September 6, Submitted electronically via:

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1 September 6, 2016 Submitted electronically via: Andrew M. Slavitt Acting Administrator Centers for Medicare and Medicaid Services Attention: CMS 1654 P 7500 Security Boulevard P.O. Box 8013 Baltimore, MD Re: Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Pricing Data Release; Medicare Advantage and Part D Medical Low Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model (CMS-1654-P) Dear Acting Administrator Slavitt: The CardioVascular Coalition (CVC) is pleased to offer its comments to the Centers for Medicare and Medicaid Services (CMS) on the Proposed Rule: CMS 1654 P, Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Pricing Data Release; Medicare Advantage and Part D Medical Low Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model. 1 The CVC was established to provide policymakers and the public with a greater understanding of the value that freestanding cardiovascular centers (CVCs) bring to their patients, and of the importance of logical, predictable payments to align incentives and ensure patient access to quality vascular care. The CVC is comprised of 255 freestanding centers and affiliated physicians and staff in 32 states, and represents more than one-third of the sector. 2 CVC members include providers (Fresenius Vascular Care, Lifeline Vascular Care, National Cardiovascular Partners, and the Outpatient Endovascular and Interventional Society) and manufacturers (Cardiovascular Systems, Inc. and Avinger). Background One of the key Medicare patient populations treated in CVCs are those patients with peripheral artery disease (PAD). PAD typically involves atherosclerosis, or the build-up of plaque inside the arteries of a patient s legs. It is estimated that 18 million persons in the United States have PAD. 3 Total annual costs associated with the hospitalization of patients with PAD in the United 1 Federal Register, 81 FR (July 15, 2016) 2 For more information about the CVC, please see 3 The Sage Group, Critical Limb Ischemia, Volume I, United States Epidemiology,

2 States are estimated to be in excess of $21 billion, and are projected to rise as the population ages. 4 CVCs focus on providing revascularization, a proven technique to restore blood flow in a patient s legs that may, in certain patients, serve as an alternative to amputation of the limb. Improvements in technology have allowed for the migration of revascularization services from the hospital setting to same-day interventions in the office setting. 5 Care in community-based, freestanding CVCs focuses on providing revascularization with minimally invasive techniques, and offers a costefficient, patient-preferred alternative site of care for patients. 6 Key revascularization service codes are included in Table I below. Table I - Key CPT Codes for PAD (Iliac revasc) (Iliac revasc w/stent) (Iliac revasc add-on) (Iliac revasc w/stent add-on) (Fem/popl revas w/tla) (Fem/popl revas w/ather) (Fem/popl revasc w/stent) (Fem/popl revasc stnt & ather) (Tib/per revasc w/tla) (Tib/per revasc w/ather) (Tib/per revasc w/stent) (Tib/per revasc stent & ather) (Tib/per revasc add-on) (Tibper revasc w/ather addon) (Revsc opn/prq tib/pero stent) (Tib/per revasc stnt & ather) Unfortunately, significant variation still exists in the provision of vascular care to patients in the year before major amputation. 7 As a result, racial and ethnic disparities in amputation rates for patients with PAD are substantial. African-Americans are about twice as likely to be amputated as Caucasians, and Hispanics are 50-75% more likely to be amputated. As the population ages and comorbidities rise, these disparities may accelerate unless access to assessment as candidates for revascularization rather than amputation among minorities improves. 8 This letter will comment on the following issues: Overview of the CY 2017 Physician Fee Schedule Proposed Rule Conversion Factor / Elimination of the Physician Payment Increase Moderate Sedation PACS Workstation Prevention of Amputations in PAD Patients CMS Refinement Panel 4 Kullo, Iftikhar J., and Thom W. Rooke. "Peripheral Artery Disease." New England Journal of Medicine N Engl J Med (2016): Carr et al., Endovascular Today, May 2016, Vol. 15, No Goodney, P. P., L. L. Travis, B. K. Nallamothu, K. Holman, B. Suckow, P. K. Henke, F. Lee Lucas, D. C. Goodman, J. D. Birkmeyer, and E. S. Fisher. "Variation in the Use of Lower Extremity Vascular Procedures for Critical Limb Ischemia." Circulation: Cardiovascular Quality and Outcomes 5.1 (2011): Web. 8 Cardiovascular Systems Inc., presented at ISPOR 21 st Annual International Meeting, May 21-25, 2016, Washington, DC USA 2

