Weekly Health Care Policy Update – January 28, 2022

February 4, 2022

In this update: 

  • Covid-19 Updates
    • HHS to Release Additional $2 Billion of PRF Funds
    • FDA Modifies Authorizations for Monoclonal Antibody Treatments
    • AHA Requests Additional Hospital Covid-19 Relief
    • Labor Department Withdraws Employer Vaccine Requirement, Rulemaking Process Continues
  • Legislative
    • Senate HELP Committee Releases Bipartisan Pandemic Preparedness Legislation
    • House Members Send Letter to Zients on Nurse Staffing Agencies
    • Senators Send Letter to Becerra and Brooks-LaSure on Covid-19 Tests
  • Regulatory
    • CMS Publishes Medicare Shared Savings Program Participation Data
    • CMS Adds Turnover and Weekend Staffing Data to Nursing Home Care Compare Website
    • HHS Announces Intra-Agency Task Force on Reproductive Healthcare Access; $6.6 Million in Title X Grants
    • HHS Announces Final 2022 ACA Enrollment of 14.5 Million and Drop in Uninsured Rate
    • CMS to Hold National Nursing Home Stakeholder Call on February 2nd
    • CMMI Listening Session on Beneficiary Engagement Scheduled for February 9th
    • CMS Publishes Transcript of January 18th National Stakeholder Call
  • Other
    • Georgia Files Lawsuit on Medicaid Work Requirements
    • SHVS Publishes Brief on Tracking Upcoming Medicaid Disenrollments
    • Biden Administration Submits 2022 Mental Health Parity Report to Congress
  • Legislative Hearings
  • New York State Updates
    • Senate Confirms Adrienne Harris to Lead DFS and Dr. Chinazo Cunningham to Lead OASAS
    • DOH Releases FY 2023 Executive Budget Medicaid Scorecard
    • DOH Releases Public Notices Regarding Rate Adjustments
    • CMS Approves New York State SPA Authorizing Nurse Practitioners to Provide Collaborative Care Services
  • Funding Opportunities
    • CMS Announces $49 Million in Grants to Connect Uninsured with Coverage
    • HRSA to Provide $5 Million for Health Workforce Research
    • NIH Offers $15 Million for Community Interventions to Reduce Health Disparities
    • OMH Releases RFP for Expansion of Adult ACT Teams

COVID-19 Updates

HHS to Release Additional $2 Billion of PRF Funds
On January 25th, the Health Resources and Services Administration (HRSA) at the Department of Health and Human Services (HHS) announced that they would be distributing an additional $2 billion in Provider Relief Fund (PRF) payments. These payments are a second batch of the Phase 4 General Distribution of the PRF, and will go to about 7,700 providers, including $300 million to 559 providers in New York. About 18 percent of Phase 4 applications remain to be processed. After this batch, only $6 billion remains in the PRF account.
 
The HHS press release can be found here, which includes links to state-by-state breakdowns of Phase 4 payments disbursed to date. The full public data set of distributions is available here.
 
FDA Modifies Authorizations for Monoclonal Antibody Treatments
On January 24th, the Food and Drug Administration (FDA) revoked the Emergency Use Authorizations (EUAs) for two monoclonal antibody (mAb) treatments, bamlanivimab/esesevimab (administered together) and REGEN-COV. These two treatments are “highly unlikely to be active against the omicron variant,” which is estimated to account for more than 99% of cases in the United States as of January 15th. The move avoids exposing patients to side effects that are not expected to provide benefit to individuals infected with, or exposed to, the omicron variant. The FDA will consider reauthorizing these two treatments again if another variant for which they would be applicable arises.
 
The FDA has continued the authorization for four other mAb treatments that are expected to work against Omicron. On January 21st, it expanded the EUA for one such treatment, remdesivir, to non-hospitalized patients, under certain conditions. Remdesivir will now be available at skilled nursing facilities, home health care settings, and outpatient facilities such as infusion centers. The approval applies to adults and pediatric patients (12 years of age and older who weigh at least 40 kilograms) with positive results from Covid-19 testing, are not hospitalized, have mild-to-moderate Covid-19, and are at high risk for progression to severe Covid-19, including hospitalization or death. The FDA also revised the remdesivir EUA to authorize use of the drug for pediatric patients under 12 years of age and weighing 3.5 to 40 kilograms under the same conditions, with doses adjusted for body weight.
 
Additional information for providers is available here. Additional information for parents and caregivers is available here.
 
