Weekly Health Care Policy Update – January 8, 2024

January 15, 2024

In this update:

  • Legislative Updates
    • Congressional Leaders Announce Spending Level Agreement; Negotiations Continue
  • Federal Agencies
    • CMS Announces New Transforming Maternal Health Model
    • HHS Releases New Data Strategy Document
    • HHS Launches Climate Change “Catalytic Program” for Health Providers
    • HHS OIG Releases Report on Medicare Enrollees’ Use of Medication for OUD
    • PCORI to Hold February 7th Webinar on 2024 Opportunities
    • CMS Releases Amended Fees for Independent Dispute Resolution in No Surprises Act
    • CMS Issues Report on New York Integrated Appeals and Grievances Demonstration
  • Other Updates
    • FTC/DOJ Finalize Merger Guidance
    • AHRQ Releases Guiding Principles for Addressing Bias in Algorithms
    • MACPAC Holds December Meeting
  • New York State Updates
    • Governor Hochul Releases 2024 State of the State Proposals on Consumer Protections and Maternal and Infant Mortality
    • DFS Issues Guidance to Commercial Insurers on Coverage of School-Based Mental Health
    • DFS Issues Guidance Regarding Coverage of RSV Immunizations
    • DFS Issues Guidance on Updates to LTC Insurance Compliance Requirements
    • DFS Issues Guidance on Acceptance of Standard Form for Designated Representatives
    • DOH Issues Provider Fact Sheet on Public Health Emergency Unwind
    • NYSOFA Adopts Updates to Nutrition Program Regulations
    • SED Adopts Regulations Regarding Licensure and Certification Requirements for Behavioral Analysts
    • OPWDD Adopts Amended Regulations to Supported Employment Services
    • NY State of Health Releases Fact Sheet on New Insurance Option for Undocumented Immigrants Over Age 65
    • DOH Updates Essential Plan Expansion Application to Include DACA Recipients
    • CMS Approves New York SPA Continuing Minimum Wage Adjustments for Article 28 Freestanding Clinics and Ambulatory Surgery Centers
    • DOH Issues Proposed Regulations on General Hospital Medical Staff Recertification Timeframes
    • Governor Hochul Signs Package of Health Care Legislation

Legislative Update

Congressional Leaders Announce Spending Level Agreement; Negotiations Continue
On January 7th, Speaker of the House Mike Johnson (R-LA) and Senate Majority Leader Chuck Schumer (D-NY) announced an agreement on topline spending numbers for the federal government’s Fiscal Year (FY) 2024 appropriations bills. The agreement sets the total level of spending at about $1.66 trillion, in line with the deal made by President Biden and former Speaker Kevin McCarthy last year.
 
The deal is the first step in avoiding a government shutdown. Congress must now agree on and pass individual appropriations bills before January 19th or February 2nd, depending on the department. While a continuing resolution (CR) to fund the government at last year’s levels through the rest of the fiscal year remains a possibility, there appears to be bipartisan support for avoiding that outcome. Because 2024 will be a Presidential election year, the appropriations bills could become one of the few legislative vehicles for a host of other provisions lawmakers hope to pass this year.

Federal Agencies

CMS Announces New Transforming Maternal Health Model 
On December 15, 2023, the Centers for Medicare and Medicaid Services (CMS) announced the new Transforming Maternal Health (TMaH) Model. TMaH is a 10-year program in which CMS will partner with State Medicaid agencies to implement whole-person approaches to maternal care in their Medicaid programs. This may include increased access to midwives, freestanding birth centers, and doula services, as well as helping health systems achieve CMS’s new “Birthing-Friendly” designation for hospitals.

Through more personalized care and increased access to maternal care providers, CMS hopes to lower instances of severe maternal morbidity in participating states. Each participating State Medicaid agency will be eligible for up to $17 million in funding during the model’s 10-year period. CMS plans to release a Notice of Funding Opportunity for TMaH in the spring of 2024.

The announcement is available here.

