California begins requiring unique serial numbers on tamper-resistant prescriptions for controlled substances
Under legislation passed by the California Assembly in September, California began requiring unique serial numbers on tamper-resistant prescriptions issued for controlled substances (Cal. Health & Safety Code §11162.1(a)(15)) on January 1, 2019. A listing of printing companies approved for printing the prescriptions was posted on the California Department of Justice website (https://bit.ly/2Fe8Wy6). On December 27, the California State Board of Pharmacy notified pharmacists that it would delay enforcement of the requirement until July 1: “On or after January 1, 2019, a pharmacist may be presented with a Schedule II, III, IV or V controlled substance prescription written on a security prescription form that was compliant prior to January 1, 2019. This may be especially true for Schedule II prescriptions. In this circumstance, the Enforcement Committee has recommended to the board and to the executive officer that prior to July 1, 2019 the board not make an enforcement priority any investigation or action against a pharmacist who, in the exercise of his or her professional judgment, determines that it is in the best interest of a patient or public health or safety to nonetheless fill such prescription.”
The board urged pharmacists to exercise their best judgment and suggested the following possible responses: (1) communicating with the prescriber about the need for a compliant prescription form; (b) advising the prescriber to substitute an electronic prescription; (3) consulting with the prescriber about whether the patient may be terminally ill and subject to an exemption under §11159.2 of the Health and Safety Code; (4) treating schedule III through V prescriptions as oral prescriptions and verifying them with the prescriber; (5) dispensing pursuant to the emergency situation requirements, if applicable, of §11167 and curing with a compliant prescription form within 7 days; (6) refusing to fill the prescription.
The board also encouraged pharmacists to “identify prescribers who do not timely begin the transition ... to the appropriate prescribing board ...” [California State Board of Pharmacy. Letter to California pharmacists, 2018 Dec 27; https://bit.ly/2TBAHVi]
[Since I became outraged at the unfair targeting of a colleague across town and wrote The Physician Primer: Prescribe Like A Lawyer, in 2017, the regulations have only gotten worse. Docs needed more, so I just released The Physician Primer 2.0: The Safe Opioid Protocol. The following story is excerpted from MedPage Today article authored by Cheryl Clark.]
I couldn't believe the articles I read today by Cheryl Clark, Contributing Editor for MedPage Today. The first, published August 30, 2018, bears the title, "Death Certificate Project Terrifies California Doctors." The second, published September 5, 2018, is entitled, "The 9 Calif. Docs Accused of Overprescribing Opioids."
I immediately recognized two of the names as solid doctors I personally knew. One was a Specialist who trained at the same institution as I, and the other was someone I referenced in The Physician Primer.
Neither could be described as an overprescriber.
California is the most aggressive state in reviewing patients' death certificates, and trolling the PDMP data to see which doctors prescribed opioids or Benzodiazepines within 3 years of their deaths--if overdose is listed on their death certificate.
450 doctors have been sent letters stating that the licensing agency had received a "complaint filed against you" when in fact there was never a complaint, only an investigation launched by the agency due to death and prescribing records.
Brain Lenzkes, M.D., got such a letter that left him shocked and scared. The letter said the man had died from "an overdose of hydrocodone, oxycodone, and zolpidem."
Dr. Lenzkes, the San Diego internist told the MedPage Today interviewer that the patient had been remarkable for multiple severe problems including diabetic ulcers, congestive heart failure, severe neuropathy, bone infections and a below knee amputation. He had tried many non-opioid treatments, had tapered opioids, and had forged a strong bond with him. The patient would often bring in homemade BBQ sauce as a thank you.
He knew of no complaints about his diligent care. The patient's friend told him that the man "would have died years earlier if it were not for my support."
If the medical board was after his license, well, the term "witch hunt" crossed Lenzke's mind. "I don't prescribe inappropriately," he said.
In fact, no patient or family member had filed a complaint against him.
Rather, Lenzkes is one of hundreds of 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 existing law, before the project, only required coroners to report deaths due to a physician's gross negligence or incompetence. This only resulted in nine cases being reported to the board in the past two years.
But the Death Certificate Project produced 2,694 certificates in those two years, with 2,256 prescriber matches in the CURES/PDMP database. These doctors' records were then reviewed which produced 522 prescribers who warranted "investigation" and complaint letters. Out of these were 450 California medical doctors.
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. Thats just how I feel."
The physicians who have received such board complaint letters describe them as "terrifying".
Ako Jacinto, M.D,, a family medicine and addiction 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 narcotics...pharmaceutical companies said prescribed opioids were safe," Jacinto 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," Jacinto 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.
Roneet Lev, M.D., the chair of San Diego County Medical Society's Emergency Medicine Oversight Commission, and an emergency room physician, heard the physician's 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 thats left California without the doctors we need to treat these patients," Lev said.
Even for deaths which occurred in 2012 and 2013, well before the PDMP/CURES database could be accessed, accused physicians are being told to read the guidelines issued by the board in 2014 and the CDC in 2016. Many physicians feel they are in a no-win situation, where they are being measured against a new standard of care, completely different from the standard that was in place before the CDC guidelines back when the deaths occurred in 2012 and 2013. They are being told they should have have known about other prescribers even 7 years ago at a time the CURES/PDMP database did not exist. Yet this very data base is being used to target and investigate them.
Sandra M. was one of my very first patients when I started my medical career in 1987.
She injured her back at work, and ended up with back surgery to "fix" her problem. I met her in the hospital as she lay recovering from the operation.
Her husband, lets call him Ernie, sat at her bedside. Ernie sat in front of me wearing a ball cap and well-worn T-shirt. He worked the night shift at the local Olive Cannery, and the dark circles under his eyes reflected a sleep-deprived and hard working breadwinner to a family of 3 young children with a disabled wife suffering from chronic spinal pain.
Over the next few years, I would treat Sandra with every known non-opioid treatment known to man, from epidural injections, to acupuncture, from counseling to Physical Therapy, from Tegretol to gabapentin. From every form of NSAID, acetaminophen, tricyclic and muscle relaxant.
Due to my conservative medical training, I declined any increase in Vicodin beyond 5 per day. Absolutely "no" to oxycodone, and absolutely no long acting opioids. When she violated her Opioid agreement by filling a script of Percocet from her family doctor, I cut her off. Arrogantly, I held my head high and announced she would receive no opioid from me.
Her family doctor telephoned and pleaded her case.
But I was unmoved, like so many of today's "Addiction Specialists".
"You can prescribe opioids for her. And if she keeps her nose clean for one year, I will reconsider taking her back at that time."
Sandra underwent another spine surgery--against my advice. "You will only develop more scar tissue I proclaimed" with the authority only a young, inexperienced, and heartless know-it-all doctor can deliver. Because I was the specialist, and I was anti-opioid and anti-surgery, I could take the high ground. I wasn't the one who suffered in pain. I also wasn't married to her and didn't have to watch her in agony day-in and day-out.
As the specialist on the case, I also had the luxury of leaving her family doctor to hold the bag and clean up the mess. But the one year passed quickly, and soon I took over her opioid prescribing once again.
I had been treating Sandy for 11 years when it happened. She showed up at my office with an odd demeanor. A look of focus and steely determination. "I have something to say Dr. Hope, and I want your full attention." I put down my pen, and looked her straight in the eye.
With a grimace and a wince, she stared at me. "I have decided that I can not and will not live this way any longer. I know you will not increase my pain medication."
With an odd muscular contortion of her mouth, one that is etched in my memory, and one that forever haunts me, she struggled to find words. "I can't do this anymore".
I didn't fully understand what she was trying to say. She did not cry, plead, or drug seek.
Uncomfortably, I offered her some of my usual non-opioid advice. "I can send you for another epidural block, but I will not increase your opioids if thats what you are asking."
"No" she said quietly.
She continued. "Worker's comp owes you a lot of money for my treatment."
Over the years, they had refused to pay me for the $12,000 functional restoration program I placed her in. The had also refused to pay for another $10,000 in various medical visits, trigger point injections, and other services. I had filed a lien against the carrier, but they would not even consider paying me until she settled her case.
"I am settling my case," she said. "I will make sure you get paid." And she did.
The carrier initially offered her $100,000 so long as she would allow them to fight my lien. She refused. When they told her the deal with her was off, she stood firm and insisted she would not take a dime unless I was paid in full.
And then in 1998, while I was away teaching at the local University Medical School, I received a telephone call.
"Doctor, Sandra M. was found dead inside her car parked alongside a desolate county rural road. There was a self-inflicted gunshot to her head."
Later I got the full story from Ernie. "Sandra took care of you and got your bill paid. She always appreciated your care, and liked you."
As I wiped the tears, Ernie continued, "She took the $100,000 in settlement money and bought me a new car, our first since her injury 11 years ago. She put the rest of the money away for the family in a bank account."
"That night, she was unusually happy. She dressed up and took the three girls out to dinner at McDonald's. They said she was smiling and joking with them. After she dropped them off at home, she came to the factory to visit me. I was on my midnight break on the graveyard shift. She brought me a sack lunch, and said she loved me. She gave me a hug and kiss and then left. Thats the last time I saw her."
As a staunch anti-opioid physician, one who relates to the well-meaning position statements of Physicians for Responsible Opioid Prescribing and NoRX Abuse, please don't forget that some patients who must live a life in pain actually need opioids, and do not use them irresponsibly.
We cannot cause any more suicides like Sandy's.
Todd Graham was a fixture in Mishawaka, Indiana. He practiced the conservative speciality of PM&R medicine which advocates for an anti-opioid and anti-surgery approach to treat chronic pain. I relate as I am also a PM&R doctor, known as a Physiatrist.
The strict new regulations and harsh enforcement have caused many of us, fearing for our licenses, to become suspicious of every new patient, some of them undercover DEA agents trying to entrap us into giving them an opioid script.
We are therefore behaving more harshly and anti-opioid than ever which can sometimes lead to disaster.
Excerpted from STAT, "A doctor's murder over an opioid prescription leaves an Indiana city with no easy answers" by Megan Thielking, August 8, 2017.
"Dr. Todd Graham wasn't yet halfway through his workday at South Bend Orthopedics when a new patient came into his office here complaining of chronic pain.
Heeding the many warnings of health officials, he told her opioids weren't the appropriate treatment. But she was accompanied by her husband, who insisted on a prescription. Graham held his ground. The husband grew irate. The argument escalated to the point that Graham pulled out his phone and started recording audio until the couple left.
Two hours later, the husband would return, armed.
Graham didn't know that the shouting in his office wasn't the end of the confrontation. It was frightening, he told his colleagues. But the incident two weeks ago wasn't out off the ordinary--physicians here and across the country have grown increasingly accustomed to disputes over opioids. So Graham didn't call the police. He didn't file a report. He just kept seeing patients.
Many of his peers say they would have done the same thing. Many of them have.
Now, they're not so sure.
That's what they whispered to one another at the funeral five days later--the funeral for Dr. Graham.
