Six Good Reasons to Repeal Kentucky’s Buprenorphine Regulation

Buprenorphine is a safe, effective, and life-saving medication for the treatment of people with opioid use disorder. However, due to buprenorphine access barriers, such as Kentucky’s buprenorphine regulation (201 KAR 9:270), buprenorphine is accessed by only approximately one out of five people who need treatment with this medication.  201 KAR 9:270 limits access to life-saving treatment with buprenorphine, worsens the societal impact of the opioid crisis, perpetuates stigma, and harms the people it was intended to help. Considering current scientific evidence, there is no plausible reason a separate buprenorphine-specific regulation, like 201 KAR 9:270, should continue to exist in Kentucky, especially considering our federal government has eliminated more restrictive national buprenorphine-specific regulations. 

Recently, I was invited to testify in Kentucky’s capital on behalf of my Kentucky Society of Addiction Medicine colleagues regarding KY’s outdated buprenorphine regulation. My televised address to the Kentucky General Assembly’s Interim Joint Committee on Health Services on October 23, 2024 focused on six good reasons 201 KAR 9:270 needs to be repealed.

My 10 minute address begins at the 39 minute mark of the video. Here’s the link: https://ket.org/legislature/archives/2024/interim/interim-joint-committee-on-health-services-agtk85

Six reasons for repeal of Kentucky’s buprenorphine regulation:

1. A Kentucky crisis.
2. Caused by a disease.
3. With effective treatment.
4. But with barriers to treatment.
5. After repeal, it will still be regulated.
6. On average, six Kentuckians die each day of overdose. Each death is preventable.

Here’s what my colleagues and I authored for the legislators to read. Please click on the link below to read it for yourself.

Click to access 10%2023%202024%204.%20Murphy%20-%20KSAM%20Statement.pdf

In truth, working together we can dramatically lower the opioid overdose rate in Kentucky and save thousands of lives each year. But a major barrier standing in our way is Kentucky’s outdated regulation (201 KAR 9:270) that restricts how physicians prescribe buprenorphine to treat patients with the disease of opioid use disorder.

I urge you to learn more about how experts, advocates, and concerned citizens are working to remove this harmful barrier to lifesaving care, by clicking on the links provided below:

https://www.kysam.org/news

Email us: Admin@kysam.org

And…

https://www.asam.org/news/detail/2024/08/05/asam-and-kysam-urge-kbml-to-stop-proposed-treatment-rules–call-for-new-workgroup-to-form

So, if you’ve read this far, first of all, THANK YOU! And secondly, you’ll probably be interested in what the Kentucky Board of Medical Licensure had to say following my testimony. The board’s “prepared statement” is only about 4 1/2 minutes, but there’s a lot to unpack here…

Link to video: https://ket.org/legislature/archives/2024/interim/interim-joint-committee-on-health-services-c5yhc3

These two presentations before the Interim Joint Committee on Health Services represent two distinctly different approaches to a problem — one by caregivers, the other by regulators. Decide for yourself which approach is most vital in this moment of crisis.

Reading a prepared statement, President Thornbury said, “The board must make decisions based on the realities of the Commonwealth, not idealized scenarios.”

Well, the reality is that our young people are dying.

Kentucky’s buprenorphine regulation is outdated, harmful, and unsalvageable. It’s not necessary. And it forces physicians to practice beneath the standard of care. This regulation needs to be repealed, not processed, analyzed, and amended over a period of years. People who could be saved are dying now because of this regulation.

And, by the way, choosing life over death happens to be an “idealized scenario” I’m OK with.

Repealing 201 KAR 9:270 is choosing life.

Let’s make that the reality of our Commonwealth.

In summary…

Kentucky is mired in the throes of a deadly public health emergency, an opioid overdose crisis that has taken the lives of over 26,000 of our neighbors, friends, family members, and loved ones since the year 2000. Buprenorphine, a DEA schedule III controlled medication, has emerged as an essential standard of care for the treatment of opioid use disorder. However since 2015, Kentucky physicians’ efforts to effectively care for patients with addiction have been hampered by a regulation, 201 KAR 9:270, that impedes access to life-saving treatment for Kentuckians most at risk of dying from an overdose. 201 KAR 9:270 forces physicians to practice below the standard of care. This is harmful to the citizens of Kentucky and worsens our state’s opioid crisis. As scholars of addiction treatment policy have explained, no evidence supports the requirements in 201 KAR 9:270, which by preventing access to buprenorphine, allows preventable deaths to occur. Kentuckians are needlessly dying because of this regulation.

Kentucky must repeal 201 KAR 9:270

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Click on the yellow banner above to sign.

