United States Court of Appeals
FOR THE DISTRICT OF COLUMBIA CIRCUIT
Norman Clement,
Case: No. 21-1262
Petitioner
v.
Drug Enforcement Administration,
Respondent
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“THE AWARD-WINNING “LONDON BRIEFS” WAS APPLIED TO THE NORMAN CLEMENT, PRONTO PHARMACY CASE BEFORE THE UNITED STATES COURTS OF APPEALS FOR THE DISTRICT OF COLUMBIA”
PETITIONER’S SECOND ADDENDUM TO DISPOSITIVE MOTION TO VACATE ADMINISTRATIVE JUDGES FINDINGS AND DEA ADMINISTER’S ORDERS, RESTORE CSA REGISTRATION of PRONTO PHARMACY LLC AN AWARD DAMAGES,
OUT OF A MOUNTAIN OF DESPAIR COMES A STONE OF HOPE
Now Comes forth a Michigan Man, the Petitioner, Norman J Clement, pro-se armed with a Laser-Guided Meteor of Wisdom and Knowledge, Pursuant to the Court’s Order of January 09, 2022, and D.C. Circuit Rule 28(a)(1), scrappy, unbowed and determine in Case No. 21-1262 submits this SECOND addendum, to his Dispositive Motion respectfully seeking and demanding justice and hereby further states,
BACKGROUND
The Petitioner, Norman Clement pro-se, was born in Detroit is the second son of 6 boys of a mother and father who immigrated from Panama in January 1951, 2 months before his birth in March. All the Petitioners’ grand-parent was from the Island of Barbados and matriculated to build the United States Panama Canal and they never returned to the Island of Barbados.
EDUCATION
The Petitioner, was the first to finish college in his family is a both licensed Pharmacist, Dentist and not a drug street dealer engaged in drug trafficking The Petitioner, is a graduate of Florida A&M University College of Pharmacy, University of Michigan School of Dentistry, and has completed all the requirements at the University of Florida College of Dentistry for his Master Degree as Fellow Academy of General Dentistry (FAGD), studied Forensic Dentistry McGill University, Montreal Canada, and taken advance classes in pain control and pharmaceutical compounding.
ARGUMENT
The DEA has engaged in deceptive enforcement where enforcement can be arbitrarily applied to any person without investigation, without law, and dangerously without oversight. The Petitioner has exposed these gross patterns of enforcement in his blog, youarewithinthenorms.com. The Blog and videos bear witnesses and all the system to be held accountable.
The Petitioner created this blog youarewithinthenorms.com, which the Respondent’s Counsel introduced as evidence in court and Judge Mark Dowd used as part of his prosed decision.
This Blog consisting of 350 articles has served as a National Platform for many health practitioners finding themselves Targets of DOJ_DEA
The Petitioner owned Pronto Pharmacy LLC and was raided May 3, 2012, and August 29, 2019, by the United States Drug Enforcement Administration (DEA) based on a signed warrant which stated No elements of a crime being committed. All schedule control medications were seized the Petitioner was never charged and equipment and property never returned.
The Controlled Substances Act (CSA) and its implementing regulations established a closed system of distribution to ensure appropriate medical care and to maintain the integrity of the system through an accountability process. One of the most important principles underlying the CSA and its implementing regulations is that to be valid, every prescription for a controlled substance must be based on a determination by an individual practitioner, that the dispensing of the controlled substance is for a legitimate medical purpose in the usual course of professional practice. United States v. Moore, 423 U.S.C. 122 (1975) and 21 CFR 1306.04(a).
Federal regulations do not define the term legitimate medical purpose nor do they set forth the standards of medical practice. It is up to each DEA-registered practitioner authorized by DEA to do so, to treat patients according to his or her professional medical judgment in accordance with a standard of medical practice that is generally recognized and accepted in the United States
DEA has not promulgated any new regulations regarding the treatment of pain. Federal law and DEA regulations do not impose a specific quantitative minimum or maximum limit on the amount of medication that a practitioner may prescribe on a single prescription, or the duration of treatment intended for a particular patient DEA has consistently emphasized and supported the prescriptive authority of an individual practitioner under the CSA to administer, dispense, and prescribe controlled substances for the legitimate treatment of pain within acceptable medical standards as outlined in DEA’s policy statement published in the Federal Register (FR) on September 6, 2006, titled, Dispensing Controlled Substances for the Treatment of Pain. 71 FR 52716.
While DEA is the agency responsible for enforcing the CSA, DEA does not act as the Federal equivalent of a state medical board overseeing the general practice of medicine and lacks the authority to issue guidelines that constitute advice relating to the general practice of medicine.
Although § 1306.04(a) regulates both prescribers and pharmacists, the two roles are far from interchangeable, including for purposes of determining potential liability. With different licenses, education, skill sets, responsibilities, and workplaces from physicians, pharmacists play a vital but distinct role in a patient’s care. (See Amicus Curiae Brief National Association Chain Drug Stores, US Supreme Court Case No. 20-1410, Ruan vs. the United States of America)
Specifically, when dispensing a controlled substance to a patient, as prescribed by a physician, a pharmacist relies on the physician’s assessment of the patient’s needs. The pharmacist has neither examined nor diagnosed the patient and lacks the information the physician has collected on the patient’s medical situation, records, and history, including such things as x-rays, ultrasounds, lab results, and treatment plans.
The CSA recognizes pharmacists’ circumscribed role in dispensing controlled substances. It provides that pharmacists may not dispense Schedule II controlled substances “without the written prescription of a practitioner,” 21 U.S.C. § 829(a) and that they risk criminal and civil liability if they do, sees id. §§ 841(a), (c), 842.
The CSA’s implementing regulations further explain that 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.” 21 C.F.R. § 1306.04(a).
The regulations separately provide that such a prescription “may only be filled by a pharmacist, acting in the usual course of his professional practice and either registered individually or employed” by a registered entity. 21 C.F.R. § 1306.06.