Graham, 56, had worked in the community for decades. He was known for wearing a suit to most every appointment. For pushing patients to push themselves--to get out of bed even when it hurt. He and his wife and raised three children in the area, two daughters and a son, who was finishing his last year of residency and planning to return to town to practice medicine.
"He was really tough, but in a good way," said Dustin Stacy who credited Graham with helping him get out of a wheelchair and back on his feet when he didn't think he ever would.
And now Graham was gone. Two hours after their verbal scuffle in the orthopedics office, Michael Jarvis--who had wanted that prescription so badly--had come after him again, this time in the parking lot. Again, Jarvis shouted. He ordered two people at a nearby picnic table to leave.
The he pulled out a semiautomatic weapon and shot the doctor who wouldn't give his wife pain pills.
After shooting Graham in the parking lot, Jarvis, who was 48 and battling his own issues with addiction, sped off in his red Dodge Neon. He raced down Dragoon Trail, a road that parents tell their newly licensed teens to stay away from because the curves and the cars both come quick.
As the police were swarming the murder scene in the parking lot, Jarvis called a friend and said he might not be around that much longer. Then he drove to his friend's home and killed himself.
In the days since, Cotter's phone in the prosecutor's office has not stopped ringing. In the first few days after the murder, he fielded roughly 20 calls from doctors concerned about the safety of their patients, their staffs, and themselves.
Those calls are forcing him to rethink his own approach to the opioid crisis.
Dr. Chopra's Story: Prescribe Cough Syrup & Risk Prison.
Last month Dr. Chopra of Modesto, California, was arrested after a one year undercover Sting Investigation involving 4 agents posing as patients had finished.
Dr. Chopra, a 71 year old East Indian Pulmonary Specialist had prescribed a total of 690 Norco and 345 Xanax to the agents. Thats the equivalent of 11 prescriptions of #60 Norco over the course of one year; not pill mill stuff.
All of the agents pretended they had a valid reason to take the pain medication ranging from elbow pain to the fact their long time physician had stopped prescribing.
The final straw was when one of the agents called up asking for a prescription of Promethazine cough syrup containing Codeine.
Dr. Chopra, a 1968 graduate of New Dehli Medical School in India, was not the sharpest documnetarian. At age 71, he was a step away from a peaceful retirement.
However, this was shattered when the DEA and U.S. Attorney's office showed up at his Modesto residence with an arrest warrant charging him with 23 counts of prescribing without a legitimate medical purpose and not in the usual course of medical care.
The elderly physician was booked and taken into custody. If convicted, he faces 20 years imprisonment in a Federal Penitentiary and a one million dollar fine or both.
He is now free in lieu of a $200,000 bond. He has hired an attorney who vows to fight the United States Government.
COMMENT: I wrote the [Legally] Safe Opioid Policy to help prevent this type of thing from happening to any other physician. It is the essence of The Physician Primer 2.0
I hope all physicians start to pay attention. I have been sounding the warning alarms since last August, but not enough doctors have taken my advice. Get The Primer Set today. Don't lose your license or go to prison. Now its about good doctors getting picked off.
THE CASE OF FOREST TENNANT M.D. BELOW:
Forest Tenant Md, PhD, a champion of prescribing opioids to the worst cases of intractable & legitimate pain, has retired while under investigation by the DEA.
With his legal fees mounting at rates of up to $1,000 per hour, and his age at 77, he made the hard choice to give up his DEA license and stop practicing medicine, rather than keep fighting and lose everything he had worked for his entire career. He will be traveling back to Kansas with his wife where the couple owns rental property.
Excerpted from REASON, "When Good-Faithed Medicine Raises 'Red Flags' by Jacob Sullum, November 22 2017.
Forest Tennant, who has been treating and researching pain at his clinic in West Covina, California, since 1975, is well-known as an expert in the field, having published more than 200 articles in medical journals and given more than 130 presentations at professional conferences. According to the DEA, all of that was an elaborate cover for drug trafficking.
Or so you would have to surmise from the affidavit supporting the search warrant that the DEA served on Tennant's offices and home last week, which describes "invalid prescriptions," "red flags of diversion and fraud," and "combinations of drugs that are consistent with 'pill mill' prescribing practices." The allegations and insinuations show how the DEA has tried to criminalize differences of opinion about pain treatment, encouraging doctors to think about their legal exposure first and their patients second.
Tennant says the "red flags" perceived by the DEA are consistent with a practice like his, which specializes in treating severe, intractable pain caused by conditions such as arachnoiditis, Ehlers-Danlos syndrome, reflex sympathetic dystrophy, and post-viral neuropathy. "We only take people who have failed the standard treatments," he says.
Tennant's willingness to take hard cases explains why some of his patients live in other states, a fact the DEA considers suspicious. "We only see them in conjunction with their local doctors," he says.
In addition to severe pain, Tennant's patients often have metabolic abnormalities that make them less sensitive to opioids and have developed tolerance after years of pain treatment. Those factors explain the doses that struck the DEA as suspiciously high and the drug combinations it deemed reckless.
By the time Tennant starts treating them, his patients are already taking large doses of opioids, often in combination with muscle relaxants and benzodiazepines. "We didn't start anybody on high dosages, " Tennant says. "We took them to study them to figure out how to get them off of high dosages, and that has remained our goal."
In nine out of 10 cases, Tennant says, he has been able to reduce patients' opioid doses substantially, by as much as 80 percent. At the same time, he defends the use of high doses for patients who need them, a stance that bothers the DEA.
The search warrant affidavit cites a 2009 article in which Tennant and two other doctors defended the prescription of "ultra-high opioid doses" for certain patients with severe chronic pain. The affidavit also notes that Tennant championed the California Pain Patient's Bill of Rights, a 1997 law affirming that "opiates can be an accepted treatment" for severe intractable pain.
Tenant, who has testified against "pill mills," says his clinic looks quite different: It has a six-hour intake process, sees a maximum of 10 people a day, and has "big thick charts" for its patients, who come with their families and tend to be middle-aged. He adds that his practice, which treats about 150 patients, has never had any overdoses, suicides, or diversion problems.
"I invite anybody to come in and see what we do, talk to our patients, see our financial records, talk to me," Tennant says. "My clinic is wide open."
The hot area of law these days is "Painkiller Law".
When I graduated Law School in 1997, many of my classmates went into "Family Law" -more commonly known as Divorce Law. There is never a shortage of divorces. Or they chose Criminal Law, because they could get paid for defending people who were usually guilty. And they seldom got sued for malpractice once the person went away to prison.
No residency, internship or specialty training required either.
Today, a more specialized area of law, "Painkiller Law" deals with defending doctors against their State Licensing Boards or the DEA.
Doctors make good clients as they have deep pockets and are usually willing to pay the 500 to 1,000 dollars per hour it takes to defend their right to practice medicine. Unfortunately, the doctor still often ends up losing, at least to the Feds. And it is often because the DEA has the unlimited resources of the Government on its side. Not to mention the weight of public opinion which has now decidedly turned against opioid-prescribing physicians.
When I wrote the first primer, The Primer 1.0, The Physician Primer: Prescribe Like a Lawyer, I had no idea that one year later, I would need to write The Physician Primer 2.0 to help doctors stay out of trouble with the DEA, and avoid going to prison. I just did not realize how much worse things would get.
Today, when I speak with my colleagues in Massachusetts and New York, experts who write on Pharmacy Policy, I am aghast when they tell me they are testifying for the defense in more Physician Prosecutions than ever, and they are fully booked. They cannot testify in all the cases they are invited. They have never seen it this bad.
My colleague in Florida, the national expert on one of the panel committees who drafted the guidelines, was less sympathetic. "All they need to do is take action on aberrant drug screens," he said. "They are not doing that."
Keep in mind medical experts routinely charge up to 10,000 dollars per day. And there are usually multiple defense experts.
A doctor defending himself in a DEA action can expect to spend at least $100,000 .
In The Physician Primer 2.0, I have documentation tools that will enable doctors to make sure they stay in compliance with the various rules and regulations, but most importantly the "Legitimate Medical Purpose" rule.
Unlike my colleague in Florida who spends his time teaching, publishing and testifying, I actually see patients, and the problem boils down to much more than failing to take action when a patient's urine test results are aberrant.
The problem is simply this: that the proliferation in various guidelines has led to a new standard that is anything but. A standard in documentation so high, that I would bet the Florida expert does not meet it, at least in all cases.
How does one stay on the right side of opioid practice law?
Most Law Firms will be unable to provide you with much usable & practical advice on prevention [aside from giving you all the guidelines already out there] as they prefer to get paid the big bucks defending you after the fact.
Because I practice with you in the trenches everyday, I have developed the Safe Opioid Policy with the all-important P.R.O.G.R.E.S.S. flowsheet & checklist that will give you the most efficient and powerful way to lower your risk. Without spending an hour in each visit.
I discuss actually cases and specifics about what the doctor did wrong, and how you could avoid doing the same.
Many innocent doctors are getting swept away unfairly with the "pill mills" and you do not want that. Take advantage of The Physician Primer 2.0 . Better yet get the Set, containing Primer 1.0 and Primer 2.0 as you need to learn to document like a lawyer first.
Its exponentially cheaper and easier to learn the law now, rather than later.
I use case examples. Because when you see what the doctor did, to get into a court hearing against the DEA in the fight of his life, you won't believe it. But you may become MUCH more humble, and take the precautions I advise.
CASE #1. The Locum Tenens Doc
Locum Tenens doctors are travelers. They prefer to go from place to place and work a month here and a couple of months there experiencing the freedom from overhead and the joy of living in a new town and experiencing everything ranging from the big city to rural practice.
But this particular doctor, lets call him RESPONDENT, got a rude awakening from the DEA. While on a job in the rural Midwest, RESPONDENT [R] learned about the DEA the hard way.
He was seeing patients of Dr. Sprague while he was away on vacation. His job was to make sure Sprague and his wife had a nice time in Europe while he held down the fort at the medical practice near Lake Michigan.
He was supposed to refill the thyroid medication, keep the diabetics under control, maintain the COPD cases, and of course, refill the Norco. But thats where the rub was.
Having never examined any of these patients before, he was easily able to refill the non-controlled blood pressure medications and prescribe antibiotics without peril. But when it came to the follow-up visits for the pain patients, R suddenly found himself on thin ice. The DEA had prepared a welcome committee of undercover agents for him. The first, a young lady, informed him she had been away for 4 months, and had no pain that day, but "usually the back pain ran about a 4 ". He asked what she had done the past 4 months. She responded that she had made due by taking her friend's pain medication when she needed it. When he asked if she had spasm, she stated she felt stiff. He had her resist his hands against hers checking her upper extremity strength.
He then refilled her Xanax and her Norco.
But perhaps his biggest mistake was that he "failed to write her address on the controlled script" in violation of the CSA law.
