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Hundreds threatened with disciplinary action for opioid scripts to patients who overdosed.

Brian Lenzkes, MD, got a letter last December from the Medical Board of California that left him shocked and scared.

The licensing agency told him it had received a “complaint filed against you” regarding a patient who died of a prescription overdose in May 2013 — four and a half years earlier.

In stern bold type, the letter’s second paragraph said the man “died from an overdose of hydrocodone, oxycodone, and zolpidem.” The state’s prescription drug database, CURES(California Controlled Substance Utilization Review and Evaluation System), showed that “Dr. Brian J. Lenzkes had been prescribing long-term excessive amounts of these, including benzos,” and that “it is unknown what conditions the patient suffered from which required such medication.”

The San Diego internist told MedPage Today he’d tried since 2006 to help this complex patient manage pain related to his many problems — so severe they at one point caused him to be admitted to hospice – including diabetic ulcers, congestive heart failure, severe neuropathy, bone infections, and a below-knee amputation, to name a few, he said.

He’d tapered dosages, changed drugs, and tried many other approaches. Though the patient was challenging, he’d “experienced a strong bond” with him, and “he would often bring me homemade barbecue sauce as a thank-you.”

He knew of no complaints about his care of this man. Lenzkes said the patient’s friend told him the man “would have died years earlier if it were not for my encouragement and support.”

If the medical board was after his license, well, the term “witch hunt” crossed Lenzkes’ mind. “I don’t prescribe inappropriately,” he said.

In fact, no patient or family member had filed a complaint against him.

Hundreds threatened

Rather, Lenzkes is one of hundreds of California physicians caught up so far in the medical board’s aggressive “Death Certificate Project,” a program that attempts to stop the epidemic of accidental deaths from prescription opioid overdoses.

The California project takes death certificates in which prescription opioids are listed as a cause, then matches each with the provider — sometimes more than one — who prescribed any controlled substance to that patient within 3 years of death, regardless of whether the particular drug caused the death or whether that doctor prescribed the lethal dose.

At the project’s launch in late 2015, board staff began reviewing 2,694 certificates of death filed in 2012 and 2013 and found 2,256 matches in CURES, showing each provider who wrote an opioid prescription filled by those deceased patients.

Those reports went to medical peer reviewers who, after extensive review, selected 522 prescribers as warranting an investigation of the patients’ files. They included including 450 allopathic physicians against whom the board has opened formal complaints along with 12 osteopathic physicians and 60 nurse practitioners or physician assistants, who were referred to their respective licensing boards. Of the 12 osteopath referrals, seven were closed for insufficient evidence; the other five remain open for investigation.

Of the nearly 450 MDs like Lenzkes who received letters notifying them of a “complaint,” the state Attorney General has filed opioid-related prescribing accusations against nine physicians, Kirchmeyer said. Four of those nine already faced possible disciplinary action on unrelated charges, and saw their accusations amended with new charges regarding opioid prescribing.

For one physician, the accusation referenced deaths of three patients under his care.

The board said 216 cases involving those 450 MDs have now been closed for insufficient evidence or no violation, or the license had already been revoked or surrendered, or the physician had died. As of last week, 38 still await further review of their cases before proceeding; the rest await completion of an investigation.

“Our goal is consumer protection,” the board’s executive director Kimberly Kirchmeyer told MedPage Today. The board wants to “identify physicians who may be inappropriately prescribing to patients and to make sure that those individuals are educated (about opioid guidelines), and where there are violations of the Medical Practices Act, the board takes (disciplinary) action.”

Addressing her board during its quarterly meeting a year ago, Kirchmeyer described the project as an “invaluable” and proactive way to prevent future opioid overdoses by revealing overprescribers — “rather than have to wait for specific complaints to come in,” which are few and far between.

Coroners are required by law to report pathologist findings indicating a death was due to a physician’s gross negligence or incompetence, but the board had received only nine such reports in the prior 2 years, she said.

