Weekly Health Policy Update – March 20, 2023

March 27, 2023

In this update: 

  • Legislative Update
    • Senate HELP Committee Issues RFI on Pandemic and All-Hazards Preparedness Renewal
  • Federal Agencies
    • SAMHSA Releases Updated Certified Community Behavioral Health Clinic Criteria
    • CMS Releases Initial Guidance for Medicare Drug Price Negotiation Program
    • HHS Reopens Health Sector Climate Pledge
    • CMS Announces Drop in Part B Coinsurance for 27 Drugs
    • Veterans’ Health Administration to Cover Leqembi
  • Other Updates
    • MACPAC Releases March 2023 Report to Congress
    • MedPAC Releases March 2023 Report to Congress
    • CDC Releases Maternal Mortality Rates for 2021
    • KFF Publishes Report on Tax Exemption for Nonprofit Hospitals
    • AHIP, Others Launch Coalition to Help with Medicaid Transition
    • ECRI Releases Top 10 Patient Safety Concerns of 2022
    • National Academies Issues Report on Use of Race and Ethnicity Labels in Genetics Research
  • New York State Updates
    • New York State Assembly and Senate Release One-House Budget Bills
    • DOH Releases Comprehensive Guidance on Telehealth Following the Covid-19 PHE; Updated SPG Regulatory Waiver Tracker
    • OMH Releases Guidance for Providers on the Impact of the End of the Federal PHE
    • Governor Hochul Announces Statewide Listening Tour and Summit on Youth Mental Health
    • CMS Approves New York SPA Authorizing a Behavioral Health License Exemption at Article 29-I Facilities
  • Funding Opportunities
    • SAMHSA Releases NOFO for Training Behavioral Health Care Professionals

Legislative Update

Senate HELP Committee Issues RFI on Pandemic and All-Hazards Preparedness Renewal
On March 15th, the Senate Health, Education, Labor, and Pensions (HELP) Committee released a bipartisan Request for Information (RFI) about policy changes related to the anticipated renewal of the Pandemic and All-Hazards Preparedness Act (PAHPA) at the end of the year. PAHPA was signed into law in 2006 with the aim “to improve the Nation’s public health and medical preparedness and response capabilities for emergencies, whether deliberate, accidental, or natural.” PAHPA established, within the Department of Health and Human Services (HHS), the Office of the Assistant Secretary for Preparedness and Response (ASPR) and authorized initiatives and funding for public health emergency response activities, such as building medical surge capacity.
 
The Committee is seeking to understand specific changes that Congress could make in the following areas: 

  • Public health emergency coordination and policy, including the role of ASPR;
  • Medical countermeasures development and deployment; and
  • Support for jurisdictional preparedness and response capacity.

The Committee is also asking for feedback on the following questions: 

  • What gaps exist in the PAHPA framework and how it has been implemented?
  • Aside from currently authorized programs, what gaps exist in HHS’ capabilities, and what types of activities are necessary for HHS to fulfill the intent of PAHPA?
  • What specific steps could Congress take to improve partnerships with states and localities, community-based organizations, and private sector and non-government stakeholders such as hospitals and health care providers, on preparedness and response activities?

The full RFI letter is here. Responses should be submitted to PAHPA2023Comments@help.senate.gov by the close of business on March 29th.

Federal Agencies

SAMHSA Releases Updated Certified Community Behavioral Health Clinic Criteria
On March 16th, the Substance Abuse and Mental Health Services Administration (SAMHSA) finalized its update to the criteria for Certified Community Behavioral Heath Clinics (CCBHCs). The update seeks to “strengthen and update the criteria without significantly adding state or clinic burden.” A first version was released for public comment in December 2022 (see SPG’s January 3rd update here). The finalized changes are largely in line with, and expand, the proposed modifications from that version. New changes since then include: 

  • Expansion of detail on 988 partnerships, including requiring CCBHCs to discuss a crisis plan with all people receiving services (which may be, at minimum, directing them to call 988).
  • Greater integration of the “National Guidelines for Behavioral Health Crisis Care” toolkit, including minimum standards for coordination of crisis services, mobile crisis care response times, and crisis stabilization. CCBHCs must track referrals from the call center to ensure timely crisis care delivery.

