Weekly Health Care Policy Update – May 8, 2023

May 15, 2023

In this update:

  • Administration Updates
    • Biden Administration to End Covid-19 Vaccination Requirement for Federal Workers
  • Federal Agencies
    • Rochelle Walensky Announces Departure from CDC
    • FDA Takes Steps to Advance Decentralized Trials
    • DEA to Temporarily Continue Telehealth Flexibilities for Prescription of Controlled Substances
    • CMS Issues Additional Guidance on End of the PHE
    • CMS Releases Innovation Center Model Data
    • FDA Approves First RSV Vaccine
  • Other Updates
    • Leapfrog Group Releases Spring Hospital Safety Grades
  • New York State Updates
    • NYS Governor and Legislature Finalize FY 2024 NYS Budget
    • Governor Hochul Signs Legislative Package to Expand Access to Reproductive Health Care
    • State Education Department Amends Educational Requirements for Nursing Licensure
    • SED Adopts Regulations to Provide Flexibility for Licensure of Clinical Laboratory Practitioners
    • DOH Issues Proposed Regulations to Update Adult Care Facility Resident Rights 
    • CMS Approves NYS Expansion of Medicaid Harm Reduction Services
    • CMS Approves NYS Telehealth Delivery of CSIDD Services 
    • OMH Clarifies Effective Dates for Updated Telehealth Guidance
  • Funding Opportunities
    • Health + Hospitals Releases RFP for Alternative Care Site Clinical Staffing
    • HRSA Issues FY 2024 FQHC Service Area Competition
    • CDC Releases NOFO for Community-Based Approaches to Reducing Sexually Transmitted Diseases (CARS)

Administration Updates

Biden Administration to End Covid-19 Vaccination Requirement for Federal Workers
On May 1st, the Biden Administration announced that it will end the Covid-19 vaccine requirement for federal employees, federal contractors, and international air travelers at the end of the Public Health Emergency (PHE) on May 11th. The Administration will also begin the process to end vaccination requirements for Head Start educators, CMS-certified health care facilities, and certain non-citizens at the land border, with further guidance forthcoming. The vaccination requirement was originally put in place in 2021. Despite legal battles, the Supreme Court ultimately let the requirement stand in January 2022.
 
More information is available here.

Federal Agencies

Rochelle Walensky Announces Departure from CDC
On May 5th, the Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky announced that she will leave her post on June 30th. Before her tenure as CDC director, which began in January 2021, Dr. Walensky led the infectious diseases division at Massachusetts General Hospital and was a professor of medicine at Harvard Medical School. She was also Chair of the National Institutes of Health’s Office of AIDS Research Advisory Council, chair-elect of the HIV Medical Association, and an adviser to the World Health Organization and the Joint United Nations Programme on HIV/AIDS. No announcement was made as to a successor.
 
The CDC press release is available here.
 
FDA Takes Steps to Advance Decentralized Trials
On May 2nd, the Food and Drug Administration (FDA) issued draft guidance to support the use of decentralized clinical trials (DCTs) for drugs, biologics, and devices. DCTs are defined as trials where some or all of the trial-related activities occur at locations other than traditional clinical trial sites, such as obtaining laboratory tests at a local facility rather than a research medical center or conducting a clinical follow-up visit using telemedicine. The FDA expects that the use of DCTs will “increase the breadth and diversity of participants in clinical trials and improve accessibility for those with rare diseases or mobility challenges,” as well as facilitate the “development of drugs including in areas of medical need, resulting in more treatment options and improved patient outcomes.”
 
The guidance covers the following topics: 

  • Design considerations for a DCT;
  • Conduct of remote clinical trial visits and clinical trial-related activities in a DCT;
  • Use of digital health technologies to remotely acquire data in a DCT;
  • Roles and responsibilities of the sponsor and investigators in a DCT;
  • Obtaining informed consent (IC) and institutional review board oversight of the IC process in a DCT;
  • Determination of the appropriateness of investigational products for use in a DCT;
  • Packaging and shipping of investigational products in a DCT; and
  • Safety monitoring of trial participants in a DCT.

More information is available here.
 
DEA to Temporarily Continue Telehealth Flexibilities for Prescription of Controlled Substances
On May 3rd, the Drug Enforcement Administration (DEA) announced that it has filed a draft temporary rule with the Office of Management and Budget (OMB) to temporarily extend Covid-era telehealth policies for some controlled substances, including buprenorphine and stimulants like Adderall. The pandemic-era rules allowed doctors to write prescriptions for certain controlled substances to patients who had only been evaluated by phone or video, not through an in-person visit.
 