Another undercover agent was seen. He asked if the patient was in pain, and the patient indicated he had back stiffness. R asked why he was taking Xanax. The patient explained that when he took the Xanax, he "did not need to drink as much moonshine." R palpated his back and noted tightness and tenderness. He wrote scripts for both Norco and Xanax. He sent him for a CT scan of the lumbar spine.
Again, perhaps his biggest blunder was to forget to write the patient's address on the controlled script--a major violation.
The Governments expert testified that the examination was inadequate, that it did not meet the standard of care. The Expert further testified that the doctor failed to chastise the woman about diverting drugs by taking her friend's Norco. After all, the doctor is supposed to feret out any criminal activity, even if he personally did not prescribe the friend's Norco.
The expert argued the doctor knew or should have known that his prescriptions would be diverted. He further stated the locums should have picked up on the moonshine comment and sent him to an addiction or psychology specialist to rule out alcoholism. The court agreed, and found the doctor guilty of "drug trafficking." For those innocent souls out there, who have never trafficked in drugs or taken drugs, like me and most of our profession, that merely translates legally into prescribing controlled substances "without a legitimate medical purpose". There is no legal difference between a criminal selling drugs on the street and a physician getting paid for a medical visit where he improperly prescribes Norco to an undercover officer. Both transactions involve illegal drugs being sold, so says the DEA and the Courts.
R lost his case, his career, and his professional standing over what amounts to the politics of the day surrounding the opioid epidemic. He was not a pill mill, or a doctor who made any extra money on opioids. Just a minority physician, who liked to travel.
COMMENT: When I wrote The Physician Primer 1.0 last year, I had no idea the climate demonizing doctors would get so much worse. But I am happy to say that as a fellow physician working in the trenches with you, there are ways you can practice good medicine and still protect yourself and your pain patients. Get both The Physician Primer 1.0 that deals with State Laws and Medical Board Regulations and The Physician Primer 2.0 that deals with the far more dangerous Federal Laws and DEA and threat of criminal prosecution.
Most law firms will prefer to deal with you only after the fact. Or in the rare cases that offer to consult with you before the fact, they will be charging their hourly rate. I prefer to help you before the fact when it is much easier and cheaper: the cost of a few handbooks. I like to explain that prevention now is so crucial. You shouldn't have to wait for your car engine to blow up, before you learn to change the oil regularly.
Unfortunately, with human nature being what it is, many physicians will wait until it is too late to learn the law. Let me teach it to you know. Us the P.R.O.G.R.E.S.S. forms & checklist I developed and use everyday for The Physician Primer 2.0. I wrote it to first protect me. Let it work to protect you as well.
It is going to get worse before it gets better. The pendulum swing very far in favor of opioid prescribing the past 15 years, and now it is swinging very far in the opposite direction.
This pendulum will take with it a great many physician casualties. I am seeing the weakest doctors getting picked off first. Those in solo practice. Those from foreign medical schools. Those with lesser computer skills. Older doctors.
If you doubt this, than read this site, and notice who the latest victims have been.
I struggle each day with my own practice. Dealing with documentation, utilization review, aberrant urine tests, and deceptive patients.
Let me share with you how I handle it from a medical legal perspective. The more law one knows, the more issues one sees, and the more careful one becomes. You need to prescribe like a lawyer in this opioid epidemic.
Watch this video on the Politics of The Opioid Crisis. It's not funny.
DEDICATED TO DR. FOREST TENNANT & HIS PATIENTS.
Written by a Physician/Attorney Pain Specialist.
25th ANNIVERSARY EDITION: The Pain Patient Handbook.
ATTENTION: PAIN PATIENTS: [ Chronic Pain, Neuropathic Pain, CRPS, Failed Spine Surgery, Fibromyalgia, Facet and Nerve Root Pain]
THE PHYSICIAN PRIMERS
ORDER THE STARTER KIT [Best value] for 179.95. Click the Bar Below:
GET PROTECTED NOW.
100 million pain patients in the U.S. suffer from chronic pain.
The U.S. opioid regulations have ignored these patients by demonizing all opioids and severely restricting the use of pain relievers in all the above.
It used to be only bad doctors who lost their licenses; only those who were incompetent. But now even leaders and specialists are getting suspended:
All physicians, even those who prescribe the occasional Tramadol are at risk if their documentation is not up to current guidelines.
90% of physicians are out of compliance. The penalty is not like the usual for poor documentation [a fine or polite reminder to take a course]. The penalty is loss of license OR worse.
Jail or prison. And if you refuse to prescribe, you may even get shot and killed by an irate patient [Dr. Todd Graham, Indiana Pain Specialist, was murdered by an irate pain patient's husband after he declined to prescribe her Percocet].
Am I being an alarmist? I have personally known and watched as three of my local colleagues were taken down.
Attorney General Jeff Sessions announced August 2, 2017 that he would take immediate action to stem the Opioid Epidemic by deploying a team of 12 Federal Prosecutors to strategic locations across the nation to investigate and arrest Doctors & Phamacicst who are profiting from the Opioid Epidemic.
The various state medical boards are requiring doctors to register and use the PDMP/CURES database to verify patients' opioid prescription activity.
I am a Physician/Pain-Specialist/Former Attorney.
I watched as three of my Colleagues, across town, lost their licenses for poor documentation.
So I wrote The Primer so doctors everywhere who prescribe Opioids don't have to live in fear. And they also don't need to discharge their pain patients.
All a doctor needs to do is to get The Starter Kit: It contains The Physician Primer and 10 Pain Patient Handbooks.
I have used these two remarkable tools to train numerous colleagues over the past year with excellent results.
My patients don't suffer because they get the opioids they need, while the addicts are easily identified and sent for suboxone treatment
My patients are REQUIRED to read the Pain Patient Handbook and turn in Quizzes demonstrating their understanding of risks and alternatives to opioids at the time of EACH visit. It take less than one minute of my time to review.
I supervise midlevels. They require the same documentation and legal education as most of my colleagues who did not attend law school. Their protocols parallel those contained in The Physician Primer.
The Physician Primer is NOT another opioid guideline. It is a method of treatment and documentation that helps keep you, the prescriber, out of trouble, and lowers your risk of both getting shot by a patient, as well as getting your license in a sling by a regulator.
I know. I practiced law. Now I just practice pain medicine.
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Last year my friend told me he did not need to be "that careful". He told me he already did all that stuff in his opioid documentation. Unfortunately he didn't. He no longer practices medicine.
Read the Article in Anesthesiology News by David Holzman 12/27/2017.
Some 28,000 pain patients commit suicide each year due to intractable pain.
Around 60,000 people die each year due to drug overdose. 2/3 of these are from Opioid Overdoses with the most increase coming from illegal opioids like Heroin and Illicit Fentanyl.
Less than 1 percent of the population suffers from opioid addiction while 11 percent or more suffer from chronic pain.
The CDC Guidelines are now being applied as rules by aggressive UR boards.
Some states like Maine have enacted laws requiring ALL opioid patients to be tapered to below 100 MEQ per day.
Other states like California have "soft limits" in place that while not legally binding place extra liability on the opioid prescriber if the patient exceeds 80 or 90 MEQ per day.
Many physicians throw in the towel and elect to stop opioids and place all patients on harsh tapers.
I wrote the Primer and Handbooks from my perspective as physician/pain specialist and former attorney to help both patients and physicians.
Use The Primer and continue to prescribe opioids to those patients who need them. It protects you legally while allowing you to honor your duty to those who truly suffer.
Blogging to you is fun. But after corresponding with many of my colleagues who are now using The Primer and Handbook, I believe the time has come for a Newsletter.
This allows me yet another way of updating all concerned about the developments in Opioid regulations, and what you all need to know to comply and keep your license and practice safe.
RECAP OF RECENT DEVELOPEMENTS:
1. Nevada has enacted some of the strictest legislation in the country regarding opioids with the 3 Strikes you're out policy for Opioid Prescribers, not patients! The fastest track to losing your medical license in any of the 50 states.
2. California is down on Opioids, but up on Marijuana. Strange but true. Seems that its ok for doctors to prescribe THC, but way too dangerous to write for Tramadol.
3. California has lowered the limit under Work Comp Guidelines from 80 to 50 MEQ. The standard is supposed to be evidenced based guidelines. Yet the evidence rooted in science has not changed. Yet in 2014 California's "evidence" supported a maximum of 120 MEQ per day. In 2016 this same evidence dropped the maximum to 80 MEQ. The CDC came out with non-binding guidelines of 50 to 90 MEQ as maximums. Only to be "trumped" by the 2018 California MTUS guidelines of 50 MEQ.
The 4-C flowsheet and the RMC sheets have made it easy for me to argue appeals for IMR reviews in California where I practice. The Primer has been an invaluable tool for me personally and has helped me help those patients who might otherwise have been thrown under the bus.
4. A 70 year old Pharmacist I have known for some 20 years called me the other day. "Doc, the DEA came into my pharmacy and asked why I filled 7 Norco per day on this elderly lady with suspected cancer. He asked me, --'How do you know she needs that many!--I responded that I trusted the doctor."
My friend said the agent was very firm that if he filled more than 6 per day, he risked his pharmacy being shut down. He told me, "Doc, I am retiring after this year. Its not worth it anymore. I have been doing this 20 years, and I have never seen the types of tactics they are using now. I can't practice like this anymore."
So my friends, keep your ear to the ground, or better yet let me do that and subscribe to the newsletter at the bottom of this page. We are not in Kansas any more.
I received a letter last week from a Bay Area physician [who received one of my flyers] who wrote me a note.
He implied my Primer and Handbooks were not necessary to prescribe opioids.
He wrote all you need are: INDICATIONS, ADVERSE EFFECTS, FUNCTION, IMPROVEMENT, ABUSE.
I assume he meant the 4 A's are all a physician needs to prescribe opioids.
I would say the less one knows, the safer one feels about prescribing opioids.
But it is instructive to hear what other experts say:
Jennifer Bolen, attorney and founder of "The Legal Side of Pain", described legal issues surrounding opioid prescribing.
"An opioid pain treatment contract, which may include patient requirements such as providing urine drug samples, and adhering to medication directions, does not serve as an informed consent acknowledgement. Further a signed acknowledgement does not supplant the requirement for an ongoing informed consent process.."
In other words, in addition to documenting the 4-As at each visit, the opioid prescriber should have an opioid agreement + an informed consent which is more than a signed document. It must be an ongoing process of education, information giving, and warnings.
In the Primer System, this is covered in depth with use of the Pain Patient Handbook and quizzes. None of my colleagues who lost their licenses did this, and had they, it may have saved them.
Dr. David Sohn, a fellow MD-JD colleague, wrote an article this past September: MEDICAL-LEGAL RISKS OF PRESCRIBING PAIN MEDICATIONS.
9/25/17 published in the Huffington Post.
He wrote that a Massachusetts physician prescribed Oxydocone for a 75 year-old male with metastatic lung cancer. The patient fell asleep at the wheel striking a pedestrian who then sued the physician for failing to warn of the possibility of sedative side effects.
