Kusserow on Compliance: 2020 DOJ compliance program guidelines on continuous improvement and use of data

The DOJ released an update to its Compliance Guidance, intended to assist prosecutors in making informed decisions about whether a company’s compliance program was effective at the time of an offense. It emphasizes the importance of using data and technology to support compliance efforts, including assisting with continuous updates of a compliance program and assessing the adequacy and effectiveness of it at the time of the offense, charging decision, and case resolution. Many of the changes involve adding questions about a company’s ability to learn from its own experience through, among other things, the use of data and technology. The guidance asks whether companies:

  1. Engage in periodic reviews limited to a “snapshot” in time, or one based on continuous access to operational data across functions?
  2. Incorporated “lessons learned” through a “process for tracking and incorporating into its periodic risk assessment” information acquired both internally and from other similarly situated companies?
  3. Update policies/procedures and if they provide enough data to allow for effective monitoring and testing their effectiveness?
  4. Publish policy documents in a searchable format for easy reference and access?
  5. Can track access to specific policies/procedures to understand which are attracting the most attention from employees?
  6. Have means for employees to ask questions arising out of training?
  7. Have evaluated extent to which training has had an impact on employee behavior or operations?
  8. Engage in continuous ongoing monitoring and improving reporting mechanisms?
  9. Periodically test[s] hotline effectiveness, and track reports from inception to conclusion?
  10. Effectively communicate compliance requirements to employees during compliance education and training?

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 © 2020 Strategic Management Services, LLC. Published with permission.

Kusserow on Compliance: DOJ reports 2019 False Claims Act Recoveries of over $3B

The DOJ obtained more than $3 billion in settlements and judgments from civil cases involving fraud and false claims against the government in fiscal year 2019. Recoveries since 1986, when Congress substantially strengthened the civil False Claims Act, now total more than $62 billion. Of the more than $3 billion in settlements and judgments recovered, $2.6 billion related to the health care industry.

This was the tenth consecutive year that health care fraud settlements and judgments have exceeded $2 billion. Whistleblower, or qui tam, actions comprise a significant percentage of the False Claims Act cases that are filed. Of the $3 billion in settlements and judgments reported by the government in fiscal year 2019, over $2.1 billion arose from lawsuits filed under the qui tam provisions of the False Claims Act.

During the same period, the government paid out $265 million to the individuals who exposed fraud and false claims by filing these actions. The number of lawsuits filed under the qui tam provisions of the Act has grown significantly since 1986, with 633 qui tam suits filed this past year—an average of more than 12 new cases every week. In its news release, the DOJ noted that it had increased holding individuals accountable and cited examples of actions taken against responsible executives.

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 LinkedIn.

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Copyright © 2020 Strategic Management Services, LLC. Published with permission.

Kusserow on Compliance: OIG program exclusions reported for second half of 2019

Total of 2640 new exclusions added to the LEIE in 2019

Under the Social Security Act, the HHS Office of Inspector General (OIG) is able to exclude individuals and entities from participation in Medicare, Medicaid, and other Federal health care programs. Exclusions are required (mandatory exclusion) for individuals and entities convicted of the following types of criminal offenses: (1) Medicare or Medicaid fraud; (2) patient abuse or neglect; (3) felonies for other health care fraud; and (4) felonies for illegal manufacture, distribution, prescription, or dispensing of controlled substances. The OIG is also authorized (permissive exclusion) to exclude individuals and entities on several other grounds, including misdemeanors for other health care fraud (other than Medicare or Medicaid); suspension or revocation of a license to provide health care for reasons bearing on professional competence, professional performance or financial integrity; provision of unnecessary or substandard services; submission of false or fraudulent claims to a federal health care program; or engaging in unlawful kickback arrangements. The Patient Protection and Affordable Care Act (ACA) added another basis for imposing a permissive exclusion, that is, knowingly making, or causing to be made, any false statements or omissions in any application, bid, or contract to participate as a provider in a federal health care program, including managed care programs under Medicare and Medicaid, as well as Medicare’s prescription drug program.

During this semiannual reporting period, the OIG excluded 1,347 individuals and entities from Medicare, Medicaid, and other federal health care programs. Most of the exclusions resulted from convictions for crimes relating to Medicare or Medicaid, patient abuse or neglect, financial misconduct, controlled substances, or as a result of license revocation. The OIG completed the deployment of a new service for State Medicaid Fraud Control Units (MFCUs) to report convictions through a central web-based portal for exclusion. This improved reporting from those agencies. A list of excluded individuals and entities can be found at https://exclusions.oig.hhs.gov/.

 

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 LinkedIn.

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Copyright © 2020 Strategic Management Services, LLC. Published with permission.

Kusserow on Compliance: Huge fraud schemes involving telemedicine and DME

– Charges against two dozen people involving over $1.2 billion

 – Administrative Action against 130 DMEs submitting $1.7 Billion in claims

The DOJ announced charges against 24 defendants—including the CEOs, COOs, and others associated with five telemedicine companies, the owners of dozens of durable medical equipment (DME) companies, and three licensed medical professionals—associated with health care fraud schemes involving more than $1.2 billion. CMS and the Center for Program Integrity (CPI) have taken adverse administrative action against 130 DME companies that had submitted over $1.7 billion in claims and were paid over $900 million. The scheme involved payment of illegal kickbacks and bribes by DME companies in exchange for the referral of Medicare beneficiaries by medical professionals working with fraudulent telemedicine companies for back, shoulder, wrist, and knee braces that were medically unnecessary.

The DOJ alleges those charged with paying doctors to prescribe DME either without any patient interaction or with only a brief telephonic conversation with patients they had never met or seen. The proceeds of the fraudulent scheme were allegedly laundered through international shell corporations and used to purchase exotic automobiles, yachts, and luxury real estate in the United States and abroad. Some of the defendants obtained patients for the scheme by using an international call center that advertised to Medicare beneficiaries and “up-sold” the beneficiaries to get them to accept numerous “free or low-cost” DME braces, regardless of medical necessity. The international call center allegedly paid illegal kickbacks and bribes to telemedicine companies to obtain DME orders for these Medicare beneficiaries. The telemedicine companies then allegedly paid physicians to write medically unnecessary DME orders. Finally, the international call center sold the DME orders that it obtained from the telemedicine companies to DME companies, which fraudulently billed Medicare. Collectively, the CEOs, COOs, executives, business owners and medical professionals involved in the conspiracy are accused of causing over $1 billion in loss.

 

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 © 2019 Strategic Management Services, LLC. Published with permission.