The DEA issued a proposed rule three months ago (see SPG’s summary here) that would have reinstated limitations on the prescribing of controlled substances via telehealth following the expiration of the Covid-19 PHE. The rule received 38,000 comments, largely critical of the proposal, leading the DEA to announce that it will extend the current flexibilities “while we work to find a way forward to give Americans that access with appropriate safeguards.”
 
The DEA statement is available here. The draft temporary rule is available here.
 
CMS Issues Additional Guidance on End of the PHE
On May 1st, the Centers for Medicare and Medicaid Services (CMS) released new guidance for the expiration of the Covid-19 PHE. The memorandum outlines the expiration of emergency waivers issued during the PHE related to the minimum health and safety requirements for long-term care, acute, and continuing care providers. Some policies have been extended by Congress through 2024, but others will be modified with the expiration of the PHE. The guidance outlines each issue by provider type.
Key elements include: 

  • Staff vaccination: CMS will end the requirement that covered providers and suppliers establish policies and procedures for staff vaccination.
  • Emergency Preparedness: Providers/suppliers are expected to return to normal operating status and comply with the regulatory requirements for EP with the conclusion of the PHE, including conducting testing exercises based on the regulatory requirements for specific provider/supplier types as outlined in the guidance.
  • Three-Day Prior Hospital Stay: These waivers will terminate immediately with the expiration of the PHE. All new skilled nursing facility (SNF) stays beginning on or after May 12th will require a qualifying hospital stay before Medicare coverage. Additionally, for any new benefit period that begins on or after May 12th, the beneficiary will need to have completed a 60-day wellness period.

The guidance also covers the following areas for long-term care facilities: pre-admission screening and annual resident review waiver infection control surveys, Covid-19 testing/vaccination/reporting, resident transfer and discharge, resident roommates and grouping, and other items.

For acute and continuing care providers, the guidance has specific sections for ambulatory surgery centers, community mental health centers, end stage renal disease facilities, home health agencies, hospice, hospitals, intermediate care facilities for individuals with intellectual disabilities, rural health clinics, and federally qualified health centers.

The full guidance document is available here.

CMS Releases Innovation Center Model Data
On May 1st, CMS announced the availability of Research Identifiable Files (RIFs) for several Innovation Center models. CMS periodically makes model data available to stakeholders to advance transparency on model performance and support external research and learning. CMS released model participation files for the Value in Opioid Use Disorder Treatment Demonstration and the Home Health Value Based Purchasing Model. CMS also released RIFs for the Million Hearts Cardiovascular Disease Risk Reduction Model, which includes information about beneficiaries, physician practices, specific providers, and clinic visits.
 
More information is available here.
 
FDA Approves First RSV Vaccine
On May 3rd, the FDA approved the first respiratory syncytial virus (RSV) vaccine for use in the United States. The new drug, Arexvy, is approved for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 60 years of age and older. According to the CDC, RSV leads to approximately 60,000 to 120,000 hospitalizations and 6,000 to 10,000 deaths among adults 65 years of age and older each year. GlaxoSmithKline data showed that, among the participants who have received Arexvy and placebo, the vaccine significantly reduced the risk of developing RSV-associated LRTD by 82.6% and reduced the risk of developing severe RSV-associated LRTD by 94.1%. A Pfizer vaccine against RSV for infants up to 6 months of age will be up for approval later this year.
 
More information is available here.

Other Updates

Leapfrog Group Releases Spring Hospital Safety Grades
On May 3rd, the Leapfrog Group released its Spring 2023 Hospital Safety Grade data, which assessed almost 3,000 general acute care hospitals across 30 measures of patient safety. Overall, 29% of hospitals received an “A,” 26% received a “B,” 39% received a “C,” 6% received a “D,” and less than 1% received an “F.” The top ten states with the highest percentages of “A” hospitals are: New Jersey, Idaho, Utah, Pennsylvania, Connecticut, North Carolina, South Carolina, Colorado, Virginia and Massachusetts. There were no “A” hospitals in Delaware, District of Columbia, or North Dakota.
 
