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Pain Management Prescribing Practices and Audits.

(August 16, 2017): Earlier this summer, the U.S. Department of Justice (DOJ) executed its most extensive “health care fraud takedown” to date, initially arresting 412 licensed healthcare providers, doctors, and nurses alleged to have engaged in fraudulent conduct (additional arrests were made in the days following the takedown).  As Attorney General Jeff Sessions stated at that time, We are sending a clear message to criminals across this country: We will find you. We will bring you to justice. And you will pay a very high price for what you have done.” Of the 412 individuals arrested, approximately 120 of the defendants, including doctors, were charged for their roles in prescribing and distributing opioids and other dangerous narcotics. The charges aggressively targeted pain management providers billing Medicare, Medicaid, and TRICARE for medically unnecessary prescription drugs and compounded medications that often were never even purchased and / or distributed to beneficiaries. Many of the charges brought against pain management professionals have alleged that these individuals have contributed to the nation’s current opioid epidemic through the unlawful distribution of opioids and other prescription narcotics.

I.  Pain Management Providers Around the Country are Being Targeted by DOJ:

To be clear, there is, in fact, a significant problem with prescription opioid abuse and diversion.  In the first six months of 2017, there have been a number of federal enforcement cases brought against pain management physicians, practices and clinics for a wide variety of opioid-related violations.  Several of these include:

February 2017:  In this Pennsylvania case, a pain management physician pleaded guilty to selling prescriptions for controlled substances in exchange for cash payments.  The government further alleged that many of the customers who went to the clinic were drug dealers or addicts who sold the medications they were prescribed.  It was further alleged that neither the defendant nor the other pain management professionals charged in the case conducted medical or mental health examinations as required by law. The government alleged that during the period that this conspiracy took place, the defendant physician illegally sold over $5 million worth of controlled substances.

March 2017:  Two Michigan physicians providing care to pain management patients were found guilty by a jury for allegedly running a “pill mill” supplying narcotics to drug-seeking individuals.  More specifically, the government argued that the evidence showed that the physicians wrote prescriptions for Schedule II narcotics to individuals outside of the course of professional medical practice and for no legitimate purpose.  The government further claimed that the clinic’s physicians prescribed over 1.5 million oxycodone pills and charged customers $250 cash for a 30-day supply of narcotics.

April 2017:  In this Louisiana case, a physician and former co-owner of a pain management practice pleaded guilty to several criminal counts.  The physician was alleged to have run a “pill mill” where he prescribed controlled substances to drug abusers and seekers for a flat fee, even though there no legitimate medical purpose for the prescriptions.

May 2017:  In this Missouri case, a medical resident pleaded guilty to writing over 70 false prescriptions.  The government reported that the defendant wrote opioid prescriptions using the names of six separate persons, despite the fact that he did not have a physician-patient relationship with any of them.

June 2017:  In this New York case, a criminal complaint was unsealed against a family practice physician with no specialized training in pain management, who is alleged to have written more than 14,000 prescriptions, totaling more than 2.2 million oxycodone pills, between approximately 2012 and 2017.  The government has alleged that thousands of illegal prescriptions were written that did not have a legitimate medical purpose.

July 2017:  This Tennessee-based pain management practice settled False Claims Act violations for $312,000.  The pain practice was alleged to have caused the submission of false claims to Medicare and TennCare for medically unnecessary urine drug tests. The settlement also resolves allegations that the [pain practice] caused the submission of false claims to Medicare and TennCare for non-Food & Drug Administration. . . approved pharmaceuticals. . . “The United States’ investigation was initiated after extensive data analysis identified [the practice] as a potential outlier in the provision of urine drug testing to Medicare patients.”

II.  Typical Criminal Violations Charged in Pain Management Diversion and / or Trafficking Cases:

As you will notice, the standard that DOJ repeatedly cites is that a prescription is illegal if it has no “legitimate medical purpose” and / or is outside the “usual course of his professional practice.”  From a practical standpoint, if your prescribing practices fall into one of these categories, DOJ is likely to argue that your practices are below the applicable standard of care and are indicative of a crime. Typical statutory offenses charged in criminal pain management diversion and / or trafficking cases include:

Drug Trafficking (21 U.S.C. §§ 84l).  Typically charged when alleging that a party knowingly and intentionally, prescribed controlled substances, not for a legitimate medical purpose and not in the usual course of professional practice.

