Weekly Health Care Policy Update – November 20, 2023

November 27, 2023

In this update:

  • Administration Updates
    • White House Announces Initiative on Women’s Health Research
  • Legislative Updates
    • Biden Signs Continuing Resolution to Keep Government Open into January 2024
  • Federal Agencies
    • CMS Releases NOFO for AHEAD Program
    • CMS Releases RFA for the GUIDE Dementia Model
    • CMS Issues 2025 Notice of Benefit and Payment Parameters Proposed Rule
    • CMS Publishes Guidance on Social Needs Services Coverage in Medicaid
    • HHS Releases 2022 National Survey on Drug Use and Health
    • FDA Announces Discussion Paper and Virtual Meeting on Pulse Oximeters
    • CMS Issues Final Nursing Home Disclosure Rule
  • Other Updates
    • KFF Releases State Medicaid Enrollment and Spending Survey Results
  • New York State Updates
    • Governor Hochul Announces Proposed Cybersecurity Regulations for Hospitals
    • DOH Postpones Transition of Long-Term Care Reassessments to the Independent Assessor
    • CMS Approves Two NYS State-Directed Payment Requests
    • OMH Issues Updated MHOTRS Billing and Fiscal Guidance
    • DOH Announces Conclusion of NYS Medicaid ET3 Program
    • DOH Adopts Regulations that Update Adult Care Facility Resident Rights 
    • DOH Proposes Regulations to Update Adult Home Quality Improvement Committee Requirements
    • Governor Hochul Signs Health Care Legislation

Administration Update

White House Announces Initiative on Women’s Health Research 
On November 13th, President Biden and First Lady Jill Biden announced the establishment of the first-ever White House Initiative on Women’s Health Research. Any agency in the federal government related to health will be required to submit a report to the White House on efforts to improve women’s health within 45 days. Further details on the Initiative are forthcoming.
 
The remarks are available here.

Legislative Update

Biden Signs Continuing Resolution to Keep Government Open into January 2024
On November 17th, President Biden signed into law the continuing resolution (CR) which was passed by both the House of Representatives (336-95) and the Senate (87-11) on a bipartisan basis to avoid a government shutdown. The bill funds government programs and agencies at current levels and punts funding decisions to two separate deadlines: 

  • January 19, 2024: Agriculture-Food and Drug Administration, Military Construction-Veterans Administration, and some others.
  • February 2, 2024: All other federal spending bills, including funding for the Department of Health and Human Services (HHS).

House Speaker Mike Johnson (R-LA) has suggested that the separate deadlines will give both chambers time to negotiate and pass full-year spending bills in time for the upcoming deadlines, though an omnibus funding bill remains a possibility. The CR itself is free of controversial policy riders or supplemental international funding.

Federal Agencies

CMS Releases NOFO for AHEAD Program
On November 16th, the Centers for Medicare and Medicaid Services (CMS) released a notice of funding opportunity (NOFO) for states interested in implementing the new States Advancing All-Payer Health Equity Approaches and Development (AHEAD) Model, a total cost of care model (TCOC) that features multi-payer (Medicare, Medicaid, and private) hospital global budgets and enhanced primary care.

This NOFO allows states to apply to CMS for a cooperative agreement to implement AHEAD in their state or a sub-state region. CMS will provide $12 million over six years to the applying state agency for capacity-building activities. Through the cooperative agreement funding structure, CMS and AHEAD states will work closely together to develop a framework for an all-payer TCOC model featuring: 

  • State accountability for keeping all-payer and Medicare fee-for-service cost growth below a target;
  • A state goal for investing more money into primary care (all-payer and fee-for-service); and
  • A plan to improve health equity throughout the state or region participating in AHEAD.

SPG released a more detailed summary of AHEAD which is available here. The NOFO is available here.

CMS Releases RFA for the GUIDE Dementia Model 
On November 15th, CMS announced the release of the Request for Applications (RFA) for health care practices interested in implementing the Guiding an Improved Dementia Experience (GUIDE) Model. Under GUIDE, physician practices and other practitioners enrolled in Medicare Part B may apply to establish Dementia Care Programs (DCPs) to support people with dementia and their unpaid caregivers. Participants must participate under a single Taxpayer Identification Number (TIN) that is eligible to bill Part B for physician services. DCPs may include other organizations as long as they are led by an eligible practice.

DCPs will serve Medicare fee-for-service (FFS) enrollees with dementia who are not long-term residents of nursing homes. DCPs will receive a supplemental Dementia Care Monthly Payment (DCMP), ranging from $150 to $390 (based on acuity) for the first six months and then decreasing to between $65 and $215, to help provide advanced services to such individuals. The DCP’s services will adhere to the GUIDE model’s standardized service package and be provided by a care team focused on navigating the needs of people with dementia that includes at least a care navigator and a clinician with dementia proficiency. DCPs may also provide caregiver respite, up to an annual cap of $2,500 per beneficiary.