Most clinics will be required to become compliant with the updated criteria by July 1, 2024.
 
SAMHSA will host a webinar providing an overview of the updates to the CCBHC criteria on March 23rd at 3pm. A link for the webinar is here, and more information is available here. The full March 2023 criteria document is available here. A summary of changes in the finalized version from the 2015 edition is available here.
 
CMS Releases Initial Guidance for Medicare Drug Price Negotiation Program
On March 15th, the Centers for Medicare and Medicaid Services (CMS) issued initial guidance on the Medicare Drug Price Negotiation Program, established in the Inflation Reduction Act. The guidance was issued for price applicability year 2026, the first year the negotiated prices will apply, though CMS is required to implement the program for price applicability years 2026, 2027, and 2028. For each price applicability year, CMS will: 

  • Publish a list of selected drugs;
  • Enter into agreements with manufacturers of selected drugs;
  • Negotiate and, if applicable, renegotiate maximum fair prices (MFPs) for such selected drugs;
  • Publish MFPs for selected drugs in accordance; 
  • Carry out administrative duties and compliance monitoring; and
  • Enforce civil monetary penalties (CMPs) and establish certain limitations on administrative and judicial review relevant to the Negotiation Program.

CMS is seeking comment on all sections of the guidance except for sections related to identification of selected drugs and the excise tax on the sale of designated drugs during a period of noncompliance. CMS specifically seeks comment on the following topics: 

  • Terms and conditions contained in the manufacturer agreement, including the manufacturer’s and CMS’ responsibilities;
  • Approach for considering (1) the manufacturer-reported data elements and (2) evidence about alternative treatments;
  • Process for the offer and counteroffer exchange between CMS and manufacturers
  • Content of an explanation for the MFP;
  • Method for applying the MFP across different dosage forms and strengths of a selected drug;
  • Dispute resolution process for specific issues that are not exempt from administrative and judicial review under section 1198; and
  • Processes for compliance monitoring and imposition of CMPs for violations.

The full guidance document is available here. CMS will accept comments through April 14th at IRARebateandNegotiation@cms.hhs.gov.

HHS Reopens Health Sector Climate Pledge
On March 9th, the HHS Office of Climate Change and Health Equity (OCCHE) announced that it was reopening the White House-HHS Health Sector Climate Pledge for new signatories. The Pledge, which originally had an October 2022 deadline for signatories, will now remain open on an ongoing basis. In 2022, 102 organizations representing 837 hospitals signed the Pledge.
 
This Pledge is a voluntary commitment by health care organizations—including hospitals, health centers, suppliers, insurance companies, group purchasing organizations, pharmaceutical companies, and others—to cut their greenhouse gas emissions by 50% by 2030 and achieve net zero emissions by 2050. The health care sector currently accounts for 8.5% of U.S. emissions. The Pledge is part of President Biden’s larger goal to reduce nationwide greenhouse gas emissions by at least 50% by 2030 and reach net-zero emissions by 2050.
 
More information on the Pledge, including a link to become a signatory, can be found here.
 
CMS Announces Drop in Part B Coinsurance for 27 Drugs
On March 15th, CMS announced that Part B beneficiary coinsurance for 27 prescription drugs will be lower for some beneficiaries from April 1, 2023 through June 30, 2023. The drugs are subject to Medicare inflation rebates under the Medicare Prescription Drug Inflation Rebate Program, as enacted in the Inflation Reduction Act, because prices for the drugs increased faster than the rate of inflation in the fourth quarter of 2022. Beneficiaries are expected to save between $2 and $390 per average dose, depending on individual coverage such as Medicare Supplemental plans.
 
