Health Care Law Client Alert – April 2020
Governor Cuomo has issued a series of Executive Orders to help health care providers combat the COVID-19 outbreak that continues to impact New York State. This Client Alert addresses the provisions relevant to health care providers in Executive Orders 202.10, 202.11 and 202.14. While Executive Orders 202.10 and 202.11 indicate earlier termination dates, Executive Order 202.14 extends all orders through May 7, 2020.
Executive Order 202.10
Executive Order 202.10 is intended to eliminate obstacles to patient care by ensuring that New York State has adequate bed capacity, supplies and providers to treat COVID-19 patients. Accordingly, Governor Cuomo has temporarily suspended or modified certain statutes and regulations applicable to the health care industry to effect the following changes:
- Increase Hospital Beds – General hospitals are permitted and required to take all measures necessary to increase the number of beds available to patients, ideally by 50%. All general hospitals, ambulatory surgery centers, office-based surgery practices, and diagnostic and treatment centers shall increase the number of beds available, by among other things, canceling all elective surgeries and procedures, as the Commissioner of Health shall define. General hospitals shall comply with such order by submitting COVID-19 plans to the New York State Department of Health (NYSDOH) on a schedule to be determined by NYSDOH.
- Redefine “Emergency Medical Services” – The Public Health Law definition of “emergency medical services” has been modified, as follows, to:
- Include emergency, non-emergency and low-acuity medical assistance;
- Eliminate any restrictions on approved ambulance services or providers operating outside of the primary territory listed on such ambulance service’s operating certificate with prior approval by NYSDOH;
- Permit the Commissioner of Health to issue provisional emergency medical services provider certifications to qualified individuals with modified certification periods as approved; and
- Allow emergency medical services to transport patients to locations other than health care facilities with prior approval by NYSDOH.
- Commissioner Oversight Over Emergency Medical Treatment Protocol – Emergency medical treatment protocol development or modification may now occur solely with the approval of the Commissioner of Health, as opposed to the New York State Emergency Medical Services Council, the State Emergency Medical Advisory Committee or Regional Emergency Medical Services Councils, as applicable.
- Nurse Administration of Anesthesia – An advanced practice registered nurse with a doctorate or master’s degree who specializes in the administration of anesthesia may administer anesthesia in a general hospital or free-standing ambulatory surgery center without the supervision of a qualified physician.
- Physician Assistant Oversight – A physician assistant may provide medical services appropriate to their education, training and experience, without oversight from a supervising physician, without civil or criminal penalty related to a lack of oversight by a supervising physician.
- Specialist Assistant Oversight – A specialist assistant may provide medical services appropriate to their education, training and experience, without oversight from a supervising physician, without civil or criminal penalty related to a lack of oversight by a supervising physician.
- Nurse Practitioner Oversight – A nurse practitioner may provide medical services appropriate to their education, training and experience, without a written practice agreement or collaborative relationship with a physician, without civil or criminal penalty related to a lack of written practice agreement or collaborative relationship with a physician.
- Redefine “Medical Control” – The Public Health Law definition of “medical control” is redefined to:
- Include emergency and non-emergency direction to all emergency medical services personnel by a regional or state medical control center; and
- Permit emergency medical services personnel to operate under the advice and direction of a nurse practitioner, physician assistant or paramedic, provided that such medical professional is providing care under the supervision of a physician and pursuant to a plan approved by NYSDOH.
- Health Care Professional Immunity – All physicians, physician assistants, specialist assistants, nurse practitioners, licensed registered professional nurses and licensed practical nurses shall be immune from civil liability for any injury or death alleged to have been sustained, as a direct result of an act or omission by such medical professional, in the course of providing medical services in support of the State’s response to the COVID-19 outbreak, unless it is established that such injury or death was caused by the gross negligence of such medical professional.
- Student Licensure – Any health care facility is authorized to allow students, in programs to become licensed in New York State to practice as a health care professional, to volunteer at the health care facility for educational credit as if the student had secured a placement under a clinical affiliation agreement, without entering into any such clinical affiliation agreement.
- Immunity from Recordkeeping Requirements – Notwithstanding any law or regulation to the contrary, health care providers are relieved of recordkeeping requirements to the extent necessary for health care providers to perform tasks as may be necessary to respond to the COVID-19 outbreak, including, but not limited to, requirements to maintain medical records that accurately reflect the evaluation and treatment of patients, or requirements to assign diagnostic codes or to create or maintain other records for billing purposes. Any person acting reasonably and in good faith under this provision shall be afforded absolute immunity from liability for any failure to comply with any recordkeeping requirement.
- Trauma Center Designation – The Commissioner of Health may designate a health care facility as a trauma center, or extend or modify the period for which a health care facility may be designated as a trauma center, or modify the review team for an assessment of a trauma center.
