NASL LEGISLATIVE & REGULATORY UPDATE

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1 September 2014 October 2015 KEY ACHIEVEMENT IN QUALITY IMPROVEMENT 2015 marks another first in NASL s illustrious 25-year history endorsement of two therapy outcome measures by the National Quality Forum (NQF). NQF s endorsement of mobility and self-care outcomes measures, which were developed jointly by the NASL- AHCA Therapy Outcomes Group, was the result of a sustained, four-year effort to develop reliable, valid quality measures. NASL, which launched this effort under the auspices of the NASL Medical Services Committee in 2011, is proud to note that the two measures align with the Centers for Medicare & Medicaid Services (CMS ) implementation of the Improving Medicare Post-Acute Care Transformation (IMPACT) Act of 2014 (Public Law ). IMPLEMENTATION OF THE IMPACT ACT OF 2014 NASL established a joint workgroup comprised of members of the Information Technology and Medical Services Committees. The workgroup reviewed the IMPACT Act of 2014, which was signed into law during the NASL 25 th Annual Meeting in October The law requires the use of standardized patient assessment instruments by post-acute care providers to afford CMS with patient data that can be compared across the post-acute care settings. The law mandates that post-acute settings begin reporting of quality measures on October 1, 2016, and standardized patient assessment data by October 1, This information is necessary for the development of Medicare Post-Acute Care (PAC) payment reform. The law also significantly impacts CMS ability to expedite the use of data to compare quality, cost and other factors across care settings. NASL co-hosted a webinar with Post-Acute Care Center for Research (PACCR) on August 27, 2015 featuring CMS staff leading efforts to implement the IMPACT Act. NASL IMPACT ACT WORKGROUP NASL IMPACT Act Workgroup Co-Chairs Robert Bob Latz of Trinity Rehab Services and Joanne Wisely of Genesis Rehab Services are leading the association s efforts to prepare for implementation of the Improving Medicare Post-Acute Care Transformation (IMPACT) Act of The newly established Workgroup held a series of conference calls to discuss clarifications needed from CMS with regard to standardized patient assessment data, quality measures, interoperability, risk-adjustment and implementation of the measures expected to begin on October 1, The Workgroup evaluated the measures on the National Quality Forum s (NQF s) Measures Under Consideration (MUC) list and provided comments to the Measure Applications Partnership (MAP), which conducts pre-rulemaking, public comment on its list of recommended measures. In April 2015, members of NASL s IMPACT Act Workgroup spoke extensively with CMS Office of Clinical Standards & Quality regarding challenges, timelines and issues identified by the Workgroup for consideration by CMS as it develops quality measures for implementation of the IMPACT Act. NASL Executive Vice President Cynthia Morton was selected to participate in a Technical Expert Panel that CMS convened on the quality measures, which will be used across all PAC settings as required under the IMPACT Act. Over the summer, the NASL IMPACT Act Workgroup held another series of calls to assist in developing comments for CMS FY2016 Skilled Nursing Facility Prospective Payment System (SNF PPS) Proposed Rule. The group engaged NASL s IT Committee members to garner feedback on interoperability provisions in the proposed rule. As a result, NASL provided very detailed comments to CMS that highlighted potential problems between Section G and Section GG and highlighted inconsistencies that could hurt standardization and the validity of the data collected by CMS.

