Pain Doctor on DOJ Settlement: ‘It Was Extortion’

By Pat Anson, PNN Editor

A southern California doctor who paid a $125,000 fine to settle allegations of illegal opioid prescribing says federal prosecutors threatened to ruin his practice and reputation if he didn’t pay up.

“They could care less if I was innocent or guilty. They wanted to see how much they could gouge out of me,” said Dr. Roger Kasendorf, an osteopathic physician who specializes in pain management in La Jolla. “They tried getting $24 million from me until they saw my bank account. I had to hire a good lawyer and pay them too.

“It was extortion and there’s nothing I was able to do about it. It’s sad and pathetic.”

The U.S. Attorney’s Office in San Diego announced the settlement last week in a press release, alleging that Kasendorf “illegally prescribed opioids to his patients.”

“This investigation arose from data analytics tools which allow the Department of Justice to perform a variety of functions, including identifying statistical outliers, such as which doctors prescribe the highest opioid dosages and which doctors prescribe combinations of opioids and other drugs known to increase the risk of addiction, abuse, and overdose,” the office said in a statement.

“Based on the investigation, the United States contends that Dr. Kasendorf wrote prescriptions for opioids, including fentanyl, that were not issued for a legitimate medical purpose and while not acting in the usual course of his professional practice in violation the Controlled Substances Act and the False Claims Act.”

The DOJ statement makes no mention of any patients being harmed or overdosing while under Kasendorf’s care, and no formal criminal charges were filed against him.

Kasendorf says the DOJ’s case was based on inadequate medical records he kept on five of his sickest patients, who were prescribed relatively high doses of opioids for pain. One of the patients has since died from cancer.

“I didn’t know my EMR (electronic medical records) very well. I didn’t keep good notes. And as a result, they went through my notes and said, ‘Oh look you didn’t do this and you didn’t do this.’ I did, but I kept poor documentation,” Kasendorf told PNN.

“Nowadays, if you see any of my notes over the last three years, they’re perfect. But back in the day I didn’t have great notes.”

DR. ROGER KASENDORF

Kasendorf has a simple explanation for why he agreed to settle rather than defend himself in court.

“It was cheaper to pay it than defend it. So, I just paid it,” he said. “If I didn’t settle, they said they would call the DEA and then the state (medical) board. That’s what they said. ‘If you don’t settle, we’re going to make it a lot worse for you.’   

“If I defend myself, I’m risking my (medical) license, even though I don’t feel like I did anything wrong. Now I’m dealing with three separate entities and then I can’t work anymore. So I almost had no choice but to settle.”

“Without reviewing the medical records, I cannot assess the fairness of this outcome,” says attorney Michael Barnes, who is managing partner at DCBA Law & Policy, a law firm that advises healthcare providers. 

“If the physician were merely a big-data outlier because he took on patients with the most complex needs, and if his prescribing were CSA (Controlled Substances Act) compliant, then the behavior of the federal government would fall squarely under the Black’s Law Dictionary definition of extortion.”

That legal dictionary defines extortion this way: “Any oppression by color or pretense of right, and particularly the exaction by an officer of money, by color of his office, either when none at all is due, or not so much is due.”

Assistant U.S. Attorney Dylan Aste, who led the case against Kasendorf, did not respond to a request for comment. As for the doctor’s claim about extortion, a DOJ spokesperson told PNN, “We’re not going to have any comment about that.”

DOJ Threatens Criminal Prosecution

Kasendorf is the latest example of the DOJ’s heavy-handed tactics in fighting the opioid crisis. Dozens of doctors around the country have been arrested and prosecuted for illegal opioid prescribing, many of them targeted by DOJ task forces that use prescription drug databases to identify high-dose prescribers.

"Sometimes the only difference between a doctor and a drug dealer is a white coat," U.S. Attorney Jay Town told reporters after federal raids in April that resulted in criminal charges against 60 practitioners in seven states.

