Medicare

Medicare

CMS creating a ‘Universal Foundation’ to align quality measures

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

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

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

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

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

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

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

CMS introduces advance notice of changes to MA capitation rates and Part C/D payment policies

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This week, our In Focus section reviews recently announced major policy updates from the Centers for Medicare & Medicaid Services (CMS) that affect the Medicare Advantage (MA) and Part D programs. First, on January 30, CMS released the final Risk Adjustment Data Validation Final Rule, a highly anticipated and controversial policy that establishes the agency’s approach to auditing MA Organizations’ (MAOs) risk-adjustment payments and collecting overpayments as needed.

Then, on February 1, CMS published the Calendar Year (CY) 2024 Advance Notice for the MA (Part C) and Part D Prescription Drug Programs. Between these two directives and the proposed MA policy changes CMS announced in December 2022, the Administration continues its efforts to actively manage Medicare Advantage and strengthen quality and oversight of the program. Read HMA’s summary of the December 2022 proposed rule.

Below are some highlights of the 2024 Advance Notice. By law, CMS must notify the public of planned changes in the MA capitation rate methodology and risk adjustment methodology annually. The deadline for submitting comments to CMS is Friday, March 3, 2023.

Payment Impact in MA: CMS is projecting an average increase in revenue of 1.09 percent in plan payments from last year. This percentage increase is based on a net number that reflects multiple factors including growth rates, change in STAR ratings, and risk score trends.

Risk Adjustment: CMS is seeking to make some refinements to the Part C risk-adjustment model. For example, CMS will begin using the International Classification of Diseases (ICD)-10 classification system (instead of the ICD-9 classification system) and updated underlying fee for service data years. More specifically, diagnoses data years are being updated from 2014 to 2018, and expenditure years are being updated from 2015 to 2019 to reflect changes in costs.

Star Ratings: CMS is proposing updates and refinements to the Star Ratings program, including:

  • Retiring the diabetes care-kidney disease monitoring and Medication Reconciliation Post-Discharge
  • Expanding the age range for colorectal cancer screening measure to 45−75 years old to align with the preventive task force
  • Adding the Care for Older Adults (COA)—Functional Status Assessment measure back to the Star Ratings, and introducing Kidney Health Evaluation for Patients with Diabetes (KED), Concurrent Use of Opioids and Benzodiazepines (COB), Polypharmacy Use of Multiple Anticholinergic Medications in Older Adults (Poly-ACH), and polypharmacy Use of Multiple Central Nervous System Active Medications in Older Adults (Poly-CNS)
  • Introducing a case-mix adjustment to Part D medication adherence measures for diabetes, hypertension, and cholesterol.

CMS also is seeking to potentially align measures with other CMS programs. Specifically, the agency is introducing a “Universal Foundation” of quality measures, which is a core set of metrics aligned across programs. Additional information can be found in this New England Journal of Medicine “Perspective”.

Part D Impact

The Advance Notice also notifies plans on the changes to the Part D benefit occurring in 2024 as a result of the Inflation Reduction Act (IRA), including:

  • Beginning in CY 2024, CMS will eliminate cost-sharing for Part D drugs prescribed to beneficiaries in the catastrophic phase of coverage.
  • Beginning in CY 2024, the Low-Income Subsidy program (LIS) under Part D will be expanded so that beneficiaries who earn 135−150 percent of the federal poverty level and meet statutory resource limit requirements will receive the full LIS subsidies that were available only to beneficiaries earning less than 135 percent of the federal poverty level prior to 2024.
  • During CY 2024, CMS will prohibit Part D plans from applying the deductible to any Part D covered insulin product and from charging more than $35 for each month’s supply of a covered insulin product in the initial coverage phase and the coverage gap phase.
  • During CY 2024, CMS will prohibit Part D plans from applying the deductible to an adult vaccine recommended by the Advisory Committee on Immunization Practices and from charging any cost-sharing payments at any point in the benefit for these vaccinations.
  • Beginning in CY 2024, CMS will cap the growth in the Base Beneficiary Premium at 6 percent. The Base Beneficiary Premium for Part D is limited to the lesser of a 6 percent annual increase or the amount that would otherwise apply under the prior methodology had the IRA not been enacted.

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 how it will affect MA plans, providers, and patients, contact our experts below.

Lee Fleisher of CMS to keynote HMA national quality conference

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

HMA’s first annual quality conference will provide organizations the opportunity to “Focus on Quality to Improve Patients’ Lives.” Attendees will hear from industry leaders and policy makers about evolving health care quality initiatives and participate in substantive workshops where they will learn about and discuss solutions that are using quality frameworks to create a more equitable health system.