- Emergency Medical Services Provider Certifications
- All existing emergency medical services provider certifications are extended for one (1) year;
- The Commissioner of Health may modify the examination or recertification requirements for emergency medical services provider certifications;
- The Commissioner of Health may suspend or modify any requirements for the recertification of previously certified emergency medical services providers;
- The Commissioner of Health may develop a process determined by NYSDOH, to permit any emergency medical services provider, certified or licensed by another state, to provide emergency medical services within New York State;
- The Commissioner of Health may suspend or modify equipment or vehicle requirements in order to ensure sustainability of EMS operations.
- Physician and Postgraduate Hours – Limits on working hours for physicians and postgraduate trainees are suspended.
- Foreign Medical School Graduates – Graduates of foreign medical schools having at least one (1) year of graduate medical education may provide patient care in hospitals without licenses to provide patient care in hospitals, if they have completed at least one (1) year of graduate medical education.
- Adequate Staffing – General hospitals affected by the disaster emergency may maintain adequate staffing, despite the provisions of medical staff bylaws, hospital governing body bylaws or 10 N.Y.C.R.R. 405.2.
- Use of Volunteers – General hospitals may use qualified volunteers or personnel affiliated with different general hospitals, subject to the terms and conditions established by the Commissioner of Health.
- Unregistered Radiologic Technologists – Radiologic technologists licensed and in current good standing in New York State, but not registered in New York State, may practice in New York State without civil or criminal penalty related to lack of registration.
- Out-of-State Radiologic Technologists – Radiologic technologists licensed and in current good standing in any state in the United States may practice in New York State without civil or criminal penalty related to lack of licensure.
- Out-of-State Respiratory Therapists – Respiratory therapists licensed and in current good standing in any state in the United States may practice in New York State without civil or criminal penalty related to lack of licensure.
- Unregistered Physician Assistants – Physician assistants licensed and in current good standing in New York State, but not registered in New York State, may practice in New York State without civil or criminal penalty related to lack of registration.
- Registered Professional Nurses – Registered professional nurses, licensed practical nurses and nurse practitioners licensed and in current good standing in New York State, but not registered in New York State, may practice in New York State without civil or criminal penalty related to lack of registration.
- Hospice Residence Beds – A hospice residence may designate any number of beds within such facility as dually certified inpatient beds.
- Laboratory Testing for COVID-19 – Laboratories holding a Clinical Laboratory Improvement Act (CLIA) certificate and meeting the CLIA quality standards described in 42 CFR Subparts H, J, K and M, may perform testing for the detection of SARS-CoV-2 in specimens collected from individuals suspected of suffering from a COVID-19 infection.
- Registered Nurse Test Orders – Registered nurses may order the collection of throat or nasopharyngeal swab specimens from individuals suspected of being infected by COVID-19 for purposes of testing.
- Certified or Registered Pharmacy Technicians – A certified or registered pharmacy technician, under the direct personal supervision of a licensed pharmacist, may assist such licensed pharmacist, as directed, in compounding, preparing, labeling or dispensing of drugs used to fill valid prescriptions or medication orders for a home infusion provider that is licensed as a pharmacy in New York, and is compliant with the United States Pharmacopeia General Chapter 797 standards for Pharmaceutical Compounding that includes sterile preparations, and providing home infusion services through a home care agency licensed under Article 36 of the Public Health Law.
In addition, as part of Executive Order 202.10, Governor Cuomo has issued the following directives:
- Student Volunteers – Any health care facility is authorized to allow students, in programs to become licensed in New York State to practice as a health care professional, to volunteer at the health care facility for educational credit as if the student had secured a placement under a clinical affiliation agreement, without entering into any such clinical affiliation agreement.
- Revocation of Hospital Operating Certificate – The Commissioner of Health is authorized to suspend or revoke the operating certificate of any general hospital should they be unable to meet the requirements of the necessary capacity directives and, notwithstanding any law to the contrary, the Commissioner may appoint a receiver to continue the operations on 24 hours’ notice to the current operator, in order to preserve the life, health and safety of the people of the State of New York.
- Insurance Company Professional Licensure List – Any licensed health insurance company shall deliver to the Superintendent of the New York State Department of Financial Services a list of all persons who have a professional licensure or degree, whether physician’s assistant, medical doctor, licensed registered nurse, licensed nurse practitioner or licensed practical nurse, and whether or not the person has a currently valid, or recently (within past five (5) years) expired license in the State of New York. The Department of Financial Services shall poll such individuals to determine whether or not such professionals would serve in the COVID-19 response effort.
- Gatherings Prohibited – Non-essential gatherings of individuals of any size for any reason (e.g., parties, celebrations or other social events) are canceled or postponed at this time.
Executive Order 202.11
Executive Order 202.11 was issued in response to travel-related cases of COVID-19 and community contact transmission. Accordingly, Governor Cuomo has temporarily suspended or modified certain statutes and regulations applicable to the health care industry to effect the following changes:
- Mental Health Services – Mental health services will be available in non-certified settings provided, however, that use of such settings shall require the approval of the New York State Office for People With Developmental Disabilities (OPWDD).