Those cases may be legitimate, but hundreds of doctors who face no charges are still being harassed by federal prosecutors – not because their patients became addicted or overdosed – but because their names turned up in a database search.

In February, U.S Attorneys in Wisconsin sent letters to 160 high-dose prescribers in the state, warning them that “prescribing opioids without a legitimate medical purpose could subject them to enforcement action, including criminal prosecution.” 

“The DOJ treats controlled-medication prescribers, especially big-data outliers, as though they are guilty unless proven innocent.”

— Michael Barnes, attorney

Similar warning letters have been sent to doctors in Georgia, Massachusetts and other states.

“The DOJ treats controlled-medication prescribers, especially big-data outliers, as though they are guilty unless proven innocent,” said Barnes. “Detailed medical records are the only affordable way for a provider to prove his innocence — or at least make the prosecutor think twice about proceeding with criminal charges.”

Although the DOJ lacked credible evidence that any of Kasendorf’s patients were harmed by his care, the lack of detailed medical records was enough to intimidate the doctor into settling on the advice of his attorney. 

“Dr. Kasendorf’s ability to provide high quality pain management to those in need of treatment never was questioned. No charges ever were filed against Dr. Kasendorf,” said attorney Robert Frank. “The government’s allegations arose from an incomplete story of Dr. Kasendorf’s care for a few patients.  No patients suffered any adverse outcomes or complications from his care.   

“Economically, it made sense for Dr. Kasendorf to put an end to yet another Government pursuit of a physician successfully treating patients for true chronic pain problems, in what now has become an opiophobia world brought on by the overzealous promotion of opioids by pharmaceutical companies and misuse of them by relatively few physicians, Dr. Kasendorf excluded.“ 

‘Glad I Found Dr. Kasendorf’

Kasendorf continues to practice medicine and remains in good standing with the Osteopathic Medical Board of California. The board has no record of any disciplinary actions, malpractice judgments or citations against him.

Online reviews of Kasendorf by patients are largely positive.  

“I am so glad I found Dr. Kasendorf. I have dealt with debilitating neck pain for years. Dr. K treated my neck and my pain not only went away, but my headaches and numbness in my fingers went away also. He is very good at what he does,” wrote Gina in a Yelp review.  

“Dr. Kasendorf is one of the most caring pain management doctors I have ever seen, and I have seen a lot of them. He is truly empathetic towards his patients which is very hard to find. He is very strict about his opiate contract rules, but most pain management doctors are nowadays,” wrote Natalie. 

“He fired me from treatment with opiates despite a chronic painful condition,” wrote Gary, who said Kasendorf cut his opioid medication in half and then dropped him for being non-compliant.

“He is afraid the DEA is going to threaten his practice. Suggest you find an MD with the integrity to stand by his patients and stand by his past decision to prescribe opiates.” 

Guilt by Association 

Federal prosecutors initially became interested in Kasendorf not because of his prescribing practices, but because of his association with Insys Therapetics, a controversial Arizona drug maker.  

Insys’ founder and four former executives were recently convicted of bribing doctors with millions of dollars in kickbacks to prescribe the company’s flagship product: Subsys, a potent fentanyl spray that costs about $5,000 for a single day’s supply.

Subsys is only FDA approved for the treatment of cancer pain, but like other drugs it can be prescribed off-label for other pain conditions. Because of its high cost, Medicare and other insurers often wind up paying for Subsys.

Some doctors were paid lucrative speaking fees by Insys to promote Subys, while others were wined and dined at upscale restaurants or taken to a strip club for free lap dances.   

Kasendorf was a promotional speaker and consultant for Insys from 2013 to 2017. For that he was paid over $167,000, according to ProPublica.

“I was starting my practice. I had no money. The fact I was able to earn money through speaking was a miracle for me. That’s what kept me afloat and my family when I first moved here,” said Kasendorf, who moved to California from the east coast after his home was destroyed by Hurricane Sandy.