The list of 27 drugs, including their temporary coinsurance percentage (lower than the normal 20%) is available here.
 
Veterans’ Health Administration to Cover Leqembi
On March 13th, Esai Co. Ltd., the manufacturer of the Alzheimer’s disease drug Leqembi, announced that the Veteran’s Health Administration will provide coverage of Leqembi to veterans with early-stage Alzheimer’s. In January, the Food and Drug Administration approved Leqembi under an accelerated approval pathway, following data from clinical trials showing the drug may slow progression of Alzheimer’s. Notably, CMS currently limits coverage of Leqembi to beneficiaries enrolled in clinical trials or other CMS-approved studies.
 
A press release from Esai may be found here.

Other Updates

MACPAC Releases March 2023 Report to Congress
On March 15th, the Medicaid and Children’s Health Insurance Program Payment Advisory Commission (MACPAC) released its March 2023 report to Congress. The report focuses on four main areas: race and ethnicity data collection; nursing facility payment transparency; Medicaid flexibility over Medicare drug decisions; and safety net hospital payment policy. MACPAC submitted the following recommendations to Congress: 

  • Race and Ethnicity Data Collection: MACPAC recommends that HHS update its model streamlined application to include race and ethnicity data based on evidence-based data collection practices. MACPAC also recommends that CMS create model training materials explaining the purpose of collecting this data for state and county workers, application assistants, and navigators.
  • Nursing Facility Payment Transparency: MACPAC recommends that CMS collect data on facility-level data on types of Medicaid payments, non-federal shares of spending, and facility finances and ownership. MACPAC also recommends that CMS assess whether Medicaid payments to facilities are aligned with statutory goals, provide states with technical assistance to complete an analysis, and make facility-level findings publicly available.
  • Medicaid Drug Decisions: MACPAC recommends that Congress allow states to exclude or restrict coverage of an outpatient drug based on coverage with evidence development (CED) requirements under a Medicare National Coverage Determination (NCD). MACPAC also recommends that Congress require managed care contracts to comply with a state’s exclusion or augmentation of Medicare’s NCD CED of an outpatient-covered drug.

MACPAC also published a congressionally-mandated report on disproportionate share (DSH) payments to hospitals. The report notes no meaningful correlation between DSH allotments to states and the number of uninsured individuals, the amount and sources of hospitals’ uncompensated care costs, or the number of hospitals with high levels of uncompensated care that also provide essential community services for low-income, uninsured, and vulnerable populations. Overall, MACPAC estimates that fiscal year (FY) 2024 DSH allotments will decrease by 54 percent (or $8 billion a year from 2024 through 2027). In its June 2023 report, MACPAC will consider recommendations to provide DSH allotments with a countercyclical adjustment.
 
The full report is available here.
 
MedPAC Releases March 2023 Report to Congress
On March 15th, the Medicare Payment Advisory Commission (MedPAC) released its annual report to Congress focused on the fee-for-service (FFS) payment system as well as a status report on Medicare Advantage and Part D. Highlights of MedPAC’s recommendations for FY 2024 payment rates include: 

  • Acute general care hospitals: Current law update plus 1%. 
    • In addition, MedPAC recommends that Congress begin a transition to a redistribution of DSH and uncompensated care payments through the Medicare Safety Net Index (MSNI), add $2 billion to the MSNI pool, scale FFS MSNI payment in proportion to each hospital’s MSNI and distribute the funds through an add-on percentage under inpatient and outpatient fee schedules, and pay MSNI rates for services provided to Medicare Advantage beneficiaries directly to hospital and carve such payments out of MA benchmarks.
  • Physician and other health services: Increase rate by 50% of the projected increase in the Medicare Economic index. 
    • In addition, MedPAC recommends that Congress create an add-on payment under the physician fee schedule for services provided to low-income Medicare beneficiaries consisting of the provider’s allowed charges plus 15% for primary care, and plus 5% for other providers.
  • End-stage renal disease: Current law update.
  • Skilled Nursing Facility: Reduce base payment rates by 3%.
  • Home Health Services: Reduce base payment rates by 7%.

