Medicare

Driving change in healthcare delivery: HMA Spring Workshop builds towards policy and strategy frameworks necessary to implement value-based care

Federal policy frameworks establishing alternative payment models in Medicare and Medicaid have been the kick-starter of value-based care (VBC) innovation in healthcare delivery. However, employers provide health insurance to most Americans, and very few employers – with the exception of jumbo, self-insured employers  – have leaned heavily into VBC. Small- and medium-sized firms rely on brokers to find an affordable health insurance plan, and often lack the resources required to negotiate more. Though the tide has been changing, our fragmented payment system has yielded only a subset voluntarily taking substantial risk for patient outcomes.

It has been said that to truly transform our American healthcare system to pay for value – improved outcomes for lower cost – it would require better alignment across public and commercial payers to support care providers in shifting their business models to take risk.

Quality and cost information are critical to implement VBC payment and delivery systems. Federal initiatives in Medicare and Medicaid have opened the door for providers, payers, and innovators  to use health information to improve outcomes, with patients more engaged and more in control; the “Universal Foundation” announced by the Centers for Medicare and Medicaid Services (CMS) in 2023 seeks to align quality measures across the more than 20 CMS quality initiatives; and policies included in the 21st Century Cures Act and CMS Interoperability and Patient Access rule are creating more transparency on price and quality.

By enabling an infrastructure to measure, digitize, and share cost and quality information, federal and state governments have set the stage for greater collaboration among all purchasers – including employers – and the healthcare delivery system to redesign care that addresses health related social needs and behavioral health, ensuring that healthcare is provided equitably and sustainably. As the care delivery system is better able to deliver high value care, more employers will demand this for their workforce to provide a better benefit to their workers.

These issues, and more, will be a part of the expert-led conversation on VBC at HMA’s 2024 Spring Workshop March 5-6, in Chicago. This workshop offers a unique opportunity for payers, government officials, community organizations, vendors, and providers to have an unvarnished conversation about the challenges, lessons, and opportunities in implementing VBC. The meeting is designed to share insights, change-oriented strategies and actions that advance VBC from top industry experts, health plan executives, state and federal leaders, and policy experts. 

Our working sessions will feature solutions-focused conversations among peers:

  • Care delivery measures that drive outcomes, equity, population health
  • Payment & risk management models for payment, pricing, attribution
  • Data that is interoperable, consumer focused, deploying technology that is aligned to deliver on strategic objectives
  • Policy & Strategy Frameworks at federal, state, and local levels that incentivize VBC

The closing panel will look at ways to take action through policy and collaboration to move our industry toward more sustainable approaches to healthcare payment and delivery.

To learn more and register for this unique event, please visit HMA’s 2024 Spring Workshop page. Act fast – online registration ends Wednesday, February 28!

Interoperability and patient access final rule: the next phase in the data exchange journey

This week, our In Focus section reviews the Centers for Medicare & Medicaid Services (CMS) Interoperability and Prior Authorization Final Rule, published on January 17, 2024. This is CMS’s latest effort to flesh out regulations mandating payer interoperability and fully electronic prior authorization (PA) policies. The 2024 final rule also represents a new phase in the agency’s work to advance interoperability as it moves beyond policymaking focused on building interoperable systems to policies centered on the applications and usage of shared data.

The new requirements affect a large segment of the nation’s public health insurance programs, including Medicare Advantage (MA) organizations, state Medicaid fee-for-service (FFS) programs, state Children’s Health Insurance Program (CHIP) FFS programs, Medicaid managed care plans, CHIP managed care organizations, and qualified health plan (QHP) issuers on the federally facilitated exchanges (FFEs). These payers must implement and adhere to Health Level 7® (HL7®) Fast Healthcare Interoperability Resources® (FHIR®) application programming interfaces (APIs). These APIs were developed by the DaVinci project and the CARIN Alliance which are both HL7 FHIR accelerator programs. Leavitt Partners, an HMA company, leads the work of the CARIN Alliance.

The final rule demonstrates a commitment to information sharing across the industry landscape and confidence in the FHIR standard to support health data exchange across all required APIs. Ultimately, FHIR APIs are creating a more patient-centered data ecosystem that can provide a tangible return on investment.

Following are details about the requirements, opportunities, and next steps for stakeholders.

Prior Authorization API and Process

Payers must build and maintain PA APIs by January 1, 2027, allowing providers to ask payers whether PA is required for a patient’s procedure, what documents must be submitted to attain authorization, and to receive the final decision and reason for denied requests electronically within a specified timeframe (seven days for standard procedures and three days for expedited decisions).

The rule finalizes requirements for the PA process, regardless of whether the payer receives the PA request through the Prior Authorization API. Specifically, CMS is requiring that:

  • Affected payers send notices to providers when they make a prior authorization decision, including a specific reason for denial when they deny a PA request
  • Payers, other than QHP issuers on the FFEs, respond to prior authorization requests within specific timeframes
  • Affected payers publicly report certain metrics about their PA processes

These prior authorization process requirements become effective January 1, 2026. The last 12 months of PA information also must be shared with patient, providers, and other payers when the member switches a plan through the respective APIs.

To promote adoption of electronic prior authorization processes, CMS is adding an Electronic Prior Authorization measure for Medicare clinicians who participate in the Merit-based Incentive Payment System (MIPS) and hospitals and critical access hospitals in the Medicare Promoting Interoperability Program as an attestation measure.

Payer to Payer FHIR API

To support continuity of care and value-based programs, payers must be able to send, receive, and incorporate enrolled member data from previous and concurrent payers if members are dually enrolled.

To comply with the new electronic data sharing, the final rule requires payers to build and use FHIR API by January 1, 2027. Payer-to-payer (P2P) data sharing will include the last five years of claims/encounters, clinical data, and the active and pending PA requests. The data collected through the P2P APIs will need to be available to the other APIs (i.e., provider, patient, and prior authorization). The rule requires payers to request data from previous payers within a week after the patient opts in to sharing data. For dually enrolled members, data sharing will incur at least quarterly.

Patients must opt in and agree to the P2P data sharing. To this end, health plans must adjust their enrollment administrative process to allow members to easily share previous and concurrent payer information and consent to data sharing. CMS allows Medicaid or CHIP agencies to contract with entities, such as Health Information Exchanges (HIEs), for the digital access and transfer of a patient’s medical records, which supports the Payer-to-Payer API.

Provider Access FHIR API

Payers also must build and maintain a Provider Access API to share patient data with in-network providers with whom the patient has a treatment relationship, enabling continuity and coordination of care, by January 1, 2027. Affected payers must maintain an attribution process to associate patients with the appropriate in-network providers responsible for the patient care. The data from the payer via the Provider Access API must be added to a provider’s electronic health record, practice management solution, or any other technology solution that a provider uses for treatment purposes.

The Provider Access API includes the same data covered in the Payer to Payer Access API (claims/encounters, clinical data, and prior authorizations). The payer has one business day to deliver the required information. Payers must offer a mechanism for members to opt out from making their data available to the attributed providers.