Consistent with the division of responsibility be- tween prescribers and pharmacists, § 1306.04 limits when pharmacists may be held liable for filling controlled-substance prescriptions to situations where a pharmacist knows a prescription is illegitimate:
The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription.
An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized
research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. [§] 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.
21 C.F.R. § 1306.04(a) (emphasis added). A pharmacist violates this provision only if the pharmacist “knowingly fill[s]” a “purported” prescription—i.e., a prescription that was not written, “in the usual course of professional treatment.”
These critical limitations on a pharmacist’s possible liability under § 1306.04 are no accident. They were added to the regulation intentionally to avoid the un- warranted and counterproductive imposition of liability.
When first proposed in 1971, the regulation lacked the word “knowingly,” which would have allowed penalties for any “person filling [an illegitimate] prescription.” Purpose of Issue of Prescription, 36 Fed. Reg. 4847, 4948 (Mar. 13, 1971).
Pharmacists protested such an expansive rule, however, and during the comment period specifically “objected to the responsibility placed upon a pharmacist under § [1306.04] to determine the legitimacy of a prescription.”
Comments and Objections to Part 306, 36 Fed. Reg. 7776, 7777 (Apr. 24, 1971).
The DEA agreed with these comments and changed the legal standard in the final regulations, noting the “language [was] revised to require knowledge.”
THE DOJ-DEA OVERREACH IN PROSECUTING PHYSICIANS
Cathleen London is a licensed Medical Doctor and 3rd year Law Student at the University of Maine College of Law. (1a)
This paper DOJ OVERREACH: THE CRIMINALIZATION OF PHYSICIANS, has won first prize in the American College of Legal Medicine’s post-doctoral Student paper contest, the year 2022. (2a
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DOJ-DEA OVERREACH IN PROSECUTING PHYSICIANS
According to Cathleen London MD, and 3rd year Law student University of Maine College of Law:
“The primary narrative driving policy is that the opioid epidemic is driven by overprescribing by clinicians, leading patients to become addicted. This has led to draconian laws that have harmed chronic pain patients and the use of invasive prescription monitoring programs throughout the country.
The black box algorithms mine data and have never been subjected to independent verification. Patients and prescribers alike are flagged as problematic. Although prescribing has dropped dramatically since the introduction of prescription monitoring, overdose deaths have risen dramatically to record highs, driven by the illicit fentanyl market. Despite this, law enforcement continues to focus on the diversion of prescription medication. The drug prohibition policy set out by the Department of Justice (DOJ) is a misguided attempt to address skyrocketing opioid overdoses.
It is their way of trying to fix the issue which was the unchecked distribution of opioids. The blame for that falls on the DEA (Drug Enforcement Agency), Congress, and lobbyists. This focus on limiting the prescribing of legal opioids has led to an increasingly lethal illicit opiate supply. The DOJ continues to erroneously cite diversion of licit legitimate prescriptions of opioids as the problem. As a result, doctors have been imprisoned for terms ranging from twenty years to life without parole, all for practicing medicine. Others have had their careers and reputations irreparably harmed.
Undertreated pain is an expensive medical condition, costing an estimated $560-635 billion annually in the United States. With the current climate of fear and prohibition, and the government’s decision to prosecute doctors who they claim overprescribe, we are in a cycle that started with the Harrison Act in 1914. Drafted as a tax law, the Harrison Act required anyone authorized to manufacture or distribute narcotics to register with the Treasury Department, pay a fee and keep records. Congress sought with this legislation to address the non-medical use of narcotics. Possession, use, and distribution of narcotics were criminalized. Physicians were easier than unlicensed distributors to target and bring to court.
A series of Supreme Court decisions transformed narcotics control from tax revenue to a cabining of physician prescribing. Doctors argued in Linder v. the United States to prescribe to alleviate the pain and suffering of withdrawal symptoms. Doctors were first criminalized for prescribing in U.S. v. Moore. Moore also set the language still used today that “registered physicians can be prosecuted under § 841 when, as here, their activities fall outside the usual course of professional practice.” The combination of the Controlled Substance Act (CSA) and the establishment of the DEA created the War on Drugs that started under the Nixon administration which began with a focus on illicit drugs. Congress criticized the DEA and in 1999 “they sought a new front for the War on Drugs to show measurable results.”
To the DEA, physicians at “pill mills” have morphed from caring, compassionate caregivers to dope dealers in white coats. A “’ pill mill’ is a term used primarily by local and state investigators to describe a doctor, clinic or pharmacy that is prescribing or dispensing powerful narcotics inappropriately or for non-medical reasons.” The majority are independent pain management centers, and they are characterized by cash only payments, lack of physical exams (or a cursory exam), lack of required medical records or imaging, patients picking their medications (often from a ‘menu’), patients are directed to an on-site or preferred pharmacy, patients are treated with medication only, security guards are present, and there are long lines and huge crowds waiting to be seen. These clinics began in Florida in the 1990s and proliferated in the early 2000s. Parking lots were filled with vehicles bearing license plates from Ohio, Kentucky, West Virginia, and elsewhere. By 2010, 90 of the nation’s top 100 opioid prescribers were Florida physicians with 85% of all oxycodone in the United States prescribed out of the Sunshine State. Florida was attractive for pill mills as there was little oversight or regulation.
In the “aftermath of the 2001 al-Qaida attacks[], Federal policies tightening border security that prevented terrorists and weapons from entering the country also curtailed the heroin trade.” Dealers, looking for a product to satisfy their customer base, substituted prescription pain killers for heroin. At its peak there were more than 1000 pain clinics in Florida attracting out of staters to purchase oxycodone that was then sold all over the country, earning it the nickname ‘Oxy Express’. Florida regulation was so lax, that anyone could own a clinic. In 2007, Chris George, a former convict with no medical training, opened his first pain clinic in South Florida.