MedPAC’s March 2023 Report to Congress is available here.
 
CDC Releases Maternal Mortality Rates for 2021
On March 16th, the Centers for Disease Control and Prevention (CDC) released maternal mortality data for 2021, based on data from the National Vital Statistics System. In 2021, 1,205 women died of maternal causes in the United States, defined as “the death of a woman while pregnant or within 42 days of termination of pregnancy, irrespective of the duration and the site of the pregnancy, from any cause related to or aggravated by the pregnancy or its management, but not from accidental or incidental causes.” The maternal mortality rate for 2021 was a sharp increase from recent years at 32.9 deaths per 100,000 live births, compared with a rate of 23.8 in 2020 (861 deaths) and 20.1 in 2019 (754 deaths). The maternal mortality rate was far higher for non-Hispanic Black women, at 69.9 deaths per 100,000 live births, 2.6 times the rate for non-Hispanic White women (26.6). Maternal mortality rates also increased with maternal age: 20.4 deaths per 100,000 live births for women under age 25, 31.3 for those aged 25–39, and 138.5 for those aged 40 and over.

The full report is available here.

KFF Publishes Report on Tax Exemption for Nonprofit Hospitals
On March 14th, the Kaiser Family Foundation (KFF) published a report on the value of tax exemptions for hospitals. The report estimates the total value of tax exemptions for nonprofit hospitals in 2020 at $28 billion, an $8 billion increase since 2011. This $28 billion figure represents 43% of net income earned by nonprofit facilities in 2020. KFF notes that this estimate is comparable to the total value of Medicare and Medicaid DSH payments in the same year ($31.9 billion). The total exemption breaks down to $14.5 billion in federal exemptions and $13.2 billion in state exemptions. KFF estimates that the total value of tax exemptions exceeded total estimated charity care costs by roughly $14 billion, although it acknowledges that charity care is only a portion of the community benefit reported by nonprofit hospitals.
 
The full report is available here.
 
AHIP, Others Launch Coalition to Help with Medicaid Transition
On March 9th, America’s Health Insurance Plans (AHIP) and other stakeholder groups announced the launch of the Connecting to Coverage Coalition. The Coalition aims to become a single industry source of information about Medicaid eligibility redeterminations and a resource to help those who are disenrolled from Medicare with finding coverage elsewhere.
 
Along with AHIP, other founding members of the Coalition include the Association for Community Affiliated Plans, Blue Cross Blue Shield Association, Medicaid Health Plans of America, the American Cancer Society Cancer Action Network, Cystic Fibrosis Foundation, and many more. The Coalition’s website provides information for Medicaid enrollees, health care navigators, and other stakeholders on all aspects of Medicaid redetermination and finding alternate forms of coverage, if necessary.
 
More information is available here.
 
ECRI Releases Top 10 Patient Safety Concerns of 2022
On March 14th, ECRI released its “Top 10 Patient Safety Concerns 2022” list. The annual report, authored by ECRI and the Institute for Safe Medication Practices, identifies potential sources of danger based on an analysis of “scientific literature, patient safety events, concerns reported to or investigated by either organization,” and other data. Authors then assessed each issue by severity, breadth, frequency, insidiousness (how difficult the issue is to recognize or challenging to address), and profile (how much pressure would the issue put on an organization). The top ten issues are: 

  • The pediatric mental health crisis
  • Violence against healthcare staff
  • Uncertainty with maternal-fetal medicine
  • Clinicians working outside their scope of practice
  • Delayed sepsis treatment
  • Care coordination for complex medical conditions
  • Not going beyond “five rights” of medication safety
  • Inaccurate patient medication lists
  • Accidental use of neuromuscular blocking agents
  • Preventable harm due to missed care

The report also includes recommendations for addressing each issue, including a “total systems safety approach.” Such an approach has four foundations: 

  • Cultivating leadership, governance, and cultures that are deeply committed to patient safety;
  • Engaging patients and families as partners to design and produce care;
  • Encouraging a healthy, safe, and resilient workforce environment; and
  • Supporting continuous and shared learning to improve safety and utility of care while reducing the risk of harm. 