Patient Access FHIR API

The final rule further enhances patient access to data to improve their treatment and shopping experience. In addition to claims and clinical data, as of January 1, 2027, payers must make PA data available through the Patient Access API to inform patients on their plan’s PA process and the status of requests.

In addition, affected payers must report annual metrics about Patient Access API usage and data requests to CMS beginning January 1, 2026.

Key Considerations and Early Results

The rule presents a significant opportunity to improve patient experiences and outcomes and to address some of the administrative burden on clinicians. Though CMS made some adjustments to timeframes in the proposed rule, immediate attention is needed to evaluate technological solutions available to payers, assess gaps between current and future required state, and develop policies to comply with new requirements and measures reporting.

Commercial payers may also leverage the improved electronic data sharing but are not required to do so. CMS-funded payers must respond to any inquiries from commercial payers and must require commercial payers to provide the same information as affected payers. Commercial payers, state governments, and other stakeholders have an opportunity to collaborate around the electronic data exchange.

This rule may have positive downstream application to other areas beyond PA, including quality measurements, risk adjustment, and population health. Early adopters who have implemented the prior authorization APIs have, on average, recorded a 150% – 300% return on investment (ROI). The implementation of API-based prior authorization represents a demonstrable increase in efficiency and significantly reduced provider burden. Given the measurable ROI, state-based regional collaboratives being led by Leavitt Partners are forming between payers and providers to implement the core tenants of the CMS rule well in advance of the 2027 deadline.

Similar initiatives are taking place in the technology space, like the Digital Quality Implementers Community, which was recently convened by Leavitt Partners and National Committee for Quality Assurance (NCQA) to build industry readiness for transitioning to FHIR-based digital measurement that hinges on improved electronic data sharing

What to Watch

The HMA team will continue to analyze the CMS’s Interoperability and Patient Access rule in the context of other federal and state policy changes affecting MA organizations, Medicaid FFS programs, state CHIP FFS programs, Medicaid and CHIP managed care programs, and QHPs.

The work and opportunities afforded with the Interoperability and Patient Access final rule will be featured prominently at The HMA Spring Workshop: Getting Real About Transforming Healthcare Quality and Value, March 5-6. In addition to rich discussions, HMA and HMA companies, including Leavitt Partners and Wakely Consulting LLC, are available to support planning and implementation and related system redesign initiatives. If you have questions about these topics, contact Ryan Howells ([email protected]) and Daniela Simpson ([email protected]).

CMS releases advance notice of methodological changes for MA capitation rates and Medicare Part C and Part D payment policies

This week, our In Focus section reviews the Centers for Medicare & Medicaid Services (CMS) Calendar Year (CY) 2025 Advance Notice for the Medicare Advantage (Part C) and Part D Prescription Drug Programs published on January 31, 2024. Alongside the advance notice, CMS published draft CY 2025 Part D Redesign Program Instructions. This guidance includes CY 2025 payment updates as well as additional proposed technical and methodological changes to Medicare Advantage (MA) and Part D. CMS previously released a proposed rule in November 2023 that included proposed policy changes to MA and Part D for CY 2025.

The proposed payment policies signal CMS is working to ensure the stability of MA and Part D programs, while also addressing concerns about the appropriateness of payments to plans. Furthermore, CMS remains highly focused on the impact methodological changes could have on payment to plans that enroll beneficiaries who are dually eligible for Medicare and Medicaid services. Proposals to align quality measures across programs and strengthen the measures used to assess the quality of beneficiary experiences and services provide directional information on CMS’s plans for the forthcoming annual payment rules for 2025.

Following are highlights from the 2025 Advance Notice and Part D Redesign Program Instructions. The deadline for submitting comments is Friday, March 1, 2024. CMS will announce the MA capitation rates and final payment policies for 2025 no later than April 1, 2024.

Payment Impact on MA: CMS is projecting that federal payments to MA plans will increase on average 3.7 percent from 2024 to 2025. The increase reflects multiple factors, including growth rates in underlying costs, change in Star ratings, continued implementation of the new risk adjustment model and fee for service (FFS) normalization, and risk score trends. Actual impacts of the proposed payment policies will vary from plan to plan.

Risk Adjustment: CMS is proposing to continue its three-year phase in of the updated Part C risk adjustment model, first published in the CY 2024 Rate Announcement. In CY 2025, risk scores will be calculated by blending 67 percent of the risk score using the 2024 CMS hierarchical condition categories (HCC) risk adjustment model and 33 percent using the 2020 CMS-HCC risk adjustment model. In addition, the MA risk score trend is being calculated separately under each model, then blended by the respective percentage to determine a CY 2025 risk score trend of 3.86 percent.

CMS is proposing a new methodology for calculating the FFS normalization factor to accurately address the effects of the COVID-19 pandemic without excluding any years of FFS risk scores.

CMS also proposes to apply the statutory minimum MA coding pattern difference adjustment factor of 5.90 percent for CY 2025.

Frailty Adjustment for FIDE SNPs and PACE Organizations. For CY 2025, CMS is proposing to blend the frailty score calculated for fully integrated dual eligible (FIDE) special needs plans (SNPs) consistent with the phase-in of the 2024 CMS-HCC model. The FIDE SNP frailty score is the sum of:

  • 33 percent of the score calculated with the 2020 CMS-HCC model frailty factors
  • 67 percent of the score calculated with the 2024 CMS-HCC model frailty factors

CMS also intends to use only the full Medicaid frailty factors to calculate frailty scores for FIDE SNP enrollees in order to align with the requirement that FIDE SNPs must have exclusively aligned enrollment, meaning that enrollment in FIDE SNPs will be limited to full-benefit dually eligible individuals, beginning in CY 2025. CMS will use the frailty factors associated with the 2017 CMS-HCC model to calculate frailty scores for Program of All-Inclusive Care for the Elderly (PACE) organizations in CY 2025.

Star Ratings: CMS reiterates its plan to further implement the “universal foundation” of quality measures. CMS first announced this subset of metrics in 2023, with the goal of aligning a core set of metrics across the agency’s programs while continuing to allow for program specific measures. CMS reminds plans that beginning with the 2024 measurement year (2026 Star Ratings), the weight of patients’ experience, complaints, and access measures will be reduced from a weight of four to a weight of two.

