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HMA Insights – including our new podcast – puts the vast depth of HMA’s expertise at your fingertips, helping you stay informed about the latest healthcare trends and topics. Below, you can easily search based on your topic of interest to find useful information from our podcast, blogs, webinars, case studies, reports and more.

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Blog

PBM Reform Accelerates: New Rules, Broader Oversight, and What’s Ahead

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The first quarter of 2026 marked a turning point in federal oversight of pharmacy benefit managers (PBMs), the intermediaries that manage prescription drug benefits for most health plans across the commercial insurance market, Medicare Part D, and other programs. New legislation, agency rulemaking, and enforcement activity collectively signal a new phase of oversight that could materially reshape PBM contracting, compensation, and transparency requirements. 

Most notably, the following developments stand out: 

  • The US Department of Labor (DOL) proposed new disclosure requirements for PBMs that serve self-insured Employee Retirement Income Security Act (ERISA) plans. 
  • The Consolidated Appropriations Act of 2026 (CAA 26), signed February 3, 2026, establishes comprehensive PBM transparency and contracting requirements in the commercial insurance market and Medicare Part D. 
  • The Federal Trade Commission (FTC) finalized a settlement with Express Scripts, Inc. (ESI), requiring significant changes to ESI’s business practices. 

Together, these actions signal a trend toward greater PBM accountability, with implications for plans, pharmacies, manufacturers, and consumers. This article provides a high-level overview of the major recent developments in the PBM reform policy landscape, along with key considerations for stakeholders. 

Medicare Part D: Key Statutory Changes 

Beginning in plan year 2028, CAA 26 makes significant changes for PBMs operating in Medicare Part D. Key provisions include: 

  • Requiring PBMs to provide annual reports to plan sponsor clients detailing aggregate and drug-specific costs 
  • Restricting PBMs compensation structures, prohibiting payments tied to drug prices, rebates, or price-based benchmarks and limiting PBMs to only receive bona fide service fees that reflect fair market value 
  • Stipulating additional parameters related to rebate guarantees, contract terminology, and audit rights 

Additional provisions that will take effect in beginning with plan year 2029 include: 

  • A requirement that plan sponsors and PBMs comply with forthcoming standards for “reasonable and relevant” pharmacy contracting terms and conditions 
  • Expansion of the enforcement infrastructure to avert potential violations of the program’s pharmacy contracting requirements 

Key considerations: The Centers for Medicare & Medicaid Services (CMS) has broad discretion in implementing these provisions, including setting pharmacy contracting standards, determining which PBM affiliates are subject to new requirements, and defining “fair market value.” PBMs will face expanded reporting and compliance obligations, while plans and other stakeholders will have opportunities to shape implementation through the regulatory process. 

Commercial Health Insurance Market: Key Statutory Changes 

For the commercial market, CAA 26 establishes similar transparency requirements for PBMs that serve fully insured and self-insured plans, with reporting required up to four times per year. Unlike Medicare Part D, the statute does not prohibit pricelinked compensation in the commercial market, but it does require detailed disclosure of PBM fees and revenue streams. For contracts with selfinsured plans, PBMs must remit 100 percent of rebates and fees tied to drug utilization, subject to specified limitations. 

Key considerations: These provisions significantly expand federal oversight in the commercial market. PBMs will need to scale compliance infrastructure, while employers and other plan sponsors may seek enhanced analytical and actuarial support to interpret disclosures and assess PBM performance. 

Medicaid Left Out, For Now. 

Unlike prior legislative packages, CAA 26 does not include Medicaid-specific PBM reforms, such as prohibitions on spread pricing (i.e., a PBM charges a payer more than the amount it pays the dispensing pharmacy for a prescription) and expanded National Average Drug Acquisition Cost (NADAC) reporting. 

Key considerations: These policies continue to have bipartisan support and could reemerge in future legislation. States, PBMs, and managed care plans should continue monitoring for renewed federal action on these policies. 

