The Way Forward: California’s New Opioid Guidelines

By Dr. Forest Tennant and Kristen Ogden

The Medical Board of California recently published new guidelines for prescribing opioids and other controlled substances for pain, which emphasize “individualized care” that is customized for each patient. 

The guidelines are a remarkable, positive and practical way forward in pain care. All persons concerned about chronic pain treatment with opioids, benzodiazepines and other controlled drugs need to know the basic concepts embedded in them.    

As the medical board was updating its guidelines, we had great concern that they would bury California’s Pain Patient's Bill of Rights and Intractable Pain Treatment Act. When these laws were passed in the 1990’s, they were a godsend to patients with chronic intractable pain, who were given the right to “request or reject the use of any or all modalities in order to relieve his or her pain.”

That means patients, with the support of their doctors, could get opiate medication without first having to submit to surgery, medical devices and other forms of pain treatment.  

To our great pleasure, the medical board’s new guidelines recognize, define and support these worthy laws.  Importantly, the guidelines also state that they are “not in any way intended to limit treatment” of patients in hospice or palliative care. And they allow for doctors to prescribe high dose opioids, provided they keep good medical records that document a need for them.

Defining Intractable Pain

The California guidelines provide a classic definition of intractable pain as “a state in which the cause cannot be removed or otherwise treated and no relief or cure has been found after reasonable efforts.” 

The problem with this definition is that intractable pain may be mild or intermittent and not curable, but may still be treated with non-opioid modalities. To require and receive treatment with opioids and other controlled drugs, one really needs a specific causative diagnosis of the unremitting “high impact” pain that produces physiologic complications such as hypertension, tachycardia, and endocrine deficiencies. 

Put another way, is intractable pain an incurable but treatable problem? Or is it constant and incurable with potentially life-threatening complications? 

Physicians, as a group, are often mystified, confused and unaware of how to determine which patients have an incurable, but readily treatable problem, and which patients have the constant and incurable pain that causes complications and require opioid therapy.

Physicians need help to make sound, defensible treatment decisions in the face of this quandary.  Some patients with complex intractable pain are greatly impacted and require non-standard treatment, which may include high-dose opioids, benzodiazepines and stimulant drugs. 

Here are the recommended criteria to identify such patients and support non-standard treatment plans.

1. A specific medical cause of intractable pain has been identified.

2. Constant pain has impacted some physiological and/or mental functions such as sleep, eating, hygiene, reading, concentration, and mobility.

3. Trials of standard medications and dosages with such agents as anti-depressants, muscle relaxants, anti-inflammatories, stimulants, anti-seizure medications, and low-dose opioids have not controlled pain or normalized functions.

4. There is objective physical evidence of the causative disease or complications of the pain, such as hypertension, tachycardia, neurologic deficits, or anatomic structural abnormalities.

5. There is an objective, diagnostic test result that documents an abnormality of the cause of pain or its complications, such as a magnetic resonance imaging (MRI), hormone deficiency, elevated autoimmune or inflammatory marker, or an abnormal electrodiagnostic test.

It is the lack of adequate treatment of complex intractable pain that is really the crux of the suffering and deaths that have emerged due to overzealous and misinformed opioid regulations and guidelines.  These legitimate, complex patients comprise about 3 to 5% of chronic pain patients.

The California medical board’s new guidelines provide clinicians the opportunity to implement individualized and effective treatments for these unfortunate and deserving intractable pain patients. 

Forest Tennant, MD, DrPH, is retired from clinical practice but continues his research on the treatment of intractable pain. Dr. Tennant was the lead physician in crafting California’s Intractable Pain Law and Pain Patient Bill of Rights, and worked with the legislature to get them passed. 

Kristen Ogden is a patient advocate from Virginia. Kristen and her husband Louis travel regularly to California for his intractable pain treatment and prescriptions, which are not available in their home state. Kristen testified during public hearings on the California guidelines and closely followed their development. 

The Tennant Foundation gives financial support to Pain News Network and sponsors PNN’s Patient Resources section.  

Letters to Doctors Reduced Their Opioid Prescribing for a Year

By Pat Anson, PNN Editor

Many doctors in the U.S. have scaled back or stopped prescribing opioid pain medication because they fear scrutiny or even imprisonment by the DEA and other law enforcement agencies.

A team of USC researchers believes there’s a better way to address risky opioid prescribing: have coroners and medical examiners notify all doctors by letter when a patient dies from an overdose.  

