Federal Update Issues Impacting Rheumatologists and their Patients. Emily L. Graham, RHIA, CCS-P VP, Regulatory Affairs Hart Health Strategies, Inc.

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1 Federal Update Issues Impacting Rheumatologists and their Patients Emily L. Graham, RHIA, CCS-P VP, Regulatory Affairs Hart Health Strategies, Inc.

2 Just a spoon full of DC?

3 Agenda MACRA & Rheumatology 2018 MPFS Proposals MedPAC & PBMs Red Tape Relief Project Other Regulatory Issues

4 MACRA & Rheumatology

5 MACRA Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) Enacted into law on April 16, 2015 Repealed the flawed Sustainable Growth Rate (SGR) formula! Established a two-track Medicare physician payment system Merit-Based Incentive Payment System (MIPS) Alternative Payment Models (APMs) Framework for these two programs is known as the Quality Payment Program MACRA QPP MIPS APMs

6 MACRA Payment Adjustments MPFS Updates % MPFS Update % MPFS Update 2026 & Beyond 0.25% or 0.75% MPFS Update MIPS Adjustment Current Programs % TO +4% (3x) + min 0.5% TO 10% % TO +5% (3x) + min. 0.5% TO 10% % TO +7% (3x) + min. 0.5% TO 10% 2022 & Beyond -9% TO +9% (3x) + min. 0.5% TO 10% APM Bonus Exceptional Performance Adjustment % bonus 2025 & Beyond no bonus

7 MIPS Year 1 Participation & Rheumatology While more than half of clinicians approximately 738,000 to 780,000 billing under the Medicare PFS will be excluded from MIPS, most Rheumatologists will be subject to MIPS Specialty Rheumatology (5,629) Newly- Enrolled 208 (3.7%) Qualifying APM Participant Status 79 (1.4 %) Low- Volume 841 (14.9%) Total Exclusions 1,128 (20%) Total Inclusions 4,501 (80%) Source: CMS MIPS/APMs Final Rule Table 58: MIPS EXCLUSIONS BY REASON AND SPECIALTY FOR MIPS TRANSITION YEAR

8 MIPS Year 1 Snapshot MIPS Year 1 Snapshot Quality (60%; 60 pts) Report 6 quality measures, including one outcome/high priority measure, for a minimum of 90 days (or a specialty measure set) Bonus points for reporting high priority measures 3-point floor for all submitted quality measures CMS will only count the top 6 reported measures toward quality score Improvement Activities (15%; 40 pts) Attest that you completed up to 4 improvement activities for a minimum of 90 continuous days* Activities are weighted high (20 pts) and medium (10 pts) CMS doubled the points for small practices* If at least one clinician in the group performs the activity, the entire group may count it Advancing Care Information (ACI) (25%; 155 pts/ 100 pts) Fulfill required measures for a minimum of 90 consecutive days (BASE 50%) Submit up to 9 measures for additional credit (PERFORMANCE 90%) Bonus points available 5%) Cost (0%; 0 pts) Calculated from claims data; no additional submissions required * 15 or fewer and solo s

9 Exceptional performance threshold set at 70 points MIPS Year 1 Transition Policies Source: CMS QPP Web site Performance threshold set at 3 points

10 From the MACRA statute: Application of MIPS adjustment factors.--in the case of items and services furnished by a MIPS eligible professional during a year (beginning with 2019), the amount otherwise paid under this part MIPS Adjustment & Part B Drugs Clarification in the 2018 QPP Proposed Rule: For Part B items and services furnished by a MIPS eligible clinician such as purchasing and administering Part B drugs that are billed by the MIPS eligible clinician, such items and services may be subject to MIPS adjustment based on the MIPS eligible clinician s performance during the applicable performance period or included for eligibility determinations. For those billed Medicare Part B allowable charges relating to the purchasing and administration of Part B drugs that we are able to associate with a MIPS eligible clinician at an NPI level, such items and services furnished by the MIPS eligible clinician would be included for purposes of applying the MIPS payment adjustment or making eligibility determinations

11 MIPS Year 2: Proposals More clinicians will be exempt from MIPS CMS proposes to increase the low-volume threshold exempt individuals or groups with fewer than $90,000 in Part B charges or 200 Part B patients (up from $30,000 and 100 patients in Year 1) This means 63% of all Medicare clinicians will be exempt from MIPS in 2018 Pick your pace will continue in Year 2 with modifications CMS proposes to maintain the 3-point floor for quality measures (in most instances) CMS proposes to increase the MIPS performance threshold from three to 15 Cost will continue to be held at 0% of the final score

12 MIPS Year 2: Proposals Use of 2015 Edition CEHRT is optional in 2018, with the option for bonus points for those who do upgrade their systems Small practices may be exempt from MIPS ACI under new significant hardship exemptions authorized under 21 st Century Cures Only 90-days of reporting for the ACI performance category will be required in 2018 and 2019 Virtual groups will be offered as a new way for practices to participate in MIPS Reporting can be accomplished through multiple mechanism with the ACI, quality and improvement activities categories to meet program requirements

