Combating the Opioid Epidemic
Last Updated: 05-18-2023
Key Takeaways from the August 2021 report: Concerns Persist about Opioid Overdoses and Medicare Beneficiaries' Access to Treatment and Overdose-Reversal Drugs
OIG's Approach to Addressing the Opioid Epidemic
Addressing the opioid epidemic is a top priority for OIG. OIG's efforts fall in three areas:
- identifying opportunities to improve the efficiency and effectiveness of HHS programs;
- identifying and holding accountable those engaged in fraud; and
- empowering and collaborating with partners through data sharing and education.
OIG's actions in these areas advance prevention, detection, and enforcement of fraud, waste, and abuse in HHS programs that intersect with the opioid epidemic and help ensure quality care and treatment for those in need of services.
Identify Opportunities to Improve HHS Programs
Many HHS programs are involved with various aspects of the opioid epidemic, giving OIG opportunities to identify program improvements. Medicare, Medicaid and the Indian Health Service have influence over program integrity in prescription drug coverage; the Food and Drug Administration oversees new drug approvals and safety of existing drugs; and agencies such as the National Institutes of Health, Substance Abuse and Mental Health Services, and the Centers for Disease Control and Prevention award grants for education and treatment programs. Identifying opportunities to improve the effectiveness of HHS programs helps prevent waste, fraud, and abuse.
- The Risk of Misuse and Diversion of Buprenorphine for Opioid Use Disorder Appears to Be Low in Medicare Part D OEI-02-22-00160
- Opioid Overdoses and the Limited Treatment of Opioid Use Disorder Continue To Be Concerns for Medicare Beneficiaries OEI-02-22-00390
- Many Medicare Beneficiaries Are Not Receiving Medication to Treat Their Opioid Use Disorder OEI-02-20-0039
- Concerns Persist about Opioid Overdoses and Medicare Beneficiaries' Access to Treatment and Overdose-Reversal Drugs OEI-02-20-00401
- SAMHSA Is Missing Opportunities To Better Monitor Access to Medication Assisted Treatment Through the Buprenorphine Waiver Program OEI-BL-20-00260
- Opioid Use in Medicare Part D During the Onset of the COVID-19 Pandemic OEI-02-20-00400
- Opioids in Medicaid: Concerns About Opioid Use Among Beneficiaries in Six Appalachian States OEI-05-19-00410
- Few Patients Received High Amounts of Opioids from IHS-Run Pharmacies OEI-05-18-00470
- FDA's Risk Evaluation and Mitigation Strategies: Uncertain Effectiveness in Addressing the Opioid Crisis OEI-01-17-00510
- CMS Should Pursue Strategies To Increase the Number of At Risk Beneficiaries Acquiring Naloxone Through Medicaid OEI-BL-18-00360
- Opioid Use in Medicare Part D Continued To Decline in 2019, but Vigilance Is Needed as COVID-19 Raises New Concerns OEI-02-20-00320
- Medicare Part D Beneficiaries at Serious Risk of Opioid Misuse or Overdose: A Closer Look OEI-02-19-00130
- HHS OIG Toolkits for Calculating Opioid Levels and Identifying Patients At Risk of Misuse or Overdose
- States' Use of Grant Funding for a Targeted Response to the Opioid Crisis OEI-BL-18-00460
- Geographic Disparities Affect Access to Buprenorphine Services for Opioid Use Disorder OEI-12-17-00240
- Medicare Part D Plan Sponsors and CMS Did Not Ensure That Transmucosal Immediate-Release Fentanyl Drugs Were Dispensed Only to Beneficiaries Who Had a Cancer Diagnosis A-09-20-03033
- More Than 90 Percent of the New Hampshire Managed Care Organization and Fee-for-Service Claims for Opioid Treatment Program Services Did Not Comply With Medicaid Requirements A-01-20-00006
- California Improperly Claimed at Least $23 Million of $260 Million in Total Medicaid Reimbursement for Opioid Treatment Program Services A-09-20-02009
- Louisiana Faced Compliance and Contracting Challenges in Implementing Opioid Response Grant Programs A-06-20-07003
- Texas Did Not Ensure Documentation Supported That Individuals Met Eligibility Requirements and That Its Annual Report Was Accurate Under Its Project for Assistance in Transition From Homelessness Program A-02-21-02001
- SAMHSA's Oversight Generally Ensured That the Commission on Accreditation of Rehabilitation Facilities Verified That Opioid Treatment Programs Met Federal Opioid Treatment Standards A-09-20-01002
- Opportunities Exist for CMS and Its Medicare Contractors To Strengthen Program Safeguards To Prevent and Detect Improper Payments for Drug Testing Services A-09-20-03017
- California Claimed at Least $2 Million in Unallowable Medicaid Reimbursement for a Selected Provider's Opioid Treatment Program Services A-09-20-02001
