By Craig Johnson

Good afternoon,

Monday morning, Governor Cuomo’s office posted Executive Order 202.82, his eighty-fifth Executive Order during the COVID-19 state of emergency.  Executive Order 202.82, dated December 13, 2020, is designed to make it easier for health care professionals and others to distribute and administer COVID-19 immunizations throughout New York State.  To that end, Executive Order 202.82 issues several modifications or suspensions of certain statutes, laws and previously released directives, as well as issue new directives, all of which are designed to aid in the effort to ensure that New Yorkers are expeditiously receiving the COVID-19 vaccine.  Executive Order 202.82 is effective from December 13, 2020 through January 12, 2021.  A copy of Executive Order 202.82 can be found here.

NEW DIRECTIVES

Executive Order 202.82 issues new directives in an effort to make it easier for New Yorkers to receive a COVID-19 vaccine as well as a standard flu shot.  To that end, pursuant to Executive Order 202.82:

  • Individuals enrolled in the following educational programs may administer vaccinations against influenza and COVID-19 pursuant to a non-patient specific order at Points of Dispensing (POD) sites overseen or approved by the New York State Department of Health (State Health Department) or local health departments and operated under the medical supervision of licensed physicians, licensed physician assistants, or certified  nurse practitioners:
    • A medical program approved and/or registered the State Education Department;
    • A registered professional nursing program or licensed practical nursing program approved and/or registered by the State Education Department;
    • A physician assistant program approved and/or registered by the State Education Department;
    • A pharmacy program approved and/or registered by the State Education Department;
      • For the purposes of Executive Order 202.82, pharmacy students who have obtained a limited permit, including a certificate to administer immunizations, pursuant to section 6806 of the Education Law and section 63.4 of Title 8 of the NYCRR shall be deemed to have the minimum necessary clinical experience to administer COVID-19 and influenza vaccinations in a POD setting, provided such students meet all other training requirements and adhere to all applicable guidance set forth in Executive Order 202.82;
    • A dentistry program approved and/or registered by the State Education Department;
    • A podiatric medicine program approved and/or registered by the State Education Department; and
    • A midwifery program approved and/or registered by the State Education Department.
  • Executive Order 202.82 directs that these students must have completed at least one year of clinical experience (unless otherwise specified in Executive Order 202.82) and first receive training in the following areas, as determined by and in accordance with guidance issued by the Health Commissioner after consultation with the State Education Commissioner:
    • (1) techniques, indications, precautions, contraindications, infection control practices;
    • (2) use of personal protective equipment sufficient to provide the basic level of competence for such tasks;
    • (3) a current certificate in basic cardiopulmonary resuscitation (CPR), which at a minimum must include a certification in basic cardiopulmonary resuscitation by an online program that has received accreditation from the American Nurses Credentialing Center (ANCC), the Accreditation Council for Pharmacy Education (ACPE), or the Accreditation Council for Continuing Medical Education (ACPE); and
    • (4) subject to any other conditions as specified by the Health Commissioner in consultation with the Education Commissioner, including but not limited to requiring the applicable educational institutions and programs in which students are enrolled to assess such students’ vaccine administration skills and issue an attestation on a form to be approved by the Health and Education Commissioners that such students have completed all required trainings and displayed competence in vaccine administration.
  • Any licensed physician, licensed physician assistant, and certified nurse practitioner medically supervising POD sites or other types of vaccination sites, as permitted by Executive Order 202.82, and overseen or approved by the State Health Department or local health departments must have a current certification in cardiopulmonary resuscitation (CPR); and
  • Within 60 days of this Order, all clinical laboratories permitted by the Health Department pursuant to Article 5, Title 5 of the Public Health Law, and having more than 25 employees, must become qualified entity participants and connect to the SHIN-NY through a qualified entity, and must allow private and secure bi-directional access to patient information by other qualified entity participants authorized by law to access such patient information, pursuant to Part 300 of Title 10 of the NYCRR.