Together with his twin brother Jeff, they had six clinics, ‘American Pain’, staffed by physicians (often sourced on Craig’s List) who were paid by the number of prescriptions written. The top prescriber often saw seventy patients per day. The clinics were staffed with strippers, bouncers patrolled the parking lots, doctors carried guns, and patients were seen shooting up in the parking lots and dealing drugs in plain sight. Ironically, the “prevailing feeling among most participants [was] that pain management clinics’ lone motivation was making a profit.” Most felt that doctors knew about their misuse but prescribed anyway. They were in it for the money. “They are coming there to get their fix; they get it, they’re eating them right out of the bag out of the office and they’re on their way. They are [a] cash-only businesses like selling drugs on the street, except they’ve got an office for it.” The doctors were drug dealers in white coats.
Sales tactics such as “first visit free”, “buy 1 pill, get the 2nd free”, or “receive $30 gift card for referrals” were commonly utilized by pain clinics to get customers in the door. The overwhelming majority of participants were not only aware of the advertisements but reported using these papers to identify which pain clinics to visit. . . .
Look on the back of Excel (local paper). . . . Flip the magazine over, and there are about 500 pain clinics, and the biggest ones are on the back page and then flip, flip, flip. All it has is pain doctors and escorts. I mean, have you ever heard of a doctor running ads with an escort service side by side? They’re legal drug dealers.
Many patients became sponsors of other clientele so that they themselves would not have a paper trail. They paid for the visit, any imaging required and the pills in exchange for half the drugs obtained. This was a common technique. Recruiters often made their living this way in addition to supporting their own habits. Participants all reported that they not only had never been examined but that there was not even an examination table in the rooms. If written documentation was required, an MRI report was the document of choice. These were often faked “created on a home computer, switching the name on an already existing MRI, printing one from the internet, or purchasing one from an unauthorized source.” Some pill-mill tourists would visit a dozen or more clinics before returning to their home state with thousands of pills to sell at profit only to return a few days later to purchase more. The risk was worth it due to the huge profits that would be made back home as each pill could net $100. This clearly was not medicine being practiced but an illegal trade under the guise of a legal enterprise.
Law enforcement was overwhelmed in the early days as they were geared towards investigations of illicit drugs. Since pill mill patients had legal prescriptions, they owned their pills. The DEA recognized that misuse and diversion of dispensed medication could be happening, but inquiry in Florida was painstaking.
There was no prescription monitoring program. DEA agents had to rely on whistleblowers. They had to review paper records at pharmacies to look at prescriber patterns and try to build a case.
Law enforcement had to establish that the prescriptions were not issued for legitimate medical purposes. Investigations required tracing the flow of cash. These probes required resources and funding. As one clinic closed another would open. By dispensing narcotics on site or using a specific pharmacy receiving kickbacks or co-owned by the clinic, the pill mills attempted to avoid contact with law enforcement.
The pill mills became an emergency when people started dying from prescription drug overdoses. At the time, “[p]rescription drug overdoses kill[ed] on average seven Floridians every single day – a tragic number five times greater than deaths caused by all illicit drugs combined. Prescription drug abuse [was] the number one public health and safety problem in Florida.” Along with the overdoses, addiction brought with it increasing drug-related crimes. Florida subsequently enacted laws and moved aggressively to shut down pill mills, and in one year more than 400 clinics were shuttered. “[A] major crackdown on Florida’s pill mills. It was a series of busts, from Palm Beach to Miami, that included more than 20 arrests and the seizure of more than $22 million in cash, exotic cars, and real estate.” By 2010 pill mills were a nationwide problem.
As Florida shut them down, pill mills moved along to Georgia, Kentucky, West Virginia, Tennessee, Texas, Michigan, Ohio, and California. The route from Florida to Georgia, Kentucky, West Virginia, and Ohio became known as the “Blue Highway.” It was named after the color of one of the most popular pills on the street — 30 mg oxycodone tablets. “From 2010 to 2018 Ohio’s rate of accidental opioid overdoses per 100,000 people rose from 9 to 28. In Scioto County, it jumped from 11 to 54.” Dr. John Lilly had the first major pill mill in Scioto County. Law enforcement noticed large amounts of cars from out of state in his parking lot, and undercover officers stated: “There was nothing at all legitimate about his medical practice.”
After he was prosecuted, a woman with no medical training opened a pain clinic in Portsmouth with Dr. Paul Volkman, who had moved into the state from Chicago.
Volkman’s practice drew attention because twelve patients died of overdoses within three years, and the DEA began receiving complaints from pharmacists and law enforcement beginning in 2003.
The DEA opened an investigation. By November of 2003, pharmacies in Kentucky would not fill his prescriptions. Patient complaints began. The following summer, the Kentucky State Police passed on information to the DEA that the majority of Volkman’s prescriptions were being filled at one pharmacy. Ultimately, the clinic started an in-house pharmacy which Volkman described in detail in a letter to Dr. Hurwitz, who was sitting in Federal Prison for misprescribing of opioids. In the same letter, Volkman described how his clinic manager and other employees had guns, there were armed guards and security cameras. Another patient informant contacted the DEA.
Investigation revealed that the clinic was cash only, there were lines of 50-100 people, no cursory medical exams were done, and large amounts of narcotics were prescribed. Nearly half of the clientele had controlled substance convictions.
In 2005 the DEA had a confidential source go for three visits confirming that cash payment was required up front, the lack of a physical exam and that prescriptions were filled on-site at the clinic. As the investigation progressed, Volkman was the number one purchaser of oxycodone in the nation. In 2004, he purchased 457,100 pills, second place purchased 351,000 according to ARCOS data. The second-place purchaser in Ohio purchased 4,160 pills.
This is twelve times more oxycodone than the average pharmacy in the nation and 97 times more than the average practitioner. Of the deaths attributed to his prescribing, eleven received a dose increase at the last clinic visit and eight died within three days of their visit. His trial took ten weeks, involved eighty witnesses from eight states – seventy called by the United States, ten called by Dr. Volkman.
