Weekly Health Care Policy Update – May 22, 2023

May 30, 2023

In this update:

  • Administration Updates
    • President Biden Officially Nominates Dr. Monica Bertagnolli to Lead NIH
  • Legislative Updates
    • Senator Cassidy Releases Draft Legislation that Would Establish Integrated Duals Plans and PACE in All States
  • Federal Agencies
    • MACs Will Make No Changes to Remote Patient Monitoring Coverage in Medicare
    • HHS and ED Announce Initiatives to Improve Health Care Delivery in Schools
    • FTC Issues Policy Statement on Misuses of Biometric Information
    • VA Restructures Cerner EHR Contract
    • CMS Announces SNF VBP Program Webinar
    • HRSA Introduces New Toll-Free Number for Maternal Mental Health Hotline
    • HHS Details Project NextGen Initiative
  • Other Updates
    • Appeals Court Issues Stay of Ruling That Struck Down ACA Preventive Care Requirements
    • GAO Issues Report on Noncompete Agreements
  • New York State Updates
    • Governor Hochul Extends Health Care Staffing Shortages Emergency to End of Legislative Session; Expiration Expected Thereafter
    • Governor Hochul Signs Legislation Expanding Use of Simulation Training for Nursing Students
    • DOH Continues Emergency Regulations Requiring 60-Day PPE Stockpiles in Hospitals and Nursing Homes
  • Funding Opportunities
    • ARPA-H Announces NITRO Program as Its First Initiative
    • NYHealth Releases RFP for Primary Care on Expanding Access and Advancing Racial Health Equity
    • SAMHSA Releases NOFO for LGBTQI+ Family Support Program

Administration Updates

President Biden Officially Nominates Dr. Monica Bertagnolli to Lead NIH 
On May 15th, President Biden announced that he would nominate Dr. Monica Bertagnolli to become the 17th Director of the National Institutes of Health (NIH) at the Department of Health and Human Services (HHS). The nomination was reported last month by the New York Times (as covered in SPG’s April 24th update here). If confirmed by the Senate, Dr. Bertagnolli will replace Dr. Lawrence Tabak, acting director of NIH since Dr. Francis Collins left the job in December 2021, after 12 years.
 
The White House press release is available here.

Legislative Update

Senator Cassidy Releases Draft Legislation that Would Establish Integrated Duals Plans and PACE in All States
On May 18th, Senator Bill Cassidy (R-LA) released a discussion draft of a bill that would require all states to establish integrated care programs for individuals who are dually eligible for Medicare and Medicaid. The draft is informed by responses to a request for information (RFI) that Cassidy and a bipartisan group of five other Senators issued last November on improving care for dual eligibles (as summarized by SPG last year here). The draft legislation would: 

  • Establish a new Title XXII of the Social Security Act which would require HHS to develop and publish “a range of program models” for providing integrated care to duals, including both full-benefit and partial duals, within 180 days;
  • Require states to choose at least one integrated care model for full-benefit duals and one model for partial duals to implement within one year of HHS’s publication;
  • Require states to implement their chosen models on a timeline that would allow enrollment within four years; and
  • Require states to implement passive enrollment (with an opt-out) for the integrated care plans.

The draft proposes various requirements for such integrated care plans, including: 

  • A process to automatically transfer individuals who lose full dual eligibility into partial duals plans;
  • A unified appeals process;
  • A standardized health risk assessment;
  • Care coordinator requirements; and
  • Data collection and reporting standards. 

States would be eligible for a shared savings payment reflecting “a share of savings to Federal spending in the Medicaid program” as a result of these plans. The draft also proposes, among other policies, to: 

  • Establish a new risk adjustment model for dual eligible beneficiaries;
  • Identify opportunities for federal-state coordination on dual eligible benefit determinations;
  • Prohibit enrollment in integrated care plans that have a quality rating of less than three stars; and
  • Require Medicare Shared Savings Program (MSSP) Accountable Care Organizations (ACOs) to have a contract with State Medicaid programs to arrange for Medicaid benefits to be provided to their beneficiaries.

Finally, the draft legislation proposes to make mandatory the current state option to Programs of All-Inclusive Care for the Elderly (PACE) services to eligible individuals. It also proposes other PACE reforms, including to: 

  • Permit enrollment of PACE beneficiaries at any time;
  • Extend eligible for PACE services to Medicare-eligible individuals under the age of 55;
  • Create a cost outlier protection program for new PACE providers for enrollees who cost over $50,000;
  • Make various changes to PACE program application and reporting requirements; and
  • Ensure Medicare-only PACE program enrollees have a choice of prescription drug plans under Medicare Part D.