“And I was actually good at it. They wanted me to go all over the place because they felt I did a good job and was very thorough. I made it entertaining. I’m a very good speaker and I’m very proud of that.”

In addition to Insys, Kasendorf also did promotional speaking and consulting for several other drug companies, including Purdue Pharma, Egalet, Pfizer, Pernix and Indivior. But it was his work for Insys that federal prosecutors focused on.

“I never took bribes. I never got lap dances or all this stuff they were talking about,” Kasendorf told PNN. “This company did a lot of bad things and I completely agree. The problem is their product happens to be very, very good.”  

Subsys was so effective at pain relief that Kasendorf prescribed it to all five patients who were flagged by DOJ investigators.

“After all this time and all this effort, I think DOJ was upset I didn’t have more money.”

— Dr. Roger Kasendorf

It’s not the first time the DOJ has gone after a doctor for prescribing Subsys and making speeches for Insys. In 2017, the DEA raided the home and clinic of Dr. Forest Tennant, alleging that he took kickbacks from Insys and ran a “drug trafficking organization.” Like Kasendorf, no charges were filed against Tennant, who decided to retire on the advice of his attorneys rather than fight a protracted legal case.    

According to Kasendorf, the DOJ initially wanted him to pay a $24 million fine, but prosecutors settled for far less.

“They were so upset when they saw they could only get $125,000. But I sent them all my records and they could see I literally had no money in the bank,” said Kasendorf. “I had to borrow $100,000 from my parents to pay them.

“They almost put me out of business. But after all this time and all this effort, I think DOJ was upset I didn’t have more money.”

Is the DEA Overreaching Its Authority?

By Lynn Webster, MD, PNN Columnist 

The U.S. Department of Justice (DOJ) does not have the legal authority to determine which health care activities constitute a “legitimate medical purpose.” However, an increasing number of prescribers have been subjected to DOJ criminal investigations that operate under an expanded interpretation of federal law.

In 1970, Congress passed and President Nixon signed into law the Controlled Substances Act (CSA). In its broadest sense, the CSA regulates every aspect of controlled substances, from production to delivery, distribution, prescribing, possession and use. The CSA’s impact is far-reaching, touching many different sectors of our society, including healthcare, pharmaceuticals, law enforcement, politics, and state and federal judiciaries.

According to the CSA, a prescription for a controlled substance “must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” This statutory language is at the root of the issue. But who decides what is a legitimate medical purpose?

The Drug Enforcement Administration (DEA) is the branch of the DOJ that is tasked with enforcing the controlled substances laws and regulations of the United States.

In the context of trying to address the opioid crisis, the DEA has taken a proactive approach in determining which medical practices have a legitimate medical purpose and which do not. This hands-on approach is in direct contravention with the CSA. 

The DEA is effectively preempting state law as it relates to the regulation of controlled substances. In Gonzales v. Oregon, the U.S. Supreme Court ruled in 2006 that the authority to determine a legitimate medical purpose rests with state governments.

This means it is state lawmakers, not federal officials, who should regulate the practice of medicine. Medical boards are established by the authority of each state to protect the health, safety and welfare of patients through proper licensing and regulation of physicians and other practitioners.

If a doctor engages in an obviously nefarious activity, such as selling or trading prescriptions for sex or money, then that doctor is not in any way prescribing for a legitimate or legal medical purpose under the CSA. Remedies for this conduct would be within the authority of the DOJ, as well as state regulators.

The key phrases -- "legitimate medical purpose" and "in the usual course of a professional practice" -- are not defined in the CSA. This omission, unfortunately, has invited conjecture about the meaning of the phrases in recent years. The only way the phrase "legitimate medical purpose" would have any legal meaning would be if the concept of an "illegitimate medical purpose" were defined by the CSA -- and it is not.