He was convicted of eighteen of the twenty counts he was charged with. Scioto County noted a seventeen percent reduction in overdose deaths and a forty-two percent decrease in drug-related deaths after his sentencing.
This type of operation happened in other states as well and was similarly often difficult to prosecute as exemplified by New York’s Astramed, where “crowds lined up outside the entrance like it was a nightclub, complete with bouncers; double-parked cars with out-of-state plates idled while dealers from as far away as Florida made buys.” These purchases were for prescriptions for oxycodone. The neighborhood all knew it was a pill mill and the “clinics served as a neutral territory for several gangs . . . a sort of Oxy wholesaler.”
A stream was started by Keven Lowe, MD who presented himself as a preventive medicine physician, promoting healthy lifestyles. He hired doctors and paid them $300 per prescription in the two Bronx locations while keeping the other Astramed locations clean. One of the doctors, Tomasito Virey, became New York State’s top prescriber of Oxycodone. A local NBC report derailed the DEA investigation when Virey landed on TV. He stopped prescribing, and that location closed. The feds had to start from ground zero on their investigation of Astramed.
As Florida and other states enacted Drug Monitoring Programs to alleviate prescription drug abuse, prosecutors were able to partner with data analysts and compile prescription data. This was the breakthrough they needed, compiling prescription statistics into spreadsheets allowed a data-driven model of targeting. The data showed law enforcement where to look. Data analysis focused on patient deaths connected to a doctor, the distances patients traveled to get prescriptions, and prescribing habits of physicians compared to their peers.
Once identified by analysts, “agents move in to monitor and surveil the pinpointed doctor’s offices and pharmacies. There are informants, there’s surveillance.” The DEA then involves medical experts to see if the prescriptions being written are within the nor
ms. “We’re a cross between investigating white-collar crime and narcotics.”
The data analytics became extremely successful. As the CDC then added guidelines for the morphine equivalents (MME) that should be prescribed by primary care in 2016, that column on a spreadsheet became another one to track. “When they [doctors] choose to overprescribe narcotics to patients, and they know that these patients may be or are abusing them, then they change from being a physician to really being a drug dealer.”
“The Opioid Fraud and Abuse Detection Unit will use data analytics to help find evidence of overprescribing.” Reports target prescription rates and identify the targets to investigate. The designation comes from studying prescription databases and analyzing which practitioners in various parts of the country are writing the most prescriptions for opioids.
Federal authorities see the doctors as “hooked on greed” writing phony prescriptions for narcotics and billing the government, fueling the opioid epidemic in the process by flooding the streets with drugs. The Department of Justice is committed to protecting the public from these unscrupulous medical professionals.
The problem with this approach is that this blunt instrument of prosecution does not address the actual issue which was that distribution went unchecked. Hundreds of millions of pills, controlled by the DEA, lobbyists, and Congress are instead blamed solely on prescribers. Nor does it account for drugs diverted in transport which accounts for much of the diverted prescription drugs “large quantities of narcotics routinely go missing en route from manufacturers to wholesalers and from wholesalers to retailers.
The DEA itself acknowledges this problem . . . the Internet has become a major underground source for the drug.” A newspaper was able to order narcotics and have them delivered to a rented mailbox, with no physician involved. “Given the poor job the DEA is doing of monitoring the narcotics it’s charged with overseeing, and the various ways the drug apparently can move from manufacturers and wholesalers to the black market, the DEA’s blame and pursuit of physicians for the drug’s street availability seem all the more arbitrary, unjustified and capricious.”
As the true pill mills were shut down, the same metrics are faulty. The flags falsely discriminate against rural patients who must travel far for any appointments, those who have suffered trauma, those who have multiple prescribers due to no fault of their own (especially now that most doctors are employees), or people who relocate due to jobs. Cash payments are flagged even though cash is often used due to the indiscriminate need for prior authorizations for medications and patients cannot wait to fill their opioids due to physical dependence.
Physicians who continue to prescribe when these red flags are present are then targeted by law enforcement in the same way they were with pill mills, but the data no longer has the same meaning. Prosecutors jump to faulty conclusions including that physical exams, imaging, and procedures are being done for illegitimate reasons. The justice department relies on the highest prescribers by the number of pills and how far patients are traveling. Data analysts tasked with finding health care fraud also target physicians previously sanctioned.
Reducing opioid prescriptions has not reduced opioid deaths, rather they have skyrocketed. Prescription opioid deaths have been constant since 2010 but the DOJ continues to use the same playbook.
“The DOJ is aggressively fulfilling its vow to use every criminal, civil and regulatory tool possible to target, prosecute and shut down entities whose conduct it deems unlawful.” The investigations are funded through asset forfeiture. “[P]hysicians had their assets seized before even being charged . . . such forfeitures [often] result in plea bargains or civil settlements, given that the cases can drag on for years, and the asset seizure leaves the accused with no means to live, much less to pay attorney’s fees and court costs.”
The DEA does not track the number of clinicians investigated. The program is self-financed and they are immune from oversight since they ever need to go to Congress for appropriation. By classifying pain patients as “addicts” they continue to pursue doctors as “dealers”.
Some of the tactics used are the same as used with drug kingpins like El Chapo. Prosecutors approach the medical staff and patients in a doctor’s office and threaten that they will be co-defendants if they do not testify against the physician. They are then pressured to give misleading testimony.
In more than one case, Dr. Bamdad and Dr. Henson for example, a patient committed suicide with prescribed opioids, and the physician was blamed for the death and sentenced accordingly. Blaming physicians for a patient overdosing on their prescription opioids is like blaming a car dealership for a motor vehicle accident.
Dr. Masoud Bamdad emigrated with his wife from Iran. He was a certified pain management specialist. He opened a practice in California in 1999. He is now in prison on a 25-year sentence. He believed (and continues to) that he is innocent, so he did not take a plea deal. The judge gave him a high sentence for lack of remorse. Dr. Bamdad was confident that he was following guidelines like other physicians in his position.
