Weekly Health Care Policy Update – July 18, 2023

In this update: 

• Federal Agencies
  • CMS Proposes CY 2024 Physician Fee Schedule Rule
  • CMS Proposes CY 2024 OPPS and ASC Payment System Rule
  • CMMI Seeks Input on Design of a Future Mandatory Episode-Based Payment Model for Specialty Care
  • HHS Issues Proposed Rule Clarifying Non-Discrimination Requirements
  • Administration Announces New Rules and Guidance for Health Care Consumer Protections
  • CMS Issues Proposed Rule on 340B-Acquired Drug Payment Policy
  • CMS Accepting Nominations for Post-Acute Quality Measurement Committees through July 30^th
  • CMS Releases Final 2023 Call Letter for QRS and QHP Enrollee Survey
  • HRSA Awards $23.5 Million for NTTAP Cooperative Agreements
  • FDA Approves First Over-the-Counter Birth Control Pill
• Other Updates
  • EPA Proposes to Strengthen Lead Exposure Standards
• New York State Updates
  • NYS Posts Unwinding FAQ Guidance Document
  • OMH Ends Enforcement of Covid-19 Vaccine Mandate for Psychiatric Facilities
  • OPWDD Proposes Updates to Supported Employment Services
  • DOH Proposes Amendments for 1915(c) HCBS Children’s Waiver
  • CMS Approves SPA for Coverage of Crisis Intervention Services
• Funding Opportunities
  • NYS Issues RFP for 13 Existing Behavioral Health Clinics to Become CCBHCs
  • OMH Releases RFP for SOS CTI Teams in Staten Island and Queens
  • OMH Releases RFP for HealthySteps Expansion
  • OMH Releases Procurement Schedule for Funding Opportunities

Federal Agencies

CMS Proposes CY 2024 Physician Fee Schedule Rule
On July 13^th, the Centers for Medicare and Medicaid Services (CMS) issued the calendar year (CY) 2024 Physician Fee Schedule (PFS) proposed rule. The PFS rule also includes changes to a number of other programs, including the Medicare Shared Savings Program (MSSP) and the Basic Health Program (BHP).

Overall, CMS will reduce total payments under the PFS by 1.25% in CY 2024, as directed by Congress in the 2022 year-end omnibus bill, the Consolidated Appropriations Act, 2023 (CAA). Because CMS is proposing increases in payment for primary care and other direct patient care, the overall budget neutrality requirement will result in a decrease (from CY 2023 to 2024) in the overall conversion factor of $1.14, or 3.3%, to $32.75. Key policy proposals in the rule include:

Medical Providers

• Evaluation and Management (E/M) Visits: CMS proposes a separate add-on payment for HCPCS code G2211 to reflect the resource costs associated with E/M visits for primary care and longitudinal care of complex patients. 
• Split/Shared E/M Visits: CMS proposes to delay implementation of the new definition of the “substantive portion” of a split/shared visit as more than half of the total time through at least December 31, 2024. It will maintain the current definition, which allowing for use of one of the three key components (history, exam, or MDM) or more than half of the total time to determine who bills for the visit until then.
• Telehealth Services under the PFS: CMS proposes to:  
  • Add health and well-being coaching services to the Medicare Telehealth Service List on a temporary basis and to add Social Determinants of Health Risk Assessments on a permanent basis;
  • Refine the process to analyze requests received for addition of services to the List; and
  • Make other changes that, taken together, would continue many of the flexibilities that providers had during the Covid-19 public health emergency (PHE).
• Telehealth Services Furnished in Teaching Settings: CMS proposes to allow teaching physicians to use audio/video real-time communications technology when a resident furnishes Medicare telehealth services in all residency training locations through the end of CY 2024, as directed by Congress in the CAA. CMS seeks comment on other clinical treatment situations where it may be appropriate to allow the virtual presence of the teaching physician.
• Outpatient Therapy, Diabetes Self-Management Training (DSMT), and Medical Nutrition Therapy (MNT): CMS proposes to continue to allow institutional providers to bill for outpatient therapy, DSMT, and NMT services furnished remotely until the end of CY 2024 and seeks comment about the effectiveness of these services when furnished remotely. 
• Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs): CMS proposes a number of policy changes for RHCs and FQHCs related to the provision of telehealth services through December 31, 2024, delaying in-person requirements for mental health visits, aligning the definitions of MFTs and MHCs with changes proposed elsewhere in the rule, and aligning the level of supervision required for services provided “incident to” a physician or NPP’s services with changes finalized for CY 2023.

