Weekly Health Care Policy Update - May 7, 2021

In this update:

Biden Administration Announces Updates on Combatting COVID-19
- Administration Sets New Vaccine Goal
- Administration Supports Lifting Vaccine Patent Protections
- HHS Offers Reimbursement for Vaccines for the Underinsured
- HRSA Allocates $1 Billion for Rural Response
- HRSA to Offer $250 Million for Vaccination Efforts in Underserved Communities
GAO Makes New MACPAC Appointments
HHS Releases $1.4 Billion in Funding for Older Americans Act Programs
CMS Issues Waiver for Ground Ambulance Services to Provide Treatment in Place
FDA Withdraws Policy on Drug Review Timelines
Paycheck Protection Program Funding Exhausted Ahead of Schedule
Hospital Leaders Make Pledge on Worker Safety
Leapfrog Group Releases New Hospital Safety Scores
Congressional Hearings
Governor Cuomo Signs NY HERO Act
CMS Approves NYS SPA to Adjust Specialty Hospital Payments for Minimum Wage Requirements
DOH Delays Transition of Adult Behavioral Health HCBS to CORE Services
Updated Guidance Documents

Administration Updates

Biden Administration Announces Updates on Combatting COVID-19
This week, the Biden Administration announced new updates on the COVID-19 response:

Administration Sets New Vaccine Goal: The Administration has set a new goal for 70% of Americans to have received at least one COVID-19 vaccine dose by July 4^th. Vaccination rates have decreased from a peak of 3.4 million doses per day in mid-April to about 2.3 million in early May. To pursue the goal, the Administration intends to expand walk-up appointments, push mobile vaccination clinics, invest in wider campaigns to boost vaccine confidence, and direct unordered doses to higher-demand states.
Administration Supports Lifting Vaccine Patent Protections: On May 5^th, the Administration, in a reversal, announced its support for waiving intellectual property protections for COVID-19 vaccines in an effort to increase worldwide vaccine production. The U.S. will now participate in negotiations at the World Trade Organization to develop a plan for such a waiver.
HHS Offers Reimbursement for Vaccines for the Underinsured: On May 3^rd, the Department of Health and Human Services (HHS) announced a new program through the Health Resources and Services Administration (HRSA) to cover the costs of administering COVID-19 vaccines to underinsured Americans (i.e., people whose health plans either do not cover vaccine administration fees or require patient cost-sharing). The new COVID-19 Coverage Assistance Fund (CAF), which will pay for eligible claims at national Medicare rates ($40 per dose), is funded through the CARES Act Provider Relief Fund (PRF) and supplements the existing PRF-funded program that covers costs for those without any insurance. The CAF will accept eligible claims from providers with dates starting December 14, 2020. More information is available here.
HRSA Allocates $1 Billion for Rural Response: On May 4^th, HHS announced the availability of nearly $1 billion from the American Rescue Plan (ARP) to strengthen COVID-19 response and vaccination efforts in rural communities. Under this initiative, HRSA will provide over $460 million to more than 4,600 rural health clinics (RHCs) to increase testing and broaden efforts to mitigate the virus, provide $398 million to existing grantees of the Small Rural Hospital Improvement Program to work with approximately 1,730 small rural hospitals (under 50 beds) and Critical Access Hospitals on testing and mitigation, provide $100 million in grants to eligible RHCs to address health equity gaps, and invite Medicare-certified RHCs to join the Rural Health Clinic COVID-19 Vaccine Distribution Program to receive a direct supply of vaccine doses. More information is available here.
HRSA to Offer $250 Million for Vaccination Efforts in Underserved Communities: On May 4^th, HHS announced the availability of approximately $250 million in funding from the ARP to develop and support a community-based workforce to promote COVID-19 vaccination efforts in vulnerable and medically underserved communities. HRSA has launched the first of two funding opportunities, offering $125 million to establish ten regional, multi-state recipients to work with multiple local organizations. Applications for this funding are due May 18^th. Smaller community-based organizations will be eligible for the second $125 million round of funding, which will be released in the near future. More information is available here.

GAO Makes New MACPAC Appointments
On May 3^rd, the Government Accountability Office (GAO) announced the appointment of five new members of the Medicaid and CHIP Payment and Access Commission (MACPAC). The newly appointed members are:

Heidi L. Allen, associate professor at Columbia University School of Social Work
Robert Duncan, Executive Vice President of Children’s Wisconsin
Laura Herrera Scott, Vice President of Clinical Strategy and Product at Anthem; and
Verlon Johnson, Senior Vice President, Corporate Strategy at CNSI.

Current member Melanie Bella was reappointed and named the Commission’s Chair. Current member Kisha Davis was named the Commission’s Vice Chair. Current member Katherine Weno was also reappointed.