DOL’s Proposed PBM Fee Disclosure Rule 

DOL’s proposed rule, “Improving Transparency Into Pharmacy Benefit Manager Fee Disclosure,” would require PBMs serving self-insured ERISA plans to disclose information about rebates, manufacturer fees, pharmacy payments, and spread pricing. In late February, DOL extended the public comment period to April 15 to allow stakeholders to address how the proposed rule should align with the newly enacted CAA 26 provisions. 

Key considerations: DOL could withdraw the proposal in favor of the statutory framework or could finalize the rule to take effect before the CAA 26 requirements begin. Either path would further increase near-term compliance for PBMs and plan sponsors, and stakeholders should monitor this space closely. 

FTC Settlement with ESI 

The FTC’s settlement with ESI resolves insulin-focused litigation against the PBM and imposes extensive requirements related to transparency, compensation, rebates and fees, and benefit design. The settlement also includes less common provisions, such as a commitment to reshore and increase disclosures related to ESI’s rebate group purchasing organization (GPO) functions. 

Key considerations: If similar settlements are reached with other PBMs, the FTC could play an expanded role in shaping PBM market behavior, supplementing legislative and regulatory reforms with enforcement-driven standards. 

State Efforts to Regulate PBMs 

States continue to pursue PBM reforms, with dozens of laws enacted in recent years addressing licensure, reporting, pharmacy reimbursement, and contracting standards. Although the Supreme Court’s 2020 decision in Rutledge v. PCMA opened the door to certain state-level reforms, subsequent court decisions have narrowed the scope of permissible state regulation, particularly when ERISA preemption or Medicare Part D conflicts arise. 

Key considerations: Stakeholders operating across multiple markets and states will continue to face a complex and evolving patchwork of requirements, underscoring the importance of ongoing policy tracking and compliance coordination. 

Connect with Us 

Recent federal and state actions suggest that PBM reform is entering a more operational phase defined by transparency and enforceable standards governing compensation, contracting, and market behavior. As implementation unfolds, stakeholders across the prescription drug supply chain will need to engage closely with regulators, assess new data flows, and adapt their business practices to a more prescriptive oversight environment. 

For more information about the policies described in this article and the PBM policy landscape more broadly, please contact our experts Conor Sheehey or Stephen Palmer. 

Brief & Report

340B Duplicate Discounts: Enforcement Inconsistent and Weak Due to Lack of Data Transparency and Despite Federal Prohibition

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At the intersection of the federal 340B Drug Pricing program and the federal Medicaid Drug Rebate Program (MDRP), a potentially large set of Medicaid claims are generating duplicate discounts, which pharmaceutical manufacturers provide to eligible entities such as hospitals and health centers. These two complex federal programs were designed to reduce the costs of prescription drugs for providers that serve low-income patients, but both state Medicaid agencies and federal policymakers have been actively working to eliminate the unintended overlap of these two programs. To gain deeper insights into why duplicate discounts continue to occur, the scope of this concern, and to identify considerations of future policymaking, HMA conducted interviews with Medicaid officials and drug policy experts across several states.

Duplicate discounts occur when for a single sale a manufacturer is required to: (1) prospectively reduce the price of the product (a discount) they sell to a 340B covered entity in advance of the delivery of care to the patient; and (2) provide a retrospective payment (a rebate) to a state Medicaid program or managed care plan under the MDRP after care is delivered to a Medicaid enrollee. When duplicate discounts occur the manufacturer’s product is discounted twice for the same sale, contravening federal law, which prohibits duplicate discounts.

Despite the statutory prohibition, duplicate discounts remain a concern. Both state and federal policymakers have been actively addressing duplicate discounts but have been unable to identify clear and consistent policy solutions that neutralize this inefficiency. On the state level, Medicaid agencies and state legislatures have implemented policies to address duplicate discounts. On the federal level, the Health Resources and Services Administration (HRSA) and the Centers for Medicare & Medicaid Services (CMS) have conducted audits and published best practices for states to eliminate duplicate discounts. Nonetheless, duplicate discounts persist. 