In addition to Fleisher, featured speakers will executives from ANCOR, CareOregon, Commonwealth Care Alliance, Council on Quality and Leadership, Intermountain Healthcare, NCQA, Reema Health, Kaiser Permanente, United Hospital Fund, and others.

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

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

View the Full Agenda

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

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

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

Background

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

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

Increased Transparency in Utilization Management and Marketing Policies

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

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

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

Increased Focus on Health Equity and Culturally Competent Care

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

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

Improving Access to Behavioral Health

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

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

Improving Drug Affordability and Access in Part D

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

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

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

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

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

Expanding Low-Income Subsidies Under Part D

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

Strengthening Current Policies for MA Plans Serving Populations with Special Needs

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

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

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

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

Link to proposed rule.

2022 Yearly Roundup: a year of successful partnerships

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

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

Reforming Colorado’s Behavioral Health System

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

From Bid to Trusted Advisor

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

Laying the Foundation for Modernizing Indiana’s Public Health System

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

Multiple Clients Accepted into ACO REACH Model

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

Pipeline Research and Policy Recommendations to Address New Innovative Therapies

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

CMS finalizes 2023 Medicare payment and policy landscape

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This week, our In Focus section reviews the remaining Medicare payment and policy rules, finalized over the last several days by the Centers for Medicare & Medicaid Services (CMS), that will shape the landscape for the Medicare program in 2023 and beyond. These include the Physician Fee Schedule (PFS), the Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System, the Home Health Prospective Payment System and Home Infusion Therapy Services updates, and the End Stage Renal Disease (ESRD) payment rules.

The final Medicare rules are directionally aligned with the agency’s policy priorities, including improving health equity and addressing the health and health-related needs of rural and underserved communities, promoting value-based, whole-person care, and removing barriers to behavioral health services, among other issues.

Across these rules, CMS took some steps where they have authority to mitigate reductions in payment rates for some provider types. Final payment and policy changes, however, will inform stakeholders’ federal advocacy efforts with Congress. Specifically, as part of an end of year legislative package lawmakers are considering legislative proposals to address the 2023 payment levels and their relationship to general inflation and the scheduled payment cuts for physicians. These issues and Medicare program solvency are expected to remain hot topics throughout 2023.

For today’s blog our HMA experts highlight a few of the finalized policy changes contained in the aforementioned regulations that will take effect on or after January 1, 2023. The HMA Medicare team will continue to analyze these policies for their immediate implications. Additionally, final policies and CMS’ response to commenters offer important insights that providers, vendors, and other stakeholders will want to incorporate in their future policy, financial, and operational strategies.

Medicare Physician Fee Schedule Final Rule

On November 1, 2022, CMS released final updates and policy changes for Medicare payments under the PFS, and other Medicare Part B issues. This rule largely finalizes many of the policies described in HMA’s earlier summary of the PFS proposed rule. Notably, CMS finalized updates to the Medicare Shared Savings Program (MSSP) largely as proposed. The agency expects these changes will renew and broaden provider interest in participating in the Medicare Shared Savings Program (MSSP). The new MSSP opportunities will support CMS’ work towards its goal that by 2030 100 percent of Medicare beneficiaries will be in a care relationship with accountability for quality and total cost of care. As expected, CMS also finalized proposals intended to enhance access to behavioral health services and strengthen the behavioral health model within the Medicare program. The changes represent a major shift in traditional Medicare’s coverage of services to identify and treat mental health conditions and substance used disorders. CMS plans to address payment for new codes that describe caregiver behavioral management training in CY 2024 rulemaking.

Notable policies that will be of interest to Medicare stakeholders include:

  • Payment Rates and Inflation: The conversion factor used to determine payments to physicians through the PFS will be $33.06 in 2023, a decrease of $1.55 from the 2022 conversion factor. The final payment update reflects the following dynamics:
    • Expiration of a statutory one-year 3 percent increase in payments,
    • A statutory 0 percent payment update for CY 2023, and
    • A budget neutrality adjustment across all billing codes resulting from modifications to PFS weights which increased the relative value of primary care billing codes.

This cut to the conversion factor is driven by statutory requirements. The physician community is actively advocating to Congress that they need an update to their payments given the high levels of inflation and the lack of automatic updates built in to the PFS.