2 MEDICAL SERVICES COMMITTEE The NASL-AHCA Therapy Outcomes Group completed the development of two outcome measures for rehabilitation services provided in skilled nursing facilities regarding mobility and self-care. AHCA submitted the measures to the National Quality Forum, which endorsed the two quality measures #2612 Mobility and #2613 Self-Care jointly developed by the NASL-AHCA team in July NASL continues regular engagement with CMS and the professional therapy associations to address modifications to the Recovery Auditor (RA) contract, which would allow the current RA process to restart some reviews. In March 2015, NASL hosted a live webinar with CMS Director of the Division of Recovery Audit Operations Brian Elza, PT, DPT, OCS. Director Elza addressed the current situation with the RAs and focused on new procedures for medical review of the 2014 backlogged Part B therapy claims above $3,700. NASL also met with American Speech-Language-Hearing Association (ASHA) representatives to discuss what their members have shared regarding therapist productivity and issues raised in an article, Under Pressure, which was published in the June 2014 edition of the ASHA Leader. Margaret Hemm of Restore Therapy Services co-authored an article with ASHA staff titled, New Information will Separate Fact from Fiction for Clinicians, Managers and Administrators in the May 2015 issue of ASHA Leader. Garry Pezzano, NASL President, led subsequent meetings with leaders and staff from ASHA, APTA and AOTA to discuss and agree upon activities that the organizations can undertake jointly to help get the right information on policy to all therapists and eradicate myths that persist. Margaret Hemm has led this effort for NASL. The Medical Services Committee discussed and developed potential legislative and regulatory options for addressing the HHS Office of Medicare Hearings & Appeals (OMHA) suspension of assignment of requests for Administrative Law Judge (ALJ) hearings. NASL also responded to OMHA s Request for Information to allow public input on its current initiatives to deal with the claims backlog in December NASL continues to participate in the Observation Stay Coalition, joining 20 provider and beneficiary organizations in advocating on Capitol Hill for legislation that would count all hospital days spent under observation toward Medicare s required three-day stay. NASL also met with Hill staff and advocated for the Improving Access to Medicare Coverage Act of 2015 (H.R. 1571, S. 843), which would allow observation stays to count toward the mandatory three-day inpatient status for Medicare coverage of skilled nursing facility (SNF) services. NASL responded to a request from the Senate Finance Committee s Chronic Care Working Group asking stakeholders for solutions to improve outcomes for Medicare patients requiring chronic care. Our May 22, 2015 letter highlighted the value of expanding telehealth, using health information technology (IT) to coordinate care across settings and eliminating the threeday SNF hospital stay. KEY ACHIEVEMENT REPEAL OF THE SGR AND MANUAL MEDICAL REVIEW OF THERAPY CHANGED TO TARGETED REVIEW The Medicare Access & CHIP Reauthorization Act of 2015 (H.R. 2) The Medicare Access & CHIP Reauthorization Act of 2015 (H.R. 2), was signed into law on April 16, The Public Law repeals the Sustainable Growth Rate (SGR) formula for Medicare Part B providers, and replaces it with new incentive programs. A major win in addition to repealing the SGR the Act also replaces the current Manual Medical Review (MMR) process for outpatient therapy with a targeted review process and allows the Secretary of Health & Human Services (HHS) to use five factors to construct the review process. The new law also includes $5 million in funding to be provided in Fiscal Years (FY) 2015 and FY The funds would require that the Recovery Auditors (RAs) not be used for medical reviews. The manual medical review provisions are modeled after the language in the Senate Finance Committee s SGR Reform Bill that was reported out of committee in December Page 2 of 8