Behavioral Health, Ambulance, and Pharmacy

• Behavioral Health Services: CMS is implementing the CAA’s provision that adds Medicare Part B coverage of services provided by licensed marriage and family therapists (LMFTs) and mental health counselors (LMHCs). CMS proposes to allow addiction counselors that meet LMHC requirements to enroll in Medicare as LMHCs. CMS proposes changes to specific CPT codes and to modify hospice Conditions of Participation (CoPs) to conform with changes made by the CAA.
• Opioid Treatment Programs (OTPs): CMS proposes to extend current flexibilities for periodic assessments that are furnished via audio-only telecommunications through the end of CY 2024.
• Drugs and Biologicals Payable under Medicare Part B: CMS proposes a number of policy changes to implement provisions of the Inflation Reduction Act (IRA) regarding Part B drugs and biologicals. In addition, CMS seeks comment on the policies on the exclusion of coverage for certain drugs under Part B that are usually self-administered by the patient.
• Preventive Vaccine Administration Services: CMS proposes to maintain the additional payment for in-home COVID-19 vaccine administration, established in June 2021 on a preliminary basis, and to extend the additional in-home payment to administration of the pneumococcal, influenza, and hepatitis B vaccines. The payment amount for administration of each vaccine would be the same and updated annually.
• Clinical Laboratory and Ambulance Fee Schedules: CMS proposes changes to both fee schedules in accordance with changes made by the CAA.
• Medicare Ground Ambulance Data Collection System (GADCS): CMS proposes changes to the GADCS data collection instrument, which went live on January 1^st to address partial year responses and improve reporting consistency of hospital-based ambulance organizations, in addition to some technical corrections.

Miscellaneous Payment Provisions

• Dental and Oral Health Services: CMS proposes to codify previously finalized payment policy for dental services prior to, or during, head and neck cancer treatments and proposes to permit payment for certain dental services inextricably linked to other covered services used to treat cancer.
• Appropriate Use Criteria (AUC) for Advanced Diagnostic Imaging: CMS proposes to pause the AUC program and rescind current program regulations while it continues to identify a workable implementation approach.
• Medicare Diabetes Prevention Program (MDPP): CMS proposes to extend the PHE flexibilities under the MDPP expanded model for four years, through December 31, 2027, with certain provider requirements.
• Provider and Supplier Enrollment for Medicare and Medicaid: CMS proposes several changes to provider enrollment requirements including a new provider enrollment status (“stay of enrollment”), required reporting of change in practice location, and others.

Medicare Shared Savings Program
CMS proposed a number of incremental changes to the MSSP, building on the major changes enacted in the CY 2023 PFS. CMS indicated these are designed to advance its value-based care strategy and respond to concerns raised by accountable care organizations (ACOs) and others. Highlights of the proposed MSSP changes include: 

• Beneficiary Alignment: CMS proposes to add a third step to the beneficiary assignment methodology to better recognize the primary care delivered by nurse practitioners, physician assistants, and clinical nurse specialists. CMS also proposes to update the definition of primary care services used for beneficiary assignment purposes and to refine policies related to the advance investment payment (AIP). CMS projects these changes will increase MSSP participation by 10-20%.
• Benchmark and Risk Adjustment: CMS proposed to make adjustments to the planned financial benchmarking methodology for ACOs in agreement periods beginning on January 1, 2024 and in subsequent years. These changes include: 
  • Applying a symmetrical cap to risk score growth in an ACO’s regional service area;
  • Applying the same CMS-Hierarchical Condition Categories (CMS-HCC) risk adjustment methodology to both the benchmark and performance years; and
  • Further mitigating the impact of the negative regional adjustment on the benchmark to encourage participation by ACOs caring for medically complex, high-cost beneficiaries.
• Quality Performance Standard: CMS proposes to establish Medicare Clinical Quality Measures (CQMs) as a new, transitional data collection type for ACOs participating in the MSSP to help them prepare to meet requirements for the all-payer/all-patient Merit-Based Incentive Payment System (MIPS) CQMs and eCQMs.

CMS seeks comment on several potential future developments in the MSSP, including: 

• A potential new track with a higher level of risk/reward than currently offered under the ENHANCED track;
• Refinements to the three-way blended benchmark update factor and the prior savings adjustment; and
• Promotion of ACO and community-based organization collaboration. 