Documenting the 4-As would not have been enough. My Primer System with the Handbooks, quizzes, and the Informed Consent Process I teach, would have been.
Look at what California's Premier Law Firm in defending medical licenses says:
John Bishop, March 21, 2017 THE CHANGING FACE OF DISCIPLINING PHYSICIANS FOR OVERPRESCRIBING.
"Since late 2015, the Medical Board of California and the California Board of Pharmacy have begun to increase enforcement actions and penalties for perceived overprescribing of prescription drugs, particularly opioid drugs such as hydrocodone and oxycodone. Physicians in California must be particularly careful, because state agencies are carefully reviewing the prescribing practices of physicians, including those in general practice, if there is a suspicion of overprescribing. "
The article goes on to explain that Pharmacists are pressured to report any and all physicians to these Boards if there is any prescription drug abuse.
Many physicians, the article states, mistakenly believe that as long as they don't prescibe a large quantity, they are not overprescribing. In other words, if the careful physician sees his patient more often, and prescribes less quantity he is safe.
"However the Medical Board has taken a different view. For every opioid prescription, the Medical Board Reviewers will be looking for a specific diagnosis: a charted reason why the opioid was necessary. The Board will reason the more frequently a patient visits the facility, the more suspicion the patient should arouse in the physician. Finally, the Medical Board will want to see referrals--to pain management if the issue is pain only, but also to neurologists, orthopedists, or other specialties depending upon the problem."
Having my extra training as a former attorney, gives me a perspective most physicians cannot appreciate. A risk Management perspective as well as a standard medical viewpoint.
The 4-A approach gives the routine opioid prescriber simply enough information to become dangerous. Enough to believe he is safe and following the rules.
Today, prescribing opioids presents not only a risk to the patient with overdose and addiction, but arguably a much greater risk to the Physician with multiple liabilities in the form of civil, criminal and administrative.
What in addition to the 4-As does a physician need to do:
1. Baseline History and Physical Exam
2. Diagnosis that warrants opioid prescription, i.e., "Legitimate Medical Purpose"
3. Opioid Risk Stratification
4. Non-opioid adjunctive and alternative treatment trials
5. Opioid Agreement
6. Opioid Informed Consent: Repeated and expanded and renewed and re documented at multiple visits.
7. Warnings re: use of muscle relaxants, benzodiazepines, and sedatives in conjunction with opioids.
8. Interval examinations and Opioid Risk Assessments using the 4-As.
9. Action for aberrant behavior
10. Goals and exit strategy
11. Perioidic dosage reductions; i.e., use of lowest effective dose
12. Compliance with CDC protocols.
13. Appropriate use of consultants.
14. Periodic CURES/PDMP reports.
15. Periodic Urine Toxicology Tests
So, no the 4-As are not all you need.
I watched a number of my non-specialist colleagues lose their licenses through failure to document and practice properly when they prescribed opioids.
Yes, I have an agenda. And that agenda is help everyone of my fellow physicians who prescribe opioids to prescribe like a lawyer, and to prescribe safely and appropriately, not only for their patients' sakes, but for their own.
I wrote The Primer this summer when I learned my colleague across town was being accused of "poor record keeping" and "improper opioid prescribing". I felt badly that a family doctor, a fixture in our community for 35 years was being sacrificed in the name of the opioid epidemic.
His name once again surfaced in the news last week. Not because he lost his license, and not because anything improper had been proven against him. But because the news media had publicized the accusations the medical board had filed against him last year.
Among the charges were:
#1. Prescribing Percocet to a patient for 5 years without ever warning the patient that it could cause addiction.
#2. Not checking the CURES database [PDMP] to notice 4 other doctors were prescribing Norco to a patient he also prescribed to. Keep in mind this covered the time period of 2014 and 2015 when it was NOT MANDATORY or THE STANDARD of CARE for doctors to check this.
#3. Failure to warn of the risks combining anxiety anti-agents, benzodiazepines, with opioids.
#4. When a patient's urine toxicology test showed an unexpected result, there was no evidence that he took action.
Also keep in mind that the charges were not that he necessarily failed to warn, or that he failed to take action, but that if he did, he failed to document.
BOTTOM LINE: This doctor now is being prosecuted in the media, and he already has been proven guilty on the 6 pm Television News which was reprinted in the newspaper.
And really, how many grown adults don't already know that Percocet can cause addiction?
The current climate is AGAINST Physicians, and We must document LIKE A LAWYER to avoid these same accusations and the family doctor's fate.
I went to law school. I know how prosecutors and regulators think. I know how they attack doctors, and The Primer is a guide that shows a doctor what to document, when to document it and how. I am glad every day that I use it. It protects me; and I believe every opioid prescriber should use it and follow it to the letter. It takes more than a decade to attend college medical school and residency to gain a medical license. Do not give it away due to poor record keeping. Pick my brain and take advantage of what I have learned. 4
Yesterday I read the news that U.S. Life expectancy has dropped a month , probable due to the influence of the tens of thousands of opioid deaths in 2016.
Not due to the millions of heart disease and cancer deaths? Not due to the increase in Morbidly obese [Class III or over BMI of 40] from 3.9% to over 7% now of our population? Not due to the rise of obesity to almost 70% of the population? Not due to the Epidemic of the Century: Diabetes?
Nope. If you enjoy fake news, then believe that opioids are bigger than heart disease, cancer, diabetes and obesity put together.
When you hear a Legislator on 60 Minutes who likens the pharmaceutical companies in the Opioid Epidemic to the Big Tobacco companies in the Cigarette Smoking Era, it is time to get a reality check.
Physician-written Opioid prescriptions have dropped 20% in the past 5 to 6 years. The bulk of overdoses now involve illegal Chinese fentanyl and heroin. These deaths, although tragic, are not related in number, even remotely, to the morbidity & mortality inflicted by cigarettes.
With opioids now, mostly of the non-prescribed and illegal variety, we are experiencing about 90 deaths per day, or around 30,000 per year. Although tragic to their families, this is simply not in the same ballpark epidemiologically speaking as cigarettes.
Compare this to the Death rate due to cigarettes. According to a 2010 report from The Surgeon General, 30% of cancer related deaths are due to cigarette smoke. Cancer accounted for 591,699 deaths in 2014. 30% of these due to smoking would amount to around 200,000 deaths in a single year. More deaths than opioids in the entire last 10 years.
And that is just cancer deaths. CVD risk is increased by 50% even with recent studies on overseas bidi smoking. 614,348 people in the U.S. died from Heart Disease in 2014 as the number 1 cause of death. Figure at least 200,000 of these related to premature CVD due to smoking as a reasonable estimate. Now we are up to 400,000 deaths per year..a few more by a factor of ten to twenty than from opioids.
Over the past 50 years we can very conservatively estimate the cost in deaths related to cigarettes of at least 5 to 10 million. Now if you begin to compare 90 opioid deaths per day to 10 million cigarette deaths, you would be laughed out of the room. No debater could make the comparison with a straight face.
It is simply wrong to compare the Opioid Epidemic to Cigarette Deaths.
Instead, we have a Global Obesity Pandemic, and The Epidemic of the Century-Diabetes, and the world pandemic of HIV with 1.2 million deaths per year, Not to mention Tuberculosis at over a million deaths per year, and Malaria at over a million deaths per year.
Lets restrict the manufacturing of high fructose corn syrup if we really are worried about deaths. Outlaw processed meats containing nitrites and nitrates. But don't feed the American public a line about opioids as an excuse to cut off paying for opioid pain relievers from 100 million Americans.
WHAT ARE THE REAL STATISTICS:
Lets look at the True Numbers from the National Vital Statistics Survey (NCHS: Published December 20, 2016. Volume 65. #10. AUTHORS: Warner & Trinidad, et al) It is easily found in PubMed.
The numbers represent Drug Overdose Deaths in the United States by Drug with raw number followed by %
YEAR 2014 versus YEAR 2010
5,417 11.5% 5,256. 13.7%
3,274. 7% 2,844. 7.4%
4,200. 8.9%. 1,645. 4.3%
10,863. 23.1% 3,020. 7.9%
3,495. 7.4% 3,020. 7.9%
Yes Drug overdose deaths were up between 2010 and 2014. Mainly due to HEROIN with 7,800 additional deaths and Illegal Fentanyl with 2500 additional deaths.
Prescribed opioid deaths from Oxycodone and Hydrocodone remained roughly the same at 8600 in 2014 and 8100 in 2010.
The heavy-handed Opioid restrictions for chronic pain and cancer patients seem to have no relationship with reality with the increase in illegal heroin and illegal fentanyl overdoses. The prescribing restrictions will not affect the street overdoses from illegal drugs.
But like the law or not, it remains the law. And physicians are under the gun. Realize that documenting the 4-A's is not nearly enough.
Make no mistake. You and I and every physician who prescribes opioids needs to document like a lawyer. Use the Primer and Handbook.
Medical Board Launches Investigation into Local Doctor
Article appeared in The Desert Trail. By Jenna Hunt. Jan 17, 2018.
Dr. Prem Parkash Salhotra is facing accusations from the California Medical Board, which launched an investigation last year. An Accusation filed Dec 14, 2017 lists four allegations against the doctor for repeated negligent acts, gross negligence, failure to maintain adequate medical records and unprofessional conduct.
They revolve around his treatment of two patients who were prescribed medicines for conditions ranging from chronic pain to schizophrenia.
If the charges are found to be true, the state could revoke Salhotra's medical license, although sometimes.a sentence may be suspended.
In November, the Morongo Basin Healthcare District honored Salhora's three-decade career and his dedication to the local medical community. The directors presented Salhora with a proclamation of appreciation during their November 2 meeting.
Then-board President Marge Doyle called Salhora "one of the finest human beings I know."
Current board President Bob Armstrong, who noted that Salhora is his personal physician, lavished praise on the doctor.
"I have never known someone who is more compassionate," Armstrong said. "I am proud to have him as my doctor."
The accusations state there were two patients' treatment in question. The first suffered from chronic pain and was prescribed morphine. There was no urine testing or signed medication agreement in the chart.
The second patient had schizophrenia and was prescribed the combination of a benzodiazepine, a sleeping medication and an opioid [The so called law enforcement Holy Trinity-not a medical term].
In spite of the fact the patient was seen in a rural desert community and by a psychiatric physician's assistant, there was no consult by a psychiatrist on the chart, and no recent urine toxicology test.
COMMENT: Your medical license is vulnerable if you fail to either do or even if you do, if you fail to document what you did.
in the Primer, I warn of the Holy Trinity. It is an audit flag for Regulators. Don't have any of your patients on it.
EVERY OPIOID PATIENT MUST HAVE A URINE TOX TEST ONCE OR TWICE PER YEAR. And it must be on the chart. Some patients need the Urine test 4x per year.
It takes 8 to 12 years of undergraduate and professional school training to acquire a medical license. Don't take a chance on losing it to poor opioid documentation.
The Primer and Handbook system is the very best insurance you can ever buy for opioid risk management.