DOL Proposes to Rescind Association Health Plans Rule and Requests Comments
On December 19th, the Department of Labor (DOL) issued a proposed rule that would rescind the Association Health Plans rule published under the Trump Administration in 2018. The 2018 rule had expanded the definition of association health plans to allow a wider range of groups to offer such plans, which are exempt from most Affordable Care Act (ACA) regulations such as essential health benefits requirements. The rule never went into effect due to legal challenges.

DOL’s press release is available here. DOL is seeking comments on whether it should engage in future rulemaking or issue guidance on AHPs, which are due by February 18th.

HHS Releases New Data Strategy Document
On December 14, 2023, the Department of Health and Human Services (HHS) released a new Data Strategy document outlining its priorities for improving the use of data within HHS and its subagencies and programs. The Strategy describes five major priority areas: 

  • Cultivate data talent within HHS’s workforce;
  • Foster data sharing within HHS and externally, to partners;
  • Integrate administrative data into program operations;
  • Enable whole-person care delivery by connecting human services data with health data; and
  • Responsibly leverage artificial intelligence in health data.

HHS noted that as part of the Strategy, it is expanding the scope of the Office of the National Coordinator for HIT (ONC) to include interoperability between health data and other human services data.

The announcement is available here. 

HHS Launches Climate Change “Catalytic Program” for Health Providers
On January 25th at 12pm ET, the HHS Office of Climate Change and Health Equity (OCCHE) will hold the first session of its new “catalytic program” to support health care providers (particularly safety net providers) in taking advantage of opportunities in the Inflation Reduction Act (IRA) to address climate change. The catalytic program will provide education and resources to help organizations assess the opportunities created by the IRA, such as tax credits, grants, and other supports. Potential investment areas include clean energy, building efficiency, infrastructure resilience, and more. The program includes seven national sessions, as well as breakouts for different safety net provider types.

More information is available here.

HHS OIG Releases Report on Medicare Enrollees’ Use of Medication for OUD
On December 11, 2023, the HHS Office of the Inspector General (OIG) released a report on the usage of medication for opioid use disorder (OUD) among Medicare enrollees. The report found that, of the roughly 1.1 million Medicare enrollees who suffer from OUD, just 18% received medication through Medicare. OIG concluded that the low utilization of this benefit indicates broader challenges in addressing the substance use needs of Medicare enrollees with these disorders.

The report is available here.PCORI to Hold February 7th Webinar on 2024 Opportunities 
On February 7th at 2pm ET, the Patient-Centered Outcomes Research Institute (PCORI) will hold a webinar to review upcoming funding opportunities for patient-centered comparative clinical effectiveness research (CER), opportunities for public input on reports and projects, advisory panels, and other PCORI programs. Speakers will include Executive Director Nakela L. Cook as well as other PCORI leaders.

Registration is available here.

CMS Releases Amended Fees for Independent Dispute Resolution in No Surprises Act
On December 18, 2023, CMS released amended fees associated with the use of the Federal Independent Dispute Resolution (IDR) process under the No Surprises Act. CMS, in consultation with other federal departments, established a fixed administrative fee of $115 per party for disputes initiated on or after the effective date of the rule (anticipated to be January 20, 2024). In addition, the final rule also established the range of fixed fees that IDR entities may charge for payment determinations.

The announcement is available here.

HHS Increases Naloxone Access in Federal Facilities 
On December 21, 2023, HHS announced new guidance for federal facilities to increase inventories of naloxone. With increased access, the hope is for naloxone to soon be everywhere a AED is located through the rollout of new “safety stations.” Naloxone became available over-the-counter for the first time in the summer of 2023.

The announcement is available here.

CMS Issues Report on New York Integrated Appeals and Grievances Demonstration 
Last month, CMS issued its third report on the New York Integrated Appeals and Grievances (A&G) Demonstration. The NY Integrated A&G Demonstration began in January 2020 and aims to integrate and streamline the differential policies for Medicare and Medicaid plan reduction, termination, or denial. The integrated demonstration was used for over 9,000 plan coverage decisions in 2022, with stakeholders pleased with the program’s interoperability. Overall, the State, CMS, and beneficiary advocates spoke highly of the demonstration, while health plans have some concerns. CMS is exploring the possibility of a two-year extension of the program.