CMS proposes several updates and refinements to the Star Ratings program, including:

  • Retiring the Care for Older Adults – Pain Assessment (Part C) measure, starting as early as the 2025 measurement year
  • Making changes to the Plan Makes Timely Decisions About Appeals and Reviewing Appeals Decisions (Part C) measures for cases submitted electronically to the independent review entity
  • Adding Social Need Screening and Intervention (Part C) to the display page for the 2025 Star Ratings and giving notice that National Committee on Quality Assurance (NCQA) is evaluating the potential addition of a utilities insecurity screening and intervention rate for this measure in the future
  • Adding Depression Screening and Follow-Up for Adolescents and Adults (Part C) and Adult Immunization Status (Part C) to the display page for the 2026 Star Ratings
  • Updating the Members Choosing to Leave the Plan (Part C and D) measure for the 2026 Star Ratings
  • Possibly adding the Initiation and Engagement of Substance Use Disorder Treatment (Part C) and Initial Opioid Prescribing for Long Duration (IOP-LD) (Part D) measures
  • Revisions to the Care Coordination (Part C) measure, and other changes through future rulemaking

Part D Impact

The advance notice reviews the significant changes to the Part D benefit occurring in 2025 as required in the Inflation Reduction Act (IRA). The IRA’s Part D changes effective in CY 2025 include:

  • Eliminating the coverage gap phase. A newly defined standard Part D benefit will consist of three phases: annual deductible, initial coverage, and catastrophic coverage. There is no initial coverage limit, and the initial coverage phase will extend to the maximum annual out-of-pocket threshold, after which the catastrophic phase begins.
  • Setting the out-of-pocket threshold at $2,000.
  • Sunsetting the Coverage Gap Discount Program and implementing of the Manufacturer Discount Program (Discount Program).
  • Making changes to the liability of enrollees, plans, manufacturers, and CMS.
  • Updating the definition of incurred costs to include, among other categories of costs, supplemental coverage and other health insurance, which was previously excluded. Manufacturer discounts provided under the Discount Program also will be excluded.
  • Premium stabilization will continue to be in effect.

CMS is recalibrating the RxHCC risk adjustment model to account for IRA changes and is proposing to calculate separate normalization factors for risk scores used to pay MA-PD plans versus PDPs.

Key Considerations

The impact of the MA risk score trend on payment will vary across individual MA plans. Plans will want to analyze these effects to inform their comments to CMS.

In the advance notice, CMS emphasized the strong growth in the dual SNP market for 2024. This market continues to present growth opportunities. CMS has sought to ensure that changes to payment accuracy better reflect more recent cost and utilization patterns and the risk profile of the sickest and most complex enrollees. Plans will want to consider payment incentives in the context of major policy, reimbursement, and operational changes required to improve integrated care for dually eligible individuals. MA organizations considering becoming FIDE SNPs and wishing to obtain frailty payments in 2025 will need to understand the specific requirements to be eligible for such payments.

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 across the multiple rules, and to support the drafting of comment letters on this notice.

If you have questions about the contents of CMS’s MA Advance Notice and payment policies and how these would affect MA plans, including SNPs, providers, and Medicare beneficiaries, contact Julie Faulhaber ([email protected]), Amy Bassano ([email protected]), or Andrea Maresca ([email protected]).

New HMA report analyzes the expanded landscape of value-based entities and market growth opportunities

This week, our In Focus section highlights a new report released on January 25, 2024, Analyzing the Expanded Landscape of Value-Based Entities: Implications and Opportunities of Enablers for the CMS Innovation Center and the Broader Value Movement. The analysis explores the growing ecosystem of new entities designed to assume accountability for the total cost and quality of care in order to understand the growth of this market and consider the role these entities play in advancing accountable care in Medicare, Medicaid, and the broader healthcare sector. The report combines the value-based payment (VBP) policy and market expertise of Health Management Associates (HMA) and Leavitt Partners, an HMA company, with support from Arnold Ventures.

At the start of the movement, value-based arrangements primarily involved traditional providers and payers engaging in relatively straight-forward and limited contractual arrangements. In recent years, the value-based care market has expanded to include a variety of risk-bearing healthcare delivery organizations and provider enablement entities, with capabilities and business models aligned with the functions and aims of accountable care. Despite their prevalence, little formal research has been conducted to determine the role, growth, and impact of these entities to date, and publicly available information is limited.

The report introduces a framework for classifying these entities and estimates the size of this market for the first time. Using insights from 60 interviews with entity leaders, providers, and policymakers, and extensive secondary research into approximately 120 organizations, the report details the common offerings, partnership models, and growth strategies of these entities. The research investigated primary care-focused entities as well as risk-bearing delivery organizations and VBP enablers focused on select specialty areas that align with total cost of care models (i.e., kidney care, oncology, cardiology, behavioral health, and palliative care). Authors examined providers’ experiences selecting and collaborating with enablement partners and the role of these entities within Medicare accountable care models, as well as the broader value movement, to inform a set of guiding principles that help providers and policymakers evaluate the attributes of ideal partners.

Market Landscape

For the past decade, the Centers for Medicare & Medicaid Services (CMS), through its Innovation Center (CMMI), has been leading the movement toward value. Going forward, the agency is focused on scaling accountable care adoption to achieve its 2030 goal, but also seeks to ensure that transformation is equitable and sustainable. These entities are helping providers to engage in accountable care, but our guiding principles and policy recommendations aim to support CMS in ensuring that their growth aligns with provider and patient priorities.

In assessing the value-based care market, the report divided the organizations into three main categories by their core business model: VBP enablers (which are not involved in the direct provision of care, but in assisting others to adopt VBP models); risk-bearing delivery organizations (entities designed to deliver value-based care and assume payment risk for the cost of care); and organizations that are a hybrid of the two (companies that own assets that enable other organizations and those that deliver care).

From risk-bearing delivery organizations with business models that hinge on effective population health management and longitudinal patient relationships, to VBP enablers that provide the population health functions needed to succeed in accountable care while sharing responsibility for those outcomes, these entities are creating more opportunities for clinicians to deliver the type of coordinated, proactive, whole-person care that is unsupported in a fee-for-service system.

A Growing Market

Fueling the growth of value enablers are signals from federal and state policymakers that value-based payment (VBP) is here to stay. The certainty of this approach is already leading to increased focus on underserved populations and safety net providers as CMS places greater focus on expanding VBP contracts in Medicaid and other public insurance programs.

As the market matures and pressure to participate in accountable care mounts, organizations will have several paths forward to implementation of alternative payment models. The growth and availability of enablement entities that are designed with the explicit purpose of helping providers overcome barriers to participation – and whose own financial success hinges on the success of their provider partners – could represent a promising gateway toward achieving accountable care.

The research found several similarities across most entities in this space, demonstrating a highly competitive market, with organizations focused on similar priorities in target providers, geographies, and key populations. Entities often use hybrid, high-touch clinical models to support physicians with patient navigators and other clinical extenders and support staff. They heavily rely on health information technology, and often develop homegrown, proprietary tech assets to better address provider pain points. Finally, most entities depend on outside capital and investment to fuel growth, and investor interest in the space seems to be robust and growing, along with the evolution of value-based care models.

Guiding Principles and Policy Recommendations

The report concludes by proposing a set of guiding principles to describe the optimal attributes of value-based enablement entities aligned with CMS, provider, and patient goals. Authors point to steps CMS can take to best engage with this expanded ecosystem in support of its efforts to scale accountable care while ensuring appropriate guardrails are in place to protect patients and providers.