- Choctaw Nation of Oklahoma Made Progress Toward Meeting Program Goals During the First Year of Its Tribal Opioid Response Grant A-07-20-04121
- Ohio Made Progress Toward Achieving Program Goals for Enhancing Its Prescription Drug Monitoring Program A-05-18-00004
- Opioid Treatment Programs Reported Challenges Encountered During the COVID-19 Pandemic and Actions Taken To Address Them A-09-20-01001
- Update on Oversight of Opioid Prescribing and Monitoring of Opioid Use: States Have Taken Action To Address the Opioid Epidemic A-09-20-01000
- Factsheet: Ohio's Oversight of Opioid Prescribing and Monitoring of Opioid Use A-05-19-00036
- Ohio Did Not Ensure the Accuracy and Completeness of Psychotropic and Opioid Medication Information Recorded in Its Child Welfare Information System for Children in Foster Care A-05-18-00007
- Factsheet: Kentucky's Oversight of Opioid Prescribing and Monitoring of Opioid Use A-04-19-02022
- SAMHSA's Oversight of Accreditation Bodies for Opioid Treatment Programs Did Not Comply With Some Federal Requirements A-09-18-01007
OIG annually publishes the top unimplemented recommendations that, in our agency's view, would most positively affect HHS programs in terms of cost savings, program effectiveness and efficiency, and public health and safety if implemented. Recommendations concerning opioids that were unimplemented as of August 2020 appear in the table below. Find all top unimplemented recommendations of 2020 here.
Recommendation Relevant Report The Centers for Medicare and Medicaid Services (CMS) should educate Part D beneficiaries about access to medication-assisted drugs and naloxone. Medicare Part D Beneficiaries at Serious Risk of Opioid Misuse or Overdose: A Closer Look, OEI-02-19-00130 (May 2020) Substance Abuse and Mental Health Services Administration should geographically target its efforts to increase the participation of waivered providers in high-need counties. Geographic Disparities Affect Access to Buprenorphine Services for Opioid Use Disorder, OEI-12-17-00240 (January 2020) CMS should:
- ensure the correct submission of prescriber National Provider Identifiers, and
- work to ensure that individual beneficiaries can be uniquely identified at a national level using T-MSIS.
National Review of Opioid Prescribing in Medicaid Is Not Yet Possible, OEI-05-18-00480 (August 2019) Indian Health Service (IHS) should:
- increase oversight of information technology (IT) systems by IHS management;
- present findings and cost savings analysis to Tribal leadership and the IHS user community to get buy-in for any significant IT enterprise changes; and
- implement a strategic and phased approach to centralization of IT systems, services, and cybersecurity functions.
- ensure that they follow the Indian Health Manual when prescribing and dispensing opioids;
- develop policies and procedures to review the electronic health records (EHRs) of patients with opioid prescriptions from non-IHS providers and document the results of the review in the EHR, particularly for those patients who had previously violated their chronic opioid therapy agreements;
- ensure that opioid dispensing data are complete, accurate, and submitted in a timely manner to the State Prescription Drug Monitoring Program for use by providers and pharmacists; and
- track all opioids prescribed at the hospital in the patient EHRs, including those being filled at an outside pharmacy.
IHS Needs To Improve Oversight of Its Hospitals' Opioid Prescribing and Dispensing Practices and Consider Centralizing Its Information Technology Functions, A-18-17-11400 (July 2019) IHS should identify all hospitals with unsupported networking equipment and implement a system development life cycle plan to ensure hardware and software replacement before end of life. Two IHS Hospitals Had System Security and Physical Controls for Prescription Drug and Opioid Dispensing but Could Still Improve Controls, A-18-16-30540 (November 2017)
Identify and Hold Accountable those Engaged in Fraud
To help detect fraud, OIG deploys state-of-the-art data analytics and algorithms to identify the most egregious providers for further scrutiny or investigation by OIG and its partners.
In addition to leveraging data to detect fraud, OIG utilizes all advanced investigative techniques in its criminal, civil and administrative cases.
Enforcing Fraud Laws
To enforce laws, OIG may investigate cases on its own, or collaborate with its law enforcement partners. In the 2018 National Health Care Fraud Takedown, OIG and its law enforcement partners worked together to charge 601 defendants for opioids-related fraud related to prescribing patterns and to patient treatment.