AHA Requests Additional Hospital Covid-19 Relief
On January 20th, the American Hospital Association (AHA) sent a letter to Congressional leadership, requesting the extension and expansion of hospital relief measures, including: 

  • Replenishing the PRF with an additional $25 billion “due to the tremendous financial strain that the delta and omicron variants are causing,” and for further flexibility on the use of PRF funds;
  • Further delaying the reintroduction of sequester cuts to Medicare until December 2022 or the end of the federal Covid-19 public health emergency (PHE); and
  • Suspending repayment and limiting recoupment of Medicare Advance and Accelerated Payments.

The AHA letter can be found here.
 
Labor Department Withdraws Employer Vaccine Requirement, Rulemaking Process Continues
On January 25th, the Department of Labor formally withdrew the Emergency Temporary Standard (ETS) requiring employers with 100 or more employees to require employee vaccinations or regular testing and masking. In doing so, the Department avoids a formal court ruling on the requirement. In its Federal Register filing, the Occupational Safety and Health Administration (OSHA) notes that ETSs also serve as proposed rules and it will continue the rulemaking process with respect to employer vaccination policies. However, such a process could take a year or more, given notice and comment requirements and controversy surrounding vaccination requirements.
 
The notice of withdrawal is available here.

Legislative Updates

Senate HELP Committee Releases Bipartisan Pandemic Preparedness Legislation
On January 25th, the Senate Health, Education, Labor, and Pensions (HELP) Committee released a bipartisan discussion draft bill aimed at improving the nation’s pandemic preparedness. The Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act was jointly drafted by Committee Chair Patty Murray (D-WA) and Ranking Member Richard Burr (R-NC). The draft employs a number of strategies to improve pandemic preparedness, including strengthening the Strategic National Stockpile and improving the supply chain, improving disease detection and monitoring, fostering better coordination among local, state, and federal preparedness agencies, addressing social determinants of health to improve public health emergency response and health outcomes, investments to enhance public health data and support the public health workforce, and more.
 
Notably, the draft bill would require a comprehensive review of the federal government’s response to the COVID-19 pandemic and require Senate confirmation of the Centers for Disease Control and Prevention (CDC) Director. The Senators continue to solicit feedback from their colleagues and note the bill is likely to evolve before it is introduced. In addition, feedback from the public will be accepted until February 4th.
 
The draft bill text may be found here; a section-by-section summary is available here; a press release is available here.
 
House Members Send Letter to Zients on Nurse Staffing Agencies
On January 25th, a bipartisan group of almost 200 members of the U.S. House of Representatives sent a letter to White House Covid-19 Response Team Coordinator Jeffrey Zients expressing their concern that nurse staffing agencies are “taking advantage” of current conditions “to increase their profits at the expense of patients and the hospitals that treat them.” The letter cites reports of vastly inflated prices as well as profit margins at or above 40%, arguing the costs are unsustainable for health systems. It requests that the Biden Administration direct an appropriate agency to investigate such conduct to determine if their work is anticompetitive or otherwise violates consumer protection laws.
 
The letter can be found here.
 
Senators Send Letter to Becerra and Brooks-LaSure on Covid-19 Tests
On January 24th, 19 Democratic Senators signed a letter to HHS Secretary Xavier Becerra and CMS Administrator Chiquita Brooks-LaSure urging the administration to extend coverage of over-the-counter, at-home Covid-19 tests for Medicare beneficiaries. While the Biden Administration recently issued a requirement for commercial health insurance plans to cover eight over-the-counter, at-home tests per month, the Senators expressed concern that “those enrolled in Medicare and private Medicare Advantage plans do not have the same access.”
 
The letter can be found here.

Regulatory Updates

CMS Publishes Medicare Shared Savings Program Participation Data
On January 26th, the Centers for Medicare & Medicaid Services (CMS) released data from its annual summary of the Medicare Shared Savings Program (MSSP). The data show that over 11 million Medicare beneficiaries were part of an MSSP Accountable Care Organization (ACO) in 2022, which was a 3% increase over 2021, but still lower than the number for 2020.
 
CMS also announced that this year, 66 new ACOs have joined the MSSP, in addition to 140 existing ACOs that renewed their participation beginning January 1, 2022. The total number of MSSP ACOs for 2022 will be 483. Of these, 50% will qualify as an Advanced Alternative Payment Model (APM), eligible for additional rewards in exchange for taking on higher levels of risk and meeting both quality and cost benchmarks.
 
