State Updates
Governor Cuomo Issues Executive Order 202.82 on Vaccination Processes
On December 13th, Governor Cuomo signed Executive Order (EO) 202.82 (available here), which authorizes the use of new/temporary vaccination sites for administering the COVID-19 and influenza vaccines. At these Points of Dispensing (PODs) and other vaccination sites, which will be approved and overseen by the State Department of Health (DOH), a broad array of individuals will be authorized to administer vaccines (with training and supervision), including those who are either:
- Not currently authorized to administer vaccinations, but who are appropriately licensed or certified health professionals, including midwives, dentists, certain dental hygienists, podiatrists, emergency medical technicians, advanced emergency medical technicians, and certain newly licensed pharmacists; or
- Enrolled in one of the following educational or training programs and evaluated and trained to administer vaccinations:
- A medical program;
- A registered professional nursing program or licensed practical nursing program;
- A physician assistant program;
- A pharmacy program (pharmacy students who have obtained a limited permit, including a certificate to administer immunizations, are deemed to have the minimum necessary clinical experience to administer COVID-19 and influenza vaccinations);
- A dentistry program;
- A podiatric medicine program; or
- A midwifery program.
This scope of practice expansion will be temporary and restricted exclusively to the circumstances of the COVID-19 pandemic. The Order also includes the following directives related to vaccine administration, supply chain, and coverage requirements:
Vaccine Ordering and Administration
- Allows non-nursing staff who have completed appropriate training to:
- collect throat, nasal, or nasopharyngeal swab specimens to test for COVID-19 or influenza;
- collect blood specimens for the diagnosis of acute or past COVID-19 disease;
- administer approved vaccinations for influenza or COVID-19, and
- perform tasks, under the supervision of a nurse, that would be otherwise limited to a licensed or registered nurse, in order to provide care for individuals diagnosed or suspected of suffering from a COVID-19 or influenza infection.
- Allows licensed physicians and certified nurse practitioners to issue a non-patient specific regimen to nurses, physician assistants, special assistants, pharmacists, or other individuals authorized by this EO to complete the above tasks.
- Permits registered professional nurses to prescribe, order, and execute non-patient specific regimens for the administration of the COVID-19 vaccine.
- Allows licensed practical nurses, following appropriate training and certification, to prescribe, order, and execute COVID-19 and influenza vaccinations at PODs under supervision and following appropriate training and certification.
- Permits licensed pharmacists to administer COVID-19 vaccines less than 90 days after approval of the vaccine by the Food and Drug Administration (FDA).
- Allows patient specific orders or non-patient specific regimens for COVID-19 or influenza vaccination administration to be prescribed, ordered to, and executed by licensed pharmacists certified to administer immunizations and newly licensed pharmacists that received a limited permit with certification to administer immunizations under certain conditions.
- Allows licensed pharmacists not certified to administer immunizations to administer COVID-19 and influenza vaccinations at PODs under supervision following appropriate training and certification.
- Permits licensed physicians and certified nurse practitioners located within any county to issue a patient specific prescription or a non-patient specific regimen for COVID-19 and influenza vaccination to licensed pharmacists certified to administer vaccines or to newly licensed pharmacists as authorized by this EO unless administering COVID-19 or influenza vaccinations at a POD.
- Permits a physician assistant to provide medical services appropriate to their education, training, and experience without oversight from a supervising physician, including administering COVID-19 and influenza vaccines and medically supervising PODs or other vaccination sites without civil or criminal penalty related to a lack of oversight.
- Permits a nurse practitioner to provide medical services appropriate to their education, training, and experience, without a written practice agreement or collaborative relationship with a physician, including administering COVID-19 and influenza vaccines and medically supervising PODs or other vaccination sites without civil or criminal penalty.
Reporting Requirements
- Allows licensed pharmacists and registered professional nurses to administer influenza and COVID-19 vaccinations without reporting such administrations to patients’ attending physicians (but are still required report the vaccination to the City or State).
