Vaccine Resources

Yes. Medicaid providers may continue to provide telephone-only services to recipients of Medicaid at this time, since the pandemic is not completely over. That may change at some time in the future but not right now.

Posted January 20, 2021

The Federal Public Readiness and Emergency Preparedness Act, otherwise know as the PREP Act, provides for immunity for, among other things, the administration to or use by an individual of a covered countermeasure (such as a vaccine), if the person is a qualified person under NY State law. This includes licensed health professionals or other individuals authorized to prescribe administer or dispense the countermeasure by state law. The immunity is applicable, unless there is willful misconduct by the professional administering the vaccine.

Yes. New York State ended its state of emergency on June 25, 2021. However, the federal guidelines issued by the CDC remain in effect.  Therefore, physicians may either adhere only to the CDC guidelines, or they may implement more stringent policies in their office.

Yes. The CDC has advised that individuals who are fully vaccinated do not need to wear a mask or observe social distancing. However, since not every patient is vaccinated, and some patients are not honest in answering the question about being vaccinated or have conditions that preclude being vaccinated, mask wearing and social distancing may well be indicated in a physician’s office to protect other patients. Thus, a stricter policy may be implemented.

When a patient calls for an appointment, the patient should be informed about the office policy. If the patient refuses at that time to wear a mask to the appointment or discloses his/her vaccine status, a telemedicine appointment should instead be offered to that patient. This is especially true because of the new COVID-19 variant now present in N.Y. If, however, the patient is unable to wear a mask for a true medical condition, the patient does need to be accommodated under the Americans with Disabilities Act. An accommodation may be scheduling the patient’s visit at the latest time of day and immediately placing the patient in a room. Regardless of the situation, it is important to try to de-escalate some of the behavior that patients who refuse to wear masks engage in.

Yes. If the patient is both competent and does not require the physical assistance of a third party, the physician may mandate that accompanying individuals wait outside of the office. However, if the patient has dementia or a physical or mental disability that requires the assistance of a third party or companion, the physician must accommodate that patient’s needs.

No. However, New York officials still recommend quarantine for all travelers who are not fully vaccinated or have not recovered from Covid-19 during the previous three months. Recommendations include either: testing three to five days after arriving in New York and self-quarantine for 7 days; or self-quarantine for 10 days if testing is not obtained.

International air travelers to New York from another country may be required to test before returning to the U.S.

Yes. The appropriateness of providing services via telemedicine or telephonically is a clinical decision which should be documented in the patient’s record.

Yes. You may use just a telephone to provide telemedicine visits to most patients, especially those who do not have computers. However, a patient’s medical condition or problem must be such that it can reasonably be treated over the telephone and does not require either a visual confirmation of a problem or an actual physical examination.

Although it is not necessarily required, it may be in the best interests of providers and patients to do so since there will be a baseline and knowledge of the actual condition of patients.

Yes. Under the current rules, you may continue to provide buprenorphine induction via telemedicine/telephone services to patients, but it may be in the best interests of providers and patients to have a baseline evaluation of patients before doing so.

Yes. Verbal informed consent may be obtained for telemedicine, but we recommend that a written consent form be sent to the patient to sign and return to you as soon as possible after the first visit. The contents of a telemedicine consent form may be read to the patient during the initial telemedicine service, and the verbal consent of the patient may be obtained. However, it is crucial that the fact that you had a consent discussion with the patient and that the patient did consent be well documented in the patient’s medical record. A copy of the consent form should be added to the patient’s record.

Posted January 6, 2021

Yes, MLMIC will pay claims that an insured becomes legally obligated to pay, subject to all the terms, conditions, limits, and exclusions described throughout the policy. The CDC Provider agreement requires that the provider keep a medical record, submit vaccine administration data, store and handle the vaccine in compliance with the package insert, report adverse events to VAERS and provide a vaccination card to recipients. Compliance with the Provider Agreement will significantly reduce exposure to allegations of negligence.