This model will launch on July 1, 2024 and run for eight years, through June 30, 2032. CMS will be accepting applications until January 30, 2024.

The RFA is available here.

CMS Issues 2025 Notice of Benefit and Payment Parameters Proposed Rule 
On November 15th, CMS released the 2025 Notice of Benefit and Payment Parameters proposed rule. This rule includes proposed standards for issuers and Marketplaces, as well requirements for enrollment personnel. The goal of this proposed rule is to simplify choice and improve the plan selection and enrollment process. Notable provisions include: 

  • Network Adequacy: CMS proposes that for plan years beginning in 2025, State-Based Marketplaces (SBM) and State-Based Marketplaces using the Federal Platform (SBM-FPs) establish and impose quantitative time and distance network adequacy standards for qualified health plans (QHPs) that are at least as stringent as those CMS established for Federally-Facilitated Marketplaces (FFMs).
  • Essential Health Benefits: CMS proposes changes to the definition of essential health benefits (EHBs) regarding:
    • Routine Adult Dental Benefits: CMS proposes to permit issuers to include routine non-pediatric dental services as an EHB.
    • Prescription Drug Benefits: CMS also proposes to codify its current policy that prescription drugs in excess of those covered by a state’s EHB benchmark plan are considered EHB and subject to EHB protections, including annual and lifetime cost-sharing protections.
  • Medicaid Eligibility for Certain Populations: CMS proposes to allow states greater flexibility in the use of income and resource disregards in determining financial eligibility for Medicaid for certain populations, including low-income individuals eligible for Supplemental Security Income (SSI), individuals older than 65 with income at or below 100% FPL, individuals in institutions, working disabled individuals, foster care children, and others (known as non-MAGI beneficiaries). These proposed changes would allow states to target income and/or resource disregards to achieve targeted Medicaid expansions.

The announcement is available here.

CMS Publishes Guidance on Social Needs Services Coverage in Medicaid
On November 16th, CMS published two new documents offering guidance on coverage of services addressing health-related social needs (HRSN) in Medicaid and the Children’s Health Insurance Program (CHIP).

The first document, the Coverage of HRSN Services in Medicaid and CHIP Framework, lists a range of HRSN services that are “considered allowable” under various Medicaid and CHIP authorities, including state plan authorities, Section 1915 waivers, Section 1115 demonstrations, and managed care “in lieu of” services (ILOS). CMS notes that a wide variety of HRSN services are potentially approvable, including: 

  • Housing and home supports, such as:
    • Respite;
    • Transitional housing;
    • Home remediations;
    • Utility assistance; and
    • Short-term or temporary room and board.
  • Nutrition supports, such as:
    • Home delivered meals;
    • Nutrition prescriptions and grocery provisions for high-risk individuals;
    • Nutrition counseling and instruction; and
    • Case management.

The second document is an Informational Bulletin that compiles the guidance CMS has published to date on HRSN service authorities in Medicaid and CHIP. This includes making HRSN services available to targeted Medicaid populations (e.g., through Section 1915 waivers) as well as for a broader population (e.g., through Medicaid MCOs offering ILOS or 1115 waivers). CMS notes that it is requiring various conditions to approve Section 1115 waivers that propose HRSN services, including that HRSN service expenditures are limited to no more than 3 percent of the state’s total Medicaid spending and that Medicaid primary care provider payment rates meet minimum thresholds.

The HRSN Framework is available here. The Informational Bulletin is available here.

HHS Releases 2022 National Survey on Drug Use and Health 
On November 13th, HHS, through the Substance Abuse and Mental Health Services Administration (SAMHSA), released the results of its 2022 National Survey on Drug Use and Health. This report presents nationally representative data on the self-reported use of tobacco, alcohol, and illicit drugs. It also surveys self-reported substance use disorders (SUD), mental health conditions, suicidal thoughts, and accompanying treatment. Notable findings among those surveyed include: 

  • Nearly 60% used tobacco products, vaped nicotine, drank alcohol or used an illicit drug in the past month.
  • Over 17% identified as having an SUD in the past year.
  • Nearly 1 in 4 adults had a mental illness in the past year.
  • Over 5% of adults had thoughts of suicide over the past year.

Nearly every one of these measures increased slightly over last year’s findings.

The survey is available here.

FDA Announces Discussion Paper and Virtual Meeting on Pulse Oximeters
On November 16th, the Centers for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA) announced that it would hold a virtual public meeting on pulse oximeters on February 2, 2024. The meeting will cover: 

  • Improving the quality of premarket studies used to evaluate the performance of pulse oximeters submitted for premarket review, including a patient’s skin pigmentation; and
  • The type and amount of data that should be provided by manufacturers to evaluate the performance of pulse oximeters submitted for premarket review.