The full report is available here.
 
National Academies Issues Report on Use of Race and Ethnicity Labels in Genetics Research
On March 14th, the National Academies of Sciences, Engineering, and Medicine (NASEM) issued a report calling for adoption of best practices in the use of race, ethnicity, ancestry, and other population descriptors in genomics research. The report, requested by the National Institutes of Health, notes that researchers across a wide range of disciplines conduct genomics research using population descriptors inconsistently and sometimes inappropriately. The authors examined best practices for research use and identified processes for their adoption in biomedical and scientific research.
 
The report is available here.

New York State Updates

New York State Assembly and Senate Release One-House Budget Bills
On March 14th, the New York State (NYS) Assembly and Senate released one-house versions of the state’s budget legislation for State fiscal year (FY) 2023-24. Each chamber’s proposal is based on the Governor’s Executive Budget, but may include modified appropriations and may include and exclude accompanying Article VII legislative proposals. The three parties will now begin negotiations on reconciling these proposals, with a target date of April 1st to finalize the Enacted Budget for 2024.
 
Some key changes proposed by the Assembly and/or Senate include: 

  • Capital allocations specifically for community-based providers;
  • Repeal of the Medicaid pharmacy carve-out;
  • Higher increases to Medicaid rates, including 10% for hospitals and nursing homes and 8.5% for
  • most human services agencies;
  • Removal of the proposal for oversight of “material transactions” among non-licensed health care entities; and
  • Removal of most of the proposed scope of practice/workforce reforms.

SPG’s (non-comprehensive) summary of notable changes, additions, and removals to proposals from the Executive Budget is available here. SPG’s Executive Budget summary is available here. As a reminder, these bills are far from final, and many omitted provisions may return or be modified in the Enacted Budget.
 
DOH Releases Comprehensive Guidance on Telehealth Following the Covid-19 PHE; Updated SPG Regulatory Waiver Tracker
On March 14th, the NYS Department of Health (DOH) released a special edition of the Medicaid Update that provides guidance on NYS Medicaid telehealth policy (including audio-only) following the expiration of the federal Covid-19 Public Health Emergency (PHE) on May 11th.
 
The guidance includes: 

  • An expanded list of reimbursable telehealth modalities, including requirements for the provision of audio-only telehealth services;
  • New consent requirements; and
  • Updated billing procedures.

The Medicaid Update is available here. SPG’s summary of the update is available here, which includes a chart that provides a comparison of pre-PHE, PHE, and post-PHE telehealth policy. SPG has also updated our overall Regulatory Waiver Tracker, available here.
 
OMH Releases Guidance for Providers on the Impact of the End of the Federal PHE
On March 13th, the NYS Office of Mental Health (OMH) released a guidance document that outlines which Covid-19-related flexibilities will end when the federal PHE expires on May 11th. Such flexibilities include in-person visit requirements, reduction in minimum service duration standards, and extended timeframes for treatment plan development and reviews. The document also indicates that the current OMH Commissioner’s waiver will expire on the same date as the PHE ends (May 11th).
 