Quality Payment Program

• MVPs: CMS proposes five new Merit-based Incentive Payment System (MIPS) Value Pathways (MVPs): 
  • Women’s health; 
  • Ear, nose, and throat disorders;
  • Prevention and treatment of infectious disorders, including hepatitis C and HIV;
  • Mental health and substance use disorders; and
  • Rehabilitative support for musculoskeletal care.
• MVP RFI: CMS also included an RFI on MVP reporting incentives for MSSP ACOs. CMS is seeking information on scoring incentives that would be applied to an ACO’s health equity adjusted quality performance score beginning in the 2025 performance year.
• Digital Measurement: CMS proposes to establish the Medicare Clinical Quality Measures (CQMs) for ACOs (Medicare CQMs) as a new collection type for MSSP ACOs under the Alternative Payment Model (APM) Performance Pathway (APP). CMS is also proposing to remove the MSSP certified electronic health record technology (CEHRT) threshold requirements beginning performance year 2024, and adding a new requirement that, for performance years beginning on or after January 1, 2024, unless otherwise excluded, all MIPS eligible clinicians, Qualifying APM Participants (QPs), and Partial QPs participating in an ACO: 
  • Report the MIPS Promoting Interoperability performance category measures and requirements to MIPS; or
  • Earn a MIPS performance category score for the MIPS Promoting Interoperability performance category at the individual, group, virtual group, or APM entity level. 
• Health IT Vendors: CMS is proposing to eliminate the health IT vendor category beginning with the CY 2025 performance period, in an effort to improve the integrity of program data. Health IT vendors would still be able to participate in MIPS as third-party intermediaries by self-nominating to become a qualified registry or QCDR.
• Performance Threshold: CMS proposes to increase the performance threshold from 75 to 82 points, applicable to all three MIPS reporting options. 
• Public Reporting: CMS proposes to modify existing policy about publicly reporting procedure utilization data on individual clinician profile pages by incorporating Medicare Advantage data. CMS also proposes to publicly report cost measures beginning with the CY 2024 performance period. CMS has included an RFI seeking comment on potential approaches and considerations for such reporting.

Comments on the proposed rule are due September 11^th. The proposed rule is available here. For a more detailed summary and analysis of specific provisions in the PFS, please contact SPG.

CMS Proposes CY 2024 OPPS and ASC Payment System Rule 
On July 13^th, CMS issued the CY 2024 Medicare Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Proposed Rule. Overall, CMS proposes to update OPPS payment rates for hospitals by 2.8%. This update reflects a market basket increase of 3.0%, reduced by a 0.2% productivity adjustment. CMS also proposes a productivity-adjusted hospital market basket update factor to the ASC rates of 2.8%.

Additional proposals include: 

• ASC rate and hospital market basket: CMS proposes to continue to apply the productivity-adjusted hospital market basket update to ASC payment system rates beyond the planned five-year period of CY 2019 through CY 2023, given that the pandemic significantly changed health care utilization patterns, particularly for elective surgeries, and therefore CMS believes more time is needed to assess the appropriateness of this process.  
• Maintaining a buffer stock of essential medicines: CMS seeks comment on making separate payment, first under the inpatient payment system and then possibly the OPPS, for establishing and maintaining access to a buffer stock of essential medicines in order to foster a more reliable, resilient supply of these medicines.
• Intensive Outpatient Program: As required by the 2022 year-end spending omnibus, CMS proposes to establish coverage for Intensive Outpatient Programs (IOP) under Medicare. IOP services under Medicare would fill a gap in the behavioral health spectrum for a high-touch outpatient level of care, with at least nine hours of services per week and at least three services per day. Eligible providers of IOP would include: 
  • Hospital outpatient departments;
  • Community Mental Health Centers (CMHCs);
  • Federally Qualified Health Centers (FQHCs);
  • Rural Health Clinics (RHCs); and
  • Opioid Treatment Programs (OTPs).
• Partial Hospitalization Program (PHP): CMS is proposing to expand the existing rate structure to include two PHP ambulatory payment classifications (APCs) for each provider type. CMS will also calculate hospital-based and CMHC PHP payment rates for three services per day and four or more services per day based on cost per day using a broader OPPS data set that includes PHP and non-PHP days. The proposed rule also clarifies that Medicare covers PHP for the treatment of substance use disorders.
• Hospital price transparency: CMS is proposing to modify the standard charge display requirements and to update the enforcement provisions of hospital price transparency regulations. Hospitals would be required to use a CMS template for disclosing standards charge data and to encode such data.
• OPS payment for 340B drugs: CMS proposes to continue to pay ASP plus 6% for 340B-acquired drugs and biologics.
• Quality reporting programs: CMS proposes to modify the Outpatient and ASC Quality Reporting Programs (QRPs) by updating the Covid-19 vaccination, cataract outcomes, and colonoscopy follow-up measures and adding new measures on patient-recorded outcomes after arthroplasty and volume data on select procedures.

