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1 September 6, 2013 Marilyn Tavenner Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services Hubert H. Humphrey Building, Room 445-G 200 Independence Avenue, SW Washington, DC Re: CMS-1600-P- Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule, Clinical Laboratory Fee Schedule & Other Revisions to Part B for CY 2014 Dear Administrator Tavenner: The Regulatory Education and Action for Patients (REAP) Council would like to thank you for the opportunity to comment on the Proposed Rule entitled Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule, Clinical Laboratory Fee Schedule & Other Revisions to Part B for CY 2014 (the Proposed Rule), which was published in the Federal Register on July 19, REAP is an umbrella coalition comprised of 61 patient advocacy groups. The unique experience and expertise of each REAP member organization allows REAP to provide the patient voice in a crossregulatory bodies, disciplinary manner. REAP s mission is to communicate issues to Federal and State Congress, health care insurers and others to regulate, develop, manage and/or impact health delivery, coverage, cost, and availability of services to the United States population. REAP will, through its member entities, contribute information and perspectives regarding important healthh care decisions to a degree that has not been possible heretofore by health care advocacy groups in the regulatory arena. Both REAP and its member organizations are concerned that in its efforts to control Medicare spending and preserve the Medicare Trust Fund operating within the current statutorily mandated Sustainable Growth Rate (SGR) formula, the Centers for Medicare & Medicaid Services (CMS) has lost sight of the subsequent impact of such efforts on patients, specifically their potential access to needed health care and the quality of care that such patients receive. While REAP members appreciate the daunting task of managing the exponential costs associated with caring for the Medicare beneficiary population which continues to expand, CMS nonetheless needs to ensure it is implementing any cost-controlling proposals or measures in the most patient-centric manner possible. It is against this background that we offer the following comments to the Proposed Rule. We have organized our comments around three overarching principles (1) proposals that may impact Medicare 1 78 Fed. Reg. 43,282 (Jul. 19, 2013).

2 beneficiary access to needed healthcare, (2) proposals focused on rewarding providers for the provision of quality care and (3) proposals focused on transparency in Medicare coverage and quality of care provided. Proposals that may impact Medicare beneficiary access to needed healthcare The Hospital Outpatient/Ambulatory Surgery Cap on Practice Expenses In the Proposed Rule, CMS has proposed refining the practice expense (PE) methodology used to construct the Physician Fee Schedule (PFS) to limit the nonfacility PE relative value units (RVUs) for more than 200 Healthcare Common Procedure Coding System (HCPCS) codes so that the total Medicare nonfacility PFS payment amount would not exceed the total combined Medicare payment amount (facility PFS payment plus facility fee) for the same service furnished in a hospital outpatient department or, if allowable, in an ambulatory surgery center (ASC) where facility fees are lower (the OPPS/ASC Cap). 2 For many capital intense treatments or procedures, such as radiation therapy for cancer and phototherapy for conditions such as psoriasis, the result is a substantial decrease in reimbursement for such treatments or procedures when performed in the physician s office setting. The chart below illustrates the projected reimbursement decreases resulting solely from implementation of the proposed OPPS/ASC Cap for several HCPCS codes: Code Description PFS 13 PFS 14 PFS % Change RT Delivery Complex $ $ % MEV RT Delivery Complex 6- $ $ % 10 MEV Radiation Therapy $ $ % Dose Plan IMRT Simulation Complex $ $ % Photochemotherapy $76.21 $ % with uv-b Photochemotherapy with uv-a $97.65 $ % As you can see from the foregoing, the CMS-proposed OPPS/ASC Cap often times has the effect of substantially reducing Medicare reimbursement for treatments and procedures provided in the physician s office setting over 2013 Medicare PFS reimbursement amounts up to 60 percent in the case of photochemotherapy with uv-a. Such substantial decreases are simply unabsorbable for physicians, particularly if commercial third party payors follow Medicare s lead in reducing reimbursement for the impacted HCPCS codes. As such, if CMS moves forward in implementing the proposed OPPS/ASC Cap, many physicians may decide to cease offering such services or cease accepting Medicare patients, forcing beneficiaries to seek alternative treatment locations, pay out-of-pocket for such treatments or procedures at their current physician offices or switch to alternative treatments which may be more expensive for Medicare and the patient. For instance, certain biologics are an 2 Id. at 43,296. 2