- Removes the requirement for registered professional nurses, licensed pharmacists, and other professionals to ensure that a record is maintained and retained for those to whom they administer influenza and COVID-19 vaccinations, provided that they comply with all DOH recordkeeping requirements.
- Suspends the requirement that individuals 19 years of age and older must consent to have their immunization information reported to the New York State Immunization Information Registry (NYSIIS) or the City Immunization Registry (CIR), so that adult immunization information may be included in NYSIIS or the CIR, as applicable, without such consent.
- Requires all influenza and COVID-19 vaccinations for any individual (child or adult) to be reported to the NYSIIS or CIR, as applicable, within 24 hours of administration of such vaccine.
Laboratories
- Upon approval from DOH, allows laboratories holding a Clinical Laboratory Improvement Acts (CLIA) certificate in the relevant specialty of testing and meeting the CLIA quality standards to perform testing for the detection of influenza virus, respiratory syncytial virus RNA, or other respiratory panels in specimens collected from individuals suspected of suffering from a COVID-19 infection, including postmortem specimens.
- Requires all clinical laboratories having more than 25 employees to become qualified entity participants and connect to the Statewide Health Information Network (SHIN-NY) through a qualified entity and allow private and secure bi-directional access to patient information by other qualified entity participants within 60 days of this EO.
- Modifies the qualification requirements of medical or clinical laboratory technologists to allow additional individuals to perform any clinical laboratory test on any specimen, provided such individual is under appropriate supervision and meets the federal requirements for testing personnel appropriate to the assay or device authorized by the FDA or DOH.
Other
- Includes temporary vaccination sites in the provision of EO 202.1 that allowed construction applications for temporary hospital locations and extensions to be approved by the Commissioner of Health without considering the recommendation of the health systems agency or the Public Health and Health Planning Council.
- Permits an authorized vaccine provider within New York State to furnish federal COVID-19 vaccine and ancillary supplies (obtained as a result of enrollment in the Centers for Disease Control (CDC) COVID-19 Vaccination Program) to another authorized vaccine provider within New York State who has also enrolled in the CDC COVID-19 Vaccination Program for the purposes of administering such vaccination at no cost in accordance with storage/handling requirements and other CDC and DOH guidance.
- Requires any licensed physician, licensed physician assistant, and certified nurse practitioner who is medically supervising PODs or other vaccination sites to have a current certification in cardiopulmonary resuscitation (CPR).
- Allows licensed pharmacists to order tests for the detection of influenza virus or respiratory syncytial virus RNA in specimens collected from individuals suspected of suffering from or having recovered from a COVID-19 or influenza infection, and to administer such tests upon completion of appropriate DOH training.
- Applies sections 3216(i)(17)(E), 3221(l)(8)(E) and (F), and 4303(j)(3) of the Insurance Law to “grandfathered health plans” with regards to COVID-19 immunization coverage.
Governor Cuomo Issues Executive Order 202.81 Extending COVID-19 Emergency Provisions
On December 11th, Governor Cuomo signed Executive Order 202.81 (available here), which extends the following provisions through January 10th:
- Authorizes the Commissioner of Health to suspend or revoke the operating certificate of any skilled nursing facility or adult care facility if that facility has not complied with regulations or directives from DOH.
- Authorizes licensed pharmacists to order tests to detect SARS-CoV-2 or its antibodies, and to administer COVID-19 tests after completion of appropriate DOH training.
- Permits licensed pharmacists to be designated as a qualified health care professional for the purpose of directing a clinical service laboratory to test patients for COVID-19 or its antibodies.
- Allows physicians to order COVID-19 tests for self-collection, without otherwise having an initial physician-patient relationship with the patient.
- Allows clinical laboratories to accept and examine specimens for COVID-19 testing from personnel of nursing homes and adult care facilities without a prescription or order from an authorized ordering source, and to report the results of such tests to the appropriate operators and administrators of the nursing home or adult care facility.