“This is not meant to be a law enforcement exercise but a simple nudge. The point is not to scare, blame or shame doctors, but to make them aware of real risks in their patient cohorts, risks they may not be aware of otherwise,” says Jason Doctor, PhD, Professor and Chair of Health Policy and Management at USC’s Sol Price School of Public Policy.

Doctor and his colleagues found that when 809 prescribers received a letter from San Diego county’s medical examiner notifying them about the overdose death of a patient, they reduced the doses of opioid prescriptions they wrote for up to a year afterward. Their findings, published in JAMA Network Open, builds upon a previous study that found the same clinicians reduced their prescribing for three months after receiving such a letter.

"Clinicians don't necessarily know a patient they prescribed opioids to has suffered a fatal overdose," said Doctor. “We knew closing this information loop immediately reduced opioid prescriptions. Our latest study shows that change in prescribing behavior seems to stick."

Nationwide, opioid prescribing has fallen dramatically over the past decade. But USC researchers found the reduction was faster and more extensive among clinicians who received the letter. After one year, their prescriptions were 7.1% lower in morphine milligram equivalent units (MME) than clinicians who hadn't received the letter. The number of new patients they prescribed opioids to also fell by two percent.

"The new study shows this change is not just a temporary blip and then clinicians went back to their previous prescribing," said Doctor. "This low-cost intervention has a long-lasting impact."

Other Drugs Often Involved

There are three major caveats to the USC study. The first is that other substances besides prescription opioids – such as illicit drugs -- were involved in many of the overdose deaths. That’s because the criteria for the study were broad and subjective, including any patient who died when "prescription drug overdose was the primary cause or contributed to the cause of death."

Second, clinicians were included in the study if they had written any opioid prescription within 12 months of the patient’s death. That would explain why 809 prescribers received letters about the overdoses of 166 patients. Doctors received a letter even if a patient was no longer under their care and without conclusive evidence that the prescription they wrote was involved in the death.

Third, the study does not address the growing number of deaths caused by illicit fentanyl, which is now responsible for the vast majority of U.S. overdoses. Letters to doctors are unlikely to have any major effect on overdoses involving street drugs. A 2022 study confirmed there is very little correlation between overdoses, prescription opioids and MME dosage levels.

There have been several previous efforts to rein in opioid prescribing by sending warning letters to doctors. Federal prosecutors in Wisconsin and other states have done it, telling high-dose prescribers they could face prosecution, even when they have not been charged with a crime or linked to an overdose.

The Medical Board of California’s “Death Certificate Project” sent threatening letters to doctors about overdoses that occurred months or years after an opioid prescription was written -- an effort that some likened to a “witch hunt.” Some doctors were targeted even when multiple drugs were involved or the cause of death was suicide.

USC’s Doctor says a gentler “nudge” is needed, not threats. And he wishes the letters sent to San Diego doctors were mandatory statewide.

“That was a terrible approach to delivering letters that the medical board carried out,” Doctor wrote in an email. “We had none of the outcry or problems the (board) did because we were supportive and met clinicians on a professional level.”

California Medical Board Urged to End Bias Against Rx Opioids

By Pat Anson, PNN Editor

The Medical Board of California got an earful from doctors, patients and their advocates during a public hearing Thursday on proposed changes to the board’s guideline for prescribing opioids and other controlled substances. Most speakers praised changes to the guideline that give physicians more flexibility in prescribing higher doses of opioids, but said they don’t go far enough.

“It continues to reflect pervasive bias that we find just about everywhere against the use of opioid pain medication,” said Kristen Ogden of Families for Intractable Pain Relief, a patient advocacy group. “There seems to be an underlying assumption that opioids are bad. Risks vs. benefit is often mentioned, but potential benefits receive very little attention in the draft. It’s kind of like a form of subliminal messaging.”

The board’s draft proposal continues to maintain that opioids “should not be the first line of treatment” for patients with chronic non-cancer pain and recommends that physicians “use extra precautions” when increasing doses above 50 morphine milligram equivalents (MME). Urine drug tests and pill counts are also strongly recommended for patients on long-term opioid therapy. Forced or rapid tapering of patients is discouraged, and doctors are urged to give patients at least 30 days’ notice before discharging them.   

“Opioid prescribing has been a major hot button issue for several years,” said board member Richard Thorp, MD, former president of the California Medical Association. “Our concern primarily is patient safety, and part of that patient safety is being able to prescribe to those patients that critically need these medications (in) a safe and viable environment.”