The text of the draft is here. Sen. Cassidy’s office seeks feedback on the discussion draft by July 1st. The November 2022 RFI is available here.

Federal Agencies

MACs Will Make No Changes to Remote Patient Monitoring Coverage in Medicare
Today (May 22nd), a report in POLITICO indicated that Medicare Administrative Contractors (MACs) have determined that they will not issue new Local Coverage Determinations (LCDs) regarding remote patient monitoring (RPM) services. MACs, who administer the fee-for-service Original Medicare program on behalf of the Centers for Medicare and Medicaid Services (CMS), are empowered to issue LCDs that outline policies regarding coverage of services that are not covered by a CMS National Coverage Determination (NCD). A group of MACs covering most of the nation held a meeting in February to discuss whether to implement LCDs for RPM coverage, following a significant increase in RPM utilization during the Covid-19 pandemic.

HHS and ED Announce Initiatives to Improve Health Care Delivery in Schools 
On May 18th, the U.S. Departments of Education (ED) and Health and Human Services (HHS) announced a series of actions intended to make it easier for schools to provide health care services, especially in mental health services, to students: 

  • The ED released a proposed rule to streamline consent provisions when billing for Medicaid services provided through a student’s Individualized Education Program (IEP), creating a uniform process applicable to all Medicaid enrolled children, regardless of disability.
  • The Centers for Medicare & Medicaid Services (CMS) released a “Comprehensive Guide to Medicaid Services and Administrative Claiming.” The guide “clarifies, consolidates, and expands” on guidance for how schools can receive payment for providing care for Medicaid- and CHIP-enrolled students, and how states can ease the administrative burden on school-based health providers.
  • CMS also announced its approval of state plan amendments (SPAs) for New Mexico and Oregon to allow Medicaid to receive funding for services provided to all children covered by Medicaid, rather than only those children with an IEP. 

More information is available here.

FTC Issues Policy Statement on Misuses of Biometric Information 
On May 18th, the Federal Trade Commission (FTC) issued a policy statement addressing “unfair or deceptive acts and practices related to the collection and use of consumers’ biometric information and the marketing and use of biometric information technologies.” The FTC warns that such technologies, including facial, iris, or fingerprint technologies or those using biometric information, raise significant consumer privacy and data security concerns, as well as the potential for bias and discrimination. For example, the FTC notes that biometric data could be used to determine whether an individual accessed certain health care services or attended religious services or political meetings. The policy statement warns that “false or unsubstantiated claims about the accuracy or efficacy of biometric information technologies or about the collection and use of biometric information may violate the FTC Act.”

More information, including a list of factors FTC will consider when determining whether a business’ use of biometric information could be in violation, is available here. 

VA Restructures Cerner EHR Contract
On May 11th, the Department of Veterans Affairs (VA) announced that it had renegotiated its $10 billion contract with Oracle Cerner for continued work on its electronic health record (EHR) infrastructure. The new contract will have five one-year terms, instead of a single, five-year term, as well as 28 performance metrics specific to improving system reliability, responding to clinician requests, interoperability with private sector hospitals, and interfacing with the Department’s website, mobile app, and other applications.

Cerner originally won the VA EHR contract in May 2018 with a goal of moving away from VistA, VA’s customized platform, to a more standardized product that would allow connection with the Department of Defense, the U.S. Coast Guard, and community care providers. (Cerner was purchased by Oracle in June 2022.) The transition is scheduled to be complete in 2028, though last month, the VA announced that future deployments of the new EHR would be halted to prioritize improvements at five sites currently using the new platform.

CMS Announces SNF VBP Program Webinar
On May 24th at 2pm ET, CMS will host a webinar, “FY 2024 SNF PPS Proposed Rule Overview” which will offer a review of major proposals for the Skilled Nursing Facility (SNF) Value-Based Purchasing (VBP) Program in the FY 2024 SNF Prospective Payment System Proposed Rule. The proposed rule was published on April 10th, and updates Medicare payment policies and rates for the SNF PPS, as well as offers proposals for the SNF Quality Reporting Program and the SNF VBP Program.

Registration is available here.

HRSA Introduces New Toll-Free Number for Maternal Mental Health Hotline 
On May 15th, the Health Resources and Services Administration (HRSA) introduced an updated toll-free number for its National Maternal Mental Health Hotline: 1-833-TLC-MAMA. The former numbers will continue to work for another year. The Hotline was established on Mother’s Day 2022 to provide emotional support, resources, and referrals to pregnant and postpartum individuals struggling with mental health concerns, and their loved ones. It provides 24/7, free, confidential help by phone or text, in English and Spanish, and offers interpreter services in more than 60 languages. Counselors include licensed health care providers such as nurses or doctors, licensed health clinicians, certified doulas or childbirth educators, and certified peer support specialists.

