(June 23, 2017): Opioid audits of the prescribing practices of pain management physicians are on the rise. As the Department of Health and Human Services (HHS), Office of Inspector General (OIG), noted in its report “High Part D Spending o Opioids and Substantial Growth in Compounded Drugs Raise Concerns,” 30% of Medicare beneficiaries have at least one prescription for opioids and the median number of prescriptions received per beneficiary each year is five. Unfortunately, opioid use disorder (addiction) and diversion problems are widespread around the country. Opioid abuse is especially prevalent among Medicare and Medicaid beneficiaries. It has been estimated that 6 out of every 1000 Medicare beneficiaries suffer from opioid use disorder. The problem is even worse with Medicaid beneficiaries where it is estimated that 8.7 out of every 1000 suffer from opioid use disorder. The addiction levels among Medicaid patients are more than 10 times as high as patients covered by private insurance.
In light of the above, both federal and state regulators are aggressively investigating and taking administrative, civil and / or criminal action against physicians and other prescribers around the country who are alleged to have engaged in improper opioid and high-risk drug prescription practices when caring for Medicare and / or Medicaid patients. While the Centers for Medicare and Medicaid Services (CMS) has engaged a number of private companies to conduct program integrity functions, one of the primary organizations that has been awarded these contracts is Health Integrity, LLC (Health Integrity).
I. Overview of Health Integrity NBI MEDIC, ZPIC and MIC Responsibilities:
The three primary program integrity contracts currently handled by Health Integrity include the following:
National Benefit Integrity Medicare Drug Integrity Contract (NBI MEDIC). As the NBI MEDIC, Health Integrity is responsible for investigating and responding to allegations of fraud, waste, and abuse around the country in the Medicare Part C (Medicare Advantage) and Medicare Part D (Outpatient Prescription Drug) programs. In large part due to the opioid epidemic currently sweeping the nation, Health Integrity is aggressively monitoring and auditing the prescription of opioids to Medicare beneficiaries under the Part D program. Opioid audits are typically initiated by Health Integrity auditors and analysts using predictive analytics and other investigative tools to identify potential physicians, nurse practitioners and physician assistants that may be engaged in opioid prescribing practices that could lead to the abuse of diversion of Medicare Part D drugs.
Zone Program Integrity Program Contractor (ZPIC). As a ZPIC, Health Integrity is responsible for reviewing Medicare fee-for-service claims for the states of Texas, Colorado Oklahoma and New Mexico. In this capacity, Health Integrity is required to employ sophisticated data mining and traditional investigative techniques (e.g. analyses of medical records, patient interviews, follow-up to hotline complaints, referrals from state and federal agencies) to identify potential targets for audit and investigation. Depending on Health Integrity’s findings, a health care provider’s case may be handled as an administrative overpayment, referred to CMS or the Office of Inspector General (OIG) for agency action, OR referred to law enforcement (e.g. U.S. Department of Justice (DOJ) or the appropriate Medicaid Fraud Control Unit (MFCU) for possible criminal enforcement.
Medicaid Integrity Contractor (Audit MIC). As Audit MIC, Health Integrity has been particularly aggressive in conducting auditing specific categories of Medicaid claims that have been associated with improper or abusing billing patterns. Although Medicaid dental claims are ongoing favorite target of MIC auditors around the country, over the past year we have seen a significant increase in the number of opioid audits focusing on a physician’s prescribing practices.
Collectively, Health Integrity’s efforts have proven effective in the detection and audit of potentially improper prescription drug practices by physicians, nurse practitioners and physician assistants that participate in the Medicare and Medicaid programs. A first step toward consolidation began in May 2016 with the award of seven Unified Program Integrity Contracts (UPICs) to private company applicants, one of which is Health Integrity. UPICs are intended to replace ZPICs, legacy Program Integrity Contractors (PSCs), the Medicare-Medicaid data match program (Medi-Medi) and MICs.
This article focuses on several of the prescriber-targeted programs that Health Integrity is currently using to identify Medicare and Medicaid providers for audit or referral to law enforcement.
II. Opioid Audits / Prescription Drug Audits by Health Integrity:
Health Integrity and other program integrity contractors are dedicating a significant portion of their resources to the audit and investigation of controlled substances and other prescription drugs that the government contends may be subject to abuse or diversion. Several of the projects currently used by Health Integrity to detect waste, fraud, abuse or diversion include:
Prescriber Risk Assessment Project – This project analyzes the prescribing practices of physicians, dentists, nurse practitioners and physician assistants Schedule II controlled substances (or opioids) prescription drug event record count and Schedule II controlled substances 30-day equivalents. Health Integrity auditors and analysts take this information and compare the prescribing practices of a provider with that of his or her peers. Health Integrity also factors in a prescriber’s primary specialty and geographical location. With this data, Health Integrity is able to readily identify outliers for audit targeting purposes.