As CMS works to accelerate adoption of accountable care to achieve its 2030 goal and beyond, the agency must find ways to bring in new providers who have yet to engage meaningfully in these models, while retaining current participants and advancing model designs for the next phase of VBP and delivery reform. The report makes policy recommendations to 1) drive new and sustained provider participation and 2) ensure high-quality partnerships for CMS and providers.

Link to Report

What’s Next

With its acquisition of Leavitt Partners and Wakely Consulting, along with its strong and growing Medicare policy practice, HMA is developing a diverse and robust set of solutions for entities engaging in value-based care and payment. On March 5 and 6, HMA will be devoting its spring event to the topic. The report authors will be featured prominently and will lead a session on the report’s implications. More information about the Spring Workshop, Getting Real about Transforming Healthcare Quality and Value, can be found here.

For details about this research, please contact report authors Kate de Lisle or Amy Bassano.

Driving change in healthcare delivery: HMA Spring Workshop provides deep dive into metrics, coordination, and partnerships for value-based care

LEARN MORE ABOUT HMA’S SPRING WORKSHOP

Within the healthcare sector, there is an imperative for a comprehensive understanding of the care delivery framework that will positively impact outcomes, equity, and the overall health of communities. Among the drivers for this imperative is renewed focus among Medicare officials and interest from states and employers to transition to alternative payment methods that focus on value for payers and patients. A variety of care delivery structures and metrics can be used, and all have a role in driving value-based care (VBC).

One critical element of VBC hinges on whether and how healthcare organizations focus their care delivery structures on patients. VBC also incorporates metrics that further validate the ability of the system to positively impact patient outcomes, reduce health disparities, and improve population health. Emphasizing technology, interdisciplinary collaboration, and streamlined communication can revolutionize the care delivery model.

The HMA workshop-style spring conference on March 5 and 6, is designed to delve deeply into the intricacies of these care delivery frameworks and metrics within the context of VBC. This unique workshop will challenge attendees to roll up their sleeves and actively engage to become part of the solution through an interactive conversation, allowing participants to discuss real-world scenarios, analyze data and metrics and, using small-group breakout sessions, engage in focused and in-depth knowledge sharing.

Break-out sessions facilitated and led by subject matter experts will challenge attendees to identify new solutions around care delivery structures and contractual metrics that improve outcomes, that may include:

  • Engaging providers around consistent approaches to enhance patient outcomes, optimize treatment plans, and ensure the delivery of evidence-based, high-quality care.
  • Developing approaches for patient engagement that improve care delivery and foster active involvement and collaboration between patients and healthcare providers.
  • Crafting strategies for seamless coordination among healthcare providers, spanning sectors, and involving non-traditional providers and community organizations.
  • Understanding components of effective provider network agreements and how they contribute to achieving healthcare goals through strong partnerships and collaborations.

The workshop promises to be a dynamic platform for professionals in the healthcare sector, offering valuable insights, practical strategies, and collaborative opportunities to secure a place for high-quality value-based care. By focusing on care delivery structures, patient engagement, care coordination services, and provider network agreements, attendees will be well-equipped to navigate the complexities of healthcare and contribute to a healthier, more equitable future.

To learn more about the HMA 2024 Spring Conference Workshop and to register, click here.

CLICK HERE TO REGISTER

CMS proposes significant changes to Medicare Advantage and Medicare prescription drug benefit programs for 2025

This week, our In Focus section reviews a wide-ranging proposed rule issued by the Centers for Medicare & Medicaid Services (CMS) on November 6, 2023. The rule would update various policies 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. These proposed policy reforms would implement changes related to Star Ratings, marketing and communications, agent/broker compensation, health equity, dual eligible special needs plans (D-SNPs), utilization management, network adequacy, and other programmatic areas. The proposals reflect the agency’s continuing focus on increasing program transparency, improving health equity, reducing the cost of care for Medicare beneficiaries, and expanding access to behavioral health services.

MA and Part D stakeholders are encouraged to provide CMS with feedback and analysis regarding the potential impact of these changes. Comments on the proposed rule are due by January 5, 2024. The final rule would take effect in contract year 2025.

Improving Access to Behavioral Health Care Providers

CMS proposes regulatory changes intended to improve access to behavioral healthcare by adding certain provider specialties to the MA network adequacy standards as follows.

  • CMS proposes to add a new facility-specialty type to the existing list of facility-specialty types evaluated as part of its plan network adequacy reviews. The new facility-specialty type, outpatient behavioral health, would be included in network adequacy evaluations, including marriage and family therapists (MFTs), mental health counselors (MHCs), opioid treatment programs, community mental health centers, and/or other behavioral health and addiction medicine specialists and facilities.
  • MFTs and MHCs will be eligible to enroll in Medicare and start billing for services beginning January 1, 2024, because of the new statutory benefit category established in the Consolidated Appropriations Act (CAA) of 2023. CMS proposes to make corresponding changes to its network adequacy requirements for MA organizations.
  • For purposes of the network adequacy requirements, the new facility-specialty type would be evaluated using time and distance and minimum number standards in the proposed regulation.

Increased Transparency for Special Supplemental Benefits for the Chronically Ill

In 2018, Congress enacted new authorities pertaining to supplemental benefits for MA members with chronic health conditions. CMS refers to this category of benefits as Special Supplemental Benefits for the Chronically Ill (SSBCI). These services are available only to enrollees with ongoing conditions and who meet certain criteria established in the statute. In contrast to the general policy that MA benefits should be offered uniformly to all plan members, MA plans may offer SSBCI tailored to a qualifying individual’s specific medical diagnosis and needs.

Supplemental benefits, including SSBCI, are generally funded with MA plan rebate dollars. CMS notes that the number of MA plans that offer SSBCI—and the number and scope of SSBCI that individual plans provide—has increased since their introduction in 2019.

Under the proposed rule:

  • MA organizations would be required to demonstrate, through relevant and acceptable evidence, that an item or service offered as SSBCI has a reasonable likelihood of improving or maintaining the health or overall function of chronically ill beneficiaries. MA plans also must, by the date on which they submit a bid to CMS, include a bibliography of evidence supporting this position. According to CMS, this expectation would shift the burden of proof from the agency to MA organizations, requiring plans to demonstrate compliance with this standard and that SSBCI items and services are evidence-based.
  • MA plans must follow their written policies based on objective criteria for determining enrollee eligibility for SSBCI when making determinations.
  • Require that MA plans document denials of SSBCI eligibility rather than its approvals.
  • CMS would codify its authority to review and deny approval of an MA organization’s bid if the plan cannot demonstrate, through relevant and acceptable evidence, that its proposed SSBCI has a reasonable expectation of improving or maintaining the health or overall function of a chronically ill enrollee.
  • CMS also would codify its authority to review SSBCI offerings annually for compliance and in light of the available evidence.

According to CMS, these proposals, if implemented, would better ensure that the benefits offered as SSBCI are reasonably expected to positively affect the health and well-being of chronically ill beneficiaries and guard against the use of MA rebate dollars for SSBCI that unsubstantiated.

