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Blog

CMS announces plans to pursue new Medicare and Medicaid drug payment models

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This week our In Focus section reviews the Centers for Medicare and Medicaid Services’ (CMS) announcement that the agency will explore three new prescription drug payment models in the Medicare and Medicaid programs:

  • Medicare High-Value Drug List Model
  • Cell and Gene Therapy (CGT) Access Model
  • Accelerating Clinical Evidence Model

The announcement – and accompanying report – responds to President Biden’s October 2022 Executive Order directing CMS’ Center for Medicare and Medicaid Innovation (the Innovation Center) to identify models that could lower cost sharing for commonly used drugs and include value-based payment for drugs.

Notably, the Innovation Center offered varying levels of specificity about the models, leaving unanswered many questions about the structures and timelines for the potential models. The Innovation Center will need to conduct more robust analysis to determine the design specifications for each model, stakeholder interest, and practical and political feasibility for each. In addition, each model will need to have its own application or rulemaking process to identify participants and other key model parameters. While this makes it difficult for the Innovation Center to specify timelines, it provides stakeholders some flexibility to analyze and develop recommendations for the potential models over the next several months.

HMA’s experts are also closely tracking CMS’ work on additional areas identified for the agency to research. For example, CMS could consider other regulatory pathways, partnerships, or campaigns to promote the following changes:

  • Opportunities to encourage price transparency for prescription drugs
  • Options to improve biosimilar adoption
  • Medicare fee-for-service options to support CGT access and affordability

The drug payment models build on other federal and state-level efforts to address prescription drug costs and total cost of care initiatives. For example, CMS’ drug payment model announcement comes just a week after the agency released its implementation approach for the drug payment policies approved as part of the inflation Reduction Act of 2022 (IRA) (P.L. 117-169). CMS is balancing the extensive implementation needs for the IRA while also acknowledging the new law may not directly address other value-based considerations impacting cost and access for certain prescription medications.

Below are some of the highlights of the Innovation Center’s drug payment models.

Medicare High Value Drug List Model

The Medicare High Value Drug List model would provide standardized approach to cost sharing for specified Part D medications. CMS suggests a standardized list with consistent cost-sharing to allow providers to easily identify and prescribe appropriate medications. Part D Sponsors could offer a Medicare-defined standard set of approximately 150 high-value generic drugs with a maximum co-payment of $2 for a month’s supply. Under this model, generic drugs included in the standardized list would not be subject to step therapy, prior authorization, quantity limits, or pharmacy network restrictions.

According to the report, CMS could explore leveraging existing systems, which would allow for a streamlined implementation. CMS also plans to seek input from beneficiaries, Part D Sponsors, manufacturers, and providers, but the agency did not provide a more specific timeline for announcing the Model specifications and start date.

Cell and Gene Therapy (CGT) Access

The Cell and Gene Therapy (CGT) Access model would be a voluntary opportunity for states and manufacturers. The model builds on existing state Medicaid initiatives to develop outcomes-based agreements (OBAs) with certain manufacturers of high-cost and breakthrough medications. CMS suggests the multistate test could inform a more permanent framework for evaluating, financing, and delivering CGTs on a broader scale. This model may also help address complexities with the federal drug rebate requirements in states that wish to pursue value-based contracting arrangements. Under this model a state Medicaid agency could choose to adopt the CMS structure for multi-state OBAs with participating manufacturers. CMS would be responsible for implementing, monitoring, reconciling, and evaluating financial and clinical outcomes. Initially the model would focus on CGTs for illnesses like sickle cell disease and cancer.  This approach could remove some of the barriers that have slowed state uptake of OBAs.

CMS plans to begin model development in 2023, announce the model sometime in 2024-25, and test it as early as 2026.

Accelerating Clinical Evidence Model

The Innovation Center is considering mandatory participation for Medicare Part B providers in the Accelerating Clinical Evidence Model. Under this potential model, the agency would adjust Medicare Part B payment amounts for Accelerated Approval Program (AAP) drugs to determine if adjustments incentivize manufacturers to timely complete trials, which in turn may facilitate earlier availability of clinical evidence.