3 During Senate floor consideration of H.R. 2, Senator Ben Cardin (D-MD) a longtime champion for repeal of the therapy cap offered an amendment that would repeal the therapy cap. The amendment failed by a narrow margin. MACRA extends the therapy cap exception process for two additional years through December 31, Even so, the agreement on pay-fors crafted by the House Leadership to include paying for only one-third of the bill is largely responsible for the exclusion of a repeal of the therapy caps. Essentially, MACRA moves payments for most providers under the Physician Fee Schedule from a fee-for-service system to a value-based system. At some point, the Secretary of HHS must decide how to expand the incentive program to other providers that are not currently eligible, such as therapists in nursing facilities. At the earliest, therapists that practice in nursing facilities could be under the new system in In terms of payment updates, MACRA applies the following schedule: January 1, 2015 through June 30, 2015: 0.0 percent; July 1, 2015 through December 31, 2015: 0.5 percent; 2016 and each subsequent calendar year through 2019: 0.5 percent; 2020 and each subsequent calendar year through 2025: 0.0 percent. A significant part of the incentive program is for physicians and others who are eligible to earn back a part of the update that they may lose. MACRA also combines existing quality programs, including: the Meaningful Use Incentive Program for Certified Electronic Health Record (EHR) Technology; the Physician Quality Reporting System (PQRS); and the Value-Based Modifier (VBM). These programs will be replaced with the Merit-Based Incentive Payment System (MIPS). THERAPY CAP CAMPAIGN (SGR/DOC FIX) We continued our grassroots campaign advocating for the Medicare Access to Rehabilitation Services Act of 2015 (H.R. 775, S.539), to remove the cap on outpatient therapy and request Congress support for extending the exceptions process until a permanent fix has been enacted. Supporting this bill and asking for additional cosponsors were part of NASL s Hill Day message for the 2015 Winter Legislative & Regulatory Conference. More than 2,600 advocates joined NASL s grassroots campaign to Stop the Therapy Cap. NASL coordinated our efforts with those of the Therapy Cap Coalition and generated more than 14,500 messages to Members of Congress and Hill staff. NASL also supported Senator Ben Cardin (D-MD) in calling for a vote on the therapy cap repeal amendment offered during Senate floor consideration of the Medicare Access & CHIP Reauthorization Act of 2015 (H.R. 2). CPT CODE REFORM WORKGROUP Workgroup members analyzed the CPT proposal and developed comments that were submitted to the American Medical Association (AMA), which maintains the Current Procedural Terminology (CPT) code set. NASL Policy Counsel, Alan Parver, and Elaine Adams of Genesis HealthCare, offered comments on behalf of NASL during the public comment session of the AMA s CPT Editorial Committee meeting in February. Their verbal comments reflected NASL s previously submitted written comments on CPT coding. The Committee approved the proposed evaluation codes, which then moved to the RVS Update Committee (RUC) process that develops values for revised CPT codes. NASL also participated in a meeting with APTA and AOTA, who gathered stakeholders to discuss the codes. MANUAL MEDICAL REVIEW WORKGROUP The Manual Medical Review (MMR) Workgroup assisted with analyzing CMS January 2015 procedures for addressing the MMR backlog of Part B therapy above $3,700 for claims paid from March 1, 2014 to December CMS also approved all four RAs to begin issuing Additional Documentation Requests (ADRs) to providers for MMR of 2014 therapy claims on a post payment basis, through five cycles. The Workgroup also developed comments on the new targeted MMR review process that were conveyed during the June 2015 CMS meeting on the MMR elements included in the law to repeal the Sustainable Growth Rate (SGR), the Medicare Page 3 of 8

4 Access & CHIP Reauthorization (MACRA) Act of 2015 (Public Law ). The law requires CMS to implement a new, targeted review program for Part B outpatient therapy services 90 days after enactment of the bill. CMS has informed NASL that the new procedures will not be ready much before the end of NASL was selected to participate in a study by the General Accountability Office (GAO). NASL shared member experiences with medical review contractors during pre-pay and post-pay reviews for GAO s study on CMS claim review contractors and Medicare post-payment review. TELEHEALTH WORKGROUP NASL established a new workgroup to focus on telehealth initiatives. Chaired by Michael Billings of Infinity