The ASCO, The American Society of Clinical Oncologists, is quite concerned that the current restrictions prescribing and obtaining opioids will have unintended consequences of increasing suffering in the cancer patient populations. The first draft of the CDC Opioid Guidelines would have lumped cancer patients into all the regulatory restrictions: less than 90 MEQ, PDMP reviews, URINE too tests, risk stratification, etc. The final version of the CDC guidelines, however, in response to objection by the Oncology community, exempted ONLY ACTIVE CANCER under treatment, for the restrictions. The ASCO responded that this exemption did not protect the pain of non-active cancer patients: The ASCO stated:that cancer survivors often suffer from recognized post cancer pain treatment syndromes, potentially unique, but nevertheless very real post-treatment syndromes such as:
The ASCO wrote on , "The approximately 12 million cancer survivors in the US population that may suffer pain related to previous cancer diagnosis may be considered similar to other populations with chronic pain. Opioid therapy may be appropriate for a carefully selected subgroups, as long as the risks over time and treatment can be monitored. Providers caring for such patients may want to consider referral to a specialist; additionally, ASCO has developed guidelines on pain management in cancer survivors.
COMMENT: Exactly. Even Cancer specialists are finding themselves disciplined in 2017 due to the expanding morass of non-scientific laws and regulations that make it difficult to properly practice good medical care for our suffering patients. I advise STRONGLY that any physician, cancer specialist or otherwise use my Primer to remain in compliance with the guidelines while at the same time offering high quality pain care to their suffering patients.
You may ask, "Why do Oncologists need to be worried about access to opioids for their cancer patients?"
The answer is because the the laws and regulations concerning prescribing opioids have gotten so complicated that even cancer patients are not able to receive opioids in many cases.
The ASCO states, "It is widely acknowledged that too much pain goes untreated, and while not all untreated pain require opioids, these agents remain an essential part of many pain treatment plans, especially among patients with cancer.
COMMENT: As a Physical Medicine Specialist, I see these "certain populations" of patients; those with phantom limb pain, those with RSD & CRPS, those with thalamic pain, those with arachnoiditis and central pain syndromes.
November 5, 2017
Excerpted from the article by Elizabeth Gardner.
Published in CURE
An ongoing opioid epidemic is making it more challenging to treat cancer pain.
EXTRA VIGILANCE, CAREFUL MANAGEMENT and emphasizing empathy can make treatment for cancer pain more effective during an opioid addiction epidemic, said Judith A. Paice, PhD, RN, during a presentation at the 19th Annual Lynn Sage Breast Cancer Symposium, in September.
Although it's understandable in the current climate that both patients and physicians might approach opioid use with extra caution, this may be excessive in some cases, said Paice, director of the Cancer Pain Programs and a research professor of medicine at Northwestern University's Feinberg School of Medicine, and past president of the American Pain Society. More patients than ever are living with pain. As of 2012, there were 32.6 million people worldwide living with cancer, and that number is expected to jump to 52.2 million by 2030, according to the International Agency for Research on Cancer.
Improvements in cancer treatment have led to millions of patients surviving for more than a decade, with a corresponding increase in the number who live with chronic pain. Paice cited a review published in Pain, estimating that 40 percent of cancer survivors live with some degree of pain and that 5 to 10 percent have severe chronic pain that limits their ability to function. One on five childhood cancer survivors reports pain.
Amid the discussion about opioid overuse, Paice is concerned that some patients remain underrated due to addiction fears that do not match the evidence. "After (the singer) Prince died, people asked me to take them off their fentanyl patches, and I had to reassure them the Prince hadn't died from a fentanyl patch." she said/ Although long-term opioid addiction often begins with the use of prescription pain killers like oxycodone, Price cited research showing that three or four such addicts acquired those pills illicitly rather than through a legitimate prescription.
The CDC issued guidelines for opioid treatment last year, and Paice said that both primary care physicians and insurance companies sometimes treat them as a mandate, even though they may be too conservative to be applied to cancer-related pain. "Many of us protested the recommendation that patients be given no more than 50 mg of Morphine and only a three-day supply at discharge," she said. "imagine that 80 year-old woman who lives far form the hospital, relies family members, is discharged on a Thursday, and now on a Saturday or Sunday has to get a new prescription."
Paice also cited that the sales and deaths from prescription opioid overdoses has plateaued ( although deaths from illicit opioids are still rising).
Paice recommended that health care practitioners who want to give patients the full benefit of opioid pain relief follow some steps [NOT SIMPLE]:
Then after you have prescribed the opioid:
COMMENT: This is how your 80 year old grandmother with cancer pain now must be treated. I don't know about you, but I don't want anyone asking my 80 year-old grandmother if she has been sexually abused.
Its a sad day when cancer patients are subjected to this, but rather than protest, use The Primer for all your opioid cases, cancer docs included.
#1. With my dual background as lawyer-pain specialist/physiatrist, I know when to be concerned and when to take protective action.
#2. Never have I been more concerned about aggressive attacks on my fellow physicians as I am today.
#3. Due to the Opioid Epidemic combined with aggressive politics, there is now enormous pressure on regulatory agencies to make examples of physicians through discipline. Even prescribers of tramadol and even physicians prescribing to cancer patients have been disciplined.
#4. The Primer's flowsheets and forms , at a glance, trigger me to order PDMP and Urine tests, or to, obtain stratified risk assessments, or to contact a colleague for a consult, or to get an informed consent signed or to issue a strike. Never before The Primer was I ever this organized.
#5. My patients all the time have comments like: "I think I took too many pain pills; I cant keep track"---or--"I don't know how I can control my pain without these drugs"---or---"I talked to my adjustor and told her I lost my Percocet bottle at the hotel. Do you have to do something?"
OR..The insurance company issues me letters saying--"Doctor, attached is a packet with special forms and guidelines on opioids. We want you to run a urine test, and conduct a SOAPP assessment and return them to us." ----"Doctor, our pharmacist has conducted a review of John X's medications, and we find that he exceeds the safe morphine equivalent level. Please schedule a teleconference so we can review this".
With use of The Primer and Pain Patient Handbook, I am always one step ahead and Never caught as lacking in my documentation or opioid care.
I read The Physician Primer: Prescribe Like a Lawyer.
I am a practicing lawyer with some familiarity of the cases he described in the Primer. As he stated, the primary case he spoke of, Dr. Young, was charged with crimes related to oversprescribing controlled medications. Doctors can, and are, scrutinized when (by) law enforcement and/or medical boards when allegations of over prescribing are brought to their attention.
I believe that a primer is a great tool in prevention of such allegations. The Primer seems to give the reader information not just regarding the criteria of prescribing, but how to document your path to avoid claims of not following accepted practices. As an attorney is constantly being instructed on how to avoid malpractice, I believe your profession should be instructed also.
David Wilson, Esquire
An Ethical Dilemma for Doctors: When is it Ok to Prescribe Opioids?
By Travis Rieder. The Conversation. Sept 26, 2017. With commentary by J.R. Hope M.D, J.D.
Travis Rieder PhD is a research scholar at the Berman Institute for Bioethics at Johns Hopkins University.
Bioethicist Travis Rieder notes that it wouldn't be ethical to simply STOP prescribing all patients opioids. Given that they are not inappropriate in ALL cases...as the government might have you believe.
He reminds us that opioids relieve suffering and are not always harmful. And that some patients, who have chronic pain and actually need them, contrary to "the evidence," may actually commit suicide when confronted with a life in pain without them.
The current Addiction Specialist--although there is no such thing according to the ABMS--touts the party line that a chronic pain patient can simply get Yoga or meditation, or counseling. Try explaining that to my multilevel instrumentation spinal fusion patient who cannot bend more than 20 degrees, and has balance so impaired they require a cane. I would like to see this so-called addiction specialist train my patient in the technique of the "downward dog".
So if opioids are prescribed responsibly ( I resent that implication as I have NEVER prescribed opioids in 30 years other than responsibly), they still may be necessary in some cases. Yes. Read The Primer. And the 25th Anniversary Pain Patient Handbook which says the same things about responsible opioid prescribing in 1991 as it does today.
The only thing today that is different is not the way I prescribe; but the way the State Federation of Medical Boards has decided to promulgate its Guidelines which change with the way the wind blows.
If you prescribe using The Primer, and the Pain Patient Handbook, and have all your patients read the Pain Patient Handbook,
then you will always prescribe responsibly.
And you won't be cutting your patients off because the Government has a new flavor of the month.
Your patients won't be tempted to commit suicide because you followed some pseudo addiction specialists advice on chronic pain management.
Or worse, you won't be tempted to succumb to pressure to turn your back on pain patients who need your help.
The video is out: BAD WILL HUNTING.
In it we try to capture the plight of pain patients and their physicians, many of whom have dedicated their careers to relief of suffering.
The video dispels two commonly held myths: #1. That opioids are not needed by a sizable minority of pain patients. #2. That irresponsible physicians created the epidemic.
RE #1: Travis Rieder PhD, bioethicist, feels strongly that when opioids are the ONLY method a chronic pain patient has to achieve a reasonable quality of life, it would be unethical to withhold these. I agree, in spite of holding the position that opioids are not my first or even second choice in a patient with chronic pain--as stated in the Pain Patient Handbook--originally published in 1991 and now in its 25th anniversary edition in 2017. However with that being said, there is a substantial place for opioids in the treatment of chronic pain. Especially when one cannot received epidural blocks or botox or functional restoration programs due to authorization or insurance issues.
RE #2: In 1998 physicians were loathe to prescribe opioids for chronic pain. The Federal Government, acting through the Veterans Administration and the Federation of State Medical Boards promulgated position statements advocating that physicians were under-treating pain and that doctors needed to recognize it as the 5th vital sign. The Federation Model Guidelines in 2004 even went so far as to state that failing to treat a patient's chronic pain was a "departure from the standard of care" meaning that if the doctor failed to treat it they could have their license disciplined.
HANDBOOKS SHIPPING NOW....11/20/17..ALL PRIMERS AND HANDBOOKS SHIPPED AND ON WAY
The Handbook has been a lifelong creation of mine and a favorite patient: Byron Boots. Originally written in 1991, the Handbook was written in the language of Byron, a former newspaper reporter.
Byron passed away in 1995 at the age of 69.
The 25th Anniversary Edition was continued in the same style out of respect to Byron, and it has updates on the most current treatments and practitioners.
It was endorsed by Dr. Arthur White, the Spine Surgeon who operated on Joe Montana, and returned him to the football field.
The Handbook contains end-of-chapter quizzes for your pain patients to complete.
The advice in the Handbook is sound and has stood the test of time....some 25 years.
Feel free to contact or fax me at my medical office 530.223.2899 if you have any questions or need status updates.
My patient today told me this story about his disabled wife:
Doctor Hope. I know doctors are afraid to prescribe opioids today. My wife is 72 years old and in a wheelchair. She gets #120 Norco for one month, but it usually lasts her two months.