MODIFICATION OR SUSPENSION OF LAWS, STATUTES, RULES, AND PRIOR DIRECTIVES

In addition to the new directives, Executive Order 202.82 also suspends or modifies, through January 12, 2021, certain laws, codes, rules and regulations, and previously issued directives, to aid in New York’s efforts to administer the COVID-19 vaccine.  Note, I have created certain defined terms to shorten repetitive provisions in the Executive Order.

To that end, Executive Order 202.82 provides the following:

Insurance coverage

  • The modification of certain provisions of the Insurance Law to apply to grandfathered health plans with regard to COVID-19 immunizations.

Administration of COVID-19 and influenza vaccinations

  • The modification in Executive Order 202 of sections 6521 and 6902 of the New York Education Law insofar as it limits the execution of medical regimens prescribed by a licensed physicians or other licensed and legally authorized health care providers to registered nurses licensed pursuant to Article 139 of the Education Law, to the extent necessary to permit non-nursing staff, as permitted by law or Executive Order and upon completion of training deemed adequate by the Health Commissioner to: (1) collect throat, nasal, or nasopharyngeal swab specimens, as applicable and appropriate, from individuals suspected of being infected by COVID-19 or influenza, for purposes of testing; (2) collect blood specimens for the diagnosis of acute or past COVID-19 disease; (3) administer vaccinations against influenza or COVID-19 pursuant to the most recent recommendations by the Advisory Committee for Immunization Practices (ACIP) and/or an applicable United States Food and Drug Administration (FDA) approval or Emergency Use Authorization (EUA), subject to any other conditions set forth in Executive Order 202.82, including but not limited to conditions related to training and supervision, where applicable; and (4) where applicable and to the extent necessary, to perform tasks, under the supervision of a nurse, otherwise limited to the scope of practice of a licensed or registered nurse to provide care for individuals diagnosed or suspected of suffering from a COVID-19 or influenza infection;
  • The modification in Executive Order 202.1 of certain provisions of New York Education Law and Title 8 of the NYCRR, to permit licensed physicians and certified nurse practitioners to issue a non-patient specific regimen to nurses, physician assistants, specialist assistants, pharmacists, or any such other persons authorized by law or by Executive Order 202.82 and consistent with guidance as may be issued by the Health Commissioner to: (1) collect throat, nasal, or nasopharyngeal swab specimens, as applicable and appropriate, from individuals suspected of suffering from a COVID-19 or influenza infection, for purposes of testing; (2) collect blood specimens for the diagnosis of acute or past COVID-19 disease; (3) administer vaccinations against influenza or COVID-19 pursuant to the most recent recommendations by the ACIP and/or an applicable FDA approval or EUA, subject to any other conditions set forth in Executive Order 202.82, including but not limited to conditions related to training and supervision, where applicable; or (4) where applicable and to the extent necessary, to perform tasks, under the supervision of a nurse, otherwise limited to the scope of practice of a licensed or registered nurse to provide care for individuals diagnosed or suspected of suffering from a COVID-19 or influenza infection;
  • The modification of certain sections of Education Law and Title 8 of the NYCRR, to the extent necessary to permit non-patient specific regimens to be prescribed, ordered to, and executed by registered professional nurses for the administration of COVID-19 vaccine;
  • The modification of certain provisions of the Education Law insofar as is necessary to permit non-patient specific regimens for the administration of COVID or influenza vaccination to be prescribed, ordered to, and executed by licensed practical nurses, so that for the purposes of Executive Order 202.82 only, such licensed practical nurses may administer COVID and influenza vaccinations at POD sites overseen or approved by the State Health Department or local health departments and operated under the medical supervision of licensed physicians, licensed physician assistants, or certified nurse practitioners, provided such licensed practical nurses must first receive training in: (1) techniques, indications, precautions, contraindications, infection control practices; (2) use of personal protective equipment sufficient to provide the basic level of competence for such tasks; and (3) a current certificate in basic CPR, which at a minimum must include a certification in basic CPR by an online program that has received accreditation from the ANCC, ACPE, or the ACCME (the “Protocols”);
  • Modification of chapter 110 of the Laws of 2020 to the extent necessary, and subject to the certification by the Health Commissioner and Education Commissioner, to permit licensed pharmacists to administer COVID-19 vaccine less than 90 days after approval of such vaccine by the FDA’s Center for Biologics Evaluation and Research;
  • The modification of certain provisions of the Education Law and Title 8 of the NYCRR, to the extent necessary to permit patient specific orders or non-patient specific regimens for the administration of COVID vaccination to be prescribed, ordered to, and executed by licensed pharmacists certified to administer immunizations by the State Education Department as well as newly licensed pharmacist, as specified and permitted by Executive Order 202.82;