To gain deeper insights into how Medicaid agencies navigate duplicate discounts, Health Management Associates (HMA) conducted semi-structured interviews with former and current Medicaid directors and pharmaceutical policy experts in 14 states. Interviewees were asked about the frequency of duplicate discounts, the extent to which Medicaid agencies devote resources to tracking them, the policies states have implemented to address them, and the extent to which state or federal authorities are working to eliminate duplicate discounts.

Based on interviews, four key themes emerged:

  • Duplicate discounts remain a problem, the scope of the problem is unclear, and better data collection from covered entities is necessary.
  • The opacity and complexity of duplicate discounts create a burden for state Medicaid agencies, influencing the policies they implement, resulting in variable state policy strategies.
  • Contract pharmacies add an additional layer of complexity, exacerbating the burden that duplicate discounts create.
  • State and federal authorities could take more decisive action to address duplicate discounts.

Policymakers should consider that the environment for addressing duplicate discounts may become more complex in the future, which may increase the need for a federally coordinated policy solution. The complexity of the environment may deepen due to the increasing presence of contract pharmacies, the increasing presence of managed care in Medicaid programs, and the implementation of the drug pricing policies of the Inflation Reduction Act of 2022. Policy action coordinated across the various stakeholders (e.g., HRSA, CMS, state Medicaid agencies, covered entities, and manufacturers) may represent the best opportunity for success in eliminating duplicate discounts.

Podcasts

Has Medicare’s Drug Policy Struck the Right Balance Between Access and Cost? 

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Kevin Kirby, managing director at Health Management Associates, gives a closer look at the evolution of Medicare’s drug coverage and the policies that have transformed patient access and affordability. From Clinton era ideas, to the launch of the Medicare Modernization Act and then the Affordable Care Act, Kevin has advised clients as these significant milestones have shaped and reshaped Medicare’s drug benefits. He discusses the implications of the Inflation Reduction Act, raising important questions about sustainability and cost control. The episode will explore how these pivotal policies will impact access to treatment and the sustainability of Medicare in a rapidly changing healthcare landscape. 

Blog

HMA annual conference on innovations in publicly sponsored healthcare

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Innovations in Publicly Sponsored Healthcare: How Medicaid, Medicare, and Marketplaces Are Driving Value, Equity, and Growth

Pre-Conference Workshop: October 29, 2023
Conference: October 30−31, 2023
Location: Fairmont Chicago, Millennium Park

Health Management Associates has announced the preliminary lineup of speakers for its sixth annual conference, Innovations in Publicly Sponsored Healthcare: How Medicaid, Medicare, and Marketplaces Are Driving Value, Equity, and Growth.

Hundreds of executives from health plans, providers, state and federal government, investment firms, and community-based organizations will convene to enjoy top-notch content, make new connections, and garner fresh ideas and best practices.

A pre-conference workshop, Behavioral Health at the Intersection of General Health and Human Services, will take place Sunday, October 29.

Confirmed speakers to date include (in alphabetical order):

  • Jacey Cooper, State Medicaid Director, Chief Deputy Director, California Department of Health Care Services
  • Kelly Cunningham, Administrator, Division of Medical Programs, Illinois Department of Healthcare and Family Services
  • Karen Dale, Chief Diversity, Equity, and Inclusion Officer, AmeriHealth Caritas
  • Mitchell Evans, Market Vice-President, Policy & Strategy, Medicaid & Dual Eligibles, Humana
  • Peter Lee, Health Care Policy Catalyst and former Executive Director, Covered California
  • John Lovelace, President, Government Programs, Individual Advantage, UPMC Health Plan
  • Julie Morita, MD, Executive Vice President, Robert Wood Johnson Foundation
  • Anne Rote, President, Medicaid, Health Care Service Corp.
  • Drew Snyder, Executive Director, Mississippi Division of Medicaid
  • Tim Spilker, CEO, UnitedHealthcare Community & State
  • Stacie Weeks, Administrator/Medicaid Director, Division of Health Care Financing and Policy, Nevada Department of Health and Human Services
  • Lisa Wright, President and CEO, Community Health Choice

Publicly sponsored programs like Medicare, Medicaid, and the Marketplaces are leading the charge in driving value, equity, and growth in the U.S. healthcare system. This year’s event will highlight the innovations, initiatives, emerging models, and growth strategies designed to drive improved patient outcomes, increased affordability, and expanded access.