CMS Adds Turnover and Weekend Staffing Data to Nursing Home Care Compare Website
On January 26th, CMS announced that it had updated its Care Compare website to include new staffing data details for nursing homes. Consumers will now be able to search for specific nursing home’s staff turnover rates (percent of nursing staff or number of administrators that stop working in a facility within a given year) as well as weekend staffing hours (registered nurse hours per resident per day on the weekend). The new data being reported is already collected by the government, but this is the first time CMS is making it publicly available. Beginning this summer, CMS will also use this staffing information in its Star Rating calculations for nursing home facilities.
 
The Care Compare website can be found here. The CMS press release is available here.
 
HHS Announces Intra-Agency Task Force on Reproductive Healthcare Access; $6.6 Million in Title X Grants
On January 21st, HHS Secretary Xavier Becerra announced the creation of an HHS Intra-Agency Task Force on Reproductive Healthcare Access. HHS’s Assistant Secretary for Health, Dr. Rachel Levine, and Assistant Secretary for Global Affairs, Loyce Pace, will serve as co-chairs. The Task Force’s primary goal is to “facilitate collaborative, innovative, transparent, equitable, and action-oriented approaches to protect and bolster sexual and reproductive health.” As part of the Task Force, HHS’s agencies have been asked to outline measurable actions they can take to protect and bolster access to sexual and reproductive health care.
 
HHS also announced $6.6 million in awards through the Title X family planning program to “address increased need for family planning services where restrictive laws and policies have impacted reproductive health access.” The Title X federal grant program provides individuals with comprehensive family planning and related preventive health services. Eight awards were granted to entities in seven states, including Public Health Solutions in New York, with funding made available through the American Rescue Plan.
 
A Fact Sheet on the Task Force can be found here. More information on the grants is available here.
 
HHS Announces Final 2022 ACA Enrollment of 14.5 Million and Drop in Uninsured Rate
On January 27th, CMS announced final enrollment numbers for the 2022 open enrollment period, which ended January 15th in states using HealthCare.gov and many state-based marketplaces. In total, 14.5 million people enrolled in coverage, including 10.3 million who enrolled in states that use the federal marketplace platform and 4.2 million who enrolled in the 17 states and District of Columbia that manage State-Based Marketplaces. This is the highest enrollment in ACA coverage to date. In addition, the total enrollment number includes 3 million individuals who were not enrolled in coverage prior to this open enrollment period.
 
Also on January 27th, the HHS Assistant Secretary for Planning and Evaluation released a report finding that the uninsured rate dropped to 8.9% for the third quarter of 2021, from 10.3% during the last quarter of 2020. The largest coverage gains were among individuals and families with income under 200% of the federal poverty level (FPL). The report attributes coverage gains to funding and outreach efforts included in the American Rescue Plan Act.
 
A fact sheet on open enrollment is available here and a press release is available here. The ASPE report may be found here.
 
CMS to Hold National Nursing Home Stakeholder Call on February 2nd
On February 2nd at 3pm ET, CMS and the CDC will jointly hold a National Stakeholder Call for nursing homes. The call will provide updates on Covid-19, revisions to nursing home guidance, and best practices, as well as frequently asked questions.
 
Registration is available here.
 
CMMI Listening Session on Beneficiary Engagement Scheduled for February 9th
On February 9th, the Centers for Medicare and Medicaid Innovation (CMMI) will hold a listening session on incorporating beneficiary perspectives. At this session, CMMI hopes to hear from patient advocacy groups and other stakeholders about ways it can successfully engage with patients to inform model development.
 
Registration is available here. Attendees may submit written comments or questions in advance to CMMIStrategy@cms.hhs.gov with the subject line “BENEFICIARY LISTENING SESSION.”
 
CMS Publishes Transcript of January 18thNational Stakeholder Call
CMS has published a transcript of the National Stakeholder Call it conducted on January 18th to review 2021 accomplishments and outline 2022 goals. CMS intends to continue conducting such calls on a quarterly basis. On this call, CMS leadership noted various key goals for 2022, among which were: 

  • Increasing enrollment in the Medicare Savings Program;
  • Handling implementation and enforcement of the No Surprises Act, including the “prudent layperson” standard definition for a medical emergency;
  • Working with states to maintain coverage for individuals disenrolled from Medicaid due to the upcoming resumption of Medicaid redeterminations;
  • Outlining new policy priorities for 1115 Medicaid waivers; and
  • Releasing guidance on how to fit social determinants of health (SDH) interventions in the Medicaid framework.

The transcript is available here January 18th.