Sign-On Opportunity for Stakeholders in Kentucky: Support KBML Process to Align Regulation of Buprenorphine Prescribing With Evidence:

Dr. James Patrick Murphy is spearheading an opportunity for stakeholders to sign onto a letter to the Kentucky Board of Medical Licensure (KBML) urging it stop finalization of proposed changes to 201 KAR 9:270, a regulation governing the prescribing of buprenorphine for the treatment of opioid use disorder (OUD), and instead form a new workgroup charged with conducting a thorough review of the regulation and recommending revisions through a transparent process. 

The KBML’s current proposed changes risk perpetuating severe harm during a rapidly evolving addiction and overdose crisis, are inconsistent with evidence-based practice, create new treatment barriers, and may even worsen the addiction and overdose crisis in Kentucky.

• By signing this form, you are indicating you would like your signature on the letter found at this link. 
• Please sign on no later than 11:59 pm, August 22, 2024. 
• Please forward this widely to stakeholders in Kentucky and urge them to also sign and pass along. 

Please also note you will also be subject to the following disclaimer if you sign the letter:

“The views expressed herein are those of the individual signatories and do not necessarily represent the views of their institutions or organizations.”

Points to ponder…

Problem: Kentucky’s buprenorphine regulation is outdated and presents a barrier to patients accessing this life saving medication.

Ask: The KBML needs to convene a new workgroup of diverse experts and stakeholders and extensively overhaul the current regulation.

Fact: Buprenorphine has been shown to decrease mortality by approximately 50% among persons with opioid-use disorder.

Background: On December 29, 2022, the Mainstreaming Addiction Treatment Act (MAT) was passed by Congress, removing the X-waiver registration requirement for prescribers of buprenorphine. The MAT Act is intended to reduce federal policy barriers for clinicians to prescribe buprenorphine in further hopes of bringing buprenorphine treatment into mainstream medical care to narrow treatment gaps and improve treatment access along the entire care continuum (e.g., hospitals, emergency rooms, skilled nursing facilities, primary care, and criminal-legal facilities that provide health care).

On January 12, 2023, heralding the elimination of the X-Waiver, the DEA sent a letter to all DEA registrants (see DEA letter), that included this declaration:

Medication for opioid use disorder helps those who are fighting to overcome opioid use disorder by sustaining recovery and preventing overdoses. At DEA, our goal is simple: we want medication for opioid use disorder to be readily and safely available to anyone in the country who needs it.

The American Society of Addiction Medicine (ASAM) does not endorse or support state-level buprenorphine regulations that are more restrictive than federal regulations. This is because restrictive buprenorphine regulations are a known potential barrier to patient access to buprenorphine treatment. Kentucky is among a minority of states with buprenorphine regulations. On measure, Kentucky’s buprenorphine regulation is significantly more restrictive than federal regulations and, indeed, creates a barrier to patients accessing care.

Kentucky’s buprenorphine regulation 201 KAR 9:270 (fundamentally unchanged since 2015) is not evidence-based (i.e., inconsistent with SAMHSA, FSMB, ASAM), dissuades clinicians from offering buprenorphine (i.e., fear of regulatory scrutiny, increased cost, encourages harmful stigma and bias, complicated and unclear), and creates an environment unattractive to patients (i.e., stigma, cost, unnecessary requirements, inconvenience, loss of autonomy).  

Studies have shown that the lack of buprenorphine treatment access is directly linked to the increased diversion of buprenorphine. And as diverted buprenorphine is very often used for its intended medical purpose by persons who cannot access treatment themselves, lowering barriers that impede access to buprenorphine may, in fact, be the most effective way to reduce diversion of buprenorphine.

Many of Kentucky’s regulatory requirements are: (1) not based on evidence and best practices as established by the addiction medicine field and (2) disregard the fact that every patient’s addiction must be treated in an individualized manner (see Michelle Dr. Lofwall’s op-ed below). Certain mandatory requirements (see list below) create a high barrier to accessing treatment with buprenorphine, while current best practices recommends a low barrier approach (see SAMHSA Advisory on low barrier models of care). 

The high barrier approach created by Kentucky’s buprenorphine regulation (see KYSAM letter) puts unnecessary burdens on providers and patients, forcing both groups to engage in certain aspects of treatment that may not be necessary based on the patient’s individual needs. This causes: (a) some providers to not prescribe buprenorphine and (b) some patients to not have access to this life-saving treatment

Specific areas where Kentucky’s buprenorphine regulation is outdated and fosters unnecessary barriers to care include:

• Required visits and frequency of visits (i.e., should be determined by an individual clinician based upon clinical judgment and the individual needs of the patient).
• Requirements for in-office initiation vs. home initiation of treatment with buprenorphine. 
• Non-evidence-based limitations and restrictions on buprenorphine monoproduct vs. buprenorphine/naloxone combination.
• Prescriber qualifications to prescribe buprenorphine products to treat OUD (i.e., educational requirements, X-waiver).
• The appropriateness of co-prescribing buprenorphine with other medications such as benzodiazepines and gabapentin.
• Appropriate treatment of pregnant patients, e.g., requirement for an independent consultation prior to initiating treatment.
• Quantity limits on buprenorphine (i.e., dose limits).
• Requirements for counseling or other behavioral modification services.
• Mandatory urine drug testing (e.g., frequency, number and specific drugs tested).
• Mandatory lab testing (e.g., pregnancy, HIV, Hep C, etc.)
• Restrictions on off-label use of buprenorphine for pain management.
• Guarantees against drug interactions.
• Mandatory use of subjective clinical tools (e.g., a COWS scale).
• Requiring patients to report the lost or stolen medications to police or other law enforcement agencies, which is punitive and unnecessary, as this could prevent patients from returning to treatment if their medication is lost, stolen, or diverted. Such requirements can put patients’ lives at risk.

Summary: Because each patient is unique, and because scientific knowledge and clinical best practices change over time, Kentucky’s buprenorphine regulation must allow for care that is informed by: 

(1) the needs of the individual patient, 

(2) the changing body of scientific and clinical knowledge, and 

(3) the clinical judgment of the physician.

Kentucky’s current buprenorphine regulation does not achieve this goal.

For the past three years, 

Kentucky’s overdose death rate 

has remained at or near a record high.

Kentucky’s current buprenorphine regulation is more harmful than helpful. 

Change is needed. 

Now.

Here is the petition you will be signing…

Dear President Thornbury: 

As deeply concerned citizens of the Commonwealth of Kentucky, we write to urge the Kentucky Board of Medical Licensure (KBML) to (1) stop its current process of finalizing proposed changes to 201 KAR 9:270, a regulation governing the prescribing of buprenorphine for the treatment of opioid use disorder (OUD), and (2) form a new workgroup – charged with conducting a thorough review of the regulation and recommending revisions through a transparent and open process. While we are incredibly grateful for KBML’s recognition of the urgent need to update 201 KAR 9:270, KBML’s currently proposed changes risk perpetuating severe harm during a rapidly evolving addiction and overdose crisis. 

On or about June 4, 2024, KBML informed several stakeholders of an updated draft of 201 KAR 9:270, aimed “to bring the regulation into conformity with current acceptable and prevailing professional standards.” However, the proposed changes will not achieve KBML’s stated goal. They are inconsistent with current evidence-based practice, create new treatment barriers, and may even worsen Kentucky’s addiction and overdose crisis. 

Buprenorphine is a highly effective treatment for OUD, which reduces illicit opioid use, reduces pharmaceutical opioid misuse, decreases risk for injection-related infectious diseases, and decreases risk for fatal and nonfatal overdoses. OUD treatment with buprenorphine is also associated with reduced general health care expenditures and utilization, such as fewer inpatient hospital admissions and emergency department visits. Despite buprenorphine’s effectiveness in significantly cutting opioid-related mortality, less than 20% of people with OUD receive medications for their disorder, partly due to regulatory barriers like those in Kentucky’s 201 KAR 9:270. 

In fact, if KBML does not reopen its rule process and address 201 KAR 9:270’s requirements that interfere with a physician’s ability to exercise proper clinical judgment, then the consequences for the Commonwealth will be severe. Continuing to restrict appropriate access to treatment for OUD with buprenorphine increases the risk of non-fatal and fatal overdoses, overall health care costs, and fear among physicians and patients alike. We only further strain Kentucky’s safety net hospitals and emergency departments whenever rules dissuade physicians from appropriately treating OUD with buprenorphine. Indeed, failure to reopen KBML’s rule process means gambling with the lives of every Kentuckian. That is unacceptable – but fixable – if KBML reopens the process and halts pending rules that can cause unnecessary suffering and death. 

In 2015, KBML promulgated its first version of 201 KAR 9:270. That year, there were 1,219 overdose deaths in Kentucky. KBML last updated the regulation in 2021, a year in which Kentucky experienced 2,250 overdose deaths – the highest annual number on record in the Commonwealth. In 2022, there were 2,135 overdose deaths, and in 2023 the total was 1,984. In sum, since the initial 2015 regulation, overdose deaths in Kentucky are more than 60% higher as of 2023. Revising the regulation now – without ensuring transparency, avoiding conflicts of interest, incorporating high- quality evidence, clearly articulating recommendations, and fully engaging stakeholder review – will only perpetuate the regulation’s unintended barriers to lifesaving care. 

In addition, it is important to note that both a recent publication by the Substance Abuse and Mental Health Services Administration and a recent position statement of the Federation of State Medical Boards emphasize the need to reduce barriers to appropriate access to buprenorphine for the treatment of OUD. Both also highlight that policies can often hamper life-saving treatment with buprenorphine. 