A fact sheet on the proposed rule is available here. The full proposed rule is available here. The proposed rule will be open for comment until September 11^th.

CMMI Seeks Input on Design of a Future Mandatory Episode-Based Payment Model for Specialty Care
On July 14^th, the CMS Innovation Center (CMMI) released a Request for Information (RFI) regarding the design of a future episode-based payment model which will be “focused on accountability for quality and cost, health equity, and specialty integration.”

CMMI intends to make this new model mandatory within covered geographies. As such, CMMI intends to launch the model through a formal rulemaking process with notice and public comment, and that the model will begin no earlier than 2026. The RFI seeks comments on a number of specific questions about the future model’s design, including: 

• How should CMMI structure clinical episodes?
• How can CMMI support providers who are mandated to participate?
• How can CMMI ensure patient choice and rights are protected?
• How can CMMI promote person-centered care, including integrated physical, behavioral, and social care, in the context of episode-based payment?
• How should CMMI support multi-payer alignment in episode-based payment?
• What key factors drive improvement in current specialty care models?
• What is the effect of ownership or affiliation between a population-based entity and a specialist on integration?
• How should CMMI incorporate health IT into this model’s design?
• How can CMS include home and community-based interventions during transitions between episodes of care?

CMMI specifically seeks comment from individuals and organizations who have experience with its existing episodic payment models, including Bundled Payments for Care Improvement (BPCI), Bundled Payments for Care Improvement Advanced (BPCI Advanced), and the Comprehensive Care for Joint Replacement (CJR) programs. However, the RFI is not seeking feedback related to models that address specific conditions over a longer period of time than 90 days, such as the Enhancing Oncology Model and the Kidney Care Choices Model.

The RFI will be open for 30 days from its date of publication in the Federal Register (August 17^th). More information is available here.

HHS Issues Proposed Rule Clarifying Non-Discrimination Requirements
On July 11^th, the Department of Health and Human Services (HHS), through the Office of Civil Rights (OCR) and the Assistant Secretary for Financial Resources (AFR), issued a proposed rule to clarify and reaffirm “the prohibition on discrimination on the basis of sexual orientation and gender identity in certain statutes.”

The existing rule prohibits discrimination on the basis of age, disability, sex, race, color, national origin, and religion in HHS programs, services, or funding opportunities, as a standard requirement for recipients of HHS grants and funding. In the modified rule, HHS is restoring and expanding Obama-era policy on nondiscrimination to: 

• Clarify that HHS requires compliance with nondiscrimination requirements across all “programs, activities, projects, assistance, and services”;
• Changing the authority for this requirement to be “substantive” rather than “housekeeping”, thereby placing it on a firmer legal footing;
• Creating a formal process for those with religious liberty-based objections to seek exemptions from (or modifications of) these nondiscrimination program requirements; and
• Incorporating the Supreme Court ruling in Bostock v. Clayton County, which held that prohibitions on discrimination based on sex necessarily also prohibit discrimination based on sexual orientation and gender identity. For clarity, HHS has promulgated a specific regulation listing programs that have a statutory prohibition on discrimination against sex, which include Head Start, refugee aid, homelessness assistance, substance abuse treatment and prevention, and community mental health services.

The full proposed rule is available here. Comments will be open through September 11^th.

Administration Announces New Rules and Guidance for Health Care Consumer Protections
On July 7^th, the Biden Administration announced a series of actions aimed at protecting consumers from “junk health insurance plans, surprise medical bills, and fees that may increase medical debt.” The actions, which are detailed further below, specifically: 

• Reinstate and introduce new limits on short-term insurance that is exempt from Affordable Care Act (ACA) requirements;
• Issue new guidance on the implementation of surprise billing protections; and
• Request stakeholder input on medical debt/credit products.

A fact sheet from the White House describing each of these actions is available here and a press release from CMS is available here.

