Weekly Health Care Policy Update – February 18, 2022

February 25, 2022

In this update: 

  • Covid-19 Updates
    • Pfizer and FDA Withdraw Plan for Expedited Covid Vaccine Review for Kids 6 Months to 4 Years Old
    • FDA Authorizes New Monoclonal Antibody Treatment Bebtelovimab
    • CDC Releases Study on Waning Booster Efficacy During Delta and Omicron Waves
    • Republicans Send Letter to Biden Administration Urging End of Covid-19 PHE
    • HHS Plans to Request $30 Billion For Covid-19 Funding
    • Governor Hochul Extends NYS Covid-19 Emergency Declaration
    • NYS DOH Extends Covid-19 HERO Act Designation Through March 17th 
  • Federal Administration
    • Robert Califf Confirmed as FDA Commissioner
    • White House Announces Replacements for Eric Lander in OSTP and Cabinet
  • Federal Legislature
    • Senate Passes Short-Term Continuing Resolution
  • Federal Agencies
    • CMS Seeks Input on Comprehensive Medicaid and CHIP Access Strategy
    • CMMI Announces Webinar on Kidney Models
    • DHS Proposes New Public Charge Rule Disregarding Medicaid and SNAP
    • SEC Proposes to Enhance Regulation of Private Fund Advisors
    • HRSA Awards $55 Million to FQHCs for Virtual Care
  • Other
    • NAACOS and Others Send Letter to HHS Supporting Direct Contracting
  • Legislative Hearings
  • New York State Updates
    • DOB Publishes 30-Day Amendments to FY 2023 Executive Budget
    • DOH Posts Second Quarterly Report on Enhanced HCBS Funding
    • NYS to Host Webinar on Executive Budget’s Medicaid Proposals
    • DOH Proposes Rule Enacting Hospital Clinical Staffing Committee Requirements
    • OASAS Updates Regulations on Telehealth, LGBTQ Endorsement, Patient Rights, and Chemical Dependence Services 
    • OPWDD Issues Rule on Emergency Capacity Increases in IRAs
  • Funding Opportunities
    • Affinity Legacy Opens Program for Community Grants of $25,000 to $1 Million
    • OASAS Offers $15,000 to Support the Purchase of Telehealth Infrastructure
    • DOH Extends Deadline for Statewide Health Care Facility Transformation Program III RFA

COVID-19 Updates

Pfizer and FDA Withdraw Plan for Expedited Covid Vaccine Review for Kids 6 Months to 4 Years Old
On February 11th, the Food and Drug Administration (FDA) canceled a planned February 15th meeting of its vaccine advisory group to review Pfizer/BioNTech’s data on two doses of its Covid-19 vaccine for kids ages 6 months to 4 years old. Last week, it appeared the FDA would move forward with approving the two-dose regimen while the three-dose trial was finalized, allowing kids to begin their vaccine course without three-dose data. Instead, FDA and Pfizer/BioNTech said they would wait until full data on three doses is available in early April. Data on the two-dose trial revealed that children aged 2 to 4 did not generate antibody levels on par with those seen in people aged 16 to 25.
 
FDA Authorizes New Monoclonal Antibody Treatment Bebtelovimab
 
On February 11th, the FDA issued an emergency use authorization (EUA) to Eli Lilly for bebtelovimab, a new monoclonal antibody for the treatment of mild to moderate Covid-19 in patients 12 and older who are at high risk of progression to severe disease and for whom alternative treatment options approved or authorized by the FDA are not accessible or clinically appropriate. The treatment is not authorized for hospitalized patients. Currently, bebtelovimab appears to be effective against both the Omicron variant and the BA.2 Omicron subvariant.
 
The FDA’s press release is available here. 
 
