Kusserow on Compliance: Most organizations reported encounters with government authorities

• Most organizations have made disclosures for HIPAA breaches and overpayments
• One third received demand letters
• Other encounters report were with OIG and DOJ

It is widely recognized that regulatory and legal enforcement activities have been increasing over the last few years. The results should be a warning bell to all compliance officers that regulators and enforcement officials are right around the corner, necessitating increased efforts on ongoing monitoring and auditing to mitigate exposure of compliance-related risk areas. In the soon to be released national healthcare “2019 Compliance Benchmark Survey” most respondents reported having encountered issues with government agencies in last five years. Ranking at the top, with nearly two-thirds of the respondents, was disclosure to the HHS Office for Civil Rights (OCR) for breaches of privacy under the Health Insurance Portability and Accountability Act (HIPAA). Over half reported making self-disclosures of overpayments received and addressing audits or investigations by government agencies. One-third reported responding to a demand letter from a government agency or contractor. Serious legal encounters with the government was reported at a much lower level.  One out of five respondents reported self-disclosure to the DOJ, OIG and CMS.  About one out of eight respondents reported their organization being involved in the settlement process with DOJ, self-disclosing to the OIG engagement of sanctioned individuals/entities, and being involved in a settlement process for a corporate integrity agreement (CIA).

The “2019 Compliance Benchmark Survey” report will be available without charge at the upcoming HCCA conference in Boston at Strategic Management Services, Booth 420. 

 

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: 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.

Subscribe to the Kusserow on Compliance Newsletter

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: OIG adds new work plan items for 2019

The HHS OIG’s six new Active Work Plan (Work Plan) items for 2019, including the following:

  1. Medicare Payments for Clinical Diagnostic Laboratory Tests in 2018: Year 1 of New Payment Rates. Medicare Part B covers most lab tests and allowable charges without beneficiary copayments. The Protecting Access to Medicare Act of 2014 (PAMA) mandates CMS release an annual analysis of the top 25 laboratory tests by expenditures and for them to set payment rates for lab tests using current charges in the private health care market; and the OIG will conduct a study on this data.

 

  1. States’ Compliance with New Requirements to Prevent Medicaid Payments to Terminated Providers. The 21st Century Cures Act requires CMS to provide states with information on Medicaid providers that have been terminated to prevent them from treating enrollees or receiving Medicaid payments. The OIG will examine the extent to which the CMS terminations database have resulted in terminations of all state Medicaid programs and the amount of payments associated with terminated providers; and examine which contracts between states and managed care entities include a provision that excludes terminated providers from all managed care networks.

 

  1. Follow-up Review on Inpatient Claims Subject to the Post-Acute-Care Transfer Policy. Previous OIG reviews found (a) hospitals did not comply with the Medicare post-acute-care transfer policy, resulting in overpayments by the Medicare program; (b) hospitals would use the “to home” patient discharge status codes on their claims even though the patient was transferred to a post-acute-care setting; and (c) CMS’s common working file edits related to beneficiary transfers to home health care, SNFs, and non-IPPS hospitals were not working properly. The review will determine if CMS corrected the CWF edits, ensure that the edits are working properly, and that they recovered the identified overpayments.

 

  1. Utilization and Pricing Trends for Naloxone in Medicaid. Naloxone is a medication designed to rapidly reverse opioid overdose. There is concern its high cost may impede increased access to the drug. The OIG will (a) produce a data showing trends in utilization of and expenditures for naloxone in Medicaid over a 5-year period; (b) compare the cost-per-dose of naloxone under Medicaid compares to other available prices; and (c) determine the proportion of all naloxone paid for under Medicaid between 2014 and 2018.

 

  1. Medicare Outpatient Outlier Payments for Claims with Credits for Replaced Medical Devices. Hospitals are required to submit a zero or token charge when they receive a full credit for a replacement medical device, however CMS does not specify how to reduce charges for partial credits. The OIG will focus on overstated Medicare charges on outpatient claims that contain both an outlier payment and a reported medical device credit.
  1. Duplicate Payments for Home Health Agency (HHA) Services Covered Under Medicare and Medicaid. HHA coverage requirements state that they are responsible for providing all services either directly or under arrangement while a beneficiary is under a physician authorized home health plan of care.  Medicare pays a single HHA overseeing the plan.  For dual eligible beneficiaries with no other coverage who are receiving HHA services, Medicare is the first payer, because Medicaid is generally a payer of last resort.  The OIG will determine whether states made Medicaid payments for HHA services provided to dual eligible beneficiaries who are also covered under Medicare.

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.