RE: CMS Innovation Center -- New Direction Request for Information (RFI)

Transcription

1 November 20, 2017 Amy Bassano Acting Director Center for Medicare & Medicaid Innovation Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore, Maryland RE: CMS Innovation Center -- New Direction Request for Information (RFI) Dear Ms. Bassano: America s Health Insurance Plans (AHIP) appreciates the opportunity to submit comments to the Centers for Medicare & Medicaid Services (CMS) in response to its Request for Information on a new direction for the CMS Center for Medicare & Medicaid Innovation (Innovation Center). AHIP is the national association whose members provide coverage for health care and related services. Our members offer coverage across the entire spectrum of private-sector and public programs. We are committed to market-based solutions and believe that every American deserves affordable coverage that provides them with access to high quality care. We applaud CMS for seeking public input on the development of priorities and guiding principles for the Innovation Center. AHIP encourages CMS to move forward in directing Innovation Center resources toward model designs most likely to encourage modernization of the Medicare and Medicaid programs and to lower costs, increase quality, and improve outcomes. We are aligned with CMS in our belief that achieving such objectives is best accomplished through models focused on market-based reforms that promote patient-centered care, expand competition and choice, and reduce unnecessary burdens. To achieve these objectives, AHIP strongly recommends that the Innovation Center design and test new models focused on Medicare Advantage (MA), Medicare Prescription Drug Coverage (Part D), and Medicaid health plans. We are encouraged that the RFI specifically identifies these three programs as potential areas for testing and have attached several recommended models. These models would modernize benefits, better prevent and treat addiction to opioids and other substance use disorders, promote better care integration for dual eligible beneficiaries, allow plans to address social determinants of health, leverage technologies to improve the beneficiary experience, better align drug coverage within Medicare, and provide plans with tools and flexibility to contain rising prescription drug costs. We also encourage CMS to work closely with health plans and other relevant stakeholders in model development and design. Health insurance providers have a proven track record of success they can bring to bear on Innovation Center models. Our members specialize in integrating and coordinating care for beneficiaries; mitigating the harm of chronic diseases by focusing on prevention, early detection, 1

2 and care management; addressing the needs of vulnerable individuals, including low-income beneficiaries and individuals with disabilities; applying evidence-based clinical practices to increase patient safety and to limit unnecessary utilization of services; reducing medication errors; and promoting clinically sound drug usage. Through collaboration with physicians, hospitals, and other clinicians, health plans provide better care, achieve better outcomes, and lower costs for beneficiaries. While these achievements are important, statutory and regulatory restrictions continue to limit the potential for further innovation and improvement in Medicare and Medicaid. We believe health plans are an ideal laboratory for testing new innovative strategies and practices. The Value of Medicare Advantage and Part D Today nearly 19 million Americans, or nearly one in three Medicare beneficiaries, have chosen to enroll in the MA program. Since 2010, MA enrollment has increased by more than 60 percent. The MA program has a beneficiary satisfaction rate of 90 percent for plans, preventive care coverage, benefits, and choice of provider. 1 Unlike traditional Medicare, whose benefit package is largely stuck in time and reflects its 1960s origins, MA plans often offer additional, comprehensive benefits such as vision, dental, and hearing coverage, as well as a cap on out-of-pocket spending, and many plans offer drug coverage as well for no additional cost to beneficiaries. In comparison to the traditional Medicare program, which is built upon a fee-for-service chassis that rewards volume over value, MA has been shown to reduce hospital readmissions 2 and institutional post-acute care admissions 3, and increase rates of annual preventive care visits 4 and screenings. 5 The benefits of the MA program accrue to taxpayers as well. For many years, average MA plan bids for delivering the basic Medicare benefit have been below traditional Medicare costs and, in 2017, average MA payments are equivalent to traditional Medicare according to the Medicare Payment Advisory Commission. Furthermore, in many geographies, increases in MA enrollment have led to decreases in traditional Medicare spending growth due to changes in practice patterns and care guidelines that have positive spillover effects by reducing Medicare fee-for-service spending. 6 In fact, private MA plans pioneered many payment and delivery reforms being tested in the traditional Medicare program. Moreover, recent studies have shown that alternative 1 Morning Consult National Tracking Poll. March 11-16, Lemieux, Jeff, Sennett, Cary, Wang, Ray, Mulligan, Teresa, Bumbaugh, Jon. Hospital readmission rates in Medicare Advantage plans. American Journal of Managed Care 18(2): February Huckfeldt, Peter J., Escarce, Jose J., Rabideau, Brendan, Karaca-Mandic, Pinar, Sood, Neeraj. Less intense postacute care, better outcomes for enrollees in Medicare Advantage than those in fee-for-service. Health Affairs 36(1): January Sukyung, Chung, Lesser, Lenard I., Lauderdale, Diane S. et al. Medicare annual preventive care visits: Use increased among fee-for-service patients, but many do not participate. Health Affairs 34(1): January Ayanian, John Z., Landon, Bruce E., Zaslavsky, Alan M., et al. Medicare beneficiaries more likely to receive appropriate ambulatory services in HMOs than in traditional Medicare. Health Affairs 32(7): July Johnson, Garret, Figuero, Jose F., Zhou, Xiner, Orav, E. John, Jha, Ashish K. Recent growth in Medicare Advantage enrollment associated with decreased fee-for-service spending in certain US counties. Health Affairs 35(9): September