13 MIPS Year 2 Impact on Rheumatology Measure Set Addition of: Measure #24: Communication with the Physician or Other Clinician Managing On-going Care Post- Fracture for Men and Women Aged 50 Years and Older Measure #39: Screening for Osteoporosis for Women Aged Years of Age Measure #110: Preventive Care and Screening: Influenza Immunization Measure #111: Pneumonia Vaccination Status for Older Adults Measure #236: Controlling High Blood Pressure Measure #238: Use of High-Risk Medications in the Elderly Removal of: Measure #337: Tuberculosis (TB) Prevention for Psoriasis, Psoriatic Arthritis and Rheumatoid Arthritis Patients on a Biological Immune Response Modifier

14 MIPS Year 2 Impact on Rheumatology In 2018, approximately 37 percent of 1,548,022 Medicare clinicians billing to Part B will be included in MIPS, which includes a majority of rheumatologists Number of MIPS eligible clinicians by specialty Rheumatology (3,340) % engaging with quality reporting % w/ + or null payment adj. % w/ exp. payment adj. % w/ - payment adj. 95% 95.5% 80.5% 4.5% Source: CMS 2018 QPP Proposed Rule Table 87

15 2018 QPP Comments Oppose inclusion of Part B drugs in MIPS payment adjustment Maintain rheumatology specialty measure set Maintain 0% cost weight in 2018; reweight cost category to 0% for rheumatology in 2019 or until appropriate episode-based measures are available Finalize FRAX tool as standalone IA or under different IA subcategory Support of Alliance of Specialty Medicine Comments

16 MedPAC Policy Considerations related to MACRA MACRA Policy Considerations Revise the MIPS program Eliminate clinician measure reporting Use a uniform set of CMS-calculated outcome and patient experience measures to assess clinicians at an aggregate level CMS-defined referral area or cliniciandefined virtual group All clinicians contribute to quality pool (e.g., 1% withhold) Withhold returned for joining Advanced APM; Do nothing and lose withhold Rebalance from MIPS toward Advanced APMs Limit potential upside in MIPS Remove 5% incentive payment cliff No threshold; incentive would be proportional to AAPM involvement Use $500M exceptional performance bonus to encourage 2-sided ACOs Improve payment for PCP Upfront payment for PCPs in 2-sided ACOs Future work to address PCP payments

17 Possible MACRA Legislative Reforms Extend Transition Policies Provide Additional Flexibility for Assessing Clinician Performance Increase Availability of Virtual Groups Delay Requirements of 2015 Edition CEHRT Apply MIPS Adjustment to Covered Professional Services Only Reduce Thresholds for Achieving Qualifying APM Participant Status Extend the Availability of APM Incentive Payment Allow Exceptions for the Use of CEHRT

18 2018 MPFS

19 2018 MPFS Comments Concerns about digital radiography incentive program and multiple modifiers; hold harmless from financial and criminal repercussions Oppose reductions in practice expense for MSUS Oppose single J-code for biosimilars Support of Alliance of Specialty Medicine and Cognitive Care Alliance Comments

20 MedPAC & PBMs

21 MedPAC & PBMs Background on PBMs and specialty pharmacies Specialty drugs will increasingly drive growth in drug spending (Part A and B) Complex transitions and incentives in the drug supply chain for specialty drugs) Potential policy questions for managing specialty drugs in Medicare Exclusive specialty pharmacy networks CMS data transparency requirement Allow MA-PDs to manage specialty drugs under the medical benefit

22 MedPAC & PBMs Commissioner Discussion Complex issue, not well understood, many terms of art Entanglement of financial interests Unclear financial impact on beneficiaries, pass-through of rebates Plans are in control of the benefit, rules, and formularies - not the PBMs Transparency of data remains an issue; PBMs say this is being provided One commissioner: Consolidation can be good, why are we opposed? Specific interest in RA drugs Need to consider other players in the drug supply chain, not just PBMs, specialty pharmacies No mention of non-medical switching, quality of care, or access to medicines

23 Red Tape Relief Project

24 Red Tape Relief Project New initiative by Ways & Means Health Subcommittee Chairman Pat Tiberi (R-OH) Aimed at delivering relief from the regulations and mandates that impede innovation, drive up costs, and ultimately stand in the way of delivering better care for Medicare beneficiaries Three stages: Request feedback Host roundtables Take Congressional action CSRO coordinated a response with the Alliance of Specialty Medicine; submitted individually on MIPS adjustment of Part B drugs

25 Other Regulatory Issues

26 Other Regulatory Issues Cancellation of Episode Payment Models; Modifications to Comprehensive Care for Joint Replacement What does this mean broadly for new payment models? Direction of CMMI? Impending 2019 Notice of Benefit and Payment Parameters Network adequacy in Marketplace plans? Revisions to program integrity programs Targeted Probe and Educate to replace original Medicare review 30-day waiting period before sending claims for adjustment; may allow providers to appeal, resubmit claims ZPICs move under UPICs FDA efforts to comply with EO 13771, Reducing Regulation and Controlling Regulatory Costs, and EO 13777, Enforcing the Regulatory Reform Agenda Seeking comments from stakeholders to identify regulations that could be modified, repealed or replaced to achieve meaningful burden reduction

27 Thank you!