Other Updates

Georgia Files Lawsuit on Medicaid Work Requirements
On January 21st, the State of Georgia filed a federal lawsuit against the Biden Administration over CMS’s decision to revoke the Georgia Pathways to Coverage demonstration, an 1115 Medicaid waiver approved by the Trump Administration which would have partially expanded Georgia’s Medicaid program, but with conditions including work requirements and cost-sharing premiums. Under Georgia’s waiver, new Medicaid recipients would have had to engage in at least 80 hours a month of qualifying work-related activities.
 
CMS revoked the waiver in December 2021. The Administration is still considering Georgia’s separate 1332 waiver, which would have enacted changes to the individual market, including a provision that would bypassed the federally-facilitated HealthCare.gov marketplace and use private agents to shop for federally-subsidized plans.
 
SHVS Publishes Brief on Tracking Upcoming Medicaid Disenrollments
On January 22nd, State Health & Value Strategies (SHVS) published an issue brief on the availability of Medicaid enrollment and retention data, in the context of the upcoming resumption of Medicaid redeterminations. Medicaid programs nationally have seen significant and sustained increases in enrollment during the pandemic because of the pause in Medicaid eligibility determinations, which are expected to be rolled back in the coming months. New York’s Medicaid program projects a peak enrollment this year of 7.7 million, up from about 6.1 million at the start of 2020. The SHVS issue brief makes recommendations on how states can use data dashboards to monitor and help stakeholders understand the rapid changes in Medicaid enrollment that may be upcoming.
 
The issue brief is available here. SHVS has compiled a larger set of resources on this topic, which are available here.

Biden Administration Submits 2022 Mental Health Parity Report to Congress
On January 25th, the Departments of HHS, Labor, and the Treasury issued their 2022 Report to Congress on the Mental Health Parity and Addiction Equity Act (MHPAEA) of 2008. The report finds that many insurers continue to not be fully compliant with MHPAEA requirements, and indicates that the Administration intends to further pursue increased enforcement going forward.

The report describes the Departments’ utilization of existing MHPAEA enforcement tools, such as the requirement included in the Consolidated Appropriations Act of 2021 that plans and insurers provide comparative analyses of their non-quantitative treatment limitations, but notes a list of additional tools that, if authorized by Congress, would improve enforcement and compliance. Finally, the report also highlights one of the Departments’ largest enforcement activities to date, a $15.6 million settlement with UnitedHealthcare. The Administration alleged that United routinely lowered reimbursement rates for out-of-network behavioral health services and flagged members with behavioral health needs for utilization reviews.
 
The 2022 MHPAEA Report to Congress is available here.

Congressional Hearings

Tuesday, February 1st:

  • At 10am, the Senate Health, Education, Labor, and Pensions (HELP) Committee will hold a hearing entitled “Mental Health and Substance Use Disorders: Responding to the Growing Crisis.” More information is available here. 

Wednesday, February 2nd:

  • At 10am, the House Financial Services Subcommittee on Housing, Community Development and Insurance will hold a hearing entitled “Housing America: Addressing Challenges in Serving People Experiencing Homelessness” that will examine legislation addressing homelessness including the proposed “Housing is Health Care Act of 2022.” More information is available here. 
  • At 2:30pm, the Senate Finance Subcommittee on Fiscal Responsibility and Economic Growth will hold a hearing entitled “The Hospital Insurance Trust Fund and the Future of Medicare Financing.” More information is available here. 

Thursday, February 3rd: 

  • At 10:30am, the House Energy and Commerce Subcommittee on Health will hold a hearing entitled “FDA User Fee Reauthorization: Ensuring Safe and Effective Drugs and Biologics.” More information is available here.

New York State Updates

Senate Confirms Adrienne Harris to Lead DFS and Dr. Chinazo Cunningham to Lead OASAS
On January 25th, the New York State Senate confirmed Adrienne A. Harris as Superintendent of the New York State Department of Financial Services (DFS). Harris was a Special Assistant to the President for Economic Policy at the National Economic Council under President Obama, and previously worked at the Department of the Treasury. A statement from Superintendent Harris is available here.
 
The Senate also confirmed Dr. Chinazo O. Cunningham as Commissioner of the Office of Addiction Services and Supports (OASAS). Cunningham most recently served as the Executive Deputy Commissioner of Mental Hygiene at the New York City Department of Health and Mental Hygiene.
 
DOH Releases FY 2023 Executive Budget Medicaid Scorecard
On January 26th, the New York State Department of Health (DOH) released the Fiscal Year 2023 Executive Budget Medicaid Scorecard (available here). The Scorecard includes additional cost/savings estimates for the creation of the Center of Medicaid Innovation, Applied Behavior Analysis (ABA) rate enhancement, implementation of the dual integration roadmap, and the Licensed Home Care Service Agency (LHCSA) Request for Offer (RFO) re-estimate, among others.
 
