Weekly Health Care Policy Update – January 14, 2022

January 21, 2022

In this update: 

  • Covid-19 Updates
    • HHS Renews Covid-19 PHE
    • Supreme Court Affirms CMS Health Care Vaccine Mandate, Blocks OSHA Employer Mandate
    • Biden Administration Requires Coverage of At-Home Covid-19 Tests
    • Biden Administration Begins Distribution of Free At-Home Rapid Tests
    • NYS to Institute Covid-19 Booster Dose Requirements for Healthcare Workers
    • NYS DOH Updates List of Hospitals that Must Temporarily Stop Elective Procedures
    • NYS DOH Issues Updated Medicaid Policy and Billing Guidance for Reimbursement of COVID-19 Therapeutics
  • Legislative
    • Senate HELP Committee Approves Califf’s Nomination
  • Regulatory
    • CMS to Hold National Stakeholder Call on January 18th
    • CMS Will Restrict Access to Aduhelm; Becerra Requests Part B Premium Reconsideration
    • HRSA Updates ACA Preventive Health Care Guidelines for Women and Children
    • CMMI Announces Kidney Care Model Participants
    • HHS Announces 2022 ACA Marketplace Signups Reach 14 Million
  • Other
    • MACPAC January Agenda Includes Medicaid Eligibility Redeterminations, Dual Eligible Strategies
    • AHRQ Opens Nominations for Preventive Services Task Force
  • Congressional Hearings
  • New York State Updates
    • DFS Suspends Certain Utilization Review Requirements for 30 Days
  • Funding Opportunities
    • OASAS Prevention Community Coalitions
    • HRSA Area Health Education Centers (AHEC) Program
    • CDC Tracking Post-Covid-19 Conditions in Diverse Population
    • NIH Small Business Innovation Research on Minority Health

COVID-19 Updates

HHS Renews Covid-19 PHE
On January 14th, Health and Human Services (HHS) Secretary Xavier Becerra announced the renewal of the Covid-19 public health emergency (PHE) declaration for an additional 90 days. This will continue various emergency provisions, including the 6.2% enhanced federal matching funds for State Medicaid programs, through April 16th.
 
The declaration is available here.
 
Supreme Court Affirms CMS Health Care Vaccine Mandate, Blocks OSHA Employer Mandate
On January 13th, the Supreme Court issued two opinions in cases challenging the legal authority of the Biden Administration to require vaccination against Covid-19 for health care workers and for employees of large businesses. The Court allowed the vaccination mandate for health care workers to continue, finding that Congress gave the administration the authority to impose the requirement on health care facilities that receive federal funds. However, the Court found no similar authority for imposing the vaccination requirement on workplaces that are not health care facilities.
 
Following the opinion, the Centers for Medicare and Medicaid Services (CMS) announced that it will begin national enforcement of its mandate, which requires all employees of health care facilities participating in Medicare or Medicaid to be vaccinated with no testing option. As such, employees of qualifying facilities are required to receive a first dose of the vaccine by January 27th and be fully compliant by February 28th.
 
The opinion regarding health care workers is available here, and the opinion regarding large employers is available here.
 
Biden Administration Requires Coverage of At-Home Covid-19 Tests
On January 10th, the Biden Administration announced that insurance companies and group health plans must cover the cost of over-the-counter (OTC), at-home Covid-19 tests starting January 15th. Tests must be authorized, cleared, or approved by the FDA to be covered by a plan or insurance.
 
Plans are required to cover eight free OTC, at-home Covid-19 tests per covered individual per month. There remains no limit on the number of tests, including at-home tests, that will be covered if ordered or administered by a health care provider following a clinical assessment. Commercial plans must offer coverage for tests without any cost sharing requirements such as deductibles, copayments or coinsurance, prior authorization, or other medical management activities. Plans will not be required to provide coverage for at-home tests purchased before January 15th.
 
The Administration is urging insurers and group health plans to set up programs that give beneficiaries access to tests through preferred pharmacies, retailers, or other entities with no out-of-pocket costs, eliminating the need to submit a claim for reimbursement. If plans implement this option, they are only required to reimburse $12 per test for tests acquired outside of this structure. For plans without such an up-front option, they must reimburse the full cost of a test.
 
