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What’s at Stake for Medical Professionals in “Pill Mill” Investigations

What’s at Stake for Medical Professionals in “Pill Mill” Investigations

In an earlier article, I detailed how the DOJ has focused its attention on the aggressive investigation and prosecution of “pill mill” cases.  In this article, I discuss the consequences physicians and other medical professionals potentially face as a result of a “pill mill” investigation.

CRIMINAL PROSECUTION

A litany of criminal charges can be heaped on medical professionals at the conclusion of a “pill mill” investigation. Exactly what charges the government pursues will obviously depend on the facts and circumstances of each particular case. One charge that will inevitably be included in every “pill mill” indictment is an alleged violation of the Controlled Substances Act (“CSA”). The CSA governs the distribution and dispensing of various listed drugs, including narcotics, that are prescribed by physicians and other licensed medical providers. To issue a controlled substance, a physician must be licensed to practice by a state authority and must have a DEA registration number.

Under the CSA, controlled substances are placed into one of five “schedules” based on whether they have a currently accepted medical use in the United States, their relative abuse potential, and their likelihood of causing dependence when abused. Most opioids are Schedule II drugs because they have acceptable medical uses and but a high potential for abuse.

To be convicted under the CSA, the government must prove that (1) the defendant physician knowingly and intentionally distributed or dispensed a controlled substance, and (2) did so “for no legitimate medical purpose and outside the usual course of professional practice.” Determining whether a physician has illegally prescribed drugs under this standard is never simple and will necessarily involve a “battle of the experts.”

A criminal conviction for violating the CSA may result in a vast array of prison sentences under the federal Sentencing Guidelines, a set of advisory sentencing rules that establish a uniform policy for individuals convicted of felony crimes in federal court. The exact range may vary significantly from case-to-case, depending primarily on the type and quantity of controlled substances involved. And these ranges can be staggeringly severe. In a recent “pill mill” case in Mobile, Ala., the physicians each faced a guidelines range of imprisonment of 30 to 240 years, although the court sentenced them well below that range (20 and 21 years, respectively) – as it had the discretion to do. In addition to applicable guidelines ranges in each case, the CSA provides for statutorily “enhanced” sentences in certain circumstances. For instance, if the government proves that a patient’s death resulted from the distribution of a Schedule II controlled substance, the convicted physician will face a sentence of no less than 20 years and up to life in prison.

SEIZURE AND FORFEITURE

In almost every “pill mill” case, the government will attempt to seize (take possession of) and forfeit (take ownership of) bank accounts, business assets, and personal assets of the targeted medical professional based on a theory that they are “proceeds” of the alleged “pill mill” operation or somehow “facilitated” the purported criminal enterprise. For example, following the physicians’ convictions in the case mentioned above, the government forfeited their bank accounts, investment and retirement accounts, college fund accounts, houses, beach-fount condominiums, and 20-plus luxury automobiles.

CIVIL LIABILITY

On top of criminal prosecution, a “pill mill” investigation could result in a civil lawsuit by the government against the targeted physician or medical professional, to the extent they have billed a federal health care program. For instance, the government might bring a direct suit under the False Claims Act (“FCA”), alleging that the physician made false diagnoses, prescribed drugs for non-covered indications, or prescribed excessive or “medically unnecessary” drugs for Medicare or Medicaid patients. Likewise, the government may join in a “qui tam” suit, which is initiated by a “whistleblower” – such as a current or former employee of the practice – claiming the targeted physician or practice has violated the FCA and other laws.

ADMINISTRATIVE PROCEEDINGS

In addition to facing criminal prosecution, the loss of asserts, and civil liability, physicians investigated or charged in a “pill mill” case can be subject to a number of administrative sanctions. The DEA, in particular, has a range of administrative actions it can take, such as: issuing a letter of admonition to the registrant providing notice of a violation of the applicable law/regulations; requiring the registrant to enter into a memorandum of understanding agreeing to take certain corrective steps to stave off revocation of the registration; or, for the most serious alleged violations, pursuing a show cause order to appear before an administrative law judge, during which the DEA will advocate for revocation of the registration.

Like the DEA, state professional boards (such as medical and pharmacy boards) have disciplinary authority and can sanction practitioners for professional violations, such prohibiting a physician from prescribing specific schedules of drugs, suspending a physician’s medical and/or dispensing license, or revoking the license.

