Plugged In To Covid-19

April 30, 2021

Coverage of State Actions Surrounding COVID-19

Since the emergence of SARS-CoV-2, the virus that causes coronavirus disease in late 2019, the state has been required to implement mitigation strategies, as well as provide resources for communities and institutions. To help keep clients informed and up to date on the pandemic, the Team at Hinman Straub has released Plugged In To COVID-19; a daily newsletter providing coverage of NY state actions.

What’s Inside Plugged In To COVID-19

Governor’s Briefings and Announcements
Legislature Repeals Portions of Executive Orders
CDC and CMS Guidance Updates
FDA Revokes EUA for Antibody Therapy – Bamlanivimab
HHS Announces $1 B from ARP for Projects at Health Centers
NY State Guidance on COVID-19
Updated Links and Resources

Governor’s Briefings and Announcements on COVID-19

During the Governor’s most recent presentation held at the State’s mass vaccination site in Johnson City, he provided an update on statewide COVID-19 data and activity as of 4/26/2021. The overall statewide positivity rate is 1.8%. Statewide hospitalizations are 2,900 which is down 183 from the week prior, the lowest since November 24, 2020, with 691 ICU admissions associated with COVID-19, of which 425 are intubated. The Governor also confirmed that, on the previous day, 38 New Yorkers have passed away as a result of COVID-19.

Vaccinations – All state mass vaccination sites are now open to all eligible New Yorkers for walk-in vaccinations on a first come first serve basis. Walk-in appointments are reserved for first doses only, and these sites should automatically schedule the recipient’s second dose appointment. The Governor is encouraging all vaccine providers, including local health department run sites, to also allow walk-in appointments for eligible residents if possible.

Joined by NYS Assembly Majority Leader Crystal Peoples-Stokes, Mayor of Buffalo, Byron Brown, and SUNY Trustee Eunice Lewin, the Governor announced that a new pop-up vaccination site will be open tomorrow and Saturday at The Greater Buffalo United Accountable Healthcare Network (GBUAHN), and the Niagara Falls Transportation Authority (NFTA) will provided 1,000 free bus vouchers to provide transportation to the vaccination site.

The State Department of Health (DOH) data shows that over 15.17 million doses of the COVID-19 vaccine have been administered, roughly 33.4% of New York residents are fully vaccinated, and 45.6% of residents have received at least one dose. The State is now focusing on the ground efforts to vaccinate younger individuals (ages 16-25) and individuals who are skeptical of getting the COVID-19 vaccine.

New York State has adopted the Centers for Disease Control and Prevention (CDC) recommendations that fully vaccinated individuals may participate in outdoor activities and recreation without a mask, with certain exceptions for crowded settings and venues. According to the Governor’s press release:

“[T]this modification will be noticed to the legislature but will take effect immediately using the exigency provisions of Ch. 71 of the laws of 2021, enacted earlier this year.”

Reopening Measures – The Governor’s Office issued a press release announcing that the 12 a.m. food and beverage service curfew will be lifted for outdoor dining areas beginning May 17^th and for indoor dining areas beginning May 31^st. Also beginning on May 3^rd, professionally catered events may resume at residences in accordance with DOH guidance, in addition to seating at NYC bars. Lastly, starting May 15^th, increased capacity limits are permitted within the following business settings:

Gyms and fitness centers outside of NYC – (increase from 33% to 50%);
Casinos and gaming facilities – (increase from 25% to 50%); and
Offices – (increase from 50% to 75%).

Legislature Repeals Portions of Executive Orders

The State Legislature has passed Concurrent Resolutions to repeal certain provisions of the series of Executive Orders (“EO”) issued by the Governor over the period of the COVID-19 pandemic. The following portions of EOs have been repealed, effective April 28, 2021.

C00214 – Portions of Executive Order 202.6 and 202.7, which applies to the Public Officer’s Law and relates to individuals hired or brought in as volunteers to assist with state work during a declared emergency;
C00215 – Portions of Executive Orders 202.86, 202.88 and 202.89, which relate to vaccine administration and penalties for improper administration; and
C00216 – Executive Order 202.52, which requires food to be sold if an individual orders an alcoholic beverage at a state liquor authority licensed establishment.

CDC and CMS Guidance Updates

CDC – The CDC has provided updated COVID-19 guidance and recommendations for “fully vaccinated” individuals, including the following.

International Travel During COVID-19 – With respect to international travel, the CDC now includes consideration of a COVID-19 vaccine authorized for emergency use by the World Health Organization (WHO) within the definition of a fully vaccinated individual.

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Resume Use of J&J Vaccine – On April 23^rd, the CDC and the FDA recommended that the use of Johnson & Johnson’s (J&J’s) COVID-19 Vaccine resume in the U.S., after a temporary pause and a thorough review of data.