Short-Term and Fixed Indemnity Insurance
HHS, the Department of Labor (DOL), and the Department of the Treasury released a proposed rule to amend the definition of short-term, limited-duration health insurance (STLDI) plans and fixed indemnity plans, which are excluded from the definition of individual health insurance under the Public Health Service Act and the consumer protections included in the ACA. The rule proposes to limit the initial contract period for STLDI to three months and the maximum coverage period to four months, including any renewals or extensions. Currently, under Trump-era standards, STLDI may be offered for up to 12 months during an initial contract period and up to 36 months maximum. The rule also proposes a prohibition on the issuance of multiple STLDI policies to the same individual within a 12-month period (a practice known as “stacking”).

The Departments also address current market practices by reminding regulated entities that STLDI sold through to individuals through a group trust or association is not considered group coverage under federal law unless it is sold in connection with a group health plan. Such policies must meet the definition of STLDI or comply with federal requirements for comprehensive individual insurance coverage.

On fixed indemnity excepted benefits coverage, the Departments propose to restore requirements in place prior to a 2014 rule change that will prohibit such products in the individual market from paying benefits on a per-service basis. The Departments propose additional refinements to the definition of “fixed” benefits and require that such coverage be offered as independent, non-coordinated coverage when offered under a group health plan.

Finally, the Departments solicit comments and information on a range of topics, including: 

• Strategies to help consumers distinguish between STLDI, fixed indemnity excepted benefits coverage, and comprehensive coverage;
• The marketing and consumer use of disease-specific excepted benefits coverage; and
• The prevalence and use of level-funded plans.

Comments on the proposed rule are due September 11^th. The proposed rule is available hereand a fact sheet is available here.

Surprise Billing
The Departments jointly issued a Frequently Asked Questions (FAQ) document aimed at helping to ensure consumers receive protections under the ACA and the No Surprises Act and clarifying requirements for health insurance plans and issuers. The FAQ is available here.

Additionally, the HHS Assistant Secretary for Planning and Evaluation (ASPE) released the first in a series of reports to Congress on the impact of the No Surprises Act. The report is available here.

Medical Credit
The Departments issued a tri-agency Request for Information (RFI) on medical credit cards, loans, and other financial products used to pay for health care. The Departments are interested in understanding the prevalence, nature, and impact of these products, including disparities across demographic groups, as well as the effects of such products on patients and the health care system, including health care cost inflation, the provision of financial assistance by hospitals, increasing patients’ costs, and effect on patients’ physical, mental, and financial well-being.

The RFI is available here and a press release is available here.

CMS Issues Proposed Rule on 340B-Acquired Drug Payment Policy 
On July 7^th, CMS issued a proposed rule on back payments for 340B-acquired drug payment policy. The rule responds to the Supreme Court’s decision in American Hospital Association v. Becerra, which deemed differential payment rates for 340B-acquired drugs unlawful, given that the HHS failed to conduct a survey of hospitals’ acquisition costs. Given the ruling, all CY 2022 claims for 340B-acquired drugs paid on or after September 28, 2022 were paid at the ongoing rate of ASP plus 6%.

The proposed rule seeks to remedy the period before the ruling by proposing to distribute $9 billion in lump-sum payments to affected providers to cover claims for CY 2018 through CY 2022. In addition, CMS will make a lump-sum payment to hospitals to account for the approximately 20% of dollars that would have been covered through beneficiary copayments. However, given that CMS must maintain budget neutrality for the program, CMS will reduce future non-drug item and service payments by adjusting the OPPS conversion factor downward by 0.5%, starting in CY 2025. This change offsets the $7.8 billion in additional funding to hospitals for non-drug items and services hospitals received under the now-reversed policy. CMS estimates that it will take 16 years until the $7.8 billion is fully offset. Providers that enrolled in Medicare after January 1, 2018 are excluded from the prospective rate reduction.

More information is available here.

CMS Accepting Nominations for Post-Acute Quality Measurement Committees through July 30^th
CMS will accept nominations for certain Partnership for Quality Measurement Committees within the Post-Acute Care Quality Reporting Programs will be accepted through July 30^th. Committees accepting nominations include Endorsement & Maintenance, Pre-Rulemaking Measure Review, and Measure Set Review. Members of these committees provide feedback on quality measures based on their personal expertise and experience.

Individuals and organizations may nominate themselves or others, though the Endorsement & Maintenance Committee accepts only individual nominees. Nominations may be submitted here.