CDC Releases Study on Waning Booster Efficacy During Delta and Omicron Waves
On February 11th, the CDC released data showing that vaccine efficacy against Covid-19-associated emergency department (ED) visits, urgent care (UC) visits, and hospitalizations was higher after a third dose than after a second dose, but waned with time. During the Omicron wave, vaccine efficacy two months after a third dose was 87% against ED/UC visits and 91% against hospitalization. Efficacy was 66% against ED/UC visits and 78% against hospitalizations four months after a third dose. Overall, vaccine efficacy was lower during the Omicron wave as compared to the Delta wave. Data were collected from 241,204 ED/UC encounters and 93,408 hospitalizations across 10 states from August 2021 through January 2022.
 
The full CDC report is available here.

Republicans Send Letter to Biden Administration Urging End of Covid-19 PHE
On February 10th, more than 70 House Republicans, led by Reps. Cathy McMorris Rodgers, Brett Guthrie, and Morgan Griffith, published a letter asking the President to end the Covid-19 public health emergency (PHE), lift all vaccine mandates, lift all mask mandates as well as federal mask guidance, and insist that schools fully open in person. The letter notes that the “PHE was certainly necessary at the outset of the pandemic” but that we are “now in a much different situation than we were when the PHE was originally enacted.”
 
Secretary of Health and Human Services (HHS) Xavier Becerra last renewed the PHE on January 16, 2022, and it is currently scheduled to lapse on April 16, 2022. The Administration has committed to providing at least 60 days’ notice before ending the PHE, so another renewal is expected.
 
The letter can be found here.
 
HHS Plans to Request $30 Billion For Covid-19 Funding
On February 15th, various news outlets reported that HHS will shortly request an additional $30 billion in funding for Covid-19 efforts. This request could be negotiated as part of the government funding deal for the remainder of 2022 currently under discussion in Congress, although several lawmakers, including Senate Appropriations Chair Patrick Leahy (D-VT), have expressed hesitance to include a new item in the government funding bill.
HHS’s funding request includes the following components: 

  • Covid-19 treatments and vaccines ($18 billion);
  • Testing capacity and at-home test development ($5 billion);
  • Reimbursing providers for treating uninsured Covid-19 patients ($3 billion);
  • Development of vaccines that are effective against future variants ($3.7 billion); and
  • Outbreak surveillance efforts ($500 million).

Covid-19 uninsured reimbursement currently flows through the $178 billion Provider Relief Fund (PRF). However, the request does not otherwise include additional PRF funding.
 
Governor Hochul Extends NYS Covid-19 Emergency Declaration
On February 14th, Governor Hochul issued Executive Order 11.3 (available here), which extends the second Covid-19 State Disaster Emergency declaration through March 16th. The Order continues the implementation of the State’s Comprehensive Emergency Management Plan and the “Surge and Flex” system, which allows the Department of Health (DOH) to limit non-essential elective procedures at health systems with limited capacity. Limited capacity is defined as having below 10% staffed bed capacity available, or as otherwise determined by DOH. The Order also continues the waiver of certain State Finance Law provisions around procurement to expedite purchasing of pandemic-related supplies. 
 
NYS DOH Extends Covid-19 HERO Act Designation Through March 17th 
On February 15th, DOH extended its designation of Covid-19 as an airborne infectious disease that presents serious risk of harm to the public health in New York State. This designation, initially implemented on September 6th, triggers the HERO Act, which requires all employers to implement workforce safety plans to protect employees against exposure and disease. The designation will now continue through March 17th.
 
The Commissioner’s designation is available here and additional details on the HERO Act are available here.

Federal Administration

Robert Califf Confirmed as FDA Commissioner
On February 15th, the Senate voted 50 to 46 to confirm Robert Califf as the next FDA Commissioner. The final vote was the tightest in history for confirmation of an FDA Commissioner, with five Senators who caucus with the Democratic Party voting against Califf’s nomination. Following the vote, Janet Woodcock, who has served as the acting FDA Commissioner for over a year, announced that she will continue to serve as principal deputy commissioner under Califf.