Moreover, the words "legitimate" and "medical" are redundant. The practice of medicine is inherently legitimate, according to the CSA. The phrase "legitimate medical purpose" can be reduced to "medical purpose" without changing its meaning.

Any practice that is medical is legitimate and should be deemed consistent with the CSA regulation. The CSA, in other words, precludes the possibility that doctors who prescribe high doses of opioids have behaved criminally based only on the level of doses they prescribe.

Standard of Care

The DOJ is now using deviation from the “standard of care” to determine whether or not practitioners have a legitimate medical purpose to prescribe opioids. A standard of care is generally considered the customary or usual practice of the average physician.

In an attempt to address the opioid problem, the DOJ has hired medical experts who claim that any deviation from standard of care amounts to practicing without a legitimate medical purpose. In some instances, the government's experts have even used the CDC opioid guideline’s dose recommendation as a test of whether or not the prescribing of opioids has a legitimate medical purpose.

Using deviations from "standard of care" as criteria for compliance with the CSA is in direct conflict with the Supreme Court ruling in Gonzalez v Oregon, which found that the Attorney General “is not authorized to make a rule declaring illegitimate a medical standard for care and treatment of patients that is specifically authorized under state law.”

Even substandard treatment by providers is not necessarily criminal behavior and should rarely involve prosecution by the DOJ. This is supported by a 1983 statement in a DEA newsletter that declares acts of prescribing or dispensing controlled substances lawful when they are done within the course of a provider’s professional practice. Even if a physician's behavior reflects the grossest form of medical misconduct or negligence, it is nevertheless legal.

The information provided in the newsletter isn't an opinion. It's the law.

Unquestionably, prescribers should be held to a high standard of care at all times. However, it is the responsibility of state medical boards to hold them to that standard. It is not the DOJ's role to determine the quality or boundaries of the practice of medicine.

 Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is a former president of the American Academy of Pain Medicine and the author of “The Painful Truth.”

You can find Lynn on Twitter: @LynnRWebsterMD. 

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

I’m Ashamed of the U.S. Justice Department

By Drew Pavilonis, Guest Columnist

I was a federal law enforcement officer with the U.S. Department of Justice (DOJ) for 14 years. Hard work, a willingness to transfer, and a graduate degree brought fast promotions and a coveted position in management at a DOJ training academy just outside of Denver.

However, a rare type of brain tumor deep in the thalamus brought everything to a sudden halt after ten years in Denver. My doctors initially said the brain tumor was inoperable due to its sensitive location, but the tumor continued to grow, and I eventually flew to Phoenix to have a talented neurosurgeon perform the difficult surgery to remove it.

The thalamus and brainstem proved to be a very challenging surgery and I suffered permanent disability because of it. I spent several months as an inpatient at a neuro-rehabilitation hospital, relearning how to walk and speak, dress and bath myself.

The DOJ medically retired me because cripples can't be law enforcement officers. Fortunately, I had 19 years of federal service and was able to retire with a pension, which was a good thing since I was not able to work due to my significant disability. 

However, the suffering didn’t end there. I developed chronic, debilitating pain 3 years after the surgery.

DREW PAVILONIS

Fortunately, at the urging of my sister, I had moved close to Duke University Hospital in North Carolina for follow up medical care. The doctors at Duke hypothesized that my pain was due to scar tissue that formed in my thalamus after the brain surgery. The thalamus is the brain's pain center and my pain “switch” had been permanently turned on.

I was bedridden and prayed for death daily. The pain was so bad that I could not walk. I was taken by ambulance to Duke Hospital for a one week stay as an inpatient and was medically tested to the extreme. Eventually, the doctors determined that I had real pain and referred me to pain management. 

I was prescribed methadone, four times a day. Additionally, to fight the debilitating nerve pain that I also have, I was put on the maximum dose of gabapentin. The medications just allow me to live, much like diabetics need insulin to survive. I am always in pain, but the medications control it to a tolerable level.