The board’s project is using death certificates and the CURES database to go beyond the individual fatality and examine a physician’s overall prescribing practices, Kirchmeyer said.

In some cases, investigations triggered by a death certificate identified other, living patients for whom that provider had possibly inappropriately prescribed, she said. That has resulted in a different letter sent directly to such patients saying that the board “is reviewing the quality of care provided to you by Dr. — ” and asking the patient to promptly authorize the doctor to turn over that patient’s medical records to the board. It also threatens to subpoena the records if the patient refuses.

Asked to address physicians’ concerns that these letters could erode patients’ confidence in their doctors, Kirchmeyer reiterated the goal to improve patient safety and said it only sends such letters to patients after a medical consultant “indicated that a physician may be inappropriately prescribing.”

It’s unclear to what extent other states may be targeting putative overprescribers in this way. A California board spokesman said their program was unique, but North Carolina’s medical board also initiates investigations based on patient fatalities involving opioids.

Specifically, North Carolina’s Safe Opioid Prescribing Initiative probes clinicians who’ve had at least two opioid-related patient deaths in the preceding 12 months and who prescribed at least 30 tablets within 60 days of the patient’s death, or when licensees have large numbers of patients on 100 milligrams of morphine equivalents (MME) per patient per day.

Letter ‘changed my practice’

On that December day, Lenzkes gathered his patient’s thick file and spent the next nights carefully writing six pages of the summary the board expected from him. Finally, nearly 3 months later, board analyst Erika Calderon exonerated him with a terse letter saying the review was complete: “No further action is anticipated and the file has been closed.”

Lenzkes was lucky. He’d kept good notes and was cleared. But, he said, “it changed my practice of medicine.” From now on, he’s referring patients like that one to pain specialists. “I’m not taking any more. That’s just how I feel.”

One physician who knows others who received these letters described it as “terrifying.” A typical response is to immediately contact an attorney and the malpractice insurance carrier.

Many doctors interviewed who received these letters say it has riddled their lives with stress and self-doubt, and then anger when they wait as long as 9 months, or longer, to hear they’ve been cleared.

Ako Jacintho, MD, a family medicine physician and addiction medicine specialist in San Francisco got a similar letter Dec. 11 about his patient who died on March 21, 2012, from “acute combined methadone and diphenhydramine intoxication.” He’d refilled the patient’s prescription for methadone 10 mg the day before, Jacintho said, but never prescribed diphenhydramine, the antihistamine sold as Benadryl.

“Back when my patient died, there was little warning on the dangers of prescribed opioids, and the Medical Board supported the treatment of intractable pain with prescription narcotics…. pharmaceutical companies said prescribed opioids were safe,” Jacintho said. “Methadone was in vogue for treating pain.”

He’s been waiting to hear back now going on 9 months of silence, despite several requests for a determination. It’s caused him loss of sleep and made it difficult for him to focus.

“I feel like I’ve been shamed,” Jacintho said. He started advising physician colleagues to stop prescribing opioids as he considered getting out of medicine altogether. He also hired an attorney.

“If they can’t see that this was me as a physician doing the best job that I could to help this patient with intractable pain, what am I supposed to do?” he asked.

Physician flight

“You can’t even begin to understand how disruptive and upsetting this is,” said Paul Speckart, MD, another San Diego internist who in March received a similar board letter about his patient who died in late 2012. The cause, Calderon’s letter said, in boldface type, was “carisoprodol, lorazepam, oxycodone, zolpidem and trazodone toxicity. Coronary artery atherosclerosis was the only medical condition noted…. Three providers prescribed heavily to this patient and one of them was noted to have been you.”

Speckart’s eight-page response went back to 1998 in which he documented his many refusals to give the patient scheduled drugs and his efforts to refer her to a pain specialist. In July, Calderon wrote Speckart “there was no problem” with his treatment of that patient, but “your overall pattern of prescribing opioids looks excessive.” He was told to read the guidelines issued by the board in 2014 and the CDC in 2016 and on prescribing controlled substances for pain, which he did.