The press release is available here. An FAQ is available here.
 
Biden Administration Begins Distribution of Free At-Home Rapid Tests
Today, January 14th, the Biden Administration announced that it would launch its program to make free at-home rapid Covid-19 tests available to all Americans. Tests may be requested on a website, COVIDTests.gov, starting January 19th, and will be mailed directly to households within 7-12 days. The Administration has purchased one billion tests for this program.
 
A fact sheet on this program is available here.
 
NYS to Institute Covid-19 Booster Dose Requirements for Healthcare Workers
On January 7th, Governor Kathy Hochul announced that healthcare workers will be required to receive a Covid-19 booster dose within two weeks of becoming eligible. Like existing New York State Covid-19 vaccination requirements, the only exemptions will be for medical reasons, and there will be no testing alternative option available, in accordance with an emergency regulation approved by the Public Health and Health Planning Council.
 
This requirement will apply to healthcare workers previously required to be fully vaccinated under the emergency regulation issued by the Department of Health (DOH) on August 26, 2021 (available here), including but not limited to personnel employed by or affiliated with general hospitals, nursing homes, adult care facilities, and home care agencies.
 
The emergency regulation will be effective upon its filing with the Department of State. The Governor’s announcement is available here.
 
NYS DOH Updates List of Hospitals that Must Temporarily Stop Elective Procedures
On January 8th, DOH updated the list of hospitals that must temporarily stop non-essential, non-urgent elective surgeries for two weeks after having met the threshold for being located in a “high risk region” or experiencing low facility capacity due to increases in Covid-19 cases and hospitalizations. The impacted list includes 40 hospitals, including all hospitals located in the regions of the Mohawk Valley, Finger Lakes, and Central New York.
 
DOH conducts weekly risk assessments of facilities and notifies those that will be subjected to procedure limitations in accordance with the Governor’s Executive Order 11 (available here) and DOH guidance (available here) to maintain the long-term resiliency of the state’s healthcare infrastructure and to ensure that hospital capacity meets regional needs. Criteria used to determine “high risk regions” includes low current regional bed capacity with 90% or more beds occupied based on the previous 7-day average; or 85-90% occupancy rate based on the previous 7-day average and a new COVID-19 hospital admission rate for the region (previous 7-day average per 100,000 population) greater than 4%.
 
The complete list of impacted hospitals is available here.
 
NYS DOH Issues Updated Medicaid Policy and Billing Guidance for Reimbursement of COVID-19 Therapeutics
On January 10th, DOH issued an update on Medicaid coverage of pharmaceutical administration of COVID-19 therapeutics, including monoclonal antibodies (mAb). Specifically, DOH detailed requirements for the coverage of AstraZeneca’s Evusheld product, which has been authorized for emergency use by the U.S. Food and Drug Administration (FDA), including:

  • Requiring that Evusheld (tixagevimab and cilavimab) be prescribed for an individual patient by a physician, nurse practitioner, or physician assistant licensed or authorized under New York State law to prescribe monoclonal antibodies for prevention of COVID-19;
  • Requiring that the prescriber’s National Provider Identifier (NPI) be included in the claim for Evusheld reimbursement;
  • Providing payment allowances for Evusheld administration, including in the home and residence.

The effective date for Medicaid coverage of Evusheld is December 8, 2021. The updated guidance is available here.

Legislative Update

Senate HELP Committee Approves Califf’s Nomination
On January 13th, the Senate Committee on Health, Education, Labor, and Pensions (HELP) voted 13 to 8 to approve the nomination of Dr. Robert Califf to become Commissioner of the Food and Drug Administration (FDA). Four Republicans joined most Democrats to advance the nomination. Senators Bernie Sanders (I-VT) and Maggie Hassan (D-NH) opposed the nomination. Dr. Califf’s nomination will now move to the full Senate for final confirmation, although timing on such consideration remains unclear.