I am able to travel internationally (I write this from my hotel room in Berlin, Germany), do volunteer work, and ride an outdoor wheelchair. However, I worry that that I will someday become collateral damage in this “war on opioids.”

I cringe every time I see a journalist cite the CDC report about opioid related deaths in America. That report was full of errors and incorrect by the CDC's own admission. Also concerning are the jack-booted tactics of the DEA, which attacks legitimate pain treatment as if doctors were responsible for all the heroin in the country.

Those rogue tactics have had a chilling effect on the practice of pain management and contributed to a growing number of patient suicides. Many chronic pain patients have taken their own lives because they could not get the appropriate medication that they so desperately need to live.

I never thought I would see human rights violations conducted by my own government against fellow Americans. It is unbelievable.  I no longer tell people that I am retired from the DOJ because I am ashamed of it. I just say that I’m retired from the federal government. That's sad.

Drew Pavilonis lives in North Carolina.

Pain News Network invites other readers to share their stories with us. Send them to editor@painnewsnetwork.org.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Sessions Creates New Task Force to Target Rx Opioids

By Pat Anson, Editor

U.S. Attorney General Jeff Sessions has announced the creation of a new task force targeting manufacturers and distributors of opioid pain medication, as well as physicians and pharmacies engaged in the “unlawful” prescribing of opioids.

“We are attacking this crisis at its root: the diversion and overprescription of opioid painkillers,” Sessions said at a news conference. “We will use criminal penalties.  We will use civil penalties.  We will use whatever tools we have to hold people accountable for breaking our laws.”

Sessions also said the Justice Department would file a “statement of interest” in hundreds of lawsuits filed by states, counties and cities seeking to recover billions of dollars in damages from opioid manufacturers who used deceptive marketing practices. Such a statement could result in the federal government joining as a party in the lawsuits and recovering damages.

Sessions said the government had borne “substantial costs” as a result of the opioid crisis, including $4 billion paid by Medicare for opioid pain medication in 2016.

“The hard-working taxpayers of this country deserve to be compensated by those whose illegal activity contributed to those costs.  And we will go to court to ensure that the American people receive the compensation they deserve,” Sessions said.

“These are not our last steps.  We will continue to attack the opioid crisis from every angle.  And we will continue to work tirelessly to bring down the number of opioid prescriptions, reduce the number of fatal overdoses, and to protect the American people.”

Sessions’ announcement avoided any mention of the growing scourge of black market opioids, such as heroin, illicit fentanyl and counterfeit medication, which are now responsible for most overdose deaths. He also did not acknowledge that opioid prescribing has been declining for several years and that less than one percent of legally prescribed opioids are diverted.

The new task force – called the Prescription Interdiction & Litigation (PIL) Task Force -- will include senior officials from the Attorney General’s Office and the Drug Enforcement Administration. It appears to be focused solely on prescription opioids.

“The PIL Task Force will use the criminal and civil tools available under the Controlled Substances Act against doctors, pharmacies, and others that break the law,” the DOJ said in a statement.

Sessions directed the task force to improve coordination with the Department of Health and Human Services – which includes the FDA, CDC and the Centers for Medicare and Medicaid Services (CMS) – in sharing healthcare data to identify “patterns of fraud related to the opioid epidemic.”

The Attorney General's single-minded focus on pain medication as the cause of the opioid crisis has angered many pain patients and advocates.

"I am operating on the assumption that this country prescribes too many opioids," Sessions said during a speech earlier this month. "People need to take some aspirin sometimes and tough it out.”

“I hope Sessions falls down, hits his head and breaks a hip and has to take two aspirin and get over it,” wrote one PNN reader.

“Jeff Sessions is an instrument of hate. He has succeeded in driving a wedge through the most sacred trusts -- the relationships between doctors and patients. Doctors now fear and loathe their patients for putting their licenses at risk, and patients fear and loathe their doctors for abandoning their compassionate care plans,” wrote another reader.

