By Cynthia Price
Legal News
Just as viruses change frequently and rapidly, the human battle against them entails adapting in a variety of ways.
As expert attorneys from Dykema noted in a recent webinar, telemedicine is one of those responses, and although many modifications have taken place, there are likely more to come.
“These changes are coming out daily and hourly, so what we can say is that this information is really accurate as of this presentation,” said Kathrin Kudner at the beginning of the webinar, “Telemedicine in the COVID-19 Pandemic: What Has Changed and What Has Not.”
Kudner represents health care providers, payors and biotechnology and life sciences companies in corporate and regulatory matters. Serj Mooradian, who represents healthcare clients, and Kathleen Reed, a former Registered Nurse who has counseled a wide range of health care providers on health care law, were also on the webinar.
All three operate out of Dykema’s Ann Arbor office.
In a time when health care professionals may be risking their lives through in-person exposure to contagious patients, telemedicine – “the remote diagnosis and treatment of patients by means of telecommunications technology” – is potentially a good solution. As the webinar detailed, some regulatory restraints have been loosened for the duration of the COVID-19 emergency.
Reed started by talking about scope of practice and licensure agreements, saying that Executive Order 2020-30 significantly changed the landscape.
Governor Gretchen Whitmer’s EO 2020-30 (March 20) was a relaxation of the requirements for in-state licensure, allowing that professionals who are licensed and in good standing in other states or territories may practice in Michigan without facing penalties. Reed emphasized the order does apply to telemedicine practice.
The order temporarily suspends provisions of Article 15 of the Michigan Public Health Code relating to scope of practice, supervision and delegation. Some examples Reed gave are that a Physician’s Assistant may provide medical services without a physician practice agreement, RNs and LPNs may order COVID-19 tests, and Advanced Practice Registered Nurses and Certified Registered Nurse Anesthetists are not subject to physician delegation and supervision requirements.
Specific decisions are to be determined by the “medical leadership” of a facility. Reed noted it is important for each medical facility to state in advance who that medical leadership is. “You might want to designate which tasks could be expanded, detail the qualifications for those, put them in place, and document it,” she said, adding that the planning should be communicated at all levels. She noted the standard of care has not changed as a result of the order.
There are additional protections in place against liability for injury sustained by reason of services in support of the COVID-19 pandemic, except in the case of gross negligence.
Reed advised that the Federation of State Medical Boards has a guide to what each state is doing, found at: www.fsmb.org/siteassets/advocacy/pdf/state-emergency-declarations-licensures-requirementscovid-19.pdf
Kudner discussed changes to telemedicine prescribing protocols. The Drug Enforcement Administration has made an exception in the federal Ryan Haight Act that required an in-person evaluation of a patient before prescribing controlled substances such as opioids. The exception allows that requirement to be suspended during the COVID-19 national emergency.
She added many things have not changed: consent to be treated by telemedicine; making referrals to in-person care that is close to the patient when applicable, including emergency services; and offering follow-up services or a referral to another health professional.
There is particular concern about the continuing requirement that a patient sign an Opioid Start Talking Form, though the Michigan Licensing and Regulatory Affairs department (LARA) has indicated that it will accept electronic signatures or mailing the form to the patient to sign and return.
Indicating that signing electronically “is not going to happen,” Kudner recommends “explaining [the] Opioid Start Talking Form during the televisit, securing patient’s intention and promise to sign the form upon receipt, and documenting same in the patient’s record.”
There are similar problems with the federal laws for using only certain telecommunications systems to send the prescription to the pharmacy, which remains in place. Kudner said addressing this is a work in progress.
That is also the case for the reimbursement process for telemedicine practice, Mooradian said, and has been since before the pandemic.
He said that on March 6 the Coronavirus Preparedness and Response Supplemental Appropriations Act waived some restrictions on reimbursing for delivery of telehealth services during the COVID19 emergency.
One example is the Originating Site requirement, which primarily applied to rural and semi-rural areas. Mooradian said providers, who are likely to want to work from home where possible, should add their home addresses to the Centers for Medicare & Medicaid Services (CMS) registry.
Providers may ask questions on special hotlines set up by each of the Medicare Administrative Contractors in the country.
Kudner spoke briefly about privacy concerns. The March 17 and March 20 guidance from the Office of Civil Rights (OCR) in the U.S. Department of Health and Human Services indicated it will waive penalties and exercise enforcement discretion for providing services through “everyday communication technologies.” In addition, the CARES Act removed requirements that if telehealth is delivered via telephone, it should have “audio and video capabilities that are used for two-way, real-time interactive communication,”?which might expose Protected Health Information. These provisions only apply when a provider is operating in good faith.
Any provider, telehealth or not, may disclose the protected patient information to a first responder, according to OCR, in the following circumstances: when it is necessary for treatment; when it is required by law; when the interaction may put first responders at risk of infection; or under the circumstances that not doing so may increase the serious threat to public health.
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