DOJ Attack on Telemedicine

Is it just me, or does it seem like the SCOTUS Ruan/Kahn ruling – which basically told the DEA that they could not use objective criteria in judging prescribers when they were treating pts with subjective diseases –  has caused the DEA to step up their actions against prescriber for exceeding some undefined or vague “exceeding standard of care and/or best practices” that the DEA uses to charge prescribers with prescribing/providing opiates and controlled substances without a valid medical need ?

DOJ Attack on Telemedicine

http://  https://doctorsofcourage.org/attack-on-telemedicine/

Last Friday, November 18, two doctors and three pain clinic operators in Detroit, MI were charged with illegal opioid distribution for providing legal telemedicine to patients in Michigan.  The doctors are Dr. Juan Bayolo, 48, of Lake Mary, Florida and Dr. Renee Gonzalez Garcia, 62, of Henderson, Nevada. Pain clinic operators were Angelo Foster, 33, of Detroit, Michigan; Brandy King 33, of Detroit, Michigan; Edward King, 33, of Northville, Michigan.

The government’s press release makes the treatment provided at these clinics sound illegal, but it isn’t. The problem is that just what is written in this press release, although all lies and fabrication, perverts the minds of the community. Hopefully the community will come here and learn the truth. The other problem is simply that the government agencies—whose bread and butter depend on indicting doctors for doing their job, fabricating a case against them, spreading propaganda against opioids, convicting doctors and sending them to prison to satisfy agreements with prison owners—are ignoring the SCOTUS decision of Ruan/Kahn, and will continue to do so.

Not being too sure of the law in this situation, I called upon the Chapman Law Group as they have a compliance division. I received a response from Mike Staples to post.

Mike Staples of Chapman Consulting Group:

Government press releases concerning healthcare practitioners are always issued in the darkest light for the accused and meant to stir public outrage and negative opinions towards the accused practitioner even before the actual evidence is presented in a court of law and ignore the fact that in America all people are innocent until proven guilty. 

While it’s not possible for me at this time to review all facts and evidence of this particular telemedicine prescribing case, I would like to point out the following laws and guidance concerning the prescribing of controlled substances via telemedicine.

Firstly, due to the Covid19 Federal Health Emergency declared and still valid. Federal laws pertaining to telemedicine prescribing, such as the Ryan Haight Act, have been suspended to allow greater access to healthcare practitioners for patients while minimizing health risks for all and that includes controlled substance prescribing.  The DEA itself issued the following guidance concerning the prescribing of controlled substances via telemedicine during this federal health emergency:

DEA COVID-19 Telemedicine Guidance

Question: Can telemedicine now be used under the conditions outlined in Title 21, United States Code (U.S.C.), Section 802(54)(D)?

Answer: Yes

While a prescription for a controlled substance issued by means of the Internet (including telemedicine) must generally be predicated on an in-person medical evaluation (21 U.S.C. 829(e)), the Controlled Substances Act contains certain exceptions to this requirement. One such exception occurs when the Secretary of Health and Human Services has declared a public health emergency under 42 U.S.C. 247d (section 319 of the Public Health Service Act), as set forth in 21 U.S.C. 802(54)(D). Secretary Azar declared such a public health emergency with regard to COVID-19 on January 31, 2020. On March 16, 2020, the Secretary, with the concurrence of the Acting DEA Administrator, designated that the telemedicine allowance under section 802(54)(D) applies to all schedule II-V controlled substances in all areas of the United States. Accordingly, as of March 16, 2020, and continuing for as long as the Secretary’s designation of a public health emergency remains in effect, DEA registered practitioners in all areas of the United States may issue prescriptions for all schedule II-V controlled substances to patients for whom they have not conducted an in-person medical evaluation, provided all of the following conditions are met: The prescription is issued for a legitimate medical purpose by a practitioner acting in the usual course of his/her professional practice; The telemedicine communication is conducted using an audio-visual, real-time, two-way interactive communication system; and the practitioner is acting in accordance with applicable Federal and State laws. Provided the practitioner satisfies the above requirements, the practitioner may issue the prescription using any of the methods of prescribing currently available and in the manner set forth in the DEA regulations. Thus, the practitioner may issue a prescription either electronically (for schedules II-V) or by calling in an emergency schedule II prescription to the pharmacy, or by calling in a schedule III-V prescription to the pharmacy. The term “practitioner” in this context includes a physician, dentist, veterinarian, or other person licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which s/he practices to prescribe controlled substances in the course of his/her professional practice (21 U.S.C. 802(21)).