In addition, CMS is proposing new policies to improve transparency regarding SSBCI so that beneficiaries are aware that SSBCI are only available to enrollees who meet the eligibility criteria. More specifically, CMS proposes to:

  • Modify the current requirements for the SSBCI disclaimer that MA organizations must use whenever SSBCI are mentioned. The SSBCI disclaimer would have to list the relevant chronic condition(s) that qualify for the benefits that MA organizations offer.
  • Establish specific font and reading pace parameters for the SSBCI disclaimer in print, television, online, social media, radio, other voice-based ads, and outdoor advertising, including billboards. Finally, it would clarify that MA organizations must include the disclaimer in all marketing and communications materials that mention SSBCI.

Requiring Mid-Year Enrollee Notification of Available Supplemental Benefits

As noted previously, over the past several years, the number of MA plans offering supplemental benefits has increased. The benefits offered are broader in scope and variety, and an increasing amount of MA rebate dollars are being directed toward these benefits. At the same time, plans have reported that the number of enrollees who use many of these benefits is low.

  • CMS proposes requiring MA plans to notify enrollees mid-year of the unused supplemental benefits available to them. The notice would list any supplemental benefits that a beneficiary does not use during the first six months of the year (January 1−June 30).
  • At present, MA plans are not required to send any communication specific to an enrollee’s usage of supplemental benefits. This policy is intended to educate enrollees on their access to supplemental benefits and encourage greater use of these benefits.

Enhancing “Guardrails” for Agent and Broker Compensation

For many years, CMS has set upper limits on the compensation that agents and brokers can receive for enrolling Medicare beneficiaries in MA and Part D plans. CMS believes that many MA and prescription drug payment plans, as well as third-party entities with which they contract, make structured payments to agents and brokers that circumvent these compensation caps.

  • In this regulation, CMS proposes to generally prohibit contract terms between MA organizations and agents, brokers, or other third party marketing organizations (TPMOs) that may interfere with the agent’s or broker’s ability to objectively assess and recommend the plan that best-suited to a beneficiary’s healthcare needs; to set a single reimbursement rate for all plans; to revise the scope of items and services included within agent and broker compensation; and to eliminate the regulatory framework that currently allows for separate payment to agents and brokers for administrative services.
  • The agency would make conforming changes to the Part D agent broker compensation rules.

Requiring an Annual Health Equity Analysis of Utilization Management Policies and Procedures

CMS proposes several regulatory changes to the composition and responsibilities of an MA organization’s utilization management (UM) committee.

  • The new rules would require that a member of the UM committee have expertise in health equity and that the UM committee conduct an annual health equity analysis of the use of prior authorization.
  • The proposed analysis would examine the impact of prior authorization on enrollees with one or both of the following social risk factors (SRFs): receipt of the low-income subsidy, dual eligibility for Medicare and Medicaid (LIS/DE), or a disability.
  • The proposed analysis must compare metrics related to the use of prior authorization for enrollees with the specified SRFs with enrollees without the specified SRFs. The results of the analysis must be made publicly available on the MA organization’s website in an easily accessed manner.

Enhancing Enrollees’ Right to Appeal an MA Plan’s Decision to Terminate Coverage for Non-Hospital Provider Services

Beneficiaries enrolled in traditional Medicare and MA plans have the right to a fast-track appeal by an independent review entity (IRE) when their covered skilled nursing facility (SNF), home health agency (HHA), or comprehensive outpatient rehabilitation facility (CORF) services are being terminated. At present, quality improvement organizations (QIOs) function as IREs and conduct these reviews.

Furthermore, MA enrollees do not have the same access to QIO review of a fast-track appeal as traditional Medicare beneficiaries.

CMS proposes to:

  • Require that QIOs, instead of MA plans, review untimely fast-track appeals of an MA plan’s decision to terminate HHA, CORF, or SNF services
  • Fully eliminate the provision requiring the forfeiture of an enrollee’s right to appeal a termination of services decision when they leave the facility

According to CMS, these proposals would align MA regulations with the parallel reviews available to beneficiaries in traditional Medicare and expand the rights of MA beneficiaries to access the fast-track appeals process.

Increasing the Percentage of Dually Eligible Managed Care Enrollees Who Receive Medicare and Medicaid Services from the Same Organization

In the proposed rule, CMS expresses concern that a significant number of dually eligible enrollees receive Medicare services through one managed care entity and Medicaid services through another (misaligned enrollment), rather than from one organization (aligned enrollment. The proposed rule states that in the long run, “for dually eligible individuals who are in Medicare and Medicaid managed care, we believe that we should continue to drive toward increasing aligned enrollment until it is the normative, if not only, managed care enrollment scenario…. For dually eligible individuals that elect MA plans, we are focused on increasing enrollment in integrated D-SNPs: fully integrated dual eligible special needs plans (FIDE SNPs), highly integrated dual eligible special needs plans (HIDE SNPs), and applicable integrated plans (AIPs) [pages 286-287].”

To move in this direction, CMS offers several interconnected proposals as follows:

  • Replace the current quarterly special enrollment period (SEP) with a monthly SEP for dually eligible individuals and others enrolled in the Part D low-income subsidy program to elect a standalone PDP
  • Create a new integrated care SEP to allow dually eligible individuals to elect an integrated D-SNP on a monthly basis
  • Limit enrollment in certain D-SNPs to individuals who are also enrolled in an affiliated Medicaid managed care organization (MCO)
  • Limit the number of D-SNP plan benefit packages an MA organization, its parent organization, or an entity that shares a parent company with the MA organization, can offer in the same service area as an affiliated Medicaid MCO

According to CMS, these initiatives would increase the percentage of dually eligible MA enrollees who are in plans that are also contracted to cover Medicaid benefits, thereby expanding access to integrated materials, unified appeal processes across Medicare and Medicaid, and continued Medicare services during an appeal.

Impose New Contracting Standards for Dual Eligible Special Needs Plan (D-SNP) Look-Alikes

Under existing regulations, CMS does not contract with and will not renew the contract of a D-SNP look-alike; that is, an MA plan that is not a SNP but in which dually eligible enrollees account for 80 percent or more of total enrollment. CMS proposes to lower the D-SNP look-alike threshold from 80 percent to 70 percent in 2025 and to 60 percent in 2026. CMS states that this proposal is intended to help address the continued proliferation of MA plans that serve high percentages of dually eligible individuals without meeting D-SNP requirements.

Other Topics in the Proposed Rule

In addition, the proposed rule calls for:  

  • Providing greater flexibility for Part D plan sponsors to substitute biosimilar products during the plan year
  • Limiting out-of-network cost sharing for D-SNP PPOs
  • Standardizing the MA risk adjustment data validation appeals process
  • Expanding permissible data use and data disclosure for MA encounter data including for support for Medicaid and state Medicaid agencies to better coordinate care for dually eligible individuals

The Health Management Associates 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. For more information or questions about the policies described, contact Amy Bassano ([email protected]), Julie Faulhaber ([email protected]), Andrea Maresca ([email protected]), or John Richardson ([email protected]).