Further, the Centers for Medicare & Medicaid Services (“CMS”) may limit, suspend, or revoke a provider’s Medicare billing privileges for, among other things, noncompliance with Medicare enrolment requirements, a felony conviction related to controlled substances, or a pattern of improper prescribing practices. Likewise, state Medicaid agencies can impose various administrative sanctions against providers, including outright exclusion from the program.

CONCLUSION

The consequences physicians and other medical professionals face as a result of a “pill mill” investigation are varied and potentially severe. Given that, pain management practitioners should be acutely aware of any signs that they are under investigation, including, among other things, receiving a government subpoena or civil investigative demand or learning that the practice’s employees or patients have been interviewed by investigating agents. Upon receiving the slightest hint of an investigation, practitioners should act quickly in obtaining legal counsel to conduct an internal investigation, determine the practice’s potential exposure, and intervene on the practice’s behalf in the hopes of warding off further government scrutiny.

For more information on these issues, please contact Burr & Forman’s Health Care team. Burr & Forman is an official partner with the Medical Association.

Posted in: Opioid

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The New Department of Justice Initiative: Aggressively Investigating and Prosecuting Opioid-Related Cases

The New Department of Justice Initiative: Aggressively Investigating and Prosecuting Opioid-Related Cases

Before joining Burr & Forman, LLP, I was a federal prosecutor for a little over a decade specializing in health care fraud and general white collar matters. In that role, I was the member of a prosecution team that secured guilty verdicts earlier this year against two pain management doctors in Mobile, Ala., following a protracted jury trial. The doctors were convicted of a litany of federal crimes arising from their operation of a pain management clinic, including, among others, violations of the Controlled Substances Act and the Anti-Kickback Statute. The doctors received substantial prison sentences of 20 and 21 years, respectively, and forfeited virtually all of their assets (including bank accounts, houses and cars) to the government.

The doctors in this case were convicted of running what the government calls a “pill mill,” a pain management clinic that allegedly prescribes narcotics for illegitimate purposes. Pain management professionals should be aware this is just one example of what will likely be an onslaught of “pill mill” and other opioid-related prosecutions by the Department of Justice (DOJ) during the current administration. In fact, just a few months after the convictions in the Mobile case, Attorney General Jeff Sessions announced a nationwide takedown of 120 doctors, pharmacists and nurses – dubbed “Operation Pilluted” – who were charged with various federal crimes related to their alleged “unlawful distribution of opioids and other prescription narcotics.” In announcing the takedown, Sessions noted the DOJ would continue to “aggressively pursue corrupt medical professionals,” and “the Department’s work is not finished. In fact, it is just beginning.”

On the heels of that announcement, in August of this year, Sessions heralded a new DOJ pilot program called the “Opioid Fraud and Abuse Detection Unit.” According to Sessions, the unit “will focus specifically on opioid-related health care fraud using data to identify and prosecute individuals that are contributing to the opioid epidemic.” Sessions warned, “If you are a doctor illegally prescribing opioids or a pharmacist letting these pills walk out the door and onto our streets based on prescriptions you know were obtained under false pretenses, we are coming after you.” Sessions explained the DOJ would be appointing a special federal prosecutor in 12 select districts across the country whose sole purpose will be to prosecute “pill mill” and other opioid-related cases.

One of the districts, which has received one of the special “pill mill” prosecutors, is the Northern District of Alabama, in Birmingham. The U.S. Attorney for that district, Jay Town, separately confirmed the new prosecutor will spend “100 percent of their time working these types of cases…What we’re going after is the medical providers who are operating outside the boundaries of the law and the medical practice.” Echoing the Attorney General’s statements, Town vowed, “We’re going to rid the Northern District of these pill mills.”

Note “pill mills” are not the only opioid-related cases on the DOJ’s radar. In fact, it is also concentrating on the “diversion” of opioids in hospital settings. Such “diversion” schemes include, for instance, the theft of opioids from a hospital “Pxyis” machine (a device hospitals utilize to regulate the dispensing of controlled substances) by nurses, or the forgery or fraudulent creation of opioid prescriptions by hospital personnel.