CMS Releases Final 2023 Call Letter for QRS and QHP Enrollee Survey
On July 5th, the Centers for Medicare & Medicaid Services (CMS) released the Final 2023 Call Letter for the Quality Rating System (QRS) and Qualified Health Plan Enrollee Experience Survey (QHP Enrollee Survey). The Final Call Letter summarizes comments received on the Draft Comment Letter issued earlier this year and finalizes CMS policy for the QRS and QHP Enrollee Survey. CMS did not propose any changes for the 2023 ratings year and is finalizing the following changes beginning with the 2024 ratings year: 

• Removing three measures from the QRS measure set: the Annual Dental Visit, Flu Vaccinations for Adults Ages 18-64, and Appropriate Testing for Pharyngitis;
• Adding four measures to the QRS measure set: Oral Evaluation, Dental Services (OED), Adult Immunization Status (AIS-E), Social Need Screening and Intervention (SNS-E), and Depression Screening and Follow-Up for Adolescents and Adults (DSF-E);
• Transitioning the Hemoglobin A1c (HbA1c) Control for Patient with Diabetes: HbA1c control (<8.0%) measure to the Hemoglobin A1c (HbA1c) Control for Patient with Diabetes: HbA1c poor control (>9.0%) measure;
• Expanding the electronic clinical data system (ECDS) reporting method for the Cervical Cancer Screening measure (making ECDS reporting optional), and transitioning the Breast Cancer Screening measure to ECDS-only reporting; and
• Expanding stratification of race and ethnicity data to help advance health equity.

CMS will next publish QRS and QHP Enrollee Survey Technical Guidance and Updated QRS Measure Technical Specifications in September or October of this year.

The Final 2023 Call Letter is available here.

HRSA Awards $23.5 Million for NTTAP Cooperative Agreements 
On July 5^th, the Health Resources and Services Administration (HRSA) announced the award of $23.5 million for fiscal year 2023 National Training and Technical Assistance Partners (NTTAPs) cooperative agreements. The grants will support 22 NTTAPs to develop and deliver training and technical assistance to health centers. The goal of the support is to help health centers deliver comprehensive care; address emergent public health priorities and health needs; improve health care access, operational effectiveness, and quality; and advance health equity. More specifically, NTTAPs might help health centers preserve their financial health, engage in effective workforce development, use health information technology, and/or offer care in culturally and linguistically appropriate ways. Each NTTAP functions as a subject matter expert, offering specialized training and technical assistance on a single topic, which are specific to populations or operational issues.

A list of all awardees is available here.

FDA Approves First Over-the-Counter Birth Control Pill
On July 13^th, the Food and Drug Administration (FDA) approved Opill (norgestrel), a daily hormonal contraceptive pill, as an over-the-counter (OTC) drug. Opill is the first such pill to be approved OTC by the FDA. The FDA’s decision follows the recommendations of two committees, the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee, which unanimously voted in May to change the drug’s status. Perrigo, the manufacturer of Opill, did not indicate a timeline for availability or cost but indicated it wants its product to be “accessible and affordable.”

The FDA Decisional Memorandum is available here and a press release is available here.

Other Updates

EPA Proposes to Strengthen Lead Exposure Standards
On July 12^th, the Environmental Protection Agency (EPA) released a proposed rule to strengthen requirements for the removal of lead-based paint hazards in buildings and child care facilities constructed before 1978. The proposed rule aligns with the 2018 Federal Action Plan to Reduce Childhood Lead Exposures and Associated Health Impacts and is part of the Biden Administration’s whole-of-government approach to reducing lead exposure, which is a neurotoxin, among families and children. If finalized, the EPA estimates the rule would reduce the lead exposures of approximately 250,000 to 500,000 children under age 6 each year. The proposed rule would achieve these reductions by reducing the dust-lead hazard standards (DLHS), which identify lead in dust on floors and window sills, to any reportable level greater than zero (from the current standard of 10 micrograms per square foot). Further, the proposed rule would revise the dust-lead clearance levels (DLCL), which is the amount of lead that can remain in dust on floors, window sills, and window troughs following lead removal activities, to the lowest levels that the EPA believes can be “reliably and effectively achieved.”
 
EPA also announced it will host a joint workshop with the Department of Housing and Urban Development (HUD) to hear stakeholder perspectives on various topics related to lead levels in paint. A public notice of the workshop is available here and a press release can be found here.
 
A press release is available here. The Federal Action Plan on lead exposures may be found here.