Please stay current with CDC and state guidelines:

• CDC Vaccines and Immunizations - Covid-19 Vaccination
• CDC COVID-19 Vaccination Program Provider Agreement & Profile Agreement
• New York State COVID-19 Vaccine Information for Providers

Updated May 7, 2021

The New York State Department of Health has issued a NYS COVID-19 vaccine consent form that that we recommend be used for both informed consent as well as a screening tool and information sheet for patients to read. Under NY State laws governing informed consent, the consent should be in written form and signed by the patient, unless there is a physical or mental disability which precludes the patient from signing the form. If that occurs, the patient who has capacity should be read the contents of the consent if feasible and give verbal consent in front of a witness as well as the person giving the inoculation. Alternatively, consent can be given by a legal guardian, a Health Care Proxy Agent (if the patient is determined to lack capacity) or other legal surrogate under NYS laws. All of this should be documented on the consent form by the provider. Because the vaccines are available under an emergency authorization (EUA) from the FDA, not all of the risks and complications may be known at this time, other than fever, pain, fatigue, and an occasional allergic or anaphylactic reaction. The patient should be advised of this as part of the consent discussion and monitored for either 15 minutes (if the patient has no history of allergic reactions and has had no untoward reaction during that 15 minutes that would requires longer observation) or for 30 minutes if the patient has a history of allergic reactions. Epinephrine should be immediately available at vaccination sites.

Both the Pfizer vaccine and the Moderna vaccine are available for distribution under an Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA). The FDA has authored “Fact Sheet for Recipients and Caregivers” which describes the risks and benefits of getting the COVID-19 vaccine. These documents were published to help educate patients and health care professionals, not as informed consent forms. However, because the Fact Sheets describe both the risks and the benefits associated with vaccinations, they may be used to assist with the informed consent process, as long as they conform to the appropriate New York state laws. The Fact Sheets also contain information that may be useful to the patient later, such as information about what to do in case of an adverse reaction.

• FDA Fact Sheet for EUA of The Pfizer-Biontech COVID-19 vaccine
• FDA Fact Sheet for EUA of the Moderna COVID-19 vaccine
• NYS-DOH COVID-19 Immunization Screening and Consent Form

Posted January 6, 2021

As with any vaccine, care should be taken prior to administration of the COVID-19 vaccine to assess for appropriateness, possible contraindications to inoculation as well as monitoring for side effects.

The CDC has provided recommendations as to the amount of time patients should be monitored in the office given their particular comorbidities. The link below discusses in detail the clinical considerations that should be reviewed prior to administration of the COVID-19 vaccine. A review of the monitoring time that should be incorporated into the visit, given the patient’s history of allergies to past vaccines or other vaccine components is included in Appendix B.

• Interim Clinical Considerations for Use of mRNA COVID-19 Vaccines Currently Authorized in the United States
• Appendix-B

Posted January 6, 2021

In the event a patient does not return for the second dose of the vaccine, an attempt should be made to contact them and determine the reason. It may be that there is a practical reason, such as their work schedule prevents them from keeping their appointment and alternative times cannot be arranged. If the patient is refusing the second dose because of misbeliefs regarding the vaccine, attempt to re-educate the patient on the vaccine’s safety and the need for a second dose to protect themselves and those that they are around. If the patient continues to refuse a second dose or you are unable to contact him or her, send a letter to their home outlining the importance of receiving the second dose of the vaccine and the possible consequences of not receiving it. Consider sending the letter via certified/registered mail as well as routine postal delivery. A copy of the letter should be kept in the patient’s medical record. Additionally, the dates and times of all attempts to contact the patient, and any responses made by the patient should be documented in the patient’s medical record.

MLMIC has a Risk Management Tip which can assist you in addressing patient non-compliance.

For further assistance on addressing a patient’s non-compliance with the COVID-19 vaccine and other treatments you may also contact the law firm of Fager Amsler Keller & Schoppmann, LLP at (877) 426-9555.

Posted January 6, 2021

There are currently no federal or state mandates for COVID-19 vaccinations, however, healthcare employers may choose to make this vaccination a condition of employment.

According to a recent update to the EEOC Guidelines, under the ADA, employers are permitted to impose “a requirement that an individual shall not impose a direct threat to the health or safety of individuals in the workplace,” Here, that threat is an unvaccinated employee in this time of pandemic. Please note that employers who mandate vaccination for COVID-19 must provide a “reasonable accommodation” for employees who have a disability or sincere religious belief that forbids vaccinations.

Employers considering mandated vaccinations must design their policies and processes to comply with any federal, state and/or local regulations or requirements and document both informed consent or refusal in the employee file. Employers should also contact their business counsel for further assistance on this issue.

Please stay current with federal, state, local and EEOC guidelines and regulations:

• What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws
• CDC Vaccines and Immunizations - Covid-19 Vaccination
• New York State COVID-19 Vaccine Information for Providers