Regulatory Updates

CMS to Hold National Stakeholder Call on January 18th
On January 18th at 1pm, the CMS leadership team, including CMS Administrator Chiquita Brooks-LaSure, Principal Deputy Administrator and Chief Operating Officer Jon Blum, and others, will host a National Stakeholder Call. On this call, CMS leadership is expected to review 2021 accomplishments and describe plans and goals for 2022.
 
Registration is available here.
 
CMS Will Restrict Access to Aduhelm; Becerra Requests Part B Premium Reconsideration
On January 11th, CMS announced its proposed National Coverage Determination (available here) for Biogen’s new Alzheimer’s drug, Aduhelm. Medicare is proposing to cover the drug only through “coverage with evidence development” (CED), meaning it will only be covered for certain patients enrolled in clinical trials. Currently, CED is limited to only about two dozen other health care products, mostly medical devices and diagnostic imaging. Medicare further specified that such clinical trials must be conducted in a hospital-based outpatient setting, and the drug may only be administered to patients with mild forms of cognitive impairment or dementia, who also have amyloid plaques. This is a much narrower patient population than was included in the FDA approval of Aduhelm. The proposal will be open for public comment for 30 days and will be finalized by April 12th.
 
Prior to this announcement, on January 10th, HHS Secretary Becerra instructed CMS to reconsider its previously-announced premium increases for the Medicare program, which were in large part attributed to the potential impact of Aduhelm. Becerra had cited Biogen’s price reduction of 50% for the drug. Since Medicare normally does not make changes to premiums after a plan year has begun, CMS is still working to determine its next steps.
 
HRSA Updates ACA Preventive Health Care Guidelines for Women and Children
On January 11th, the Health Resources and Services Administration (HRSA) updated its preventive care and screening guidelines for women and infants, children, and adolescents. Under the Affordable Care Act (ACA), certain group health plans and insurance issuers are required to provide coverage for such services with no out-of-pocket cost, meaning the updates will result in additional services at no cost for many beneficiaries.
 
For women, HRSA added new services to the existing guidelines regarding: 

  • Counseling midlife women with normal or overweight body mass index to maintain weight or limit weight gain to prevent obesity;
  • Comprehensive lactation support services and coverage of double electric breast pumps and breast milk storage supplies;
  • Coverage of a full range of contraceptives currently listed in the FDA’s Birth Control Guide;
  • Directed behavioral counseling for sexually active adolescent and adult women at an increased risk for sexually transmitted infections;
  • Screening for HIV at least once during a patient’s lifetime, screening for HIV for all pregnant women, and risk assessment and prevention education for HIV infection beginning at age 13; and
  • At least one preventive care visit per year beginning in adolescence and continuing across the lifespan.

For children, HRSA added new services to the existing guidelines regarding: 

  • Universal screening for suicide risk for individuals ages 12 to 21;
  • Behavioral, social, and emotional screening;
  • Assessing risk for cardiac arrest or death for individuals ages 11 to 21; and
  • Assessing risks for hepatitis B virus infection in newborn to 21-year-olds.

The press release can be found here.
 
CMMI Announces Kidney Care Model Participants
On January 10th, the Center for Medicare and Medicaid innovation (CMMI) announced that 30 CMS Kidney Care First practices and 55 Kidney Contracting Entities will be participating in Performance Year 2022 of the Kidney Care Choices (KCC) Model, which began on January 1st, 2022. Under the KCC Model, dialysis facilities, nephrologists, and other health care providers form accountable care organizations to manage care for Medicare beneficiaries with End Stage Renal Disease (ESRD). The Model includes strong financial incentives to delay the onset of dialysis for Medicare beneficiaries with chronic kidney disease stages 4 and 5 and ESRD, and to incentivize kidney transplantation.
 
The full list of participants can be found here.
 