Furthermore, medical ethics require physicians to respect the law while recognizing their ethical responsibility to seek changes in those requirements which are contrary to the best interests of patients. 

For all these reasons, we humbly urge KBML to stop the process of finalizing the currently proposed changes to 201 KAR 9:270 and to form a new workgroup. This new workgroup should include addiction medicine specialists, pain specialists, psychiatrists, primary care physicians, pharmacists, and patient advocates who share a common goal of recommending regulatory changes that will ensure competent, patient-centered addiction care, rooted in scientific evidence, clinical experience, nationally recognized guidelines, and expert consensus, as well as compassion, respect, and responsiveness to individual patient preferences, needs, and values. 

Thank you in advance for considering this important request. We strongly support KBML’s mission to protect the public and promote the public welfare of the citizens of the Commonwealth, and we stand with you in that endeavor. If you have any questions, or wish to discuss this request further, please do not hesitate to contact Dr. James Patrick Murphy at james.murphy.2@louisville.edu. 

Note: The views expressed herein are those of the individual signatories and do not necessarily represent the views of their institutions or organizations. 

 Sincerely, 

Note: On 8/1/2024, the petition was hand-delivered to the KBML with 450 signatories. We have over 550 signatories now, and the list is growing. You can still sign on and join health care advocates like:

Brian Hurley, M.D.
President, American Society of Addiction Medicine 

Stephen M. Taylor, MD
President-Elect, American Society of Addiction Medicine 

Kelly J. Clark, MD, MBA, DLFAPA, DFASAM
Past President, American Society of Addiction Medicine and Past President of KYSAM 

Colleen Ryan MD, FASAM President-Elect, KYSAM 

James Patrick Murphy MD, DFASAM
Immediate Past President, Kentucky Society of Addiction Medicine (KYSAM) 

And here’s the resolution that the Greater Louisville Medical Society will be preventing to the Kentucky Medical Association at KMA’s annual meeting August 23, 2024:

RESOLUTION

https://kyma.org/wp-content/uploads/2024/07/2024-12-Review-of-Buprenorphine-Regulation-GLMS.pdf

 WHEREAS, according to the 2023 Kentucky Drug Overdose Fatality Report, 1,984 Kentuckians lost their lives last year to a drug overdose, which is more than a 50% increase from 2019; and WHEREAS, recent CDC data  lists Kentucky as having the seventh highest overdose death rate in the country; and WHEREAS, recent CDC data indicates approximately 70% of overdose deaths are caused by opioids; and WHEREAS, buprenorphine treatment has been associated with more than a 60% reduction in the risk of opioid-involved overdose death; and WHEREAS, new research out of Kentucky, recently published in the Journal of Addiction Medicine, suggests that higher doses of buprenorphine are associated with reduced opioid-involved overdose deaths and death from other causes; and  WHEREAS, 201 KAR 9:270 is a recognized barrier to patients accessing treatment with buprenorphine; and  WHEREAS, American Society of Addiction Medicine (ASAM) policy states it is vital that unnecessary and over-burdensome barriers to buprenorphine treatment be avoided so patients can have timely access to care; and  WHEREAS, ASAM policy further recommends any state regulation regarding buprenorphine be evidence-based so as not to dissuade clinicians from offering buprenorphine treatment, nor create environments unattractive to patients because of unnecessary and unhelpful regulatory burdens; and WHEREAS,  201 KAR 9:270 is seriously outdated and long overdue for a review and update; and WHEREAS, on or about June 4, 2024, KBML informed stakeholders of an updated draft of proposed changes to 201 KAR 9:270; and  WHEREAS, the Kentucky Society of Addiction Medicine and other field experts, have reviewed the KBML’s proposed changes to 201 KAR 9:270 and have concluded that the proposed changes will create environmentsunattractive to patients because of unnecessary and unhelpful regulatory burdens and will not bring the regulation in accord with evidence-based practice but will instead create new treatment barriers and may even worsen Kentucky’s overdose crisis; now therefore be it RESOLVED, that KMA call upon the Kentucky Board of Medical Licensure (KBML) to stop KBML’s process of finalizing proposed changes to 201 KAR 9:270 and promptly convene a diverse workgroup, comprised of experts in the field, tasked with recommending regulatory changes that will ensure competent, evidence-based, and patient-centered treatment of opioid use disorder with buprenorphine.

Addendum and important some links of interest:

Kentucky’s buprenorphine regulation

KYSAM letter to KBML asking for revisions to the buprenorphine regulation

Op-ed by Dr. Michelle Lofwall

Science-Based Addiction Treatment Must Drive U.S. Policy

Dr. Michelle Lofwall

June 17, 2024

When you’re sick, you go to the doctor.

