Weekly Health Care Policy Update - April 16, 2021

In this update:

Biden Administration Announces Updates on Combatting COVID-19
Senate Finance Committee Holds Hearing on Nominations of Chiquita Brooks-LaSure and Andrea Palm
FDA Names Dr. Patrizia Cavazzoni as Permanent Drug Center Director
House Energy and Commerce Leaders Press HHS to Enforce Hospital Price Transparency Rule
President Biden Signs Bill Delaying Medicare Sequestration Cuts
COVID-19 Health Equity Task Force Holds Second Meeting
Medicaid and CHIP Payment and Access Commission (MACPAC) Convenes Monthly Meeting
HRSA Issues Rural Maternity and Obstetrics Funding Opportunity
ASPE Releases Report on Medicaid Churn
CMS Extends Deadline for Second Cohort of Primary Care First
FDA Pauses In-Person Dispensing Requirement for Mifepristone
Moderna Vaccine More than 90% Effective After Six Months
FAIR Health Releases January Telehealth Tracker Report
Congressional Hearings
DOH Submits 1115 Waiver Application for 30-Month Transfer of Assets Lookback for Community Based Long Term Care Services
OMH Seeks Stakeholder Input on Supplemental Block Grant and Enhanced FMAP
Mother Cabrini Foundation Announces Application Period for Statewide Grants
Updated Guidance Documents

Administrative Updates

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

On April 13^th, the Food and Drug Administration (FDA) recommended an immediate halt to the use of Johnson & Johnson’s COVID-19 vaccine following six reported cases of cerebral venous sinus thrombosis (CVST).
- All cases occurred in women between the ages of 18 and 48, within 6 to 13 days after vaccination. One case has been fatal and three women remain hospitalized. An official at the Centers for Disease Control and Prevention (CDC) said the cases appeared to be three times greater in the J&J vaccine group than among women aged 20 to 50 years with similar backgrounds. More than 6.8 million doses of the vaccine were administered before the pause.
- On April 14^th, the CDC convened a meeting of the Advisory Committee on Immunization Practices to review the cases. The panel postponed a decision on the vaccine.
- Jeff Zients, the White House COVID-19 Response Coordinator, has stated that the Administration does not believe the pause will have a significant impact on the vaccination program, since Pfizer and Moderna vaccine capacity is sufficient to meet the current timeline of having enough doses to vaccinate the adult population by the end of May.
The Administration is deploying $1.7 billion from the American Rescue Plan (ARP) to combat COVID-19 variants through genomic research and bioinformatics (announced here). This specifically includes:
- $1 billion for the CDC and state and local jurisdictional health departments to conduct, expand, and improve SARS-CoV-2 sequencing activities. This includes $240 million invested in May and the remainder spread out over the next several years. Of this amount, New York State will receive about $7 million, and New York City will receive about $5.5 million.
- $400 million for innovation initiatives, including the launch of six Centers for Excellence in Genomic Epidemiology, operating as partnerships between state health departments and academic institutions.
- $300 million for a National Bioinformatics Infrastructure, including training to increase sequencing in clinical settings.
The Administration is releasing $39 billion of funds from the ARP to the states to support child care needs, including $24 billion for stabilizing child care providers (about $1.8 billion for New York) and $15 billion of flexible funding (about $700 million for New York). The Administration will also release further guidance on the deployment of these funds shortly. More details are available here.
The Department of the Treasury has established the new Office of Recovery Programs, to be led by Jacob Leibenluft, to administer COVID-19 recovery programs including $420 billion from the ARP. This includes the $350 billion State and Local Fiscal Recovery Fund and $10 billion Capital Projects Fund, from which New York will be eligible to receive about $23 billion across all levels of government. The press release is available here.

Senate Finance Committee Holds Hearing on Nominations of Chiquita Brooks-LaSure and Andrea Palm
On April 15^th, the Senate Finance Committee held a hearing on the nominations of Chiquita Brooks- LaSure to lead the Centers for Medicare and Medicaid Services (CMS) and Andrea Palm to serve as Deputy Secretary of the Department of Health and Human Services (HHS). All Democrats, but only six Republicans, attended the hearing, with many members focusing their questions on telehealth and drug pricing. Chairman Wyden is yet to schedule a vote on either nominee.