HHS Announces 2022 ACA Marketplace Signups Reach 14 Million
On January 13th, the Department of Health and Human Services (HHS) announced that more than 14.2 million individuals have enrolled in Affordable Care Act coverage that started on January 1, 2022. Overall, HHS reported a 21% increase in enrollment in states using HealthCare.gov. Most of that enrollment increase is concentrated in states that have not expanded Medicaid eligibility. Open enrollment for 2022 ends on January 15th, after which enrollment figures will be finalized. After several years of decreasing enrollment, this figure will represent the highest ever ACA Marketplace enrollment; the previous high was 12.7 million in 2016.
 
A press release is available here. State-by-state enrollment data is available here.

Other Updates

MACPAC January Agenda Includes Medicaid Eligibility Redeterminations, Dual Eligible Strategies
The next meeting of the Medicaid and CHIP Payment and Access Commission (MACPAC) will be held on January 20th and 21st. Notable items on the agenda include: 

  • An panel discussion on restarting Medicaid eligibility redeterminations;
  • Review of the recent CMS Medicare Advantage rule’s provisions on Dual Eligible Special Needs Plans (D-SNPs); and
  • Requiring states to develop a formal strategy to integrate care for dual eligibles.

The full agenda is available here.
 
AHRQ Opens Nominations for Preventive Services Task Force
On January 13th, the Agency for Healthcare Research and Quality (AHRQ) posted a solicitation for nominations for members of the U.S. Preventive Services Task Force (USPSTF). The USPSTF makes recommendations around clinical preventive services for adults and children, including screening tests, counseling services, and preventive medications. AHRQ particularly encourages nominations of women, members of underrepresented populations, and people with disabilities.
 
The notice has been posted here. Nominations are due March 15th for appointments to begin in 2023.

Congressional Hearings

Wednesday, January 19th:

  • At 10am, the House Rules Subcommittee on Legislative and Budget Process will hold a hearing entitled “Using Budget Principles to Prepare for Future Pandemics and Other Disasters.” More information is available here.

Thursday, January 20th:

  • At 10am, the House Financial Services Subcommittee on Housing, Community Development and Insurance will hold a hearing entitled “Ending Homelessness: Addressing Local Challenges In Housing the Most Vulnerable.” More information is available here. 
  • At 10am, the House Homeland Security Committee will hold a hearing entitled “FEMA: Building a Workforce Prepared and Ready to Respond.” More information is available here.

New York State Updates

DFS Suspends Certain Utilization Review Requirements for 30 Days
On January 6th, the New York State Department of Financial Services (DFS) issued a circular letter directing DFS-regulated insurance plans to suspend certain utilization review requirements for 30 days to assist hospitals with staffing shortages and resource issues during the current COVID-19 surge. This suspension will allow hospitals to increase bed capacity and balance patient load by facilitating the rapid transfer and discharge of patients.
 
Specifically, regulated insurance plans are required to suspend the following requirements for 30 days: 

  • Preauthorization review for in-network hospital transfers; and
  • Preauthorization requirements for in-network inpatient rehabilitation services provided by a hospital or skilled nursing facility following an inpatient hospital admission.

Hospitals are encouraged to provide notifications to insurance plans, including information necessary for the plan to assist in coordinating care and discharge planning, within 48 hours of the transfer or discharge.
 
If an insurance plan does not have a contract with a hospital that addresses transfers within the hospital system or between other hospitals, the plan and hospital should collaborate in determining the appropriate policies and payment for the transferring or the receiving hospital. In the absence of contract language providing for a transfer payment policy, payments for transfers involving Medicaid managed care beneficiaries should be guided by Medicaid fee-for-service program policies.
 
DFS also strongly recommends that Medicare Advantage Plans and third-party administrators of self-funded plans adhere to the circular letter’s provisions in order to alleviate statewide hospital capacity issues.
 
The DFS circular letter is available here.

Funding Opportunities

OASAS Prevention Community Coalitions
On January 5th, the New York State Office of Addiction Services and Supports (OASAS) announced a Request for Application (RFA) for not-for-profit community coalitions or agencies with experience in prevention coalition building to develop prevention programs to reduce underage and binge alcohol and/or heavy cannabis use in underserved communities. Selected coalitions must use the Strategic Prevention Framework (SPF) to address substance misuse and implement evidence-based environmental prevention strategies in vulnerable health disparate populations.
 