  • The modification of certain provisions of the Education Law and Title 8 of the NYCRR, to the extent necessary to permit non-patient specific regimens for the administration of COVID or influenza vaccination to be prescribed, ordered to, and executed by licensed pharmacists not certified to administer immunizations by the State Education Department, so that for the purposes of this Order only such pharmacists may administer COVID and influenza vaccinations at POD sites overseen or approved by the State Health Department or local health departments and operated under the medical supervision of licensed physicians, licensed physician assistants, or certified nurse practitioners, provided such pharmacists must first receive training in the Protocols;
  • The modification of certain provisions of the Education Law and Title 8 of the NYCRR, to the extent necessary to permit licensed physicians and certified nurse practitioners, located in any county within New York State, to issue a patient specific prescription or a non-patient specific regimen for COVID-19 and influenza vaccination to a pharmacist who is certified to administer vaccinations as well as to newly licensed pharmacists, as specified and permitted by Executive Order 202.82 unless administering COVID-19 or influenza vaccinations at a POD site;
  • The modification of certain provisions of the Education Law and Title 8 of the NYCRR to the extent necessary to permit newly licensed pharmacists, previously issued a limited permit with certification to administer immunizations to continue to provide such immunizations in New York State for ninety days immediately following licensure and registration in New York State and pending certification of administration for which an application has been filed with the State Education Department;
  • The modification of certain provisions of the Education Law and Title 8 of the NYCRR so that for the purposes of Executive Order 202.82 only, midwives may administer vaccinations against influenza and COVID-19 to any patient pursuant to a non-patient specific order at POD sites overseen or approved by the State Health Department or local health departments, and operated under the medical supervision of licensed physicians, licensed physician assistants, or certified nurse practitioners, provided, however, that a midwife without a certificate issued by the State Education Department for administering immunizing agents, must first receive training in the Protocols;
  • The modification of Education Law, so that, for the purposes of Executive Order 202.82 only, dentists may administer vaccinations against influenza and COVID-19 pursuant to a non-patient specific order at POD sites overseen or approved by the State Health Department or local health departments and operated under the medical supervision of licensed physicians, licensed physician assistants, or certified nurse practitioners, provided such dentists first receive training in the Protocols;
  • The modification of sections under the Education Law and Title 8 of the NYCRR so that, for the purposes of Executive Order 202.82 only, dental hygienists who have been issued a dental hygiene restricted local infiltration anesthesia/nitrous oxide analgesia certificate in accordance with New York Law may administer vaccinations against influenza and COVID-19 pursuant to a non-patient specific order at POD sites overseen or approved by the State Health Department or local health departments and operated under the medical supervision of licensed physicians, licensed physician assistants, or certified nurse practitioners, provided such dental hygienists first receive training in the Protocols;
  • The modification of Education Law, so that, for the purposes of Executive Order 202.82 only, podiatrists may administer vaccinations against influenza and COVID-19 pursuant to a non-patient specific order at POD sites overseen or approved by the State Health Department or local health departments and operated under the medical supervision of licensed physicians, licensed physician assistants, or certified nurse practitioners, provided such podiatrists first receive training in the Protocols;
  • The modification of certain provisions of the Public Health Law and sections of Title 10 of the NYCRR, so that, for the purposes of Executive Order 202.82 only, emergency medical technicians (EMTs) and advanced EMTs may administer vaccinations against influenza and COVID-19 pursuant to a non-patient specific order sites overseen or approved by the New York State Department of Health or local health departments and operated under the medical supervision of licensed physicians, licensed physician assistants, or certified nurse practitioners, provided such EMTs first receive training in the Protocols; and
  • The modification of certain provisions of the Public Health Law and sections of Title 10 of the NYCRR, to the extent necessary to allow certified EMT-paramedics, providing community paramedicine services in accordance with Executive Order 202 and with prior approval of the State Health Department, to administer vaccinations against influenza and COVID-19 pursuant to a non-patient specific order and under the medical direction of a licensed physician, provided, however, that EMT-paramedics must first receive training in the Protocols.