Quarterly Prescriber Spike Analysis Project – Health Integrity auditors and analysts utilize this project to detect unusual billing trends of nationwide prescribers of Schedule II, III, IV and V controlled substances, human immunodeficiency virus medications, and antipsychotics. Simply put, Health Integrity uses this program identify prescribers who have “unusual spikes in billing.”
Quarterly Drug Trend Analysis Project – Health Integrity’s participation in this project has better enabled the contractor detect and address sudden increases and emerging issues that may arise from one period to another. This program is primarily utilized analyze trends in the utilization of Schedule II, III, IV and IV controlled substances.
Transmucosal Immediate Release Fentanyl (TIRF) Drug Project – This form of Fentanyl is often used in the management of breakthrough pain in adult cancer patients. In an effort to guard against the unapproved use of this drug, Health Integrity carefully monitors its utilization of this drug to identify improper payments made by Prescription Drug Plans (PDP) and Medicare Advantage-Prescription Drug (MA-PD) Plans.
Pill Mill Doctor Project – Under this project, Health Integrity uses data analytics to identify prescribers who may be engaged in the prescription of Schedule II-IV controlled substances without a legitimate medical purpose. Prescribers engaged in this type of activity are often referred to as “Pill Mill” doctors. Health Integrity carefully investigates high-risk leads and refers them to law enforcement and plan sponsors for further action.
Trio Prescriber Project – Health Integrity’s participation in this project is intended to allow the contractor to readily identify providers that prescribe all three of the following to a Medicare or Medicaid beneficiary: (1) an opioid, (2) a benzodiazepine, and (3) the muscle relaxant carisoprodol. Notably, this “cocktail” of drug is often abused due to the fact that both benzodiazepines and carisoprodol can heighten or enhance the effect of the third component of the cocktail -- opioids.
III. What Do These Opioid Audits Mean for the Typical Pain Management Physician?
It is important to keep in mind that all of the projects discussed above share one major weakness – they completely rely on data analytics. As a result, Health Integrity has based its audit targeting efforts solely on data, without any knowledge of whether the prescribing decision was medically necessary and appropriate or whether the patient’s medical records support the care and treatment decisions made by the physician.
Do you have an effective Compliance Program in place? In the absence of an active internal auditing and monitoring program, if an audit is initiated by Health Integrity, there is a high likelihood that the contractor will find problems with your documentation. Unfortunately, we have found this to be the case regardless of whether a practice was still using paper records or had transitioned over to an Electronic Health Records (EHR) system. Therefore, if you or the physicians in your pain practice regularly prescribe Schedule II through V controlled substances, human immunodeficiency virus medications, antipsychotics, Transmucosal Immediate Release Fentanyl, or the trio cocktail described above, there is a good chance that those utilization practices are subject to review by Health Integrity or another CMS program integrity contractor.
Pain management physicians are under enormous scrutiny by both regulators and licensing authorities around the country. If you or your practice is audited, we recommend you immediately contact a qualified health lawyer to assist you in navigating the complexities of the audit process. Every case is different, and your ability to prevail in an audit will depend, in large part on the quality of your medical documentation. Nevertheless, there are steps you can take early in the audit that can greatly increase the likelihood that Health Integrity or another CMS program integrity contractor will find that your documentation fully meets applicable requirements and the care provided qualifies for coverage and payment.
Robert W. Liles, J.D., M.B.A., M.S., serves as Managing Partner at Liles Parker, Attorneys and Counselors at Law. The health law firm Liles Parker represents pain management physicians and practices around the country in connection with ZPIC / UPIC audits. Opioid audits conducted by ZPICs / UPICs have been especially frequent in 2017. For a free consultation about your case, please give us a call: 1 (800) 475-1906.
 HHS OIG. “High Part D Spending on Opioids and Substantial Growth in Compounded Drugs Raise Concerns” (OEI-02-16-00290). 6/21/2016. http://oig.hhs.gov/oei/reports/oei-02-16-00290.asp
 Lembke A, Chen J. Use of Opioid Agonist Therapy for Medicare Patients in 2013. JAMA Psychiatry. 2016; 73(9): 990-992.
 Ghate SR, Haroutiunian S, Winslow R, McAdam-Marx C. Cost and comorbidities associated with opioid abuse in managed care and Medicaid patients in the United States: a comparison of two recently published studies. Journal of Pain & Palliative Care Pharmacotherapy. 2010 Sep; 24(3): 251-8.
 HHS.gov News. (2016).HHS takes strong steps to address opioid-drug related overdose, death and dependence, Retrieved from, http://www.hhs.gov/about/news/2015/03/26/hhs-takes-strong-steps-to-address-opioid-drug-related-overdose-death-and-dependence.html