Federal Update July 29, 2016 News MACRA, Opioid Update 0 I. MACRA UPDATE CMA Responds to Proposed MACRA Regulations On April 27, the Centers for Medicare and Medicaid Services (CMS) issued proposed regulations to implement the MACRA Medicare payment reform legislation. CMA formed a large MACRA Technical Advisory Committee, Chaired by Larry DeGhetaldi, MD, with wide representation from physicians across the state in various specialties and modes of practice. The TAC developed a comprehensive report with nearly 40 recommendations to respond to the regulations. The report was approved by the CMA Executive Committee because of the tight deadlines and on June 24, 2016, CMA submitted extensive comments to CMS. CMA also worked closely with the AMA MACRA Task Force, comprised of the major state medical associations and national specialty societies, to develop a uniform response. The detailed CMA comment letter to CMS is attached, along with the AMA comments. The full TAC report is presented in the Executive Committee Report to the BOT, July 29, 2016. Below is a summary of CMA’s concerns and recommendations for improvement. CMA will be aggressively advocating before CMS to make the changes listed below, as well as the additional changes recommended by AMA and the national specialty societies, before the final rule is published in October-November 2016. In the CMA letter, President Steve Larson told CMS Administrator Andy Slavitt that CMA believes MACRA is an improvement over the existing SGR law (with its burdensome reporting programs, large penalties and no bonus payments), and that while CMS made substantial changes to reduce the Medicare reporting burdens, CMS did not go nearly far enough “to fix the outlandish administrative burdens in the Medicare program as required by MACRA” and the “promising Alternative Payment Model track has been all but amputated.” CMA wants an end to the regulatory morass. SUMMARY OF CMA’S PRIORITY CONCERNS WITH THE MACRA REGULATIONS The accommodations for solo, small and rural practices are inadequate. The MIPS reporting programs continue to be unnecessarily burdensome and complex, particularly the EHR Advancing Care Information category. There is no accountability for EHR vendor compliance and interoperability. The MIPS Resource Use category will continue to discourage physicians from treating high-risk, vulnerable patients. The Advanced Alternative Payment Models are limited and the financial risk requirements severely inhibit the expansion of innovative APMs. The performance reporting period starts too soon - January 1, 2017. SUMMARY OF CMA’S RECOMMENDATIONS FOR IMPROVEMENT 1. The accommodations for solo, small and rural practices are inadequate. CMA Recommended Improvements: A. Significantly expand the permanent MIPS low-volume exemption for small practice physicians and physicians located in Health Professional Shortage Areas (HPSAs). It should be voluntary for physicians. B. Create an additional phase-in pathway for small and rural practices to transition to MIPS. It would exempt the 40th percentile of all small and rural practices in each specialty in Year 1; the 30th percentile of all small and rural practices in each specialty in Year 2; the 20th percentile of all small and rural practices in each specialty in Year 3; and the 10th percentile of all small and rural practices in each specialty in Year 4. This phase-in is voluntary and would provide more time for resource-limited small practices to prepare, finance new systems and upgrades, change workflow, and transition to MIPS. C. Exclude the Dual Eligible Medicare-Medicaid beneficiaries from all MIPS measure calculations for at least Years 1-4. California physicians have a substantial dual-eligible patient caseload that will hinder their ability to be successful under MIPS. In 2/3rds of California’s counties, more than 20% of Medicare beneficiaries are dual eligible. In fifteen of the largest California counties, more than 30% of the Medicare population is dual eligible. This exclusion would help small practices avoid penalties for treating high-risk, low-income patients and will ultimately protect access to care for these vulnerable patients. D. Immediately Allow virtual groups to report on behalf of small and HPSA practices starting in Year 1. Virtual groups could provide the infrastructure to help small practices successfully report and meet the MIPS standards. E. Exempt small practices from MIPS penalties until CMS authorizes virtual groups. 