CMS also updated the information under the PFS to account for current trends in the delivery of health care, especially concerning independent versus facility-based practices. CMS indicated the updates and improved public use files respond to requests the agency has received to provide more granular information that separates the specialty-specific impacts by site of service. According to CMS, stakeholders are seeking to better understand how Medicare payment policies are directly responsible for the consolidation of privately-owned physician practices and freestanding supplier facilities into larger health systems.

  • Medicare Shared Savings Program: CMS finalized significant updates to MSSP that are aligned with the agency’s overall value-based care strategy of growth, alignment, and equity. These policies include paying advance shared savings to certain new ACOs that can be used to support their participation in the Shared Savings Program, a health equity adjustment to an ACO’s quality score, a revised benchmarking methodology, and allowing longer periods of time for ACOs to transition to downside risk. This package of changes are intended to increase participation in MSSP and in particular participation in rural and underserved areas.
  • Behavioral health: The final rule expands the types of behavioral health providers eligible for reimbursement under Medicare Part B. Marriage and family therapists, licensed professional counselors, addiction counselors, certified peer recovery specialists, and others will be able to provide behavioral health services while being under general supervision rather than “direct” supervision. Psychologists and social workers that are part of a primary care team will also be eligible for payment to help manage behavioral health needs. Additionally, CMS confirmed that Opioid Treatment Programs may bill Medicare for services performed by mobile units without obtaining a separate registration and increasing payment rates to Opioid Treatment Programs.
  • Telehealth: CMS finalized several policies related to Medicare telehealth services, reflecting statutory requirements of the Consolidated Appropriations Act (CAA) of 2022 and the agency’s ongoing evaluation of temporarily available services. The changes related to the CAA of 2022 include extending for 151 days beyond the end of the Public Health Emergency (PHE) the following coverage provisions: allowing telehealth services to be furnished in any geographic area and in any originating site setting (including the beneficiary’s home); allowing certain services to be furnished via audio-only telecommunications systems; allowing physical therapists, occupational therapists, speech-language pathologists, and audiologists to furnish telehealth services; delaying the onset of the in-person visit requirements for mental health services furnished during the PHE; and making policy changes consistent with those named above under the payment systems for Federally Qualified Health Centers (FQHCs) and Rural Health Clinics (RHC).
  • Ground Ambulance: CMS affirmed that its expanded list of covered destinations for ground ambulance transports was for the duration of the COVID-19 PHE only. The regulation also finalized changes to the long awaited Medicare Ground Ambulance Data Collection Instrument, including clarifying to process for requesting exemption from reporting cost data through this collection device.

Outpatient Prospective Payment System and Ambulatory Surgical Care Payment System Final Rule

Also on November 1, 2022, CMS published the calendar year 2023 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System final rule. The rule presents new opportunities to address access to emergency services in rural communities and updates other outpatient and ASC policies.

  • Payment rates and Inflation: CMS increased hospital outpatient and ambulatory surgical center payments by 3.8 percent in 2023 above 2022 rates. This reflects a 4.1 percent hospital market basket increase plus a 0.3 percentage point reduction for productivity and is consistent with Medicare’s 2023 hospital inpatient payment increase. The hospital industry has expressed deep concern to Congress and CMS that although the 4.1 percent market basket increase is as high as it has been in many previous years, it lags behind the measure of general inflation (October 2022 consumer price Index = 8.2 percent)
  • Remote Behavioral health: CMS finalized its proposal to cover as an outpatient service remote behavioral health services provided by clinical staff of hospital outpatient departments, including critical access hospitals (CAHs), to beneficiaries in their homes. This policy was initially permitted under CMS’ COVID-19 PHE emergency rulemaking but this is now covered on a more permanent basis.
    • In 2023 beneficiaries would need to receive an in-person service within the 6 months prior to the first time hospital clinical staff provide the remote behavioral health services. CMS also is requiring an in-person service without the use of communications technology within 12 months of each behavioral health service furnished remotely.
    • The agency also finalized coverage of audio-only telehealth services in instances where the beneficiary is unable to use, does not wish to use, or does not have access to two-way, audio/video technology.
  • Algorithm driven services: CMS finalized policy to pay separately (rather than bundle payment) for Algorithm-driven services that assist practitioners in making clinical assessments. This includes clinical decision support software, clinical risk modeling, and computer aided detection (CAD).
  • Rural Emergency Hospitals (REH): CMS finalized conditions of participation, payment rates, and Medicare enrollment procedures for the new REH provider type largely as proposed. The new REH program will be effective January 1, 2023. Federal policymakers believe the REH provider type could provide a more sustainable option for rural hospitals facing closure and to support access to care in rural and underserved communities. A previous HMA blog explains the payment and service parameters for the REH option.
    • Hospitals and health systems and the rural communities they serve will want to analyze the final requirements for health and safety standards, staffing, and physical environment and emergency preparedness and other expectations and balance these with community perspectives to determine the feasibility of this pathway.
  • Site neutral payment policy: CMS finalized its proposal to exempt Rural Sole Community Hospitals (SCHs) from the Medicare policy which pays clinic visit services 40 percent of the OPPS payment rate when provided at hospital outpatient departments. Instead, CMS will pay these providers full OPPS rates for clinic visits.
  • 340B Drug Program: CMS finalized a payment rate of Average Sales Price plus 6 percent under the 340B program.