Recordkeeping Provisions

  • The modification of provisions of Education Law, and Title 8 of the NYCRR, insofar as they require licensed pharmacists administering immunizing agents pursuant to a non-patient specific regimen to report such administrations to patients’ attending physicians and provide information to patients on the importance of having a primary health care practitioner, so that, for purposes of Executive Order 202.82 only, licensed pharmacists may administer vaccinations against influenza and COVID-19 without reporting such administrations to patients’ attending physicians, but must, at a minimum, report the vaccination to the CIR or NYSIIS;
  • The modification of Title 8 of NYCRR, insofar as it requires registered professional nurses administering immunizing agents pursuant to a non-patient specific regimen to report such administration to patients’ attending physicians, so that, for the purposes of Executive Order 202.82, registered professional nurses may administer vaccinations against influenza and COVID-19 without reporting such administrations to patients’ attending physicians, but, at a minimum, must report the vaccination to the CIR or NYSIIS, as applicable;
  • The modification of paragraph 3 of subdivision a of section 29.2 of Title 8 of NYCRR, insofar as it makes it an act of professional misconduct for the professions listed within that section to fail to maintain and retain a record for each patient which accurately reflects the evaluation and treatment of the patient, so that, for the purposes of Executive Order 202.82 only, persons practicing the professions listed within that section who are authorized to administer vaccinations pursuant to this Executive Order are not required to maintain and retain such record for those to whom they administer vaccinations against influenza or COVID-19, provided that such persons must comply with all recordkeeping requirements directed by the State Health Department;
  • The modification of provisions of Title 8 of the NYCRR, insofar as it requires a registered professional nurse administering an immunizing agent pursuant to a non-patient specific regimen to ensure that a record of all persons immunized is recorded, maintained, and retained in accordance with paragraph 3 of subdivision a of section 29.2 of the regulations of the Board of Regents of the State Education Department, so that, for the purposes of Executive Order 202.82 only, registered professional nurses are not required to ensure that such a record is maintained and retained for those to whom they administer vaccinations against influenza or COVID-19, provided that such persons must comply with all recordkeeping requirements directed by the State Health Department;
  • The modification of Title 8 of NYCRR, insofar as it requires a pharmacist administering an immunizing agent pursuant to a non-patient specific regimen to ensure that a record of all persons immunized is recorded, maintained, and retained in accordance with paragraph 3 of subdivision a of section 29.2 of the regulations of the Board of Regents of the State Education Department, so that, for the purposes of this Executive Order only, pharmacists are not required to ensure that such a record is maintained and retained for those to whom they administer vaccinations against influenza and COVID-19, provided that such persons must comply with all recordkeeping requirements directed by the State Health Department; and
  • The modification to provisions of the Public Health Law and Title 10 of the NYCRR, to the extent necessary to: (1) suspend the requirement that persons 19 years of age or 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 for the purposes of Executive Order 202.82, the New York State Health Commissioner or the New York City Health Commissioner may include adult immunization information in NYSIIS or the CIR, as applicable, without the consent of the vaccine, and subject to guidance issued by the State Health Department; and (2) require 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.  Nothing in this provision shall be read to permit the vaccination of any person without their consent, or the consent of another person legally authorized to provide such consent on their behalf such as a parent or guardian.