3 Overview of the CY 2016 Physician Fee Schedule Proposed Rule Major changes in the Proposed Rule relate to reductions to services for certain specialties due to the Misvalued Code Initiative. Interventional radiology and independent labs would experience significant decreases while endocrinology and family practice would experience increases. For the three primary specialties involved in the treatment of PAD (cardiology, interventional radiology and vascular surgery), the overall impact from the rule is provided below. Table 2 - Proposed CY 2017 PFS Rule on Total Allowed Charges (By Specialty) Specialty Percent Change Cardiology 1 % Interventional Radiology - 7 % Vascular Surgery - 2% Conversion Factor / Elimination of Physician Payment Increase Pursuant to the Medicare Access and CHIP Reauthorization Act of 2015, Medicare payments to physicians under the Physician Fee Schedule are to be updated by 0.5% for each of the years of 2016 through In the proposed rule, CMS proposes to create a new add-on code that could be billed with E/M codes for physicians treating people with mobility-related impairments. This proposal is funded with an across-the-board cut in payment rates which eliminates the 0.5% legislated update for While the CVC supports improving access to care for patients with mobility impairments, we urge CMS to utilize alternative approaches which will not increase out-of-pocket costs for patients with mobility impairments or undercut the intention of Congress to provide a payment update for physicians in Impact of Moderate Sedation Policy on Revascularization Services In the proposed rule, CMS notes it believes anesthesia services are increasingly being separately reported for endoscopic procedures, meaning that resource costs associated with sedation were no longer incurred by the practitioner reporting the procedure. Consequently, CMS is proposing (1) values for new moderate sedation codes and (2) a uniform methodology for valuation of the procedural codes that currently include moderate sedation as an inherent part of the procedure. Appendix G of the American Medical Association (AMA) CPT manual identified more than 400 procedures for which the CPT Editorial Committee has determined that moderate sedation is an inherent part of furnishing the procedure, including revascularization services. CMS further notes (in cases other than gastrointestinal services) practitioners should report moderate sedation using one of the new moderate sedation CPT codes. New moderate sedation codes billable in the nonfacility setting include 991X1 (moderate sedation services for patients 3

4 younger than 5 years old), 991X2 (moderate sedation services for patients age 5 years old or older) and 991X5 (each additional 15 minutes of moderate sedation intraservice time). CMS notes in the proposed rule that it believes RVUs assigned under the PFS should reflect the overall resource costs of PFS services, regardless of how many codes are used to report the services. Therefore, our proposed methodology for valuation of Appendix G procedural services would maintain current resource assumptions for the procedures when furnished with moderate sedation. It is in this light that we urge CMS to clarify with Medicare Administrative Contractors that moderate sedation services are billable separately from the underlying service in the case of revascularization and other Appendix G services. PACS Workstation In the proposed rule, CMS proposes to include a new Professional (Picture Archiving and Communication System) PACS Workstation (ED053) in addition to the current technical PACS workstation (ED050) for many codes in the CPT series. In addition to the workstation used by the clinical staff acquiring the images and furnishing the TC of services using digital imaging, CMS also accepted pricing information regarding a workstation used by the practitioner interpreting the image in furnishing the PC of many of these services. CMS requests comment on whether a professional workstation should be included for codes outside the series. We note that the current technical PACS workstation (ED050) is included for all of the revascularization and stent codes represented by the to series. We believe a professional PACS workstation should be added to this series as well. The currently included technical PACS workstation is utilized on a routine basis by technical staff for revascularization services. These staff must have full-time access to the PACS systems and are in locations separate from clinical spaces used by physicians. While physicians certainly have access to computer screens which they utilize routinely for review of electronic health records and static images such as single simulation films, these screens are inadequate for review of threedimensional volume images developed for revascularization, which involve visualization of images though large sections of the body, employing a number of individual images. The volume of images requires use of multiple screens available only on modern PACS systems. Shared used of these devices by multiple staff members is not practical. Based on the above rationale, the CVC requests CMS to add a professional PACS workstation to the to series. Prevention of Amputations in PAD Patients A key focus of the CVC is the utilization of appropriate vascular interventions to prevent nontraumatic amputations in patients. If untreated, PAD can lead to critical limb ischemia (CLI), a condition frequently associated with lower limb amputations. Data suggest that the increased use of vascular care procedures can be associated with lower rates of amputations. A recent study of more than 1 million Medicare patients with CLI found that proper intervention reduced the odds of 4

5 amputation by 90%. 9 Increased access to interventions appears to have resulted in a reduction of lower extremity amputations for people with severe lower extremity PAD in the United States. From , the rate of lower limb amputations among Medicare patients in the US decreased by 45%, including a 48% decrease in the rate of above-knee amputations and a 39% decrease in the rate of below-knee amputations. 10 Lowering the incidence of non-traumatic amputations through clinically appropriate intervention has the potential to reduce healthcare spending, particularly Medicare expenditures. As noted above, a 2016 study in the New England Journal of Medicine noted that the total annual costs associated with the hospitalization of patients with PAD are estimated to be in excess of $21 billion. Much of hospitalization costs for patients with PAD relate to amputations, and Medicare is the largest payer of major amputations in the U.S., paying for 66% of procedures in In addition, interventions that ultimately result in limb preservation offer the best possible clinical outcome. When comparing patient amputees vs. those whose limbs were preserved, data show intervention produces positive results. Limb Preservation 12 Amputation 13 The 2-year mortality rate is 16% to 24% Almost two-thirds of patients are routinely discharged home Fewer than 20% of patients are discharged to a nursing home At 2 years, 80% are walking and almost 90% are living independently Data suggest patients who experience limb preservation have higher quality of life The one-year mortality rate for patients over 65 years old is 48% and the 3-year mortality rate is 71% Only 18% to 24% of patients are routinely discharged home A majority of patients (70%) go to another institution (a nursing home, rehabilitation facility) Sixty percent to 80% are unable to walk again One-third or more of patients experience depression, and in some, severe depression Unfortunately, studies show vascular diagnostics are underutilized notwithstanding the proven benefit of revascularization in amputation-free survival and quality of life. 14 Vemulapalli et al. found overall arterial testing rate of 68.4% prior to amputation, including a rate of preamputation testing with ankle brachial indices (ABI) of only 47.5% (notwithstanding PAD guidelines recommend ABI as part of initial management of patients undergoing amputation), and angiography rates of only 38.7% (invasive angiography), 5.6% (MR angiography), and 6.7% (CT angiography) 15 9 Yost, Mary. Cost-Benefit Analysis of Critical Limb Ischemia in the Era of the ACA, May JAMA Surgery, Fifteen-Year Trends in Lower Limb Amputation, Revascularization, and Preventative Measures Among Medicare Patients, January Yost ML. The economic cost of dysvascular amputation. Atlanta (GA): The Sage Group. In press. 12 Yost, Mary. Cost-Benefit Analysis of Critical Limb Ischemia in the Era of the ACA, May Vemulapalli et al., Circ Cardiovasc Qual Outcomes. 2014; 7:

6 Perhaps as a result of this underutilization of vascular diagnostics, the CVC notes that there are still almost 43,000 Medicare patients per year receiving non-traumatic amputations, with one-third of those patients receiving multiple amputations in the same year. 16 Medicare spending on CLI patients with major amputations averages $90,000, while Medicare spending on CLI patients who undergo revascularization and subsequently do not require an amputation is almost 40% less (around $58,000). 17 According to Avalere Health, policies that would encourage revascularization rather than a major amputation for Medicare patients could reduce Medicare spending by up to $2 billion over 10 years. 18 Further underscoring this point is the significant variation in care for CLI patients in Medicare. Specifically, revascularizations and amputations for CLI are performed by a wide range of providers, including vascular surgeons, cardiologists, interventional radiologists, general surgeons, and orthopedic surgeons as seen in the table below. 19 % of all events with CLI diagnosis performed by specialty Specialty Revascularization Amputation, any Other Care Vascular Surgery 49.2% 17.6% 16.7% Cardiology 15.7% 0.9% 7.3% General Surgery 13.4% 15.8% 9.1% Interventional 2.6% 0.0% 0.5% Radiology Orthopedic Surgery 0.1% 13.2% 0.9% Podiatry 0.0% 20.8% 15.1% As the table notes, some providers tend towards revascularization (interventional cardiologists and radiologists), others perform or are associated with a mix of revascularization and amputations (vascular surgeons and general surgeons), and others almost exclusively perform amputations (podiatrists and orthopedic surgeons). It is important for CMS to adopt policies that would require vascular diagnostics to determine if a patient is a candidate for revascularization prior to major, non-traumatic amputation being performed. Such a forward-thinking policy change could help to avoid variation in clinical assessment and treatment of CLI patients among specialties. It is inappropriate for important decisions to be based simply on the type of physician the patient sees, or to which they are referred. It is for these reasons that we believe a new high priority quality measure should be developed relating to amputation prevention in patients with PAD. CMS Refinement Panel In the CY 1993 PFS final rule, Medicare adopted a Refinement Panel process to assist in reviewing the public comments on CPT codes with interim final work RVUs for a year and in developing 16 Avalere Health, May 2015 analysis of CY Medicare claims Avalere Health, June 2015 analysis of CY Medicare claims 6

7 final work values for the subsequent year. The panel was composed of a multispecialty group of physicians who would review and discuss the work involved in each procedure under review, and then each panel member would individually rate the work of the procedure. Since that time, CMS has convened the Refinement Panel to carefully review public comments, hear testimony from practicing physicians and independently recommend refinements to relative values. Unfortunately, in the CY 2016 PFS, CMS effectively eliminated the Refinement Panel process. Absent any independent mechanism for appeal, the Agency is free to make valuation decisions without having to provide a compelling rationale when rejecting relative value recommendations from the RUC and other stakeholders. The CVC believes the original Refinement Panel process provides an effective mechanism to utilize the expertise from physicians and other stakeholders to determine the resources utilized in the provision of a service to a Medicare beneficiary. We are hopeful that CMS will return to a Refinement Panel process that is fair to physicians and the patients that they serve. Conclusion CVC s comments on the Physician Fee Schedule regulations seek to ensure ongoing access to high-quality, state-of-the-art freestanding centers. CVCs provide an integral service in the overall healthcare continuum. These places of service are an important part of patient access to care and their survival depends on a balanced approach to reimbursement for their services. We hope that our comments highlight our sincere interest in continuing to provide cost-avoiding CVC services that are fairly reimbursed and readily accessible to Medicare patients. We look forward to continuing to work with CMS to guarantee quality cardiovascular services are provided by our centers to every Medicare patient. If you have additional questions regarding these matters and the views of the CVC, please contact Jason McKitrick at (202)