Home Health Prospective Payment System Rate Update and Home Infusion Therapy Services Requirements

On October 31, 2022, CMS finalized the calendar year 2023 Home Health Prospective Payment System (HH PPS) payment rates. CMS projects that aggregate spending for home health agencies in 2023 will increase by 0.7 percent, compared to 2022. This is a significant update as compared to the 4.2 percent decrease the agency proposed earlier this year. The originally proposed payment cut was in part due to CMS’s requirement to implement at statutory budget neutrality requirement for the Patient-Driven Groupings Model. While there was fervent industry pushback and advocacy to eliminate the proposed payment adjustments, CMS instead used its discretionary authority to implement a phased approach to payment reductions. The first half will be effective in 2023, and the remaining permanent adjustment and any other potential adjustments needed to account for behavior change will be proposed in future rulemaking. CMS’ payment approach is expected to factor heavily in the overall stability and market dynamics within the home health agency industry in the months ahead.

Other notable final rule Home Health policies include:

  • CMS finalized a permanent cap on wage index decreases to promote predictability in payments and smooth year-to-year changes. This was also implemented within the Inpatient Prospective Payment System.
  • CMS finalized the Expanded Home Health Value-Based Purchasing (HHVBP) Model home health agency baseline year to CY 2022 and the Model baseline year to CY 2023.
  • CMS will begin collecting data on the use of telecommunications technology on home health claims voluntarily starting on January 1, 2023, and on a mandatory basis beginning on July 1, 2023. Further details are expected to be issued in January 2023.

ESRD Prospective Payment System Final Rule

Also on October 31, 2022, CMS released the calendar year 2023 ESRD Prospective Payment System Final Rule. In addition to updating the payment rates, the rule updates requirements for the ESRD Quality Incentive Program (QIP). Looking ahead CMS plans to consider comments in response to several requests for information as it updates the ESRD QIP, works to align resource use with payment, ensure equitable access to technologies that improve health and quality of life.

Additional impactful policies for providers and stakeholders include:

  • CMS did not approve any of the three new technologies which applied for pass-through payment. While CMS has created a payment mechanism to promote innovation, it has proved challenging to actually access this payment mechanism. That may slow investment in the space if CMS continues to set such a high bar.
  • As laid out in the final rule, CMS remains on track to fold all oral drugs including phosphate binders into the bundle when the statutory ban expires in 2025.
  • CMS received many comments for its RFI regarding TDAPA, the new drug pass-through payment program in ESRD. It is likely that CMS will dedicate significant attention to this topic in the next rulemaking cycle. In particular, the RFI focused on how CMS might add new money to the ESRD bundle when new drugs exit pass-through, including the potential for accounting for other drugs which are replaced by the new products.

While providers and stakeholders must analyze the immediate impact of the final rules, it is also essential to consider the broader context of CMS’ reimbursement and policy decisions.

Notably, there is more urgency for the provider community, Medicare Advantage plans, and the broader Medicare stakeholder community to prepare for the imminent end of the federal COVID-19 Public Health Emergency (PHE) declaration. Congress and the Administration have already begun to identify and make permanent certain flexibilities afforded during the COVID-19 PHE. Other flexibilities will be phased out or ended. Looking ahead to this transition, thoughtful preparation and consideration of the Medicare policy context and opportunities will be critical.

For additional information, please contact our experts below.

HMA consultants pen Health Affairs blog post, “Advancing Health Equity And Integrated Care For Rural Dual Eligibles”

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HMA Consultants Ellen Breslin, Samantha Di Paola, Susan McGeehan, Rebecca Kellenberg, and Andrea Maresca recently wrote the Health Affairs blog post, “Advancing Health Equity and Integrated Care for Rural Dual Eligibles.”