When you have a life-threatening disease, you get medical treatments to save your life.

When you have opioid use disorder (OUD), you can hit a brick wall, because America’s healthcare systems cannot always deliver the care you need. This is true for several reasons, including stigma, a lack of understanding that addiction is a treatable, chronic medical disease, and an array of restrictive policies and practices, including federal legal barriers that prohibit your state from providing access to one (i.e., methadone) of three OUD medications through prescriptions dispensed from your nearby pharmacy.

In the era of high-potency synthetic opioids, like fentanyl, expanding access to life-saving medications for OUD, particularly methadone and buprenorphine, is critical. Both medications are associated with reduced mortality in people with OUD. They help doctors treat addiction and save lives at a time when opioid-involved overdose deaths are near historic highs. While the latest statistics show the first nationwide drop in overdose deaths in 5 years and an even bigger drop in Kentucky, many states are actually recording significant increases, and Black and Indigenous Americans are still disproportionately more likely to die from an opioid overdose. Illicitly manufactured synthetic opioids can be much more powerful—and deadlier—than heroin and are flooding our communities. Since opioid withdrawal isso excruciating, people with untreated OUD often seek out illicit opioids to prevent pain –– both physical and emotional –– even when they want to stop using them. In contrast, methadone and buprenorphine are proven to help people with OUD manage their disease and be part of the recovery process. New research out of Kentucky, recently published in the Journal of Addiction Medicine, suggests that higher doses of buprenorphine are associated with reduced opioid-involved overdose deaths and death from other causes. Relatedly, methadone may be needed for patients who don’t respond well to buprenorphine. Yet, physicians, even those who are experts in treating addiction, are not always trusted to make appropriate clinical decisions when it comes to these medications.

Unfortunately, despite the recent elimination of a registration requirement for prescribing buprenorphine for OUD, buprenorphine continues to be hindered by burdensome policies, such as non-evidence-based state regulations and unnecessary prior authorization requirements by insurers, even on injectable formulations that cannot be diverted by patients. All these hurdles impede timely access to buprenorphine for OUD and fuel our overdose crisis. Similarly, methadone’s potential is limited by a 50-year-old federal law that is preventing regulators from even trying to increase access to it through prescriptions dispensed from community pharmacies – an approach that has been used successfully in other countries for decades. Consequently, patients who need methadone for OUD must visit one of approximately 2,100 opioid treatment programs (OTPs) in the United States to get their medicine, and for those who can access an OTP, it can still be difficult for some to stay in methadone treatment and maintain their recovery. While OTPs play an important role in the addiction treatment continuum, it’s past time for Congress to pass federal legislation that would empower federal and state regulators to determine how best to access methadone prescribed by addiction specialist physicians for OUD through local pharmacies, which overwhelmingly outnumber OTPs.

Tragically, concerns around methadone and buprenorphine diversion tend to slow necessary reforms. While diversion concerns must be considered and appropriately addressed, they should represent only one aspect of our national conversation when it comes to life-saving medications for OUD, not dominate it. Outdated laws, regulations, and policies governing both buprenorphine and methadone for OUD are failing to meet the moment—and worse, are exacerbating the deadliest overdose crisis in American history.

Dr. Michelle Lofwall is board-certified in psychiatry and addiction medicine. She is a professor of behavioral science and psychiatry and the Bell Alcohol and Addictions Chair at the University of Kentucky College of Medicine. The views expressed herein are those of Dr. Lofwall and do not necessarily represent the views of the University of Kentucky.

Relatively recently, I’ve participated in three presentations that I’d like to share: (1) Louisville Bar Association, (2) Louisville Forward Radio, and (3) the KY Harm Reduction Coalition

First is a discussion about the medical potential, as well as the risks, of marijuana.

Here’s four good references I used for the medical marijuana forum…

(1) American Medical Association: https://www.ama-assn.org/delivering-care/public-health/marijuana-policy-should-be-guided-evidence-not-ballot

(2) American Society of Addiction Medicine: https://www.asam.org/docs/default-source/public-policy-statements/2020-public-policy-statement-on-cannabis.pdf?sfvrsn=aa3c58c2_2

(3) American Psychiatric Association: https://www.psychiatry.org/File%20Library/About-APA/Organization-Documents-Policies/Policies/Position-Cannabis-as-Medicine.pdf

(4) Greater Louisville Medical Society (my article begins on page 16): https://viewer.joomag.com/louisville-medicine-volume-69-issue-6/0686559001635953238?short&

And second, I’d like to share a two-part discussion on “the opioid crisis” from Louisville Forward Radio…

Part 1 • March 10, 2022 https://www.forwardradio.org/podcast/episode/9116edf9/single-payer-radio-or-dr-pat-murphy-or-pain-and-addiction-treatment-or-march-10-2022

Part 2 • June 7, 2022 https://www.forwardradio.org/podcast/episode/9212e948/single-payer-radio-addiction-crisis-part-2-dr-pat-murphy-may-2022

And finally, here is a video posted on the Kentucky Harm Reduction Coalition’s Facebook page with me discussing, what else? – Harm Reduction.