Rehab, the Workgroup convened a conference call where Tax & Health Counsel for Representative Mike Thompson (D-CA) Lakecia Foster provided an overview of the Medicare Telehealth Parity Act. The proposal would authorize reimbursement for therapy services in originating sites, and as additional covered telehealth providers. NASL sent a letter of support to the sponsors for the Medicare Telehealth Parity Act that included suggestions for improving the proposal for the 114 th Congress. NASL s Telehealth Workgroup also responded to the Federation of State Boards of Physical Therapy s (FSBT s) request for comments on FSBT s draft document, Telehealth in Physical Therapy: Policy Recommendations for Appropriate Regulations. NASL s letter to the House Energy & Commerce (E&C) Committee s Telehealth Workgroup commented on the Committee s draft legislative proposal on telehealth that was part of the Committee s 21 st Century Cures initiative. Early in the 114 th Congress, NASL sent a letter of endorsement to the sponsors of the Medicare Telehealth Parity Act (H.R.2948), which we are pleased to note includes a few of the improvements recommended by NASL. To become more actively engaged in expanding telehealth, NASL joined the Alliance for Connected Care s Patient & Provider Advisory Board. The group s goal is to create legal and regulatory environments using telehealth technology and remote patient monitoring. MEDICAL PRODUCTS COMMITTEE NASL continued work with other Durable Medical Equipment (DME) industry suppliers on legislative strategies in conjunction with the SGR reform legislation. The Senate Finance Committee s SGR reform bill included an amendment that would require State licensure to gain the right to submit a bid in a state in which the supplier is not currently doing business. It would limit expansion in any single year to no more than two product categories in which the supplier is not currently doing business. NASL endorsed the Medicare Competitive Bidding Improvement Act (S. 148, H.R. 284), which increases transparency and fairness in the Medicare Durable Medical Equipment, Prosthetics, Orthotics & Supplies (DMEPOS) Competitive Bidding Program. We were especially supportive of the provisions that prohibit the Secretary of HHS from accepting a bid unless it meets state licensure requirements for the area for all items in the submitted bid for a product category and establishes requirements for the treatment of successful bidders that do not accept a contract. Additionally, NASL supported the provisions that require the Secretary to obtain a surety bond of between $50,000 and $100,000 for each product category. The Medicare Access & CHIP Reauthorization (MACRA) Act of 2015 (Public Law ) modifies policies in the DMEPOS Competitive Bidding Program to require bid surety bonds and entities submitting bids to meet State licensure requirements applicable within a product category. MACRA also expands the categories of providers permitted to document that a face-to-face encounter with a patient occurred prior to an order being written for DME. On May 27, 2015, the Centers for Medicare & Medicaid Services (CMS) hosted a Special Open Door Forum to discuss eliminating the Certificate of Medical Necessity (CMN) and Durable Medical Equipment Information Forms (DIFs) and opened comment on the issue. CMS noted that the CMN/DIF forms are notoriously unreliable and often conflict with medical Page 4 of 8

5 records. CMS would eliminate the requirement that suppliers collect the data on a CMS-developed form. However, suppliers would be required to collect the required information and submit the data elements on the 837 claim form. CMS has not yet established a timetable for its decision on this issue. Page 5 of 8