3 payment models within MA lead to the delivery of care that is of higher quality and lower cost than other types of payment arrangements. 7 Part D covers most medications including many biologics and vaccines that are not otherwise covered by Medicare Part A (hospital insurance) or Part B (medical insurance). Over the past 10 years, Part D has been a model of consumer choice and market competition that has improved access to prescription drugs and reduced out-of-pocket costs for tens of millions of beneficiaries. Today, 43 million seniors and individuals with disabilities are covered by private plans participating in the program, and enrollees are overwhelmingly pleased with their coverage and benefits. The program is highly popular, as nearly 90 percent of seniors are satisfied with the Part D program. 8 Part D premiums also have been relatively stable over time. For 2018, according to CMS, the average Part D premium is projected to fall 3 percent, from $34.70 to $33.50, which is the first projected premium decrease since The Value of Medicaid Managed Care Medicaid health plans are at the forefront of implementing systems and programs across the country that promote high-quality, coordinated care for millions of our most medicallyvulnerable citizens, including lower-income individuals, people with disabilities, and pregnant women and children. More than 52 million low-income individuals representing over 70 percent of total Medicaid enrollment rely on private health plans for their Medicaid coverage. Thirty-nine states have adopted Medicaid managed care and 26 states have adopted managed long-term services and supports (MLTSS), a six-fold increase since AHIP members have a proven track record in addressing the needs of Medicaid beneficiaries with complex needs, including individuals with physical or developmental disabilities, people with multiple chronic conditions, older adults, foster children, and those in need of long-term services and supports and/or home and community based services. Medicaid health plans focus on chronic care and disease management and delivery of patient-centered care improves quality and care coordination for these vulnerable populations. Moreover, Medicaid health plans remain committed to the success and sustainability of the Medicaid program. Medicaid health plans help states and, by extension, the federal government control escalating program costs and achieve high value for their scarce health care dollars. By coordinating medical and pharmacy benefits, Medicaid health plans saved $2.06 billion in state and federal expenditures in 2014 alone. 9 In many states, Medicaid health plans have provided savings of up to 20 percent compared to Medicaid fee-for-service and between 10 and 15 percent lower per-member per-month drug costs. 10 In addition, a report from the Ohio Association of Health Plans shows that Ohio s Medicaid health plans saved the state Medicaid 7 Mandal, Aloke K., Tagomori, Gene K., Felix, Randell V., Howell, Scott C. Value-based contracting innovated Medicare Advantage healthcare delivery and improved survival. American Journal of Managed Care 23(2): e41- e49. January Morning Consult for Medicare Today, Ten Years After Implementation, Nearly Nine in 10 Seniors are Satisfied with Part D (July 2016). 9 The Menges Group, Comparison of Medicaid Pharmacy Costs and Usage in Carve-In Versus Carve-Out States, April The Lewin Group, Medicaid Managed Care Cost Savings: A Synthesis of 24 Studies, March