The DOJ accused him of being a ‘pill mill’ as he was one of the state’s highest prescribers. Data analytics are driving investigations and prosecutions even though the algorithms are faulty.
The DOJ counts on the vague definition in the CSA of “legitimate medical purpose” to prosecute, even though agents admit they do not know what that is. The government uses this legal ambiguity to its advantage and the result is policing and terrorizing physicians.
In 2004, after much urging, the DEA released guidance on opioid administration. Less than two months later, the support of the guidelines was withdrawn, and it was removed from the website.
“The DEA has refused to explain why it withdrew its support, and the agency has issued no further guidance.” The timing of the withdrawal curiously coincided with the trial of one of the early pain specialists prosecuted, William Hurwitz, MD who openly cooperated with law enforcement. Investigators continued to let Dr. Hurwitz prescribe to known dealers who were lying to him and diverting to the black market. The DOJ later offered the lying patients lenient sentences in exchange for testimony against Dr. Hurwitz. “The jury’s foreman told the Washington Post that Hurwitz was sloppy, a bit cavalier and that no, he wasn’t running a criminal enterprise. Yet the jury convicted Hurwitz of ‘conspiracy to distribute controlled substances and trafficking.’” Per the DEA neither malicious intent nor profit is necessary for a conviction of doctors.
“[T]he federal government has made physicians the scapegoats for the failed drug war . . .legitimate, well-meaning professionals who keep accurate records, pain physicians also present a better target than underground, black market drug dealers.” Acquittals are an aberration, and attributable to the prosecutions’ failure to flip witnesses.
It is a flawed argument that people became accidentally addicted from a prescription for pain medication. It is misleading as the vast majority of non-medical use of opioids has been in people who obtained the drugs from friends, relatives, or dealers. As far as pharmaceutical pain medication being a ‘gateway drug’ the government’s own data refutes this; approximately 4% of people who abuse prescription drugs go on to use heroin. Cochrane reviews show addiction rates to pain medication at about one percent.
There is a tendency, even amongst medical professionals to conflate physical dependence with addiction. “Addiction is a compulsive behavior whereas physical dependence describes the symptoms abrupt withdrawal will cause.” Tolerance and physical dependence are predictable results of opioid prescribing. It is why doses need to increase over time for the same analgesic effect. Addiction on the other hand is not a predictable result of opioid prescribing. “Cardinal features of addiction include a pronounced craving for the drug, obsessive thinking about the drug, erosion of inhibitory control over efforts to refrain from drug use, and compulsive drug-taking.” The behavioral changes are associated with structural changes in the brain.
The overdose epidemic has tracked along with exponential growth since at least 1979. There have been minor accelerations and decelerations. The dominant drugs vary by geography and population.
“Exponential growth in overdose deaths. The smooth overall U.S. overdose mortality curve (left panel) is a composite of multiple subepidemics, as revealed by changing patterns of overdose deaths by age distribution (middle panel; color indicates deaths per 100,000 persons), and by geography (right panel; color shows hotspots), for prescription opioids (upper) and heroin (lower).“
What happened is that people lied. They went to physicians seeking medication to divert. They posed as patients. Physicians are not trained to be law enforcement but suddenly were thrust into that role and many of the convictions depended on the premise that ‘physicians are smart and should have seen’ or ‘should have known. While physicians are adept at diagnosis, they depend on what they are told and can see. They have a truth bias embedded in their training. Physicians see their role as helping people to the best of their ability, not as policemen. Physicians cannot control what patients do with that prescription.
Dr. Steven Henson received a life sentence without the eligibility of parole because the judge in his case though he showed no remorse and still thought he was the smartest person in the room at the end of the trial. Dr. Henson dedicated his life to treating people. The death he is charged with causing was a suicide. The patient had been stable on his pain medication regimen. The patient was approached by the DOJ on a three-strikes offense. Rather than face prison, he committed suicide by overdose. Dr. Henson was charged with his death for writing the prescription.
Leo Beletsky of Northeastern calls the government crackdown on prescribers getting low-hanging fruit. The DEA measures success based on the number of arrests and prosecutions. Doctors are minor players. 263 physicians were convicted by the DEA on charges between 2003-2017, and over 3000 were forced to surrender their licenses. Data mining billing records and prescription databases has become the hunting ground. The DOJ has partnered with insurance companies to share data.
They create their targets. Who is the biggest prescriber in a region, state, and nationwide? They are investigated. Who does the most procedures? They use ‘flags’ like distance traveled forgetting that by disincentivizing and terrorizing prescribers there is no one left to prescribe, and patients must travel farther for the same services. The flags created during the pill mill era are now self-perpetuating. If you mine data enough you might find something and law enforcement can access data without individualized suspicion, probable cause, or any judicial review.
Two doctors recently indicted who have run a pain clinic for decades were under investigation for four years. One was indicted over two prescriptions for a moderate number of opioids. “Numbers alone can’t determine whether a crime has been committed: The ‘normal’ amount of opioid prescribing for a physician treating pain or addiction will inevitably be much higher than the average for all doctors or the typical amount in most other specialties.”
No simple change in prescribing can alleviate all risks while properly managing patients and their pain. “Review of the evidence showed very little data on the efficacy of any of the mitigation strategies against opioid diversion and misuse including screening tools, PDMP data, UDS (urine drug screens), contracts.” Despite the lack of evidence, the DEA and DOJ continue to insist that physicians who do not do each of these things are instead ‘pill mill’ doctors.
Christopher Russo, MD, a physician who has been on home arrest for over 3 years since his indictment, at which time the clinic he was employed by was shut down by prosecutors. Agents and prosecutors do not understand how medicine works. “[I]t’s easier to find ‘drug dealers with a pen’ if you simply define dealing as prescribing more than a certain amount—and busting doctors is certainly less risky for officers than going after violent cartel kingpins who run the fentanyl trade.” He is accused of billing fraud, but he properly billed for a procedure that was done on multiple sites of the spine. Medical coding is quite convoluted. Physicians first must bill a code for the first procedure and then if they do more procedures the same day there is a different code – which is precisely what this physician did.