3 alternative treatment to phototherapy for psoriasis. Such biologics can cost up to $30,000 a year compared to the average cost of $3,000 a year for phototherapy. 3 Implementation of the proposed OPPS/ASC Cap will undoubtedly hinder patient access to needed treatments or procedures since patients will be forced to travel to hospital outpatient departments, which are often inconvenient and hours from a patient s home, pay out-of-pocket for the entire cost of treatment at their current physician s office or switch to an alternative course of treatment, which will often result in a higher co-insurance obligation for a beneficiary given the higher costs associated with such a treatment alternative. REAP urges CMS to reconsider the proposed OPPS/ASC Cap given the potential negative impact on beneficiaries access to needed medical treatments and procedures. REAP is concerned that by capping the values as proposed, CMS is arbitrarily setting values for non-facility PE in the RVU calculation to achieve the goal of equalization. Rather, the goal should be to adequately reimburse physicians for quality care so that their clinical decisions are driven by what is in the best interests of the patient and not by the economics of their decision(s). If CMS is truly interested in Medicare reimbursement parity between the hospital outpatient and physician s office sites of service, we recommend that CMS explore establishing universal Medicare reimbursement for treatments and procedures regardless of the site of service for Sustainable Growth Rate REAP members are concerned thatt substantial decreases in Medicare reimbursement, whether targeted or specific to certain specialties, procedures or treatments or more global in nature, can result in diminished access for Medicare patients to specialists, treatments and procedures. REAP members are particularly concerned that the projected 24.4 percent decrease in Medicare reimbursement which will result absent Congressional action due to implementation of the conversion factor reduction required by the SGR formula, will negatively impact Medicare beneficiaries on a global basis. In November 2011, when physicians were facing a similar cut in Medicare reimbursement absent a Congressional fix, the Medical Group Management Association released the results of a survey of 2,176 medical groups representing more than 93,000 physicians assessing the impact of a potential decrease in Medicare reimbursement on physician group practice management. 4 In response to this survey, 51 percent of medical groups surveyed indicated they would reducee the number of appointments for new Medicaree patients in response to the projected decrease in Medicare reimbursement. In addition, the annual threat of a drastic reduction in Medicare reimbursement due to the SGR formula and the uncertainty stemming from such potential reimbursement reductions have taken a toll on the potential quality of care available to patients at physicians practices. According to the Medical Group Management Association survey, 64.7 percent of physician groups surveyed indicate 3 Beyer V, Wolverton DE, Recent Trends in Systemic Psoriasis Treatment Costs. Archives of Dermatology. 2010: 146(1): A summary of the survey results is available at

4 they delayed purchasing new clinical equipment or upgrading facilities because of a potential cut in Medicare reimbursement while 31 percent of physician groups indicated they delayed purchasing electronic medical record software because of the anticipated decrease in Medicare reimbursement. As evidenced by the 2011 Medical Care Management Association survey, even the threat of a dramatic decrease in Medicare reimbursement due to implementation of the conversion factor reduction under the SGR formula has a negative impact on Medicare beneficiary access. For instance, as the survey results indicated, many physicians had actually already put off acquiring needed diagnostic machines and other clinical equipment. We urge CMS to continue to support Congressional efforts to permanently repeal the SGR formula for the benefit of all Medicare beneficiaries, and to ensure that this repeal is not funded by reducing funds to other important aspects of patient health such as the Prevention and Public Health Fund. REAP members believe that until Congress enacts a new, more appropriate methodology for regulating the growth in Medicare payments to physicians, patients will continue to face challenges in physician access for both primary and specialty care. The estimated 24.4 percent cut in physician s payment rates, in addition to payment reductions due to sequestration, simply cannot be implemented without dire consequences to patient care. Until such permanent reform is enacted, CMS should do everything possible to mitigate these cuts and ensure that Medicare patients continue to have access to high quality care. Failure to do so will not only impact patient care but potentially could contribute to the increasing costs of caring for this vulnerable population. Proposals focused on rewarding providers for the provision of quality care to Medicare beneficiaries Chronic Care Management In the Proposed Rule, CMS proposes establishing a new G-code for ongoing chronic care management and coordination. Many of the member organizations which comprise REAP focus their advocacy efforts related to one or more chronic conditions; REAP s member organizations know first-hand the impact of proper management of such conditions on an individual s overall quality of life. REAP applauds CMS for its commitment to the management of chronic conditions by qualified health care professionals evidenced through its proposed G-code for chronic care management and coordination. By providing adequate Medicare reimbursement for the management of chronic conditions, CMS will ensure that physicians dedicate sufficient resources to effectively managing their chronic conditions. CMS has proposed defining a chronic condition via reference to the list of chronic conditions in the CMS 2012 Medicare Chronic Conditions Chartbook. The World Health Organization (WHO) defines a chronic disease as a disease of long duration and generally slow progression. 5 As example of the Chartbook s limitation, while Multiple Sclerosis (MS) and Amyotrophic Lateral Sclerosis (ALS) would certainly meet that WHO s definition of a chronic disease, they are absent from the chronic conditions listed in the CMS 2012 Medicare Chronic Conditions Chartbook. We encourage CMS to adopt the WHO s definition of chronic disease or condition and work with the WHO, other global health organizations and federal government agencies to obtain, or if necessary, compile a more thorough and comprehensive list of chronic conditions. Furthermore, according to the Proposed Rule, in order for a physician to receive Medicare reimbursement for chronic care management for a given patient, the patient must have at least two 5 See WHO definition of chronic disease at (last visited Aug. 28, 2013). 4