2. The four MIPS reporting programs (Quality, EHR-Advancing Care Information (ACI), Resource Use, and the Clinical Improvement Activities (CIA)) continue to be unnecessarily burdensome and complex. CMA Recommended Improvements: A. Reduce the scoring complexity. The four reporting programs need to be more unified, with similar scoring methods to reduce the complexity of the composite score calculation so physicians can understand it and plan for the future. B. Allow physician groups to use the group’s sub-tax identification numbers based on the Medicare physician fee schedule area or the hospital payment area in which they provide care. C. Telehealth services should be treated the same as all other in-person services for purposes of calculating MIPS program requirements. D. For the Quality Category: · Further reduce the number of required quality measures. · Maintain the existing requirement to only report on 50% of a physician’s patients vs. the proposed 80-90% of patients. · Eliminate the manual chart audits for the quality measures. · Ensure quality measure uniformity between the Medicare MIPS program and the Medicare Advantage program. E. For the EHR-Advancing Care Information Category (ACI): · Physicians should be given partial credit for the Base Score which should automatically advance physicians to the Performance Score component. · Reinstate the 90-day performance reporting period instead of the proposed 365-day period for at least Years 1 and 2. · Maintain all existing Meaningful Use Program exclusions and hardship exemptions and provide additional exemptions for physicians close to retirement, subject to cyber attack or experiencing vendor problems. · Eliminate the irrelevant Meaningful Use Stage 3 measures related to “coordination of care through patient engagement” and “health information exchange.” · Reduce the number of required Clinical Improvement Activities and provide more credit for the key patient quality activities. 3. There is no accountability for EHR vendor compliance and interoperability. CMA Recommended Improvements: A. Vendors must be held accountable for compliance and interoperability with stronger enforcement penalties. B. Certify only those EHRs with the ability to satisfy all MIPS measures requirements in its basic package, including the ability to securely interface with health information exchanges, registries and hospitals. C. All software vendors should have a standardized implementation timeline for interoperability that is clearly outlined in a vendor’s contract with physicians. D. Interoperability should be a software vendor’s basic responsibility and there should be no additional cost to physicians for interoperability to either State or Regional Health Information Organizations (RHIOs). E. Remove the proposed Advancing Care Information (ACI) mandate for physicians to attest on data blocking. This is a vendor responsibility. Instead, CMS should institute a mandatory revocation of vendor certification for systems that are not interoperable. F. Physicians contracting with vendors that lose their certification should be made whole by those vendors and granted an automatic hardship exemption by CMS if the system is not updated to compliance within 90 days. G. Clarify that physicians do not need to develop EHR communication interfaces with patient electronic health monitoring devices, such as FitBit. 4. The MIPS Resource Use category will continue to discourage physicians from treating high-risk, vulnerable patients. CMA Recommended Improvements: A. A specific adjustment should be made for the number of Dual Eligible Medicare- Medicaid beneficiaries in a physician’s practice to protect physicians from penalties for treating these complex patients and to protect access to care for those most in need. B. Bonus points should be awarded to physicians treating a certain threshold of Medicare-Medicaid dual-eligible patients to ensure that physicians are not discouraged from treating fragile, costly, high-risk patients and to protect access to care. In 2/3rds of California’s counties, more than 20% of Medicare beneficiaries are dual eligible. C. Eliminate the Medicare deductible for Medicare-Medicaid Dual Eligible beneficiaries who are not enrolled in health plans so physicians are not disincented from caring for these patients. D. Vast methodology improvements should be made to the Resource Use category including better adjustment for 1) subspecialty physician expenditure comparisons, 2) geographic cost adjustment factors and 3) socioeconomic status of the patient (race, ethnicity, income, previous insurance coverage). E. The total per capita cost and the Medicare spending per beneficiary (MSPB) measures for individual physicians should be removed until better measures are developed. The proposed episode groupers should be thoroughly pilot tested before being implemented. F. Physicians within 1-2 standard deviations of the national average should be rewarded and the all-or-nothing component removed. 