New York State Updates

NYS Posts Unwinding FAQ Guidance Document
On July 14^th, the New York State of Health (NYSOH) posted a FAQ document on the current status and policies of New York’s Medicaid unwinding process. The State intends to continue updating this document with more information. Notable information in the document includes: 

• NYS intends to post copies of enrollment waivers and its unwinding plan once finalized with CMS.
• About 40% of NYSOH Medicaid enrollees are expected to be renewed administratively (ex parte). IRS data is only being used for such renewals for NYSOH enrollees, but NYS NYS “is pursuing multiple avenues to allow for administrative renewal at the local districts.”
• MAGI-eligible individuals enrolled through local districts “were transitioned to NYSOH  the end of April 2023.” This generally included all adults under 65.
• The State’s April 2023 guidance to plans on updating enrollees’ contact information is available here.

The FAQ also provides guidance on marketing, outreach, distinctions between enrollment systems, and other topics. The document is available here.

OMH Ends Enforcement of Covid-19 Vaccine Mandate for Psychiatric Facilities 
On July 5^th, the New York State Office of Mental (OMH) released new guidance stating that effective immediately, OMH will no longer enforce the Covid-19 vaccine mandate for personnel at the following hospitals and programs: 

• Psychiatric Inpatient Units of General Hospitals;
• Comprehensive psychiatric emergency programs (CPEPs);
• Inpatient services of freestanding psychiatric facilities;
• Mental Hygiene Law 7.17 (b) Psychiatric hospitals (listed here); and
• Secure Treatment and Rehabilitation Center (STARC) programs.

However, OMH may continue to seek sanctions based on previously cited violations that occurred prior to July 5^th. Official repeal of the vaccine mandate is pursuant to the State Administrative Procedure Act and is pending.

The waiver is available here.

OPWDD Proposes Updates to Supported Employment Services 
On July 12^th, the Office for People with Developmental Disabilities (OPWDD) issued a proposed rule in the State Register (available here) to update Supported Employment (SEMP) service standards. The changes include: 

• Information related to new allowable billable services under SEMP;
• Clarification of self-employment under SEMP;
• Clarification of sub-SEMP categories (e.g., intensive vs. extended SEMP);
• Updated staff training requirements;
• New limits on service provision hours and allowances for rounding billable service units; and
• Updated documentation requirements.

Public comments may be submitted to Mary Beth Babcock at rau.unit@opwdd.ny.gov by September 10^th. The effective date of the regulations is November 1^st. The full text of the proposed regulations is available at the OPWDD website here.

DOH Proposes Amendments for 1915(c) HCBS Children’s Waiver 
On July 5^th, the New York State Department of Health (DOH) issued public notice on its proposal to amend the 1915(c) Children’s Waiver that authorizes an array of Home and Community-Based Services (HCBS) for children and youth meeting institutional level of care (LOC) criteria. Specifically, the following changes are proposed for CMS approval: 

• Authorization of payments for Financial Management Services for children/youth requiring Adaptive and Assistive Technology, Environmental Modifications, and Vehicle Modifications, which will now be provided via the fee-for-service delivery system;
• Updates to the Palliative Care service definition to focus on care for chronic conditions/illness and deemphasize terminal illness;
• Adjustments to palliative care provider qualifications to reduce the years of experience required to serve the medically fragile pediatric populations from three years to one year;
• Clarification that the annual service limit for Respite is to not exceed 14 days/336 hours/1344 cumulative 15-minute units unless medically necessary;
• Changes to the Planned Group Respite rate structure to include groups of 2 and 3;
• Allowing Children’s Single Points of Access (SPOAs) through local county departments of mental health to perform HCBS LOC evaluations for children/youth with Serious Emotional Disturbance (SED); and
• Addition of rural rates to the rate structure.

The proposal maintains the 25% and 5.4% COLA rate increases implemented during the Covid-19 PHE.

Public notice of the waiver amendment was posted in the State Register here. The full text of the draft waiver is available here. Public comments may be submitted to HHSC@health.ny.gov. The proposed effective date for the amendment is November 1^st.

CMS Approves SPA for Coverage of Crisis Intervention Services 
On June 29^th, CMS approved New York’s State Plan Amendment (SPA) to expand access to crisis intervention services previously available to children and populations under the 1115 waiver only under the State Plan. The SPA also authorizes crisis intervention services provided in crisis stabilization centers to both adults and children.

The SPA is effective as of April 1, 2022. The original SPA submission is available here and the CMS approval letter is available here.

Funding Opportunities

NYS Issues RFP for 13 Existing Behavioral Health Clinics to Become CCBHCs
On July 6^th, OMH, DOH, and the Office of Addiction Services and Supports (OASAS) jointly released a Request for Proposals (RFP) for the development of 13 new Certified Community Behavioral Health Clinics (CCBHCs) across the State’s ten economic development regions (EDRs) to participate in the federal CCBHC demonstration.