5 significant chronic conditions whichh are listed in the CMS 2012 Medicare Chronic Conditions Chartbook. REAP recommends that CMS eliminate the dual chronic condition requirement. Depending on the chronic disease, the patient s lifestyle and individual characteristics of the patient, managing even one chronic condition can result in extensive care coordination, distress screenings and patient education and counseling on the part of a treating physician. Physicians managing such a chronic condition should be properly compensated for their management and coordination activities. In addition, we believe that the proposed requirement that a physician have an annual wellness visit with a given patient in order to bill Medicare for chronic care management using the designated G-code limits the types of physicians eligible to bill for chronic care management to internistss and primary care physicians because annual wellness visit is already defined as a general, preventative health assessment under the Medicare program. 6 In order to avoid such a limitation on the use of the chronic care management G-code, REAP urges CMS to expand the scope of the annual wellness visit requirement to include a face-to-facdistress screening of the patient, related to the chronic condition within the past year in order for the visit with the patient, including a physical examination and physician to bill Medicare for chronic care management under the new G-code. As discussed above, specialists, and particularly oncologists in the case of cancer patients, often play a vital role in managing certain chronic conditions. Giving particular attention to these chronic conditions should not preclude an examination from being considered an annual wellness visit for Medicare billing purposes, if it includes services otherwise required within the definition of annual wellness visit. Value-Based Payment Modifier REAP members are strong advocates for reimbursement systems which promote and reward quality patient care. We support CMS in its continued implementation of the value-based payment modifier required under the Affordable Care Act, and appreciate the methodical approach CMS has taken in introducing value-based elements into the cost-based Medicare reimbursement system; such an approach has allowed physicians to slowly adapt to reimbursement changes over a period of years. For 2016, CMS has proposed a downward 2 percent adjustment for physicians who fail to report Physician Quality Reporting System (PQRS) data. In addition, CMS has proposed narrowing the options for PQRS submission by eliminating the claims-based option. REAP urges CMS to retain the claims-based submission option. While we understand that most larger physician groups are able to submit PQRS data through the Registry, Electronic Health Records or Group Practice options, many smaller, rural practices that are less technologically advanced cannot and do not employ such options. Absent the 6 See the description of yearly wellness visits on medicare.gov at a personalized yearly-wellness-exams.html (explaining that annual wellness visits are aimed at developing or updating prevention plan for a given patient to prevent disease and disability based on the patient s current health and risk factors. The annual wellness visit includes: a review of a patient s medical and family history; developing or updating of the patient s list of current providers and prescriptions; height, weight, blood pressure, and other routine measurements; detection of any cognitive impairment; personalized health advice; a discussion of risk factors and treatment options for the given patient; and a screening schedule for appropriate preventive services).