Thorp headed a task force that reviewed the medical board’s policies, which like many others around the country are modeled after the CDC’s 2016 opioid guideline.

“Unfortunately, many agencies, health plans and other kinds of oversight agencies took the guidelines as very strict guidelines,” said Thorp. “As result, many people who were on larger doses of opioid medications for chronic conditions that were intractable were significantly disadvantaged. Maybe that’s an extreme understatement. Many of them were really harmed by rapid tapering off of medications. Many primary care physicians, in particular, on which this burden had fallen basically backed out of the arena in prescribing chronic narcotics.”

The CDC has acknowledged the harm its opioid guideline has caused, but has been slow in revising it. An updated guideline is not expected to be finalized until late this year, nearly seven years after the original guideline was released.

‘It Has Killed People’

The medical board heard from several patients and physicians who are critical of its past efforts to rein in opioid prescribing, such as the board’s controversial “Death Certificate Project,” which resulted in hundreds of letters threatening disciplinary action being sent to doctors who prescribed opioids to patients who later overdosed. A study found that overdose deaths doubled in California after the project was launched, with many of the deaths linked to street drugs, not prescription opioids.

“It has killed people. My son is one of those people,” said Rosie Arthur, who said her son was abruptly taken off opioids after 24 years and put on antidepressants, which led to his death. “I don’t want to see anybody else die needlessly.”

Doctors told the board its enforcement efforts have had a chilling effect on pain management across the state.

“Some of our physicians are under investigation for compliance with these guidelines, which are resulting in serious unintended consequences,” said Lee Snook, Jr., MD, a pain management specialist in Sacramento. “Our physicians specializing in pain management have stopped taking new referrals, leaving patients and their primary physicians without local accessible options for complex pain management. One of these physicians announced his retirement last week.”   

“We have found it impossible to find pain consultants. There is nobody to refer our pain patients to, particularly patients who are on public programs. There is nobody in our community who will manage chronic medical pain,” said Aaron Roland, MD, a family physician in Burlingame. “Unfortunately, one of our clinicians recently had to leave us, leave our practice, because she had to devote herself full time to defending herself in a case brought by the Medical Board of California for opiate prescribing.”

“In the minds of our primary care docs, they really don’t want to have anything to do with any level of pain management for fear they will lose their license and lose their job,” said Michael Conroy, MD, chief medical officer for a large primary care practice in Sacramento. Conroy pointed out the board’s draft guideline uses the word “should” 44 times and the word “must” seven times.

“Very few of these statements are backed by much in the way of hard science,” he said. “The use of this language can be viewed as signaling an intent to use these statements to discipline doctors who aren’t perfect. Nobody is ever going to be perfect in documenting or attending to 51 separate things on a simple visit with a chronic pain patient.”

Conroy urged the board to modify its draft guideline to indicate that most of its recommendations are based on opinion and should not be used for disciplinary purposes or viewed as hard requirements.

California Doctor Reluctantly Agrees to Probation for Opioid Prescribing

By Pat Anson, PNN Editor

After a two-year battle with the state medical board, a northern California doctor accused of overprescribing opioid pain medication has agreed to a settlement that allows her to continue practicing while under probation for the next 35 months.

“I settled because I could not afford the legal fees to fight it further and because I was offered a deal that allowed me to continue to prescribe as I see fit, so that no one would get cut off their meds suddenly,” says Corinne (Connie) Basch, MD, a primary care physician in Arcata, a small city in rural Humboldt county.

“I was afraid if I went to a hearing and tried to appear pro se (without an attorney) and somehow pissed off the judge I might wind up with a settlement that prohibited prescribing for a year, which was their initial proposal, and that there might be preventable deaths in my patient population as a result.”

If Basch’s medical license was suspended or revoked, all 1,500 of her patients would have to find new doctors, not a simple task in a remote community where healthcare choices are already limited, especially for pain patients.

The 2019 complaint against Basch by the Medical Board of California centered on her treatment of five patients on relatively high doses of opioids and benzodiazepines, an anti-anxiety medication.

Although Basch tried to taper the patients to lower doses, the complaint alleges their dosages were still excessive and placed them at risk of overdose. No allegations were made that any of Basch’s patients were harmed while under her care.