CMS issues final 2024 provider payment rules

This week, our In Focus section reviews several calendar year (CY) 2024 Medicare payment final rules that the Centers for Medicare & Medicaid Services (CMS) issued in recent weeks, including those pertaining to:

CMS also announced the OPPS Rule for 340B-Acquired Drug Payment Policy in response to court-invalidated payment rates and on November 6, 2023, released the 2025 Contract Year Policy and Technical Changes to Medicare Advantage. The latter regulation addresses guardrails for brokers, behavioral health expansions, and several dual eligible-related policies. We will analyze these provisions in next week’s In Focus.

These final rules set the payment rates and other Medicare payment policies for services that applicable providers provide under the fee-for-service Medicare program and take effect January 1, 2024. Additionally, the final rules, particularly the Physician Fee Schedule, are expected to further inform Congress’ discussions and, ultimately, any action on healthcare policies in a possible year-end legislative package.

For example, the Senate Finance Committee has released draft language that would mitigate the projected physician payment reduction, among other policy changes. Provider organizations and interested stakeholders will want to analyze the impact of the final policies across the rules, including new codes, payment rates, and opportunities to participate in accountable care organizations (ACOs).

Overall, Health Management Associates (HMA) notes several trends across these three Medicare payment regulations:

  • Health equity remains a significant focus of CMS under the Biden Administration.
  • The agency continues to expand its coverage of behavioral health services under Medicare and enhance payment for and access to these services.
  • Medicare is moving toward incrementally supporting care delivered in accordance with beneficiaries’ preferences, such as moving away from reimbursing largely for in-person services and toward supporting telehealth services.
  • CMS is creating pathways for reimbursement for a broader range of clinicians and caregivers who are addressing Medicare beneficiaries’ needs.
  • CMS continues its efforts to improve hospital price transparency with policies aimed at encouraging providers to publicly report data.

2024 Medicare Physician Fee Schedule and Other Part B Payment Policies Final Rule

On November 2, 2023, CMS released the final rule for the Medicare Physician Fee Schedule (MPFS) for CY 2024. CMS finalized an overall 1.25 percent decrease in MPFS payment rates from 2023 to 2024. The final 2024 PFS conversion factor remains largely unchanged ($32.74) from the proposed rule ($32.75) but will result in a 3 percent decrease from the CY 2023 conversion factor ($33.89). Among the most important policy changes in the final rule is the establishment of a new add-on code (G2211) for complex care provided in the primary care setting.

In addition, CMS will begin allowing additional behavioral health providers to participate in Medicare (described further below) and make numerous telehealth policy changes mandated in the Consolidated Appropriations Act of 2023. CMS also finalized changes to the Medicare Shared Savings Program (MSSP), which CMS estimates will increase ACO participation in MSSP by roughly 10−20 percent.

CMS finalized several policies to address health equity, including coding and payment changes focused on providing access to new services and addressing Medicare beneficiaries’ unmet health-related social needs (HRSNs). The final changes affect mental health and substance use disorder (SUD) treatment providers, address payment accuracy for primary care in the context of whole-person care, and expand access to dental care for cancer patients. The changes for 2024 include:

  • Caregiver training: Medicare will now pay practitioners who train caregivers to support patients with certain diseases (e.g., dementia) in carrying out a treatment plan. Services must be furnished by a physician or a non-physician practitioner or therapist.
  • Community health integration (CHI) services: The final rule includes separate coding and payment for CHI services, including person-centered planning, health system coordination, and facilitating access to community-based resources to address unmet social needs that interfere with a practitioner’s diagnosis and treatment plan.
  • Principal illness navigation (PIN) services: The final coding and payment rules for PIN services describe care navigation services for individuals with high-risk conditions. CMS included a subset of PIN services to support individuals with severe mental illness and SUD through use of auxiliary personnel (i.e., peer support specialists). The definition of a serious, high-risk condition is dependent on clinical judgment. CMS will monitor utilization across beneficiaries and specialties to ascertain how PIN services are best used going forward.
  • Social determinants of health risk assessments: This evaluation can be provided and billed as an add-on service to an annual wellness visit or with an evaluation and management or behavioral health visit.
  • Marriage and family therapists and mental health counselors, including eligible addiction, alcohol, or drug counselors who meet qualification requirements for mental health counselors: These types of providers may now enroll in Medicare and bill for their services starting January 1, 2024. The rule expands coverage and increases payment for crisis care (including mobile units), SUD treatment, and psychotherapy as well as psychotherapy performed in conjunction with an office visit and for health behavior assessment and intervention services.

2024 Hospital OPPS and ASC Final Rule

On November 2, 2023, CMS released a final rule for hospital OPPS and ASCs. The following policies are included in the final rule:

  • A 3.1 percent increase in payment rates for hospitals and ASCs that meet certain quality reporting requirements. This amount is based on the projected 3.3 percent increase in the hospital market basket and is consistent with the 2024 payment increase for inpatient services.
  • No services will be removed from the inpatient-only (IPO) list, but 10 procedures will be added to the IPO.
  • The list of ASC-covered surgical procedures will be updated to include 37 additional surgical procedures.
  • Drugs and biologicals acquired through the 340B program will have the same payment rate as those not acquired under the 340B program—the average sales price plus 6 percent.
  • CMS will pay for intensive outpatient program services. The final rule includes the scope of benefits, physician certification requirements, coding and billing, and payment rates.

340B Rule

Section 340B of the Public Health Service Act (340B) allows participating hospitals and other providers to purchase certain covered outpatient drugs or biologicals from manufacturers at discounted prices. Until 2018, the Medicare payment rate for Part B-covered outpatient drugs provided in outpatient hospitals was generally the average sales price (ASP) plus 6 percent. From 2018 through September 2022, CMS paid for these drugs at ASP (22.5 percent). After extensive litigation and a Supreme Court ruling, CMS returned payment for 340B drugs to ASP plus 6 percent in late 2022, and payment has continued at that level since. Consequently, payment for other services was reduced slightly more than 3 percent in 2023 to meet statutory budget neutrality requirements.

In this rule, CMS finalizes a remedy for 2018−22 payments in light of the court rulings. The agency will provide lump sum payments to 340B hospitals to cover the difference between ASP + 6 percent and ASP – 22.5 percent. Lump sum payments to 340B hospitals will result in roughly $9 billion in payouts to these facilities, in addition to the $1.5 billion they already have received through resubmitted claims. CMS had proposed that beginning in 2025, non-drug OPPS payments would be reduced by 0.5 percent to recover the budget neutrality-based payment increases resulting from the rescinded 340B cuts. According to CMS, hospitals received approximately $7.8 billion in additional spending on non-drug items and services because of budget neutrality. Earlier this year, CMS proposed a 0.5 percent pay cut to all hospitals, which would be in place for 16 years to fully adjust for the payment changes. CMS is finalizing the budget neutrality adjustment but will defer implementing these cuts to 2026 based on public comments about hospital budgetary pressures.