FDA Names Dr. Patrizia Cavazzoni as Permanent Drug Center Director
On April 12^th, acting FDA commissioner Janet Woodcock announced that Dr. Patrizia Cavazzoni will succeed her as permanent director of the FDA’s Center for Drug Evaluation and Research (CDER). Cavazzoni has been leading the drug center in an acting role since last spring, when Woodcock left her post to help with Operation Warp Speed. It remains unclear whether Woodcock will become the next permanent commissioner, as media reports have stated that President Biden may be continuing to consider additional candidates.

More info on Dr. Cavazzoni is available on the FDA website here.

Legislative Updates

House Energy and Commerce Leaders Press HHS to Enforce Hospital Price Transparency Rule
On April 13^th, Energy and Commerce Committee Chair Frank Pallone (D-NJ) and Ranking Member Cathy McMorris Rogers (R-WA) co-authored a letter to HHS Secretary Xavier Becerra expressing their concern about non-compliance with the Hospital Price Transparency Final Rule. The Trump-era regulation, which went into effect on January 1^st, requires hospitals to provide clear, accessible pricing information online about the items and services they provide. A recent Health Affairs report (available here) found 65 of the nation’s 100 largest hospitals were “unambiguously non-compliant” as of early February 2021.

The letter follows new technical guidance posted by CMS on March 23^rd regarding the Transparency in Coverage final rule (available here), which states that all files must be published in formats “available to the public without restrictions that would impede the re-use of that information.” The guideline appears to be in response to news reports of providers blocking pricing information from appearing in web searches.

The Energy and Commerce press release is available here.

President Biden Signs Bill Delaying Medicare Sequestration Cuts
On April 15^th, President Biden signed H.R. 1868, a bill which delays a 2% across-the-board cut to Medicare payments (the Medicare “sequester”) for the remainder of 2021. The sequester cuts originally took effect in 2013 but have been paused during the pandemic. The pause was scheduled to end this month. An earlier version of the bill also addressed a series of automatic spending cuts that are set to go into effect across the board as a result of increased deficit spending from the ARP, but the Senate removed that provision.

Regulatory Updates

COVID-19 Health Equity Task Force Holds Second Meeting
On April 9^th, the COVID-19 Health Equity Task Force held its second meeting, focused on vaccine access and confidence. During the meeting, Task Force members heard three presentations on the following topics:

Equity in COVID-19 Vaccinations: Understanding and Addressing Gaps
Achieving Health Equity for Asian American and Native Hawaiian and Pacific Islander Communities
Equitable Vaccine Access for People with Disabilities

A full list of the Task Force’s recommendations from the meeting, as well as a recording of the meeting, can be found here. The next meeting is tentatively scheduled for April 30^th.

Medicaid and CHIP Payment and Access Commission (MACPAC) Convenes Monthly Meeting
On April 8^th and 9^th, the Medicaid and CHIP Payment and Access Commission (MACPAC) convened for its monthly public meeting. Among the highlights of the meeting was the Commission’s 16 to 1 vote to approve recommendations to increase rebates on drugs approved by the FDA through the accelerated approval program. MACPAC believes the changes will lower Medicaid spending on high-cost specialty drugs. MACPAC also unanimously approved a set of recommendations pertaining to mental health care for children and adults, including that CMS and the Substance Abuse and Mental Health Services Administration (SAMHSA) should issue:

Guidance for funding a crisis continuum for adults experiencing behavioral health crises;
Education and technical assistance for states to put an adult behavioral health care continuum into practice; and
Guidance for addressing the structure and implementation of Medicaid and CHIP benefits for children with mental health conditions.

More information, including the transcript of the meeting is available on the MACPAC website here.