DR. CORINNE BASCH

“I have a number of people who have been absolutely unsuccessful with every attempt to taper, for whom I was afraid,” Basch wrote in an email to PNN. “I also read some old decisions, basically convictions of doctors in my region. I read how the judges made their decisions: basically going completely on the credibility of this or that expert witness, imputing expertise on state expert witnesses who had not seen any patients for multiple years. 

“It was becoming increasingly clear to me that nobody was going to actually read any of the medical literature that objects to forced tapers and so on — that this whole thing was not going to be argued on its merits, that I was going to be perceived as a defensive miscreant, not as someone bound by conscience to make a different choice.”

Under the strict terms of her settlement, which takes effect today, Basch is required to keep detailed records of all controlled substances she prescribes, which must be “available for immediate inspection and copying” by board investigators. She must also take a series of educational classes on safe prescribing and medical record keeping, and have her practice monitored by another physician throughout her probation – all at her own expense.

Basch is worried about how she will pay for it all -- her entire income last year was $50,000 – but feels obligated to her patients to keep practicing.

“I have some guilt about caving, and also some fear about whether I can actually survive the financial costs of the probation, particularly in the middle of this pandemic which has been so incredibly expensive and challenging for my practice already, but ultimately I felt that I was going to be best able to protect my patients with this choice,” she said.

“As you can tell, I am still incredibly angry about the whole thing, and I feel that the medical board is actually contributing to increased deaths in California, as well as tragically harming our profession.” 

Doctors Shamed for Prescribing Opioids

The California medical board has come under fire in recent years for its controversial “Death Certificate Project,” which resulted in threats of disciplinary action against hundreds of doctors who wrote opioid prescriptions for patients who fatally overdosed, sometimes years later.

The goal was to shame doctors to reduce opioid prescribing, but a recent study found that overdose deaths actually increased in the state after the project was launched. Many of the deaths involved street drugs, not prescription opioids.

Critics say the Death Certificate Project and other enforcement actions have had a chilling effect on doctors statewide.

“I am still incredibly angry about the whole thing, and I feel that the medical board is actually contributing to increased deaths in California, as well as tragically harming our profession.”

— Dr. Corinne Basch

“Through your project, you have attacked many prominent, respected physicians, publicly shaming them as careless prescribers and threatening any doctors who had ever prescribed opioid pain medications for someone who ultimately died. This ‘witch hunt’ has caused many deaths and much suffering,” Kristen Ogden and other patient advocates with Families for Intractable Pain Relief wrote in a recent letter to the medical board.

“When you consider how many California physicians have left the practice of pain care, only a small percentage of the patients harmed have managed to continue to receive pain care at all. Most have not found any pain care, and are suffering agonizing lives for no reason. A few patients we knew have committed suicide because they did not find adequate care and were unable to live with the agony of untreated severe, constant intractable pain.”

The Death Certificate Project is now under review by the medical board and has been given the less inflammatory name of “Prescription Review Program.”

Basch was not targeted under program, but believes the board’s disciplinary actions against her and other doctors have only made the opioid crisis worse.  

“I feel there is a significant parallel to the medical board claiming to ‘do something about the opioid crisis’ and in fact doing the exact wrong thing, taking stable patients off of predictable prescribed medications and throwing them out to street supply which is increasingly adulterated and hazardous. This triumph of appearance over substance is at the root of so many wrongs in our current system,” Basch said.

“I do feel that the medical board should in some way be held accountable for their own negligence, for making policies and not monitoring the outcome, for doubling down on these policies even when the error has been pointed out to them. I am not sure how to get politicians interested in the situation, because it implies understanding the situation with enough depth to see that ‘opioids – bad’ is not a well- conceived policy.”

Doctor Accused of Overprescribing Opioids Fights to Keep Her License

By Pat Anson, PNN Editor

A northern California doctor who is beloved by many of her patients could lose her medical license because of allegations by the state medical board that she overprescribed opioid medication and other drugs. Dr. Corrine (Connie) Basch runs a solo primary care practice in Arcata, a small city in rural Humboldt county.

“They were looking to put a head on a spike so they could claim they were doing something about the opioid crisis,” Basch told PNN. “I am not considered a negligent doctor in town, nor am I a pill mill. And it would have taken them all of ten minutes to figure that out if they had asked anyone in my community if there was a problem here.”

