Intro by Linda Cheek, MD
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.
Anyone reading the story of Jessica would initially say ‘glad she’s off the street’ and then move on. However, until a situation like this happens to you, or someone close to you, then you understand how the justice system works – at state and federal level. They employ a carousel of hired guns who are sworn in as witnesses. They bring up disgruntled patients or worse, disgruntled family members.
The system is corrupt to the core, but yet people, waving the American flag, claim we live in the best country in the world.
I could go on and on – please consider, there are two sides to a story, and often, the winner is not the real truth. Thirty years is a virtual death sentence. THIS IS JUSTICE?
It’s true about the non believers and the brainwashed. I have even been told by a medical doctor “There are no sick people “. They think this way until it happens to them. Then they want to be taken out of pain right away. The main stream media negative propaganda, the simultaneous media blackout of the pain patient suffering and deaths, the continual enabling of addiction, and the persecution of doctors in my opinion is intentional. Whether it be for money, power, or whatever insanity, the corruption involving aligned entities is out of control.
It is truly amazing how people believe the propaganda. When are we going to learn? Look at the comments by people on this reprint of the government press release in a Detroit newspaper? https://www.clickondetroit.com/news/local/2022/11/22/4-from-detroit-northville-sterling-heights-charged-in-500000-pill-telehealth-opioid-scheme/. If people don’t start to learn the truth, I’ve told you what the future holds. But only two people came to my Clubhouse room last night, both returnees. No one new. The suffering will get worse.
Oh, Linda, I am so sorry I missed this. I did not know it was happening. Thank You so much for using your precious energy to make it happen anyway, even though you must have known there would not be a crowd there.
Recently, a person wrote an opinion piece in our local newspaper about opiates and the comments this person received were so unbelievably stupid and uninformed. Those comments, which were all from random community members, all said the same thing: anyone who needs opiates is an addict and will end up in a gutter somewhere with a needle in their arm. NO ONE got the benefits of opiates. It was never even mentioned, let alone promoted that the struggles those of us face who are STILL living with chronic pain and have to endure it every single minute of every day. The fact that people like me could could live lives that are productive and functional again, if we had our opiates back, was never mentioned. I live in Missoula, MT. We are a strongly Blue community ( in a sea of red ). Even my neighbors, who are all good compassionate people, don’t get it. They have no idea even now, six years post Guidelines what has happened to patients and doctors all around the world. Opiates will be extinguished and replaced by expensive BS like Ketamine and LSD, spinal stimulators, etc. etc.
The comments by the public just show the 20 y/o propaganda machine working. And it usually takes 50 years for propaganda to reach its end and be changed. Before that, though, we will see the end of opiates in the United States by 2030 is my prediction. That is because the addiction rate is now increasing exponentially, doubling every 9 years and by 2025 it will be doubling every 4 years. So the government, in order to attack more doctors, will be blaming prescription opioids for this, clamping down more, and eventually there won’t be any at all. Mark my words. I have the solution with what I teach, but people just won’t listen. Maybe that’s a God-thing. We have left God, and so now he has left us. Ears are deafened and eyes are blind. But the answer is available if ever people do want to listen.