6 claims-based submission process, such smaller, rural physicians practices will not be able to submit PQRS data and will receive a 2 percent reduction in Medicare reimbursement. REAP members are concerned that smaller, accumulating decreases in Medicare reimbursement can result in beneficiary access issues with many physicians offices choosing to close completely or consolidate with hospital systems in the face of such declining reimbursement or simply cease accepting Medicare patients. CMS has proposed basing the 2016 value-based payment modifier adjustment on PQRS data submitted 2 years prior. In other words, the 2016 value-based payment would be based on PQRS data submitted for the 2014 calendar year. REAP urges CMS to attempt to reduce the 2-year lag between PQRS data collection and the use of such data in establishing the value-based modifier adjustment for physicians. A lag between PQRS data measurement and the resulting payment adjustment does not reward improvements in quality of care made by physicians practices during the current year. Furthermore, with physicians facing a 4 percent decrease in Medicare reimbursement across the board due to sequestration beginning in 2014, the provision of a 2 percent value-based modifier payment is more critical than ever. Physicians should be entitled to such 2 percent payments if their current PQRS measures evidence the provision of quality of care to patients. Lastly, CMS has proposed (1) allowing physicians to include patient experience data collected via the voluntary Clinical and Group Consumer Assistance of Healthcare Providers and Systems (CG-CAHPS) survey in their PQRS data and (2) including efficiency measures focused on total Medicare spending per beneficiary into the PQRS data. REAP members believe a positive patient experience is indicative of quality healthcare and commend CMS for proposing to include patient experience measures into the PQRS data. REAP urges CMS to continue exploring means of further incorporating patient experience into the value-based payment modifier system. Proposals focused on transparency in Medicare coverage and quality of care provided The Physician Compare Website REAP members are excited to see that, under the Proposed Rule, CMS continues to expand the types of physician-specific data that CMS will make publicly available on the Physician Compare Website. Furthermore, CMS has proposed publishing such data for small and large physicians practices alike. 7 REAP members value and support patient choice as to the selection of their health care providers. The publication of data regarding outcomes, quality of care and patient experiences with health care providers, including physicians, is useful to health care consumers generally in the comparison and selection of a health care provider. We commend CMS for making such data available to the public at large and not just the Medicare population, and we urge CMS to ensure that all data published on the Physician Compare Website is fair, accurate, impartial and presented in plain English at a 6 th grade reading level. We also recommend that the Website be designed to automatically translate into languages other than English which are commonly spoken throughout the United States, such as Spanish, for use by those with limited English proficiency. We recommend that CMS utilize the 5 percent threshold as it does for Medicare Part D plan marketing materials when determining a language commonly spoken throughout the United States. 8 In addition, as not all physicians report on the same 7 In the Proposed Rule, CMS proposes to expand the publication of the Physician Quality Reporting System (PQRS) data for physicians group practices that not only report via the Group Practice Reporting Option (GPRO) but also through the Registry or EHR reporting options. The result will be the publication of PQRS data for a smaller physician practices in addition to large group practices. 8 See Chapter 2 of the Medicare Prescription Drug Benefit Manual Section

7 PQRS measures, consumers might misinterpret the absence of certain PQRS measures or patient experience data generally for a given physician as a negative outcome or review of such physician. We recommend that CMS include clear explanations for such unreported measures so that consumers will understand that the absence of a reported measure is not indicative of negative performance. We further encourage CMS to ensure that information published on the Physician Compare Website be in a simple format, easy to navigate and unencumbered with graphics that will slow down Internet operations so consumers will be able to view such information on smartphones or other mobile devices, which are often utilized by lower-income individuals as personal computers. ********* Again, we appreciate the opportunity to share our perspective on the Proposed Rule with you. REAP members stand ready to answer questions and provide any additional information about the patient groups for whom we advocate. Sincerely, Alpha-1 Association Alpha-1 Foundation American Kidney Fund Cancer Support Community C-Change COPD Foundation Cutaneous Lymphoma Foundation Epilepsy Foundation HealthHIV Kidney Cancer Association Leukemia & Lymphoma Society LUNGevity Foundation National Osteoporosis Foundation National Patient Advocate Foundation Prevent Cancer Foundation Retiresafe Sisters Network Susan G. Komen for the Cure Us TOO International Prostate Cancer Education and Support Network Zero - The Project to End Prostate Cancer

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