The report is available here.

Other Updates

FTC/DOJ Finalize Merger Guidance 
On December 18, 2023, the Federal Trade Commission (FTC) and the Justice Department (DOJ) issued final 2023 Merger Guidelines. The culmination of a two-year process, these guidelines outline the factors and frameworks that the two agencies use when reviewing mergers and acquisitions. In an effort to better reflect the nature of modern business, these guidelines included extensive public feedback. Importantly, this guidance is not legally binding, but rather, offers added transparency to the FTC and DOJ review process.
 
The announcement is available here.
 
AHRQ Releases Guiding Principles for Addressing Bias in Algorithms
On December 15, 2023, the Agency for Healthcare Research and Quality (AHRQ) released a paper published in JAMA Network Open on the use of health care algorithms. Taking lessons learned from other sectors, researchers developed a conceptual framework to apply guiding principles to such work. These principles address accountability, trade-offs, and appropriate patient engagement. This paper is part of broader efforts by the Biden Administration to address discrimination through regulatory engagement.
 
The announcement is available here.
 
MACPAC Holds December Meeting
On December 14 and 15, 2023, the Medicaid and Children’s Health Insurance Program (CHIP) Payment and Access Commission (MACPAC) convened for its December public meeting. The Commissioners expressed support for improving transparency in Medicaid financing. Additionally, the Commissioners reviewed Disproportionate Share Hospital payments for the year and data from the ongoing Medicaid unwind.
 
Slides from the presentation are available here.

New York State Updates

Governor Hochul Releases 2024 State of the State Proposals on Consumer Protections and Maternal and Infant Mortality
On January 2nd, Governor Hochul released her first 2024 State of the State proposal related to consumer protections and affordability. As part of this agenda, the Governor proposes to: 

  • Expand consumer protection laws and enhance the State’s ability to enforce consumer protections;
  • Increase the maximum benefit for paid medical and disability leave;
  • Eliminate patient cost-sharing for insulin; and
  • Update and expand the hospital financial assistance law to protect individuals against medical debt, including limiting hospitals’ ability to sue patients earned less than 400 percent of the Federal Poverty Level ($120,000 for a family of four).

On January 4th, Governor Hochul announced another State of the State proposal that aims to address maternal and infant mortality. The Governor is proposing to: 

  • Expand New York’s Paid Family Leave policy to include 40 hours of paid leave to attend prenatal appointments;
  • Allow mothers to access doula services without a referral from a physician;
  • Eliminate cost-sharing for pregnancy-related benefits in the Essential Plan and Qualified Health Plans, and expand coverage for doulas in the Essential Plan;
  • Implement new oversight measures to avoid unnecessary C-sections and new Medicaid financial incentives for hospitals to reduce the number of unnecessary C-sections;
  • Address maternal mental health and post-partum depression through enhanced training initiatives; and
  • Provide funding for the distribution of portable cribs to low-income families.

The Governor’s press release on consumer protections is available here. The Governor’s press release on maternal and infant health is available here.

DFS Issues Guidance to Commercial Insurers on Coverage of School-Based Mental Health 
On December 21, 2023, the New York State (NYS) Department of Financial Services (DFS) issued guidance to regulated commercial insurance plans regarding new reimbursement requirements for Article 31 school-based mental health clinic services. As implemented in the 2023-2024 NYS Enacted Budget and effective January 1, 2024, commercial insurance plans are required to pay at minimum the Medicaid rate for school-based mental health clinic services. Services must be covered regardless of network participation.

The guidance is available here. Questions may be submitted to health@dfs.ny.gov.

DFS Issues Guidance Regarding Coverage of RSV Immunizations
On December 22, 2023, DFS issued guidance to regulated commercial insurance plans regarding coverage requirements for respiratory syncytial virus (RSV) immunizations. Effective August 3, 2023, as per recommendations issued by the federal Advisory Committee on Immunization Practices (ACIP), such plans are required to cover RSV immunizations without cost sharing for infants and young children. DFS also strongly encourages plans to immediately cover RSV immunizations for adults aged 60 years and older and pregnant individuals at 32-36 weeks gestation. Coverage for these populations, with no cost-sharing, will be required upon policy issuance or renewal that occurs six months from the date of the ACIP recommendation (June 21, 2023 for older adults and September 22, 2023 for pregnant individuals).