A formal complaint against Basch by the Medical Board of California, first reported by the Lost Coast Outpost, centers on her treatment of five pain patients on relatively high doses of opioids and benzodiazepines, an anti-anxiety medication. Although Basch had tapered them to lower doses, the complaint alleges the amounts are still excessive and the combination of drugs places the patients at risk of overdose and death.

Board Executive Director Kimberly Kirchmeyer is seeking the revocation or suspension of Basch’s license for excessive prescribing, gross negligence and failure to maintain adequate medical records.

At no point in the 25-page complaint is it alleged that any of Basch’s patients have overdosed or been harmed while under her care.  The board began its investigation of Basch in early 2018 but didn’t file the accusation until last month – suggesting it didn’t think there was any imminent threat to her patients.

“They went after me for no good reason, conducted an ‘investigation’ that was so obviously flawed, published a defamatory accusation on the Internet prior to giving me a chance to defend myself or even correct the factual errors, revealed private details of my patients’ cases on the Internet when those people live in a small town where people already know each other’s business, and would force a small town doc who treats poor people  to come up with several years’ income to defend herself and her license,” Basch said.   

DR. CONNIE BASCH

All five of the patients in the medical board complaint were already on high doses of opioids and benzodiazepines before Basch started treating them. She tapered these “legacy” patients to lower doses, but some remained on opioid doses as high as 664 MME (morphine milligram equivalent) – well above the CDC guideline’s recommended ceiling of 90 MME.   

The CDC and FDA recently acknowledged that patients should not be forcibly tapered to lower doses and that doctors should “work with patients” before tapering or discontinuing opioids. Basch was already using that approach in her own practice. She says patients who’ve become tolerant to opioids should be weaned slowly and it could take 6-12 months just to get them off benzodiazepines.

“I’ve helped a lot of people get off pain meds,” she said. “Some of my patients stay on meds. I have a patient who is super functional on 145 MME. She’s comfortable, she can sleep through the night, and she works. I don’t see a need to lower her, except that she’s afraid. They’re all feeling insecure. They want to get off (pain meds) because there will be literally no one left to prescribe.”

Afraid to Prescribe

In recent years, California’s medical board has aggressively gone after doctors who prescribe opioids at high doses. The state’s controversial “Death Certificate Project” has resulted in threats of disciplinary action against hundreds of physicians, often years after they wrote an opioid prescription for a patient who fatally overdosed. Some doctors received warning letters even though the cause of death was suicide or involved multiple drugs – both legal and illegal.

These and other enforcement actions have had a chilling effect on doctors statewide.

“What we’re finding is that more and more primary care doctors are afraid to prescribe and more of those patients are showing up on our doorsteps,” Dr. Robert Wailes, a pain specialist and chair of the California Medical Association’s Board of Trustees, told Kaiser Health News.

Should Basch lose her license or stop practicing, all 1,500 of her patients would have to find new doctors, not a simple task in a remote community where healthcare choices are already limited, especially for pain patients.

“There are now two docs I know of in our area who have retired early because of similar accusations, and another older doc who lives in a small coastal community south of us who is going through a similar thing right now,” said Basch. “There’s nowhere even to get primary care up here. And if you call and say you want to be a new patient and chronic pain is anywhere on your problem list, you are denied. So these people are literally going to be left with no one.” 

‘Medical Board Malpractice’

Basch has received over 300 letters of support from patients and several from colleagues in the medical community. Her attorney plans to present them as evidence to the medical board.

“Dr. Corrine Basch is my beloved primary care physician,” one patient wrote. “Taking away her right to assess her individual patients for risk vs benefit, forcing a bureaucratic, possibly ill-conceived set of ‘guidelines’ is what I consider Medical Board Malpractice.

“FEAR caused by actions such as yours are keeping legitimately suffering human beings from having a quality of life they deserve. THIS IS SHAMEFUL.”

“I have had my share of doctors over the years but I never had a doctor like Connie. She has ultimately saved my life and I am not just saying that,” wrote another patient who credits Basch for his sobriety after years of addiction to pills and alcohol.

“You don’t punish someone for doing the right thing and helping people get off of drugs. That is not how you fix the opiate problem plaguing America you do it by employing more people like Dr. Connie who knows the right way to get a person clean.”

Basch, who is 55, continues to practice and is gathering evidence to support her case. A hearing date has not been set on the medical board’s complaint.

“They went after the wrong person this time,” she says. “Shaming and humiliating doctors who have lived lives of service, and placing them in a position where they have to give up their calling because the cost of defense is too great late in their careers, is shameful.”