5. The Alternative Payment Models are limited and the financial risk requirements severely inhibit the expansion of innovative APMs. CMA Recommended Improvements: A. Multiple APM pathways should be provided so that more physician organizations can participate. Track 1 Shared-Savings ACOs should be included. B. Physician APMs should only be at risk for costs they can control. C. Varying levels of financial risk should be established for different types of APMs: · Path 1: 1% total financial risk for a Part A and Part B expenditure benchmark. · Path 2: 2.5% total financial risk for a Part B expenditure benchmark. · Path 3: Upside only Shared-Savings organizations. Shared-Savings risk includes start-up and administrative costs, and the 18-month waiting period for potential shared savings. D. Alternatively, financial risk could be set at 2.5% of an APM’s Medicare Part B revenue vs. the proposed 4% of an APM’s total Medicare expenditures. The percent can be increased for integrated physician-hospital APMs. E. Medical Homes: · No additional downside financial risk should be imposed on Medical Homes beyond the initial standard due to their rigorous regulatory requirements, high start-up costs, and the need to promote access to primary care. · Eligibility should be expanded to specialty medical homes. · The 50-clinician cap should be eliminated. F. A Division of Financial Responsibility (DOFR) should be created for APMs modeled after the California health plan-medical group risk arrangements that exclude from the expenditure benchmark calculation the following services: out-of-area emergency services, out-of-area urgent care services, pre-existing cancer conditions, cancer care, mental and behavioral health care services, burn cases, transplants, cases costing over $100,000 annually, and Medicare Part B and Part D prescription drug costs. G. The APM Minimum Loss Ratio should be increased from 4% to 10% of the APM’s benchmark. A reasonable MLR will help small APMs manage the substantial start-up and administrative costs that consume a large percentage of their budgets. H. Most important for California, the APM expenditure benchmarks must be set at the national mean of Medicare expenditures per beneficiary so that efficient physicians are not penalized and discouraged from participating. Otherwise, physician groups who have consistently provided high value care (high quality/ low spending), such as California’s medical groups, will not be able to participate in the APM track. The APM expenditure benchmark must include any current year inflation-related Medicare Physician Fee Schedule payment increases, such as the conversion factor, the geographic practice cost index (GPCI), and the CBSA hospital wage index updates. I. The Advanced APM Comprehensive Primary Care Plus Initiative application deadlines need to be extended to allow California primary care physicians time to collaborate with the private payers to develop robust, multi-payer medical homes. J. Multiple Physician-Focused Payment Models should be approved and expedited by the Technical Advisory Committee and CMS. 6. The performance reporting period starts too soon - January 1, 2017 CMA Recommended Improvements A. The performance reporting period should start on January 1, 2018 instead of January 1, 2017 to give all physicians, vendors, and registries time to prepare and update their systems since the final program requirements will not be published until October or November 2016. MACRA Education and Assistance for Physicians CMA has created a MACRA Resource Center on the CMA website www.cmanet.org/MACRA. In addition to providing CMA information, it contains links to the CMS information, extensive AMA resources, including the STEPS Forward program, and additional resources provided by the national specialty societies, with information about their clinical data registries. CMA hosted two webinars in early July about the implementation and the steps physicians can take now to be ready. CMA will continue to provide education, information, tools and resources, and assistance to help practices prepare for MACRA. CMA will continue our extensive regulatory and legislative advocacy to continue to improve MACRA for the practicing physician. STEPS PHYSICIANS CAN TAKE NOW TO PREPARE FOR MACRA While the MACRA regulations are not yet final, CMA is urging physicians to take steps now to ease the transition for physician practices. Because some of the program requirements are likely to change, please watch for announcements and new educational materials from CMA, AMA and your specialty society this fall. But most important, CMA is urging physicians to GET EDUCATED ABOUT MACRA NOW! See www.cmanet.org/MACRA and http://www.ama-assn.org/ama/pub/advocacy/topics/medicare-new-payment-systems.page. II. 2017 Medicare Physician Payment Rule Released July 9, 2016 Includes the California GPCI/Locality Update CMS recently released the proposed 2017 Medicare Fee Schedule. Comments are due September 6, 2016. Included in the payment rule is the long-awaited “California GPCI Fix.” The locality changes and payment updates will be phased-in from 2017 to 2022. CMA is reviewing the complex California GPCI implementation proposal and will