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.

Kusserow on Compliance: Emerging government enforcement priorities for 2018

At the HCCA conference in April, there were several presentations regarding the government’s enforcement priorities. There were a number of emerging issues that were the subject of considerable attention: the opioid crisis, electronic health record (EHR) fraud, and telehealth/telemedicine. By far, the area given the most attention was the opioid crisis.  More than a dozen presenters included comments in their presentations on this subject, including presenters from the DOJ, OIG, CMS, and the OCR. This is not surprising in that last October the President declared this to be a national public health care crisis and marshaled regulatory and enforcement agencies to actively focus on steps to alleviate it. Other agencies not present at the HCCA are included in this effort, such as the FDA, FCC, CDC, Indian Health Service, Veterans Administration, Department of Defense TRICARE program, and others. At the federal and state level, there is increased legislative, regulatory, and enforcement actions activity related to substance abuse and behavioral health services. In January, the Attorney General announced the DEA was increasing its focus on pharmacies and prescribers who dispense unusual or disproportionate amount of such drugs. He also has created the Prescription Interdiction and Litigation (PIL) task force to aggressively deploy and coordinate all available criminal and civil law enforcement tools to address the crisis. Both DOJ and OIG presenters noted the July 2017 “take down” of 412 defendants in 41 different judicial districts. The defendants included over 100 doctors, nurses, and other medical license professionals. Together these individuals were responsible for over $1.3 billion in false billings.

The second most reported topic concerned cyber and IT security of Protected Health Information (PHI). This was a main topic in the presentation by OCR, but was alluded to in seven other presentations on cybersecurity and threats and complying with HIPAA Privacy and Security standards. The OCR reported that since 2009, there have been 2178 reports of breaches over 500 files with more than 300,000 cases of breaches affecting fewer than 500 files. The OCR has responded to over 170,000 complaints that resulted in over 25,000 cases being resolved with corrective action measures.  The OCR expects about 17,000 new complaints this year.  The top 10 recurring issues involve: (1) disclosure of sensitive paper information, (2) business associate agreements, (3) risk analysis, (4) failure to manage risks, such as with encryption, (5) lack of transmission security, (6) failure of ongoing auditing, (7) no patching of software, (8) insider threats, (9) improper disposal of records, and (10) insufficient backup of information and contingency planning.

Several sessions focused on physician arrangements and how they could implicate the Anti-Kickback Statute and Stark Laws.  Statistics from DOJ indicated the continuing trend of increased number of qui tam cases that has grown from 426 in 2015 to around 500 in 2017 with annual settlements averaging about $2.5 billion per year.

New cases involving Meaningful Use Fraud were reported with the promise that more new cases were under development.  Another area getting a lot of enforcement attention by the DOJ and OIG relate to telehealth and telemedicine. Cases surfacing now are focusing on claims arising from billings for these areas that did not qualify as such.  Only certain telehealth services are covered by Medicare and providers should take care to follow CMS guidance on what qualifies.

It is interesting to compare these priorities with results for the 2018 Compliance Benchmark Survey of compliance officers. There was no mention of the opioid crisis, as it was just an emerging national issue at the time the survey was taken. HIPAA security/cyber-security was the highest priority. It is troubling that corrupt arrangements with referral sources remains the number one regulatory and enforcement priority for the OIG and DOJ but is ranked fifth in priority to respondents. The other major and continuing enforcement priority related to claims submissions and that ranked third in priority by compliance officers.  A complementary webinar relating to this survey will be presented on May 9th.

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.

First ever indictment against Chinese manufacturers of opioids

The Justice Department recently took unprecedented steps to combat the opioid crisis in the United States by filing indictments against Chinese manufacturers of fentanyl and other opioid substances. The department has labeled these manufacturers as Consolidate Priority Organization Targets (CPOTS), which it believes are the “most significant drug trafficking threats in the world,” because they have elements of the most productive money laundering and drug trafficking organizations.

The investigations of the Chinese manufacturers revealed a new and disturbing facet of the opioid crisis in America—fentanyl and fentanyl analogues are coming into the United States in numerous ways, including highly pure shipments of fentanyl from factories in China directly to U.S. customers who purchase it on the Internet. Unwary or inexperienced users often have no idea that they are ingesting fentanyl until it is too late. The Centers for Disease Control estimates that over 20,000 Americans were killed by fentanyl and fentanyl analogues in 2016, and the number is rising at an exponential rate.

The indictments, filed against two Chinese nationalists and a handful of American citizens which are alleged to have conspired with the nationalists, claimed that the nationals operated chemical plants and labs in China and sold fentanyl to United States citizens via the internet. The indictment against one manufacturer further alleged that the chemical structure of the drugs had been modified in order to evade prosecution. If convicted, the nationalists could face prison time and significant monetary penalties.

Sessions creates opioid fraud detection unit, focuses on 12 districts

Twelve federal districts have been selected to participate in an Opioid Fraud and Abuse Detection Unit, created by the Department of Justice (DOJ). The DOJ will fund twelve Assistant United States Attorneys for three year terms to focus solely on investigating and prosecuting fraud related to prescription opioids. Attorney General Jeff Sessions announced the program’s formation at the Columbus Police Academy in Ohio.

Data analytics program

The unit will consist of a data analytics program, which will allow targeted investigation and prosecution. Sessions stated that the team would use such information as physicians who prescribe opioids at a higher rate than peers, the average age of patients receiving the prescriptions, and pharmacies dispensing large amounts of opioids to focus its investigation.

The federal prosecutors, located in districts across the country, will work with various agencies to investigate and prosecute opioid fraud, including pill mills and unlawful diversion of opioids. Most of the districts are located in the east and Midwest, such as Florida, Michigan, Alabama, Kentucky, Ohio, and West Virginia.