Her family doctor told me last visit that he had to get a urine test on her. She is incontinent, so it is very difficult to get a sample. He said, "I know she is not addicted, but I have to get a urine test on her. It is the law, and I don't want to get into trouble."
So he ordered the test at Lab Corp. I went into the bathroom with her and she fell onto the ground, I had to drag her to the bathroom door and needed the Lab Corp employee to help me get her up. It was awful. She required total care. We got a few drops and they said it would have to do.
My doctor said there was no other way. He knows she is in pain, and he told me he knows she is not abusing her medicine, taking less than 2 pills per day, but I saw the look of fear in his eyes. He is afraid to write the prescription, but he knows she needs the medication.
COMMENT: We have a system that creates either over or under regulation that relies more on politics than science.
Regardless, if a doctor wishes to retain their license and at the same time not violate their Hippocratic oath to keep patients from suffering he must walk a fine line. Thats why I wrote the Primer. This allows physicians to practice without fear. It keeps them in compliance with the current regulatory guidelines while not creating suffering in their patients.
Today I reviewed a letter from a colleague about opioid prescribing concerns. He wrote:
I am a physical medicine specialist working in a rural area where there is limited access to comprehensive and alternative pain management services due to distance, insurance coverage and cost:
Over the years, I have inherited a volume of legacy pain management patients who are on higher dose opioid regimens [100 to 400+ MEQ daily]. What do you suggest for these patients given that insurance companies are increasingly limiting provision of high dose opioids, and many are begrudging or unwilling ro consider tapering off their current regimen?
The Primer and Handbook combination are the best first step.
As I am also a physical medicine specialist, and I have previously directed a multi-disciplinary functional restoration program [pain clinic], I too have accumulated many patients on opioids, some of whom are on high levels of opioids, and who have done well, with consistent toxicology tests, PDMP reports, family support and function for years. And they do not see any need to change what has been effective for them.
The answer has several facets:
#1. Legal and Regulatory: The CDC has established guidelines that specify 90 MEQ as a maximum level for new opioid patients with justification and Specialist consultation required for higher doses. As I write in The Primer, I strongly recommend that even a specialist get a second opinion when maintaining someone on higher doses than this, even with justification. In today's anti-physician climate, it is a good risk management strategy.
I also write that if the patient is on Fentanyl or Methadone, you will want to rotate them to safer opioids, such as Butrans or Suboxone or even Nucynta. This may not always be possible due to insurance issues, but it is desirable.
If they have any elements of high addiction risk, such as a positive risk stratification screen [ORT, CAGE, or SOAAP] or mental health issues, then I also recommend a Psych evaluation for opioid use disorder.
If they remain stable, are of low risk, and are off the above opioids, and you have a concurring second opinion, then the last thing you need to remember is to try a taper of some small amount at least twice per year. Of course, you will need to implement all the usual opioid risk tools such as urine too, 4-A reviews at each appointment, etc, but I am speaking now of the special considerations of the high opioid case.
#2. Clinical Considerations. Most patient on opioids for many years will be resistant and closed minded to any changes. The physician needs to do some soul searching and see if his/her philosophy is also encouraging ongoing opioid use.
I REQUIRE every opioid patient to read and take the quizzes in The Pain Patient Handbook. This is a comprehensive 12 chapter book covering almost every known treatment for chronic pain, both opioid and otherwise. It is written in patient friendly language and not meant to be a text or comprehensive, but to provide an overview.
Even in the most resistant patient, I have found that after about 3 or 4 chapters with discussion of the quizzes, the patient suddenly become more open about trying injections, therapies and non-opioid adjunct medication. I seize these occasions as teachable moments, and use them to add Lyrics, acupuncture, epidurals, RFLS, and TENS type treatments.
I might lower their 125 mag Fentanyl to 112 while doubling their Lyrica or adding Elavil. I meant double their Depakote while changing their Percocet from 10 mg strength to 7.5. Nothing big, and nothing fancy.
I use small increments. Even writing a script for #68 Norco instead of #70 is a move in the correct direction.
#3. Make use of Buprenorphine. Whether it is in patch form or sublingual, it tends to lower any hyperalgesia and make subsequent rotations and tapers better tolerated.
SUMMARY: None of us need to panic, and we absolutely do not need to make our patients suffer. Your treatment should never depend upon third party payors or sudden new and arbitrary regulations.
My Primer and Handbook are practical, and they help both patient and prescriber.
ARTICLE FROM THE FRESNO BEE. April 13, 2017. Barbara Anderson.
A Porterville doctor accused of excessive prescribing opioids and sedatives to four patients between 2010 and 2015 has agreed to discipline by the California Medical Board.
In a stipulated settlement, Dr. R.G.'s medical license was revoked, but the revocation was stayed and he was placed on 5 years probation. The board had accused R.G. of unprofessional conduct, gross negligence, excessive prescribing and inadequate record keeping. The settlement and disciplinary order became effective April 7. R.G's lawyer said the doctor provided appropriate care and was prepared to challenge the board's accusations, "But it was easier for him to agree to the limitations and keep practicing," he said.
R.G., a family doctor at the clinic in Porterville agreed to the five-year probation and terms of the settlement. In a 26 page accusation filed against R.G. by the board on July 21, 2016, the medical board said that in the care of four female patients R.G. had "inappropriately and excessively prescribed high-dose opioid and sedative medications in the absence of an appropriator prior medical examination and medical indication."
An expert who reviewed the accusation against R.G. was prepared to support the treatment R.G. had provided to the patients. The attorney said that R.G. decided to agree to the terms of the settlement partly because of the cost, expense, time and effort of fighting the accusation.
COMMENT: 4 patients in 4 years. The medications involved were Vicodin, Soma, and alprazolam.
This combination is a MAJOR AUDIT FLAG and is referred to as the Holy Trinity by law enforcement. It is well described in The Primer.
This is a case that COULD HAVE BEEN AVOIDED had the doctor read The Primer and followed its advice. Now the doctor cannot prescribe most controlled substances and must take 200 hours in threes courses: ETHICS, DOCUMENTATION, AND PRESCRIBING, and hire a Specialist Physician at his expense to monitor his charts for 5 years. Not to mention the cost of his attorney.
Your car shouldn't have to blow up first before you learn how to change the oil. The Primer is easier & way cheaper than 200 hours of court-ordered education.
A Northern California doctor found out the hard way the Tramadol prescribing can cause one to lose their license.
First let us consider that doctors universally consider Tramadol as the least dangerous analgesic with very low mu-receptor activity. It was NOT even classified as a controlled substance because of this prior to 2014.
However, on July 2, 2014 was officially reclassified to a schedule IV controlled substance, immediately creating huge liability for physicians who misprescribe it.
So in 2016, a Northern California doctor's license was revoked by the Medical Board when the doctor misprescribed tramadol to two patients. The patients had chronic pain, one from a low back injury at work. And when the tramadol didn't do the job Percocet was added. Big mistake. Because prescribing tramadol with Percocet constitutes the use of two short-acting opioids. The chart reviewers felt this was gross negligence as the doctor should have chosen a single long acting opioid instead.
Her license was revoked for 3 years for prescribing tramadol to these 2 patients. But the revocation was stayed on terms of 3 years of probation. She will need to take courses in Prescribing, Documentation, and will need to pay a Specialist Practice Monitor to review all charts for 3 years. And she may not supervise Physicians's Assistant for the 3 years.
COMMENT: This is one of the harsher examples I have seen, and quite frankly, I was shocked. But documentation would have saved her. Had she included warnings of the danger of opioids, had she documented her reasoning in detail about why two short acting controlled substances were needed, and had she obtained and had a specialist consultation on the chart agreeing with her, all of this could have been avoided.
I am convinced that at least 90% of prescribers now are out of compliance with the new laws, including reclassifying tramadol as controlled.
With the new CDC guidelines, she could have been criticized for adding a long-acting opioid as the guidelines specifically recommend AGAINST these too.
The Primer contains all of these recommendations and more, as well as flowsheets and forms that guide and remind you. It is a lot cheaper and less painful than a Medical Board investigation and 100 hours of remedial coursework.
Since I had to first get my own opioid practice in order, I developed various forms and flowsheets to simplify the process. All your opioid patients will need to sign at least two additional forms, separate from the pain Contract. Some states require doctors to provide informed consent with EACH OPIOID SCRIPT WRITTEN.
That is just the tip of the iceberg.
I reviewed dozens of Actual Medical Board Accusations and the legal language. I walk you through examples, and what the doctor could have done differently to avoid the suspension. Naturally, my forms and flowsheets and system will protect you as they do me. Nothing is guaranteed in life; however I prescribe opioids to those who need them, and I sleep well at night. So should you. Get the Starter Kit and get protected.
Most Physicians only take a documentation course ONLY AFTER THEY ARE COURT-ORDERED as part of their License-Discipline program. Look up the ones at U.C. Irvine or U.C. San Diego School of Medicine. They are designed to meet requirements:
"It is specifically developed for those who have been found deficient in medical documentation either by hospitals or Regulatory agencies." At a cost of $1350 for the 17 unit CME class. Not to mention the cost of attending the class, missing time away from the office, and traveling to the course.
But your car shouldn't have to blow up first before you learn how to change the oil.
My Primer is what all opioid prescribers should learn before they get into trouble, not after.
New products are coming soon!
Great Question. Let me answer it with another question(s):
Why is it that the Past President of The American Academy of Pain Medicine got investigated for 4 years by the DEA?
Why is it that the Past President of the Mississippi Medical Association who was also The Family Practice Physician of the Year in 2003 surrendered her DEA license?
Do you honestly feel you are either more qualified or more careful than either of these two?
The answer is two-fold:
1. Public Policy dictates how forcefully and with how much scrutiny the Regulatory agencies will pursue prescribers.
2. Currently with the Opioid Epidemic the Public Policy is this: The Opioid Epidemic is felt to be doctor-driven. And the Attorney General has declared war on doctors who profit from it. That means any physician who prescribes any opioids is at risk. And if your documentation is less than perfect, and any patient of yours has a bad outcome, or if you stand out in any way in the PDMP database, there is a good chance your charts will be scrutinized.
Trust me. I am concerned and I have ramped up my documentation. So should you.
Attorney General Jeff Sessions announced Wednesday August 2nd, 2017 that he was starting a Health Fraud unit and dispatching 12 Federal Prosecutors to strategic locations across the country to feret out and apprehend overprescribing practitioners. This means that the CDC Pain Management Guidelines will take center stage. If you prescribe anyone over 90 MEQ, you had better have spot on documentation in this Opioid Epidemic Doctors need doctors license protection in this environment.
Translation: Jeff Sessions is going after doctors who prescribe lots of opioids. Regardless of who they treat or why, their names will be investigated if the PDMP database reflects they write a lot of prescriptions.
So take heed pain and cancer specialists. The best protection is to obtain and follow the Primer. Get your documentation and practice up to snuff immediately. Opioid prescribing in 2017 requires precision; precision found in The Physician Primer: Prescribe Like a Lawyer.