This article was the latest in the Health Affairs Forefront series, Medicare and Medicaid Integration which features analysis, proposals, and commentary that inform policies on the state and federal levels to advance integrated care for those dually eligible for Medicare and Medicaid.

Read the full article here.

HMA perspectives on the 2022 federal policy landscape

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This week, our In Focus section looks at the current federal policy landscape and trends and the legislative outlook for the remainder of 2022 and beyond. Experts from HMA continue to monitor developments in this area and provide additional updates as more information becomes available.

Legislative Branch

To date in 2022, Congress passed multiple comprehensive bills, including the Inflation Reduction Act (IRA), which was signed by President Biden on August 16, 2022. The IRA extends Exchange plan premium tax subsidies through 2025, institutes an out-of-pocket drug spending cap for Medicare beneficiaries, expands Medicare, Medicaid, and CHIP coverage protections for certain vaccines, allows Medicare to negotiate drug prices, and implements a penalty payment in the Medicare program for prescription drug prices that rise faster than the rate of inflation.

Going forward, stakeholders have an extensive list of immediate Medicare payment issues for Congress to tackle while lawmakers continue to consider fundamental reforms to the program. Priorities include mitigating Medicare payment reductions scheduled for 2023; providing relief to address inflationary cost pressures; extending the 5 percent bonus for physicians participating in Advanced Alternative Payment Models (APMs), which expires at the end of 2022 for Accountable Care Organizations (ACOs); and permanently expanding telehealth access and payment policies after the federal COVID-19 public health emergency (PHE) declaration expires. Many stakeholder groups are also urging the Senate to act on the House-approved legislation, Improving Seniors Timely Access to Care Act (H.R. 3173), to reform Medicare Advantage prior authorization policies.

Congress did not include major Medicaid proposals in the Inflation Reduction Act. Medicaid stakeholders want Congress to revisit certain Medicaid policies in one of the remaining legislative vehicles this year. Significant proposals of interest include closing the Medicaid coverage gap in non-expansion states, enhanced coverage for justice involved populations, and expanding support for home and community-based services (HCBS). States and some stakeholders have also sought more certainty in the timing and guardrails for ending the COVID-19 Public Health Emergency (PHE) policy that links enhanced federal Medicaid funding with the requirement for continuous Medicaid coverage.

Congressional leaders and key influencers are laying the groundwork for 2023 legislative efforts. Congress is likely to defer action on most major legislative issues until after the November mid-terms, including finalizing federal fiscal year 2023 funding for most departments. A change in control of either or both chambers of Congress will likely lead to greater scrutiny of the Biden Administration’s health care policies and actions, which have largely gone untested by this Congress.

Executive Branch

Executive orders have been a major source in driving federal workstreams in 2022. Following enactment of several major bills, implementation responsibilities have shifted to the Executive Branch and stakeholders will have multiple opportunities to further shape and support new programs, regulatory and policy updates, and funding opportunities. Executive orders passed include:

  • Advancing Racial Equity and Support for Underserved Communities, January 21, 2021
  • Promoting Competition in the American Economy, July 9, 2021
  • Improving the Customer Experience, December 13, 2021
  • Access to Affordable, Quality Health Coverage, April 5, 2022
  • Equality for LGBTQI Individuals, June 15, 2022
  • Protecting Access to Reproductive Healthcare Services, July 8, 2022

The Administration will continue to address COVID-19 emergency needs while stepping up efforts to support states, health plans, providers and other stakeholders as they prepare for the post-COVID environment. The current PHE declaration expires October 13, 2022, but since HHS has not signaled that it plans to end the PHE in October, another extension is likely until January 11, 2023. The next advance notification about the end of the PHE would be Nov. 12, 2022. Once the PHE declaration expires, numerous Medicare and Medicaid, TANF, and SNAP flexibilities will end, including Medicaid’s continuous coverage requirement and certain telehealth flexibilities, among others. Additional federal agency guidance is expected to support post-PHE transitions.

The Centers for Medicare & Medicaid Services (CMS) plans to advance new policy direction across several service and delivery areas, including strengthening long-term services and support and innovations via Section 1115 demonstration programs. CMS is expected to approve transformational 1115 proposals in additional states. Several state proposals focus, in part, on building capacity among local and regional entities and community-based organizations to address social drivers of health. Many state proposals are also strengthening behavioral health delivery systems and seek to meet enrollees’ urgent behavioral health needs. Additionally will want to monitor CMS’ regulatory efforts to align and strengthen managed care and fee-for-service (FFS) access and network adequacy policies as well as updates to the agency’s in lieu of services policy in managed care programs.