HRSA Issues Rural Maternity and Obstetrics Funding Opportunity
On April 12^th, the Health Resources and Services Administration’s (HRSA) Federal Office of Rural Health Policy released a Notice of Funding Opportunity (NOFO) for the Rural Maternity and Obstetrics Management Strategies (RMOMS) program. Three award recipients will each receive up to $1 million per year for four years to improve maternal obstetrics care in rural communities in a certain region. Award recipients will dedicate the first year to planning and the remaining years to activities that implement the program’s focus areas:

Risk appropriate care approaches in rural regions;
Coordinating the continuum of care through network approaches;
Telehealth and specialty care; and
Financial sustainability.

More information is available here. Applications are due June 4^th.

ASPE Releases Report on Medicaid Churn
On April 12^th, the HHS Office of the Assistant Secretary for Planning and Evaluation (ASPE) published an issue brief reviewing evidence on Medicaid churn, including policy options for states and the federal government to reduce churn in the Medicaid program. The brief details options including continuous eligibility, Medicaid expansion for adults, express-lane eligibility, presumptive eligibility, multimarket plans, and limiting premiums and cost sharing.

The brief is available here.

CMS Extends Deadline for Second Cohort of Primary Care First
The CMS Innovation Center (CMMI) has extended the deadline for the second cohort of the Primary Care First (PCF) model. Practice applicants now have until May 21^st to apply, while payer applicants have until June 18^th. CMS also announced two additional Office Hours events for potential practice and payer applicants to ask questions ahead of the deadline:

Wednesday, May 5^th at 2pm (registration here)
Wednesday May 12^th at 2pm (registration here)

FDA Pauses In-Person Dispensing Requirement for Mifepristone
On April 13^th, the FDA announced that it would pause enforcement of a rule requiring in-person dispensing of Mifepristone. The drug is approved for use to end pregnancy through 70 days gestation. Citing the potential risk of COVID-19 exposure to patients and providers, the FDA will now allow the drug to be mailed to patients by certified prescribers. The American College of Obstetricians and Gynecologists (ACOG) has long argued that the in-person dispensing requirement is unnecessary.

Other Updates

Moderna Vaccine More than 90% Effective After Six Months
On April 13^th, Moderna issued a press release announcing that its COVID-19 vaccine is still more than 90% effective against infection, and more than 95% effective against severe disease, for six months after a person receives their second dose. The study included cases through April 9^th, with data from 900 coronavirus cases, including over 100 severe cases. Moderna also announced that it has fully enrolled its trial in adolescents ages 12 to 17, with about 3,000 participants in the U.S. A trial testing the vaccine in children six months to 11 years old is currently enrolling participants.

The press release is available here.

FAIR Health Releases January Telehealth Tracker Report
On April 6^th, FAIR Health, a national not-for-profit organization focused on health care cost data, released results of its Monthly Telehealth Regional Tracker from January 2021. Overall, between December 2020 and January 2021, telehealth claim lines increased 7.69 percent nationally. Although down from the peak of 13 percent of all claim lines nationally in April 2020, telehealth claims remain about 30 times more common than they were pre-pandemic, at 7 percent of all claim lines.

In January 2021, mental health diagnoses represented a majority of all claims for the first time, at 51.3%. The most common specific diagnosis was Generalized Anxiety Disorder as the most common specific diagnosis nationally, and the most common telehealth procedure was 60-minute psychotherapy (CPT 90837), the first time that procedure has ranked in the top position since FAIR Health began releasing the tracker in January 2020.

The Telehealth Tracker is available here.

Congressional Hearings

Tuesday, April 20^th:

At 10am, the Senate Health, Education, Labor, and Pensions (HELP) Committee will hold a hearing on COVID-19 recovery, focusing on supporting workers and modernizing the workforce through quality education, training, and employment opportunities. More information is available here.

Wednesday, April 21^st:

At 10am, the Senate Judiciary Subcommittee on Criminal Justice and Counterterrorism will hold a hearing to examine behavioral health and policing, focusing on interactions and solutions. More information is available here.

New York State Updates

DOH Submits 1115 Waiver Application for 30-Month Transfer of Assets Lookback for Community Based Long Term Care Services
On March 25^th, the New York State Department of Health (DOH) submitted an application to CMS for 1115 Waiver authority to implement a 30-month transfer of assets lookback period for coverage of community based long term care (CBLTC) services, and to exclude certain enrollees from these rules.