In sum, the DOJ has fired a warning shot that physicians, pharmacists and other medical professionals involved in the treatment of patients will be under intense scrutiny for the foreseeable future. This is especially true for physicians who operate pain management clinics. These doctors should, in general, prescribe opioids reasonably and carefully in the context of each patient’s presentation and thoroughly document their treatment.

To that end, doctors should, among other things: maintain a thorough intake procedure, which requires the patient to give a detailed medical history and provide previous diagnostic studies; have the patient sign, if applicable, an “opioid treatment agreement” requiring the patient to abide by certain opioid use guidelines; perform exhaustive physical examinations during the initial visit and at regular intervals during the patient’s treatment (which should be carefully documented); consider alternatives to opioid treatment, such as non-narcotics drugs, physical therapy and surgery (and, where applicable, carefully document why alternative treatments would be ineffective); prescribe the lowest dosage and quantity of opioids possible to treat the patient’s condition; closely monitor for signs of diversion and addiction by regularly ordering urine drug screens and reviewing the patient’s prescription drug monitoring data; and have regular independent audits conducted by a billing consultant or another pain management specialist to ensure compliance with all regulations and laws. Implementing these practices should help doctors avoid government scrutiny as part of the DOJ’s new initiative to crack down on alleged “pill mill” operations.

Adam Overstreet is counsel at Burr & Forman, LLP. Prior to joining Burr, Adam practiced with the U.S. Attorney’s office and gained extensive experience with health care fraud matters. Burr & Forman, LLP, is a partner with the Medical Association. Please read other articles from Burr & Forman, LLP, here.

Posted in: Legal Watch

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An Overlooked Epidemic: Older Americans Taking Too Many Unneeded Drugs

An Overlooked Epidemic: Older Americans Taking Too Many Unneeded Drugs

Consider it America’s other prescription drug epidemic.

For decades, experts have warned that older Americans are taking too many unnecessary drugs, often prescribed by multiple doctors, for dubious or unknown reasons. Researchers estimate that 25 percent of people ages 65 to 69 take at least five prescription drugs to treat chronic conditions, a figure that jumps to nearly 46 percent for those between 70 and 79. Doctors say it is not uncommon to encounter patients taking more than 20 drugs to treat acid reflux, heart disease, depression or insomnia or other disorders.

Unlike the overuse of opioid painkillers, the polypharmacy problem has attracted little attention, even though its hazards are well documented. But some doctors are working to reverse the trend.

At least 15 percent of seniors seeking care annually from doctors or hospitals have suffered a medication problem; in half of these cases, the problem is believed to be potentially preventable. Studies have linked polypharmacy to unnecessary death. Older patients, who have greater difficulty metabolizing medicines, are more likely to suffer dizziness, confusion and falls. And the side effects of drugs are frequently misinterpreted as a new problem, triggering more prescriptions, a process known as a prescribing cascade.

The glide path to overuse can be gradual: A patient taking a drug to lower blood pressure develops swollen ankles, so a doctor prescribes a diuretic. The diuretic causes a potassium deficiency, resulting in a medicine to treat low potassium. But that triggers nausea, which is treated with another drug, which causes confusion, which in turn is treated with more medication.

For many patients, problems arise when they are discharged from the hospital on a host of new medications, layered on top of old ones.

Alice Cave, who divides her time between Alexandria, Va., and Tucson, Ariz., discovered this when she traveled to Cheyenne, Wyo., after her 87-year-old aunt was sent home following treatment for a stroke in 2015.

Before her hospitalization, Cave said, her aunt, a retired telephone company employee whose vision is impaired by glaucoma, had been taking seven drugs per day. Five new ones were added in the hospital, Cave said.

“She came home and had a huge bag of pills, half of which she was already taking, plus pages and pages of instructions,” she said. Some were supposed to be taken with food, some on an empty stomach. Cave said she spent several hours sorting the medications into a giant blue pillbox. “It was crazy — and scary.”

Cave said she felt helpless to do much; her aunt’s doctors didn’t question the need for more drugs.

When Shannon Brownlee’s mother was taken to an emergency room recently to determine whether her arm pain might signal a heart attack (it didn’t) a cardiologist prescribed five new drugs — including an opioid — to the small dose of a diuretic she had been taking to control her blood pressure.