4 program as much as $2.5 to $3.2 billion compared with the fee-for-service Medicaid program from 2013 to Potential Model Considerations As noted above, we have developed a variety of recommendations for pursuing innovations in MA, Part D, and Medicaid programs. Brief summaries of these proposals are attached. They reinforce the guiding principles in the RFI that are aimed at increasing beneficiary choices in the marketplace and testing new payment and delivery models to improve quality and decrease costs. By focusing more models on opportunities and added flexibility for health plans to implement innovative programs and services, the Innovation Center will be able to identify and test new approaches and develop best practices that could provide greater value to Medicare and Medicaid beneficiaries in managed care and ultimately be implemented in the traditional fee-forservice programs. At the same time, these approaches may better align health plan practices and quality standards in commercial and public programs, reduce burden for providers participating in health plan networks across multiple products, and reinforce efforts to improve quality and reduce costs across the health care system. In our comments submitted to the Agency earlier this year regarding transformational ideas in the RFI within the 2018 Advance Notice for MA and Part D, we recommended several changes to transform and modernize the MA and Part D programs. We have included several of those proposals as potential Innovation Center models. We strongly urge CMS to implement those suggestions as permanent program changes by exercising its interpretive regulatory authority. However, we have included these suggestions in this RFI response to the extent CMS may have questions about the Agency s regulatory authority or CMS is otherwise hesitant to implement the suggested changes through regulation. We also want to address several other elements in the RFI. First, CMS requests input on the possibility of developing models that would test alternatives to traditional Medicare and MA, presumably through new types of risk bearing entities. We have serious concerns with such an approach. The traditional Medicare and MA programs already provide robust, alternative forums for the Innovation Center to explore different models in pursuit of the principles in the RFI. Introducing alternative financing programs that require providers to assume substantial new levels of financial risk would divert significant government and private sector attention and resources. For example, such an approach could lead to the financial insolvency of providers and other entities that lack the capacity to effectively manage risk. This would, in turn, invariably create confusion for beneficiaries and potential harm as a result of provider challenges and potential failures. Based on their track record, plans in the MA program are in the best position to test and implement innovative models that offer long-term value to beneficiaries and taxpayers. We urge the Innovation Center to focus on working with stakeholders to identify and solve specific problems within traditional Medicare and MA. 11 Ohio Association of Health Plans, The Impact of Private Industry on Public Health Care: How Managed Care is Reshaping Medicaid in Ohio, January