The Administration is also expected to accelerate work on its top policy priorities and regulatory agenda in advance of the next Presidential election, and this will require ongoing engagement among health care stakeholders.

For additional information on these and other policies, contact our experts below.

How can Medicare and Medicaid providers utilize CMS’ COVID-19 roadmap?

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On August 18, 2022, the Centers for Medicare and Medicaid Services (CMS) released a roadmap to support healthcare providers with preparing for the eventual end of the COVID-19 public health emergency (PHE) declaration. CMS also published a series of fact sheets summarizing the status of Medicare Blanket waivers and flexibilities by provider type as well as flexibilities applicable to the Medicaid providers and stakeholders.

In its announcement, CMS expressed concern that the continued PHE flexibilities could contribute to further decline in patient, resident, and client safety beyond what has already been observed. As a result, the agency is cautiously working to balance ongoing PHE needs while conveying more urgency for providers to prepare for the eventual end of the PHE flexibilities and waivers.

CMS has already ended certain flexibilities and waivers. The agency could phase out other flexibilities as it prepares to let the PHE declaration lapse. This means that providers and health plans should act now to assess flexibilities and waivers in use and develop a plan to transition to post-PHE environment.

Phase-out of COVID-19 Flexibilities

During the COVID-19 PHE, CMS has utilized Medicare and Medicaid waivers and flexibilities extensively. For example, Medicare has not enforced certain federal requirements during this time to allow hospitals to utilize off-site locations to screen and treat patients when needed as well as to minimize certain reporting requirements. The agency’s flexibilities also have accelerated adoption of telehealth and audio only services, particularly for behavioral health services.

Medicare and Medicaid providers across the states utilized PHE flexibilities to varying degrees, in part depending on experiences in individual communities, capacity, and other provider specific factors. Additionally, over the course of the PHE health plan and provider staffing and workflows have changed dramatically. This means health plans and providers will need a tailored plan to support the transition to the post PHE environment.

HMA’s experts are working with hospitals, health systems, clinics, and other providers as well as health plans on the steps they need to take now to prepare for multiple transitions. Our experts identified six immediate steps that Medicare and Medicaid plans and providers can be undertaking now to ensure they can effectively return to normal operations, including:  

  • Review performance on the patient and clinician safety metrics cited in the new CMS resources. In instances where providers have gaps and suboptimal safety and quality outcomes they will need assistance developing and implementing mitigation and quality improvement plans.
  • Utilize CMS’ tailored fact sheets to identify specific flexibilities and waivers in use now and the “normal” federal regulations that will be in effect once the PHE lapses. This assessment should include the blanket waivers and provider specific flexibilities, including:
    • Flexibilities around the requirements and timing for practitioner training
    • Expansion of allowable sites of service that permitted more expansive use of telehealth and virtual services as well as screening and treatment provided at alternative sites
    • Relaxation of federal requirements pertaining to surge capacity protocols
    • Flexibilities for staffing requirements, including medical records departments, nursing facilities, among others
    • Waiver of requirement for hospitals to submit occupational mix surveys and to have a utilization review plan with a UR committee focused on services furnished to Medicare and Medicaid enrollees
    • Applicable of the Extreme and Uncontrollable Circumstances Policy in Medicare’s Shared Savings Program and use of other flexibilities for MSSP Accountable Care Organizations (ACOs)
    • Non enforcement of certain physician self-referral laws
    • Waiver of numerous reporting requirements including those pertaining to verbal orders, discharge planning, HEDIS and STARs measure reporting, among others
  • Project impact of ending Medicaid’s continuous coverage policy and support individuals with actions they may need to take at the end of the PHE. Once the PHE ends, Medicaid’s enhanced federal funding for states and continuous coverage policy will end. HMA is working with health plans, providers and other stakeholders to project how this change will impact the enrollment and payer mix on state and local levels. Additionally, patients and their caregivers will need support from plans, providers, and consumer groups to ensure they renew their coverage or transition to other coverage programs when needed. HMA’s experts have written extensively about our work to support the Medicaid unwinding activities in two blog posts – The PHE is continuing—what’s next for Medicaid? and How stakeholders can prepare now for unwinding of Medicaid public health emergency continuous eligibility.
  • Develop a plan to transition from “PHE” to “post-PHE” expectations that is informed by the assessment of flexibilities in use. Key components of the plan include:
    • Anticipated resource needs to reflect changes in staffing and workflows during the PHE
    • Articulation of specific compliance procedures and regular reporting requirements that will resume and the process for this transition
    • Develop training and education opportunities for staff that may be new or need refresher on normal policies and procedures as well as timeframes for making these changes
  • Update budgets projections to account for changes in reimbursement rates for certain services post-PHE. Certain reimbursement amounts and payment methodologies will change post-PHE, such as payment for administering the COVID-19 vaccine in a Medicare patient’s home among other changes. Providers will need to project the financial impact of these payment changes and update coding and billing manuals and procedures where applicable.
  • Build strategies to sustain changes to care models implemented during the COVID-19 PHE while also addressing health disparities. Some providers and facilities adopted care models and modified existing ones during the PHE that may have improved patient outcomes and experiences, maximized expertise of practitioners, and improved value-based care. For example, some providers have embraced the Medicare Hospital Without Walls Initiative and will need to assess their options as some of those flexibilities are phased out. Other federal opportunities have newly emerged during the pandemic, such as the Rural Emergency Hospital designation and pending changes to the Medicare Shared Savings Program (MSSP).