Brownlee, senior vice president of the Lown Institute, a Boston-based group that seeks to improve health care quality by reducing unnecessary treatment, said that when her brother questioned the necessity of so many new drugs for a woman in her late 80s, the specialist replied frostily, “I don’t see anything wrong with prescribing lots of medication to older people.”

Bring the Pill Bottles

“This problem has gotten worse because the average American is on a lot more medications than 15 years ago,” said cardiologist Rita Redberg, a professor of medicine at the University of California at San Francisco.

Studies bolster Redberg’s contention: A 2015 report found that the share of Americans of all ages who regularly took at least five prescription drugs nearly doubled between 2000 and 2012, from 8 percent to 15 percent. University of Michigan researchers recently reported that the percentage of people older than 65 taking at least three psychiatric drugs more than doubled in the nine years beginning in 2004. Nearly half of those taking the potent medications, which include antipsychotic drugs used to treat schizophrenia, had no mental health diagnosis.

Redberg and other doctors are trying to counter the blizzard of prescriptions through a grass-roots movement called “deprescribing” — systematically discontinuing medicines that are inappropriate, duplicative or unnecessary.

Interest in deprescribing, which was pioneered in Canada and Australia, is growing in the United States, bolstered by physician-led efforts, such as the five-year-old Choosing Wisely campaign. The Beers Criteria, a list of overused and potentially unsafe drugs for seniors first published in 1991, has been followed by other tools aimed at curbing unnecessary drug use.

“Lots of different medications get started for reasons that are never supported by evidence,” said Redberg, editor in chief of JAMA Internal Medicine. “In general, we like the idea of taking a pill” a lot better than non-drug measures, such as improved eating habits or exercise.

“That’s what we were taught as physicians: to prescribe drugs,” said Ranit Mishori, a professor of family medicine at Georgetown University and a proponent of deprescribing. “We are definitely not taught how to take people off meds.”

Kathryn McGrath, a Philadelphia geriatrician, said she tries to begin every appointment with a review of medications, which she asks patients to bring with them. “I think having the pill bottles” is much more powerful than a list, said McGrath, who has written about how to deprescribe safely.

Although support is growing, deprescribing faces formidable obstacles.

Among them, experts say, is a paucity of research about how best to do it, relentless advertising that encourages consumers to ask their doctors for new drugs, and a strong disinclination – baked into the culture of medicine — to countermand what another physician has ordered. Time constraints play a significant role. So do performance measures that are viewed as a mandate to prescribe drugs even when they make virtually no sense, such as giving statins to terminally ill patients.

A Reluctance to Overrule

“There’s a reluctance to tinker or change things too much,” said University of Michigan geriatric psychiatrist Donovan Maust, who labels the phenomenon “clinical inertia.” When inheriting a new patient, Maust said, doctors tend to assume that if a colleague prescribed a drug, there must be a good reason for it — even if they don’t know what it is. Maust said he tries to combat inertia by writing time-limited orders for medication.

He recently began treating a man in his 80s with dementia who was taking eight psychiatric drugs — each of which can cause significant side effects and most of which had been prescribed for undetermined reasons.

“It’s very typical to see a patient who has a few episodes of reflux and is then put on a [proton pump inhibitor, or PPI] and a few years later are still taking it,” said Georgetown’s Mishori. Many experts say the heartburn drugs are overprescribed, and studies have linked their long-term use to fractures, dementia and premature death.

“This is a cultural problem and an awareness problem exacerbated by the fragmentation of care,” said Brownlee, the author of “Overtreated: Why Too Much Medicine is Making Us Sicker and Poorer.” Many doctors, she added, have never heard of deprescribing.

Before his death several years ago, doctors advised Brownlee’s father, a hospice patient, to continue taking a statin, along with several other medications. None would improve or extend his life, and all had potentially harmful side effects.

Rx: What For?

Older people taking lots of medication was what Canadian pharmacist Barbara Farrell encountered when she began working at a geriatric hospital in Ottawa nearly two decades ago. Her experience, she said, was a catalyst for the Canadian Deprescribing Network, a consortium of researchers, physicians, pharmacists and health advocates she co-founded. The group seeks to drastically reduce inappropriate medication use among Canadian seniors by 2020.