He then prescribed a prescription for hydrocodone for the patient following the procedure (ablation) as discomfort from nerve ablation is common. The indictment accuses him of not only fraudulent billing but also prescribing without a legitimate medical purpose. This is typical of the indictments. Meanwhile, this fellowship-trained physician is confined to home, has no source of income, and is left with nothing.
On December 4, 2018, Dr. Christopher Russo and his co-defendants were indicted in
a thirty-seven-page indictment. He was indicted on five counts of health care fraud, aiding, and abetting. These allegations include that he prescribed opioids and other controlled substances to induce patients to attend reoccurring office visits and undergo medical procedures. Also alleged is that he submitted claims for procedures that were not necessary and ordered imaging and diagnostic tests that were unnecessary. Specific counts in the indictment:
Count 32. 4/25/2017 patient MM interlaminar lumbar/sacral injection $925 CPT code 62323
- Count 33. 11/16/2017 patient DS SI joint injection $1300 CPT code 27096
- Count 34. A separate count for the medication injected – dexamethasone J1100 $25.00
- Count 35. 3/14/2018 patient DS destruction lower spine facet joint CPT 64635 – code for the first vertebral nerve ablated $1650 and
Count 36. CPT 64636 $2475 code used for all the other vertebral nerves ablated the same day.
- Dr. Russo is a Board Eligible Anesthesiologist who went on to do a pain fellowship and a fellowship in interventional pain techniques. He sub-specializes in the spine. The procedures listed are precisely what he was trained to do. It is not the purview of the DEA nor the DOJ to determine whether these are medically necessary procedures – that is the jurisdiction of the state medical board.
Dr. Russo is a graduate of the University of Michigan Medical School, he completed his residency in Anesthesiology at Ann Arbor, did a two-year fellowship in Pain Medicine at the University of South Florida, and a Post Fellowship in Advanced Interventional Pain Techniques at Moffit Cancer Center in Tampa, Florida. At the time of the indictment, Dr, Russo was on the Board of Directors for the Michigan Society of Interventional Pain Physicians and an Assistant Professor of Surgery at Michigan State University College of Osteopathic Medicine. Dr. Russo is in the cohort that is defining pain management in medicine today.
The prescribing of narcotics for pain necessitates return visits. That is the standard of care. Controlled substance contracts require return visits for the prescribing of such substances and at this time, most state legislatures have enacted laws that require face-to-face visits every 28-30 days for any controlled substance prescription.
Michigan Public Act 247 of 2017 requires follow-up care for controlled substances. Medical billing is not a simple, straightforward endeavor. Physicians bill insurance as a courtesy to patients. Physicians are paid long after services are rendered, in a several month’s long process that requires multiple steps, any of which can go awry, delaying payment.
Current Procedural Terminology Codes (CPT) codes denote the procedures that were done, and they must be matched to the proper International Classification of Disease (ICD)-10 code.
That code is then submitted through a clearinghouse that reviews the claims and submits them in a standard format to the payor. The payer reviews the claim and rejects or pays an allowable amount. The adjudication of the claim is sent to the physician whether this is the rejection of part or all of the claim.
When physicians set up fee schedules, they consider not just the cost of that particular service but all the work that is required to do that job such as malpractice insurance expenses, rent, equipment, utilities, staffing – the cost of doing business. Also figured into the fee schedule is the fact that insurance companies only reimburse at “allowable” amounts. No physician sets their fee expecting to be reimbursed 100%. The majority of pain practices bill at three to ten times Medicare rates with six to seven times Medicare rates being the average.
Dr. Russo’s fees for his spinal injections and nerve ablations were all reasonable. The indictment had separate counts for standard billing: physicians are required to bill for the substance injected in the spine (dexamethasone J1100) separately from the injection itself. When doing ablations there is a code for the first nerve ablation (64635 for $1650) which is billed at a higher rate than all the subsequent nerves ablated which are billed as one code (64636).
The multiplier of 3 has been omitted from the indictment (so each additional ablation was $825 and the total charge for 3 additional nerves was $2475). Count 54 alleges that patient DS received 90 Hydrocodone on 3/14/2018. That is the same day the patient underwent nerve ablation of 4 nerves. Procedures require pain medication post-procedure. It is not up to the DEA nor the DOJ to conclude that this is distribution outside of the usual course of professional medical practice when post-procedure pain management is the very definition of the appropriate medical use of narcotics.
In addition, this patient had been a stable patient of the clinic for over 3 years, had failed back surgery (post-laminectomy pain syndrome with lumbar fusion). This is the precise reason for the referral to a pain clinic.
Dr. Russo used his extensive training to treat legitimate pain patients. The Government has charged Dr. Russo with practicing medicine and billing for his services. These are not crimes. There is no billing fraud present here, these were medically necessary procedures that are commonly done, and pain medication was appropriately prescribed following the procedure, not as the Government alleges, outside the usual course of professional medical practice, but indeed in the course of the practice of medicine.
The government “can rack up big numbers of busts by targeting docs, who, unlike dealers, list their addresses and contact information in public records.” Three years after his arrest, Dr. Russo is receiving new discoveries about a 30MME prescription (one-third of the maximum dose for a chronic pain patient in primary care per the 2016 CDC guidelines).
“The statistics don’t mention the individuals who died by suicide because their physician who prescribed them opiate pain medication was [indicted or] incarcerated and deprived of their ability to practice medicine.” Increasingly physicians are criticizing the CDC guidelines that the DOJ and its experts rely on for the 90MME limitation in prescribing. They are also criticizing the DEA’s presence in medical practices. “[F]ive professional groups representing 560,000 physicians . . . called on politicians to ‘end political interference in the delivery of evidence-based medicine.’”
They expressed that physicians should not face prison for providing the necessary care and that the laws that were being enacted are forcing physicians to choose between caring for their patients and facing criminal charges.