White House Announces Replacements for Eric Lander in OSTP and Cabinet
On February 16th, the Biden Administration announced that Alondra Nelson, the current Deputy Director for Science and Society at the Office of Science and Technology Policy (OSTP), will serve as the interim Director of OSTP. It also announced that Francis Collins, the recently retired head of the National Institutes for Health, will become President Biden’s Cabinet-level science advisor. Both roles were previously held by Dr. Eric Lander, who resigned last week after reports of abusive behavior towards subordinates.

The White House announcement is available here. 

Federal Legislature

Senate Passes Short-Term Continuing Resolution
On February 17th, the Senate passed H.R. 6617, a bill to extend funding for the federal government for an additional three weeks, through March 11th, by a vote of 65-27. As a continuing resolution, the bill will keep the federal government funded at fiscal year (FY) 2021 levels. Congressional leadership continues to work towards an agreement on a full-year appropriations package. Democrats seek a significant increase in non-defense spending, while Republicans have argued for an equal increase in defense and non-defense spending.

Regulatory Updates

CMS Seeks Input on Comprehensive Medicaid and CHIP Access Strategy
On February 17th, the Centers for Medicare and Medicaid Services (CMS) Office of Legislation released a Request for Information (RFI) seeking input on a “comprehensive access strategy” to improve accessibility of benefits for people enrolled in Medicaid and the Children’s Health Insurance Program (CHIP). This RFI represents the first step in addressing CMS’s stated priorities in its strategic vision for Medicaid and CHIP (access and coverage; equity; and innovation and whole-person care). The RFI identifies the following five objectives and asks for feedback on specific actions CMS can take to achieve them: 

  • Beneficiary Awareness: “Medicaid and CHIP reaches people who are eligible and who can benefit from such coverage.” 
    • CMS seeks comment on how to promote timely determinations, barriers to awareness and enrollment among specific subgroups, and how CMS can monitor eligibility denial rates.
  • Consistent Coverage: “Medicaid and CHIP beneficiaries experience consistent coverage.” 
    • CMS seeks comment on strategies to avoid inappropriate disenrollments and to minimize gaps in coverage when transitioning between programs.
  • Minimum Standards for Access: “Whether care is delivered through fee-for-service or managed care, Medicaid and CHIP beneficiaries have access to timely, high-quality, and appropriate care in all payment systems, and this care will be aligned with the beneficiary’s needs as a whole person.” 
    • CMS seeks feedback on setting federal minimum standards for equitable and timely access to services, including what standards to set, how to monitor them, and how it can promote whole-person care and care coordination (including issues such as behavioral health parity compliance).
  • Monitoring and Measurement: “CMS has data available to measure, monitor, and support improvement efforts related to access to services (i.e., potential access; realized access; and beneficiary experience with care across states, delivery systems, and populations).” 
    • CMS seeks feedback on developing a uniform monitoring approach across programs and benefits, and specifically asks about monitoring access to long-term services and supports (LTSS), including home and community-based services (HCBS).
  • Adequate Payment: “Payment rates in Medicaid and CHIP are sufficient to enlist and retain enough providers so that services are accessible.” 
    • CMS seeks input on ways to help ensure the adequacy of Medicaid and CHIP payment rates, including: 
      • Setting minimum standards for payment regulation and compliance;
      • Assessing of states’ Medicaid-specific payment and contracting arrangements and encouraging the adoption of payment policies that improve access;
      • Considering additional data sources to assess rate sufficiency for services that are not covered by Medicare, such as HCBS; and
      • Reducing administrative burdens that discourage provider participation in Medicaid and CHIP.

CMS’s press release on the RFI is available here. The RFI is available here.
 
CMMI Announces Webinar on Kidney Models
On March 2nd at 3pm, the CMS Innovation Center (CMMI) will host a webinar to provide updates on three programs: 

  • Comprehensive End Stage Renal Disease Care Model
  • Kidney Care Choices Model
  • End-Stage Renal Disease Treatment Choices Model

The webinar is open to the first 1,000 registrants. Registration is available here.
 