Farrell, a clinical scientist at the Bruyere Research Institute, has also helped write guidelines, used by doctors in the United States and other countries, to safely deprescribe certain classes of widely used drugs, including proton pump inhibitors and sedatives.

“I’ve found a lot of receptivity” to the guidelines among physicians, Farrell said. “We know there are pockets around Canada and the world where they’re being implemented.”

One of Farrell’s most memorable successes involved a woman in her late 70s who was using a wheelchair and was nearly comatose.

“She would literally slide out of her chair,” Farrell recalled. The woman was taking 27 drugs four times per day and had been diagnosed with dementia and a host of other ailments.

After reviewing her medications, Farrell and her colleagues were able to weed out duplicative and potentially harmful drugs and reduce the doses of others. A year later, the woman was “like a different person”: She was able to walk with a cane and live mostly independently, and she reported that her doctor said she did not have dementia after all.

When Farrell asked another patient why she was taking thyroid medication, the woman replied that her doctor had prescribed it for weight loss after her last pregnancy — in 1955.

“The patients I see are the tip of the iceberg,” Farrell said.

One way to facilitate deprescribing, Farrell said, is to require doctors to record why a drug is being prescribed, a proposal the deprescribing network has made to Canadian health officials. A recent study by a team from the Boston VA Healthcare System found strong support among doctors for this concept.

While some doctors are reluctant to discontinue medications, patients can be wary, too.

“They may say, ‘I tried stopping my sleeping pill and I couldn’t sleep the next night, so I figured I needed it,’” Farrell said. ” Nobody explained to them that rebound insomnia, which can occur after stopping sleeping pills, lasts three to five days.”

Mishori said that she deprescribes only one medication at a time so she can detect any problem that arises from that change. And, she adds, “I never take people off of a medication without doing something else.” In the case of heartburn drugs, she might first recommend taking the drug only when needed, not continuously. Or she might suggest a safer alternative, such as an over-the-counter antacid tablet.

Maust, the geriatric psychiatrist, recommends that doctors actively focus on “the big picture” and carefully weigh whether the benefits of a drug outweigh its risks.

“In geriatrics,” he said, “less is more.”

By Sandra G. BoodmanKHN’s coverage related to aging and improving the care of older adults is supported in part by The John A. Hartford Foundation.

Posted in: Opioid

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Trump: Opioid Epidemic “Worst Drug Crisis” in U.S. History

Trump: Opioid Epidemic “Worst Drug Crisis” in U.S. History

President Trump called the opioid epidemic the “worst drug crisis” to strike the U.S. in its history while declaring a public health emergency – not a national emergency as promised earlier in the summer. According to the Centers for Disease Control and Prevention, more than 140 American die every day from an opioid overdose, which made President Trump’s announcement one of the most anticipated of the last few months yet not quite what health care advocates were expecting.

“Nobody has seen anything like this going on now. As Americans, we cannot allow this to continue,” Trump said at a White House ceremony. “It is time to liberate our communities from this scourge of drug addiction. … We can be the generation that ends the opioid epidemic. We can do it.”

There’s a legal distinction between a public health emergency, which the secretary of Health and Human Services can declare under the Public Health Services Act, and a presidential emergency under the Stafford Act or the National Emergencies Act. The President’s Opioid Commission recommended in July for a declaration of national emergency in order for the president to have more power to waive privacy laws and Medicaid regulations.

However, declaring a public health emergency, which can only last for 90 days and be renewed a number of times, demonstrates the complexity of an opioid crisis that continues to grow through an ever-evolving cycle of addiction, from prescription pain pills to illegal heroin to the lethality of fentanyl.

What the public health emergency won’t do is free up much federal funding. Acting Health and Human Services Secretary Eric Hargan will be given more room to loosen certain regulations that he otherwise would not be able to.

The declaration will expand access to telemedicine to better help those with an addiction in remote areas receive medications; allow for the shifting of resources within HIV/AIDS programs to help people eligible for those programs receive substance use disorder treatments; and more. It could spur a fight for funding in Congress, as Senate Democrats have introduced a bill to put $45 billion toward the epidemic. Many Republicans also back much more funding to combat the epidemic.

The opioid action is the first public health emergency with a nationwide scope since a year-long emergency to prepare for the H1N1 influenza virus in 2009 and 2010.

Posted in: Opioid

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