The State seeks approval to impose a lookback period of 30 months for non-institutionalized individuals seeking coverage of CBLTC services on or after January 1, 2022. Previously, New York had no such lookback, but if it did, without a waiver, federal statute would require the period to be 60 months. This change will only apply to individuals newly seeking CBLTC services through Medicaid fee-for-service or through Managed Long Term Care (MLTC) plans, and would exclude individuals seeking CBLTC services through mainstream managed care or a Medicaid Advantage plan.

State statute makes these rules effective October 1, 2020. Therefore, the State proposes to initially limit lookbacks to that date. As such, any applications from January 1, 2022 to April 2023 would only be assessed for transfers occurring on or after October 1, 2020 (a 15-month period). Afterwards, the State would review for asset transfers on a rolling 30-month period.

The State’s application is available here. CMS’s letter of acknowledgement and preliminary review of the request is available here. CMS will be accepting public comments on the application through May 9^th. Comments may be submitted here.

OMH Seeks Stakeholder Input on Supplemental Block Grant and Enhanced FMAP
This week, the New York State Office of Mental Health (OMH) announced that it seeks to identify opportunities for the use of the following supplemental funding provided by recent federal legislation:

Funding for the Community Mental Health Services (CMHS) Block Grant;
Enhanced Federal Medical Assistance Percentage (FMAP) of 10 percent for Home and Community Based Services (HCBS).

For the CMHS Block Grant, supplemental funding must be used in accordance with standard CMHS program requirements; however, states may request waivers. SAMHSA has indicated that funding should be used to address unmet need and capacity growth with an emphasis on crisis services. New York has received initial supplemental funding of $46 million, to be used between March 15, 2021 and March 2023. Also, the ARP allocates $1.5 billion to states for further expansion of CMHS Block Grant awards. The allocation for these funds, which must be expended by September 30, 2025, has not yet been established.

The 10 percent increased FMAP for HCBS is available for spending during New York’s fiscal year (FY) 2022 (i.e., April 1, 2021 through March 31, 2022). In the FY 2022 budget, OMH was allocated $160 million representing these funds. Since CMS has not yet published directives on how these funds may be distributed to Medicaid mental health services, OMH will provide more guidance as it becomes available.

OMH will be hosting public feedback sessions to receive input from service recipients, health care providers, and members of the public on the use of these funds. Regional feedback sessions have been scheduled for the following dates:

Hudson River Region, April 19, 2021, 2pm – 4pm (registration here)
Long Island Region, April 20, 2021, 12pm – 2pm (registration here)
New York City, April 26, 2021, 9am – 11am (registration here)
Western New York Region, April 29, 2021, 2pm – 4pm (registration here)
Central New York Region, April 30, 2021, 12pm – 2pm (registration here)

Stakeholders are invited to attend any session that meets their availability. Stakeholders are also invited to submit written feedback on CMHS or FMAP opportunities using the contact form here. Additional information is available here.

Mother Cabrini Foundation Announces Application Period for Statewide Grants
On April 15^th, the Mother Cabrini Foundation announced that the online grants portal for its Statewide Grants Program will open on April 29^th and will accept Letters of Inquiry through June 4^th. Through this program, the Foundation annually provides awards to support not-for-profit organizations that sponsor activities, programs, and initiatives to enhance access to affordable, high-quality health care and related services. The Foundation focuses on funding programs that provide services to the following communities:

Young children, pregnant women, and new mothers;
Low-income individuals and families;
Youth and young adults;
Older adults;
Persons with special needs;
Immigrants and migrant workers;
Veterans; and
Formerly incarcerated individuals.

Last year, the Foundation awarded $115 million in grants through its Statewide Grants Program to organizations serving vulnerable populations in New York State. A list of awardees is available here.

The Foundation will host a webinar on May 4^th from 3pm to 4pm to review the Statewide Grants program and application process. Registration is available here. The application process has not changed from prior years.

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

This Week’s SPG Updates

Please find below links to updated SPG resource documents and grant opportunity summaries.