LAKEVILLE, Minn. — On August 1, a change to a Minnesota state statute regarding opioid prescribing quietly ushered in a change that could be life-saving for people who suffer of severe, chronic pain. 

The change addresses issues that arose from the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain. While the guideline was “intended to improve communication between providers and patients,” it had an unintended consequence for sufferers of intractable pain. It led to dosing restrictions and tapering of the only medication that worked for them.

“This is severe, unrelenting, incurable pain, where other medications have not worked as well or don’t work at all,” said Cammie LaValle, who suffers from complex regional pain syndrome. “It is an incurable, rare disease, rare condition. It is systemic, and at one point I was using a wheelchair, I was begging for amputation of my arm and my leg, because the pain is that severe.”

“It is considered one of the suicide pains,” said Dr. Todd Hess, who has worked in pain management for more than 30 years. “It is very difficult to treat, and it’s what I specialize in.”

Technically, Dr. Todd Hess is recently retired from that specialty, and says it’s a direct result of the impact the CDC guideline had on his ability to treat patients.

 “It felt like I couldn’t do my job any more,” Dr. Hess said. “The 2016 CDC guideline had good intentions, I believe, at the start, but it was not meant to be anything more than a guideline.”

The guideline featured specific numeric thresholds for opioid prescribing, which were later adopted widely and used in regulations and state laws to police opioid prescribing.

“Pain doctors were literally being investigated,” Dr. Hess said. “I mean, I’ve been investigated numerous times and luckily they’ve all come out in my favor because we’ve done the right thing, and that has sent a chilling effect to the medical community.”

And that left Cammie and many other patients out in the cold.

During a hearing in the Minnesota Senate this spring, Laura Johnson, a chronic pain patient, provided emotional testimony of her own struggles.

“I have suffered with chronic pain for over 20 years. I have MS and a deformed spine,” Johnson said. “I can no longer sit, I can’t sleep and I can’t walk. I don’t have a pain doctor anymore. I got dumped because he was so afraid of the fear of the DEA and the guidelines.”

Johnson said she represented just one of many patients who were no longer able to share their stories.

“Many have turned to the streets out of desperation,” she said. “Many more have ended their lives.” 

Both the Minnesota Medical Association and American Medical Association backed up that patient testimony, sending letters in support of the bill.

“For too many years, patients with pain have suffered because of inflexible, numeric thresholds on opioid therapy,” wrote Dr. James Madera, CEO of the AMA.

But thanks to the advocacy, led by Cammie, there is finally hope. The revised statute changes Minnesota law in several ways:

Provides new or updated definitions for intractable pain, drug diversion, palliative care, rare disease and establishes criteria for the evaluation and treatment of intractable pain when treating non-terminal and terminal patients.

• No physician, advanced practice registered nurse, or physician assistant shall be subject to disciplinary action by the Board of Medical Practice or Board of Nursing for appropriately prescribing or administering a controlled substance in Schedules II to V of section 152.02 in the course of treatment of a patient for intractable pain, provided the physician, advanced practice registered nurse, or physician assistant keeps accurate records of the purpose, use, prescription, and disposal of controlled substances, writes accurate prescriptions, and prescribes medications in conformance with chapter 147 or 148 or in accordance with the current standard of care.
• No physician, advanced practice registered nurse, or physician assistant, acting in good faith and based on the needs of the patient, shall be subject to disenrollment or termination by the commissioner of health solely for prescribing a dosage that equates to an upward deviation from morphine milligram equivalent dosage recommendations or thresholds specified in state or federal opioid prescribing guidelines or policies, including but not limited to the Guideline for Prescribing Opioids for Chronic Pain issued by the Centers for Disease Control and Prevention and Minnesota Opioid Prescribing Guidelines.
• Prohibits a prescriber from tapering a patient’s medication dosage solely to meet a predetermined dosage recommendation or threshold if the patient is stable; is experiencing no serious harm from the level of medication prescribed, and is in compliance with treatment plan and patient-provider agreement.
• No pharmacist, health plan company or pharmacy benefit manager shall refuse to fill a prescription for an opiate issued by a licensed practitioner authorized to prescribe opiates solely based on the prescription exceeding a predetermined morphine milligram equivalent dosage recommendation or threshold.
• Requires the prescriber and patient to enter into an agreement that includes the patient’s and prescriber’s expectations, responsibilities, and rights according to the best practices and current standard of care with agreement to be signed by the patient and the prescriber, and a copy of the agreement included with the patient’s medical record and a copy to the patient, to be reviewed at least annually and when there are any changes to treatment plan.
• Absent clear evidence of drug diversion, nonadherence with the agreement must not be used as the sole reason to stop a patient’s treatment with scheduled drugs.

“Opioids are not for everybody, and this is not a pro-opioid bill at all,” Dr. Hess said. “It’s a doctor/patient relationship bill, where patients and doctors and nurse practitioners and PA’s will have a safe zone to do it properly. We know this is dangerous, but we also know not treating pain is dangerous too.”

“It will hopefully protect patients like me, and worse off than me,” Cammie said. “There are people actively dying right now that don’t have access to medications because their oncologist are afraid to prescribe.”

I did a word search of this text for “DEA” and it only appeared ONCE…  “It will hopefully protect patients like me, and worse off than me,” Cammie said. “There are people actively dying right now that don’t have access to medications because their oncologist are afraid to prescribe.”

Does this mean, that if any entity – like the DEA or VA system – decides to impose some daily MME system limit as to a pt’s daily dose.. will this law back the prescriber’s belief as to what the pt’s valid medical needs are. Could a insurance/PBM company does not impose a limit, just refuses to pay for a particular med or category of meds or refuse to pay for any Rx above a certain MME.

DEA Policy Reversal on Allowed Prescription Annotations for Schedule II Prescriptions

here is a post I did recently and I am not sure what the DEA is up to with information contained in the letter in this post,  but I suspect that it has something to do with prescribers sending out controlled med Rxs that is missing a “i” being dotted and/or a “t” being crossed.  Could the DEA start collecting data on such prescribers and could they determine that a particular prescriber is sending out controlled med Rx and track data on such prescribers and could they look to such a prescriber as providing “illegal Rxs” because of those “i’s” not dotted or “t’s” not crossed.  Here is a post : Supreme Court hearing for the Doctors Xiulu Ruan, MD and Shakeel Kahn, MD

Where the SCOTUS with a 9-0 vote decided that the DEA had been using OBJECTIVE CRITERIA to judge prescribers treating pts dealing with SUBJECTIVE DISEASES and it was ILLEGAL for the DEA to do so… Could this be what the DEA is going to use as “go around” to what they have used in the past to “take prescribers down” ?  Only time will tell, but this SCOTUS decision maybe a good example the path the chronic pain community needs take to get some better pain management… and that would mean using law firms.