CDRH is also seeking public comment on a discussion paper entitled “Approach for Improving the Performance Evaluation of Pulse Oximeter Devices Taking Into Consideration Skin Pigmentation, Race and Ethnicity.” The paper is intended to “offer an approach to improve the quality of premarket studies and associated methods used to evaluate the performance of pulse oximeters, taking into consideration patient skin pigmentation and patient-reported race and ethnicity.”

More information, including a link to the discussion paper, is available here.

CMS Issues Final Nursing Home Disclosure Rule
On November 15th, CMS issued a final rule to implement portions of the Affordable Care Act requiring the disclosure of certain ownership, managerial, and other information regarding Medicare skilled nursing facilities (SNFs) and Medicaid nursing facilities. The rule also adds definitions of “private equity company” and “real estate investment trust” for Medicare provider enrollment purposes.

The rule is available here.

Other Updates

KFF Releases State Medicaid Enrollment and Spending Survey Results
On November 14th, the Kaiser Family Foundation (KFF) released a brief analyzing Medicaid enrollment and spending trends based on data provided by nearly every state Medicaid director. Key survey findings include: 

  • Average growth in total enrollment in Medicaid slowed from 8.4% in fiscal year (FY) 2022 to 6.5% in FY 2023. Medicaid enrollment is expected to drop significantly during FY 2024 as the continuous enrollment requirement from the Covid-19 public health emergency unwinds, with an estimated decline of 8.6%.
  • Average growth in total Medicaid spending (state and federal) slowed from a peak of 9.8% in FY 2022 to 8.3% in FY 2023. Spending growth is expected to decline further to 3.4%, largely due to enrollment changes.
  • The State share of spending on Medicaid is projected to increase by 17.2% on average in FY 2024, due in large part to the expiration of the 6.2% enhanced Federal Medical Assistance Percentage (FMAP) associated with the continuous enrollment requirement. However, the overall average state share of spending will remain lower than before the pandemic. Since 2019, total Medicaid spending will have increased by about 44%, while state share spending will have increased by about 31%.

The survey is available here.

New York State Updates

Governor Hochul Announces Proposed Cybersecurity Regulations for Hospitals 
On November 13th, Governor Hochul announced that the State is proposing new cybersecurity regulations for hospitals. Under the proposed regulations, hospitals would be required to: 

  • Establish a cybersecurity program and take steps to assess internal and external cybersecurity risks;
  • Use defensive techniques and infrastructure;
  • Implement measures to protect information systems from unauthorized access or other malicious acts; and
  • Take actions to prevent cybersecurity events before they happen.

The proposed regulations would also require hospitals to develop response plans for a potential cybersecurity incident, including notification to appropriate parties, and to run tests of their response plan to ensure continuity of care while systems are restored back to normal operations. Hospitals would be required to establish a Chief Security Officer role, if not already in existence, to enforce and update the cybersecurity policies. Hospitals will be eligible to apply to a pool of the upcoming round of the Statewide Health Care Facility Transformation Program (with up to $500 million in total funding, as allocated in this year’s Enacted Budget) to support projects that will make improvements to technology systems to help hospitals comply with the proposed regulations.

The regulations will be sent to the Public Health and Health Planning Council (PHHPC) for approval. They will also be published in the State Register and are expected to be open to public comment through February 5, 2024. Once finalized, hospitals will have one year to come into compliance with the new regulations.

The Governor’s press release is available here.

DOH Postpones Transition of Long-Term Care Reassessments to the Independent Assessor
On November 17th, the New York State (NYS) Department of Health (DOH) sent a notice to alert managed care organizations (MCOs), local departments of social services (LDSS), and other interested parties that, due to stakeholder feedback and other concerns, the State will be postponing the rollout of the New York Independent Assessor Program (NYIAP) conducting reassessments. The State had previously planned for the New York Independent Assessor to begin conducting reassessments in January 2024.

As a result of this delay, the LDSS and MCOs should continue to perform both routine and non-routine reassessments of the members under their responsibility. The new timeline and rollout schedule will be determined and communicated at a later date.

Questions may be submitted to independent.assessor@health.ny.gov.

CMS Approves Two NYS State-Directed Payment Requests
On October 31st, CMS approved the following state-directed payment requests for the rating period covering April 1, 2023 through March 31, 2024:   

  • A $14 million pool to be distributed by Managed Long Term Care (MLTC) Partial Capitation and Medicaid Advantage Plus (MAP) plans to qualifying Social Adult Day Care (SADC) sites. The actual payment each site receives will be based on its achievement of performance measures.
  • A $650 million pool to be distributed by Mainstream Medicaid Managed Care and Health and Recovery Plans (HARPs) to qualified hospitals for inpatient services. For the purposes of this directed payment, the sole recipient will be New York City Health and Hospitals Corporation.