5 Second, the RFI indicates potential CMS interest in an MA demonstration that incentivizes MA plans to compete for beneficiaries, including those beneficiaries currently in Medicare fee-forservice (FFS), based on quality and cost in a transparent manner. We note that existing competition in the MA and Part D programs is robust. Enrollment continues to increase despite significant changes that have been made to these programs over the past decade. However, we believe CMS can take steps to enhance beneficiary understanding of their choices, including the additional value that MA plans offer. For example, we recommend that CMS work with stakeholders to develop a way to measure the quality of care received by beneficiaries in traditional Medicare. Beneficiaries could then have more information available to compare the performance of traditional Medicare against MA plan options in their service areas. We also recommend that CMS work with stakeholders to improve the Medicare Plan Finder so that beneficiaries have a clearer and better understanding of their Medicare coverage options. Third, we support CMS s interest in further exploring the voluntary use of value-based contracts (VBCs) for new high cost drug therapies. We encourage CMS to prioritize VBC arrangements that include independently-developed outcome measures, appropriate and adequate safeguards and guarantees for the promised impact and length of therapeutic effects and to explore alternatives to traditional end of the year payment reconciliations. We believe these types of arrangements can ensure the maximum value for patients and taxpayers. Finally, we would like to take this opportunity to recognize and support the work of the Medicare-Medicaid Coordination Office (MMCO). The MMCO was created to serve individuals who are dually eligible for Medicare and Medicaid, with a focus on integrating program benefits and improving federal and state coordination. Achieving these goals is critical to reducing avoidable costs and enhancing quality for these often-vulnerable beneficiaries. AHIP believes the MMCO has been extremely successful in furthering those objectives, as reflected in the implementation of the Medicare-Medicaid Plan (MMP) demonstrations and the office s role in resolving broader issues for dually eligible beneficiaries. The MMP demonstrations are a crucial laboratory for testing the impacts of eliminating regulatory conflicts, increasing stakeholder engagement, and implementing other activities to achieve the highest value care for dual eligibles. Therefore, as indicated in our attached recommendations, AHIP strongly urges CMS to continue and expand the MMP demonstrations. We also encourage enhanced intra-agency coordination in the design and oversight of programs impacting dual eligibles, under the leadership of the MMCO, so that decisions affecting these programs are made through the lens of an integrated program that considers the impact on beneficiaries, as well as coordination with state partners. We look forward to providing any additional information you may need and to continue working with you to promote innovation and strengthen the Medicare and Medicaid programs for the beneficiaries they serve. Sincerely, Matthew Eyles Senior Executive Vice President & Chief Operating Officer 5

6 MA Innovation Models Medicare Access and CHIP Reauthorization Act (MACRA) Medicare Advantage (MA) Advanced APM Demonstration Telehealth demonstration Expansion of MA Value Based Insurance Design (VBID) Model Expanded Supplemental MA Benefits Under the current MACRA rule, MA plans are treated as Other Payers and payments and members attributable to MA plans are not counted toward qualifying alternative payer model (APM) determinations under the Medicare Option. Clinicians taking risk in a contract with an MA plan are only eligible to receive credit for their participation through the All-Payer Combination Option beginning in payment year The original Medicare fee-for-service (FFS) program restricts the covered services that can be delivered via telehealth to a limited list of geographies, covered services, and provider types. MA plans can only provide coverage for telehealth services beyond those restrictions through supplemental benefits. CMS is currently testing a model allowing MA plans to offer VBID, but the model is limited to 10 states and to certain types of clinical conditions. CMS rules restrict the types of items and services that MA plans can offer as supplemental benefits to those that are primarily health related, defined by CMS as having a primary Test whether including provider risk arrangements with MA plans as qualifying APM arrangements under the Medicare Option will expand the adoption and impact of value based arrangements. Additional details about this recommended model were submitted to CMS as part of AHIP comments on the proposed 2017 MACRA rule. We note and appreciate that the MACRA CY2018 final rule confirms CMS interest in moving forward with a demonstration. Test whether permitting MA plans to incorporate telehealth costs in the basic MA benefit, and thereby expand the use of telehealth and remote patient monitoring, will reduce costs and enhance quality and access to care for Medicare plan enrollees. Enhance testing of the cost and outcomes impacts of VBID by expanding the model nationwide and providing plans with more flexibility to identify clinical conditions eligible for VBID and consider expanding to other plans types. Test the cost and quality impacts of allowing MA plans to cover a broader range of assistive devices, items and services that help beneficiaries compensate for physical disabilities, diminish the impacts of an illness or injury, and enhance quality of life. We note, for 1