Important note: If the prescribing practitioner has previously conducted an in-person medical evaluation of the patient, the practitioner may issue a prescription for a controlled substance after having communicated with the patient via telemedicine, or any other means, regardless of whether a public health emergency has been declared by the Secretary of Health and Human Services, so long as the prescription is issued for a legitimate medical purpose and the practitioner is acting in the usual course of his/her professional practice. In addition, for the prescription to be valid, the practitioner must comply with applicable Federal and State laws. (Exhibit A: DEA COVID-19 Chart).

Secondly, the State of Michigan also allows the prescribing of controlled substances via telemedicine both before, during (with less regulations during the state declared COVID19 health emergency via  Michigan EO 2020-86 https://content.govdelivery.com/attachments/MIEOG/2020/05/14/file_attachments/1451862/EO%202020-86%20Emerg%20order%20-%20telehealth.pdf ) and after the COVID19 health emergency.

Michigan law permits a healthcare professional to prescribe a patient a drug via telemedicine if the healthcare professional is acting within the scope of his or her practice in prescribing the drug, and meets certain additional requirements, such as referring the patient for geographically accessible health care services (including emergency care services) if medically necessary, and either referring the patient or making the healthcare professional (or a person acting under his or her delegation) available to provide follow-up health care services.

If the healthcare practitioner is prescribing a controlled substance, the healthcare practitioner must meet the Public Health Code’s requirements applicable to the healthcare professional for prescribing a controlled substance (e.g., controlled substance license, establishing a bona fide prescriber-patient relationship, obtaining and reviewing the patient’s MAPS report, etc.).

So to sum all of this up, it is absolutely legal from a compliance viewpoint to prescribe controlled substances via compliant telemedicine practices and even more so during the declared state and federal covid-19 emergency declarations.

If you are a healthcare professional facing state or federal make sure you have an attorney well versed and established in healthcare law with a team of compliance professionals to help you build the best possible defense against an overzealous government that will even ignore their very own guidance and laws just to make a name for themselves and to pretend they are doing something to fight the opiate epidemic, even though studies have shown that legitimately prescribed pain medications were never the issue.

Guest Author Michael Staples, CMBI
Chapman Consulting Group

Michael Staples is a former police detective, former State of Ohio Medical Board Investigator, Certified Medical Board Investigator (CMBI), former Director of Compliance for two large Greater Cincinnati pain clinics, CME presenter, healthcare regulatory expert witness, and healthcare regulatory consultant. He has spent the majority of his life dedicated to investigating, enforcing, educating, and maintaining healthcare compliance with a focus on controlled substance prescribing and diversion risk analysis.

As a police detective, he actively was involved in drug investigations- including diversion, trafficking, doctor-shopping cases, fraud, and undercover operations.

As a State Medical Board of Ohio Investigator, he has investigated hundreds of cases involving the standard of care, “pill mills”, and controlled substance prescribing. He has participated in, had training on, and consulted on undercover operations regarding physician practices accused of illegally trafficking in controlled substances.

As a public speaker and CME presenter, he has taught law enforcement officers at the Ohio Chapter of the National Association of Drug Diversion Investigators about the difference between naive and criminal prescribers and was previously the education and training coordinator for the Ohio chapter of NADDI. He has educated Doctors, Nurse Practitioners, and Physician Assistants at CME and private events on aberrant behaviors, detecting diversion, and documentation.

As Director of Compliance for two large Greater Cincinnati area Pain Management Practices,  he has have personally observed, formulated, and implemented policies and procedures to reduce drug diversion and address aberrant behaviors. He has screened and vetted new patients for intake at the practices, including making sure the patients had the proper pain management referral. He has personally witnessed and monitored patients being treated with controlled substances for pain for compliance.

As a healthcare regulatory consultant, he has helped healthcare practices, including pain clinics and pharmacies, improve regulatory compliance, detect and address diversion, improve documentation, and more.

 

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