More information is available here.

HHS Details Project NextGen Initiative
On May 11th, the Biden Administration published a fact sheet on Project NextGen, an initiative to “accelerate and streamline” the development of next generation Covid-19 vaccines and treatments through public-private collaborations.  Project NextGen will be housed within HHS and led by the Administration for Strategic Preparedness and Response (ASPR’s) Biomedical Advanced Research and Development Authority (BARDA) and the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) with a goal of advancing the pipeline of innovative vaccines and therapeutics. It will receive a $5 billion initial investment. Project NextGen will focus on: 

  • Mucosal vaccines;
  • Vaccines that provide broader protection against variants of concern and a longer duration of protection;
  • Pan-coronavirus vaccines;
  • New and more durable monoclonal antibodies; and
  • Technologies to enable faster, cheaper, rapid, and more flexible production of vaccines and therapeutics.

More information, including an RFI to collect feedback from current and potential pharmaceutical partners on the advanced developmental landscape of next-generation Covid-19 vaccines, is available here.

Other Updates

Appeals Court Issues Stay of Ruling That Struck Down ACA Preventive Care Requirements
On May 15th, a panel of judges on the Fifth Circuit Court of Appeals paused a District Court ruling (Braidwood Management v. Becerra) that struck down the Affordable Care Act’s (ACA) requirement that health plans cover preventive care items and services with an A or B rating from the U.S. Preventive Services Task Force (USPSTF) and Pre-Exposure Prophylaxis (PrEP) for HIV without cost-sharing. This means that health insurance plans and issuers must continue to offer coverage of these items and services as required by the ACA while the Appeals Court considers the Biden Administration’s appeal. A timeline for the Court’s consideration of the appeal has not yet been made public.
 
GAO Issues Report on Noncompete Agreements 
On May 16th, the Government Accountability Office (GAO) published a report entitled “Noncompete Agreements: Use is Widespread to Protect Business’ Stated Interests, Restricts Job Mobility, and May Affect Wages.” Noncompete agreements (NCAs) are “provisions in employment contracts that can restrict workers from seeking employment with a competitor.” GAO reports that 18% of workers (or up to 38% of workers at some point in their careers) are subject to NCAs, and such NCAs are usually a condition of employment. GAO reports that NCAs restrict job mobility, and may reduce wags and new firm creation.
 
The highest percentage of workers with noncompete agreements were found in engineering, but “life, physical, and social science” ranked sixth, and “health care practitioner, technical” ranked 11th. GAO also reported that use of NCAs among health care and social assistance employers was 57.1%, the fourth highest among all sectors. Most such employers reported using NCAs to prevent “recruitment of their staff” or to “minimize worker turnover.”
 
The full report is available here.

New York State Updates

Governor Hochul Extends Health Care Staffing Shortages Emergency to End of Legislative Session; Expiration Expected Thereafter
Today (May 22nd), Governor Hochul issued Executive Order 4.21 (available here), which extends through June 8th the remaining provisions in Executive Order 4 and its successors that reinstate many workforce and scope of practice flexibilities that applied during the original New York State (NYS) Covid-19 public health emergency. Some provisions of the original Order have already been ended, including those related to prior authorization and nursing home staffing and revenue requirements. However, Executive Order 4 still allows practitioners who are licensed in other states or Canada but lack New York licensure to practice in New York.

As this extension is only for 17 days (until the end of the NYS legislative session), rather than the maximum allowed 30-day period, it is expected to be the final such extension. As such, these flexibilities would expire without action by the Legislature.

Governor Hochul Signs Legislation Expanding Use of Simulation Training for Nursing Students
On May 15th, Governor Hochul signed a bill, S447/A3706, which aims to address nursing shortages by expanding nurse training outside of clinical placements in hospital settings. Specifically, the bill allows more flexibility in the use of simulation training for nursing students. It: 

  • Permits nursing students in registered nursing certificate and degree programs to complete up to one-third of their clinical education through simulation training experiences;
  • Allows nursing education programs to provide greater than one-third of clinical training through simulation experiences, provided that the State Education Department (SED) had issued the program a waiver to do so prior to January 2023; and
  • Allows SED to prescribe an expedited process for programs seeking curriculum changes to implement simulation experiences.

The Governor’s press release is available here.