The Order also extends a provision stipulating that an employee may not be entitled to legally required paid benefits if they voluntarily travel to a state or country with significant community spread of COVID-19.
Additionally, the Order modifies a provision contained in Executive Order 202.79 (available here) regarding balancing patient load in hospitals to allow an Article 28 general hospital to discharge a patient who has not obtained a negative COVID-19 test result if the patient is beyond the infectious period of time in accordance with CDC policy. Such patients may only be discharged to a COVID-19 positive-only facility that certifies it is able to properly care for the patient.
Effective December 14th, the Order suspends indoor dining in New York City and allows gyms and fitness centers/classes located in “orange zones” to continue to operate at 25 percent capacity. Personal care services located in “orange zones” will be allowed to open under strict guidelines, including required weekly COVID-19 testing for employees.
Governor Cuomo Announces Updated Micro-Cluster Zone Metrics and Hospital Directives
On December 14th, Governor Cuomo held a press conference during which the first official COVID-19 vaccination was administered, following the FDA’s December 11th issuance of an Emergency Use Authorization (EUA) to Pfizer for its COVID-19 vaccine. At the Governor’s previous press conference on December 11th, he announced the following updated zone metrics as part of the State’s micro-cluster strategy to address COVID-19:
- “Red Zone” designation will be implemented in a region where hospital capacity is within 21 days of reaching 90 percent, even after the cancellation of elective procedures and a 50 percent increase in bed capacity in hospitals in the region.
- “Orange Zone” designation will be implemented if a region has a 4 percent positivity rate (7-day average) over the last 10 days and the region has reached 85 percent hospital capacity. A region may also receive an Orange Zone designation if DOH determines the region’s rate of hospital admissions is unacceptably high and the zone designation is appropriate to control the rate of growth.
- “Yellow Zone” designation will be implemented if a region has 1) a 3 percent positive rate (7-day average) over the past 10 days, 2) is in the top 10 percent in New York State for hospital admissions per capita over the past week, and 3) is experiencing week-over-week growth in daily admissions.
The State also issued a directive for hospitals to take the following steps to remain below 85 percent capacity:
- Adding an additional 25 percent bed capacity (on top of the 25 percent ordered by the State last week);
- Eliminating elective surgeries; or
- A combination of adding bed capacity and eliminating elective surgeries.
The Governor’s press release is available here.
Updated Guidance Documents
The following New York State guidance document has been updated:
Federal Updates
HHS Updates PRF General Information FAQs
The Department of Health & Human Services (HHS) continues to update the Provider Relief Fund (PRF) General Information FAQs. Notable updates include the following:
- The minimum amount for the PRF to issue payments is $100.
- The PRF will refund returned payments that are determined to be $500 or more in excess of a required returned amount.
- If a provider returns a PRF payment to HHS, they are also required to return any accrued interest on the payment.
- A parent organization that received a PRF Targeted Distribution on behalf of a subsidiary in which it is has a direct ownership relationship is required to remit the payment to the subsidiary.
- Expenses related to securing and maintaining adequate personnel (e.g., hiring bonuses and retention payments, childcare, transportation, and temporary housing) are reimbursable under the PRF.
- Outsourced or third-party vendor services that enable sustained access to health care services and daily operations are considered reimbursable expenses if they are attributable to the COVID-19 public health emergency.
- Providers can use PRF payments to pay the taxes on income from the PRF.
- Providers who use accrual or cash basis accounting may report the relevant depreciation amount based on the equipment useful life, purchase price and depreciation methodology otherwise applied.
- Provider Relief Fund payments may be used to support expenses associated with distribution of a COVID-19 vaccine licensed or approved by the FDA, but only if such costs have not been reimbursed from other sources or that other sources are not obligated to reimburse.
The PRF General Information FAQs are available here.