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.

Connect with Richard Kusserow on Google+ or LinkedIn.

Subscribe to the Kusserow on Compliance Newsletter

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

Kusserow on Compliance: OIG testifies regarding Detroit investigation results

The HHS OIG provided testimony before the House Ways and Means Subcommittee on Oversight, describing their work in Detroit to protect Medicare and Medicaid beneficiaries and to fight health care fraud from the field agent’s perspective. The OIG typically conducts investigations in partnership with other Federal and State agencies, as well as the private sector. Often investigations are part of the Detroit-based Medicare Fraud Strike Force, which combines the resources of Federal, State and local law enforcement entities to prevent and combat health care fraud across the country.

The OIG receives complaints or investigative leads from a variety of sources, including the OIG hotline, law enforcement partners, beneficiaries, providers, and informants. Traditional means of identifying fraud include conducting interviews of cooperating witnesses and surveillance. The schemes investigated range from billing for services not actually performed to organized criminal enterprises. The perpetrators of these frauds can range from highly respected physicians to individuals with no prior experience in the health care industry. The OIG highlighted some major areas of where they have been focusing, including:

  • Home and community-based services. Home and community-based services, including personal care services (PCS), which are particularly vulnerable to fraud, with investigations resulting in more than 350 criminal and civil actions and $975 million in investigative receivables for fiscal years 2011 – 2015.
  • Unnecessary prescriptions. Physicians write medically unnecessary controlled substance prescriptions in exchange for cash or submission by a patient to medically unnecessary services.
  • Prescription drug fraud. Enforcement action against and prevention of prescription drug fraud is a major priority to address a rapidly growing national health care problem, and an opioid epidemic with 678 pending complaints and cases involving Medicare Part D, which represents a 152-percent increase in the last 5 years.

The OIG employs data analytics and real-time field intelligence to detect and investigate program fraud and to target our resources for maximum impact. They also reported being a leader in the use of data analytics, employing a dedicated data analytics unit. The OIG also has direct access to Medicare claims data and use innovative methods to analyze billions of data points to identify trends that may indicate fraud, geographical hot spots, emerging schemes, and individual providers of concern. Testimony summarized the OIG national investigative results during the period of 2013 through 2015, as follows:

  • $11 billion in receivables, or money ordered or agreed in settlements
  • 2,856 criminal actions
  • 1,447 civil actions, and
  • 11,343 program exclusions.

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 © 2016 Strategic Management Services, LLC. Published with permission.

Kusserow on Compliance: Whistleblowers receive $98M in $784.6M FCA settlement

Pharmaceutical companies Wyeth and Pfizer Inc., agreed to pay $784.6 million to resolve allegations that Wyeth knowingly reported to the government false and fraudulent prices on two of its proton pump inhibitor (PPI) drugs, Protonix Oral® and Protonix IV®. The case was brought under the qui tam provisions of the federal False Claims Act (FCA) (31 U.S.C. § 3729 et seq.) by two relators, a former hospital sales representative for AstraZeneca Pharmaceuticals and a practicing physician. They will receive $98,058,190.00 as their share from the settlement. This amount ranks among the largest award for whistleblowers ever.

Pfizer acquired New Jersey-based Wyeth in 2009, approximately three years after Wyeth had ended the conduct that gave rise to the settlement. The Department of Justice (DOJ) alleged that Wyeth failed to report deep discounts on Protonix Oral and Protonix IV that it made available to thousands of hospitals nationwide through a bundled sales arrangement in which a hospital could earn deep discounts on both drugs, if it placed them on formulary and made them “available” within the hospital. Through this bundled arrangement, Wyeth sought to induce hospitals to buy and use Protonix Oral, which hospitals otherwise would have had little incentive to use, because other pre-existing oral PPI drugs were priced competitively and were considered to be as safe and effective. Wyeth wanted to control the hospital market because patients discharged from the hospital on Protonix Oral were likely to stay on the drug for long periods of time, rather than switch to competing PPIs, during which time payers, including Medicaid, would pay nearly full price for the drug.

All this resulted in their wrongfully avoiding paying hundreds of millions of dollars in rebates to Medicaid. Under the terms of the settlement, Wyeth will pay $413,248,820 to the federal government and $371,351,180 to state Medicaid programs.

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 © 2016 Strategic Management Services, LLC. Published with permission.

 

Kusserow on Compliance: OIG issues favorable opinion related to patient assistance charitable foundation

The HHS Office of Inspector General (OIG) released Advisory Opinion 15-16 addressing a 501(c)(3) charitable foundation (the “Requestor”) that would seek donations from third parties (including drug manufacturers) and provide financial assistance to out-of-pocket patient expenses for outpatient prescription drugs. The Requestor would maintain two disease funds, one of which would provide assistance to patients with various types of cancer, and the other of which would provide assistance to patients with chronic kidney disease or iron deficiency anemia. The donors could earmark their donations for either fund but would have no control over the specific types of diseases each fund would apply to them.

The OIG concluded that the proposed arrangement would not violate the federal prohibition against inducements to patients with regard to the Civil Money Penalties (CMP) law or the Anti-Kickback Statute (AKS). The OIG cited the following characteristics of the arrangement that led it to its conclusions:

  • No donor, affiliate of any donor, physician, or health care provider would exert direct or indirect control over the Requestor or its program.
  • The Requestor is a nonprofit, tax-exempt charitable organization that operates with absolute, independent, and autonomous discretion as to the use of donor contributions.
  • The Requestor has no financial relationship with any physician or other health care provider that treats patients eligible to receive assistance from the Requestor.
  • Before applying for assistance, each patient already would have selected his or her health care providers, practitioners, or suppliers, and already would have a treatment regimen in place so that the existence of the program would not influence the selection of a provider.
  • The Requestor would not refer patients to, recommend, or arrange for the use of any particular practitioner, provider, supplier, drug, or insurance plan.
  • Donors would not receive any data that would facilitate a donor in correlating the amount or frequency of its donations with the amount or frequency of the use of its drugs or services.
  • No donor or affiliate of any donor would directly or indirectly influence the identification or delineation of the diseases covered by its two disease funds.
  • The determination of a patient’s qualification for assistance would be based solely on financial need, without considering the identity of the health care providers, practitioners, suppliers, drugs, or insurance plans; the identity of any referring party; or the identity of any donor.
  • The Requestor would assist all eligible, financially needy patients on a first-come, first-served basis to the extent funding is available.
  • The Requestor will permit donors to earmark donations for both of the disease funds, which generally should not significantly raise the risk of abuse.
  • Diseases covered by its disease funds: (i) would be defined in accordance with widely recognized clinical standards and in a manner that covers a broad spectrum of available drugs; and (ii) would not be defined by reference to specific symptoms, severity of symptoms, the method of administration of drugs, stages of a particular disease, type of drug treatment, or any other way of narrowing the definition of widely recognized disease states.

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 © 2016 Strategic Management Services, LLC. Published with permission.