Deeper Than the Headlines: OIG Senate Testimony-Opioids

The OIG continues its voice of concern over opioid overutilization and misuse in the context of Medicare and Medicaid. Most recently, Maureen Dixon, OIG Special Agent in Charge for the Philadelphia Regional Office testified before the U.S. Senate Committee on Finance, Health Care Subcommittee.

Her testimony highlighted law enforcement activities led by the Office of Investigations and she discussed OIG projects currently underway to combat opioid-related fraud, waste, and abuse. She also highlighted key OIG recommendations that would, if implemented, have a positive impact on the opioid problem.

She began by reminding the committee that more than 60,000 Americans died from drug overdoses in 2016, of which 66 percent reportedly involved opioids. Deaths from prescription pain medication remain far too high, and in 2016, there was a sharp increase in deaths involving synthetic opioids such as fentanyl and an increase in heroin-involved deaths. According to the CDC, approximately three out of four new heroin users report having abused prescription opioids prior to using heroin. Prescription drug diversion—the redirection of prescription drugs for an illegal purpose—is a serious component of this epidemic.

What I found most interesting in her testimony were the case examples she shared. Case examples like these tend to demonstrate the seriousness of these issues because they are happening to real people.

Case Examples:

PATIENT HARM

In Philadelphia, Dr. Norman Werther was sentenced to 25 years in prison for distribution of a controlled substance resulting in death and more than 300 counts stemming from his operation of a pill mill. Werther was part of a multimillion-dollar drug conspiracy involving illegal prescriptions, phony patients, and multiple drug trafficking organizations. The drug traffickers recruited large numbers of pseudo-patients who were transported to Werther’s medical office for cursory examinations. The “patients” paid an office visit fee, usually $150, by cash, check, or money order, and Werther wrote prescriptions for them to obtain oxycodone-based drugs without a legitimate medical purpose and outside the usual course of professional practice. The phony patients were then driven to various pharmacies to have their prescriptions filled. The drugs were then turned over to drug traffickers so their organizations could sell them to numerous drug dealers who resold them on the street. At one point, Werther knowingly dispensed approximately 150 pills containing 30 milligrams each of oxycodone, and 30 pills containing 15 milligrams each of oxycodone, to a patient for no legitimate medical purpose, ultimately resulting in the individual’s death from overdose.

PRESCRIPTION FRAUD

In Williamsport, Dr. John Terry was sentenced to 20 months in prison for writing fraudulent prescriptions for oxycodone. Along with Terry, Thomas Ray was sentenced to 71 months in prison on charges of possession with intent to distribute a controlled substance. Terry wrote prescriptions for oxycodone and other narcotics for Ray in reckless disregard of the fact that the drugs were not being used by Ray for legitimate medical purposes, but being diverted and sold on the street. Medicaid paid for the fraudulent prescriptions written for Ray. Terry also wrote prescriptions for oxycodone in Stephen Heffner’s name knowing that Heffner was not his patient and the drugs would later be diverted to another individual, David Hatch. Because Medicare paid for these drugs, Heffner and Hatch were both sentenced to 6 months of probation for theft from the Medicare Program

In Pittsburgh, Dr. Brent Clark was sentenced to 60 months in prison on charges of distribution of oxycodone and amphetamine outside the usual course of professional practice and health care fraud. He was also ordered to pay more than $225,000 in restitution and forfeit $131,000, the building he owned where he conducted his medical practice and where the offenses were committed, his Drug Enforcement Administration prescribing number, his Pennsylvania State medical license, and a vehicle he owned. Clark distributed oxycodone on 13 occasions and amphetamine on 3 occasions outside the usual course of professional practice.

TREATMENT RELATED FRAUD

In Philadelphia, Dr. Alan Summers was sentenced to 48 months in prison and ordered to pay over $4.6 million in restitution after pleading guilty to charges of conspiracy to distribute controlled substances, distribution of controlled substances, health care fraud, and money laundering. Dr. Summers ran a clinic that sometimes operated under the business name NASAPT (National Association for Substance Abuse-Prevention & Treatment). Co-defendants Dr. Azad Khan and Dr. Keyhosrow Parsia were employed by Dr. Summers. The defendants executed a scheme in which they sold prescriptions for large doses of Suboxone and Klonopin in exchange for cash payments. Experts testified at trial that Suboxone and Klonopin should never be prescribed together except in rare cases when absolutely necessary. At the clinic, virtually all customers received prescriptions for both Suboxone and Klonopin regardless of their medical need. During the duration of the conspiracy, Dr. Khan and other doctors at the clinic illegally sold more than $5 million worth of these controlled substances. Almost all of the prescriptions for Suboxone and Klonopin were pre-printed before the customer met with a doctor. Khan and the other doctors working at the clinic failed to conduct medical examinations or mental health examinations as required by law to legally prescribe these controlled substances. Several customers who frequented the clinic testified that they were, in fact, drug dealers or drug addicts who sold the prescribed medications. Three other doctors involved in the scheme have pleaded guilty and have either already been sentenced or await sentencing.

In Johnstown, Dr. John Johnson was sentenced to 84 months in prison and ordered to pay more than $3 million in restitution after pleading guilty to charges of paying kickbacks and tax fraud. Johnson owned and operated a group of pain management clinics and entered into an agreement with Universal Oral Fluid Labs (UOFL) and its owner, William Hughes, to refer patients to UOFL in exchange for kickback payments. UOFL was a clinical drug testing and drug screening lab located in Greensburg, Pennsylvania. Johnson received cash payments and monthly checks from Hughes and UOFL in exchange for referring patients, including Medicare and Medicaid beneficiaries, to UOFL. Johnson referred all of his patients to UOFL for drug testing and related services. He received more than $2,300,000 in kickbacks from Hughes and UOFL for these referrals. As a result of Johnson’s referrals, UOFL received millions of dollars from third-party payors, including approximately $3,443,528 from Medicare and $1,147,768 from Pennsylvania Medicaid.

OIG EFFORTS

In addition to sharing these examples in her testimony, Special Agent Dixon also outlined the efforts the OIG and other federal agencies are taking to try and combat these types of occurrences.

Among these efforts are:

• Data analysis to identify questionable prescribing, dispensing, and utilization of opioids
• In July 2017, OIG released a data brief entitled Opioids in Medicare Part D: Concerns about Extreme Use and Questionable Prescribing
• OIG currently has numerous opioid-related audits or evaluations underway.
• They address the following issues: Questionable prescribing patterns in Medicaid
• Medicaid program integrity controls
• Medicare program integrity controls in the prescription drug benefit
• CDC’s oversight of grants to support programs to monitor prescription drugs
• FDA’s oversight of opioid prescribing through its risk management programs
• SAMHSA’s oversight of opioid treatment program grants
• Beneficiary access to buprenorphine medication-assisted treatment
• Opioid prescribing practices in the Indian Health Service.
• OIG will soon release a new data brief on opioid use in Medicare Part D
• OIG will also release an analysis toolkit which will provide detailed steps for using prescription drug data to analyze patients’ opioid levels and identify those at risk of opioid misuse or overdose, such as those who receive extreme amounts of opioids or appear to be doctor shopping.
• Medicare Fraud Strike Force
• Opioid Fraud and Abuse Detection Unit
• The Healthcare Fraud Prevention Partnership and the National Healthcare Anti
• Fraud Association
• Pharmacy Diversion Awareness Conferences

Compliance officers today should at least be aware of what their organization is doing by way of policies, procedures, monitoring and auditing to ensure their opioid practices are in line with all legal, regulatory, ethical, and best clinical practice standards available.