Kusserow on Compliance: OIG testimony highlights opioid crisis actions

Gary Cantrell, HHS OIG Deputy Inspector General for Investigations, testified before a Senate Special Committee hearing on enforcement activities currently underway to combat the opioid crisis. He provided key policy recommendations to address the crisis. Opioid fraud encompasses a broad range of criminal activity from prescription drug diversion to addiction treatment schemes. Many of these schemes can be elaborate, involving complicit patients or beneficiaries who are not ill, kickbacks, medical identity theft, money-laundering, and other criminal enterprises. Some schemes also involve multiple co-conspirators and health care professionals such as physicians, nonphysician providers, and pharmacists. These investigations can be complex and often involve the use of informants, undercover operations, and surveillance. The OIG provided critical support in the establishment of the new Opioid Fraud and Abuse Detection Unit established by the Attorney General to focus on opioid-related health care fraud. This collaboration led to the selection of 12 judicial districts around the country where OIG has assigned Special Agents to support 12 prosecutors identified by the DOJ to focus solely on investigating and prosecuting opioid-related health care fraud cases.

The OIG collaborates with a number of HHS agencies, including CMS and the Agency for Community Living (ACL), on fraud- and opioid-related initiatives to educate providers, the industry, and beneficiaries on the role each one plays in the prevention of prescription drug and opioid-related fraud and abuse. The OIG is engaging ACL’s Senior Medicare Patrol and State Health Insurance Assistance Program through presentations on the prevention of fraud, waste, and abuse. The OIG is also working with the DEA to provide anti-fraud education at numerous Pharmacy Diversion Awareness Conferences held across the United States, which are designed to assist pharmacy personnel with identifying and preventing diversion activity.

OIG currently has numerous opioid-related audits or evaluations underway that address:

  • 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; and
  • opioid prescribing practices in the Indian Health

In the OIG’s data brief entitled Opioids in Medicare Part D: Concerns about Extreme Use and Questionable Prescribing and other reports, the OIG noted the following:

  • 60,000 individuals died from drug overdoses in 2016, of which two-thirds involved opioids
  • The CDC reported 75 percent new heroin users having abused prescription opioids prior to using heroin.
  • One in three Medicare Part D beneficiaries received opioids (14.4 million beneficiaries)
  • 500,000 beneficiaries received high amounts of opioids
  • 90,000 beneficiaries were at serious risk of opioid misuse or overdose for receiving extreme amounts of opioids and those who appeared to be “doctor shopping”
  • 70,000 beneficiaries received extreme amounts of opioids
  • 22,308 beneficiaries appeared to be doctor shopping for more opiods
  • 400 prescribers had questionable opioid prescribing for beneficiaries at serious risk
  • Prescribers with questionable billing wrote 265,260 opioid prescriptions for beneficiaries at serious risk at a cost under Part D for $66.5 million

The OIG is planning to release a new data brief on opioid use in Medicare Part D as a follow-up to a previous data brief, Opioids in Medicare Part D: Concerns About Extreme Use and Questionable Prescribing (OEI-02-17-00250) to: (1) determine the extent to which Medicare Part D beneficiaries received high amounts of opioids; (2) identify beneficiaries who are at serious risk of opioid misuse or overdose; and (3) identify prescribers with questionable opioid prescribing patterns for these beneficiaries.  In conjunction with this, they will release an analysis toolkit to assist the public and private sector in analyzing prescription drug claims data.  It will provide steps for using prescription drug data to analyze patients’ opioid levels and identify those at risk of opioid misuse or overdose or who appear to be doctor shopping.

The OIG has made numerous pending recommendations to improve HHS programs to better protect beneficiaries at risk of opioid misuse or overdose, including:

  • Restrict certain beneficiaries to a limited number of pharmacies or prescribers, implementing the new lock-in authority.
  • Require plan sponsors to report to CMS all potential fraud and abuse and any corrective actions they take in response; and provide guidance on how Part D sponsors identify and investigate these matters.
  • Improve Medicaid CMS does not have complete and accurate data needed to effectively oversee the Medicaid program, including opioids. OIG call for CMS to establish a deadline for when national T-MSIS data will be available for multistate program integrity efforts.

 

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.

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Copyright © 2017 Strategic Management Services, LLC. Published with permission.

CDC urges providers to consider risks of opioid treatments

Although opioid prescriptions declined for five years since a peak in 2010, the Centers for Disease Control and Prevention (CDC) found that the highest-prescribing counties dispensed six times more opioids per resident in 2015. The CDC urges providers to consider evidence-based guidance for opioid prescriptions and weigh the risks and benefits of such treatment with patients.

