Weekly Health Care Policy Update – December 8, 2023

December 15, 2023

In this update: 

  • Administration Updates
    • White House Announces Actions Intended to Increase Competition in Health Care
  • Federal Agencies
    • CMS Publishes Interim Final Rule on Medicaid Redetermination Disenrollments
    • Home Test to Treat Program Expands Nationwide
    • GAO Issues Report on Federal Agency Response to Cybersecurity Events
    • PCORI Seeks Input on Economic Outcomes Landscape Document
  • Other Updates
    • Joint Commission Launches Voluntary Responsible Use of Health Data Certification Program
    • Fitch Publishes 2024 Non-Profit Hospitals Outlook Report
  • New York State Updates
    • DOH Publishes Proposed Hospital Cybersecurity Regulations
    • NYS Attorney General Report Finds Serious Difficulties Accessing Mental Health Care through Managed Care
    • DOH Issues Proposed Regulations on EMS Provider Certification Requirements
    • CMS Approves New York SPA Ending the 1.5% Rate Reduction for Nursing Homes and Specialty Care Facilities
    • OMH to Host All-Provider Virtual Meeting on Hospital and Community Connections
    • DOH to Host Webinar on Home Care Worker Minimum Wage Guidance

Administration Update

White House Announces Actions Intended to Increase Competition in Health Care
On December 6th, the Biden Administration announced actions intended to increase competition in health care, including the promotion of lower prescription drug costs. The most significant of these actions is the release of a proposed framework for federal agencies to exercise “march-in rights.” March-in rights, which were established by the Bayh-Dole Act of 1980, enable the federal government to license an invention to another party if that invention was made using taxpayer funds. The Biden Administration is proposing to use this authority if taxpayer-funded inventions are not accessible to the public due to price.
 
In addition, the Administration announced that it will shortly issue a Request for Information (RFI) seeking input about “how private equity and other corporations’ increasing power and control of our health care is affecting Americans” and to “identify areas for future regulation and enforcement prioritization.” Finally, the Administration also announced the release of ownership data for Federal Qualified Health Centers (FQHCs) and Rural Health Clinics.
 
A fact sheet from the White House is available here.

Federal Agencies

CMS Publishes Interim Final Rule on Medicaid Redetermination Disenrollments
On December 6th, the Centers for Medicare & Medicaid Services (CMS) released an interim final rule regarding reporting requirements and enforcement authorities for the ongoing Medicaid eligibility redeterminations. States are currently required to provide CMS with monthly redetermination reports. Under this rule, states that do not comply with the redetermination reporting requirement would be required to submit corrective action plans, with monetary penalties as specified in legislation for ongoing violations.
 
Although the rule is in effect immediately, CMS is accepting comments on this rule until February 2, 2024. The rule is available in the Federal Register here.
 
Home Test to Treat Program Expands Nationwide 
On December 6th, the National Institutes of Health (NIH) announced a nationwide expansion of the Home Test to Treat program. Until now, the pilot program, which provides entirely virtual, free Covid-19 services, including at-home tests, telehealth consultations, and at-home treatments, has been operating at select locations for eligible participants. The expansion also includes the addition of testing and treatment for influenza A and B. Any adult, regardless of insurance status with a positive test for either illness may receive free telehealth care and a prescription if applicable. This is the first public health program of its kind to use at-home testing technology.
 
The announcement is available here.
 
GAO Issues Report on Federal Agency Response to Cybersecurity Events 
On December 4th, the Government Accountability Office (GAO) issued a report on federal agency response to cyber threats. GAO found that, on the whole, federal agencies have made progress in preparing for these threats, including incident detection and analysis, but have not universally met federal requirements for event logging. Adequately maintaining federal IT logs is imperative for government cyber resiliency, per GAO’s recommendations. 
 
The report is available here.
 
PCORI Seeks Input on Economic Outcomes Landscape Document
On November 17th, the Patient-Centered Outcomes Research Institute (PCORI) announced an RFI in response to their draft landscape on economic outcomes research in PCORI-funded studies. The Landscape aims to lay out a set of appropriate and relevant economic outcomes (including costs and other burdens) for studies to consider in determining the impact of interventions. PCORI intends this Landscape as a reference for applicants to use when considering research questions, patient populations, and other parameters of potential studies.
 
The deadline for input is January 16, 2024. The announcement is available here.

Other Updates

Joint Commission Launches Voluntary Responsible Use of Health Data Certification Program 
On December 5th, the Joint Commission launched a new voluntary Responsible Use of Health Data Certification program to help health care organizations manage data responsibly to improve outcomes and equity. Launching January 1, 2024, this certification will be available to accredited and nonaccredited hospitals and critical access hospitals. This program will assess an organization’s capacity to protect secondary use of deidentified health data.
 
The announcement is available here.
 
Fitch Publishes 2024 Non-Profit Hospitals Outlook Report
On December 5th, Fitch Ratings released its U.S. Non-Profit Hospitals and Health Systems Outlook 2024. The report focuses on core credit drivers for the sector, including rebounding volumes and overall liquidity following the Covid-19 pandemic. Labor shortages and salary/wage/benefit pressure were highlighted as pressing concerns for the industry; Fitch anticipates this pressure to persist in the near future and slowly resolve with time.
 
The announcement is available here.

New York State Updates

DOH Publishes Proposed Hospital Cybersecurity Regulations
On December 6th, the New York State (NYS) Department of Health (DOH) released proposed regulations for hospital cybersecurity requirements, as announced by Governor Hochul last month. The proposed regulations would create a new section 405.46 of Title 10 of the New York Codes, Rules, and Regulations (NYCRR) to create cybersecurity regulations for all general hospitals licensed under Article 28 of the Public Health Law.