“A”-rated hospitals in the New York Metro region include Long Island Jewish Forest Hills, Mather Hospital, Huntington Hospital, North Shore University Hospital, Northern Westchester Hospital, NYU Langone – Brooklyn, NYU Langone, NYU Langone – Long Island, Peconic Bay Medical Center, South Shore University Hospital, St. Francis Hospital & Heart Center, Syosset Hospital, and White Plains Hospital.
 
More information, including all hospital safety grades, is available here.

New York State Updates

NYS Governor and Legislature Finalize FY 2024 NYS Budget
On May 2nd, the New York State (NYS) Legislature passed the Enacted Budget for NYS Fiscal Year (FY) 2023-2024. Total spending across all sources (including NYS and federal funds) is estimated at approximately $229 billion, up from the Executive Budget’s proposal of $227 billion, and a year-over-year increase from SFY 2022 of $8.6 billion.
 
Some notable changes in the Enacted Budget from Governor Hochul’s Executive Budget include:  

  • Medicaid Rates: The Budget includes a 7.5% increase for inpatient hospital rates and a 6.5% for outpatient hospital rates, nursing homes, and assisted living programs. This is an increase from the 5% proposed by the Executive, but less than the 10% proposed by the Assembly and Senate.
  • Cost of Living Adjustment (COLA): The Budget includes a 4% COLA for FY 2024 for eligible human services programs. This is an increase from the 2.5% proposed by the Executive, but less than the 8.5% proposed by the Assembly and Senate. 
  • Workforce and Scope of Practice: The Budget does not include the Governor’s proposals to:  
    • Join the Interstate Medical and Nurse Licensure Compacts; 
    • Move oversight of health care professions from the State Education Department (SED) to the Department of Health (DOH); 
    • Create an option for experienced physician assistants (PAs) to practice independently, and make other scope of practice expansions for nurses, PAs, and pharmacists; and 
    • Create a credential for “qualified mental health associates.”
  • Home Care Minimum Wage: A new provision in the Budget removes the planned $1 per hour minimum wage increase for home care aides scheduled to take effect later this year, and replaces it with a new annual increase schedule through 2026. Beginning in 2027, minimum wage increases for home care workers will be indexed to inflation.

Other major proposals have been included, but with modifications. These include:  

  • Capital Funding: The Budget includes the proposed $1 billion for health care capital projects, with additional details on eligible projects within each competition pool. 
  • Managed Long Term Care (MLTC) Plans: The Budget includes the proposal to establish new “performance standards” for MLTC plans, with updated requirements. The Budget does not include the Executive proposal authorizing a competitive procurement process for MLTC plans.
  • Disclosure of “Material Transactions”: The Budget includes a modified form of the Executive’s proposal to establish new reporting requirements for “material transactions” involving less-regulated health care providers and affiliates. 
  • Behavioral Health Network Adequacy: The Budget includes the establishment of enhanced network adequacy standards for behavioral health but does not include the specific requirements outlined in the Executive Budget. 

SPG’s detailed summary of the Enacted Budget is available here.
 
Governor Hochul Signs Legislative Package to Expand Access to Reproductive Health Care
On May 2nd, Governor Hochul signed two legislative bills to expand abortion services and over-the-counter contraception in New York State: 

  • A1060/S1043: Authorizes licensed physicians and certified nurse practitioners to prescribe and order a non-patient specific order to pharmacists for the dispensing of self-administered hormonal contraceptives. Prior to dispensing, pharmacists are to provide the patient with a self-screening risk assessment questionnaire and a fact sheet for use of the contraception.
  • A1395/S1213: Requires every SUNY and CUNY campus to either employ/contract with individuals authorized to prescribe medication abortion prescription drugs to all enrolled students or to provide students with information and referrals to providers who are authorized to prescribe medication abortion prescription drugs.

The Governor’s press release on the reproductive healthcare legislative package is available here.
 
State Education Department Amends Educational Requirements for Nursing Licensure
On May 3rd, the New York State Education Department (SED) released an emergency/proposed rule that requires registered nurses (RNs) and licensed practical nurses (LPNs) who graduate from out-of-state nursing educations and are seeking licensure in New York to meet the same minimum competency for licensure as applicants who received their education from an SED-registered nursing education program. Specifically, SED would have the explicit authority to reject RN and LPN licensure applicants who graduated from out-of-state nursing programs that do not satisfy SED standards, even if the program has been approved by the other State’s licensing authority.
The emergency rule will expire July 16th. It is anticipated that the rule will be presented for permanent adoption at the September Board of Regents meeting and that additional emergency actions will be taken to extend this rule until it is permanently adopted.