Early bird registration ends July 31. Group rates, government discounts, and sponsorships are available.

Blog

New experts join HMA in April 2023

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HMA is pleased to welcome new experts to our family of companies in April 2023. This diverse team brings significant expertise in Medicare, Medicaid, regulatory strategies, and managed care, strengthening HMA’s capabilities in healthcare consulting across areas like actuarial support, regulatory compliance, and strategic leadership in Medicare Advantage and Medicaid programs.

Headshot of Jed Abell

Jed Abell

Consulting Actuary I

Headshot of Elrycc Berkman

Elrycc Berkman

Senior Consulting Actuary I

Headshot of Monica Bonds

Monica Bonds

Associate Principal

Headshot of Yucheng Feng

Yucheng Feng

Senior Consulting Actuary I

Headshot of Ryan McEntee

Ryan McEntee

Senior Consultant II

Blog

Medicare drug negotiation guidance: what you need to know

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This week our In Focus section reviews the Centers for Medicare and Medicaid Services’ (CMS) announcement of initial guidance for the new Medicare Drug Price Negotiation Program for 2026. This initial guidance is one of many steps CMS described in the Medicare Drug Price Negotiation Program timeline for the first year of negotiation.

The Drug Price Negotiation Program was approved as part of the Inflation Reduction Act (IRA) (P.L. 117- 169) in August 2022. As discussed in our previous In Focus, the IRA includes several other policies aimed at addressing cost, affordability and access to prescription drugs within the Medicare program.

The Drug Negotiation Program allows the U.S. Department of Health and Human Services (HHS) to negotiate maximum fair prices (MFPs) for Part D drugs. Negotiations between HHS and prescription drug manufactures will begin in 2023 and continue into 2024 before negotiated prices go into effect Jan. 1, 2026.

For Medicare payment in 2026, HHS can negotiate prices for up to 10 Part D drugs that do not have generic or biosimilar competition. CMS can increase the number of Part D drugs selected for price negotiation each subsequent year. Starting in 2028, the agency can annually add up to 20 new Part B or Part D drugs to the program.

The published guidance describes CMS’ approach for identifying the drugs selected for the initial year of the program. However, CMS is finalizing these policies as announced for the initial drug negotiation year.

The initial guidance also details the requirements and procedures for implementing the process for the first set of negotiations. For example, the guidance details aspects related to the offer-counter-offer exchange process, confidentiality terms following an agreement, penalties for violations, and the dispute resolution process.

Key Considerations

The drug negotiation program presents numerous operational and policy questions for CMS, manufacturers, and the healthcare sector broadly. The program is expected to have a direct impact on prices and affordability for the Medicare program and its beneficiaries. Additionally, other public and commercial payers will want to consider the potential downstream impacts on their costs. Ongoing monitoring of HHS’ implantation of the drug negotiation program and the pharmaceutical industry’s response to the drug negotiation program will help health plans, providers, and other interested stakeholders navigate this new landscape.

What’s Next

In the short-run, CMS will benefit from feedback from stakeholders about the outstanding policy and operational issues the agency has identified. Comments can be submitted until April 14, 2023

CMS anticipates issuing revised guidance for the first year of negotiation in Summer 2023. By September 1, 2023, CMS plans to publish the first 10 Part D drugs selected for the initial program year. The negotiated maximum fair prices for these drugs will be published by September 1, 2024 and prices will be in effect starting January 1, 2026.