What’s Next

The COVID-19 PHE declaration next expires on October 12, 2022. While a renewal of the PHE declaration is possible into early 2023, providers should be using this time to prepare for resumption of normal policies and procedures.

The expiration of PHE flexibilities and waivers are not, however, happening in a vacuum. Providers need to make this transition amidst a dynamic healthcare sector with high expectations for continuous improvement in quality, patient experiences, and value. During this transitional period HMA’s experts are working with health plans and providers to develop or revisit strategic plans and investments to refocus attention on improving models of care and value-based payment approaches, including strategies that will help mitigate health disparities.

For questions, please contact our experts below.

Congress approves major healthcare proposals, but work begins for CMS and stakeholders

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On August 7, 2022, the Senate passed the Inflation Reduction Act of 2022 (the IRA). The House approved the bill on August 12, and President Biden is expected to sign the IRA into law in the coming weeks.

The IRA addresses a range of policy topics across health care climate, energy, and taxation. Regarding health care, the IRA makes structural changes to the Medicare Part D prescription drug benefit and provides new authority for the Medicare program to address the pricing of prescription drugs in the Part B and Part D programs. The measure also extends the temporary enhanced assistance for health coverage purchased from Marketplaces, which was first approved in the American Rescue Plan Act (ARPA). In addition, the IRA updates vaccine coverage policies in Medicare, Medicaid, and the Children’s Health Insurance Program (CHIP). 

While the IRA provides a critical framework for the structural changes to the nation’s largest public health insurance programs, the U.S. Department of Health and Human Services will be responsible for building out the policy and operational components necessary to support implementation.  

Notably, the Centers for Medicare and Medicaid Services (CMS) will lead implementation of the IRA’s Medicare and Marketplace provisions. The changes to the Part D benefit and the development of entirely new processes and policies to support the IRA’s drug pricing provisions require significant resources and consideration of direct as well as indirect impacts for the health care market. The agency can use a variety of regulatory tools to support implementation, including issuing standalone Requests for Information (RFIs), convening stakeholder engagement sessions, updating policy manuals, and undertaking notice and comment via the formal rulemaking process, among others.

CMS’ strategic plan emphasizes the value of stakeholder engagement, and this is likely to lead to multiple opportunities for public input, particularly as CMS implements the new Medicare provisions of the IRA. For example, the agency must develop the policy parameters for reforming the Part D benefit design and is likely to seek input from Medicare Advantage (MA) and MA Prescription Drug Plans (MA-PDPs), providers, vendors, and consumer advocacy groups among others to inform its approach. CMS will also need input from the stakeholder community as it establishes the timelines, reporting, and negotiating mechanisms impacting Part B and D prescription drugs pricing and how it will implement the inflation penalty policies outlined in the IRA.

The IRA’s extension of the American Rescue Plan Act’s (ARPA) enhanced eligibility for premium assistance through 2025 provides more near certainty around eligibility and enrollment for this market. This may led to renewed momentum for CMS to engage with states and stakeholders on Marketplace policies and structures.

Many of the details around how the IRA’s health care policies will be implemented are unknown at this time. Stakeholders will want to monitor CMS’ progress and provide feedback with data-informed analysis and concrete and practical recommendations as these opportunities are announced. 