The Innovation Center identified some challenging aspects for this model and stated the agency will need to consult with the U.S. Food and Drug Administration (FDA) in 2023 to consider approaches for this model. Statements from agency officials about the model also indicate the need for consultation with the Medicare Payment Advisory Commission (MedPAC) and other stakeholders, including through an Advance Notice of Proposed Rulemaking.

If the Innovation Center determines this model is feasible, the agency will provide more details about a targeted launch. The Innovation Center has previously attempted to implement mandatory Part B drug payment models but never implemented them due to legal challenges and stakeholder opposition.

HMA and HMA companies will continue to analyze these potential models and initiatives developing in parallel with the Innovation Center’s work. We have the depth and breadth of expertise to assist with tailored analysis, to model policy impacts of the potential models, and to support the drafting of feedback to CMS as it considers these options.

If you have questions about the Innovation Center’s proposed models and how it will affect manufacturers, Medicare providers, Medicaid programs and patients, contact Amy Bassano ([email protected]), Kevin Kirby ([email protected]) or Andrea Maresca ([email protected]).

Blog

Mental health and addiction crises top the federal policy agenda in 2023

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This week our In Focus section reviews President Joseph R. Biden’s 2023 State of the Union Address (SOTU) to Congress. The President highlighted specific actions that Congress, and the Administration have taken over the last two years to advance his health care priorities.

During his first SOTU address in 2022, President Biden announced the creation of a “Unity Agenda”, which included priority policy areas with potential for bi-partisan support. The President highlighted several steps the Administration has taken to advance the “Unity Agenda” including:

  • The bipartisan effort to enact the Mainstreaming Addiction Treatment (MAT) Act, which removed the federal requirement for practitioners to have a waiver (known as the X-waiver) to prescribe medications, like buprenorphine, for the treatment of opioid use disorder
  • The Cancer Moonshot announcements for almost 30 new programs, policies, and resources to close the screening gap, tackle environmental exposure, decrease preventable cancers, advance cutting-edge research, support patients and caregivers, and more.
  • Addressing mental health needs through the expansion of Certified Community Behavioral Health Clinics and launch of the 988-suicide prevention hotline.

In his SOTU and accompanying White House materials, the President also proposed new policies and initiatives to further advance his health care agenda. These actions include a combination of issues that would require Congressional approval as well as actions regulatory agencies can already advance. Congress and the Administration are expected to build on previous bipartisan achievements to tackle the nation’s dual crises with addiction and mental health.

Notably, the policies outlined in the SOTU foreshadow an active regulatory agenda over the next 18 months as the Administration seeks to solidify key aspects of the President’s health care agenda ahead of the next Presidential election.

The Administration’s planned actions include the following:

Opioids

  • Calling on Congress to pass legislation to permanently schedule all illicitly produced fentanyl-related substances into Schedule I.
  • SAMHSA will provide enhanced technical assistance to states who have existing State Opioid Response funds, and will host peer learning forums, national policy academies, and convenings with organizations distributing naloxone beginning this spring.
  • By this summer, the Federal Bureau of Prisons will ensure that each of their 122 facilities are equipped and trained to provide in-house medication-assisted treatment (MAT).
  • This spring CMS will provide guidance to states on the use of federal Medicaid funding to provide health care services—including treatment for people with substance use disorder—to individuals in state and local jails and prisons prior to their release. California is the first state to receive approval for a similar initiative.

Mental Health

  • CDC plans to launch a new campaign to provide a hub of mental health and resiliency resources to health care organizations in better supporting their workforce.
  • The Department of Education (ED) will announce more than $280 million in grants to increase the number of mental health care professionals in high-need districts and strengthen the school-based mental health profession pipeline.
  • HHS and ED will issue guidance and propose a rule to make it easier for schools to provide health care to students and more easily bill Medicaid for these services.
  • The Administration is scheduled to propose new mental health parity rules this spring.
  • HHS will improve the capacity of the 988 Lifeline by investing in an expansion of the crisis care workforce; scaling mobile crisis intervention services; and developing additional guidance on best practices in crisis response.
  • HHS also plans to promote interstate license reciprocity for delivery of mental health services across state lines.
  • HHS intends to increase funding to recruit future mental health professionals from Historically Black Colleges and Universities and to expand the Minority Fellowship Program.
  • The Department of Veterans Affairs (VA), working with HHS and Defense, will launch a program for states, territories, Tribes and Tribal organizations to develop and implement proposals to reduce suicides in the military and among veterans.
  • VA will also increase the number of peer specialists working across VA medical centers to meet mental health needs

Cancer Moonshot

  • The President called on Congress to reauthorize the National Cancer Act to overhaul cancer research and to extend the funding for biomedical research established in the 21st Century Cures Act.
  • The Administration will take steps to ensure that patient navigation services are covered by insurance. This could require legislation depending on which type on insurance an individual has.

