measures to target. We urge CMS to actively engage stakeholders in this effort to properly develop measures in a systematic approach that do not disrupt physicians who provide quality care or reduce participation in a voluntary program.

Registry-Based Reporting Of Quality Measures
HRS agrees in principle with the use of registries for PQRI-reporting and encourages the agency to have a face-to-face meeting with interested parties. HRS agrees that the registry-based reporting should be through explicit authorization or permission by the physician to provide such reporting. HRS generally agrees with the American College of Cardiology’s comments on data submission of quality measures through a medical registry. Specifically, HRS encourages CMS to consider the following registry requirements in determining eligibility:

• The registry must demonstrate HIPPA and Consolidated Health Informatics Initiative standards (CHI) Compliance.
• The purpose of the registry should be to improve quality of care and patient outcomes.
• The registry must demonstrate a scientifically rigorous and unbiased methodology for developing data elements that is valid for participants and is recognized nationally by appropriately qualified groups.
• The registry must require data submissions be of sufficient size to be statistically and clinically relevant.
• The registry must collect and report data back to the participant to support physician self-assessment and quality improvement initiatives.
• The registry must demonstrate proven systems for data collection, data element structure, on-going personnel training and inter-rater reliability, data storage, monitoring, and review.
• The registry must demonstrate processes and procedures for ensuring data completeness at the individual data element level and the overall data composite level.
• The registry must demonstrate data consistency and validity.

CMS Should Consolidate Quality Programs Within Agency
HRS urges CMS to consolidate quality programs within the agency to support physician’s goals to make it easier to provide quality care for patients. CMS needs to make it easier for doctors to care for their patients through reduced documentation requirements and redundant quality programs with incongruent data definitions and participation requirements. We believe that PQRI and Coverage with Evidence Development (CED) programs overlap in intent and requirements that physicians receive incongruent messages from the agency. HRS believes that centralizing quality programs within the agency would be a significant advance in allowing physicians that provide quality care to prove it.

In summary, HRS is grateful for the opportunity to share our views on the proposed rule. Please contact Lisa Miller-Jones, Director of Reimbursement and Regulatory Affairs at lmiller-jones@HRSonline.org or (202) 464-3433 to discuss how HRS and CMS might work together to develop an appropriate solution to address additional Medicare expenditures associated with device recall actions. Please direct any inquiries regarding PQRI to Joel Harder, Director of Quality Improvements and Outcomes at jharder@HRSonline.org or (202) 464-3489.

Sincerely,
 
Bruce D. Lindsay, MD FHRS
President, Heart Rhythm Society

cc:  James H. Youngblood, Chief Executive Officer

 

¹  see HRS website, CMS Physician Quality Reporting Initiative Launched