CY 2024 Home Health Prospective Payment System Final Rule

On November 1, 2023, CMS issued the CY 2024 Home Health Prospective Payment System (HH PPS) Rate Update final rule, which informs Medicare payment policies and rates for home health agencies (HHAs). This rule includes routine revisions to the Medicare Home Health PPS payment rates for CY 2024 in accordance with existing statutory and regulatory requirements. According to CMS estimates, Medicare payments to HHAs in CY 2024 will increase in the aggregate by 0.8 percent, or $140 million, from CY 2023.

However, CMS also finalized a permanent prospective payment adjustment to the CY 2024 home health 30-day period payment rate that reduces the update. This adjustment is intended to account for any increases or decreases in aggregate expenditures that result from the implementation of the Patient-Driven Groupings Model (PDGM) and 30-day unit of payment as required in the Bipartisan Budget Act of 2018. The finalized −2.890 percent adjustment is half the total projected adjustment of negative 5.779 percent. As a result, CMS estimates that Medicare payments to HHAs in CY 2024 will increase in the aggregate by 0.8 percent, rather than the 2.2 percent decrease as initially proposed.

CMS’ decision to implement only half of the permanent prospective payment adjustment in CY 2024 was in response to concerns from public commenters about the magnitude of implementing the proposed large single-year payment reduction. However, CMS also maintains that it will have to account for the remaining permanent adjustment it chose not to apply in CY 2024 and make other potential adjustments to the base payment rate in future rulemaking.

Other Proposals

CMS also is finalizing proposals to:

  • Rebase and revise the home health market basket to adopt a 2021-based home health market basket, including proposed changes to the market basket cost weights and price proxies
  • Reduce the labor-related share of the market basket to 74.9 percent based on the 2021-based home health market basket compensation cost weight (down from 76.1 percent)
  • Recalibrate the PDGM case-mix weights using CY 2022 data
  • Update the low utilization payment adjustment thresholds, functional impairment levels, and comorbidity adjustment subgroups for CY 2024
  • Codify statutory requirements for disposable negative pressure wound therapy
  • Establish regulations to implement payment for items and services under two new benefits: lymphedema compression treatment items and home intravenous immune globulin
  • Establish several enrollment provisions for hospices and other provider types and create a new informal dispute resolution process for hospice programs and a special focus program to provide enhanced oversight of the poorest-performing hospices
  • Implement various changes to the Home Health Quality Reporting Program and Home Health Value-Based Purchasing Model

2024 End-Stage Renal Disease Prospective Payment System Final Rule

On October 27, 2023, CMS issued a final rule that updates payment rates and policies under ESRD PPS for renal dialysis services furnished to Medicare beneficiaries on or after January 1, 2024. This rule also updates the acute kidney injury (AKI) dialysis payment rate for renal dialysis services that ESRD facilities furnish in CY 2024.

For CY 2024, CMS will increase the ESRD PPS base rate to $271.02, upping total payments to ESRD facilities by approximately 2.1 percent. The CY 2024 ESRD PPS final rule also includes several changes related to ESRD PPS payment policies.  First, the rule includes a payment adjustment that will increase payment for certain new renal dialysis drugs and biological products after the transitional drug add-on payment adjustment period ends. According to CMS, the increase will ensure payment is not a barrier to accessing innovative treatments for Medicare ESRD beneficiaries.

For more details about the policies described herein, contact Amy Bassano ([email protected]), Zach Gaumer ([email protected]), Andrea Maresca ([email protected]), John Richardson ([email protected]), Kevin Kirby ([email protected]), or Rachel Kramer ([email protected]).

Cut to the Point: A Summary of 2024 Star Rating Cut Point Changes

This week, our In Focus section highlights a white paper that Wakely, a Health Management Associates company, released in October 2023, “Cut to the Point: A Summary of 2024 Star Rating Cut Point Changes”. The paper reviews 2024 Medicare Star Rating data, including the Star Rating Technical Notes, which the Centers for Medicare & Medicaid Services (CMS) released October 13, 2023.

The data summarizes how Medicare Advantage Organizations (MAOs) performed on various quality measures during the 2022 measurement year and serves as an indication of changing Medicare Advantage spending in 2025 as a result of changes in Medicare Advantage Prescription Drug (MA-PD) Overall Star Ratings. The publication of the 2024 Star Rating Technical Notes provided an opportunity for Wakely to analyze measure-level cut point changes. This paper looks at the latest cut point changes to determine how the Tukey Outlier Deletion methodology and changes in the overall quality performance have affected Star Rating cut points.

Link to White Paper

Wakely will also host a webinar, Stars and Strikes: 2024 Star Ratings and the Impact of Tukey, at 2:30 pm ET on November 14, 2023. The webinar will cover the recently released 2024 Star Ratings, including an analysis of the expected impact on 2025 Medicare payments. Attendees should expect to hear discussions about the latest program changes and resulting impact on the contract-level star ratings, including implementation of the Tukey outlier deletion methodology. In addition, Wakely colleagues will cover the upcoming changes to the Star Rating program and discuss their potential impact on Medicare Advantage Organizations.

For questions, please contact Suzanna-Grace Tritt, [email protected], or Lisa Winters, [email protected].

CMS AHEAD model offers a flexible framework for state-led total cost of care initiatives

This week, our In Focus section reviews the new States Advancing All-Payer Health Equity Approaches and Development (AHEAD) Model, which the Centers for Medicare & Medicaid Services (CMS) Center for Medicaid and Medicare Innovation (the Innovation Center) announced on September 5, 2023. AHEAD is the third major model that the Innovation Center has introduced to its payment portfolio since July, clearly signaling that CMS has transitioned from conducting its internal review to laying the groundwork for action on approaches that will be tested over the next decade.

CMS views this model as the next iteration of earlier total cost of care (TCOC) models that were designed and tested in three states—Maryland, Vermont, and Pennsylvania. The AHEAD model includes several important updates based on its experience with these earlier models. For example, the AHEAD model is designed to be scalable in multiple states. Although it most certainly will be adapted to state-specific markets, landscapes, and provider needs, CMS intends to apply a consistent framework across participating states.

Additionally, though Medicare has been involved in formulating some state-level total cost of care initiatives, the AHEAD model promises specific investments in primary care and enhanced member engagement to support all-payer movement toward patient-centered care.

AHEAD Model Parameters

The goal of the AHEAD Model is to improve population health and health equity in states that apply and that CMS selects for participation. CMS plans to select up to eight pilot states, each eligible to receive up to $12 million to support statewide implementation over a six-year period. States will be accountable for constraining overall growth in healthcare expenditures. Requirements centered on health equity mirror other CMS policies and are integrated throughout the model.

The model focuses heavily on strengthening primary care. The primary care AHEAD component includes Medicare reimbursement for care management, a commitment to align with ongoing Medicaid transformation efforts, and expectations for primary care practices to achieve certain goals on quality measures.

The investments in primary care are paired with global budgets for hospitals. Participating hospitals will receive a fixed payment that will include both Medicare fee-for-service and Medicaid. States will need to ensure participation among other payers, including at least the state employee health plan, Marketplace Qualified Health Plans, or other commercial payers in the state or sub-state region. Other payers will have the option to pay participating hospitals based on a global budget.

