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]).

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:

• The Physician Fee Schedule and Other Changes to Medicare Part B Policies
• The Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) reimbursement
• The Home Health Prospective Payment System Rate Update, Quality Reporting Program Requirements, and Value-Based Purchasing Expanded Model Requirements
• The End-Stage Renal Disease (ESRD) Prospective Payment System (PPS)

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]).

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].