The notice is available in the State Register here. Comments may be submitted to Sarah Benson at REGCOMMENTS@nysed.gov through July 2nd.  

SED Adopts Regulations to Provide Flexibility for Licensure of Clinical Laboratory Practitioners
On May 3rd, pursuant to legislation passed in 2022, SED published a notice of adoption of regulations that provide flexibilities to license additional qualified individuals as clinical laboratory practitioners, which will help to alleviate workforce shortages of such practitioners and improve access to clinical laboratory testing services. Specifically, the regulations: 

  • Establish a pathway for clinical laboratory technicians to qualify for New York licensure as a clinical laboratory technologist;
  • Makes the following changes for clinical laboratory practitioners (i.e., clinical laboratory technologists, cytotechnologists, clinical laboratory technicians, and histotechnicians):  
    • Allows applicants to fulfill certain requirements for New York licensure if licensed in another jurisdiction or certified by a national certifying organization approved by SED;
    • Increases the duration of limited and provisional permits from up to one year to up to two years and makes such permits non-renewable; and
    • Removes expired licensure pathways and obsolete requirements for admission to the licensing examinations for these practitioner types.

The notice of the adopted rules is available in the State Register here.
 
DOH Issues Proposed Regulations to Update Adult Care Facility Resident Rights 
On May 3rd, the NYS Department of Health (DOH) released proposed regulations to update resident rights standards for all adult care facilities, including Adult Homes, Enriched Housing Programs, and Residences for Adults, in order to align with the federal Home and Community Based Services (HCBS) Final Rule. 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.

Many of these updates that are required in order to be in compliance with the Final Rule have already been communicated to facilities through Dear Administrator Letters. The notice is available in the State Register here. The proposed regulations are available here. Comments can be submitted to Katherine Ceroalo at regsqna@health.ny.gov through July 2nd.  

CMS Approves NYS Expansion of Medicaid Harm Reduction Services
On April 28th, CMS approved New York’s State Plan Amendment (SPA) to expand Medicaid Harm Reduction Services provided at NYS Commissioner of Health-waivered comprehensive harm reduction programs. The SPA makes reimbursement changes, including increases to the rest-of-state and group service rates and adding reimbursement for off-site services. Service changes adding Linkage and Navigation as a new reimbursable service, clarifying service definitions for existing services, and clarifying the qualified providers and organizations who are permitted to provide such services. These changes have an effective date of April 1, 2022.

The SPA is available here. The CMS approval letter is available here.

CMS Approves NYS Telehealth Delivery of CSIDD Services 
On April 28th, CMS approved New York’s SPA to allow for the remote delivery of Crisis Services for Individuals with Intellectual and/or Developmental Disabilities (CSIDD) through telephonic or other two-way, real-time communication telehealth/technology modalities meeting HIPAA requirements. The monthly rates used to reimburse CSIDD services delivered face-to-face will be applied to the same services delivered via telehealth. However, for the moderate interventions, no more than one of the two required services (plus any additional services) may be delivered via remote service delivery. For the intensive intervention, no more than two of the required services delivered on a weekly basis (plus any additional services) may be provided via remote service delivery. The SPA will be effective May 12th.
 
The SPA is available here. The CMS approval letter is available here.
 
OMH Clarifies Effective Dates for Updated Telehealth Guidance
On May 1st, the Office of Mental Health (OMH) sent a memo to providers clarifying the effective dates for the following telehealth guidance: 

  • The “April 2023 Telehealth Services Guidance for OMH Providers” (available here) will be effective May 12th, consistent with the expiration of the federal PHE on May 11th. OMH will begin incorporating the terms of the telehealth guidance in OMH certification reviews, effective August 1st, and will inform the Office of the Medicaid Inspector General (OMIG) of this date to use for future audits. SPG’s summary of this guidance is available here.
  • The February DOH Medicaid Guidance on the use of telehealth (including telephonic services) after the PHE (available here) is effective May 12th, although flexibilities are permitted for the following provisions: 
    • This guidance included information on the use of the FQ modifier for audio-only Medicaid behavioral health services. OMH providers will not be sanctioned for failing to use the FQ modifier after May 12th, so long as providers are actively working towards compliance and are taking steps to start using the modifier as soon as possible. Providers should be compliant by August 1st.
    • The DOH guidance includes requirements that providers document the justification for audio-only encounters and that audio-visual or in-person appointments be made available upon request. However, OMH will delay these requirements for OMH-licensed providers and designated services to August 1st.
  • The “Impact of the end of the Federal Public Health Emergency (PHE) on the OMH System” memo (available here) has a firm effective date of May 12th. This guidance includes a requirement that providers must obtain approval to provide telehealth on a permanent basis before the effective date and also outlines permissible locations for certain services. SPG’s summary of this guidance is available here.  

