RE: CMS-1677-P; Medicare Program; Request for Information on CMS Flexibilities and Efficiencies

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1 June 13, 2017 Ms. Seema Verma Administrator Centers for Medicare and Medicaid Services Department of Health and Human Services Attention: CMS-1677-P P.O. Box 8011 Baltimore, MD RE: CMS-1677-P; Medicare Program; Request for Information on CMS Flexibilities and Efficiencies Dear Ms. Verma: The American College of Rheumatology (ACR) represents over 9,500 rheumatologists and health professionals. Rheumatologists provide ongoing care for over 50 million Americans with complex chronic and acute conditions that require specialized expertise. We appreciate the opportunity to provide input on the Centers for Medicare and Medicaid Services Request for Information on CMS Flexibilities and Efficiencies. Rheumatologists provide face-to-face, primarily non-procedure-based care, and serve patients with serious conditions that can be difficult to diagnose and treat, including rheumatoid arthritis (RA), systemic lupus erythematosus, and other debilitating diseases. Early and appropriate treatment by rheumatologists slows disease progression, improves patient outcomes, and reduces the need for costly downstream procedures and care that is complicated and made more expensive by advanced disease states. The ACR is dedicated to ensuring that our providers have the resources they need to work with CMS and to provide patients with high-quality care. We believe that for CMS, clinicians, and patients to all achieve their objectives, payment programs must be designed to reflect the way practices treat patients. Please find our ideas for regulatory, sub-regulatory, policy, practice, and procedural changes. E/M Documentation and E/M Code Deficiencies We believe revising the current medical documentation guidelines for Medicare s evaluation and management (E/M) codes offers the ideal opportunity to both provide an immediate and substantial reduction of administrative burden for all practicing physicians and address longstanding deficiencies in the relative value of these services. The deficiencies in the E/M code definitions and valuations used to establish the relative pricing of these services under the resource-based relative value scale (RBRVS) of the PFS will distort all payment reforms currently in discussion across the full political spectrum. WDC v1

2 These out-of-date 1995/97 E/M documentation expectations fail to capture the cognitively intense patient care work of the services delivered by rheumatologists. We believe there are four necessary steps that CMS must take to ensure the accuracy and reliability of physician payment for all E/M services 1. Commission research, administered by the CMS, to accurately describe the full range of E/M (cognitive) physician services; 2. Use this knowledge-base to develop new E/M service codes that accurately and discretely capture the purely cognitive patient care delivered by physicians; 3. Ensure the appropriate relative valuations for the E/M service codes; and 4. Establish documentation expectations for these new service codes that are appropriate in the context of current health information technology. MACRA Merit-based Incentive Payment System (MIPS) The ACR believes CMS should establish a more gradual transition period. The Medicare Access and CHIP Reauthorization Act (MACRA) provides flexibility to the Centers for Medicare & Medicaid Services (CMS) in how it structures the MIPS program for 2017 and CMS has limited this flexibility to 2017 without providing guidance for what will occur in future program years. CMS should take advantage of this flexibility and adopt a similar transition year for 2018 to allow physicians to become more familiar with the program and keep program requirements stable. Further, CMS can set the MIPS performance score threshold to promote successful participation by ensuring a greater number of physicians are held harmless from penalties. Specifically, the agency should be flexible about the data used to set performance and should maintain a substantial low-volume threshold that exempts physicians with few Medicare patients or little revenue. We also encourage CMS to simplify MIPS Scoring. The MIPS program establishes a complex scoring system that requires physicians to understand numerous point systems, benchmarks, thresholds, case volumes and other calculations to determine their performance. To avoid creating confusion, CMS could simplify the scoring in a number of ways, including defining what must be reported to avoid a penalty, earn a bonus and earn a maximum incentive payment (similar to the approach taken in pick-your-pace) and harmonizing the scoring requirements across MIPS categories. CMS should also consider developing tools that physicians could use to help predict their score with examples tailored to the type of practice and specialty. Regarding MIPS scoring, several providers report the requirements of counting patient portal use is very onerous on small practices that serve older populations in rural, poorer areas. We recommend CMS explore the patient portal requirements and how they may adversely affect those who serve patients with limited or non-existent access to the