On July 26, 2017, Dr. Todd Graham, a rehabilitation specialist in Mishawaka Indiana followed CDC Guidelines and told a patient that her pain should not be treated with Oxycodone.
The patient accepted this; however her husband became enraged and left the office in a fury. He returned later and confronted the doctor in the parking lot where he shot and killed him with a semi-automatic weapon.
COMMENT: There are no easy answers here. In the Primer, I write a lot about patient selection which can lower your legal and physical risks, I also advise some other strategies that may be applicable to this situation. They will not hurt and may well help protect you and decrease the chance of this type of event occurring.
Dr. Fishbain, a Florida expert has written extensively about pain patient suicide risk and homicide risk. I would advise you to read his articles and studies as well.
The Primer is designed to lower your Regulatory risk, the risk of overdose to your patient, and finally to reduce the risk of angry retaliation from patients by showing them that you care.
There at least half a dozen guidelines out there which in general provide "best practices".
These provide ZERO guidance for what documents and steps each provider NEEDS to show to stay out of trouble. 90% of the charts I have reviewed could be subject to discipline if reviewed with a critical legal eye [such as by the DEA or Board].
Its really similar to a freshman college student feeling good about knowing the class and the material UNTIL he takes that first test and finds out where his knowledge gaps actually are. My flowsheets contain built-in reminders to document each and every warning, consent, patient education, change in dose, change in opioid risk in an efficient, quick, and chart-friendly manner. I provide 5 and 10 point chart-review tools for self-assessment so you can check your compliance.
I reviewed dozens of Medical Board filings and designed my flowsheets and risk tools accordingly. Reviewers for the Medical Board who are trained to discover charting gaps and errors felt my primer was an excellent tool for staying out of trouble and in compliance.
Is it Pediatric Neurosurgery?
Or Redo Coronary Artery Bypass Grafting in Patients with CHF?
No, its prescribing opioids to those in Chronic pain. Given the country's Opioid Epidemic, law enforcement agencies are aggressively going after medical professionals who illegally prescribe these highly addictive drugs.
"Physicians and other practitioners who prescribe controlled substances are participating in what is perhaps the most high-risk practice of medicine today." writes attorneys Brandon Essig and Jack Sharman of the Alabama law firm of Lightfoot, Franklin & White in Medical Economics.
"The risks to doctors who prescribe opioids to treat pain patients are compounded by the fact that the federal and state regulations do not clearly define what is unlawful."
COMMENT: The best steps to take are to document and utilize best practices in terms of informed consent and patient education. The biggest problems I see when I review discipline cases are:
1. Failure to document.
2. Failure to warn.
3. Co-prescribing risky combinations.
4. Failure to get consultations.
5. Failure to update opioid risk.
I cover all this in my Primer and provide easy to use flowsheets and real time risk tools to make you much safer in this treacherous environment.
The best way I can answer it is this. I didn't have the Primer written a couple of years ago. This is how I practiced:
1. PDMP checked whenever
2. Urine Toxicology checked whenever
3. Opioid Agreement done.
4. Patients rarely stopped or lowered opioids.
I flew by the seat of my pants more. I did not focus on legally polishing opioid charts.
Now here is how I practice differently today with The Primer.
1. Opioid Informed Consent Forms done In addition to Opioid Agreement.
2. Every patient given detailed informed consent on other dangerous medications.
3. Real time Opioid Risks updated each visit.
4. Warnings documented each visit.
5. Morphine Equivalents calculated each visit.
6. PDMP and Urine Toxicology schedule checked each visit for frequency and compliance.
7. Strikes documented with Standardized form.
8. Every patient given comprehensive education on all non-opioid treatments.
9. Major focus on strict opioid risk management.
10. Multiple patients have successfully lowered opioid equivalents without compromising their pain control.
Nothing falls through the cracks with my flowsheets, forms and risk management and educational tools.
Keep in mind, with the system of forms and flowsheets this does NOT take much more time. It is a matter of getting organized. And it is crucially important for ANY physician who prescribes opioids. Being a lawyer too no doubt has helped me design these forms. Let me share them with you. They work. And it is the best and cheapest insurance you will ever get. You don't want to spend 10,000 dollars later once you have to defend yourself to the DEA or Medical Board.
I reviewed a recent Medical Board Accusation against a fellow physician across town. I had attended a concert with him 10 years ago.
He was supervising mid-level practitioners who practiced at their own office. His duty was to review a sampling of their charts every month. Although he practiced good medicine, one of his mid levels had not documented well in a few of her opioid patients.
As a result, his license was revoked, and he was placed on probation for 3 years. The Medical Board wrote that he had never examined the patient, the patient had never been warned of the risks of opioids combined with benzos, and there had been no tapering attempt on the opioid patient in 5 years.
I supervise PAs and NPs. Make sure your protocols are clear on opioid patients and USE THE PRIMER to insist they use the flowsheets and risk tools. Also, I review ALL of the opioid charts regularly because today that is the area of greatest liability.
My friend across town, a kindly Family Practice Physician of 35 years, just got fined $100,000 by the DEA for documentation errors. Now the Medical Board is accusing him of over-prescribing opioids and wishes to suspend his license to practice medicine. I reviewed the legal language of the Medical Board Filings against him. Although he had signed opioid agreements, did urine toxicology testing, and practiced good medicine, the board nit-picked his documentation to death.
Although he had warned that Percocet can cause opioid addiction, he could not prove he told the patient that. Although he conducted baseline testosterone tests, he did not have the labs in his chart.
Although he performed testosterone injections, he failed to record the lot number of the testosterone vial he used. He failed to record responses to the patient's daughter's telephone calls expressing concern over her father's Percocet use.
Furthermore he failed to document his patient education regarding alternative non-opioid forms of treatment. All of these was considered "an extreme departure from the standard of care" that would subject him to license revocation. In addition, there were 14 more counts added to this for other acts, or shall we say, "non-acts", or shall we say "non documentation of acts".
This does not seem fair. The Medical Board, comprised of many lawyers and enforced by police, against a book-smart but naive family doc is not a fair fight.
So I had to write the Primer. Doctors don't know what they don't know; especially when it comes to legal issues. If only my friend had used the Primer before his charts got reviewed.
Have you noticed that the physician's documentation burden has grown exponentially over the past 10 to 12 years?
Nowhere is this truer than with opioids.
Whereas in 2005, doctors had reasonable documentation requirements, 2017 has become the brave new world of Big Brother, where doctors seemingly have an impossible documentation battle.
What if you forget a consent or a warning? What if you lapse on the time to do a CURES/PDMP or a URINE? Trust me, the Regulatory Boards are NOT forgiving. Ask Dr. Lucias Lampton of the Mississippi Board of Health. Ask Dr. Dwalia South, family practice physician of the year and board of health member. Ask Dr. Lynn Webster, past president of the American Academy of Pain Medicine.
No where is compliance with rules and deadlines and consent forms more important than with following the Opioid Regulations.
I developed The Primer to provide my fellow doctors a system to protect themselves. It is simple and powerful. It is user friendly. It triggers you to get the right forms, opioid risk measures, and toxicology screens at the right time. So you don't miss deadlines. And don't become vulnerable to Regulatory Agencies. I like The Primer more each day as I use the Flowsheets in my own practice.
Don' let your license become the next statistic of the Opioid Epidemic.
If you think a malpractice lawsuit is bad, then imagine that multiplied by ten and you have an idea what a Medical Board Action can do to you.
With a malpractice case, you still can practice medicine, while your insurance company fights for you, all expenses paid (assuming you have malpractice insurance).
With a Medical Board Action, you may be suspended from practice while you contest the charges. Imagine having 25,000 in attorney expenses and having to pay all your bills with zero income. If any of your opioid patients die, the Board may place you on immediate suspension because of a public health risk. Even if the patient's death was a suicide while taking your opioid medication--if you did not document properly, you may be suspended.
Doctors are brought to the attention of the State Medical Board through 4 main avenues:
1. Patient and family complaints
2. Insurance Carrier reports
4. Law Enforcement/Coroner
THE ACCUSATION: Once the medical Board has determined that there is a prima facie case for discipline due to substandard practice, they will issue an accusation. This usually will contain background information and multiple counts of negligence. The background will contain the date your license was issued and the history of any prior discipline.
Once the Board has established a prima facie case, the burden shifts to the doctor to attempt to disprove each and every count.
At this point the doctor usually hires a lawyer who specializes in License defense. The retainer fee can vary from $5,000 to $15,000.
A hearing is scheduled at which time the parties may produce witnesses and evidence. Often, a deal is struck and the doctor essentially "pleads guilty" or accepts the charges as true in exchange for leniency by the Board. This usually means the license is revoked, but the revocation is "stayed" so long as the doctor follows the terms of probation strictly.
Probation terms are usually as follows:
1. Doctor must take remedial courses in
a. Medical Records Keeping aka Documenting.
b. Professionalism aka Ethics.
This course work is at least 40 hours per year, usually for at least 5 years. This is to be done in addition to CME requirements
2. The doctor must hire a practice monitor with an ABMS certification to review him and supervise all care for the period of 5 years. This is done at the doctor's expense.
3. The doctor must notify the board if he intends to travel out of the state or if he intends to take a break from practice.
4. If the doctor fails to do any of the above for any reason, his license revocation is applied meaning he loses his right to practice medicine.
This is all highly humiliating, expensive, and awkward.
The bottom line, an ounce of prevention is worth the pound of cure, and it is much better to study documentation with the Primer now when it is cheap and easy, rather than later when it is expensive and court-ordered.
In The Primer, I include many examples of both what NOT TO DO and what TO DO.
This is THE KEY to documenting properly. And it is THE REASON most doctors don't know how to do it.
Informed Consent is a legal term. It applies when someone with higher knowledge imparts this to someone with lesser knowledge,
If a Ski resort sells you a lift ticket and you ski off the mountain and break your spine, and become a paraplegic, you can sue because they failed to warn. They failed to warn you of this possibility and you could claim had you been warned, you never would have taken such a risk. So the Ski Resort posts a warning on the back of each lift ticket, "this activity may result in severe injury, death or paralysis". Now you cannot claim you did not know. You cannot sue as easily.
The same goes for surgical informed consent. And now the same goes for opioid informed consent.
If you don't warn, the argument is this, "Doctor, if you had only told me that if I took this Norco I might become addicted for life, I NEVER would have taken it.:" Or " Doctor if you had only told me there was another way to control my pain like epidural blocks, I never would have risked dying of an overdose with this Fentanyl".
So, doctors as fiduciaries, this imbued with special medical knowledge have an obligation, a duty, to warn and inform. If they breach this duty they become liable for civil, criminal and administrative punishment.
I explain all of this in The Primer and how best to provide effective informed consent that protects you. You might say that I also have a fiduciary duty to share my legal knowledge with the you, my fellow physician who uses The Primer. I love to teach, and I enjoy helping not only my patients suffering from pain, but helping also my colleagues who I feel are being unfairly targeted in this Opioid Epidemic. That is my motivation for writing it.