DHS Proposes New Public Charge Rule Disregarding Medicaid and SNAP
On February 17th, the Department of Homeland Security (DHS) announced the issuance of a Notice of Proposed Rulemaking to establish a new definition of “public charge.” Under federal law, immigrants’ applications for visas, permanent residency, or other changes to their status may be denied if they are found to be “likely to become a public charge.” The Trump Administration issued a rule in 2019 that would have expanded on previous policy to consider additional factors, such as an immigrant’s receipt of benefits under Medicaid or the Supplemental Nutrition Assistance Program (SNAP). This rule was stayed and eventually overturned in 2021. The new rule will formally return to a definition of “public charge” that includes the receipt of Supplemental Security Income (SSI) and Temporary Aid for Needy Families (TANF), but does not include Medicaid or SNAP.
 
DHS’s press release is available here.
 
SEC Proposes to Enhance Regulation of Private Fund Advisors
On February 9th, the Securities and Exchange Commission (SEC) voted to propose new rules on the regulation of private fund advisors. These changes are expected to affect certain health care entities, including health systems who invest in such funds and those who have in-house venture or private equity funds that have outside investors. Under the proposed rules, such entities will need to meet significant new disclosure requirements, including providing quarterly statements on fees and performance.
 
The SEC press release is available here.
 
HRSA Awards $55 Million to FQHCs for Virtual Care
On February 15th, the Health Resources and Services Administration (HRSA) at HHS announced the award of about $55 million to 29 HRSA-funded federally qualified health centers (FQHCs) to improve access to virtual health care. Virtual care projects may include telehealth, remote patient monitoring, digital patient tools, and health information technology platforms. Between 2019 and 2022, the number of health centers offering virtual visits grew by 130%. Grant recipients in New York include Sunset Park Health Council, Housing Works Health Services, Project Renewal, The Institute for Family Health, and Hudson River Healthcare, each receiving between $1 million and $2 million.
 
A full list of grant recipients can be found here.

Other Updates

NAACOS and Others Send Letter to HHS Supporting Direct Contracting
On February 14th, the National Association of Accountable Care Organizations (NAACOs) sent a letter cosigned by 222 other health care organizations to HHS Secretary Xavier Becerra urging HHS not to cancel the Global and Professional Direct Contracting (GPDC) model. The letter urges HHS to “make necessary refinements to improve” GPDC, but that ending the program would “undermine our health system’s move to value-based payment models” and undermine the credibility of CMMI. Instead, it recommends adjusting the model by limiting participation to certain types of DCEs, placing additional guardrails, adding more beneficiary protections, and rebranding the program for clarity. The letter’s signatories include major health systems, insurers, and others.
 
The GPDC model has faced criticism from progressive Democrats in recent weeks. However, news outlets have reported that CMMI’s leadership does not want to end the GPDC model, and changes to the program are considered more likely than termination. Areas for change could include the incentives for provider participation, the benchmarking system for earning shared savings, makeup of governing bodies, risk adjustment calculations, model size, and programmatic rebranding. CMS is expected to make an announcement on the program as soon as next week.
 
The NAACOS letter is available here.

Legislative Hearings

No major health care-related hearings are scheduled next week. The Senate and House will return from recess on February 28th.

New York State Updates

DOB Publishes 30-Day Amendments to FY 2023 Executive Budget
Today (February 18th), the Division of the Budget (DOB) published 30-day amendments to Governor Hochul’s FY 2023 Executive Budget proposals. The Assembly and Senate will now develop their own one-house versions of the budget proposal for negotiation, aiming to enact a final budget by April 1st. Some notable health care-related changes in the amended proposal include: 

  • The income limit for eligibility for one-time Healthcare Worker Bonuses will be raised from $100,000 to $125,000.
  • Language in the proposal for modernization of emergency medical services (EMS) has been revised.
  • The language indicating expiration of the 1% Medicaid across-the-board increase at the end of FY 2024 has been removed.
  • The proposed addition of adult care facilities (ACFs) as eligible for temporary safety net payments has been removed (while retaining the proposed addition of nursing homes).
  • All CHIP oversight functions of the Department of Financial Services (DFS) will be moved to DOH.
  • DFS Subsidies for physician coverage under the hospital excess liability pool will be paid directly to policy providers, rather than being reimbursed to physicians.