Demographics

According to the CDC’s Vital Signs report, a breakdown of the number of opioids prescribed per person in 2015 by county revealed considerable variation, with clusters of high-rate counties located in various places across the country. The CDC believes that the variation reveals inconsistencies among providers who prescribe opioids. Counties with higher prescribing tended to have small cities or large towns, more white residents, more dentists and primary care providers, a higher rate of uninsurance or unemployment, and more people with a chronic condition like diabetes or arthritis, or a disability.

Issues

The CDC identified three specific issues with high prescribing that pose risks for patients. In 2015, there were enough opioids prescribed to keep every American constantly medicated for three weeks. This level of prescription may indicate that providers need to consider more non-opioid treatment options, such as physical therapy and other medications, and only use opioids when the benefits are most likely to outweigh the risks.

Even for those on low doses, taking an opioid for more than three months increases a patient’s risk of addiction 15 fold. When treating acute pain, opioids should only be prescribed for the expected duration of severe pain. In addition, a dose of 50 morphine milligram equivalents (MMEs) or more per day doubles a patient’s risk of overdose death. The CDC believes that the average daily MME per prescription remains too high.

Resources

The CDC recommends continuously balancing risks and benefits throughout opioid treatment, from the starting prescription through dosage increases. The agency’s Guideline for Prescribing Opioids for Chronic Pain outlines when a provider should initiate or continue opioids for chronic pain, treatment options, and risks and harms of opioid use.

AGs request Medicaid policy change to fight in-home elderly abuse, neglect

The Centers for Disease Control and Prevention’s (CDC) estimate that one in 10 people aged 65 and over who live at home will become the victim of abuse has drawn the attention of the National Association of Attorneys General (NAAG). Millions of people in this age group are enrolled in Medicaid and the NAAG believes that a change in policy allowing federal funds to investigate more abuse and neglect cases—even those that occur in the home—will help.

Medicaid Fraud Control Units (MFCUs) are charged with investigating and prosecuting state Medicaid provider fraud as well as resident abuse and neglect complaints at Medicaid-funded health care facilities, and can choose to look into complaints at board and care facilities. The MFCUs usually operate within the state attorney general’s office. Because there are strict limitation on the use of MFCU funds to investigate fraud and abuse, the NAAG is now asking Secretary of HHS, Tom Price, to replace or eliminate the “outdated” policies. Instead NAAG provided two recommendations to the Secretary: (1) allow MFCU funds to investigate and prosecute abuse and neglect of Medicaid beneficiaries in non-institutionalized settings; or (2) allow use of MFCU funds to freely screen or review any and all complaints or reports of whatever type, in whatever setting.

The May 10, 1017, letter to Price was signed by attorneys general of 37 states and the District of Columbia. Montana Attorney General Tim Fox noted “abuse and neglect in the home takes many forms, including physical abuse, sexual abuse, and drug diversion. Abuse and neglect is perpetrated by family, friends, and caregivers alike. The requested change in policy would allow our MFCU to investigate reports…regardless of where they reside, whether it’s a home or in a healthcare facility.” David Y. Chin, Attorney General of Hawaii, cited “[the Hawaii MFCU] receives thousands of complaints relating to fraud and abuse and neglect every year…We hope that the federal government will hear our concerns and support our efforts to protect Hawaii’s most vulnerable residents.”

Owner of compounding company at the center of the 2012 meningitis outbreak acquitted of murder

A Boston jury convicted Barry Cadden, the owner and head pharmacist of the New England Compounding Center (NECC), of racketeering and mail fraud in connection with the 2012 nationwide fungal meningitis outbreak but acquitted him of 25 second-degree murder charges. His sentencing is scheduled for June 21, 2017; he faces a statutory maximum sentence of up to 20 years’ imprisonment on each of the mail fraud and racketeering counts.

Outbreak. In September 2012, the Centers for Disease Control and Prevention (CDC) began investigating a multistate outbreak of fungal meningitis and other infections among patients who received contaminated preservative-free methylprednisolone acetate (MPA) steroid injections from NECC. The CDC reported that 753 patients in 20 states were diagnosed with a fungal infection after receiving injections of NECC’s MPA. Of those 753 patients, the CDC reported that 64 patients in nine states died.

Indictment. In December 2014, the U.S. Attorney’s Office in Massachusetts announced a 131-count federal criminal indictment in connection with the outbreak. Cadden and NECC’s supervisory pharmacist, Glenn A. Chin, were charged with 25 acts of second-degree murder in Florida, Indiana, Maryland, Michigan, North Carolina, Tennessee and Virginia. Twelve other individuals associated with NECC, including six other pharmacists, the director of operations, the national sales director, an unlicensed pharmacy technician, two of NECC’s owners, and one other individual were charged with additional crimes.

Prosecutors alleged that Cadden directed and authorized the shipping of contaminated MPA nationwide. In addition, he authorized the shipping of drugs before test results confirmed their sterility, failed to notify customers of nonsterile results, and compounded drugs with expired ingredients. NECC also used fictional and celebrity names on fake prescriptions to dispense drugs.