Kusserow on Compliance: Measuring culture using compliance benchmark surveys

– Evidencing compliance program effectivenes

– Provides quantifiable compliance program effectiveness metrics

– Internally developed and administered surveys lack credibility

The Sentencing Commission in its Federal Sentencing Guidelines states that businesses must “promote an organizational culture that encourages ethical conduct and a commitment to compliance with the law.” The OIG in its Compliance Program Guidance for Hospitals noted that “as part of the review process, the compliance officer or reviewers should consider techniques such as…using questionnaires developed to solicit impressions of a broad cross-section of the hospital’s employees and staff.”  Daniel Peake of the Compliance Resource Center explains that a culture survey can identify gaps between the compliance culture that is intended and the one that employees actually experience. Importantly, it can identify whether the investments in the compliance program and employee attitudes and perception are truly aligned.  Surveys of this type can measure employee perceptions regarding the day-to-day management behavior.  However, to be truly useful, the culture survey should be a professionally developed, tested, validated, and independently administered. It would be best if responses to the individual questions can be evaluated, analyzed, and benchmarked against a large universe of organizations that have used the same questions. This permits comparisons to industry peers and national averages. Using the same survey every couple of year can assist in benchmarking and monitoring progress of a compliance program against its own results (i.e., trending historical company survey data). Results from a survey report should provide enormous value in identifying organization strengths as well as opportunities for improvement. This can help ensure the organization is on a track towards creating an organizational compliance culture of the highest quality. It can provide great insights into how effective the compliance program has been in changing and improving the compliance of an organization and signal not only strengths in the compliance program, but areas of potential weakness warranting attention. Culture surveys can measure:

  • beliefs and values that guide thinking and behavior of the workforce;
  • outcomes or the “impact” of compliance program activities;
  • the extent to which individuals and leaders demonstrate commitment to compliance; and
  • the current state of the compliance climate or culture.

 

For more information, contact Daniel Peake at (dpeake@complianceresource.com) (703-236-9854).

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.

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Copyright © 2018 Strategic Management Services, LLC. Published with permission.

Kusserow on Compliance: 2018 FCA enforcement and 10 tips for channeling whistleblowers internally

 New health care qui tam cases average 9 per week

$2.5 billion in recoveries from health care sector

75 percent of cases predicated by “Whistleblowers”

Whistleblowers are entitled to up to 25 percent of recoveries

The vast majority of False Claims Act cases are brought to the DOJ by “whistleblowers” (qui tam relators), under the qui tam provisions of the False Claims Act (FCA). In 2018, this continued to be the case. The DOJ’s Civil Division reported having 645 new qui tam actions initiated last year, at an average of 14 new cases per month. Of that total, 446 were health care cases—about nine a week average. Federal recoveries, including settlements and judgments, amounted to over $2.8 billion. Most of this, over $2.5 billion, related to health care and life sciences. FCA violations occur when someone knowingly submits a false or fraudulent claim for payment to the government.  The penalty for doing this is up to three times the amount of each claim, plus penalties as high as $21,563 per claim. Whistleblowers file cases with the DOJ on behalf of the United States as well as themselves and must provide all the evidence they have supporting the complaint. The DOJ decides to intervene (take over prosecution) or not. If the DOJ decides to intervene, the government takes the lead in prosecuting the case; and if not, the relator may proceed with the prosecution on their own in federal court.  The relator is entitled to 15 to 25 percent of the government’s recovery, plus attorneys’ fees and expenses.

The recovery results in 2108 marked the ninth consecutive years where recoveries have exceeded $2 billion. Of the health care recoveries, more than three quarters of that sum were as result of qui tam cases. Health care and life sciences settlements involved drug and device manufacturers, hospitals, Medicare Advantage plans, pharmacies, and laboratories. The largest settlement, for $625 million, was with AmerisourceBergen Corp. and its subsidiaries, and it involved resolution of allegations that it repackaged and resold cancer drugs to profit from “overfill” in the original packaging. The other major settlements also involve pharmaceutical manufacturers. In those cases, the FCA was violated as result of payment of kickbacks to induce the flow of business.  The largest case among providers involved an independent physician association that entered into a $270 million settlement with another case resulting in a $216 million settlement with the former hospital chain, Health Management Associates.