The text of the 30-day amendments can be found here.
 
DOH Posts Second Quarterly Report on Enhanced HCBS Funding
On February 15th, DOH submitted New York’s second quarterly update for spending proposals to enhance HCBS using enhanced matching funds under the American Rescue Plan. Notably, DOH has rescinded its proposal to use $415 million in enhanced funds to support the “natural growth” of personal care and Consumer Directed Personal Assistance Program (CDPAP) services. Instead, DOH has proposed nine new projects for which it is seeking CMS approval. All amounts in parentheses represent enhanced funds only, which may be matchable: 

  • Homecare Worker Bonus ($418 million)
  • Improve and Support the Assisted Living Program (ALP) Workforce ($20 million)
  • Incentivize Child Welfare Step-Down Programs ($2.2 million)
  • Evidence Based Children’s Services ($4.7 million)
  • New Children’s Waiver HCBS ($2.5 million)
  • School Supportive Health Services Expansion ($5.7 million);
  • Invest in Outpatient Mental Health Rehabilitative Services ($31.8 million)
  • Strengthen the NYS Multiple Systems Navigator ($14.8 million)
  • Expansion of the Community Care Connections Program ($2.8 million)

The report also provides an update on implementation progress for previously submitted and approved proposals, of which there are 37 of the original 39.
 
The full quarterly report can be found here.
 
NYS to Host Webinar on Executive Budget’s Medicaid Proposals
On February 23rd from 9:30am to 11:30am, NYS Medicaid Director Brett Friedman and executive staff from the New York State Office of Health Insurance Programs (OHIP) will host a webinar outlining the Medicaid proposals included in the FY 2023 Executive Budget. There will be a Q&A period open to all stakeholders at the conclusion of the presentation. Questions may be submitted in advance to mrtupdates@health.ny.gov.
 
Registration for the webinar is available here.
 
DOH Proposes Rule Enacting Hospital Clinical Staffing Committee Requirements
On February 16th, DOH posted a Proposed Rule in the State Register (available here) to implement the hospital clinical staffing committee requirements passed in June 2021 (S.1168). The rule would require general hospitals to create a clinical staffing committee comprised of registered nurses, licensed practical nurses, ancillary staff members providing direct patient care, and hospital administrators. The committee would be responsible for developing and overseeing the implementation of a clinical staffing plan with specific guidelines, ratios, matrices, or grids indicating how many patients are assigned to each nurse and the number of ancillary staff in each unit.
 
Comments may be submitted to regsqna@health.ny.gov through April 17th.
 
OASAS Updates Regulations on Telehealth, LGBTQ Endorsement, Patient Rights, and Chemical Dependence Services
On February 16th, the Office of Addiction Services and Supports (OASAS) issued a Notice of Adoption in the State Register (available here) that amends Part 830 of Title 14 of NYCRR to continue telehealth flexibilities allowed during the New York State Disaster Emergency and to make those flexibilities permanent. The final regulations also add an optional LGBTQ endorsement to develop a distinction for OASAS-certified programs meeting additional criteria for the provision of LGBTQ-affirming care.
 
The final regulations are available here.
 
OASAS has also adopted amendments to:  

  • Part 800 Chemical Dependence Service Provisions (available here), including a new section addressing “Access to Treatment.”
  • Part 815 Patient Rights (available here), which includes various changes related to patient rights and provider requirements for developing policies and procedures.