My Best Answer: If You Currently have ANY patients who have a SIGNED OPIOID AGREEMENT, then you need The Primer. Without Question.
Since I have published the Primer, I have reviewed nearly 100 Medical Board Accusations and License Revocations. This is what I found:
This scenario played out just today in my office:
Patient doing well on her Butrans Patch 15 mcg per 7 days with Tramadol 100 mg for breakthrough pain. The patient passed her 4-A review and a CURES (PDMP) printout was compliant.
She exercises regularly, does daily stretches, and is very pleasant. She is on 46 MEQ per day.
Opioid Risk Assessment was updated using the ORT. On intial consult, 2 years ago, she denied any history of substance abuse. On her ORT today, she admitted Cocaine and Meth in her 20s, but she has been clean and sober for 20 years.
Her Opioid Risk Tool scored her "High Risk". Most recent UTOX was 5 months ago. I told her we would need a urine sample today. We also agreed her goal would be to lower her opioid to 20 MEQ or less given her risk for addiction.
At the conclusion of the visit, I reminded her to stop at the restroom and leave a urine sample. She looked concerned and said, "I need to warn you, it will be a dirty test, because I took two Norco."
What would you do?
COMMENT: If you answered, "Issue a Strike!" then you are correct. If you said, "Ah, don't worry about it today, we will get one next time." then get ready to surrender your DEA permit because thats what they would want you to do. If you failed to do anything else, get ready for the Medical Board to revoke your license, because if this came to light they would. If the patient were reporting back to their compensation carrier, you had better believe they would shine a BRIGHT SPOTLIGHT on it.
If you would have gone on to your next patient, because you were too busy to deal with it after the visit had already ended, get ready to spend some time driving to and from the Medical Board office, because you will eventually have to attend a Revocation Hearing.
The patient was issued a strike and referred to a psychologist to test for Opioid Use Disorder. The patient was brought back into the exam room and further history was obtained. She had obtained the Norco script a year earlier for dental work.
I took additional steps which I advise in the Primer. A Strike is a legal document that MUST be issued in these circumstances. I also lowered her to Butrans 10 MEQ.
If all of these steps did not occur to you, you MUST get the Primer immediately. Your license depends upon it.
Dr. Alwin Carl Lewis v. The Medical Board of California: CASE DECIDED BY THE CALIFORNIA Supreme Court on July 17, 2017.
ISSUE: Can the Medical Board of California Search the CURES database whiteout a warrant to gather information against a doctor?
FACTS: In 2008, Dr. Alwin Carl Lewis, a physician in California, was reported to the Medical Board by a disgruntled patient who took issue with his recommendation that she go on the "5-bite diet". The diet is to eat nothing for breakfast, eat 5 bites for lunch, and another 5 bits for dinner. Thats it.
After receiving this complaint, Board began its investigation against Dr. Lewis. Finding the diet advice rather flimsy evidence over which to discipline the doctor, the investigators decided to dig deeper. They printed out the doctor's CURES reporting records which totaled 205 pages and contained prescribing information on hundreds of of Dr. Lewis' patients.
Out of these hundreds they found 5 patients to have investigable issues. So they asked the five patients for permission to review their records. Three patients agreed and two refused. The Board got the three patient's records from the doctor, and then used subpoena power to obtain the other two cases.
The Board obtained 3 years of prescribing records from CVS pharmacy.
They reviewed the opioid prescribing documentation, and issued a number of charges including:
#1. Excessive prescribing.
#2. Unprofessional Conduct.
#3. Prescribing dangerous drugs without an appropriate examination.
#4. Failure to maintain adequate and accurate records.
The Board revoked the doctor's license but stayed it provided her follow probationary terms for 5 years.
The doctor appealed challenging the use of the CURES report without a warrant arguing that it violated the patients' privacy rights and the State and Federal Constitutions.
DECISION: The court ruled against the doctor and for the Medical Board upholding the revocation. The reasoning was that the doctor was not the holder of the patient's privacy privilege, and that the states interest in investigating the use of dangerous drugs outweighed any privacy concerns.
COMMENT: Prior to 1991 the California Medical was know as BMQA, the Medical Board of Quality Assurance, and there were only 150 to 200 cases of doctor discipline per year. Following the renaming, investigations were stepped up immediately to 5 or 10 fold.
Now there are about 5,000 assistant attorneys working on many thousands of investigations against doctors who are viewed as greedy and arrogant, and drivers of health care costs. Even though doctors account for around 18 percent of direct health costs through their fees, through their prescription pens (medical equipment, prescriptions, and hospitalizations) they account for 82 % of costs.
5,000 lawyers investigating around 100,000 or so physicians is not really fair fight, especially when the doctor reported for the "5 bite" advice by a disgruntled patient is disciplined because of an all-out investigation over totally unrelated issues.
Shooting fish in a barrel is a more apt description.
If the doctor had used my Primer in his opioid documentation, it would likely not have been so easy. As a lawyer, I know what they look for and how to make sure you are not an easy mark when they review your records.
Everyone has heard of the Opioid Contract. But why a Controlled Substances Agreement?
Because the DEA and State Medical Boards will both Discipline you for prescribing long term benzodiazepines without such an agreement.
Benzos are the new opioids. If you prescribe lorazepam 3x per day for years, and the patient gets into trouble, you had better have a CSA on the chart, and have issued warnings on Benzo risk. You also had better have a Psych Consult on the chart agreeing with your prescribed lorazepam.
If you have documented well, and have done your warnings, and have a consultant who concurs, then you stand a chance of defending your license if the patient overdoses. If you have prescribed Opioids with the Benzo, your ability to defend gets much tougher.
The DEA refers to Opioid + Benzo + Soma as the Holy Trinity. It is not a scientific term, but it is a law enforcement term you had better learn if you wish your license to survive the Opioid Epidemic.
What do you feel the chances are that the Medical Board will review your charts or worse, sanction your license?
The answer might shock you.
In California consider this:
Bottom line. If you prescribe opioids in 2017 and thereafter, get protected by documenting by the book.
Lets say you do everything right. Signed Opioid Contract, Urine Tox Tests, CURES/PDMP checks.
Let me ask you some questions.
#1. How many different patients do you see each month?
#2. Of those how many take Schedule II opioids (Oxycodone or Hydrocodone or Long Acting Preparations)?
#3. How many of those take sleeping meds, muscle relaxants, or benzodiazepines?
#4. How many of those have bi-polar, unipolar depression, anxiety, psychosis, or PTSD?
#5. Of those opioid patients, how many test positive for Alcohol or THC?
#6. Of those with more than just Class II opioids and some of #3, #4, and #5, how many of those have received Psych Consults on the chart?
#7. Do you have written warnings in place for all patients on opioids? And additional warnings on all other dangerous medications?
#8. How many of your patients you have prescribed Tramadol do not have Opioid Contracts on their charts?
#9. How many patients do you have that are on more than 90 MEQ per day?
#10. How many patients do you have that are on more than 120 MEQ per day?
#11. How many patients do you have on more than 200 MEQ per day?
#12. More than 300 MEQ?
#13. More than 400 MEQ?
COMMENT: The rules have changed so fast that most prescribers are out of compliance. Not because they are not conscientious, but because it really isn't fair to change the rules in the middle of the game.
In 2014 the California Medical; Board stated that 120 MEQ was appropriate provided the Medical Board Guidelines were followed. In 2016, the Board changed this to 80 MEQ making all patients over this suddenly out of compliance with the stroke of a pen.
New rules are emerging daily that can subject you to discipline. My goal is to help all opioid prescribers stay in compliance while at the same time providing good and compassionate pain management care.
Get the Starter Kit:
#1. Arm your patients with complete education on non-opioid and non-pharmacologic strategies and treatments via the Pain Patient Handbook.
#2. Use My Physician Primer on Prescribing Opioids like a Lawyer. I wrote this with my backgrounds as lawyer-physician-pain specialist. It is much more than a best practice guideline. Although it incorporates best opioid practices, it gives you invaluable insights and tips on how to lower your chances of being audited, standing out, and getting into compliance fast. The strategies also guide you on how to treat your patients with compassion and care, while at the same time lowering opioids and enhancing quality of patient care.
It goes beyond the standard opioid agreement and UTOX testing and PDMP report checking. 90% of prescribers are out of date at this time and subject to discipline
Use my informed consents, flowsheets, real time opioid risk tools. Use my code of conduct guidelines, my formulary recommendations and the tools developed for my own practice that quickly get you into compliance.
Don't let your license become the next statistic of the opioid epidemic.
in 2015 California and the Medical Board considered up to 120 MEQ per day reasonable.In 2016 the Medical Board revised the "maximum" without special justification to 80 MEQ per day.
How does one justify the need for amounts exceeding these?
I cover this in The Primer.
My pain patient and I wrote this in 1991, and it is a concise, short and easy-to-read synopsis of all treatments for chronic pain. It has been updated to include Buprenorphine and addiction treatments.
It contains risks of all the commonly used classes of medications including opioids, benzodiazepines, muscle relaxant, sleeping pills, NSAIDS, gabapeninoids, tricyclics, SSRI, SNRIs etc.
It discusses pain clinics, physical therapy, cognitive therapy, epidural and facet blocks, as well as spinal stimulators, pain pumps, tens units, chiropractic, accupuncture, etc.
There are extensive discussions on spine surgery, fusion, laminectomy and how & when to select a spine surgeon. The book describes all the practitioners from rheumatologist to neurologist to physiatrist. And it is the best informed consent any pain physician can provide.
It is the companion book to the Primer and is mandatory reading for your opioid patients. It takes much of the legal & educational burden off of you, and requires the patient to do the work and more importantly, to shoulder at least one half the responsibility.
You no longer can be blamed for forcing him to swallow the pills and keeping him in the dark about the risks of opioids. You also cannot be accused of failing to educate and offer non-opioid alternatives.
You are seeing a new patient with few records.
He is moaning and groaning, and explaining how he has been in bed for the last 4 weeks because he has no pain medications. You run a PDMP and see he has been taking long acting Oxycodone 30 mg QID for the past 6 months. However his doctor of 15 years has been disciplined by the Regulatory Board and has stopped prescribing.
At the first visit the patient has a consistent toxicology test, and has no history of addiction. However he is 65 years old, and is covered with tattoos. He admits he did prison time for 2 years some 3 years ago.
He also admits federal prison time 25 years ago. His MRI shows degenerative disc disease. His exam shows normal reflexes and strength.
What do you do?
The Primer helps you deal with this but many issues of HUGE legal risk are raised by this example.
1. Obtain at least the last 3 years of records.
2. Realize that this patient could be working with law enforcement to investigate you.
3. DO NOT start with opioids.
4. Offer non opioid treatment.
5. Gather updated imaging.
6. Send out for spine specialist consultation.
ANSWER: Great Question!