DOH Continues Emergency Regulations Requiring 60-Day PPE Stockpiles in Hospitals and Nursing Homes
On May 17th, the NYS Department of Health (DOH) posted a notice of adoption for the continuation of emergency regulations that all general hospitals and nursing homes maintain 60-day supplies of personal protective equipment (PPE) to ensure that sufficient PPE is available in the event of a resurgence of COVID-19 or another communicable disease outbreak. Facilities must maintain stockpiles of all PPE categories (gloves, gowns, surgical masks, and N95 respirator masks) based on the number of applicable hospital staffed beds or nursing home census. DOH may increase the stockpile requirement from 60 days to 90 days where there is a declared State or local public health emergency.

Hospitals and nursing homes will be considered to possess and maintain the required PPE if: 

  • PPE is maintained on-site; or
  • PPE is maintained in off-site storage locations within New York State and can be accessed within 24 hours, provided that the facility maintains at least a 10-day supply of required PPE on-site.

Failure to possess and maintain required supplies of PPE may result in the revocation, limitation, or suspension of the facility’s license, provided that DOH has provided the facility with a 14-day grace period to meet requirements after a first violation.  

The emergency rule is available here and is set to expire June 24th. DOH intends to adopt the provisions of the emergency rule permanently. Comments may be submitted to Katherine Ceroalo at regsqna@health.ny.gov by July 16th.

Funding Opportunities

ARPA-H Announces NITRO Program as Its First Initiative
On May 18th, the Advanced Research Projects Agency for Health (ARPA-H) posted a funding opportunity for the agency’s first initiative, the Novel Innovations for Tissue Regeneration in Osteoarthritis (NITRO) Program. ARPA-H was launched by the Biden Administration to support transformative biomedical and health breakthroughs. NITRO is aimed at developing new osteoarthritis treatments with a particular focus on injectable bone regeneratives, injectable cartilage regeneratives, and replacement joints built from human cells. ARPA-H’s goal is to complete Phase 1 clinical trials in five years. Osteoarthritis currently affects around 32 million people in the United States, with an economic burden of more than $136 billion per year.

Abstracts are due June 23rd and full proposals are due July 28th. ARPA-H will host a Proposers Day on June 15th from 9pm to 6pm ET. More information, including Proposers’ Day Registration, is available here.

NYHealth Releases RFP for Primary Care on Expanding Access and Advancing Racial Health Equity
On May 16th, the New York Health Foundation (NYHealth) released a Request for Proposals (RFP) to support Primary Care Projects. The RFP is focused on the following two core program strategies: 

  • Expanding primary care access; and
  • Advancing racial health equity through primary care.

Applicants may submit projects that fall under one or both strategy areas. NYHealth aims to fund projects that have regional or statewide impact, disseminate best practices, test replicable models, contribute to policy and systems change, and can leverage resources to sustain the work after the end of the grant period. Proposals limited to a specific health system or facility must articulate how the project will lay the groundwork to be scaled across health systems, regions, or the State.

Eligible applicants must be based in New York State. The following organization types are eligible to apply: 

  • Not-for-profit 501(c)(3) organizations;
  • For-profit organizations;
  • Academic organizations; and
  • Government agencies.

Individual project budget requests are capped at $250,000 for the entire project period. Projects cannot exceed 24 months in duration. Funding requests that include the hiring of additional clinicians and staff, expansion of service hours, or start-up for new facilities or new service lines must support the implementation of a specific, time-bound project and cannot solely be for general care delivery. Furthermore, NYHealth will not fund general operating support, capital expenses, or lobbying.

The full RFP is available here and an FAQ is available here. Applicants are required to submit a Letter of Intent (LOI) by June 13th. Full proposals (for invited applicants only) are due August 24th. Questions can be emailed to PCRFP@nyhealthfoundation.org.

SAMHSA Releases NOFO for LGBTQI+ Family Support Program 
On May 19th, the Substance Abuse and Mental Health Services Administration (SAMHSA) released a Notice of Funding Opportunity (NOFO) for the Family Counseling and Support for LGBTQI+ Youth and their Families Program (LGBTQI+ Family Support Program), which aims to address health and behavioral health risks faced by LGBTQI+ youth by funding entities that will conduct the following activities: 

  • Implement an evidence-based family counseling intervention that promotes family acceptance of LGBTQI+ youth;
  • Conduct training sessions about LGBTQI+ family counseling interventions for youth-serving community-based organizations and providers; and
  • Establish or enhance an existing LGBTQI+ advisory workgroup comprised of youth, their families, behavioral health providers, and representatives from youth-serving organizations.

Eligible applicants include public or private non-profit entities as well as state and local governments. SAMHSA expects to issue four awards, each averaging $425,000 annually, for a three-year performance period.  

The NOFO is available here. Applications are due on July 3rd. Questions may be sent to Amy Andre at Amy.Andre@samhsa.hhs.gov or Samantha Dock-Herbster at Samantha.DockHerbster@samhsa.hhs.gov.