OPWDD Issues Rule on Emergency Capacity Increases in IRAs
On February 16th, the Office for People with Developmental Disabilities (OPWDD) posted two Emergency/Proposed Rules in the State Register (available here) which would allow OPWDD to authorize and issue operating certificates for supervised community residences, including Individualized Residential Alternative (IRA) facilities, to temporarily exceed a capacity of 14 individuals, which under current regulation is the maximum for which any IRA may be approved. The two rules modify sections 686.3 and 686.14 of Title 14 of the New York Code of Rules and Regulations (NYCRR). OPWDD states that these rules are necessary due to increased service needs and challenges meeting current minimum staffing requirements during the Covid-19 pandemic, and that they will allow OPWDD to concentrate staff and individuals in a single location as needed.
 
The emergency adoption of the rules will expire on April 25th. Comments may be submitted to rau.unit@opwwd.ny.gov through April 17th.

Funding Opportunities

Affinity Legacy Opens Program for Community Grants of $25,000 to $1 Million
On February 15th, Affinity Legacy, Inc. announced the opening of its Community Grant Program, which will provide one-time grants of between $25,000 and $1 million to community organizations operating in the downstate and Lower Hudson areas. Affinity previously operated a regional Medicaid managed care plan whose assets were purchased by Molina Healthcare in 2020 for about $380 million. Affinity Legacy continues to operate to administer the accompanying charitable asset distribution.
 
Eligible applicants to the Community Grant Program must be not-for-profit 501(c) organizations that: 

  • Have purposes consistent with Affinity’s mission to “improve the health and well-being of the communities we serve”;
  • Operate programs within the 10-county service area (New York City, Long Island, and Orange, Rockland, and Westchester Counties); and
  • Not have received funding from any other component of the Affinity charitable asset distribution.

Eligible projects should be in one of the following areas: 

  • Mental health programs for underserved communities;
  • Food insecurity;
  • Formerly incarcerated individuals’ re-entry into the community; and
  • Consumer health education and workforce development, including training and skill development for health care workers.

The amount of grant awards will vary based on the strength and scale of the organization and its alignment with the program requirements. Awarded applicants will be expected to submit reports to Affinity six months and one year after grant receipt.
 
Letters of Intent (LOIs) are due by April 15th. Select applicants will be invited to submit a full application on June 15th. LOIs should include preliminary information about the organization, the objectives of the program/project to be funded, the target population, and the timeline for implementation.
 
Additional information on the grant program is available here.
 
OASAS Offers $15,000 to Support the Purchase of Telehealth Infrastructure
On February 11th, OASAS released an RFA for one-time telehealth infrastructure funding, including the purchase of equipment (e.g., phones for programs, tablets) and connectivity. Through this opportunity, OASAS will award a total of up to $1.5 million in funding to eligible providers for the purchase of infrastructure to support the continued provision of services via telehealth. This funding is made available through supplemental funding allocated by the federal Coronavirus Response and Relief Supplemental Appropriations Act to the Substance Abuse Prevention and Treatment Block Grant program.
 
OASAS will issue one-time awards up to $15,000 for the purchase of equipment, software, and other technology to establish the necessary infrastructure to deliver substance use disorder treatment via telehealth. Funding may not be used to purchase any items for consumers/clients.
 
The full RFA is available here and SPG’s summary of the opportunity is available here. Applications are due on March 11th and will be reviewed in order of receipt.
 
DOH Extends Deadline for Statewide Health Care Facility Transformation Program III RFA
DOH has extended the deadline for Round 3 of the Statewide Health Care Facility Transformation Program (SHCFTP III) Request for Applications (RFA) to February 22nd at 4pm. Organizations that have already applied, but would like to request for the application to be reopened, may email grantsreform@its.ny.gov. The email request should include the organization’s name, application number, and the following statement: “I acknowledge that it is my responsibility to re-submit the application prior to the new deadline.”
 
Details are available in Addendum #5 of the application, which can be found by searching “Statewide Health Care Facility Transformation Program III” on the Grants Gateway website here.