Health care costs

  • Urging Congress to pass legislation to cap insulin prices in all health care markets. Expanding the $35 insulin cap to commercial markets will require the 60 votes in the Senate.

Home and community services

  • Working with Congress to approve legislation to ensure seniors and people with disabilities can access home care services and to provide support to caregivers.

HMA and HMA companies are closely monitoring these federal policy developments. We can assist healthcare stakeholders in responding to the immediate opportunities and challenges that arise and contextualize these actions for longer-term strategic business and operational decisions.

If you have questions about these or other federal policy issues and how they will impact your organization please contact Andrea Maresca ([email protected]) or Liz Wroe ([email protected]).

Blog

How will changes to Medicare Part C and D Star Ratings impact your plan?

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What are your plans to minimize your risk to avoid dropping in your Star Rating or to plan a head to maintain or improve your Star Rating?

On February 1, 2023, the Center for Medicare and Medicaid Services (CMS) released the 2024 Advance Notice and included some key specifics on the upcoming changes to the Medicare Star Rating program. CMS is proposing changes that will align with the recently announced “Universal Foundation” of quality measures, a core set of measures that are aligned across CMS quality rating and value-based care programs. The Advance Notice also included information on substantive measure specification updates, new measure concepts, and the addition of measures to align with other CMS programs.

You can learn more about these proposed changes along with a blueprint for improving your Medicare Advantage Star Ratings at the HMA quality conference on March 6 in Chicago. The working session “Moving the Needle on Medicare Stars Ratings” will feature speakers Katharine Iskrant, MPH, CHCA, CPHQ, HEDIS/Stars Auditor, President and Owner, Healthy People; John Myers, BS, M.Eng., VP of Health Quality & Stars, Humana; Vanita Pindolia, PharmD, MBA, VP of Stars Program, Emergent Holdings; and Dr. Kate Koplan, MD, MPH, FACP, CPPS, Chief Quality Officer & Associate Medical Director Quality and Safety, Kaiser Permanente of Georgia

Moderators of this session are HMA’s Mary Walter, Managing Director of Quality and Accreditation, and David Wedemeyer, Principal. Both have health plan legacy experience in Stars strategy, execution and getting results.

Objectives of this session:

  1. Overview of the CMS proposed changes and their impact on the Stars program
  2. Attendees will obtain a blueprint for improving Medicare Advantage Star Ratings, including the importance of ensuring executive management buy-in
  3. Discussion of how the use of data analytics can help plans to identify quality gaps, target interventions, and track improvement
  4. Strategies to avoid the type of siloed initiatives that often fail to achieve lasting results
  5. Speakers will also address the importance of quality in achieving market viability and financial
    sustainability

Stay in the know about the upcoming proposed changes and develop your organization’s strategy in this interactive impactful working session. This session will allow attendees to integrate any learnings and take-aways into your Stars program to meet your overall Star Rating strategic goal.

Follow #HMAtalksQuality on Twitter and LinkedIn for more updates on Stars and quality initiative efforts throughout the year. View the full agenda and register for HMA’s first annual quality conference on March 6 in Chicago. Registration closes on February 21, 2023.

Blog

What is “adequate” behavioral health provider capacity?

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At HMA, our subject matter experts get questions every day from people working in state agencies, counties, health plans and provider groups about how to “right size” the behavioral health continuum to obtain equitable access for growing behavioral health demand. From legislatures to providers, improving access to mental health services is critical to improving overall health outcomes. It is time for behavioral health to create a specific definition of network adequacy that accounts for the complexity and nuance of access to mental health and substance use care. It is time to identify and define the factors that lead to “adequate” provider capacity, to ensure that the right level of care is available to individuals when they need care. Network adequacy in behavioral health needs an overhaul to meet the complexity that is driving access challenges.