HMA and HMA companies will continue to analyze this and subsequent guidance. We have analytical capabilities and expertise to assist with tailored analysis for manufacturers, providers, patient groups, health plans, and other stakeholders. HMA has the ability to model policy impacts of the drug negotiation program, support the drafting of feedback to CMS as the program is designed and implemented, and provide technical assistance in considering how this new program may interact with other Medicare and Medicaid initiatives.

If you have questions about the Drug Negotiation Program or other aspects of the Inflation Reduction Act and how it will affect manufacturers, Medicare providers, Medicaid programs and patients, contact our experts below.

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 our experts below.

Blog

Lee Fleisher of CMS to keynote HMA national quality conference

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Join us on Monday, March 6, 2023, at the Fairmont Chicago, Millennium Park, for “Healthcare Quality Conference: A Deep Dive on What’s Next for Providers, Payers, and Policymakers,” where Lee Fleisher, MD, chief medical officer and director of CMS’ Center for Clinical Standards and Quality, will deliver the keynote titled A Vision for Healthcare Quality: How Policy Can Drive Improved Outcomes.

HMA’s first annual quality conference will provide organizations the opportunity to “Focus on Quality to Improve Patients’ Lives.” Attendees will hear from industry leaders and policy makers about evolving health care 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 Fleisher, featured speakers will executives from ANCOR, CareOregon, Commonwealth Care Alliance, Council on Quality and Leadership, Intermountain Healthcare, NCQA, Reema Health, Kaiser Permanente, United Hospital Fund, and others.

Working sessions will provide expert-led discussions about how quality is driving federal and state policy, behavioral health integration, approaches to improving equity and measuring the social determinants of health, integration of disability support services, stronger Medicaid core measures, strategies for Medicare Star Ratings, value-based payments, and digital measures and measurement tools. Speakers will provide case studies and innovative approaches to ensuring quality efforts result in lasting improvements in health outcomes.

“What’s different about this conference is that participants will engage in working sessions that provide healthcare executives tools and models for directly impacting quality at their organizations,” said Carl Mercurio, Principal and Publisher, HMA Information Services. 

View the Full Agenda

Early Bird registration ends January 30. Visit the conference website for complete details. Group rates and sponsorships are available.

Blog

CMS proposes significant changes to Medicare Advantage and Part D for 2024

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This week, our In Focus section reviews a rule proposed by the Centers for Medicare & Medicaid Services (CMS) on December 14, 2022, that would revise regulations governing Medicare Advantage (MA or Part C), the Medicare Prescription Drug Benefit (Part D), Medicare cost plans and Programs of All-Inclusive Care for the Elderly (PACE).

Background

The proposed rule reflects the agency’s focus on increasing transparency, improving health equity, reducing the cost of care, and improving access to behavioral health services. Collectively, these are among the most impactful policy changes CMS has proposed to the MA and Part D programs in recent years. CMS also writes that many of the policy proposals are informed by public comments to the agency’s earlier requests for input.

MA and Part D stakeholders will want to consider providing feedback and analysis to CMS regarding the impact of these changes. The changes would begin to take effect for contract year 2024, but stakeholders can begin gap assessments and strategic planning now. Comments on the proposed rule are due by February 13, 2023.

Increased Transparency in Utilization Management and Marketing Policies

The rule proposes to increase the transparency of MA plans’ utilization management and prior authorization policies, with the goal of ensuring that MA enrollees receive the same access to medically necessary care they would receive in Traditional Medicare.

  • CMS proposes that MA organizations must include current evidence in widely used treatment guidelines or clinical literature made publicly available to CMS, enrollees, and providers when creating internal clinical coverage criteria, in situations when no applicable Medicare statute, regulation, National Coverage Determinations (NCD), or Local Coverage Determinations (LCD) establishes when an item or service must be covered.
  • The proposed rule also would streamline prior authorization requirements, including adding continuity of care requirements in ongoing care for beneficiaries by requiring that when an enrollee is granted prior authorization approval it will remain valid for the full course of treatment.
  • The rule would require all MA plans to establish a Utilization Management Committee to review policies annually and ensure consistency with Traditional Medicare’s national and local coverage decisions and guidelines.

