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.

Breakthrough cancer detection device gets parallel FDA, CMS review

A breakthrough cancer in vitro diagnostic (IVD) device that uses next generation sequencing (NGS) to detect genetic mutations in solid tumors took only six months from product application to FDA approval and a preliminary national coverage determination (NCD) from CMS, thanks to the Parallel Review program. Foundation Medicine’s FoundationOne® CDx™ (F1CDx) received simultaneous overlapping review by the FDA and CMS, which reduces the time necessary to marketing and coverage of innovative medical devices.

The Parallel Review program for medical devices was fully implemented in October 2016 following a pilot program (see Parallel Review program will be fully implemented and extended indefinitely, Health Law Daily, October 24, 2016). Ordinarily, CMS does not begin the NCD decision-making process until after a device has been approved or cleared for marketing by the FDA, which results in a longer wait before Medicare beneficiaries can access the device. Through Parallel Review, manufacturers receive feedback from both agencies through the clinical trial design stage, which helps them to design trials that fulfill evidentiary requirements for both steps of the process, potentially eliminating the need for additional trials.

Although the F1CDx device is a laboratory-developed test and therefore generally would not require premarket review from the FDA, Foundation Medicine requested Breakthrough Device designation for the test. The 21st Century Cures Act (P.L. 114-255) expanded the Expedited Access Pathways (EAP) program to breakthrough technologies that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions (see Will the Cures Act address what ails the FDA approval process?, Health Law Daily, March 9, 2017). The FDA granted that designation because the F1CDx test has “potential to consolidate multiple companion diagnostic claims for patients and health care providers into a single test.”

New York dietary supplement maker accused of failing to comply with cGMP regulations

At the request of the FDA, the U.S. Department of Justice filed a civil complaint against Riddhi USA Inc. of Ronkonkoma, New York, and its owner and President Mohd M. Alam, to enjoin the distribution of adulterated and misbranded dietary supplements. The complaint alleges that Riddhi and Alam prepared, packed, and held dietary supplements under conditions that failed to comply with the FDA’s current good manufacturing practice (cGMP) regulations for these products.

According to the complaint, the FDA inspected the Riddhi facility in January 2017 and found numerous significant deviations from cGMP regulations, including a failure to: (1) establish product specifications for identity, purity, strength, and composition of their finished dietary supplements; (2) conduct at least one appropriate test to verify the identity of a dietary ingredient; and (3) establish and follow written procedures for quality control operations.

The complaint further alleges that many of the cGMP deviations were the same as those observed by the FDA during a previous inspection that occurred in January 2016. The complaint notes that on April 27, 2016, the FDA issued a warning letter detailing violations of cGMP regulations observed during the 2016 inspection and that these violations are the same as those observed during the FDA’s subsequent 2017 inspection.

The complaint also alleges that the dietary supplements were misbranded under the labeling provisions of the federal Food, Drug & Cosmetic Act (FDC Act) (21 U.S.C. §301 et seq.) because the products are fabricated from two or more ingredients but fail to declare any ingredients on their product labels or labeling. Specifically, the complaint alleges that the dietary supplement Neuroxygen is misbranded because it is manufactured using soy lecithin, which contains “soy,” but soy is not listed on the product label. The complaint also alleges that the products Prenatal Formula, Osteo Gest, Neuroxygen, Inflam-Ease, and All-Ease, are misbranded because their label or labeling fails to declare the place of business of the manufacturer, packer, or distributor.

FDA effectively spends prescription drug user fee collections

After conducting its 2017 review of FDA policies and procedures and financial records related to the FDA’s use of prescription drug user fee collections, the Office of Inspector General (OIG) concluded that, overall, the FDA spent prescription drug user fee collections appropriately. Since the passage of the Prescription Drug User Fee Act (PDUFA) of 1992 (P.L. 102-571), prescription drug user fees have significantly helped in expediting the drug approval process and eliminating backlogs of pending human drug applications. The average approval time for an application prior to the PDUFA was two years (OIG Report, A-05-16-00040, September 2017).

The PDUFA

The PDUFA, which must be reauthorized by Congress every five years, authorizes the FDA to collect user fees from pharmaceutical and biotechnology companies that are seeking FDA approval of certain human drug and biological products to expedite the review of human drug applications. The user fees provide the FDA with resources, including the ability to hire more reviewers and support staff and upgrade information technology systems. According to the OIG, these resources help the FDA meet its goal of timely review of human drug and supplement applications.

Inadequate documentation

The OIG reviewed $796,065,980 in prescription drug user fees reported for October 1, 2014, through September 30, 2015, and determined that the FDA did not have adequate supporting documentation for $6,402 in travel expenses, made a duplicate payment for airfare of $1,213, and overpaid a traveler $587. The OIG attributed the inadequate documentation to oversight by FDA staff rather than a systemic issue. Therefore, the OIG made no recommendations.