3 internet, computers, or advanced technology. Lastly, physicians should receive timely feedback so that they can assess their performance and plan for future reporting periods. Quality We strongly encourage CMS to maintain the reporting thresholds within MACRA. The 2016 MACRA Final Rule increased the thresholds for reporting on quality measures from 50 percent of Medicare Part B patients to 60 percent of all patients starting in 2018 and indicates increased thresholds in future programs year. Instead of increasing the thresholds, we urge CMS to reduce the reporting burden and maintain the threshold at 50 percent. Also we believe at a minimum CMS should maintain a 90-day reporting period which would allow physicians flexibility to report for 90-days to a full year in order to receive full credit for reporting a measure under the quality performance category. We are also concerned that the number of required quality measures is administratively burdensome. We recommend CMS reduce the number of required measures from six to three. Additionally, we recommend CMS allow specialties to exercise flexibility and innovation in Qualified Clinical Data Registries (QCDRs). Specialties are spending millions of dollars to improve the quality of care for Medicare beneficiaries by creating QCDRs. CMS requirements for QCDRs, however, are making the registries less innovative and meaningful. CMS should allow QCDRs to adopt measures that vary from those in PQRS in order to provide meaningful measurement for physicians in all specialties. Specialty societies should also have the opportunity to determine when a measure is relevant to their specialty. Frequently physicians are required to report on measures that are arbitrary and are not clinically relevant to their practice. CMS should collaborate with the ACR and other medical groups to develop a process to replace the Measures Applicability Validation process which accurately evaluates whether a physician should be required to report certain measures. Alternative Payment Models (APMs) The ACR would like CMS to increase opportunities for physicians to succeed in MACRA through APM participation. There are few APMs that CMS counts as MIPS APMs, which compounds the problem of having so few Advanced APMs. Physicians participating in models like Bundled Payments for Care Improvement and Independence at Home should be able to use their participation for IA credit in MIPS. We also believe APM startup fees should qualify as enough financial risk for an APM to be qualified. Further, CMS should adopt physician-focused APMs. With the right data, physicians can see where the best opportunities are to improve the delivery of care and reduce avoidable spending. We suggest CMS consider reducing burdens to be considered a qualifying participant (according to payment amount method or patient count method) for physician focused APMs that will apply to specialty practices such as rheumatology. These APMs will be inherently different from ACOs, therefore using the same methods to determine qualifying participants is not adequate. We welcome the opportunity to work with CMS and the Physician-focused Payment Models advisory committee (PTAC) to implement

4 physician-focused APMs, including providing technical assistance and data, and allowing small numbers of practices to pilot innovative models. Interoperability We have concerns around EHR transparency and costs. Physicians have made significant investments in their EHRs, yet vendors often require additional, yearly fees to connect those EHRs to registries, information exchanges, and public health agencies. The Office of the National Coordinator for Health Information Technology (ONC) already requires vendors to state extra charges may be required; however, the dollar figures are not made public. Most EHR vendors overly generalize costs and are not upfront with physicians when selling their products. This drastically affects small and solo physician offices. These fees are often both a surprise and overly excessive acting as a roadblock to the exchange of vital patient data while limiting the interoperability between EHRs. We recommend that vendors seeking ONC certification should publically provide detailed examples of fees (including dollar figures) typically charged to physicians to enable data sharing. Vendor data blocking is also of concern. CMS implementation of MACRA requires physicians to attest to a multipart attestation on data blocking, vendors currently do not face any limits on data-blocking activities. In the vast majority of cases, the vendors implement cost, technical, or contractual limitations to block the flow of patient data. We ask that ONC take immediate actions to implement a vendor data-blocking attestation requirement as part of all current and future health information technology certification editions. Further, ONC should refocus its certification program to test and validate an EHR's ability to conform to features, functions, and capabilities described and sold by the vendor and should reflect the real-world needs of patient care. NON-QPP Regulatory Relief Items Prior Authorization and Utilization Management According to a recent AMA survey of 1000 practicing physicians, a medical practice completes an average of 37 prior authorization (PA) requirements weekly per physician, taking a physician and their staff an average of 16 hours, or the equivalent of two business days, to process i. We believe this is a waste of valuable resources that results in delays in care. Several organizations representing physicians, hospitals, pharmacists, medical groups, and patients have endorsed 21 Prior Authorization and Utilization Management Reform Principles that are intended to serve as best practices and reasonable reforms for utilization management (UM) programs. The ACR urges all entities engaged in UM including the Center for Medicare and Medicaid Services (CMS) to follow these principles. Recommendations: CMS should require Part D plans to accept and respond to pharmacy PA and step therapy over-ride requests through the NCPDP electronic PA transactions;

5 CMS should accelerate automation of medical services PA by (a) issuing a rule for an electronic clinical attachment standard and (b) enforcing health plan compliance with the X12 278; CMS should ensure that all UM requirements are based on accurate and up-to-date, publicly available clinical criteria and never cost alone; CMS should require all MA and Part D plans to publicly disclose to both patients and physicians in a searchable electronic format all drugs and medical services that are subject to coverage restrictions (PA, step therapy, formulary restrictions, quantity limits) and provide this information to vendors to be displayed in electronic health record systems; CMS should require a 60-day grace period for UM requirements when a patient changes MA and Part D plans, align PA approvals with the duration of the prescribed/ordered treatment, and prohibit plans from requiring patients to retry therapies failed under previous plans; MA and Part D plans should abide by PA decisions and pay for any services approved in a PA request by performing eligibility and all other medical policy coverage determinations as part of the PA process and not revoking or restricting coverage for authorized care provided within 45 business days from the date the authorization was received; Except where there is evidence of widespread misuse, PA should not be required for drugs that are standard treatment for the patient s condition and/or have been previously approved for treatment of an ongoing/chronic condition. CMS should ensure that any peer-to-peer reviews utilize physicians from the same specialty/subspecialty as the ordering physician; CMS should restrict PA requirements to outlier providers whose prescribing or ordering patterns differ significantly from their peers after adjusting for patient mix; In conclusion, lessening the administrative burden on providers will allow them to focus on medical decision-making, the prioritization care, careful resource allocation, and result in an improved, more efficient healthcare system. We applaud CMS for creating the opportunity to provide public feedback on reducing administrative burden. If you require any additional information, please contact Kayla L. Amodeo, Ph.D., Director of Regulatory Affairs, at kamodeo@rheumatology.org or (202) Sincerely, Sharad Lakhanpal, MBBS, MD President, American College of Rheumatology i