After data mining through billing and prescription records to find what the DOJ considers red flags, investigators use paid experts to establish probable cause for search warrants and for trial testimony. Experts “can provide an overview of the various standards of care that exist in the medical system” This is one of the issues.
There is no one standard of care. This is a matter of opinion and once you are arguing over medical standards of care this is out of the realm of a criminal case and is a medical malpractice standard. Yet this goes on in courtrooms and sends prescribers to prison. This is part of the ambiguity that the DOJ relies on. “If you want to question my decision making, then let’s work together to create guidelines and optimize decision making, but to state that a (medical) decision you may not agree with is a criminal decision is, I believe, a step too far.”
Disciplinary actions against opioid prescribers combined with restrictive prescribing policies led to prescriber fears and lead to forced tapering and underprescribing. Physicians feel that taking on legitimate patients who require opioids could jeopardize their career a form of defensive medicine which leads to longer distances traveled, and higher numbers of prescriptions for fewer prescribers.
Additionally, there is a circuit split as to whether prescribing without a legitimate medical purpose is an element that needs to be proven beyond a reasonable doubt.
The Supreme Court has just granted certiorari in Ruan v. U.S. The question raised is whether a physician, alleged to have prescribed controlled substances outside the usual course of professional practice may be convicted of unlawful distribution under 21. U.S.C. § 841(a)(1) without regard to whether, in good faith, he ‘reasonably believed’ or ‘subjectively intended’ that his prescription fall with that course of professional practice.
The Court is consolidating the case with Kahn v. the U.S. where the questions raised are (1) whether, when the government prosecutes a medical practitioner under the Controlled Substances Act for issuing a prescription outside “the usual course of professional practice,” that the prescription is outside the scope professional practice; (2) whether a ‘good faith’ defense in the context of a licensed medical practitioner prosecuted under the Controlled Substance Act protects doctors who have an honest but mistaken belief that they have issued the charged prescription in “the usual course of professional practice,” and, if so, whether that belief must be objectively reasonable; and (3) whether the “usual course of professional practice” and “legitimate medical purposes” prongs of 21 C.F.R. § 1306.04(a) must be read in the conjunctive or disjunctive. These are important precedent-setting cases as pain patients are increasingly unable to find treatment and out of desperation to escape pain some have turned to suicide or to street drugs, including heroin, to get relief after being stable on a treatment regimen for years.
The DOJ has not limited its targets to pain prescribers. Several addiction specialists have also been raided. Stuart Gitlow MD, a forensic psychiatrist, was raided. Dr. Gitlow is a Past President of ASAM and the Past Chair of the AMA’s Council on Science & Public Health. He has not been charged nor has his property been returned. “Nothing stops the FBI from saying our practice is illegitimate based on some random expert they bring in to say that we didn’t do x, y, or z ‘correctly’ in their eyes.”
A few months later, Tom Reach, MD had his addiction clinics closed down. Ironically, over eight years, Dr. Reach had worked with the DEA and state agencies through attorneys (spending well over $500,000) to ensure they were complying with all laws and regulations. They asked for site visits and opinions. Dr. Reach is a past president of the Tennessee Society of Addiction Medicine and was on the legislative committee of ASAM. He was on the governor’s commission to help write the rules and regulations around buprenorphine in Tennessee and Virginia. Now the DOJ is accusing him of conspiracy on those same laws.
What triggered his case was a nurse practitioner, Matthew Sikes, who was attempting to swing a deal on his case. While he was working at one of Dr. Reach’s clinics, Sikes relapsed and wrote prescriptions for himself and others off-book. To negotiate a better plea he made up some stories: that Dr. Reach was receiving money from Mexican drug cartels. The DOJ expected to find “lost millions.” However, that never materialized. Instead, they charged Dr. Reach with conspiracy. Now patients in two states with substance use disorder have lost access to treatment. These raids and investigations put patients’ lives at risk in addition to destroying the livelihoods of professionals.
The fallout is a vast chilling effect that directly undermines any attempts to expand access to treatment for substance use disorder which is greatly needed.
More harm is being caused by the DOJ as overdose deaths have reached new records. There were 100,00 fatal overdoses between April 2020 and April 2021 representing a 30% increase over the previous year. Prescription opioid use is at historic lows. The deaths are a result of “a volatile and lethal drug supply. More people are not choosing fentanyl but the street supply is dangerous. People think they are purchasing one thing but get cocktails that are often dangerous or lethal. . . . There are now more overdose deaths from illegal fentanyl than there were overdose deaths from all drugs in 2016.” Since 2010, deaths involving heroin and fentanyl have risen much more dramatically than those involving prescription opioids.
According to DEA data illicitly produced fentanyl and its analogs are manufactured in Asia or Mexico and brought to the United States via mail or private courier. “[F]ewer than 10% of opioid-related deaths involved prescription pain relievers without those other dangerous substances.”
Repeatedly, it is found that these users obtain the prescription drugs from friends, relatives, or dealers not from a prescriber. The irony of tracking data on the treatment of substance use disorder during an increasing overdose crisis from illicit fentanyl is astounding. It has led to a reluctance to practice and prescribe the very medications needed to stop the deaths. No one wants to be the highest prescriber. The very agency that oversees access to opioids has made this crisis go from bad to worse.
“The solution: overhauling the agency, or even getting rid of it entirely.” While politicians, the public, and the media go after ‘Big Pharma’ and physicians for greed and recklessness, very little attention has been paid to the DEA and DOJ. “This wasn’t just incompetence on the part of the DEA and the Department of Justice, it was knowing and intentional failure to do what most people think is their jobs. . . .
They were completely asleep at the wheel. . . .Over a period of 20 years, the DEA provided the green light to a 39-fold increase in the oxycodone quota and a 12-fold increase in the hydrocodone quota, even as our opioid epidemic unfolded.”