7 MA Innovation Models Limited Home and Community Based Services (HCBS) Benefit for Near Dual Eligibles Hospice and Palliative Care in MA purpose to prevent, cure or diminish an illness or injury. CMS rules for home health services require that the enrollee need intermittent skilled nursing care. MA plans cannot provide supportive home health services to people who have difficulty performing activities of daily living (ADLs), except in combination with skilled services, and such services cannot be provided as supplemental benefits. Many individuals with ADL impairments would qualify for nursing home level care but have incomes too high to qualify for Medicaid, and a significant number of these near dual eligibles spend down their resources to eventually qualify for Medicaid. MA members who elect to receive hospice care receive such coverage exclusively through Part A of the FFS program. In addition, beneficiaries receiving hospice care are generally limited to the receipt of palliative care, not additional curative care. The Innovation Center is currently testing a model that allows beneficiaries receiving hospice benefits to also receive curative care. example, that CMS permits certain D-SNPs to offer supplemental benefits for enrollees needing assistance with activities of daily living (Medicare Managed Care Manual, Chapter 16b, Sec ); a model could test the impacts of extending similar flexibility to all MA plans. Test whether allowing MA plans to cover a limited HCBS benefit as a supplemental benefit for this population reduces the number of Medicare enrollees who progress to Medicaid and dual eligibility, and whether such limited HCBS would have positive impacts on use of Medicare acute services, e.g. inpatient hospital and ER. Test whether providing a more integrated hospice benefit by including it as an MA covered service can reduce costs and enhance quality of life of MA beneficiaries. Further test the cost and quality impacts of offering concurrent palliative and curative care in this MA benefit. 2

8 MA Innovation Models MA Rewards and Incentives Program MA Health Savings Account (HSA) Demonstration CMS rules limit the types and amounts of rewards and incentives that are permissible under the MA program for plans to provide to their members. Medical savings account (MSA) plans, first offered as a demonstration under the Balanced Budget Act of 1997, have been a permanent MA option since the Medicare Modernization Act of However, enrollment in MSA plans represents less than 0.1 percent of total MA enrollment. The program was developed before modern HSAs and lacks features such as the ability of beneficiaries to contribute their own funds to an MSA. Other restrictions that may affect enrollment include a prohibition on mandatory supplemental benefits. Allow plans more flexibility to design innovative reward and incentive programs for beneficiaries, including innovative educational outreach to targeted member populations, and permit use of cash or monetary rebates as a form of reward or incentive. Test whether modifying Medicare MSA rules to be more consistent with commercial HSA arrangements could increase Medicare beneficiary interest and ultimately lead to higher value utilization of Medicare services. 3

9 MA Innovation Models MA Coverage of Home Infusion Drugs The FFS program limits the coverage of home infusion services. Some MA plans provide broader coverage of home infusion services, and have the option of bundling Part D home infusion drugs with equipment, supplies, and nursing services as a supplemental benefit. The Innovation Center is currently testing a model in the FFS program that provides bundled payments for a specific type of home infusion service that is usually available only to homebound members. Test the program cost impacts and other potential benefits of providing MA plans additional incentives to offer services to enrollees who are not homebound, and/or including Part D home infusion coverage under a bundled payment. 4

10 State-Based and Local Innovation, including Medicaid-Focused Models Extension and Expansion of the Medicare-Medicaid Plan Financial Alignment Demonstrations The Financial Alignment Demonstrations (FADs), which currently serve more than 400,000 Medicare-Medicaid beneficiaries in 11 states, are highlighting interactions between Medicare and Medicaid, helping policymakers to understand and bridge the disconnects between the two programs. The FADs serve as important laboratories in several respects: Identifying and understanding challenges and inconsistencies between benefits, rules and requirements of the two programs; Understanding state, provider and beneficiary perspectives and behavior toward integrated care models; and Refining integrated delivery of care and services to improve outcomes, while working within the existing statutory and regulatory framework. The Medicare-Medicaid Plans (MMPs) operating in the capitated FADs provide greater flexibility for the delivery of services to these vulnerable beneficiaries and reduced administrative burden for the providers and health plans serving them. To enable health plans and state Medicaid agencies to continue investing in the coordination and integration of benefits and services for Medicare-Medicaid dual eligibles, to allow sufficient time for evaluation reports and other demonstration results to become available, and to allow sufficient time for state budget planning and CMS processes, AHIP strongly recommends that the Innovation Center work with all interested states to extend the MMP FADs, consistent with the extensions CMS previously offered to states with 2018 demonstration end dates. We also strongly recommend that CMS expand opportunities for additional plans and states to participate. Moreover, we believe that there are additional opportunities to further enhance the levels of integration within the MMPs. Extending the demonstrations will provide time to realize those enhancements, for example, testing the cost and quality impacts of allowing states additional flexibility and permitting greater integration and streamlining of Medicaid and Medicare administrative processes in the FADs, including network adequacy reviews, financial and program reporting, appeals and enrollment. The MMPs are the most integrated currently available plan option for dual eligibles, and we urge the Innovation Center to continue its commitment to this important care delivery model, partnering with states and the MMPs to refine it as program evaluations and results become available. We believe that there is much more to be learned from the MMP 5