The memo is available here.

Funding Opportunities

Health + Hospitals Releases RFP for Alternative Care Site Clinical Staffing
On May 2nd, the New York City Health and Hospitals Corporation (NYC H+H) released a Request for Proposals (RFP) seeking to contract with vendors capable of providing time-sensitive and short-term clinical and support staffing at temporary Emergency Response Alternative Care Sites (ERACS), including Special Medical Needs Shelters (SMNS), that may be activated as part of health system or city emergency response activities. Specifically, H+H is seeking vendors that meet the following requirements:   

  • Ability to supply the following staff during emergencies (prospective vendors will not be required to supply all staffing titles but should be able to activate staff within a minimum of 2 weeks for any type of ERACs or a minimum of 72 hours for a SMNS during a coastal storm or other environmental emergency): 
    • Physicians;
    • Advance practice providers (nurse practitioners or physician assistants);
    • Registered nurses; and/or
    • Nursing support staff (home health aides and/or certified nursing assistants)
  • Be Minority or Women Owned Business Entity (M/WBE)-certified (applicants not meeting M/WBE certification must provide an M/WBE utilization plan to award at least 30% of their total contract value to subcontracted certified M/WBEs);
  • Have been in business for at least five years; and
  • Have an annual revenue of at least $5 million in each of the last three fiscal years.

Applicant vendors are asked to propose budgets for their proposed staffing services, accounting for the type(s) and number of staff deployed, proposed staff hourly rates, operating hours, and the duration of deployment and urgency of deployment. Contracts will last for three years, beginning in August, with two one-year options to renew.

The RFP is available here. Applications are due May 30th. Interested applicants must participate in a mandatory pre-proposal conference call on May 15th at 2pm (registration is required by May 12th and is available here). Questions can be submitted to Randy Lee at leer31@nychhc.org and/or Nishant Kondamudi at kondamun@nychhc.org through May 17th.

HRSA Issues FY 2024 FQHC Service Area Competition
On April 27th, the Health Resources and Services Administration (HRSA) posted a new Service Area Competition (SAC) opportunity for FY 2024. Through the SAC, organizations may apply to participate in the federally qualified health center (FQHC) program by taking over a grant in an existing service area. FQHCs are typically approved for a three-year period and, if they seek to renew, must reapply to the SAC. For this opportunity, there are additional SACs open in the Bronx, Brooklyn, Queens, and Westchester.

Applications are due June 26th. More information is available here. 

CDC Releases NOFO for Community-Based Approaches to Reducing Sexually Transmitted Diseases (CARS)
On April 28th, CDC released a NOFO for the Community-Based Approaches to Reducing Sexually Transmitted Diseases (CARS) cooperative agreement, which aims to improve the health of populations disproportionately affected by sexually transmitted diseases (STDs) by maximizing the health impact of public health services, reducing disease incidence, and advancing health equity. Specifically, CARS recipients will receive funding to support the following activities: 

  • Implementation of community engagement methods to achieve health equity, specifically by establishing and engaging a Community Advisory Board (CAB) representing groups disproportionately affected by STDs;
  • Implementation of structural change strategies that promote personal health, support healthy behaviors, and community-clinical linkages to build support for interventions to prevent and reduce STD disparities;
  • Enhancement and sustainability of multi-sectorial partnerships;
  • Support for communication strategies to promote STD program successes, and leverage additional resources for STD control and prevention; and
  • Evaluation of the efficacy of intervention approach and implementation.

Eligible applicants include non-profit and for-profit (other than small businesses) organizations with relevant experience. The CDC expects to issue four awards, each averaging $325,000 annually, for a three-year performance period.

The NOFO is available here. Applications are due on June 27th. An informational conference call for potential applicants will be held on May 18th at 12pm; the call information is available in the NOFO. Applicants may submit a letter of intent (LOI), which is recommended but not required, to Norman Hayes at NHayes3@cdc.gov by May 28th. Questions may be sent to NHayes3@cdc.gov.