The guidance is available here. Questions may be submitted to health@dfs.ny.gov.

DFS Issues Guidance on Updates to LTC Insurance Compliance Requirements
On December 22, 2023, DFS issued guidance to regulated insurance plans on new requirements related to long term care insurance disclosure statements and long term care premium rate adjustment applications submitted to DFS. On November 17, 2023, Governor Hochul signed Chapter 655 into law, which amends the Insurance Law to establish new requirements for such disclosure statements and premium rate adjustment applications.

As a result, effective January 1, 2024, insurance plans must update the disclosure statement to include additional information, including actions that members may take in response to premium rate increases. Members must receive at least 90 days’ notice before any premium change takes effect. If a plan seeks to increase premium rates, DFS will post notice of the rate filing on its website prior to any determination.

The guidance, which includes a list of all new information that must be included on the disclosure statement, is available here. Questions may be submitted to health@dfs.ny.gov.

DFS Issues Guidance on Acceptance of Standard Form for Designated Representatives 
On January 2nd, DFS issued guidance to regulated insurance plans indicating that such plans are required to accept the standard form (available here) developed by DFS for members to designate a representative to assist with authorizations, complaints, grievances, and appeals. Plans are also strongly encouraged to make the form available on their websites.

The guidance is available here. Questions may be submitted to health@dfs.ny.gov.

DOH Issues Provider Fact Sheet on Public Health Emergency Unwind
On January 2nd, the NYS Department of Health (DOH) issued an informational fact sheet to help providers inform patients who may be at risk of losing their health insurance as a result of the Public Health Emergency (PHE) unwinding process. The fact sheet includes information on how provider practices can alert patients regarding renewal procedures and support patients with the renewal process.

The fact sheet is available here.

NYSOFA Adopts Updates to Nutrition Program Regulations
On December 27, 2023, the NYS Office for the Aging (NYSOFA) adopted amendments to update the regulations governing the Nutrition Program for older adults, as follows:  

  • Implement the portable meals service option, which has temporarily been in place during the Covid-19 pandemic; and
  • Expand the types of nutrition professionals, beyond Registered Dieticians, who can be employed by or contracted with an area agency on aging.

Details on the regulations are available in the State Register here. The Notice of Adoption is available here.

SED Adopts Regulations Regarding Licensure and Certification Requirements for Behavioral Analysts 
On December 27, 2023, SED adopted regulations that more closely align NYS education standards with evolving national certification requirements for Licensed Behavior Analysts (LBAs) and Certified Behavior Analyst Assistants (CBAAs). Additional details on the changes are available in SPG’s update here.

The final regulations are available here. The Notice of Adoption is available here.

OPWDD Adopts Amended Regulations to Supported Employment Services 
On December 27, 2023, the NYS Office for People with Developmental Disabilities (OPWDD) adopted amendments that update regulations for Supported Employment (SEMP) services. The updated regulations: 

  • Include information related to new allowable services under SEMP;
  • Update staff training requirements;
  • Implement new limits on service provision hours;
  • Refine definitions of sub-SEMP categories (e.g., intensive or extended SEMP);
  • Update documentation requirements; and
  • Allow rounding for billable service units.

The final regulations are available here. The Notice of Adoption is available here.

NY State of Health Releases Fact Sheet on New Insurance Option for Undocumented Immigrants Over Age 65
On December 18, 2023, the New York State of Health (NYSOH), New York’s health plan marketplace, released a fact sheet on the new health insurance option available to undocumented immigrants over age 65. Starting January 1, 2024, such individuals will be eligible for preventive and primary care benefits through Medicaid Managed Care plans. Previously, this population only qualified for Emergency Medicaid.

