Kusserow on Compliance: HHS OIG Spring 2018 semi-annual report on sanctions and exclusions

1,678 administrative sanctions

1,588 individuals and entities excluded

$35.5 million in CMPL penalties/assessments

The OIG released its first semi-annual report for 2018 that included the number of administrative sanctions, exclusion actions taken, and CMPL penalties imposed. There were a total of 1,588 individuals and entities excluded from Medicare, Medicaid, and other Federal health care programs.  Most of the exclusions resulted from convictions for crimes relating to Medicare or Medicaid, for patient abuse or neglect, or as a result of license revocation. The OIG has a number of Administrative Sanction authorities whereby they have added steadily to the LEIE database.  In the last three years the OIG added over 10,000 exclusions to the List of Excluded Individuals and Entities (LEIE). The OIG also imposed 1,678 administrative sanctions and Civil Monetary Penalty Law penalties and assessments involving more than $35.5 million.

Comments from experts concerning sanctions

Tom Herrmann, JD, served for 20 years in the OIG Counsel’s Office, including being the Chief of the Administrative Litigation Branch, responsible for the litigation of cases involving the imposition of civil monetary penalties and program exclusions.  He explained that the OIG has been delegated the authorities to impose Civil Monetary Penalties, assessments, and program exclusion on health care providers and others determined to have engaged in defined wrongdoing. The effect of an OIG exclusion is that no payment may be made for any items or services furnished by an excluded individual or entity, or directed or prescribed by an excluded physician. In almost all instances where the OIG’s imposition of program exclusion or CMPs is appealed, it is upheld by an Administrative Law Judge (ALJ), the Departmental Appeals Board (DAB), and federal courts. As such, it is absolutely essential to have ongoing sanction-screening of anyone engaged by a health care organization.

Jillian Bower-Concepcion is another highly experienced health care compliance consultant, who has assisted scores of clients in meeting the sanction-screening obligations through the Compliance Resource Center (CRC). She notes the OIG posts their exclusions on their LEIE and calls for screening of all individuals and entities engaged by or with whom they do business against that listing. CMS has also been very aggressive in calling for sanction screening, not only of the LEIE, but Debarments posted by the GSA, as well as pressuring state Medicaid Directors to establish exclusion databases and mandate monthly screening by their enrolled providers. In order to meet screening mandates, it is almost a necessity to use a vendor search engine tools to assist in sanction-screening. This saves organizations from downloading the sanction databases of all the entities and developing their own search engine. Using a vendor for this purpose is a step in the right direction; however the bulk of the work remains with the organization to do screening and resolving potential “hits” remains with the organization. Altogether this can be a considerable effort and many organizations have to dedicate one or many employees to meet all these obligations.  Alternatively, many just outsource the entire process, including verification and certification of results to a vendor.

 

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

Kusserow on Compliance: OIG cases involving sanctioned parties and tips to avoid violations

Compliance Officers must screen employees against the List of Excluded Individuals and Entities (LEIE). This is stressed in all of the OIG’s compliance guidance documents. CMS makes it a condition of participation and enrollment. The LEIE continues to change and grow with more than 3,000 exclusions added annually. Failure to screen employees, medical staff, contractors, and vendors results in a great risk. The OIG may consider claims that include work or products from a sanctioned party to be false and fraudulent. Violations can result in monetary penalties. Most cases that deal with this issue are brought to the OIG’s attention through the “Self-Disclosure Protocol.”  In all the recent cases posted, the OIG imposed penalties, but the penalties were mitigated by the fact the matters were self-disclosed—as a result, none of these cases resulted in a Corporate Integrity Agreement (CIA). The OIG posts a number of these cases on its website. The following are examples of recent actions against organizations that engaged individuals they knew or should have known were excluded from participation in the federal health care programs:

  • Southwest Trinity Management, LLC (STM), in Oklahoma paid $141,986.36 in settlement for employing an excluded licensed practical nurse that provided items or services that were billed to Federal health care programs.
  • Diamonds & Pearls Health Services, LLC (DPHS), Cleveland, Ohio paid $75,471.92 for employing an excluded individual who was a scheduling/staffing coordinator, provided items or services to DPHS patients that were billed to Federal health care programs.
  • Center for Ear, Nose Throat & Allergy, P.C. (CENTA) in Indiana, paid $51,564.14 for employing an excluded medical records file clerk, provided items or services to CENTA’s patients that were billed to Federal health care programs.
  • MHMR, Fort Worth, Texas, paid $97,869.78 for employing a program director who had been excluded to provide items or services to clients who were receiving services funded by a Medicaid waiver program.
  • Shawnee Health Services (Shawnee), Carterville, Illinois, paid $107,761.08 as result of employing an excluded individual as a case manager, provided items or services to clients that were receiving services under a Medicaid waiver program.
  • Arkansas Department of Health (ADH) paid $39,343.61 as result of employing an excluded hospice social worker that provided items or services to patients of a community based hospice operated by ADH.
  • Century Pharmacy (Century), Brooklyn, New York, paid $10,000 for an employed excluded individual, who assisted in filling prescriptions in addition to performing other clerical tasks, provided items or services to Century patients that were billed to Federal health care programs.
  • Sundance Behavioral Healthcare System (Sundance), Texas, paid $49,183.48 for an employed sanctioned licensed vocational nurse that provided items or services to patients that were billed to Federal health care programs.
  • ASAP Professional Home Health (ASAP), Houston, Texas, paid $21,797.76 for an employed excluded attendant, provided items or services to ASAP patients that were billed to Federal health care programs.

Practical Screening Tips

  1. Ensure periodic sanction screening of employees, medical staff, contractors, and vendors against the LEIE—best practice is monthly screening.
  2. Inasmuch as most states have developed their own exclusion database, with many states mandating monthly screenings, care should be taken to understand and meet state screening requirements.
  3. Inasmuch as most LEIE exclusions arise from another underlying court, state agency, or licensure board action, it is advisable to also conduct background checks and seek written assurances in applications that prospective employees, contractors, and vendors have not been subject to any prior court or licensure board actions.
  4. It is common for individuals that may be the subject of an investigation, but not yet sanctioned with final actions, to be under investigation for considerable time, therefore it is a best practice to require as a condition of employment, gaining staff privileges, or engagement for the applicant to attest that they have not been, nor are they now, the subject of an investigation by any duly authorized regulatory or enforcement agency. It is also advisable to add a condition that they must promptly report any notice of investigation that involves them.
  5. Educate and inform management and employees on their obligation to promptly report any notification of an adverse action by any duly authorized regulatory or enforcement agency.

Daniel Peake of the Compliance Resource Center (CRC) works with many organizations in ensuring proper sanction screening and from that experience offers a number of practical tips to avoid creating an actionable violation.  He can be reached at dpeake@strategicm.com or (703) 236-9850.

 

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: Using sanction-screening tools vs. outsourcing the entire process

In order to save time and costs, more and more health care organizations have been moving to outsource functions that are not core business activities. Compliance programs have been part of that trend: (1) 80 percent of compliance offices use vendors to provide hotline services, (2) 50 percent of compliance offices use vendors to provide policy development tools, and (3) two-thirds of compliance offices use vendors to provide E-learning tools. Included in the growing list of outsourced tasks has been the movement to address the rapidly growing cost and time commitment obligations related to sanction-screening. Two-thirds of compliance offices use a vendor search engine tools to assist in sanction-screening that saves an organization from downloading the sanction databases and developing a search engine. This is a trend driven by the rapid development of many new databases against which to screen employees, medical professionals, contractors, vendors, etc., including the following:

  • OIG List of Excluded Individuals and Entities (LEIE)
  • GSA Excluded Parties List System (EPLS)
  • 40 Medicaid states now have sanction data bases requiring monthly screening
  • Drug Enforcement Administration (DEA)
  • FDA

All this has increased the burden of sanction-screening exponentially, not only for the compliance office, but also human resource management for new hires and periodic screening of current employees and procurement with vendors and contractors. Medical credentialing is involved as result of having to screen physicians who are granted staff privileges. Using vendors has been a great help, but the most difficult part of the process is resolving “potential hits.” This can be a considerable effort and many organizations have to dedicate staff for investigation and resolution of these hits. It is complicated by the fact that most sanction data does not provide sufficient information to make positive identification. As a result of this heavy burden, many have moved beyond simply using a vendor tool to outsourcing the entire process to vendors. The following address selecting a sanction-screening vendor and outsourcing the process.