The State aims to develop six CCBHCs in the New York City (NYC) economic development region (EDR) and seven CCBHCs in the remaining EDRs. Eligible applicants must be licensed, certified, or otherwise authorized by OMH and OASAS with an Article 31 and Article 32 license.
Each awarded agency will implement the CCBHC model at an existing clinic site.

Awarded agencies will receive one-time startup funding ($265,000 per awardee) and programmatic support to grow existing operations to reach Demonstration standards by July 1, 2024. Ongoing operations will be supported through a cost-based Prospective Payment System (PPS), in accordance with federal rules of the Demonstration.

SPG’s detailed summary of the RFP is available here. The RFP is available here. Applications are due via Grants Gateway (available here) by September 28^th. Questions may be submitted to Carol Swiderski to OMHLocalProcurement@omh.ny.gov by August 14^th (answers will be posted here).

OMH Releases RFP for SOS CTI Teams in Staten Island and Queens
On July 11^th, the NYS Office of Mental Health (OMH) released a Request for Proposals (RFP) for funding to support Safe Options Support (SOS) Critical Time Intervention (CTI) teams to operate in New York City. One team will be awarded in each of the following boroughs: Staten Island and Queens (Rockaways area only). SOS CTI teams are expected to use an evidence-based approach to provide intensive outreach, engagement, and care coordination services to street homeless individuals who are referred to the team through the SOS Referral Hub and who are transitioning into stable housing. Teams will be comprised of licensed clinicians, care managers, peer specialists, and registered nurses who provide services for up to 12 months, pre- and post-housing placement.

Eligible applicants are not-for-profit 501(c)(3) agencies with experience providing outreach, case management, and/or behavioral health services to populations with a history of housing instability and/or street homelessness.

Each team will be granted more than $1.3 million annually, for a five-year contract period starting on January 1, 2024. This funding includes $120,000 in wrap-around dollars. Teams may explore opportunities to provide billable services under the Health Home Plus program.

The full RFP is available here. Applications are due by August 30^th. Questions may be emailed to Carol Swiderski at carol.swiderski@omh.ny.gov by August 2^nd, with “SOS CTI Inquiry” in the subject line.

OMH Releases RFP for HealthySteps Expansion 
On June 29^th, OMH released a Request for Applications (RFA) for a new round of funding to support the implementation of the HealthySteps program at new sites statewide. HealthySteps is an evidence-based program that serves young children (ages 0-3) and their families in a pediatric health care setting. Through this RFA, OMH will award a total of more than $33.5 million across up to 70 awardees during the five-year program. 35 of the 70 total awards will be granted to sites located in counties with the highest percentages of children in poverty.

Eligible applicants are pediatric or family medical practices located in New York State, including FQHCs, that serve children ages 0-3 and that are able to deliver well-child visits. Each applicant must be applying to become a new HealthySteps site. Small practices may apply in partnership with another practice in the same healthcare system, but both practices should submit separate applications concurrently. Each applicant practice must have a minimum caseload of 100 children and for partnering practices, have a maximum caseload of 2,000 children.

Each awarded practice will be required to establish an Implementation Team of at least three members, including: 

• A HealthySteps Specialist who is responsible for serving as a liaison between the family and the healthcare team and for promoting the child’s developmental, social-emotional, and behavioral health (partnering practices can share a specialist);
• A Physician Champion who leads the integration of HealthySteps into the medical practice (this role may also be fulfilled by a Nurse Practitioner, if discussed with OMH); and
• A practice manager who can make practice-wide changes or other support team members.

In the first year, awardees will receive program development grants to support staff training and technical assistance (at least $20,000) and to align practice data systems with program reporting requirements ($25,000, which is split in equal payments for partnering practices). Over the five-year contract term, individual practices will receive $433,000 (partnering practices will receive $216,998 each) to support the staff expenses of their HealthySteps Specialist and ongoing operations.

The full RFA is available here. Applications are due by October 3^rd. Questions may be submitted to Carol Swiderski at OMHLocalProcurement@omh.ny.gov through August 3^rd(answers will be posted here).

OMH Releases Procurement Schedule for Funding Opportunities
In the State Fiscal Year 2024-2025 budget, Governor Hochul initiated a multi-year plan to transform the continuum of mental health care in New York State. As a result, OMH has issued a tentative procurement schedule for the next four quarters to inform providers and other stakeholders of upcoming procurement opportunities for new mental health supports and services. The schedule is available here.