According to the CDC, the Advisory Committee on Immunization Practices (ACIP) has concluded that the benefits of resuming the use of J&J’s COVID-19 vaccine for persons aged ≥18 years outweighed the risks and reaffirmed its interim recommendation to approve J&J’s emergency use authorization (EAU), with the addition of new warnings for rare clotting events among women aged 18–49 years.

On Saturday April 24^th, Governor Cuomo and State Health Commissioner, Dr. Howard Zucker announced that NY will resume the use of the J&J Covid-19 Vaccine, effective immediately.

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Interim Public Health Recommendations for Fully Vaccinated People – The April 29^th update to recommendations for fully vaccinated individuals include guiding principles for the following areas.

Fully vaccinated people no longer need to wear a mask outdoors, except in certain crowded settings and venues.
Clarification that fully vaccinated workers no longer need to be restricted from work following an exposure as long as they are asymptomatic.
Fully vaccinated residents of non-healthcare congregate settings no longer need to quarantine following a known exposure.
Fully vaccinated asymptomatic people without an exposure may be exempted from routine screening testing, if feasible.
Underscore that immunocompromised people, need to consult their healthcare provider about these recommendations, even if fully vaccinated.

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Updated Healthcare Infection Prevention and Control Recommendations in Response to COVID-19 Vaccination – The CDC’s summary of changes to this guidance include the following.

Updates to SARS-CoV-2 testing recommendations.
Updates to visitation guidance to include recommendations for acute care facilities and to describe circumstances when source control and physical distancing are not required during visitation.
Additional guidance for communal activities and dining in healthcare settings.

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CMS – The Centers for Medicare & Medicaid Services (CMS) has also provided the following revised guidance in accordance with the CDC’s updated recommendations.

Nursing Home Visitation – Revisions include changes to communal dining activities and the relaxation of the use of face coverings when outdoors, as well as reference to the updated infection prevention and control recommendations above.

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Interim Final Rule – Long-Term Care (LTC) Facility Testing Requirements and Revised COVID19 Focused Survey Tool – Revisions includes changes that define “fully vaccinated” and “unvaccinated” individuals and that changes to COVID-19 testing in LTC facilities with respect to LTC facility staff or residents who have been fully vaccinated or those who are unvaccinated.

FDA Revokes EUA for Antibody Therapy – Bamlanivimab

On April 16, 2021, the U.S. Food and Drug Administration (FDA) announced the revocation of the Emergency Use Authorization (EUA) for emergency use of bamlanivimab for the treatment of mild to moderate COVID-19 in adults and pediatric patients who are at high risk of severe illness and/or hospitalization. The FDA has conducted an ongoing analysis of emerging new data and additional new information, and has determined that – “the known and potential benefits of bamlanivimab, when administered alone, no longer outweigh the known and potential risks for its authorized use.”

For a summary of new data and new information on this EUA can be found here, along with a series of frequently asked questions (FAQs).

HHS Announces $1 Billion from ARP for Projects at Health Centers

The U.S. Department of Health and Human Services (HHS) announced the availability of $1 billion for Health Resources and Services Administration (HRSA)-Health Center Program funded health centers to support major construction and renovation projects across the country.

The funding provided under the American Rescue Plan (ARP), is available to eligible applicants for COVID-19 related capital needs and construction of new facilities, renovation and expansion of existing facilities, along with purchase of new equipment to enhance, and expand health care infrastructure. For more information on eligibility and application submissions, click here.

NY State Guidance on COVID-19

Department of Health (DOH):

Update to NYS COVID-19 Vaccine Program Guidance – This updated guidance reflects most recent changes in Executive Order No. 202.102 which eliminates the enhanced civil penalty for failure of a provider to administer its allocated COVID-19 vaccine within seven days, and requires that providers must attempt to use all vaccine doses within seven days.

This update also makes technical changes respective to the previous expansions in vaccine eligibility permitting all New Yorkers age 16 and older as eligible to be vaccinated.

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Revised Protocols for Healthcare Personnel (HCP) to Return to Work Following COVID-19 Exposure – The DOH recently issued updated guidance regarding return to work protocols for HCPs to return to work after COVID-19 exposure which supersedes the previously issued April 1, 2021 Return to Work guidance for Healthcare Personnel.

The updated guidance includes technical changes allowing facilities to choose to implement furlough for asymptomatic recovered HCP if certain concerns exist, and updates reference to NYS travel advisory guidance.

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Weekly update to Healthcare Providers – The DOH has posted the slide presentation from the April 15, 2021 – Weekly Update to Healthcare Providers on COVID-19. A recording of this meeting is also available here.

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Medicaid Billing Guidance for COVID-19 Testing, Specimen Collection and Monoclonal Antibody Infusions – The DOH has issued updated guidance regarding Medicaid billing for COVID-19 testing, specimen collection and monoclonal antibody transfusion. To include fee updates and updated effective dates.