An overview of many of the IRA’s health care provisions follows. Our team of experts can provide tailored analysis and support to clients as they begin to unpack the full breadth of the IRA’s policy changes and implications for Medicare Advantage and Part D plans, providers, vendors, consumer advocacy groups and other stakeholders.

  • Part B and Part D Drug Pricing. Requires the Secretary of HHS to select a list of drugs eligible for negotiation, and enter into agreements with select manufacturers, negotiating a “maximum fair price” (MFP) for each selected drug in the Medicare program. The Secretary is required to negotiate on a certain number of drugs per year, 10 drugs in 2026; 15 drugs in 2027 and 2028, and 20 drugs in 2029 and subsequent years.  The number of drugs negotiated will accumulate over the years, such that up to 60 drugs could be negotiated by 2029.  Manufacturers who are not in compliance will face an excise tax that could far exceed the cost of drugs sold over time and civil monetary penalties.
  • Prescription Drug Inflation Rebates. Requires manufacturers to pay rebates for Medicare Part B and D drugs with prices rising faster than inflation. The rebate calculation would be based on units and pricing in Medicare and would determine an inflation-adjusted payment amount based on the percentage by which the price exceeds the inflation benchmark, as determined by the Consumer Price Index for All Urban Consumers (CPI-U). If a manufacturer fails to pay the rebate, then they would be subject to a civil monetary penalty either equal to or at least 125 percent of the rebate amount for the quarter.
    • The Part D inflation rebate takes effect October 2022 for Part D drugs and biologics.
    • The Part B inflation rebate begins January 2023 for single-source drugs or biologics and certain biosimilar products. The IRA also includes an inflation growth cap on beneficiary coinsurance in Part B, beginning April 2023.
  • Part B Payment for Biosimilar Biological Products. Amends Medicare’s Average Sales Price (ASP) payment methodology in cases where the ASP during the first quarter of sales is unavailable to establish a payment rate for biosimilars. The IRA also updates Medicare Part B reimbursement for certain biosimilar products for a five-year period beginning on October 1, 2022, by increasing the add-on payment from six percent of the reference product’s ASP to eight percent of the reference product ASP.
  • Medicare Part D Assistance for Beneficiaries and Benefit Design. Increases the qualifying income amount (federal poverty level (FPL)) for the full Low-Income Subsidies (LIS) under Part D, from 135 percent of the FPL to 150 percent of the FPL, starting in 2024. The IRA also adjusts the cost-sharing requirements in the Part D benefit by:
    • Eliminating cost sharing in the catastrophic phase of the benefit in 2024;
    • Setting an annual out-of-pocket (OOP) limit for enrollees at $2,000 beginning in 2025;
    • Capping monthly premium increases for a prescription drug plan in 2024 through 2029 at six percent per year.  The Secretary may make a one-time adjustment to the beneficiary Part D premium contribution percentage in 2030 to ensure longer-term beneficiary premium reduction; and  
    • Adjusting the benefit coverage liabilities for the initial coverage phase and catastrophic coverage phase.
  • Coverage for Insulin. Requires Medicare to cover select insulin products and not apply a deductible or impose cost-sharing more than $35 or 25 percent of the negotiated price (including all discounts) for a 30-day supply. Beginning in July 2023, Medicare must exempt from beneficiary deductibles insulin provided through durable medical equipment (DME) and ensure that coinsurance for a month’s supply of insulin administered through DME does not exceed $35. High-deductible health plans (HDHPs) will be able to cover selected insulin products with no deductible without impacting their status as a HDHP, starting in 2023.
  • Medicare, Medicaid, and CHIP Coverage for Vaccines. Requires full coverage of Advisory Committee on Immunization Practices (ACIP)-recommended adult vaccines under Medicaid and CHIP without cost-sharing. The IRA also increases the Federal Medical Assistance Percentage (FMAP) by one percentage point, for adult medical assistance for such vaccines and their administration, during the first eight fiscal quarters on or after the date of the IRA’s enactment.
    • Requires Medicare Part D provide full coverage without cost sharing of ACIP-recommended adult vaccines for plan years beginning on or after January 1, 2023.
  • Enhanced Temporary Assistance for Marketplace Coverage. Extends the ARPA’s expansion of Advanced Premium Tax Credit (APTC) eligibility and amounts through 2025. ARPA modified the affordability percentages used for the calculation of APTC to increase subsidy amounts for individuals eligible for assistance.

Experts from HMA and HMA companies are supporting clients as they begin to strategize and formulate initial recommendations for federal agencies and plan for implementation.  We will continue to monitor developments in this area and provide additional updates as more information becomes available. 

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