11 State-Based and Local Innovation, including Medicaid-Focused Models Unified Dual Eligible Integration Demonstration Current Medicare and Medicaid benefits and administrative processes are independent and not aligned, creating significant challenges for beneficiaries in understanding and navigating the two programs, and challenges for providers and health plans in coordinating care and services. Non-alignment also creates incentives to shift costs between Medicaid and Medicare. demonstrations, and allowing adequate time for those insights and lessons learned to be realized will contribute significantly to the long-term outlook for person-centered, integrated care and services for dual eligibles. A Unified Dual Eligible Integration Demonstration would take the evolution of integration of care and services for Medicare- Medicaid dual eligibles to the next level. The Innovation Center could select up to ten states to implement fully integrated programs in all or part of the state. States would apply to administer integrated funding and benefits for full benefit dual eligibles, including Medicare Parts A, B and D, and Medicaid covered services such as behavioral health and MLTSS. CMS would provide Medicare funds, along with FFP for Medicaid, to demonstration states, who would administer funds and provide rigorous accounting of Medicare and Medicaid attributable expenditures. States would contract with qualified managed care organizations to provide delivery systems, care management and coordination. Beneficiary-centered processes such as enrollment, continuous coverage, benefits and appeals would be completely aligned and integrated. 6

12 State-Based and Local Innovation, including Medicaid-Focused Models Enhanced Integration for Medicare/ Medicaid Dual Eligible Special Needs Plans (D- SNPs) Special Needs Plans for Dual Eligibles (D-SNPs) have been an option under the Social Security Act for more than ten years. They offer an alternative approach to providing integrated and coordinated benefits for duals, and also provide flexibility in CMS rules to enable more simplified processes. More recently, Fully Integrated Dual Eligible (FIDE) SNPs were developed to offer additional integration with respect to benefits, member facing processes and materials. There is still substantial work that can be done in D-SNPs to further integrate funding, benefits and administrative processes, limit challenges for beneficiaries, and enhance the ability of SNPs to achieve the most effective care and service coordination. For example, some states have been reluctant to expend scarce state resources on FIDE SNP participation because such SNPs are not designed to provide states with tangible financial benefits that may be realized by the SNPs through the delivery of higher quality, more cost-effective care. Test the cost and quality of permitting all D- SNPs to use fully integrated member correspondence, marketing and member materials, for member-facing administrative processes, such as enrollment, appeals and medical management, with complete alignment of Medicare and Medicaid requirements. In addition, for FIDE SNPs, the Innovation Center could test a model that allows states to participate financially in savings that accrue to Medicare through intensive coordination and management of services provided to dual enrollees through their Medicaid coverage, such as Medicaid-covered long-term services and supports that reduce use of Medicare-covered inpatient and emergency room use. 7