Health Care Fraud (18 U.S.C. § 1347).  It is unlawful for any person to knowingly: (1) defraud any health care benefit program; or (2) obtain by false pretenses any money or property owned or under the control of a health care benefit program.   Any person convicted under this statute could be fined and/or imprisoned for a maximum of 10 years.  If the offense resulted in serious bodily injury, then the eligible term of imprisonment is increased to 20 years.  If the offense resulted in death, then the maximum term of imprisonment is increased to life.

Aggravated Identity Theft (18 U.S.C. § 1028A).  Under this statute, whoever during and in relation to any felony enumerated in subsection (c) [predicate offense], . . . knowingly transfers, possesses, or uses without lawful authority a means of identification of another person, shall, in addition to the punishment provided for such [predicate offense], be sentenced to a term of imprisonment of 2 years. . .

Examples of the 60 predicate offenses include:

18 U.S.C. 1001 (relating to false statements or entries generally),

18 U.S.C. 1035 (relating to false statements relating to health care matters),

18 U.S.C. 1347 (relating to health care fraud)

18 U.S.C. 1343 (relating to wire fraud)

18 U.S.C. 1341 (relating to mail fraud)

Obstruction of a Federal Audit (18 U.S.C. § 1516).  It is illegal to intentionally influence, or obstruct a federal auditor in the course of performing his or her official duties relating to any person or organization receiving more than of $100,000 from the federal government in any one-year period.  The penalty for violating this section is the imposition of a fine and/or a maximum of five years imprisonment.  A federal auditor is any person employed for the purpose of conducting an audit or quality assurance inspection on behalf of the federal government.

Obstruction of a Criminal Investigation into Health Care Offenses (18 U.S.C. § 1518).  It is unlawful to prevent, obstruct, or delay the communication of information relating to a federal health care offense to a criminal investigator. Any person convicted for violating this statute could face a fine and / or up to five years imprisonment. 

Prohibition Against Kickbacks (Anti-Kickback Statute) (42 U.S.C. § 1320a–7b(b)). The federal Anti-Kickback Statute makes it a crime to knowingly and willfully offer, pay, solicit, or receive remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to purposefully induce or reward referrals of items or services payable by a federal health care program. Simply put, it is against the law to pay or provide anything of value in an effort to induce referrals or business related to a federal health care program.

III.  What is Behind the Current Crackdown on Improper Opioid Prescribing Practices?

The DOJ currently believes that these pain management medications are a large contributing factor to the ongoing opioid epidemic. Essentially, federal prosecutors contend that opioid medications are being over prescribed and are not being used for the intended purposes, but are ending up on the streets for illegal sale and use. From 1999 to 2015, more than 183,000 patients died from overdoses related to prescription opioids with over 30,000 of those deaths occurring in 2015. Almost half of those deaths from 2015 being from prescription opioid overdose. With nearly 2 million Americans either abusing or dependent on opioids, the Center for Disease Control and Prevention (CDC) took significant steps last year to address the growing problem of opioid abuse in this country. In March 2016, the agency published its CDC Guideline for Prescribing Opioids for Chronic Pain (CDC Guideline). Since the issuance of the CDC Guideline, a growing number of states have either adopted this voluntary guidance or implemented similar restrictions on the prescribing practices of physicians, nurse practitioners and physician assistants in their respective states.

IV.  The Role of Medicare Part D:

Medicare Part D is an optional prescription drug program for Medicare beneficiaries. As of 2016 it covered more than 40 million individuals. While Medicare Part D can be very beneficial when it comes to helping its beneficiaries handle their pain management it can also easily be taken advantage of. While Medicare part D was aimed at providing medication for beneficiaries, it has substantially contributed to the opioid crisis through over prescription as well as the redirection of prescriptions for unlawful and abusive purposes, such as recreational use and the sale of opioids.

The CDC recently posted guidelines for medical prescription providers on how to prescribe opioids to patients with chronic pain. The CDC cautions providers on prescribing patients more than 90mg or more of morphine per day, any higher dosage and the patient becomes at risk for overdose or fatality.  A result of over prescription of opioids was one-third of all beneficiaries receiving at least one prescription opioid through Medicare Part D in 2016. In total, approximately 14 and a half million people received opioid prescriptions, out of a total of 43.6 million Part D beneficiaries. These 14.4 million prescriptions totaled $4.1 billion for nearly 80 million prescriptions.

Several states such as Alabama and Mississippi have significantly higher proportions of opioid prescriptions for Medicare Part B beneficiaries, 46% and 45% respectively. Approximately 10% of Medicare Part B recipients received one or more opioids on a regular basis, with 5 million beneficiaries receiving opioids for three months or more in 2016.  More than half a million beneficiaries received high amounts of opioids through Part D in 2016. All of these beneficiaries received a morphine equivalent dose (MED) of greater than 120mg per day for at least 3 months[1].