The proposed rule also takes steps to address potentially misleading marketing while also ensuring that Medicare beneficiaries have accurate information to make coverage choices.

Increased Focus on Health Equity and Culturally Competent Care

The prosed rule includes several policies designed to increase health equity across the program.

  • In addition to a number of other changes in the Star Ratings program, which measures the quality of care across MA and Part D plans, the proposed rule introduces a health equity index (HEI) reward, beginning with the 2027 plan year. This reward will use data from 2024 and 2025 and is intended to further encourage MA and Part D plans to improve care for enrollees with certain social risk factors (dual eligibility, low-income subsidies, and disability).
  • CMS also proposes clarification of a current requirement for MA organizations to expand the list of populations that they must provide services to in a culturally competent manner.
  • CMS proposes requiring MA organizations to develop and maintain procedures to offer digital health education to enrollees to improve access to medically necessary covered telehealth benefits.
  • In addition, CMS proposes requiring MA organizations to include providers’ cultural and linguistic capabilities in provider directories.
  • CMS proposes that MA organizations must address health disparities as part of existing requirements to develop and maintain quality improvement programs.
  • CMS also proposes to specify in Medicare regulations that MA organizations, cost plans, and Part D sponsors must provide materials to enrollees on a standing basis in any non-English language that is the primary language of at least 5 percent of the individuals in a plan benefit package service area or accessible format using auxiliary aids and services upon receiving a request for the materials or otherwise learning of the enrollee’s preferred language and/or need for an accessible format using auxiliary aids and services. The agency also proposes to extend this requirement to individualized plans of care for special needs plans.

Improving Access to Behavioral Health

CMS proposes policies to strengthen network adequacy requirements and reaffirms the responsibility of MA organizations to provide behavioral health services.

  • Specifically, CMS proposes to specify certain types of mental health professionals as specialty types for which there are specific minimum standards and on which MA networks are evaluated by CMS; amend general access to services standards to explicitly include behavioral health services; codify standards for appointment wait times for both primary care and behavioral health services; clarify that the emergency medical services that must not be subject to prior authorization include behavioral health services to evaluate and stabilize an emergency medical condition; require that MA organizations notify enrollees when the enrollee’s behavioral health or primary care provider(s) are dropped midyear from networks; and require MA organizations to establish care coordination programs, including coordination of community, social, and behavioral health services.
  • CMS also proposes to require organizations to identify certain providers waived to treat patients with medications for opioid use disorder (MOUD) in their provider directories.

Improving Drug Affordability and Access in Part D

CMS proposes greater formulary flexibility for MA and Part D plans for certain biological products and authorized generics. CMS proposes to permit Part D sponsors to immediately substitute: (1) a new interchangeable biological product for its corresponding reference product; (2) a new unbranded biological product for its corresponding brand name biological product; and (3) a new authorized generic for its corresponding brand name equivalent.

In addition, CMS proposes several new requirements for Part D sponsors related to Medication Therapy Management (MTM) programs.

  • Part D sponsors are required to provide an MTM program that ensures Part D drugs are appropriately used to optimize health outcomes through improved medication use and to reduce the risk of adverse events.
  • CMS is proposing several changes to MTM eligibility criteria with the goal of promoting more consistent, equitable, and expanded access to MTM services.

Making Permanent the Limited Income Newly Eligible Transition (LI NET) Program

The LI NET program currently operates as a demonstration program that provides immediate and retroactive Part D coverage for eligible low-income beneficiaries who do not yet have prescription drug coverage. In this proposed rule, CMS proposes making the LI NET program a permanent part of Medicare Part D, as required by statute.

Expanding Low-Income Subsidies Under Part D

CMS proposes to implement a section of the Inflation Reduction Act (IRA), enacted in August 2022, which expands eligibility under the Part D low-income subsidy (LIS) program. Under the provision, individuals with incomes up to 150 percent of the federal poverty level (FPL) and who meet statutory resource requirements will qualify for the full low-income subsidy beginning on or after January 1, 2024. This change will provide the full subsidy to those who currently qualify for only a partial subsidy.