- 2022 Opioid Enforcement Action
- Doctor Sentenced to 24 Months in Prison for Selling Prescriptions of Suboxone and Klonopin (2018)
- Physician Owner of HNC and Wife Sentenced for Health Care Fraud Offenses Involving Prescription Opiate Pain Medication (2018)
- Former Doctor Sentenced to 75 Months in Prison for Illegally Prescribing Opiates and Committing Health Care Fraud (2018)
- Berea Pharmacist Sentenced To 30 Years For Illegally Dispensing Prescription Pills And Pseudoephedrine And Money Laundering (2017)
- Former Doctor Sentenced to 23 Years in Prison for Distributing Prescription Drugs, Health Care Fraud and Money Laundering (2017)
- Doctor Sentenced for Running Pill Mill And Contributing To A Death (2013)
- Physician Sentenced to 7 Years in Prison for Accepting Kickbacks and Failing to Remit Employment Taxes (2017)
- Jury Finds Philadelphia Doctor Guilty of Running Pill Mill And Causing A Death Through Illegal Distribution (2016)
- Kentucky Anesthesiologist Sentenced to 100 Months for Unlawful Distribution of Controlled Substances, Health Care Fraud, Conspiracy and Money Laundering (2016)
- Pair Sentenced on Health Care Fraud, Conspiracy Charges: Beth Palin, Joseph D. Webb Billed Programs over $14 Million for Unnecessary Drug Screenings (2016)
- Jury Convicts Doctor, Pharmacist, Marketer in Health Care Fraud Scheme (2014)
- OIG excluded Kentucky pharmacist, Lonnie Hubbard for 50 years as a result of his conviction of 71 counts, including 56 drug counts involving the illegal dispensing of controlled substances without a legitimate medical purpose and dispensing pseudoephedrine knowing it would be used to manufacture methamphetamine. From 2010 until 2015, Hubbard, who owned RX Discount Pharmacy in Berea, KY sold prescription pain pills without a legitimate medical purpose, and sold pseudoephedrine knowing or having reason to believe that it was being used to manufacture methamphetamine. Many of the people Hubbard sold to were addicts and drug traffickers in central and eastern Kentucky.
- OIG excluded Dr. Xiulu Ruan and Dr John Couch for 50 years because of their convictions for running a massive pill mill in Mobile, AL. Of particular importance in the trial were two brand name instant-release fentanyl drugs - Subsys and Abstral. Subsys and Abstral are only FDA-indicated for breakthrough cancer pain in opioid-tolerant adult patients. However, evidence showed that Dr. Ruan and Dr. Couch almost exclusively prescribed these drugs off-label for neck, back, and joint pain. Dr. Ruan and Dr. Couch received illegal kickbacks from drug manufacturer Insys Therapeutics in exchange for prescribing massive quantities of these drugs.
- OIG excluded Dr Adam Duer indefinitely because he voluntarily surrendered his license to the State of California while under investigation for unprofessional conduct and gross negligence related to his prescribing practices of controlled substances. The State's formal complaint alleged Dr Duer prescribed "clearly excessive amounts of controlled substances" for medical and non-medical purposes such drugs as hydrocodone, oxycodone, Serequel, alprazolam, Soma, and Cymbalta.
OIG has the authority to exclude individuals and entities from participating in Federal health care programs if they are convicted of certain criminal offenses, including felony convictions related to controlled substance for individuals connected to the healthcare industry. In addition, OIG has discretion to exclude individuals and entities on a number of grounds, including misdemeanor convictions relating to controlled substances for individuals connected to the healthcare industry. In the 2018 National Health Care Fraud Takedown, OIG issued exclusion notices to 587 individuals based on their conduct related to opioid diversion and abuse.
Empowering and Collaborating with Partners through Data Sharing and Education
OIG recognizes that its data analytics capabilities and on-the-ground intelligence about fraud schemes and health care system vulnerabilities can support the efforts of other stakeholders in the fight against the opioid epidemic and its consequences.
OIG shares databases, statistics, risk score models, and methodology with other law enforcement partners, state entities, the Centers for Medicare and Medicaid Services, fraud organizations, and the Healthcare Fraud Public Private Partnership (HFPP). Recently, OIG released an analysis toolkit to assist its public and private sector partners with analyzing their own prescription drug claims data and to help combat the opioid crisis. Through conference presentations, webinars, brochures, and podcasts, OIG also educates pharmacists, providers, and compliance officers about pharmaceutical fraud trends, recreational use of potentiator medications, case examples, and how to use data metrics to improve compliance reviews.