provide additional information once that analysis is complete. Moreover, CMS made updates to the Geographic Practice Cost Index (GPCIs) nationwide based on new wage, rent, and malpractice expense data. CMA is also analyzing these changes for accuracy. CMS is improving Medicare payment for services provided by primary care physicians for patients with multiple chronic conditions, mental and behavioral health issues, and cognitive impairment or mobility-related disabilities. CMS is also expanding the Diabetes Prevention Program innovation center model. For Primary Care, CMS plans to: Make separate payments for certain existing Current Procedural Terminology (CPT) codes describing non-face-to-face prolonged evaluation and management services. Revalue existing CPT codes describing face-to-face prolonged services. Make separate payments using new codes to describe the comprehensive assessment and care planning for patients with cognitive impairment (e.g., dementia). Make separate payments using new codes to pay primary care practices that use inter-professional care management resources to treat patients with behavioral health conditions. Several of these codes describe services within behavioral health integration models of care, including the Collaborative Care model that involves care coordination between a psychiatrist or behavioral health specialist and the primary care clinician, which has been shown to improve quality. Make separate payments using new codes to recognize the increased resource costs of furnishing visits to patients with mobility-related impairments. Like several of these proposed codes, this is especially relevant for the Medicare-Medicaid dually-eligible population. Make separate payments for codes describing chronic care management for patients with greater complexity. Make several changes to reduce administrative burden associated with the chronic care management codes to remove potential barriers to furnishing and billing for these important services. Below are additional highlights of the proposed payment rule: Modifications to the Medicare Shared Savings Program to update the quality measures set and align them with the new MACRA regulations, changes to take beneficiary preferences for ACO assignment into consideration, and changes that would improve beneficiary protections when ACOs are approved to use the skilled nursing facility (SNF) 3-day waiver rule. Requiring health care providers and suppliers to be screened and enrolled in Medicare in order to contract with Medicare Advantage health plans. Increasing transparency of Medicare Advantage and Medicare Drug Plan pricing data and medical loss ratio (MLR) data. Continued implementation of the Appropriate Use Criteria for advanced diagnostic imaging services. Additional adjustments to misvalued codes identified by CMS. Based on AMA CPT and RUC recommendations, proposing values for the new CPT moderate sedation codes and proposing a uniform methodology for valuation of the procedural codes that currently include moderate sedation as an inherent part of the procedure. CMS is also proposing to augment the new moderate sedation CPT codes with an endoscopy-specific moderate sedation code, and proposing valuations reflecting the differences in physician survey data between gastroenterology and other specialties. Expanding payment for the following services provided via telehealth: End-stage renal disease (ESRD) related services for dialysis, Advance care planning services, and Critical care consultations using new Medicare G-codes. Implementing new CPT codes for mammography services. III. Veteran’s Administration Advanced Practice RN Scope of Practice Expansion Recently, the VA issued a proposed rule that allows all VA-employed Advanced Practice Registered Nurses (APRNs) to practice independently without the clinical supervision of physicians and without regard to state law. The VA is attempting to address the access to care problems within the VA related to staffing shortages and long patient wait times. However, CMA is strongly opposing the proposed rule. CMA joined the multi-state medical society coalition and the AMA in sending joint opposition letters to the VA. The CMA sent a separate letter on July 25, 2016. Letters are on the CMA website. Organized medicine is arguing that APRN’s education and training does not provide the same level of experience as a physician and it will reduce the quality of care provided to our nation’s Veterans – who deserve better. Moreover, the rule conflicts with state laws that require physician supervision and oversight. We are proposing alternatives that prioritize a team-based care approach rather than totally independent nursing practice. IV. Department of Education Medical Student Public Service Loan Forgiveness CMA continues to press the Department of Education to fix the regulation that inappropriately excludes California