The publication of these approvals is part of CMS’s recent efforts to provide transparency into how states are directing Medicaid managed care plan expenditures related to delivery system and provider payment initiatives within managed care contracts.

The SADC approval is available here and the hospital approval is available here.

OMH Issues Updated MHOTRS Billing and Fiscal Guidance
On November 14th, the NYS Office of Mental Health (OMH) updated the Mental Health Outpatient Treatment and Rehabilitation Services (MHOTRS) clinic billing and fiscal guidance. Changes to the guidance include, but are not limited to: 

  • Adding School-Based Mental Health (SBMH) rate codes to the rate chart and payment modifiers section. The SBMH rate codes pay 125% of the base rate APG codes.
  • Including the new modifier combination for Language Other than English when provided by a contracted vendor. This modifier will enhance the rate by 35%.  
  • Removing the limit of one off-site service per client, per day.
  • Adding SBMH services, off-site, health services/peer support services, crisis intervention, Intensive Outpatient Program (IOP), and Integrated Outpatient Services (IOS-OMH Host) to the Utilization Threshold exemption list.
  • Adding a new chart to outline services and their allowable time durations.

The guidance is available here and a summary of edits is available here. Questions may be submitted to medicaidffsbillinghelp@omh.ny.gov.

DOH Announces Conclusion of NYS Medicaid ET3 Program
In the October Medicaid update, DOH announced that, in accordance with the early suspension of the federal Emergency Triage, Treat, and Transport (ET3) model, the NYS Medicaid ET3 program will also end of December 31st. CMS is ending the ET3 model two years prior to the performance period end date due to lower than expected participation and lower than projected interventions. The statute authorizing the NYS Medicaid ET3 model, which mirrors the federal program, only authorized the program for the duration of the Medicare demonstration.

In accordance with current NYS Medicaid policy, the State will continue to pay for emergency ambulance transportation to urgent care centers, Federally Qualified Health Centers (FQHCs), mental health or substance use disorder treatment centers, and physician offices for all enrolled ambulance providers (not only those that had previously obtained ET3 approval). However, after December 31st the State will no longer provide reimbursement for treatment in place.

The Medicaid Update is available here. Questions may be submitted to MedTrans@health.ny.gov.

DOH Adopts Regulations that Update Adult Care Facility Resident Rights 
On November 15th, DOH adopted regulations that update resident rights standards for all adult care facilities, including Adult Homes, Enriched Housing Programs, and Residences for Adults, to align with the federal Home and Community Based Services (HCBS) Final Rule. In accordance with the new regulations, facility operators will be required to:    

  • Allow residents to have unrestricted access to common areas between 9am and 8pm and accommodate visitor access in common areas and resident living spaces;
  • Ensure resident rights such as freedom of choice in selecting a medical services provider and opportunities to engage in community life outside the facility, to be included in the statement of rights provided to residents upon admission; and
  • Submit reports to DOH and the Justice Center for the Protection of People with Special Needs within 24 hours of a resident’s attempted suicide or when a felony crime is committed by or against a resident, if the resident had at any time received services from a mental hygiene service provider.

The final regulations are available here. DOH made minimal edits to the final rule as compared to the proposed regulations, including updating language to specify that the residents’ rights statement must reviewed with the resident at least annually. 

DOH Proposes Regulations to Update Adult Home Quality Improvement Committee Requirements
On November 16th, DOH issued proposed regulations that would update the quality improvement committee requirements for Adult Homes and residences for adults. The proposed regulations would require the development of plans for quality assurance activities, including infection control standards, and within such plans would require the creation of a quality improvement committee. The quality improvement committee would be charged with meeting at least every six months to review findings from the facility’s monitoring of their plans, evaluate the effectiveness of corrective action policies, and identify trends and improvement activities. The committee would include the administrator or operator of the facility, the resident council president or other resident representative, and representatives from frontline employees from each area of operation.

The proposed regulations are available here. Public comment may be submitted to regsqna@health.ny.gov through January 14, 2024.

Governor Hochul Signs Health Care Legislation
This week, Governor Hochul signed the following health care-related legislation: 

  • S6463A/A7366 requires Office of Children and Family Services (OCFS) statewide training for mandated reporters to include how to identify an abused or maltreated child with an intellectual or developmental disability.
  • S5907/A5520 directs the State Office for the Aging (SOFA) to conduct a study on the number of older adults residing in naturally occurring retirement communities (NORCs) who are suffering from social isolation and loneliness and the services provided to such individuals.
  • S5100/A2190 provides for remote witnessing of health care proxies using audio-video technology.
  • S2330B/A345 requires the Department of Financial Services (DFS) to make public any rate filing or application submitted by long-term care insurance carriers, and requires certain notices to be provided to policyholders regarding premium rate increases.