The press release is available here.

HHS Releases $1.4 Billion in Funding for Older Americans Act Programs
On May 3^rd, the HHS Administration for Community Living (ACL) announced the release of $1.4 billion in funding provided by the ARP for Older Americans Act programs. Such programs are administered by State Units on Aging, such as New York’s State Office for the Aging (SOFA). The Federal funds allocated include:

$750 million for meals, including home-delivered meals and “grab and go” meals from community centers;
$460 million for Home and Community Based Services (HCBS), which may be used for COVID-19 vaccination and to combat the effects of social isolation;
$44 million for health promotion and disease prevention, such as fall prevention or chronic disease management;
$145 million for the National Family Caregiver Support program; and
$10 million for State Long-Term Care Ombudsman programs to allow advocates to return to facilities as they work on behalf of residents.

The White House fact sheet is available here. ACL has posted two FAQ documents, one on programmatic questions (available here) and one on fiscal questions (here).

Regulatory Updates

CMS Issues Waiver for Ground Ambulance Services to Provide Treatment in Place
On May 5^th, HHS issued guidance to implement a provision of the ARP that waives the Medicare requirement that ambulance services must include the transport of an individual to qualify for reimbursement. Under this waiver, Medicare payment will be allowed for ground ambulance services furnished in response to a 911 call (or the equivalent) in which the patient would have been transported to a permitted destination but the transport did not occur due to community-wide emergency medical service protocols in place during the COVID-19 public health emergency. Many localities established such protocols to direct ground ambulance providers to treat patients at the scene of the response (“treatment in place”). The waiver is retroactive to March 1, 2020.

A fact sheet on the ambulance waiver is available here. CMS has also updated its description of all COVID-19 emergency declaration blanket waivers, which is available here, and its FAQ document, which is available here.

FDA Withdraws Policy on Drug Review Timelines
On April 30^th, the HHS and the Food and Drug Administration (FDA) issued a withdrawal of a policy announced under the Trump Administration that would have required FDA to publish review timelines for certain drug product applications. The policy, which was announced on January 15^th, would have required FDA to publish the date on which a New Drug Application or Abbreviated New Drug Application was filed or received, the date of approval, the total time elapsed during review, and the total number of days in excess of 180 days. Among its many objections, the FDA said the policy would have required it to publish duplicative information, that it was created by HHS without any FDA input, and that the 180-day review period is often extended by mutual agreement by the agency and the applicant.

The full withdrawal notice is available here.

Paycheck Protection Program Funding Exhausted Ahead of Schedule
On May 4^th, the Small Business Administration (SBA) announced to trade groups that funding for the general fund of the Paycheck Protection Program (PPP) has been exhausted and that lenders should stop accepting new applications. The scheduled end of the program was May 31^st. SBA has set aside $6 billion for applications that are still under review or need more information, and $8 billion is still available from the dedicated funds to be loaned by Community Financial Institutions who serve underserved communities.

Other Updates

Hospital Leaders Make Pledge on Worker Safety
On May 4^th, the CEO Coalition, a newly founded group of CEOs from ten major hospital systems across the nation, shared a signed declaration expressing a commitment to “a renewed and expanded definition of safety” for the health care workforce. The Declaration of Principles includes safeguarding psychological and emotional safety, promoting health justice, and ensuring physical safety. The Coalition’s founders include the CEOs of Cleveland Clinic, Hackensacks Meridian Health, HealthPartners, Henry Ford Health System, Intermountain Healthcare, Mass General Brigham, Providence, SSM Health, UCLA Hospital System, and Zuckerberg San Francisco General.

More information is available on the Coalition’s website here.

Leapfrog Group Releases New Hospital Safety Scores
On April 29^th, the Leapfrog Group released the spring 2021 Leapfrog Hospital Safety Grades, a consumer-focused hospital quality rating system that combines up to 27 national performance measures. Of 2,700 hospitals graded, 33% of facilities received an “A” grade; 24% received a “B,” 35% received a “C,” 7% received a “D,” and 1% received an “F.” In New York, however, out of 149 hospitals, only 16 received an “A.” Leapfrog reported that 1% of hospitals nationally have achieved an “A” in each of the 19 biannual grading cycles since the Safety Grade launched in 2012.

The press release is available here. Leapfrog is also announcing updates to the fall 2021 Safety Grade methodology and inviting public comment through May 31^st. More information on submitting comments is available here.

Congressional Updates

Tuesday, May 11^th:

At 10am, the full Senate Health, Education, Labor, and Pensions (HELP) Committee will hold hearings to examine an update from Federal officials on efforts to combat COVID-19. More information is available here.