- Person-Centered Behavioral Intervention – Person-centered behavioral intervention training and/or the extension of recertification deadlines will be available for direct support professionals employed in programs and facilities certified pursuant to Article 16 of the New York Mental Hygiene Law that are experiencing staff shortages.
- Domestic Violence Services – The duration or amount of reimbursement for residential programs for victims of domestic violence will not be limited to the per diem rate established by the Office of New York State Children and Family Services.
- Registered Resident Pharmacies – Registered resident pharmacies, and registered resident outsourcing facilities, are temporarily permitted to compound certain alcohol-based hand sanitizer products, consistent with the Food and Drug Administration’s Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (March 2020).
- Alternative Practice Locations for Pharmacists – Pharmacy technicians and pharmacists may practice at an alternative location, including their home, as long as there is adequate security to prevent any Personal Health Information from being compromised.
- Graduates of Nursing Programs – Graduates of registered professional nurse and licensed practical nurse licensure qualifying education programs registered by the New York State Education Department may be employed to practice nursing under the supervision of a registered professional nurse, and with the endorsement of the employing hospital or nursing home, for 180 days immediately following graduation.
- Physicians in SUNY Facilities – Physicians assisting in the State’s response to COVID-19 in a facility owned or leased by SUNY and operated by SUNY are not excluded from defense and indemnification under Section 17 of the Public Officers Law for the medical services provided as part of the State’s response to COVID-19.
- SUNY Volunteers – Volunteers in SUNY’s State volunteer program for SUNY Upstate Hospital, SUNY Stony Brook University Hospital, and University Hospital SUNY Downstate, are compensated and uncompensated volunteers for purposes of defense and indemnification.
In addition, as part of Executive Order 202.11, Governor Cuomo has issued the following directives:
- Hydroxychloroquine or Chloroquine Dispensation – No pharmacist shall dispense hydroxychloroquine or chloroquine except when written:
- As prescribed for an FDA-approved indication;
- For an indication supported by one or more citations included or approved for inclusion in the compendia specified in 42 U.S.C. 1396r–8(g)(1)(B)(i);
- For patients in inpatient settings and acute settings;
- For residents in a subacute part of a skilled nursing facility; or as part of a study approved by NYSDOH Institutional Review Board. Any person authorized to prescribe such medications shall denote on the prescription the condition for which the prescription has been issued.
- COVID-19 Guidance – Any guidance issued by NYSDOH related to prevention and infection control of COVID-19 shall be effective immediately, and shall supersede any prior conflicting guidance issued by NYSDOH, and any guidance issued by any local board of health, any local department of health or any other political subdivision of the State related to the same subject.
Executive Order 202.14
Executive Order 202.14 was issued to further address travel-related cases of COVID-19 and community contact transmission that have been documented in New York State and are expected to continue. Accordingly, Governor Cuomo has temporarily suspended or modified certain statutes and regulations applicable to the health care industry to effect the following changes:
- 2020 Medical School Graduates – Any physician who will graduate in 2020 from an accredited academic medical program, and has been accepted by an Accreditation Council for Graduate Medical Education accredited residency program within or outside of New York State, may practice at any institution under the supervision of a licensed physician.
In addition, as part of Executive Order 202.14, Governor Cuomo has issued the following directives:
- State Appropriation of PPE – Any medical equipment (personal protective equipment (PPE), ventilators, respirators, bi-pap, anesthesia, or other necessary equipment or supplies as determined by the Commissioner of Health) that is held in inventory by any entity in the State, or otherwise located in the State, shall be reported to NYSDOH. NYSDOH may shift any such items not currently needed, or needed in the short-term future by a health care facility, to be transferred to a facility in urgent need of such inventory, for purposes of ensuring New York hospitals, facilities, and health care workers have the resources necessary to respond to the COVID-19 pandemic, and distribute them where there is an immediate need. NYSDOH shall either return the inventory as soon as no longer urgently needed and/or, in consultation with the New York State Division of the Budget, ensure compensation is paid for any goods or materials acquired at the rates prevailing in the market at the time of acquisition, and shall promulgate guidance for businesses and individuals seeking payment.
- Health Insurance Premiums – The New York State Superintendent of Financial Services shall have the authority to promulgate an emergency regulation to:
- Extend the period for the payment of health insurance premiums for certain policies and policyholders facing financial hardship as a result of the COVID-19 pandemic; and
- Require that certain insurers are responsible for the payment of claims and shall not retroactively terminate the insurance policy for non-payment of the premium, during the applicable period.
- Waiver of Late Fees – The New York State Superintendent of Financial Services shall have the authority to promulgate emergency regulations necessary to implement Executive Order 202.14, including regulations regarding (1) the waiver of late fees, and (2) the prohibition on reporting negative data to credit bureaus.
Additional Assistance
For further assistance, please contact a member of the Health Care Practice Team, the Coronavirus (COVID-19) Response Team, or the Phillips Lytle attorney with whom you have a relationship.