Together let’s re-define what “adequate” means in behavioral health to ensure we build systems that meet the needs of communities. At HMA’s quality conference on March 6 in Chicago, the “Developing a Behavioral Health Quality Strategy” working session will engage participants in an in-depth discussion on identifying factors to inform a more accurate definition of behavioral health network adequacy. Speakers will outline some of the core challenges in network adequacy and innovations they have used.  Attendees will work collaboratively in a structured exercise on three knotty challenges within network adequacy to identify factors that could improve measurement for states, plans and providers. The goal is for participants to walk away with tangible actions they can implement in their work on behavioral health access.

Please join HMA’s Serene Olin, Rachel Bembas, and Gina Lasky with our expert panelists:

Nazlim Hagmann, MD, Chief Medical Officer, Commonwealth Care Alliance

Rhonda Robinson Beale, MD, SVP, Chief Medical Officer, Mental Health Services, UnitedHealth Group

Claire Wang, MD, ScD, Associate Deputy Director, Delaware State Department of Health and Social Services, Division of Substance Abuse and Mental Health

And follow #HMAtalksQuality on Twitter and LinkedIn for more updates on behavioral health quality efforts throughout the year. View the full agenda and register for HMA’s first annual quality conference on March 6 in Chicago. Registration closes on February 21, 2023.

Blog

CMS creating a ‘Universal Foundation’ to align quality measures

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Leaders at the Centers for Medicare and Medicaid Services (CMS) announced in the New England Journal of Medicine this month a new initiative called the “Universal Foundation,” which seeks to align quality measures across the more than 20 CMS quality initiatives. The implications for the broader healthcare system are immense. 

At Health Management Associates upcoming quality conference March 6 in Chicago, Dr. Lee Fleisher, one of the authors of the Universal Foundation initiative and, Chief Medical Officer and Director, CMS’ Center for Clinical Standards and Quality, will deliver the keynote address “A Vision for Healthcare Quality: How Policy Can Drive Improved Outcomes.”

Attendees will hear from industry leaders and policy makers about evolving healthcare quality initiatives and participate in substantive workshops where they will learn about and discuss solutions that are using quality frameworks to create a more equitable health system. In addition to Dr. Fleisher, featured speakers will include executives from American College of Surgeons, ANCOR, CareJourney, CareOregon, Commonwealth Care Alliance, Council on Quality and Leadership, Denver Health, Institute on Public Policy for People with Disabilities, Intermountain Health, NCQA, Reema Health, Kaiser Permanente, Social Interventions Research and Evaluation Network, UnitedHealth Group, United Hospital Fund, 3M, and many other organizations.

The Universal Foundation seeks to align quality measures to “focus providers’ attention on measures that are meaningful for the health of broad segments of the population; reduce provider burden by streamlining and aligning measures; advance equity with the use of measures that will help CMS recognize and track disparities in care among and within populations; aid the transition from manual reporting of quality measures to seamless, automatic digital reporting; and permit comparisons among various quality and value-based care programs, to help the agency better understand what drives quality improvement and what does not.”

CMS has established a cross-center working group focused on coordination of these processes and on development and implementation of aligned measures to support a consistent approach. As part of this announcement, the group published a list of Preliminary Adult and Pediatric Universal Foundation Measures. This new quality program will affect clinicians, healthcare settings such as hospitals or skilled nursing facilities, health insurers, and value-based entities such as accountable care organizations.

HMA can help organizations improve their quality efforts in line with the new CMS Universal Foundation initiative. HMA’s more than 500 consultants include past roles as senior officials in Medicaid and Medicare, directors of large nonprofit and social services organizations, top-level advisors, C-level executives at hospitals, health systems and health plans, and senior-level physicians. Our depth of industry-leading policy expertise and clinical experience provides comprehensive solutions that make healthcare and human services work better for people.

To learn more about HMA and Quality, follow #HMAtalksQuality on Twitter and LinkedIn. View the full agenda and register for HMA’s first annual quality conference on March 6 in Chicago. Registration closes on February 21, 2023.