Kusserow on Compliance: OIG toolkit for calculating opioid levels and opioid misuse risk

The OIG toolkit provides detailed steps for using prescription drug claims data to analyze patients’ opioid levels and identify certain patients who are at risk of opioid misuse or overdose. It is based on the methodology that OIG has developed in its extensive work on opioids. This provides technical information to support the OIG’s public and private sector partners, such as Medicare Part D plan sponsors, private health plans, and State Medicaid Fraud Control Units. It is intended to assist OIG partners with analyzing their own prescription drug claims data to help combat the opioid crisis. It provides steps to calculate patients’ average daily morphine equivalent dose (MED), which converts various prescription opioids and strengths into one standard value. This measure is also called morphine milligram equivalent (MME). The toolkit includes a detailed description of the analysis and programming code that can be applied to the user’s own data. The resulting data can be used to identify certain patients who are at risk of opioid misuse or overdose. Users can also modify the code to meet their needs, such as identifying patients at other levels of risk. The toolkit has three chapters:

 

(1) Analysis of Prescription Drug Claims Data,

(2) Explanation of the Programming Code To Conduct the Analysis, and

(3) Programming Code.

 

Opioid abuse and overdose deaths are at epidemic levels in the United States. As one of the lead federal agencies fighting health care fraud, the OIG is committed to supporting public and private partners in its efforts to curb the opioid epidemic. These partners include Medicare Part D plan sponsors, other private health plans, State Medicaid Fraud Control Units, State prescription drug monitoring programs, and researchers. They can use this toolkit to analyze claims data for prescription drugs and identify patients who may be misusing or abusing prescription opioids and may be in need of additional case management or other follow-up. This toolkit can also be used to answer research questions about opioid utilization.

Copies can be obtained by contacting the Office of Public Affairs at Public.Affairs@oig.hhs.gov.

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

Connect with Richard Kusserow on Google+ or LinkedIn.

Subscribe to the Kusserow on Compliance Newsletter

Copyright © 2018 Strategic Management Services, LLC. Published with permission.

Device manufacturer’s misrepresentations result in $12.5M FCA settlement

Medical device manufacturer AngioDynamics, Inc., settled with the United States for $12.5 million following allegations that the company caused health care providers to submit false claims related to the use of the LC Bead® and the Perforator Vein Ablation Kit® (PVAK) to Medicare, Medicaid, and other federal health care programs. The government alleged that the manufacturer both provided instructions to use inaccurate billing codes and misrepresented Medicare billing policy related to the devices. The settlement came as a result of a suit filed under the whistleblower provision of the False Claims Act (FCA) (31 U.S.C. § 3729).

LC Bead allegations

The medical device manufacturer will pay $11.5 million—$10.9 million paid to the federal government and $600,000 paid to state Medicaid programs—to resolve allegations that the company caused the submission of false claims for procedures involving an unapproved drug delivery device marketed with false and misleading promotional claims. The government alleged that between 2006 and 2011, AngioDynamics served as the distributor for the manufacturer of the LC Bead and marketed the product for use as a drug delivery device in combination with chemotherapy drugs. Employees of the manufacturer routinely claimed that this use of the LC Bead was “better,” “superior,” “safer,” and “less toxic” than alternative treatment, despite lack of clinical evidence to support the statements and despite the FDA’s repeated declination to approve the product. Knowing that many insurers did not provide coverage for certain LC Bead procedures, the company instructed health care providers to use inaccurate billing codes for claims related to these uses.

PVAK allegations

AngioDynamics will also pay $1 million to resolve allegations that the company caused the submission of false claims in connection with the use of PVAK, used to close or collapse malfunctioning veins and which was approved by the FDA only for use in treating superficial veins and not for perforator veins. The manufacturer voluntarily recalled the PVAK and reissued the product under the name “the 400 micron kit.” Despite the recall and rebranding, certain AngioDynamics employees took part in a continued campaign to market the device to treat perforator veins, falsely representing to providers that Medicare would cover this use

Kusserow on Compliance: Four physicians charged in $200M prescription fraud scheme

A CEO and four physicians were charged in a superseding indictment in an investigation of a $200 million health care fraud scheme that involved a network of Michigan and Ohio pain clinics, laboratories, and other medical providers. Additional charges included wire fraud conspiracy, money laundering, and distribution of over 4.2 million medically unnecessary dosage units of controlled substances and medically unnecessary injections to Medicare beneficiaries, some of whom were addicted to narcotics. These included oxycodone, hydrocodone and oxymorphone. Some of the opioids were resold on the street.

When a medical review was made of the injection claims, it was found that 100 percent of the claims were not eligible for Medicare reimbursement. In order to conceal the continued billing of these fraudulent claims to Medicare, the defendants created new shell companies and continued to engage in the same billing of fraudulent claims, often changing only the name of the company on the door to the medical practice and/or inventing new suite numbers to conceal the continuation of the fraudulent practices at the same location. Defendants also owned a diagnostic laboratory to enable them to order medically unnecessary urine drug testing from the laboratory. When Medicare conducted a medical review of claims submitted by the laboratory, it determined that 95 percent of the claims were not eligible for Medicare reimbursement and ordered the diagnostic laboratory to repay $6.9 million in improper payments.

Another scheme involved money laundering in connection with a $6.6 million wire transfer and the withdrawal of $500,000 in cash, which was hidden in plastic bags in the closet of the house.  The indictment alleges that transferred proceeds derived from the conspiracy were used to allow the defendants to live an extravagant lifestyle and spend millions of dollars on luxury items—clothing from retailers like Hermes, rare Richard Mille watches, and exotic automobiles such as a Lamborghini and Rolls Royce Ghost. The proceeds were also used to purchase a mansion and other real estate in the Detroit, Michigan area and to sit courtside or in the first row of NBA basketball games, including the NBA Finals.

 

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

Connect with Richard Kusserow on Google+ or LinkedIn.

Subscribe to the Kusserow on Compliance Newsletter

Copyright © 2018 Strategic Management Services, LLC. Published with permission.

Important news for IntelliConnect customers

It’s no secret that technology is changing the way each of us works and Wolters Kluwer is committed to helping you harness the power of technology to drive greater efficiencies and improved outcomes for your business. As part of that commitment, we continue to invest roughly 10% of our annual revenues into the development and enhancement of new and existing products.

In 2015, based on close collaboration with our customers, we launched Cheetah™, an intuitive legal research platform, powered by Wolters Kluwer’s world-class content enabling legal professionals to quickly understand and advise on today’s complex matters. In 2018, Cheetah™ won the SIIA CODiE Award for Best Legal Solution.

Over the past year, Cheetah™ has been successfully adopted by more than 2,500 law firms, law schools, and corporate legal departments. Based on this adoption, we’ve reached the point where we have decided to sunset the IntelliConnect platform and move to one research platform, Cheetah™. This move will allow us to further invest in enhancements to Cheetah™ and other value-added solutions for the legal marketplace. As part of this change, we will migrate any remaining IntelliConnect customers to Cheetah™ over the next few months.

Your successful transition to Cheetah™ is very important to us and we are here to support you along the way. We will also provide you with dual access to your subscribed content on Cheetah™ and IntelliConnect at no additional charge at this time.

If you have questions in the meantime, please contact us at 1-800-955-5217 or CheetahSupport@wolterskluwer.com. If you would like to learn more about Cheetah™, please go to our dedicated site for Training & Support.

Thank you for being a valued customer. We greatly appreciate your patronage, and look forward to our continued partnership.

Sincerely,

Dean Sonderegger
Vice President, Legal Markets & Innovation
Legal & Regulatory, U.S.

WoltersKluwerLR.com