13 State-Based and Local Innovation, including Medicaid-Focused Models Integrated Coverage for Social Determinant(s) of Health There is a growing body of evidence about the impacts of social determinants such as employment, food security and access to affordable housing on health costs and outcomes for Medicaid beneficiaries and other individuals. Yet community, state and federal programs aimed at these social issues are not coordinated with public health policies. For example, social determinants clearly have impacts on Medicaid utilization and costs, but key aspects of federal programs, such as funding criteria, eligibility standards and benefit duration for Medicaid, housing, nutrition and job training programs vary significantly. These differences severely limit the ability of Medicaid health plans and others to combine health and social services to address the needs of people with Medicaid in a holistic manner. Test the impacts of allowing Medicaid health plans to coordinate the offering of a more integrated and seamless set of medical and other services. For example, Medicaid buy-in (MBI) programs are widely available for Medicaid enrollees with disabilities, allowing participants to work while retaining Medicaid coverage within limits. A potential demonstration could expand the MBI model to all adults with Medicaid to test the long-term savings for Medicaid and low-income assistance programs by Medicaid coverage of job readiness, placement, and retention services; for example, similar to Ohio s successful JobConnect program. By allowing enrollees to retain Medicaid eligibility for a period of time, regardless of income, this would eliminate the financial eligibility cliff that discourages permanent employment. Such a demonstration also could test expanded flexibilities, such as eliminating upper age limits, and varying premiums and cost sharing on a sliding scale according to income. Another example would be a model incentivizing and testing the cost impacts on Medicaid and other low-income programs of providing coordinated and integrated health services for people moved from chronic homelessness into permanent supportive housing, building on a study by the Providence Center for Outcomes Research & Education and work done by the Assistant Secretary for Planning and Evaluation. 8

14 State-Based and Local Innovation, including Medicaid-Focused Models HCBS Infrastructure Medicaid Drug Costs The practicality and viability of HCBS programs in some states or certain geographies within states may be affected by a range of barriers, including workforce attrition and resistance/concerns from facilitybased providers to diversify into HCBS. Some states are trying to address these barriers but may not have federal financial support. Medicaid rules allow states and health plans to develop formularies and certain utilization management processes such as prior authorization common in commercial and other programs for prescription drug coverage, but they generally have less flexibility to incentivize use of the highest value drugs. At the same time, MACPAC finds that prescription drug spending has been a key driver in rising Medicaid costs. Test the impacts on costs, availability of services and institutionalization rates of making state Medicaid and federal matching funds available to address HCBS infrastructure barriers through MLTSS health plans. Examples include: training programs to improve the number of direct care service workers; increased support for direct care service worker wages; and assistance for LTSS providers in rural areas to diversify and convert facilitybased resources to the provision of meaningful, bona fide HCBS that comply with the HCBS settings rule. Test the cost impacts and clinical outcomes of providing states working with health plans with additional flexibility to develop medication management policies for high cost drugs targeted to the needs of a state s population. Any such model should ensure policies are developed in consultation with clinicians and other experts on pharmacy and therapeutics committees or drug utilization review boards, taking into account evidence (from scientific literature, cost effectiveness studies and specialty provider practice guidelines) and statespecific factors (such as the availability of specialists). 9

15 Prescription Drug Models MA-VBID Model Focused on Opioids Expand Enhanced MTM Demonstration The Secretary has declared the opioid crisis a nationwide public health emergency. HHS released a five-point strategy in April of 2017 to combat the opioid crisis, including improvement of access to prevention, treatment, and recovery support services. A large part of this strategy relies on the full range of medicationassisted treatments (MATs). Currently, the MA-VBID model tests the impact of providing plans with the tools and flexibility to promote better health and outcomes among beneficiaries. However, CMS currently limits MA-VBID to certain specified clinical conditions. Currently, CMS has limited the Part D Enhanced MTM model test to five out of 34 Part D regions (i.e., to only 11 states), preventing many plans that are ready and willing to participate nationwide from doing so. In fact, only 6 standalone Part D plan sponsors currently participate in the program. In addition to expanding the geographic and clinical scope of the MA-VBID model, specifically test the public health impact of leveraging innovative benefit designs centered around improving access to prevention, treatment, and recovery support services. Models can include: Expanding coverage and reducing cost sharing for non-opioid and non-medical treatments for pain; Improving access to MATs by allowing MA plans to reimburse Methadone under Part D when used for treating addiction; and Enhancing recovery support services by giving plans the flexibilities to better coordinate medical, behavioral, and mental health services. Enhance testing of the cost and outcomes impacts of the Part D Enhanced MTM model by expanding the model to nationwide testing and providing more plans with the flexibility to identify a wide array of targeting criteria, intervention activities, and provider-beneficiary engagement strategies allowed under the model. 10