The pharmaceutical industry did not create the demand. It was a business proposition. Additionally, fifty years after its creation, the DEA has not only failed to eradicate the illicit drug market, but users can easily obtain stolen and counterfeit pills laced with fentanyl. Heroin and cocaine use is rampant and methamphetamine use is once again on the rise. All are found laced with illicitly manufactured fentanyl.
Those who would seek treatment for substance use disorder have difficulty accessing it due to the relentless and “evolving regulatory and enforcement strategies, like blocking the expansion of mobile methadone clinics and shutting down addiction treatment providers.” Rather than winning the war on drugs, the DEA’s tactics have fueled the opioid crisis and made it deadlier than ever. Reducing prescriptions has driven up the death toll by pushing nonmedical users toward deadlier drugs and abandoned pain patients to suicide and the same deadly counterfeit supply. “The primary tools of police—interdiction and criminal enforcement—work against the interests of public health.”
The aggressive policing and its collateral consequences, arrest, incarceration, loss of reputation, inability to seek treatment all lead to a range of poor outcomes. This has limited a public health approach to the opioid crisis which would require a reallocation of funding to health care and social services and “cede power and resources from police to public health.”
A public health approach looks at structural factors of substance use disorder: “lack of economic opportunity, poor working conditions, and eroded social capital in depressed communities accompanied by hopelessness and despair” and approaches these with healthcare and not criminalization. Harm reduction and treatment provided as a centerpiece of policy would follow countries like Portugal.
This requires “accepting the reality of drug use rather than eternally hoping that it will disappear as a result of repressive legislation . . .[and] allows drugs to be treated as a health, rather than [a] criminal justice issue.” Portugal’s success resulted in an 80 percent reduction of overdose deaths after decriminalization. Their policies focus on the individual person and their well-being. Drug prohibition, like alcohol prohibition before it, is a failed policy. We need to stop the over-criminalization and particularly the terrorizing of clinicians. We need policy not at odds with population health promotion.”
CONCLUSION
DEA’s mission is to enforce the controlled substances laws and regulations of the United States and bring to the criminal and civil justice system of the United States, or any other competent jurisdiction, those organizations and principal members of organizations involved in the growing, manufacture, or distribution of controlled substances appearing in or destined for illicit traffic in the United States; and to recommend and support non-enforcement programs aimed at reducing the availability of illicit controlled substances on the domestic and international markets.
However, the Office of the Inspector General reports the inadequacies of the DEA in combating diversion, the major issues are the illicit drugs and not the prescribed medications. So once again the DEA is off-target by targeting Healthcare Providers while largely ignoring the low-level diversion actors in the street.
Healthcare Providers are assumed by DEA to be lacking due diligence if they don’t prove beyond a shadow of a doubt that they have addressed any red flags but in court hardly ever produce evidence of real diversion but rely on suspicions and glitzy presentations.
In fact, DEA is the single most government agency whose tactics have the increased cost of medication and healthcare all across America by misinterpreting purpose and roles of medications needed to treat acute, chronic, neuropathic, and psychological, pain.
The DEA has been waging a campaign of disinformation to sway the public to a point prescribed narcotic analgesic medications are indeed drugs, dangerous drugs whose dosages are red flags indicating abuse and trafficking contributing to the so-called Opioid crisis around America.
DEA’s Pharmacy expert, Don Sullivan, interviewed no physicians/dentists, no patients receiving prescriptions, nor reviewed any prescriptions of any patients from Pronto PHARMACY. Further DEA, expert Don Sullivan reviewed no radiographs, performed no physical examinations on the patients of Pronto Pharmacy to impeach the primary physician’s initial diagnosis. DEA Diversion Investigator had no training and stated he did no investigation.
Notably, DEA’s evidence always realizes upon execration on numbers of “pills” and street language such as “pill mills,” “Holy Grails,” and “Cocktails,” not on medical disease states or clinical conditions. Prosecutors have found these forms of distortion, redefinition of medical procedures effectively sells juries. Further Judges often instruct the juries to ignore any clinical presentation or will not allow such testimony on the record.
The damage to Healthcare Providers and the chronic pain patient populations is devastating and the DEA never takes into account the clinical needs of the patients. It’s as if they have criminalized pain management without the benefit of clinical knowledge.
WHEREFORE, WE DEMAND UPON THIS COURT:
- Grant this motion and reverse to findings and decision of the Administrative Court, return and restore all privileges of the DEA Control Registration Certificates of Pronto Pharmacy LLC.
- Further, Dismiss the Decision of the Administrative Judge Mark Dowd in agency case No: 19-42, Federal Registry filed 1927282 on December 20, 2021with extreme prejudice.
Return all Files, Equipment, Medication to Pronto Pharmacy Llc and its owner Norman J Clement of Tampa, Florida.
- To be made more than whole and to Reward damages and penalties of amounts greater than $187 million U.S. dollars
RESPECTFULLY SUBMITTED
- February 18, 2022
Norman J Clement
Norman J Clement, pro se
CERTIFICATE OF SERVICE
I HEREBY CERTIFY that on February 18, 2022, a true and correct copy of the foregoing was electronically filed via ECF and/or served via e-mail upon the following:
I, Norman J Clement, hereby certify that I electronically filed and agree to utilize jointly the foregoing Respondent’s Notice of Filing the Certified List of the Record with the Clerk of the Court for the United States Court of Appeals for the District of Columbia Circuit, by using the appellate CM/ECF system, on February 18, 2022. I certify further that Petitioner is pro se, and that service will is accomplished by electronic mail to
Anita Gay, Esq United States Department of Justice
Criminal Division/ Narcotic and Dangerous Drugs Section
145 N Street, NE, Room 2E-404 Washington, D.C. 20002
(202) 353-7629 anita.gay2@usdoj.gov
Respectfully Submitted
Norman J Clement
Norman J Clement pro. se
prontopharmacy@aol.com
LOW HANGING FRUIT
FOR NOW, YOU ARE
WITHIN THE NORMS
The DEA needs to focus on illicit drugs coming into the US from other countries. We need to protect our doctors from the DEA.