 

Tips for selecting sanction-screening vendor

 

Tips for outsourcing the sanction-screening process

  • Determine the cost of moving from use of a vendor search engine tool to outsourcing the screening, along with investigation and resolution of “potential hits.”
  • Inquire as to the methodology they follow in resolving potential “hits,” a critical part of any screening effort.
  • Ensure the vendor provides a certified report of the results that can be made part of the compliance office records.
  • Review an example of the type of reports they would provide to determine if it meets the documentary needs of the organization.

 

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: Temporary staffing and interim compliance officers

When individuals from a compliance office, including compliance officers, retire, move to new organizations, or are replaced for any reason, it can leave a gap in the day to day management of the compliance efforts that can create a serious risk. This underscores the importance of not only finding a suitable replacement quickly, however, that process can be time consuming. As such, it is not surprising that many organizations turn to engaging temporary expert assistance, including acting the use of Interim Compliance Officers (ICOs). This decision is often made with the realization that having a gap in the program over a period of months, or designating someone internally to do the work can be dangerous. Smaller organizations are not likely to have anyone sufficiently qualified to carry out all the duties. It is also risky to have someone making decisions, or failing to make decisions, that may create liabilities. The worst decision is selecting someone to take on the role of compliance officer as a temporary set of secondary duties to his or her current job. This will always lead the individual to continue giving priority to their regular job and do as little as possible in compliance.

Temporary staffing has the advantage of quickly filling immediate needs, including addressing any pending issues or problems. Properly experienced professionals can hit the ground quickly and be effective, not just be a placeholder. This approach will permit the organization to continue its search for the permanent replacement.  Using a properly qualified outside expert presents a lot of advantages. The expert can bring the experience of having served in other organizations and dealing with many of the same issues already addressed by prior jobs.  Important also is that they have not been invested in any prior decisions, nor have they been aligned with any parties in the organization. Most importantly, the expert brings “fresh eyes” to the program. An outside expert can provide an objective assessment on the state of the compliance program, offer suggestions, and give guidance for improvements.

Finding the right ICO with a lot experience and technical skills can make significant improvements for any compliance program in a relatively short order.  In fact, it may be the most economical means to have an independent evaluation of a compliance program. However, care needs to be taken when deciding on an expert. It is important that someone is not hired who is a “cast off” from another organization. As such, it is important that references be checked carefully to be assured of someone who is competent and reliable. It is important to design the engagement to bring maximum return of benefit for the cost. Therefore, in the case of an ICO, consideration should be given to the added scope of work. Organizations should expect to have the outside expert:

  • provide an independent assessment of the status of the compliance program;
  • make an assessment of high-risk areas that warrant attention;
  • be able to efficiently and effectively address compliance risk issues that may arise;
  • offer suggestions to build a firmer foundation for the compliance program;
  • review the existing Code, compliance policies, and other guidance;
  • evaluate the quality and effectiveness of compliance training;
  • develop a “road map” for the incoming compliance officer to follow;
  • assist in identifying and evaluating candidates for the permanent position;
  • assess resources needed to effectively operate the compliance program;
  • identify or build metrics that evidence compliance program effectiveness; and
  • develop comprehensive briefings for management and board on the state of the program.

Finally, for even fairly large organizations, a true compliance expert can hold things together for several months without having to be full time on site. Most organizations can keep their compliance program operating with many of the added benefits noted above, using an expert for 50 to 80 hours per month. After all, the ICO is holding the compliance program together, not building it.

 

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.