All-Payer Health Equity Approaches and Developments (AHEAD)

Source: https://www.cms.gov/files/document/ahead-infographic.pdf

The model will be in operation 2024−2034, and three cohorts will be to accommodate variation in readiness among participating states and providers. The first cohort pre-implementation period is scheduled to begin in summer 2024, and the performance period is scheduled to begin as soon as January 2026. CMS expects to release additional details in fall 2023.

AHEAD Opportunities and Considerations

The AHEAD Model will need significant gubernatorial leadership and possibly from state legislators, depending upon the particular state’s related healthcare laws, and the model does provide flexibility for interested states and relevant stakeholders to develop programs that are adaptable to their needs.

Health Management Associates (HMA) experts have identified the following list of policies and considerations that states; hospitals, health systems, and provider organizations; other payers, including employers; and other stakeholders will need to bear in mind when determining whether to participate in the program.

  • States will need to describe their partners and provide an assessment of their readiness to implement the AHEAD model. CMS will expect states to address whether they have legislation in place related to primary care investment and/or cost growth. Potential participating states should be able to describe their vision for population health improvement and primary care transformation, a proposed strategy for hospital and primary care provider recruitment, a plan for Medicaid and multi-payer alignment, and their current population health and health equity activities. Interested states will need early input from hospitals and health systems, providers, and other payers to define, develop, and implement a model that accommodates their healthcare landscape.
  • States will develop a Medicaid hospital global budget methodology that must have CMS approval. Medicaid hospital global budgets must be implemented in the first performance year. CMS will develop a standardized Medicare fee-for-service (FFS) hospital global budget methodology, that also accommodates critical access hospitals (CAHs).
  • CMS will set the parameters for quality measurement, but states will have significant flexibility to establish the metrics that will be applied for accountability and bonus purposes. CMS will use the current CMS hospital quality programs as the basis for determining eligibility for a health equity improvement bonus. CAHs will have a similar opportunity. States will work with CMS to set quality measures for participating primary care practices.
  • The model requires a statewide health equity plan. Additionally, participating hospitals will need to create their own health equity plans in alignment with statewide priorities and activities.
  • Participating states will need to generate savings. CMS will identify state-specific factors to determine the level of expected savings. All-payer cost growth targets include Medicare FFS, Medicare Advantage, Medicaid, commercial, state employee health plans, and marketplace-qualified health plans. States will also be responsible for performance on all-payer and Medicare FFS primary care investment targets.

The HMA team will continue to evaluate the AHEAD model as more information becomes available. We also can answer questions about the Innovation Center’s other recently announced models and the linkages with new Medicare and Medicaid regulations. For more information, contact Amy Bassano, Caprice Knapp, and Andrea Maresca.

CMS Takes Next Major Step in Medicare Drug Price Negotiation Program

This week’s In Focus centers on the U.S. Department of Health and Human Services (HHS) August 29, 2023, announcement of the first 10 prescription medications that will be subject to price negotiation for Medicare coverage. This week, Health Management Association (HMA) experts offer their perspective on what this change means and what to expect next.

Background

Medicare was granted the authority to negotiate prescription drug prices through the Inflation Reduction Act (IRA), which the president signed into law on August 16, 2022. HHS, acting through the Centers for Medicare & Medicaid Services (CMS), will lead negotiations and enter into agreements with manufacturers for these products, negotiating a maximum fair price (MFP) for each selected drug in the Medicare program. HHS is required to negotiate on a certain number of drugs each year: 10 drugs in 2026, 15 drugs in 2027 and 2028, and 20 drugs in 2029 and subsequent years. Up to 60 drugs could be negotiated by 2029. Manufacturers that are noncompliant will face an excise tax that could far exceed the cost of drugs sold over time and civil monetary penalties.

Medicare Drug Negotiations: The Latest Development

Since passage of the IRA, CMS has been working to establish the regulatory infrastructure and policies to support implementation of Medicare’s new drug price negotiation authority on an expedited timeline. Guidance on the approach the agency will take in negotiating MFPs, along with other provisions of the act, has been issued.

With this week’s action, CMS will begin the first round of negotiations. Table 1 lists the drugs CMS has identified for the first round of negotiations. Products selected for negotiation (with prices effective in 2026) are medications that represent the highest spending in the Part D drug benefit, excluding products with generic or biosimilar competition as well as certain orphan drugs and other products that qualify for a small biotechnology exemption.

Alongside CMS’s announcement, HHS’s Office of the Assistant Secretary for Planning and Evaluation (ASPE) released its analysis of prescription drug use and out-of-pocket spending for each of the 10 drugs for all Part D enrollees and separately by whether an enrollee receives the low-income subsidy (LIS). The report also examines demographic information about enrollees who use the selected products.

Takeaways

The products selected were largely in line with initial modeling that Moran Company analysts and others performed, but with some surprises. Variation from earlier projections could be expected for a number of reasons, including:

  • The June 2022−May 2023 data CMS used were not generally available to outside analysts, and it is clear that several products had spending increases (whether because of volume or price increases) relative to prior years that moved them up the list.
  • Some higher spending products have seen generic or biosimilar competitors launch, making them ineligible for selection for negotiation.
    • For the top 30 products identified in previous dashboard data, at least 10 have evidence of generic or biosimilar competition.
  • CMS’s decision to treat multiple products together for purposes of negotiations also affected the products included on the list.
  • For a few other products, it is still unclear how CMS decisions were made.

What to Expect Next

The drug negotiation policy is highly controversial and is the subject of litigation that could delay the process. If litigation does not affect the timeline for implementation, manufacturers of selected drugs have until October 1 to agree to negotiate and provide initial information to CMS. If a manufacturer opts out of the negotiations, the company must pay either an excise tax or withdraw all its products from the Medicare and Medicaid programs. CMS and participating companies will then meet to discuss manufacturer submissions, and CMS will receive information from other stakeholders. Several listening sessions will take place.

CMS will make initial price offers by February 1, 2024. After a counteroffer process, negotiations may continue into the summer of 2024, but final determinations will be made by August 1, 2024. CMS plans to publish any agreed-upon negotiated prices for the selected drugs by September 1, 2024. Those prices take effect starting January 1, 2026.

In addition to the short-term impact on prices for specific drugs, several questions about the potential effects of the policy are worth monitoring over the long-term:

  • How will research and development of new products and trends in the type of products prioritized change as a result of these policies?
  • How will the policies affect pricing for competitor products and the launch prices of products in the future?
  • Beyond the Medicare population, for whom the prices are directly applicable, how will MFPs affect negotiations on costs and supplemental rebates for other payers. including state Medicaid programs, state employee programs, drug purchasing pools, and commercial insurers?
  • Will negotiations affect the design of standalone Prescription Drug Plans (PDPs) and Medicare Advantage PDPs.

The IRA included several other changes to the Medicare program, which we discussed in a previous In Focus.