We interviewed board member and addiction specialist Dr. James Murphy on all things addiction, harm reduction, and the opioid epidemic. Give it a watch and spread the word – together we can break the stigma!

On June 13, 2022, I had the pleasure of presenting on the topic of MAT, i.e., Medication Assisted Treatment, or more recently known as MOUD, Medication for Opioid Use Disorder. Here is a selected portion of my slides, with some recommended references at the end. I sincerely appreciate being asked to give this presentation to such a wonderful and vital group of people serving our community and our justice system. It was an honor to be there with them for their Annual Public Defender Education Conference.

References:

• AMA  –  The nation’s drug-related overdose epidemic https://end-overdose-epidemic.org

 • OPIOID TASK FORCE 2020 PROGRESS REPORT (AMA), Physicians’ progress toward ending the nation’s drug overdose and death epidemic https://www.ama-assn.org/system/files/2020-07/opioid-task-force-progress-report.pdf

• Methadone and buprenorphine reduce risk of death after opioid overdose – News Release, June 19, 2018 https://www.nih.gov/news-events/news-releases/methadone-buprenorphine-reduce-risk-death-after-opioid-overdose

• 2020 Overdose Fatality Report Kentucky Office of Drug Control Policy https://odcp.ky.gov/Documents/2020%20KY%20ODCP%20Fatality%20Report%20%28final%29.pdf

• 2021 Overdose Fatality Report Kentucky Office of Drug Control Policy https://odcp.ky.gov/Reports/2021%20Overdose%20Report%20Press%20Release%20PDF.pdf

• A COLLABORATIVE APPROACH TO THE TREATMENT OF PREGNANT WOMEN WITH OPIOID USE DISORDERS https://store.samhsa.gov/sites/default/files/d7/priv/sma16-4978.pdf

• Public Policy Statement on Substance Use, Misuse, and Use Disorders During and Following Pregnancy, with an Emphasis on Opioids – ASAM  https://www.asam.org/docs/default-source/public-policy-statements/substance-use-misuse-and-use-disorders-during-and-following-pregnancy.pdf?sfvrsn=644978c2_4

• Treatment in Correctional Settings Toolkit – ASAM https://www.asam.org/advocacy/advocacy-in-action/toolkits/treatment-in-correctional-settings

• SAMHSA TIP 63: Medications for Opioid Use Disorder – Full Document. https://store.samhsa.gov/product/TIP-63-Medications-for-Opioid-Use-Disorder-Full-Document/PEP21-02-01-002

• Parsons, Jim: Minimizing Harm: Public Health and Justice System Responses to Drug Use and the Opioid Crisis by Jim Parsons. Vera Evidence Brief. December 2017

Click to access Minimizing-Harm-Evidence-Brief.pdf

• Against Our Instincts: Decriminalization of Buprenorphine – John C. Messinger, Anand Chukka and J. Wesley Boyd.The Journal of the American Board of Family Medicine March 2022,  35 (2) 394-397; DOI: https://doi.org/10.3122/jabfm.2022.02.210308. https://www.jabfm.org/content/35/2/394.long

• The Science of Opioid Addiction and Treatment – NOVA PBS https://youtu.be/0Gnj-DKlbd4

*FIRST PUBLISHED ON APRIL 2,2020 AND UPDATED ON APRIL 9, 2020 & MAY 28, 2020

MAY 28, 2020: ON OR ABOUT APRIL 23, 2020 THE MEDICAL LICENSING BOARD OF INDIANA UPDATED THEIR WEBSITE TO SAY:

Once a prescriber has conducted an in-person medical evaluation or has conducted an evaluation using an audio-visual, real-time, two-way interactive communication system for the initial prescription; further health consultation may be done via audio-only or audio-visual telecommunication, as long as all other applicable state and federal laws are followed.  (LINK: https://www.in.gov/pla/medical.htm)

I AM CERTAIN I SPEAK FOR MOST OF THE PROVIDERS, CITIZENS,  AND PATIENTS OF INDIANA WHEN I SAY “THANK YOU” FOR THIS NECESSARY ACTION.

•

Dear Governor Holcomb,

I am a New Albany, Indiana physician with an urgent plea. During the COVID-19 emergency, Indiana must allow prescribers to treat pain patients on opioids via audio-only telemedicine. Currently the requirement is for audio-visual telemedicine.