V.  Both Patients and Legitimate Pain Management Professionals are in a No-Win Situation:

From a patient standpoint, many individuals suffering from chronic pain report that it’s a bad time to be in pain.  Patients suffering from chronic pain are increasingly finding it more difficult to obtain care and treatment.  A recent survey by the Pain News Network and International Pain Foundation found that more than 90% of the respondents did not think that the 2016 CDC Guideline improved the quality of pain care in the United States.  Additionally, more than 80% reported that their level of pain had increased and their quality of life had decreased over the past year since the CDC Guideline had been issued. These increases in patient dissatisfaction are due, in large part, to the growing reluctance of non-specialists to prescribe opioids and other controlled substances. This is a result of the ever-increasing level of scrutiny that is being given to a physician’s opioid and controlled substance prescribing practices. Patients suffering from chronic pain are now often referred to pain management clinics and centers for specialized pain care and toxicology monitoring.

Unfortunately, legitimate pain management physicians, practices and clinics around the country are now finding themselves at the center of an ongoing effort by state and federal regulators to address opioid dependence, diversion and abuse.  As they diligently work to alleviate the painful conditions of their patients they must also worry about their medical decision-making and opioid prescribing practices being second-guessed by well-meaning federal and state investigators, regulators and prosecutors. Regretably, legitimate pain management professionals, practices and clinics are inadvertently being swept-up in the government’s current enforcement efforts targeting opioid abuse and diversion.

VI.  Conclusion:

While the government’s interest in opioid and controlled substance prescribing practices isn’t new, there is no question that this area is currently the subject of heightened enforcement.  The number of opioid-related administrative investigations initiated by state medical and  dental boards has significantly grown over the last year.  During this same period, the opioid prescribing practices of physicians, nurse practitioners, physician assistants, podiatrists and dentists have been carefully assessed (primarily through data mining) by state and federal law enforcement in an effort to identify and prosecute providers engaging in illegal conduct.  Now, more than ever, it is essential that you review your care and treatment practices to ensure that your documentation accurately reflects the medical necessity of any pain medications prescribed.  Despite the fact that the CDC March 2016 guidance is “voluntary,” we recommend that pain management professionals review their prescribing practices and verify whether their particular practices are consistent with the recommendations set out in the CDC’s March 2016 guidance.  Additionally, you should ensure that your opioid prescribing practices also comply with any requirements established by your state legislature and any state licensing authorities.

Pain Management

[1] United States of America. U.S. Department of Health & Human Services. Office of Inspector General. HHS OIG Data Brief OEI-02-17-00250.

Are your opioid prescribing practices currently being investigated or audited by the state medical board, state AG’s office, DEA or DOJ?  If so, give us a call.  Liles Parker attorneys represent health care providers around the country in regulatory audits and investigations.  For a free consultation, please call Robert: 1 (800) 475-1906.

Texas Licensing Boards Have Announced a Pain Clinic Takedown and Have Disciplined Multiple MDs and PAs

The Texas Medical Board is Paying Particular Attention to Pain Clinic MDs and PAs(February 5, 2013):  In late December 2012, the Texas Medical Board and the Texas Physician Assistant Board announced that they had suspended or restricted the licenses of seventeen physicians and four physician assistants as part of coordinated “Pain Clinic Takedown.”  These licensing Boards met over a two-week period in back-to-back disciplinary hearings last December and took action against multiple licensed clinicians in connection with their pain clinic activities. Commenting on the massive enforcement action taken, Dr. Irvin Zeitler, Jr., the President of the Texas Medical Board said:

“This represents more than two years of hard and sometimes dangerous work by TMB staff. . . . . The doctors and physician assistants involved in these illegal operations have been fueling an epidemic of prescription drug abuse and fraud that is killing more people than heroin and cocaine combined. We hope this sends the message that pill mills aren’t welcome in Texas.”

According to the Texas Medical Board, when handling this investigation, their staff worked closely with officials of the Drug Enforcement Administration, the Texas Department of Public Safety, the Texas State Board of Pharmacy, the Texas Board of Nursing and local law enforcement authorities in and around Houston.

A review of the following pain clinic related disciplinary action examples can be quite instructive and can give a real sense of the specific concerns presented by the clinicians’ conduct.  These risk areas can be incorporated into your practice’s Compliance Plan, and can be used to strengthen your efforts to ensure that subordinate licensed clinicians are properly supervised and that pain medications are appropriately handled.