Under the proposed regulations, hospitals would be required to establish a cybersecurity program that would: 

  • Identify and assess internal and external cybersecurity risks;
  • Use defensive techniques and infrastructure to protect information systems;
  • Detect cybersecurity events;
  • Respond to cybersecurity events to mitigate negative effects; and
  • Recover from cybersecurity events and incidents and restore normal operations and services.

The State estimates that effective cybersecurity programs will cost anywhere from $250,000 to $10 million to develop and anywhere from $50,000 to $2 million to maintain annually, depending on facility size and level of cybersecurity programs/policies currently in place. Hospitals will be eligible to apply to a pool of the upcoming round of the Statewide Health Care Facility Transformation Program (with up to $500 million in total funding, as allocated in this year’s Enacted Budget) to support projects that will make improvements to technology systems to help hospitals comply with the proposed regulations. Facilities will also be permitted to contract with appropriate third-party vendors/contractors to support compliance.

SPG has prepared a more detailed summary of the regulations, available here. The full text of the proposed regulations is available here. Public comment may be submitted to regsqna@health.ny.gov through February 4, 2024. Once finalized, hospitals will have one year to come into compliance with the new regulations.

NYS Attorney General Report Finds Serious Difficulties Accessing Mental Health Care through Managed Care
On December 7th, the Office of the Attorney General (AOG) Letitia James released a report outlining the results of a statewide “secret shopper” survey of 13 health plans: Aetna, CDPHP, Cigna, Emblem, Empire BlueCross BlueShield, Excellus, Fidelis, Healthfirst, Independent Health, MetroPlus, Molina, MVP, and UnitedHealthcare. OAG staff reviewed plan directories and attempted to schedule an appointment for an adult or child with a mental health provider listed as accepting new patients.

According to the report, of the total 396 providers called across plans, appointments were offered with 56 providers (14 percent). OAG therefore determined that 86 percent of the listed, in-network mental health providers were determined to be unreachable, not in-network, or not accepting new patients. Such “ghost networks” are illegal under NYS and federal law, which require health plans to maintain accurate provider directories for both mental health and physical health providers.

The OAG report includes the following recommendations for the State to address the findings: 

  • Require health plans to conduct regular audits of their provider networks (including secret shopper studies) to verify compliance with directory accuracy, network adequacy, and mental health parity requirements;
  • Mandate robust appointment wait time standards for mental health treatment;
  • Require health plans to analyze and submit to regulators data regarding key network adequacy indicators;
  • Require health plans to improve inadequate networks, ensure that network providers are culturally and linguistically competent, and improve consumer complaint mechanisms;
  • Impose monetary penalties and other consequences for violations of the law; and
  • Explore the possibility of a centralized provider directory for all health plans. 

In accordance with this year’s Enacted Budget, DOH, in partnership with the Office of Mental Health (OMH), the Office of Addiction Services and Supports (OASAS), and the Department of Financial Services (DFS), is required to proposed regulations on behavioral health network adequacy standards by December 31st.

The Attorney General’s press release is available here. The report is available here.

DOH Issues Proposed Regulations on EMS Provider Certification Requirements
On December 6th, DOH issued proposed regulations to “improve the overall educational and certification experience that will ease barriers to recruitment” for certified Emergency Medical Services (EMS) providers. The proposed regulations would amend Part 800 of Title 10 of NYCRR to: 

  • Allow individuals who are 17 years of age prior to the last day of the month to qualify for initial certification;
  • Clarify the process for obtaining a certification through reciprocity;
  • Remove reference to Emergency Critical Care technician, which are being phased out as a certification option;
  • Allow for the completion of all requirements, including a passing grade on both the practical skills evaluation and a written examination, within two years of the end of course date;
  • Increase the number of attempts to pass the written examination to three;
  • Modify the requirements for recertification to allow a broader definition of continuous practice;
  • Change the term “examination” to “evaluation” for determining skills competencies; and
  • Clarify that remediation is required when the candidate is unsuccessful with the skills evaluation and/or written examination.

The proposed regulations are available here. Public comment may be submitted to regsqna@health.ny.gov through February 4, 2024.

CMS Approves New York SPA Ending the 1.5% Rate Reduction for Nursing Homes and Specialty Care Facilities 
On December 7th, CMS approved New York’s State Plan Amendment (SPA) that implements an April 1, 2022 end date for the 1.5% across-the-board rate reduction for nursing homes and specialty care facilities. This reduction was in place since April 2, 2020.

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

OMH to Host All-Provider Virtual Meeting on Hospital and Community Connections
On December 12th from 10am-11am, the NYS Office of Mental Health (OMH) will host an all-provider virtual meeting focused on hospital and community connections. The meeting will provide updates on: 

  • The newly issued guidance for psychiatric inpatient programs, emergency departments, and Comprehensive Psychiatric Emergency Programs (CPEPs) (see SPG summary of the guidance here);
  • Ambulatory and residential program guidance currently under development;
  • Plans for fostering improved communications between hospitals and community-based programs; and
  • Progress on network adequacy.

Registration is available here.

DOH to Host Webinar on Home Care Worker Minimum Wage Guidance
On December 13th from 1pm-2pm, DOH will host an informational webinar regarding the home care worker minimum wage increase set to take effect January 1, 2024. As per this year’s Enacted Budget, there will be a $1.55 minimum wage increase in the eight-county downstate region of New York City, Long Island, and Westchester (to $18.55) and $1.35 (to $17.55) in the remainder of the state. There will be annual increases thereafter through 2026, and starting in 2027 the minimum wage increases for home care workers will be indexed to inflation. Stakeholders will have an opportunity to submit questions during the webinar.

Registration is available here.