Wednesday, May 12^th:

At 10am, the House Science, Space, and Technology Subcommittee on Investigations and Oversight will hold a hearing entitled “COVID-19 Variants and Evolving Research Needs.” More information is available here.
At 10:30am, the House Energy and Commerce Subcommittee on Health will hold a hearing on the Fiscal Year 2022 HHS Budget. More information is available here.
At 3pm, the Senate Finance Subcommittee on Health Care will hold a hearing to examine the COVID-19 pandemic, with a focus on improving mental health and addiction services. More information is available here.

Thursday, May 13^th:

At 10am, the Appropriations Subcommittee on Labor, HHS, Education, and Related Agencies will hold a hearing entitled “Mental Health Emergencies: Building a Robust Crisis Response System.” More information is available here.

New York State Updates

Governor Cuomo Signs NY HERO Act
On May 5^th, Governor Cuomo signed the “NY HERO Act” (S1034B/A2681B), which would establish requirements for employers to implement COVID-19 infection control practices. The bill directs the New York State (NYS) Department of Labor, in consultation with the NYS Department of Health (DOH), to develop an airborne infectious disease exposure prevention standard for all work sites, differentiated by industry, and to establish minimum requirements for preventing exposure to airborne infectious diseases in the workplace. The standard will include, but not be limited to, establishing requirements on procedures and methods for:

Employee health screenings;
Face coverings;
Required personal protective equipment applicable to each industry, which shall be provided and maintained at the expense of the employer;
Accessible workplace hand hygiene stations and adequate break times for workers to use handwashing facilities as needed;
Regular cleaning and disinfecting of shared equipment and frequently touches surfaces;
Effective social distancing for employees and consumers or customers;
Compliance with mandatory or precautionary orders of isolation or quarantine that have been issued to employees;
Compliance with applicable engineering controls such as proper air flow;
Designation of one or more supervisory employees to enforce compliance with the airborne infectious disease exposure prevention plan and any other governmental guidance;
Compliance with any applicable laws, rules, regulations, standards, or guidance on notification to employees and relevant state and local agencies of potential exposure to airborne infectious disease at the work site; and
Verbal review of infectious disease standard, employer policies, and employee rights under this regulation.

The standard also includes anti-retaliation requirements preventing discrimination or retaliation against employees who exercise their rights under the prevention plan, report violations, or refuse to work in a workplace that puts them at risk of exposure to an airborne infectious disease.

All employers must adopt the standard airborne infectious disease exposure prevention plan or establish an alternative plan that equals or exceeds the minimum requirements established by the State. Employers must provide the prevention plan to employees in writing and post the plan in a visible and prominent location within the worksite. Employers must also allow employees to establish and administer a joint labor-management workplace safety committee.

The Governor’s press release is available here.

CMS Approves NYS SPA to Adjust Specialty Hospital Payments for Minimum Wage Requirements
On April 28^th, the Centers for Medicare and Medicaid Services (CMS) approved New York State’s Medicaid State Plan Amendment (SPA) to revise the reimbursement for inpatient hospital services. Effective January 1, 2017, the SPA provides additional payments to specialty, critical access, and physical medical rehabilitation hospitals to account for increases in the minimum wage. The add-on will be developed in the form of a per diem add-on reflecting total hospital-specific minimum wage costs.

The texts of the SPA and CMS approval letter are available here.

DOH Delays Transition of Adult Behavioral Health HCBS to CORE Services
On May 5^th, DOH announced that the planned transition of the current Adult Behavioral Health Home and Community Based Services (BH HCBS) to a new service array called Community Oriented Recovery and Empowerment (CORE) services will be delayed from its previously scheduled implementation date of June 1^st. With this transition, which is pending CMS approval, DOH intends to simplify the service array by consolidating and eliminating certain services and to increase utilization by removing administrative requirements that have resulted in lower-than-expected service utilization.

DOH indicated that the implementation delay is a result of the federal American Result Plan Act, which contains a one-year increase to the Federal Medical Assistance Percentage (FMAP) for HCBS services of 10 percentage points. If services were transitioned away from HCBS, NYS might be unable to utilize this opportunity on those services. NYS is still working with CMS to understand these new opportunities and the conditions imposed on the receipt of such funding.

DOH will notify relevant stakeholders, including Health and Recovery Plans (HARPs), HIV Special Needs Plans (SNPs), Health Homes, Care Management Agencies, and service providers, when the revised CORE services implementation and timeline information is available. In the meantime, all stakeholders must comply with existing Adult BH HCBS policies. Questions may be submitted to Adult-BH-HCBS@omh.ny.gov, OMH-Managed-Care@omh.ny.gov, and/or PICM@oasas.ny.gov.

Updated Guidance Documents
Recently updated or released New York State and City COVID-19 guidance documents are listed below.