physicians who provide care in non-profit hospitals for ten years from the public service student loan forgiveness. Physicians in every state except California and Texas are afforded loan forgiveness. Leader Nancy Pelosi (D-SF) and Congressman Xavier Becerra (D-LA) called Education Secretary John King to their office to advocate for an immediate change in the regulation this year. Secretary King agreed to develop a plan and respond. CMA is now working with the Secretary’s lawyers on potential solutions. The coalition letter and Governor Brown’s letter to the Secretary are attached. V. CMA fights CMS Proposal to Reduce Physician Reimbursement for Part B Drugs Provided in a Physician’s Office In April, the Centers for Medicare and Medicaid Services (CMS) recently released a proposal to restructure the way Medicare reimburses physicians for Part B drugs. The California Medical Association, along with the American Medical Association (AMA) and other medical associations and patient organizations, is urging CMS to reconsider the proposal, as it fails to address the underlying causes of rising drug costs, reduces the amount of payment to physicians, and increases patient cost-sharing. Patients served by practices that are small, rural, or located in economically disadvantaged areas could be disproportionately affected. Although CMA and AMA share the concern that rising drug costs could make life-extending therapies unavailable to a growing number of patients, we do not accept CMS’s assumption that this problem can be solved by reducing Medicare reimbursement to physicians who purchase and administer those drugs and have no influence over their prices. Today, Medicare reimburses physicians and hospitals for the cost of Part B drugs at a rate tied to the average sales price (ASP) for all purchasers—including those that receive large discounts for prompt payment and high volume purchases—plus a percentage of the ASP. Currently, the percentage add-on is 6 percent, which is then reduced to 4.3 percent because of the 2011 Budget Sequestration Act. Under the new proposal, CMS would retain the current rates in some communities and in other communities it would set a reduced rate of ASP+2.5 percent in addition to a $16.80 flat fee. After sequestration is factored in, the add-on in the demonstration areas would be 0.86 percent of ASP plus $16.53. Five additional “value-based” drug payment strategies are on tap for implementation in specified localities next year or later. As a result, Medicare payment policy would remain unchanged in some communities while multiple changes could be applied in others. Because the ASP includes payments that were heavily discounted to reflect volume, prompt pay and other such adjustments, it does not reflect the true prices paid by many physician practices with relatively low-volume purchases. Even with the current 4.3 percent add-on, Medicare reimbursement may not cover actual costs, especially for practices that face high wholesaler fees or state and local drug taxes, which are not counted in the ASP. CMA and AMA also protested the underlying premise of this demonstration project - that physicians choose their patients’ drug therapy based on the drug with the highest reimbursement to the physician. The Medicare Payment Advisory Commission (MedPAC) looked at that question and concluded that there is little evidence to support it. CMS also cannot offer evidence of significant abuse. As noted in recent MedPAC discussions, many factors, other than reimbursement, drive physician medication therapy decisions. Moreover, under the proposal, many physicians would no longer be able to afford to provide these drugs in their offices. Thus, the administration of these drugs would shift from physician’s offices to hospital outpatient departments, which would increase costs for both patients and the Medicare program. VI. Congress and HHS Take Action on Opioid Prevention and Treatment President Obama signs the House-Senate Conference Committee Agreement on Opioids on July 22, 2016 ( PL 114-198). House Adopted S 524 by a vote of 407-5; Senate Adopted it 92-2. HHS finalizes regulations to increases access to buprenorphine for opioid use disorders and delink the patient satisfaction pain survey from hospital quality payments. This year, Congress has passed more than 25 new bills aimed at supporting opioid abuse prevention and treatment. On July 9-13, the House and Senate overwhelmingly passed a compromise Conference Committee agreement (S 524) despite Democratic concerns that the bill won’t include new spending to address the problem. Republican leaders have vowed to fund the legislation through the annual appropriations process, but some are worried that opioid funding could be offset with corresponding cuts to other public health programs. CMA and AMA are supporting most of the legislative package and will continue to promote additional