OASAS will award up to $150,000 annually, for up to 3 years, to one provider/coalition in each of the 10 Empire State Development Regions.
 
The complete RFA is available here. Electronic and facsimile applications will notbe accepted; applications must be delivered by mail or in person to the OASAS office listed in the application by 5pm on February 3rd.
 
HRSA Area Health Education Centers (AHEC) Program
On January 6th, HRSA released a Notice of Funding Opportunity (NOFO) for the AHEC program to support a diverse healthcare workforce. Through this opportunity, HRSA will fund up to 55 cooperative agreements with medical schools to: 

  • Develop and implement strategies to recruit individuals from underrepresented minority populations and/or disadvantaged and rural backgrounds into health professions;
  • Implement strategies to provide community-based training and education to individuals seeking careers in health professions within underserved areas;
  • Conduct and participate in interdisciplinary training;
  • Facilitate continuing education for healthcare professionals; and
  • Establish a youth public health program to recruit high school students into health careers.

Eligible applicants include public or nonprofit private accredited schools of allopathic medicine or osteopathic medicine; an incorporated consortium made up of such schools; or the parent institution(s) of such schools.
 
Applicants must request to participate in one of two phases: the Infrastructure Development (ID) phase or the Point of Service Maintenance and Enhancement (POSME) phase. HRSA will award up to $148,000 in annual funding for up to five years to awardees in the ID phase and up to $250,000 in annual funding for up to five years to awardees in the POSME phase.
 
The NOFO is available here. Applications are due on April 6th.
 
CDC Tracking Post-Covid-19 Conditions in Diverse Populations
On January 5th, the Centers for Disease Control and Prevention (CDC) released a Notice of Funding Opportunity (NOFO) to fund multi-year cooperative agreements to track and investigate the burden of post-Covid-19 conditions (PCC) in diverse populations. The CDC will fund: 

  • Four surveillance sites to conduct a standardized population-based approach to monitor and track post-Covid-19 conditions by age, sex, race/ethnicity, geographic area, severity of initial infection, and risk factors in a population of at least 1,000 enrollees; and
  • One coordinating center to act as a repository of the data generated by the surveillance sites and to provide an infrastructure for standardized approaches, analytical methods, and surveillance measures.

The CDC will award up to $2 million annually to surveillance sites and up to $1 million annually to the coordinating center during the 5-year project period. Eligible applicants include, but are not limited to nonprofit organizations, public or private institutions of higher education, and state and local governments.
 
The NOFO is available here. Applicants are recommended but not required to submit a letter of intent, which are due on January 24th. Applications are due on March 8th.  
 
NIH Small Business Innovation Research on Minority Health
On January 5th, the National Institutes of Health (NIH) posted a Funding Opportunity Announcement (FOA) inviting small businesses to submit Small Business Innovation Research (SBIR) grant applications for proposals to develop a product, process, service, or technology with the aim of improving minority health and reducing health disparities. The product should be effective, affordable, and culturally appropriate. Applicants must meet the criteria for a small business concern (SBC) by being a for-profi organization with 500 or fewer employees.
 
The following NIH components will provide funding for projects that address their specific areas of research interest:

  • National Institute on Minority Health and Health Disparities (NIMHD): will provide up to $1 million in total annual funding for 3-4 awardees
  • National Heart, Lung, and Blood Institute (NHLBI): will provide to $2.9 million in total annual funding for three phase I small clinical trials and one phase II trial
  • National Institute on Aging (NIA): will provide up to $1 million in total annual funding for 3-4 awardees
  • National Institute Of Biomedical Imaging And Bioengineering (NIBIB): will provide up to $1 million in total annual funding for 3-4 awardees
  • National Institute On Drug Abuse (NIDA): will provide up to $1 million in total annual funding for 1-3 awardees
  • National Institute of Mental Health (NIMH): will provide up to $250,000 in total annual funding for 1 awardee
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): up to $1 million in total annual funding for 1-3 awardees

Optional letters of intent are due on March 5th. Applications are due on April 4th. The FOA is available here.