10 Tips: Channeling Whistleblowers Internally 

  1. Review/update hotline-related polices/procedures (confidentiality, anonymity, non-retaliation, duty to report, etc.)
  2. Promote the reporting of wrongdoing (newsletter, intranet, training programs, etc.)
  3. Find ways to provide feedback so that employees know reporting is taken seriously
  4. Consider engaging experts to evaluate compliance communication channels effectiveness
  5. Allegations of potential violations of law or regulations must be promptly investigated.
  6. Ensure that individuals are trained and competent to conduct prompt investigations.
  7. All cases where investigation indicates potential violations, disclose promptly
  8. Take appropriate disciplinary action against identified wrongdoers
  9. Understand CMS and OIG self-disclosure protocols that may avoid FCA investigation
  10. Ensue investigations finding of potential violations of law are promptly disclosed to the DOJ

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.

Kusserow on Compliance: New anti-kickback law for clinical labs

– Law creates new compliance risk areas for 2019

– Compensation of sales personnel affected

– Not limited to federal health care programs

For the new year, compliance officers should recall Congress passing into law the Eliminating Kickbacks in Recovery Act of 2018 (EKRA), which became effective October 24, 2018. It applies to Medicare and Medicaid, as well as many commercial health insurance plans. It has the effect of eliminating “safe harbors” used by clinical labs in marketing services. The law was intended to be part of the effort to target the national opioid crisis. It makes it a criminal offense to solicit or receive any remuneration, directly or indirectly, in return for referring a patient or patronage to a recovery home, clinical treatment facility or clinical laboratory; or to offer or pay a kickback to “induce” a referral of an individual to a recovery home, clinical treatment facility or clinical laboratory, or in exchange for an individual using the services of a recovery home, clinical treatment facility or clinical laboratory. Penalties for each violation can include a fine of up to $200,000 and imprisonment of up to 10 years. The law has seven “safe harbors,” some of which are similar to the safe harbors under the federal Anti-Kickback Statute that is generally applicable to Medicare and Medicaid services, however the safe harbor for employees and independent contractors under the law expressly excludes from safe harbor protection any payment made to an employee or independent contractor that is determined or varies by:

  • the number of individuals referred;
  • the number of tests or procedures performed; or
  • the amount billed or received.

The EKRA adds an all payor (public and private) provision that enables the federal government to monitor provider arrangements intended to generate business for any laboratory services, not only those related to individuals in treatment for substance abuse disorders, payable by a federal health care program or commercial health insurer.

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 © 2018 Strategic Management Services, LLC. Published with permission.

Kusserow on Compliance: The cost-benefit of engaging interim compliance officers

Carrie Kusserow is COO for Strategic Management, which provides interim compliance officers (ICOs) for health care organizations. She noted that in making the decision about engaging an ICO, close consideration should be given to the return on investment (ROI). In fact, most decisions of this type are made around this time of the year, as organization begin thinking about revitalizing their compliance program in the New Year. The best results from engaging ICOs come from having several different related tasks in a single engagement. First and foremost is managing the program. However, that by itself may not gain the best ROI. She recommends that the ICO engagement include cost avoidance from incidents and event that could give rise to liabilities. Part of this task would be include a “gap analysis” on the status of the program.  Another task should be to help define what is needed in the recruitment of a permanent compliance officer. Also, before the ICO leaves, it is highly advisable to have a full report provided to the executive leadership and board on what was found with regards to the program and anything needed to ensure that it operates in a manner to achieve the desired outcome.  Additionally, the ICO can assist in identifying the education, skills, leadership experience and personality needed in the permanent replacement.

Kashish Parikh-Chopra, J.D., MBA, CHC, CHPC notes that a growing number of health care provider organizations have been turning to her firm to find an Interim Compliance Officer (ICO) to fill temporary vacancies, evaluate status of the compliance program, and mentor current compliance office staff.  Her firm, Strategic Management provides such services with individuals who have all the necessary experience, technical skills, proven leadership and personality to properly fit into the senior management team. Often, executive leadership or the Board decides it is necessary to engage an expert to make improvements or to keep operations running smoothly and addressing issues, while the organization searches for the right permanent candidate. It also provides a fresh set of professional eyes examining and testing the compliance program for any potential deficiencies. By including these evaluations and reporting requirements in the ICO engagement, the organization receives a benefit, which if contracted for separately, would cost twice as much. What this means is that for the cost of a full compliance program evaluation, the ICO would also manage the program for the gap period.

 

For more on Interim Compliance Officers, Kashish Parikh-Chopra can be reached at kchopra@strategicm.com or via telephone at (703) 535-1413.  Also visit https://compliance.com/services/interim-compliance-officer/ or see Journal of Health Care Compliance at https://compliance.com/publications/understanding-the-role-of-an-interim-compliance-officer/

 

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 © 2018 Strategic Management Services, LLC. Published with permission.