Strengthening Current Policies for MA Plans Serving Populations with Special Needs

The proposed rule includes several proposals to codify existing policies that govern special needs

plans (SNP), which are MA plans specifically designed to provide targeted care and limit enrollment to special needs individuals. Specifically, CMS proposes to codify recent statutory requirements concerning the definition of severe or disabling chronic condition and several other provisions relating to the definition of a Chronic Condition SNP. The rule also proposes several updates to policies governing Programs of All-Inclusive Care for the Elderly (PACE), including technical changes to PACE contracting and application evaluation processes, requirements for medical clearance of PACE personnel, requirements for contracting for specialty services, and codification of certain care planning and care coordination requirements.

The HMA Medicare team will continue to analyze these proposed changes. We have the depth and breadth of expertise to assist with tailored analysis, to model policy impacts, and to support the drafting of comment letters to this rule.

If you have questions about the contents of CMS’s Medicare Advantage proposed rule and how it will impact MA plans, providers, and patients, please contact our experts below.

Link to proposed rule.

Blog

2022 Yearly Roundup: a year of successful partnerships

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The holiday season is grounded in gratitude. At HMA, we are grateful for successful partnerships that have fueled change to improve lives.

We are proud to be trusted advisors to our clients and partners. Their success is our success. In 2022 our clients and partners made significant strides tackling the biggest healthcare challenges, seizing opportunities for growth and innovation, and shaping the healthcare landscape in a way that improves the health and wellness of individuals and communities.

Reforming Colorado’s Behavioral Health System

HMA partnered with the Colorado Department of Human Services to support the planning and implementation of a new Behavioral Health Administration (BHA). HMA provided technical research and extensive stakeholder engagement, drafted models for forming and implementing the BHA, employed an extensive change management approach, and created a detailed implementation plan with ongoing support. Today the BHA is a cabinet member-led agency that collaborates across agencies and sectors to drive a comprehensive and coordinated strategic approach to behavioral health.

From Bid to Trusted Advisor

Wakely Consulting Group, an HMA Company, was engaged to support the launch of a Medicare Advantage (MA) joint venture partnership between a health plan and a provider system. Wakely was responsible for preparing and certifying MA and Medicare Part D (PD) bids, a highly complex, exacting, and iterative effort. The Wakely team quickly became a trusted advisor and go-to resource for the joint venture decision makers. The joint venture has driven significant market growth over its initial years, fueled by a competitive benefit package determined by the client product team.

Laying the Foundation for Modernizing Indiana’s Public Health System

In 2021 Indiana Governor Eric Holcomb appointed a 15-member commission to assess Indiana’s public health system and make recommendations for improvements. The Indiana Department of Health (IDOH) engaged HMA to provide extensive project management and support for six workstreams. HMA prepared a draft report summarizing public input as well as research findings and recommendations. The commission’s final report will form the basis of proposed 2023 legislation, including proposals to substantially increase public health service and funding across the state.

Multiple Clients Accepted into ACO REACH Model

In early 2022 HMA and Wakely Consulting Group, an HMA Company, assisted multiple clients with their applications to participate in the new CMS ACO REACH model. The purpose of this model is to improve quality of care for Medicare beneficiaries through better care coordination and increased engagement between providers and patients including those who are underserved. The team tailored their support depending on each client’s needs. The application selection process was highly competitive. Of the 271 applications received, CMS accepted just under 50 percent. Notably, nine out of the 10 organizations HMA and Wakely supported were accepted into the model.

Pipeline Research and Policy Recommendations to Address New Innovative Therapies

HMA, and subsidiaries The Moran Company and Leavitt Partners, were selected by a large pharmaceutical manufacturer to analyze the current pipeline of innovative therapies, examine reimbursement policies to assess long-term compatibility with the adoption of innovative therapies and novel delivery mechanisms, and make policy recommendations to address any challenges identified through the process. The project equipped the client with a holistic understanding of future potential impacts and actions to address challenges in a detailed pipeline analysis of innovative therapies.