"This is exactly why we don't need, a group of people that know nothing about what they are making laws for. Jeff Sessions, if you or one of your family had Reflex Sympathetic Dystrophy, you would never have made a fool out of yourself with your aspirin remarks," said another.

Sessions Resumes Enforcement of Marijuana Laws

By Pat Anson, Editor

Attorney General Jeff Sessions has followed through on his threat to resume enforcing federal laws that outlaw the cultivation, distribution and possession of marijuana.

Session has rescinded the Cole memo, a lenient policy adopted by the Justice Department in 2013 that instructed U.S. Attorneys not to investigate or prosecute marijuana cases in states that have legalized cannabis. Although 29 states and the District of Columbia have legalized marijuana in some form, federal law still prohibits its sale or possession under the Controlled Substances Act.

ATTORNEY GENERAL JEFF SESSIONS

In a one-page memorandum sent to U.S. Attorneys around the country, Sessions called the Cole memo “unnecessary” and authorized prosecutors to use their own discretion in investigating and prosecuting marijuana cases.

"It is the mission of the Department of Justice to enforce the laws of the United States, and the previous issuance of guidance undermines the rule of law and the ability of our local, state, tribal, and federal law enforcement partners to carry out this mission," Sessions said in a statement.

"Therefore, today's memo on federal marijuana enforcement simply directs all U.S. Attorneys to use previously established prosecutorial principles that provide them all the necessary tools to disrupt criminal organizations, tackle the growing drug crisis, and thwart violent crime across our country."

“This change will allow any US Attorney who is looking to make a name for themselves to take unilateral action, thus depriving any semblance of certainty for state-lawful consumers or businesses moving forward," said Justin Strekal, NORML Political Director.

Sessions released his memo just three days after California legalized the recreational use of marijuana by adults – the eighth and largest state to do so. California was the first state to legalize medical marijuana in 1996.

It is not yet clear how rigidly Sessions plans to enforce federal marijuana laws. Since 2013, Congress has attached a rider to the Justice Department budget that prevents it from using federal funds to enforce federal law in states where medical marijuana is legal. The Rohrabacher-Blumenauer amendment is still in force, but is set to expire on January 19 unless it is extended by Congress.

Sessions’ memo drew a swift and angry response from some members of Congress.

“This reported action directly contradicts what Attorney General Sessions told me prior to his confirmation. With no prior notice to Congress, the Justice Department has trampled on the will of the voters in CO and other states,” Sen. Cory Gardner (R-CO) said in a tweet. “I am prepared to take all steps necessary, including holding DOJ nominees, until the Attorney General lives up to the commitment he made to me prior to his confirmation.”

“This is outrageous. Going against the majority of Americans -- including a majority of Republican voters -- who want the federal government to stay out of the way is perhaps one of the stupidest decisions the Attorney General has made,” said Rep. Earl Blumenauer (D-OR), one of the co-authors of the Rohrabacher-Blumenauer amendment.

“One wonders if Trump was consulted -- it is Jeff Sessions after all -- because this would violate his campaign promise not to interfere with state marijuana laws.”

In an interview during the 2016 campaign, President Trump said he would not change the federal enforcement policy on marijuana. “I wouldn’t do that, no,” Trump said. “I think it’s up to the states. I’m a states’ person. I think it’s up to the states, absolutely.”

According to a recent Gallup Poll, 64% of Americans say marijuana should be legalized. The issue has broad bipartisan support, with 51% of Republicans and 72% of Democrats supporting legalization.

“The rollback of this policy towards state legalized marijuana will only create chaos and confusion for an industry that is currently responsible for creating over 150,000 American jobs and generating countless millions in state tax revenue. This instability will only push consumer dollars away from these state sanctioned businesses and back into the hands of criminal elements," said Erik Altieri, NORML Executive Director.

"This is not just bad policy, but awful politics and the Trump Administration should brace itself for the public backlash it will no doubt generate."