On March 6, 2020, Indiana declared a state of emergency due to COVID-19. As a result, extraordinary measures have been taken to allow patients to shelter in their homes. However, many chronic pain patients, among the most vulnerable to the SARS-CoV-2 Coronavirus, are still required to have in-person face-to-face visits with prescribers in order to receive a prescription for a controlled substance. This is because, although Indiana now allows audio-visual telemedicine for follow-ups, the state does not allow audio-only telephone calls to serve as telemedicine for controlled substance follow-up visits.

This has to change immediately.

We know that many people, especially the elderly, do not have access to audio-visual telecommunication. However, everyone has a telephone. Therefore, Indiana practitioners must be allowed to conduct audio-only telephone follow ups when prescribing controlled substances for their patients, especially patients who have previously had an in person examination. As it stands now, to prescribe an opioid via telemedicine, the Indiana Professional Licensing Agency still includes a requirement that: “The telecommunication is conducted using an audio-visual, real-time, two-way interactive communication system.”

Indiana has fallen dangerously behind the curve on this issue.

For example, look to the DEA’s COVID-19 Prescribing Guidance, which has been updated “to allow DEA-registered practitioners to prescribe controlled substances without having to interact in-person with their patients.” Specifically, the DEA now allows prescribers who have “previously examined the patient in person” to “conduct any needed follow-up evaluation by any method: in person, telemedicine, telephone, email, etc.”

And the American Medical Association’s “COVID-19 policy recommendations for OUD, pain, harm reduction” could not be more clear: “For patients with chronic pain, waive testing requirements and in-person counseling requirements for refills; allow for telephonic counseling to fulfill state prescribing and treatment requirements.”

In these extraordinary times, we must do everything in our power to ensure that all patients can access care remotely when at all possible. And for our patients with chronic pain on opioid therapy, the extreme stress from withdrawal or fear of withdrawal must be prevented or else we shall see increased and unnecessary morbidity and mortality amongst our citizenry. When patients are forced to leave their safe homes for face-to-face visits with providers, they imperil their lives, the lives of healthcare workers, and the lives of their community.

Audio-visual telemedicine, despite the perceived advantages as compared to a simple telephone call, is not feasible for many vulnerable Hoosiers. Indiana must join with the DEA, the AMA, and numerous other private and government organizations and immediately allow providers to remotely treat patients, for whom controlled substances are necessary, via any appropriate method, including audio-only telecommunication.

Thank you for your service to Indiana and thank you for taking the time to read this e-message. As soon as I hit “send” I will be on the telephone with my patient, Judy, who is 73, crippled with unimaginable arthritis, sheltering in her home, and anxiously waiting for her doctor to call. I have provided you my personal cell phone number in case you or someone on your staff would like to call me. I must apologize in advance, however, if the line is busy. As you well know, these are extraordinary times.

Respectfully,

James Patrick Murphy, MD

Medical Director, Murphy Pain Center, New Albany, IN
Assistant Clinical Professor, University of Louisville School of Medicine
Past-president, Greater Louisville Medical Society
Member, American Medical Association Pain Care Task Force

April 2, 2020

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Addendum:

Governor Eric J. Holcomb’s phone number is: 317-232-4567
And the Governor can be emailed via this link: https://www.in.gov/gov/2752.htm

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(DEA-DC-023)(DEA075)Decision_Tree_(Final)_33120_2007

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https://www.ama-assn.org/delivering-care/public-health/covid-19-policy-recommendations-oud-pain-harm-reduction

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Where a prescription for a controlled substance is issued by means of the Internet, the CSA (as amended by the Ryan Haight Act) requires that such prescription involve at least one in-person medical evaluation, with limited exceptions. After conducting one in-person medical evaluation, a practitioner may thereafter prescribe controlled substances by means of the Internet or via telephone.

• DEA068 – March 31, 2020

https://www.samhsa.gov/sites/default/files/dea-samhsa-buprenorphine-telemedicine.pdf

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A verbal response to my question (see above) was transmitted during the Q&A portion of the Indiana State Department of Health Provider Webcast on April 3, 2020 and was encouraging:

Yes, we are doing this. We are putting together all the waivers that are done into a package and as soon as all the right people approve that will be done. So we heard you. I brought your question last week to the powers that be and they agree. So we’re working on that. 

• Lindsay Weaver, MD, FACEP, Chief Medical Officer, Indiana State Department of Health

Thank you, Dr. Weaver.

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APRIL 9, 2020 UPDATE: 

Today another Indiana State Department of Health Provider Webcast took place. At the conclusion, I asked this question of Dr. Weaver:

DoctorJamesMurphy: Just to be clear, the information on the slide you posted today regarding controlled substances prescribing does not allow for audio-only telephone calls. The DEA specifically allows for audio-only telephone calls. Kentucky allows this. We are behind the curve on this. We need this in Indiana. Can you comment on the progress made in getting this done?