To be eligible, individuals must have income and resources below the standard Medicaid income threshold, which is 138 percent of the Federal Poverty Line (FPL). Individuals who already had Emergency Medicaid will be automatically transitioned to the new insurance and will be able to choose a Medicaid Managed Care plan. Individuals who are uninsured must apply through their Local Department of Social Services or New York City Human Resources Administration. They cannot apply for the new coverage through NY State of Health. Individuals may also choose to opt out by calling NY State of Health and requesting Emergency Medicaid only.

The fact sheet is available here.

DOH Updates Essential Plan Expansion Application to Include DACA Recipients 
On December 18, 2023, DOH submitted updates to its 1332 Waiver Application for the proposed expansion of the Essential Plan. As a result of public comments received, DOH has revised the application to include Deferred Action for Childhood Arrivals (DACA) recipients as part of the proposed expansion.

The Essential Plan is a health insurance option for adults aged 19 to 64 with incomes too high for Medicaid, or those with lower incomes but who are ineligible for Medicaid. As implemented in this year’s Enacted Budget, the State is seeking to move the authority for New York’s Essential Plan, which is authorized under the Basic Health Program in Section 1331 of the Affordable Care Act (ACA), to an ACA Section 1332 State Innovation Waiver that would allow the State to expand eligibility. Additional details on the proposed expansion are available in SPG’s update here.

The State’s previous update to the waiver, submitted on November 14, 2023, included the following policy changes: 

  • Elimination of $15 member premium for those between 200-250% of the FPL;
  • Revised implementation date of April 1, 2024; and
  • Introduction of the Insurer Reimbursement Implementation Plan (IRIP).

The updated materials are available here.

CMS Approves New York SPA Continuing Minimum Wage Adjustments for Article 28 Freestanding Clinics and Ambulatory Surgery Centers 
On December 15, 2023, CMS approved New York’s State Plan Amendment (SPA) that continues minimum wage adjustments for Article 28 freestanding clinics and ambulatory surgical centers through current Medicaid reimbursement methodologies until all regions have reached an hourly wage of $15.00. The SPA is effective as of January 1, 2022.

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

DOH Issues Proposed Regulations on General Hospital Medical Staff Recertification Timeframes
On December 20, 2023, DOH issued proposed regulations that would change the Article 28 general hospital medical staff recredentialing timeframe from every two years to every three years.

The proposed regulations are available here. Public comment may be submitted to regsqna@health.ny.gov through February 18th.

Governor Hochul Signs Package of Health Care Legislation
At the end of the 2023 New York State Legislative Session, Governor Hochul signed the following health care-related legislation: 

  • S7211/A7218 enhances communication between DOH and the Long-Term Care Ombudsman Program, requires long-term care ombudsmen to receive training in cultural competency and diversity, and establishes and outreach and awareness program to promote and recruit long-term care ombudsmen. 
  • S6641/A7365 provides reimbursement for certain home health services that meet the definition of core public health services.
  • S6897/A7328 establishes a four-year demonstration project to reduce the use of temporary staffing agencies in residential health care facilities and a joint labor-management nursing home staffing workgroup to review and assess the impact of such demonstration project.
  • S6337A/A6779A removes the limitation of injections by pharmacist into the deltoid and requires pharmacists to notify the licensed prescriber within five days of administration of the injection.
  • S6521/A3089 re-establishes the Adult Cystic Fibrosis Assistance Program (ACFAP) to reimburse the cost of providing health care or insurance to eligible individuals with cystic fibrosis.
  • S4401A/A5985 requires DOH to develop, maintain, and distribute to practicing and licensed physicians a resource library regarding continuing medical education and training opportunities related to nutrition.
  • S7274/A793 requires the NYS Office of Mental Health (OMH) to establish a training program for the diagnosis and treatment of post-traumatic stress disorder (PTSD) for military veterans.
  • S1196A/A1673 requires health insurance policies and Medicaid to cover certain biomarker tests.
  • S2677A/A463 requires written notice to the patient and their doctor of an adverse determination made by a utilization review agent in relation to a step therapy protocol override determination.

The Governor’s press release is available here.