Pipeline Research and Policy Recommendations to Address New Innovative Therapies

Pipeline Research and Policy Recommendations to Address New Innovative Therapies

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THE CLIENT

Large national pharmaceutical manufacturer government affairs team focused on innovative therapies, including cell and gene therapies.

BACKGROUND

The client was looking for an experienced team who could assess the current pipeline of innovative therapies, examine current reimbursement policies to assess long-term compatibility with the adoption of innovative therapies and novel delivery mechanisms, and make policy recommendations to address any challenges identified through the process. HMA, The Moran Company, and Leavitt Partners, both HMA subsidiaries, were selected as the team with the needed expertise and capacity to create several deliverables. These deliverables were focused on the impact of the upcoming pipeline of certain innovative therapies on different payment systems, as well as working with the client’s team to develop and refine federal and state policy recommendations to address identified challenges.

APPROACH

Our collective team developed the following qualitative and quantitative analyses:

  • Pipeline analysis of near-term innovative therapies
  • Analysis of this pipeline’s interaction with current Medicare payment systems
  • Site of services for delivery of therapies and movement across payment systems
  • Overview of FDA oversight of cell and gene therapy
  • Medicaid reimbursement and budgetary issues resulting from pipeline of therapies
  • Payment system capacity issues analysis
  • Development and refinement of policy program recommendations

Pipeline analysis. With the pipeline analysis, the team assessed the types of products and stage of development before undertaking research on characteristics of individual therapies potentially entering the market. Data on potential new products was then stratified to allow for further analysis of key characteristics, such as patient population, type of clinical treatment, acute and chronic use, sites of service, and type of effect of the treatment.

Payment system impacts. The payment analyses included a combination of quantitative and qualitative sources to project the impacts of the pipeline on Medicare and Medicaid, as well as other impacts on payment system capacity.

Policy recommendations. After completing analyses on the different areas of payment impacts resulting from the pipeline of potential therapies, the team developed more than two dozen policy recommendations that could prepare, and further improve, existing payment systems for the pipeline of expected therapies. The team also identified potential strategies to educate policymakers and advance policies. Recommendations included policies related to Medicaid, Medicare, and value-based payments.

RESULTS

The project equipped the client with a holistic understanding of future potential impacts and actions to address challenges in a detailed pipeline analysis of innovative therapies.

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The Impact of the 340B Program on drug prices charged by manufacturers and covered entities

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This week, our In Focus highlights a Leavitt Partners white paper, The Impact of the 340B Program on Drug Prices Charged by Manufacturers and Covered Entities, published in November 2022. Leavitt Partners examined publicly available resources to determine the 340B Drug Pricing Program’s (340B) impact on drug prices charged by both covered entities and pharmaceutical manufacturers. To answer these questions, Leavitt Partners undertook a comprehensive literature review of publicly available governmental reports, peer-reviewed journal articles, white papers, news articles, and other publicly available sources to identify the degree to which, and to what extent, the 340B program may impact drug prices. To supplement this literature review, Leavitt Partners also conducted interviews with ten subject matter experts representing the perspectives of covered entities (including Federally Qualified Health Centers, Ryan White Clinics, and Disproportionate Share Hospitals) and drug manufacturers, as well as the analysis of health economists and academic researchers.

Insights/Key Findings:

  • The 340B program is a mandatory program for pharmaceutical manufacturers wishing to participate in the Medicaid drug rebate program. Today, the program has more than 53,000 participating covered entities and the total amount of drugs purchased at the 340B ceiling price under the program is almost $44 billion (Drug Channels).
  • Drug list prices, like other prices in health care, are increasing. The research for this white paper suggests that 340B is one of many factors putting upward pressure on launch prices.
  • Covered entities can generate savings from the prices charged for 340B drugs. There are no requirements for hospitals for how they use the savings, so pricing for services vary.
  • Lack of comprehensive data across the program limits insights on pricing and discount strategies.
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