Disciplinary Case — Physician #1:  A disciplinary panel of the Texas Medical Board temporarily suspended license of this licensed physician, ruling that he posed a “. . . continuing threat to the public welfare due to his failure to adequately supervise mid-level providers and due to inappropriate prescribing of controlled substances.”  Physician #1 was responsible for supervising advanced practice nurses and physician assistants who prescribed controlled substances without a legitimate medical need.

Disciplinary Case — Physician #2: As in the earlier case, a disciplinary panel of the Texas Medical Board temporarily suspended license of this licensed physician, ruling that he posed a “. . . continuing threat to the public welfare due to his failure to adequately supervise mid-level providers and due to inappropriate prescribing of controlled substances.”   Physician #2 was responsible for supervising advanced practice nurses and physician assistants who prescribed controlled substances without a legitimate medical need.

Disciplinary Case — Physician #3:   A disciplinary panel of the Texas Medical Board temporarily suspended license of this licensed physician on the basis that he posed “. . . a continuing threat to the public welfare due to his failure to adequately supervise mid-level providers and due to inappropriate prescribing of controlled substances.”

Disciplinary Case — Physician #4:  A disciplinary panel of the Texas Medical Board temporarily suspended the license of a physician on the basis that he posed  “. . . a continuing threat to the public welfare due to his improper and illegal operations of four pain clinics including two unregistered pain clinics and due to inappropriate prescribing of controlled substances.”

Disciplinary Case — Physician #5:  A disciplinary panel of the Texas Medical Board temporarily restricted the medical license of this physician and ordered him to immediately surrender his DEA/DPS controlled substance certificates.   The physician was also “. . .prohibited from treating chronic pain patients and shall not supervise or delegate prescriptive authority to physician extenders.”   The Board further found that the physician posed  “. . . a continuing threat to the public welfare due to his improper and illegal operation of a pain management clinic based on his inappropriate ownership and unlawful method and manner of prescribing controlled substances.”

Disciplinary Case — Physician #6: A disciplinary panel of the Texas Medical Board temporarily restricted the medical license of this physician, requiring that she immediately cease treating chronic pain patients and surrender her DEA/DPS controlled substance certificates. In addition, the physician was “. . . prohibited from supervising or delegating prescriptive authority to physician extenders, may not prescribe for herself or her family and must surrender any Pain Management Certificates issued to her by the Board.”  The TMB further found that the physician’s “. . . continued practice of medicine [posed] a continuing threat to public welfare, and that she failed to adequately supervise advanced nurse practitioners and/or physician assistants at two pain clinics.”

Disciplinary Case — Physician Assistant #1:  A disciplinary panel of the Texas Physician Assistant Board temporarily restricted the license of this physician assistant, thereby “ . . . immediately prohibiting him from the practice of treating chronic pain patients and requiring him to surrender the DPS/DEA certificates that allow him to prescribe controlled substances.”  The Board further found that the licensee posed “. . . a continuing threat to the public welfare because he inappropriately prescribed controlled substances and was not adequately supervised by a physician.”

Disciplinary Case — Physician Assistant #2: A disciplinary panel of the Texas Physician Assistant Board temporarily the license of this physician assistant after determining that her continued practice of medicine posed “. . . a threat to public welfare.”   The Board’s order prohibits the physician assistant from “. . . treating chronic pain patients and requires her to surrender her DPS/DEA certificates that allow her to prescribe controlled substances.”  The TPAB further found that the physician assistant poses “. . . a continuing threat to the public welfare because she participated in the illegal operation of a pain clinic and inappropriately prescribed controlled substances.”

As these examples reflect, both the Texas Medical Board and the Texas Physician Assistant Board take controlled substances quite seriously.  Physicians responsible for supervising subordinate physician assistants and nurse practitioners with prescriptive authority have an affirmative obligation to properly oversee and manage these professional staff members and their pain management practices.

Should you receive notice that a complaint has been filed against you or your practice with the Texas Medical Board or the Texas Physician Assistant Board, it is essential that you take such a matter seriously.  The informal and formal hearing processes are fairly complex.  If at all possible, don’t try to handle this alone – retain experienced legal counsel to represent your interests.

Robert W. Liles and other Liles Parker attorneys are experienced in representing physicians and other licensed clinicians in front of the Texas Medical Board and its associated non-physician licensing Boards.  Should you have any questions, call Robert for a free consultation.  He can be reached at:  1 (800) 475-1906.