16 Prescription Drug Models Aligning Part B and D Drug Coverage Preferred & Non- Preferred Specialty Tiers Flexibility in Implementing the Protected Class Requirement Flexibility in Implementing the Two Drugs Per Class Requirement While the Part D program generally covers outpatient prescription drugs purchased at retail pharmacies, some pharmacy drugs are covered by Part B. This sometimes can create confusion, including cases involving delayed/inconsistent Part B Local Coverage Determinations. In addition, there can be significant differences in payment rates, cost sharing, and other matters for Part B and Part D drugs. CMS has the authority to allow plans to use preferred and non-preferred specialty drug tiering in their Part D plans. However, to date CMS has not permitted this design. Part D plans generally are required to cover all drugs in six protected classes. The statute gives CMS authority to modify the list of classes but has not done so. Though CMS has the authority to allow for one drug per therapeutic class to be covered by a plan, plans are currently required to cover two drugs for each class of drugs. Test the cost and access impacts of applying Part D to all drugs and supplies dispensed at a retail pharmacy. These would include drugs and supplies currently covered by Part B, such as oral anticancer drugs and oral antiemetic drugs. Test the cost and outcomes impacts of preferred and non-preferred specialty tiering. Test the cost and access impacts of providing Part D plans with the flexibility to apply common formulary management tools, developed based on clinical evidence and best practices via a Pharmacy and Therapeutics (i.e., P&T) committee process, for drugs in one or more protected classes. Test the cost and access impact of requiring the coverage of one drug per therapeutic class. 11

17 Mental and Behavioral Health Models Early Identification and Care Coordination for Behavioral Health Conditions Coordinating care for individuals with behavioral health issues presents a broad range of challenges for providers, health plans, and other stakeholders in the current legislative and regulatory environment. These challenges include: Federal rules limiting the sharing of substance use information among providers, affecting coordination and integration of care. A quality measurement infrastructure that is less developed than that for medical/surgical care. A lack of validated evidencebased quality standards and certification/accreditation standards for behavioral health facilities, particularly inpatient or 24-hour residential care facilities. There is significant ambiguity and wide variation in what is considered a residential treatment facility. The laws and regulations applicable to mental health and substance use disorder treatment are subject to multiple jurisdictions and differing interpretations. Test the cost and access impacts of a proactive identifying and conducting outreach to patients with behavioral health concerns using care managers and founded on quality metrics and evidence-based care. 12

18 Program Integrity Models Explore Models of Data Sharing and Aggregation that Allow for Improved Efforts to Reduce Fraud, Waste and Abuse Enhancing Provider Competition Efforts to deter fraud, waste, and abuse are often deterred by the failure to collect and report information or the fragmentation of information that is reported. CMS should ensure that all models tested enhance, and in no case, reduce provider competition. Test models that allow for better sharing of data and information related to fraud, waste, and abuse to further improve efforts to reduce them. The Healthcare Fraud Prevention Partnership (HFPP) has demonstrated the important results that can happen when information is collected, analyzed, and (in an appropriate form) shared. We encourage the Innovation Center to explore incentives for enhanced collection and reporting of information related to fraud, waste and abuse, and also for enhanced processes for utilizing such information including in aggregated form if it is combined with information from other entities. Test actively promoting approaches that are based upon provider competition and reject approaches that rely upon a reduction in provider competition. For example, the Innovation Center should focus on ways in which existing provider competition can be enhanced, e.g., through reporting on common data elements and reward structures based on relative outcomes on those elements. 13