The document covers the following topics: 

  • Telehealth: OMH has adopted final telehealth regulations that make permanent many of the flexibilities established during the Covid-19 pandemic. OMH will soon release telehealth guidance to further clarify expectations for OMH-licensed and funded programs. Providers are required to add the optional/additional service “Telehealth” to the operating certificate and must receive specific approval for each site and satellite. Providers that have not received permanent approval for telehealth by the end of the PHE must cease offering services via telehealth.
  • Documentation: Effective May 11th, all medically necessary services must be documented in a treatment, recovery, or service plan within the required timeframes and with appropriate signatures.
  • Utilization Review: All programs must resume utilization review requirements pursuant to OMH regulations.
  • Billing Standards: After May 11th, programs may no longer submit Medicaid claims using the modifier code CR (Catastrophe/Disaster related).
  • HIPAA Enforcement: When the PHE expires, HIPAA enforcement for the provision of telehealth services will resume. Providers must ensure their telehealth platforms and practices comply with HIPAA privacy and security rules.
  • Hospital Conditions of Participation: All waivers for hospitals that provided flexibilities to handle the Covid-19 surge/staffing crisis will expire at the end of the PHE.

The document also includes program-specific guidance for community-based services, including Adult Behavioral Health Home and Community-Based Services (HCBS), Article 31 Mental Health Outpatient Treatment and Rehabilitative Services (MHOTRS), and Children and Family Treatment and Support Services (CFTSS), among others.
 
The guidance document is available here.
 
Governor Hochul Announces Statewide Listening Tour and Summit on Youth Mental Health
On March 16th, Governor Hochul announced a series of statewide listening sessions and a summit to explore youth mental health issues and advise future policy recommendations. The listening sessions will take place this spring and will be coordinated by the New York State (NYS) Office of Mental Health (OMH) and Office of Children and Family Services (OFCS). Each session will be moderated by representatives from these agencies and will involve school-age youth from each host community. 
 
The Summit on Youth Mental Health and Wellness will take place in May and will convene youth, parents, and subject matter experts from the mental health, education, technology, and law enforcement fields. The Summit will focus on the challenges and opportunities impacting youth wellbeing, including the role of social media.
 
The Governor’s press release is available here.
 
CMS Approves New York SPA Authorizing a Behavioral Health License Exemption at Article 29-I Facilities
On March 13th, CMS approved New York’s proposed State Plan Amendment (SPA) to allow Article 29-I Health Facilities to be reimbursed for care and services provided by previously license exempt, unlicensed practitioners who were employed by an authorized setting as of June 24, 2022 and continue to work there or in another authorized setting under the supervision of an appropriate licensed individual. The SPA is effective May 12th.
 
The SPA is available here. The CMS approval letter is available here.

Funding Opportunities

SAMHSA Releases NOFO for Training Behavioral Health Care Professionals
On March 10th, the Substance Abuse and Mental Health Services Administration (SAMHSA) released a Notice of Funding Opportunity (NOFO) for the 2023 Minority Fellowship Program. This program aims to recruit, train, and support master’s and doctoral level students in behavioral health care professions by: 

  • Increasing the knowledge of behavioral health professionals on issues related to prevention, treatment, and recovery support for racial and ethnic minority populations;
  • Increasing the number of culturally competent mental and substance use disorders professionals who teach, administer services, conduct research, and provide services to racial and ethnic minority populations; and
  • Improving the quality of mental and substance use disorder prevention and treatment services delivered to racial and ethnic minority populations.

Through this opportunity, SAMHSA will award over $15.7 million in total annual funding to eight applicants (over $1.9 million annually per awardee) during a five-year program period. Funding will be used for training and to provide stipends to post-baccalaureate level professionals pursuing a degree in one of the eight behavioral health disciplines outlined in the NOFO. SAMHSA will only make one award for each of the eight academic disciplines; a separate application must be submitted if an applicant chooses to address more than one discipline. It is expected that each recipient support a minimum of 40 fellows each year. Eligible applicants include public or private non-profit professional organizations representing mental and substance use disorder treatment professionals.
 
The NOFO is available here. Applications are due on May 9th. Questions may be submitted to Dr. Nima Sheth at Nima.Sheth@samhsa.hhs.gov.