And here was the answer that Dr. Weaver recited on air:

So this again is a question about audio-only telephone calls. So I spoke specifically with our group about this and they did feel like it allowed for audio-only telephone calls. So I don’t know where the miscommunication is. I think there probably is another point to that waiver or that order that wasn’t included in that slide. If you just want to go ahead and send you name, then we can follow up with you or your email address. [Addendum: I immediately sent my email address]

Here is what I believe to be the miscommunication:

Dr. Weaver’s slide says this:

This slide indicates that Executive Order 2020-13 allows for “using a real-time, two-way interactive communication system.” This would appear to include audio-only telephone calls. But wait…

Dr. Weaver’s slide is not consistent with what Executive Order 2020-13 actually says, see below:

And there is more to the story… Executive Order 20-13 also says this:

In other words, Executive Order 20-13 seems to lift the prohibition against audio-only telemedicine by amending Indiana’s definition of telemedicine to include audio-only phone calls. Here is actual language from Indiana Code 25-1-9.5-6 that Executive Order 20-13 amends:

Therefore, it would seem that telemedicine in Indiana might now include “audio-only communication.”

So, as of 4:30 pm on April 9, 2020 here is where I believe this stands:

The slide presented today from Dr. Weaver, acting as an agent of the Indiana Department of Health, would appear to give a green light to audio-only telephone calls for issuing a controlled substance. But Dr. Weaver’s slide references Executive Order 20-13 that clearly does not say that audio-only telephone calls are sufficient.  Where did Dr. Weaver get the verbiage for her slide?

And the COVID-19 updates to the the Indiana PLA website only references the previous Executive Order 20-12, which, like Executive Order 20-13, does not give the “OK” for audio-only telephone calls.

On top of that, the Indiana prescribing regulations, which no one is mentioning, still mandate a face-to-face visit (i.e. no mention of a telemedicine option) at least every four months.

From my non-lawyer, not offering legal advice, physician taking care of patients day in and day out point of view, it seems that somewhere in this cacophony of regulations, orders and pronouncements there is probably enough leeway to allow Indiana prescribers to go ahead and act in the best interest of their patients.

Dr. Lindsay Weaver is a board-certified Emergency Medicine physician engaged in battling the defining medical crisis of our time. She is doing an admirable job. And, with regards what the regs and the laws say we can and cannot do when prescribing controlled substances, she and I can totally agree on this…

What we’ve got here is failure to communicate.

 

 

In the United States, prescribers may be federally indicted and prosecuted based upon interpretation of these ten words:

legitimate medical purpose in the usual course of professional practice

The entire phrase found in the DEA Practitioner’s Manual reads:

To be valid, a prescription for a controlled substance must be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice.

Importantly, the DEA Practitioner’s Manual goes on to say:

Federal courts have long recognized that it is not possible to expand on the phrase “legitimate medical purpose in the usual course of professional practice” in a way that will provide definitive guidelines to address all the varied situations physicians may encounter.

Based on my research, terms like “legitimate medical purpose” and “usual course of professional practice” are not found in medical textbooks, nor are they taught in medical schools. It does not seem to be necessary. It is intuitive to physicians what we do and why we do it.

Nevertheless, courts need more definitive guidance, otherwise they might default to: “You just know it when you see it.”

I am simply not comfortable with such a vital phrase remaining so inscrutable. And as a physician, I feel the dearth of clarity surrounding those ten words places all physicians, including myself, at risk. Consequently, this physician set out on a journey to “define thyself.”

The following (with links to references) represents a work in progress that, with help from numerous colleagues, wordsmiths, legal experts, patients, friends, lay people and trusted advisors, comprises my current best effort at expanding upon:

Legitimate medical purpose in the usual course of professional practice

In essence, for a duly licensed M.D or D.O. physician practicing medicine in the United States, this phrase from the DEA Practitioner’s Manual corresponds to a generally accepted process that, in the context of a patient-physician relationship, can correctly be expanded to mean: a science-based, moral art of caring wherein a physician serves a patient’s medical needs, primarily, by accessing and evaluating information that is utilized by the physician in deriving a clinical assessment, leading to the physician formulating a plan of care. With intent to mitigate harm to the patient, intent to provide benefit to the patient, intent to respect the patient’s right to autonomy, and intent to be mindful of how consequences might affect others, the physician in this course of practice exercises judgment that is considerate of scientific evidence, judgment that is reasoned by the physician to be in accord with standards in the field of medicine, and judgment that is born out of the physician’s knowledge, observations and intuition.

James Patrick Murphy, MD

First draft: 1/17/2020; most recent revision: 2/22/2020

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