funding for prevention and treatment. The appropriations bills will have to wait until Congress returns from the summer recess in September. S 524, the House-Senate Conference Agreement on the Comprehensive Addiction and Recovery Act, would generally do the following: · Authorize grants to states to fund education, prevention, law enforcement, treatment, and recovery programs. · Establish a task force to review best practices for chronic and acute pain management and prescribing pain medications and to look for gaps and inconsistencies that have been adopted by federal agencies. · Reauthorize the National All Schedule Prescription Electronic Reporting System (NASPER) and provides funding to state prescription drug monitoring programs (PDMPs) of $10 million/year for 5 years. · Expand access to naloxone. · Expand NIH Research for understanding pain and alternative treatments. · Provide addiction and treatment services, particularly to women, infants, children, and veterans. · Expand the Prescription Drug Take-Back Program. · Authorize a GAO study on the states’ Good Samaritan laws. · Authorize new safety measures and programs within the Veterans Administration, including more education and training for prescribers, use of PDMPs and care management of patients. · Allow physicians and patients to “partially fill” an opioid prescription. · Direct the Secretary of HHS to institute abuse prevention measures in the Medicare Advantage and Medicare Part D programs in consultation with stakeholder groups. It could limit patient choice of provider and pharmacy. Access to Buprenorphine: The Substance Abuse and Mental Health Services Administration (SAMHSA), a branch of the U.S. Department of Health and Human Services (HHS), issued a final rule that will expand access to buprenorphine, one of three medications currently approved by the Food and Drug Administration (FDA) for medication-assisted treatment of opioid use disorder. The new rule increases the limit on the number of patients that qualified physicians who have a waiver can treat with buprenorphine from 100 to 275, increasing access to life-saving addiction treatment services. CMA supported the final rule. Across the country, many people suffering from opioid use disorder are unable to access medication-assisted treatment for their condition due to a lack of nearby physicians with waivers to prescribe buprenorphine. Delinking patient pain survey from hospital payment: In another proposed rule, the Center for Medicare and Medicaid Services (CMS) is proposing to remove the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) hospital patient satisfaction survey questions related to pain management from the Medicare hospital payment scoring calculation. Hospitals could continue to use the questions to survey patients about their pain management experience, but the questions would not impact hospital payments. CMS said, “Many clinicians report feeling pressure to overprescribe opioids because scores on the HCAHPS survey pain management questions are tied to Medicare payments to hospitals. But those payments currently have a very limited connection to the pain management questions on the HCAHPS survey. In order to mitigate even the perception that there is financial pressure to overprescribe opioids, [we] are proposing to remove the HCAHPS survey pain management questions from the hospital payment calculation. CMA supported 2016 federal legislation to delink the pain survey from hospital payments and welcomes this significant proactive regulatory action from CMS. HHS issued a Request for Information (RFI) seeking comments from the medical profession and other stakeholders on current HHS opioid prescriber education and training programs to improve their effectiveness and has asked for additional recommendations that would augment ongoing activities. HHS also announced it is launching more than a dozen new scientific studies on opioid use and pain management to help fill knowledge gaps and inform efforts to end this epidemic. HHS said, “Research on opioids conducted and funded by HHS helps the department better track and understand the epidemic, support the development of new pain and addiction treatments, identify evidence-based clinical practices to advance pain management, reduce opioid misuse and overdose, and improve opioid use disorder treatment – all areas of research that are critical to our national response to the opioid epidemic.” VII. ADDITIONAL LEGISLATIVE ACTION The House had a surprisingly productive July, passing additional health care related legislation, including a Conference Committee report on Zika virus response funding; HR 2646, a package overhauling mental health programs; and HR 1270, which expands the role of health savings accounts. All bills await Senate action. The Zika Virus Conference Agreement has been stalled in the Senate for several weeks. Comments are closed.