Practice modifications

  • The modification of Title 8 of the NYCRR, insofar as it requires a registered professional nurse authorized to administer immunization agents pursuant to a non-patient specific order to be currently certified in CPR, to clarify that for the purpose of Executive Order 202.82, registered professional nurses must have a current certificate in basic cardiopulmonary resuscitation, which at a minimum must include a certification in basic cardiopulmonary resuscitation by an online program that has received accreditation from the ANCC, ACPE, or ACCME;
  • The modification in Executive Order 202.10 of paragraph 1 of section 6542 of the Education Law to the extent necessary to include any associated regulations, including, but not limited to, subdivisions (a) and (b) of section 94.2 of Title 10 of the NYCRR and paragraph 5 of subdivision a of section 29.2 of Title 8 of the NYCRR to permit a physician assistant to provide medical services appropriate to their education, training and experience without oversight from a supervising physician, including, but not limited to, administering COVID-19 and influenza vaccine and medically supervising points of dispensing  or other types of vaccination sites, as permitted by Executive Order 202.82, without civil or criminal penalty related to a lack of oversight by a supervising physician; and
  • The modification in Executive Order 202.10 of subdivision (3) of section 6902 of Education Law, and any associated regulations, including, but not limited to, sections 29.2, 29.14, and 64.5 of Title 10 of the NYCRR, to the extent necessary to permit 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, but not limited to, administering COVID-19 and influenza vaccine and medically supervising points of dispensing or other types of vaccination sites, as permitted by Executive Order 202.82, without civil or criminal penalty related to a lack of written practice agreement, or collaborative relationship, with a physician.

COVID-19 Testing

  • The temporary modification of Title V of Article 5 of the Public Health Law and parts 19 and 58 of Title 10 of the NYCRR, contained in EO 202.10, as extended, authorizing certain laboratories to perform testing for the detection of SARS-CoV-2 specimens, to the extent necessary to further allow laboratories holding a Clinical Laboratory Improvement Acts (CLIA) certificate in the relevant specialty of testing and meeting the CLIA quality standards described in 42 CFR Subparts H, J, K and M, upon approval from the State Health Department, to perform testing for the detection of influenza virus, respiratory syncytial virus RNA, or other respiratory panels as approved by the Department of Health, in specimens collected from individuals suspected of suffering from a COVID-19 infection, including postmortem specimens;
  • The temporary modification of Sections 8602 and 8603 of the Education Law, and section 58-1.5 of Title 10 of the NYCRR, contained in EO 202.16, as extended, insofar as such modification authorized individuals to perform testing for the detection of SARS-CoV-2, or its antibodies, in specimens collected from individuals suspected of suffering from a COVID-19 infection, to the extent necessary to further allow such 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 the State Health Department; and
  • The temporary modification of Section 6801 of the Education Law, contained in EO 202.24, as extended, insofar as such modification authorized licensed pharmacists to order and administer COVID-19 tests, to the extent necessary to further allow 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 a COVID-19 or influenza infection; and to administer tests for the detection of influenza virus or respiratory syncytial virus RNA, subject to certificate of waiver requirements pursuant to the federal clinical laboratory improvement act of nineteen hundred eighty-eight, in patients suspected of suffering from a COVID-19 or influenza infection, or suspected of having recovered from COVID-19 infection, upon completion of appropriate training developed by the State Health Department.

Construction of temporary vaccination sites and distribution of vaccine

  • The provision of EO 202.1 as extended, that suspended and/or modified parts 709 and 710 of Title 10 of the NYCRR, to the extent necessary to allow 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, is modified to clarify that such temporary location and extensions may include temporary vaccination sites; and
  • Section 6808 of the Education Law and any regulations promulgated thereunder, to the extent necessary to permit 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 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 and subject to applicable storage and handling requirements; the conditions set forth in CDC COVID-19 Vaccination Program Provider Agreement; and any guidance issued by the New York State Department of Health in consultation with the New York State Education Department.

Long Point Advisors remains vigilant during this crisis, working continuously to ensure that you are protected in these uncertain times.  As always, Long Point Advisors is a steady conduit to New York government officials, both state and local, on matters that are crucial to your business.  A copy of this alert and all previous alerts can be found on my website at www.longpointadvisors.com.

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Stay safe.

Craig