DOH Releases Public Notices Regarding Rate Adjustments
On January 26th, DOH posted a public notice in the State Register (available here) outlining its intent to increase reimbursement rates by 5 percent for state plan-approved Outpatient Mental Health Rehabilitative Services, effective February 1st, and by an additional 11.5 percent from February 1st through September 30th. The proposed changes are contingent upon CMS approval of the State’s spending plan for the enhanced Federal Medical Assistance Percentage (FMAP) for Home and Community Based Services (HCBS) contained in the American Rescue Plan Act.
 
DOH also posted a public notice that, effective February 1st, Residential Treatment Facilities (RTF) rates may be adjusted to consist of a percentage increase on the clinical/direct care (C/DC) rate component to include additional funds appropriate to maintain the required level of care that are not reflected in the base year.
 
Stakeholders may submit public comments on the proposed changes via email to spa_inquiries@health.ny.gov.
 
CMS Approves New York State SPA Authorizing Nurse Practitioners to Provide Collaborative Care Services
On January 24th, CMS approved New York State’s State Plan Amendment (SPA) authorizing nurse practitioners designated by the Office of Mental Health (OMH) to provide Collaborative Care Services, including screening for mental illness, diagnosis of patients who screen positive, the provision of evidence-based care, ongoing tracking of patient progress, and care management. Services may also include consultation between a designated psychiatric practitioner, care manager, and primary care physician for the purpose of managing mental health conditions in primary care settings.
 
The SPA is available here and the CMS approval letter is available here.

Funding Opportunities

CMS Announces $49 Million in Grants to Connect Uninsured with Coverage
On January 27th, CMS announced a $49.4 million funding opportunity for organizations that can connect eligible individuals to coverage through Medicaid and the Children’s Health Insurance Program (CHIP). Awardees will receive up to $1.5 million for a three-year period to promote and retain enrollment in Medicaid and CHIP. Eligible organizations include state and local governments, tribal organizations, federal health safety net organizations, non-profit entities, schools, and more.
 
The grant opportunity is available here, and a press release is available here. Applications are due by March 28th.
 
HRSA to Provide $5 Million for Health Workforce Research
On January 27th, HRSA announced a funding opportunity in support of the Health Workforce Research Center Cooperative Agreement Program. Nearly $5 million is available for up to nine cooperative agreements to support and disseminate applied research that strengthens evidence-based policy and enhances understanding of issues and trends in the health workforce.
 
The grant opportunity is available here. The application deadline is April 14th.
 
NIH Offers $15 Million for Community Interventions to Reduce Health Disparities
On January 20th, the National Institutes for Health (NIH) announced a funding opportunity to provide a total of $15 million across 10 awards to support research to develop and test community-level interventions to improve minority health and reduce health disparities. This is the next iteration of NIH’s community-based participatory research program, established in 2005.
 
NIH will fund projects that assess and intervene on health determinants beyond the individual level, led by or conducted in collaboration with community partners, such as community-based organizations (CBOs), healthcare systems, social service agencies, and others. Areas of special interest include: 

  • Promoting screening, detection, and self-management of acute or chronic disease (e.g., Covid-19, HIV, depression, substance use disorders);
  • Enhancing the ability of community-dwelling older adults or individuals with disabilities to live independently;
  • Promoting community re-integration of individuals transitioning back to the community.

More information is available on the NIH site here. Applications are due by March 28th.
 
OMH Releases RFP for Expansion of Adult ACT Teams
On January 25th, OMH released a Request for Proposals (RFP) for the development of eight Adult Assertive Community Treatment (ACT) teams. The Adult ACT teams will serve individuals with serious mental illness (SMI) who have not been successfully engaged by the traditional mental health treatment and rehabilitation system.
 
Adult ACT teams provide 24/7 comprehensive treatment, support, and rehabilitation services in the community or where the individual lives. OMH will provide start-up and ramp-up funding to support the development of the ACT teams, and teams will be funded on an ongoing basis through Medicaid and net deficit funding per the approved ACT model for an upstate 48 slot team, upstate 68 slot team, or downstate 68 slot team, as applicable.
 
Eligible applicants are not-for-profit 501(c)(3) agencies that have experience providing mental health services to individuals with SMI through programs that are licensed by OMH. The awarded applicant will be further subject to the submission and approval of a Prior Application Review (PAR) application to become a licensed ACT team and receive an official operating certificate.
 
The full RFP is available here and SPG’s summary of the opportunity is available here. Applications are due on April 11th.