6 DIAGNOSTIC TESTING COMMITTEE FOR CLINICAL LABS & PORTABLE X-RAY Clinical laboratories that serve nursing home patients and the homebound are unique in that specimens are collected at the bedside and the reimbursement contains a draw fee and a reimbursement for travel to the patient to collect the specimen. The Protecting Access to Medicare Act of 2014 contained a $3 increase in the draw fee. NASL continues to seek a payment update in the travel portion. NASL developed a legal analysis demonstrating that CMS has a statutory obligation to pay, and continually update, a travel allowance for clinical laboratories for the personnel expenses incurred in sending trained personnel to collect specimens from homebound patients and patients in inpatient facilities other than hospitals. At request of CMS, the Committee presented this legal analysis to the agency and sent it to the Office of General Counsel. NASL also continues to lobby Congress for support of an update to the personnel portion of the travel allowance. NASL supported the nomination of the NASL Diagnostic Committee Chair for CMS Advisory Panel on Clinical Diagnostic Laboratory Tests. The Committee is seeking a regulatory solution for the need to modernize the portable x-ray regulations and pursuing a fix for inconsistent application of medically necessity of portable x-ray by Medicare contractors. The Committee prepared an updated version of the regulation for CMS. NASL and members of the Committee met with several offices at CMS to present and discuss this position. Additionally, the updated approach was submitted as part of NASL s comments on the CY2016 Physician Fee Schedule Proposed Rule. INFORMATION TECHNOLOGY (IT) COMMITTEE NASL continues to work extensively with the Office of the National Coordinator for Health Information Technology (ONC) and others involved in the development and adoption of standards for health information technology as well as the inclusion of LTPAC in electronic exchange of health information, especially around the transitions of care. Key ONC staff addressed NASL s IT Committee at NASL s 25 th Annual Meeting in October 2014 and the full membership at the Winter Legislative & Regulatory Conference in February NASL also arranged for ONC s Director of the Office of Care Transformation Kelly Cronin and LTPAC Coordinator in the Office of Policy Liz Palena-Hall to join NASL vendor members for lunch during the LTPAC Health IT Summit in June NASL members spent considerable time with high level ONC staff. NASL provided information on a number of health IT-related activities, including CMS new Payroll-Based Journal (PBJ) System to members. NASL is coordinating with ONC s Health IT Policy Committee s Health IT Implementation, Usability & Safety Workgroup, which is providing recommendations to ONC that will be shared with the Senate Health, Education, Labor & Pensions (HELP) Committee this fall that will inform potential legislation on interoperability. NASL reviewed many drafts of the 21 st Century Cures Act and provided legislative authors with extensive comments on sections impacting HIT vendors. NASL was the only LTPAC representative to reach out to Congress around a sweeping e- prescribing provision in early drafts of the 21 st Century Cures Act. The provision would have required all states to implement e-prescribing for controlled substances which was pulled from the legislation. E-PRESCRIBING RULE NASL spearheaded efforts to engage a variety stakeholders and CMS around the lifting of the LTC exemption from the e-prescribing Rule on November 1, NASL serves on the NCPDP s LTPAC e-prescribing Work Group, which is working to improve the e-prescribing standard, and continues to monitor for updates by the Drug Enforcement Agency (DEA) to its 2010 Interim Final Rule on e- prescribing. Page 6 of 8

7 21 ST CENTURY CURES INITIATIVE The 21 st Century Cures Act (H.R. 6) is a comprehensive bi-partisan proposal sponsored by House Energy & Commerce Committee Chair Fred Upton (R-MI) and Diana DeGette (D-CO). The proposal primarily looks at the cycle of medical cures and recommends improvements from development to delivery. NASL commented on several iterations of draft legislation. Our comments focused on how the provisions in the initial draft addressed the telehealth services under the Medicare program, as well as the interoperability and SOFTWARE Act sections that were authored by Representative Michael Burgess, MD (R-TX) and House E&C Vice Chair Marsha Blackburn (R-TN) respectively. Prior to the House Floor vote, several offsets from the Medicare and Medicaid programs were released. NASL was concerned about the offset that limits Medicare s medical imaging reimbursement, and the reimbursement for film x-rays to promote digital imaging, for a savings of $200 million. NASL also lobbied extensively to request a change in the offset that would have excluded portable x-ray companies that serve long term care patients from the digital imaging offset. NASL has met with staff from the Senate Health, Education, Labor & Pensions (HELP) Committee that is crafting the companion bill to the 21 st Century Cures Act, which is expected to be released this fall. NATIONAL HEALTH IT INITIATIVES LTPAC HIT COLLABORATIVE & NATIONAL HEALTH IT WEEK For more than a decade, NASL has been a leader in the Long Term and Post-Acute Care Health Information Technology Collaborative (LTPAC HIT Collaborative). NASL sponsors the Collaborative website, which serves as a central repository for the work of the Collaborative. NASL worked alongside members of the Collaborative in planning the 11 th Annual LTPAC HIT Summit, which was held in June The LTPAC HIT Summit highlights the many innovations in use by LTPAC providers and encourages partnerships within the sector and across the healthcare spectrum. NASL members and staff presented at the conference on a variety of topics with many of the IT Committee. NASL drafted and contributed to a number of comments that the Collaborative submitted to the ONC, including ONC s draft of Connecting Health and Care for the Nation: A Shared Nationwide Interoperability Roadmap; CMS proposed rule for Stage 3 of its Electronic Health Record (EHR) Meaningful Use Program; and ONC s 2015 Certification Criteria Proposed Rule. NASL is coordinating with other members of the Collaborative on comments regarding CMS Medicare & Medicaid Programs: Reform of Requirements for Long Term Care Facilities Proposed Rule, which are due October 14, NASL also partners with a variety of stakeholders involved in National Health IT Week. This year, National Health IT Week takes place October 5 9, LEADERSHIP APPOINTMENTS NASL members are involved in Federal and State advisory committees and workgroups. NASL has encouraged its members to apply to various committees. NASL supported the nomination of members to various Federal Advisory Committees, including both the ONC Health IT Policy and Standards Committees and CMS Advisory Panel on Clinical Diagnostic Laboratory Tests. Additionally, NASL Executive Vice President Cynthia Morton was selected to participate in a Technical Expert Panel (TEP) that CMS convened on the quality measures that will be used across all PAC settings as required under the IMPACT Act. Page 7 of 8

8 NASL WEBINARS, MEETINGS & PRESENTATIONS All webinars are archived for continued access by NASL Members. Data Standardization & the IMPACT Act Co-hosted by NASL and the Post-Acute Care Center for Research (PACCR), Presented by Stella Mandl, RN, Deputy Director, DCPAC, and Tara McMullen, PhD, MPH, Measure Lead, DCPAC with CMS Division of Chronic & Post Acute Care (DCPAC) -- August 27, 2015 After the SGR Fix What You Need to Know About Valued-Based Medicine Joint presentation by AMDA Director of Public Policy Alex Bardakh, MPP, PLC and NASL Executive Vice President Cynthia Morton, MPA -- July 21, 2015 Update on MMR of Outpatient Therapy Services Presented by Commander Brian Elza with CMS Division of Recovery Audit Operations to the NASL Medical Services Committee -- March 12, 2015 The Status of SGR Legislation & 2014 Policy Wrap Up Presented by NASL Policy Counsel, Alan Parver, Esq. of Arnall, Golden Gregory, LLC and NASL Executive Vice President Cynthia Morton, MPA -- December 17, 2014 NASL-AHCA Therapy Outcomes Project Presented by AHCA Senior Vice President of Quality & Regulatory Affairs David Gifford, MD September 4, 2014 NASL IN THE MEDIA Stakeholders Need to Prepare for the Loss of Long-Term Care's Exemption to e-prescribing (Guest Column) McKnight s September 15, 2014 New Legislation to Promote Standardization Across PAC Heralds Major Provider IMPACT PPS Alert for Long-Term Care -- December 2014 Homecare Direction December 2014 Interviewing Rehab Companies: How to Find an Ethical Job The ASHA Leader Volume 19, December 2014 Back to Faxing Orders? McKnight s January 1, 2015 CMS' DME, Home Health, Hospice RAC Stalled By Performant Recovery Protest Inside Health Policy January 12, 2015 NASL winter conference to focus on regulatory, legislative issues McKnight s February 5, 2015 AHCA To Back SGR Package Limiting Therapy Reviews, But Others Still Seek Caps Repeal Inside Health Policy March 23, 2015 Bipartisan Senate Duo Joins Therapy Groups' Push For Caps Repeal FDA Week March 26, 2015 Inside CMS March 26, 2015 CMS Not Expected To Unveil New Therapy Review Processes Until Late 2015 Inside Health Policy July 22, 2015 Inside CMS July 23, 2015 Page 8 of 8