He does not overly prescribe, he said. The few for whom he does prescribe opioids genuinely need pain relief for their multiple conditions.

As chair of a San Diego County Medical Society’s Emergency Medicine Oversight Commission, emergency room doctor Roneet Lev, MD, heard the physicians’ outcries. “We’ve definitely heard physicians say, ‘I’m done. I’m not going to see these patients; I don’t need this headache.’ And that’s left California without the doctors we need to treat these patients,” Lev said.

Her own study, published earlier this month in the journal Science, tested a gentler approach — a letter directly from the San Diego County medical examiner notifying physicians that a patient they treated died of an opioid overdose, rapidly informing them what happened to their patients. It served as an informed warning, unlike the medical board’s implied threat of disciplinary action.

Lev’s study found that within 3 months of receiving those letters, those physicians prescribed nearly 10% fewer opioid drugs compared with physicians in a control group who were not sent a medical examiner’s letter.

She said the medical board’s approach is “alarming” for several reasons. For starters, most physicians did not have easy access to the CURES database before 2014 to see what other drugs their patients had been prescribed by other providers, a concern since most patients who overdosed did not do so on one drug alone. Mandatory reporting for the system does not start until Oct. 1, 2018.

Second, at the time, there was no uniform standard on the total morphine equivalent dosage doctors should be prescribing, or how much is too much had been in dispute.

Third, the medical board’s approach is simply unrealistic, she said. “You have to remember, there’s still thousands of Americans who are on high-dose opioids, and you can’t just cut them off. They need to be weaned. Our job is to taper them to be safe.”

Lev said she reached out to Ted Mazer, MD, California Medical Association president, and Kelly Pfeifer, director of the California Health Care Foundation’s High-Value Care staff. She hoped to persuade the board to restructure the Death Certificate Project as an educational tool. Otherwise they worry that physicians will fear disciplinary action so much they feel they must hire lawyers, decide to stop taking patients, or refuse to prescribe pain relief.

The California Academy of Family Physicians declined to comment on the board’s project when approached by MedPage Today, but its web page sternly advises doctors to protect themselves by consulting and retaining an attorney “immediately upon contact” from the board regarding a patient who overdosed. “At no point during an investigation should a family physician be without legal counsel,” the organization said.

The California Medical Association’s associate director, Charlie Lawlor, said his group “remains committed to our continued work on effective policies that increase access to proven treatments for patients with addiction and dependency,” but is still reviewing the board’s program and wouldn’t comment on the merits of the project.

Kirchmeyer sought to refute arguments against the program’s tactics. She said all prescribers were held to the standard of care that was in place in 2012 and 2013. The medical board believes in its current approach because the CURES database shows that many deceased patients had received controlled substances from more than one prescriber, she said, and “it’s unclear whether any of these providers were actually aware that their patients were using multiple prescribers.”

Letter toned down

One criticism of the program, that the letters to physicians were far too threatening and inaccurately implied a family member had filed a “complaint,” has resulted in a major rewording, “based on feedback we received from doctors and consumers,” Kirchmeyer said.

Instead of telling them the board received a “complaint,” new letters sent this summer specify the source — records from the state Department of Public Health — and explain that the inquiry is meant to reduce “the alarming number of overdose deaths.”

It specifies that the review is “routine,” and stresses that “just because a patient death occurred, it does not automatically mean the physician deviated from the standard of care.”

Lenzkes, Jacintho, and Speckart said in separate interviews that the board is right to be concerned about overprescribing. “There’s a lot of abuse, we all agree,” Speckart said.

Added Lenzkes: “When you hear a bunch of doctors all at the same time all getting the same letter, and you realize they’re going through the same thing, you see why some are saying [to patients], ‘Sorry, if you have a lot of medical conditions, we’re not going to take care of you.'”