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.

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Copyright © 2017 Strategic Management Services, LLC. Published with permission.

Kusserow on Compliance: Changes in the Stark Law

Over the years, the Stark law has evolved considerably from regulatory requirements to use by the DOJ in enforcement of the False Claims Act. Unlike the Anti-Kickback Statute, which is enforced by the OIG, the Stark law is considered regulatory and under CMS jurisdiction. The Stark law was designed to prohibit doctors from referring Medicare patients to hospitals, labs, and colleagues with whom they have financial relationships, unless they fall under certain exceptions. Stark prevents hospitals from paying providers more when they meet certain quality measures, such as reducing hospital-acquired infections, while paying less to those who miss the goals. Providers have registered numerous concerns that the Stark Law is inhibiting their ability to participate in Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) reforms. The CMS Administrator, Verma, has acknowledged the difficulty of reconciling the Stark Law’s restrictions with the current shift to value based payment structures, noting that that the Stark Law “was developed a long time ago” with current payment systems and operations being different, requiring some changes in the rules. This is not the first time CMS has tried to move the easing of rules concerning the Stark law. In 2015, CMS published a Proposed rule relaxing aspects of the Stark law, including easing of some of the strict liability features of the law and the CMS burden in dealing with the interpretation of key terms, requirements, and other issues.  After reviewing an enormous amount of self-disclosures, CMS realized that a large part of its docket involved arrangements that may technically violate the statute but do not actually pose significant risks of abuse, thus necessitating some changes and clarifications.

Inter-Agency Group formed to focus on easing Stark Barriers

During a January, 2018 American Hospital Association webinar, the CMS Administrator announced plans to convene an inter-agency group consisting of CMS, the OIG, HHS General Counsel, and the DOJ to focus on how to minimize the regulatory barriers of the Stark law that began in 1989 and underwent expansion in the 1990s. Verma noted that the review is in line with CMS’s “Patients Over Paperwork” initiative, which is in accord with the President’s Executive Order that directs federal agencies to “cut the red tape” to reduce burdensome regulations.

Congress Acts

Regardless of the results of the inter-agency review, the fact remains that only so much can be done by regulatory policy changes. All real changes must be made in the law will necessarily have to come from Congress. The Bipartisan Budget Act of 2018 imposed changes on laws related to health care fraud and abuse. On one side they quadrupled fines and doubled potential prison time from five to ten years for violation of the Anti-Kickback Statute.  The Civil Monetary Penalties (CMP) law penalties were doubled. On the other side, Congress moved to reduce some of the burdens by codifying CMS regulatory guidance. Some specific relief involved expired leases and personal services contracts that, if otherwise compliant, will remain protected as long as the terms and conditions continue unchanged.

 

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: Oncology remains high federal enforcement priority

Oncology continues to be a high enforcement priority for the DOJ, OIG, FBI, and CMS.  The latest fraud investigation by the DOJ involves CCS Oncology, large and prominent providers of cancer care. The reported question being investigated relates to possible billing irregularities involving Medicare and Medicaid. As with most cases related to oncology irregularities, the predication was by a “whistleblower.” The complaint alleges CCS billed for more expensive procedures than were actually performed, billed for procedures that never were performed, and performed medically unnecessary procedures on patients, among other violations, according to the source. The stream of cases is long enough to outline key factors that have led to settlements with the DOJ and OIG. Compliance Officers, whose portfolio of responsibilities include oncology services may wish to review the following to ensure none of these factors are at work in a manner that may trigger investigation.

Common Oncology Enforcement Issues

  1. Employees knowingly submitted false records to Medicare and Medicaid to increase revenue
  2. Claims submitted for services performed without required physician supervision
  3. Offering unnecessary treatments and services to patients
  4. Recruitment and treatment of terminal patients that should have been referred to hospice care
  5. Re-treatment of patients in excess of prescribed dosage limits
  6. Claims for services when physician reviews had not taken place
  7. Claims where treatment occurred without prior required IGRT scan
  8. Physicians allowed registered nurses to fill out prescriptions for medications
  9. Offering inducements (“kickbacks”) to patients by waiving their co-pays
  10. Conducting not necessary fluorescence in situ hybridization (FISH) tests for bladder cancer
  11. Filing payment claims for GAMMA functions by improperly trained physicians and staff
  12. Seeking payments for tests whose results doctors had not reviewed
  13. Billing E&M services on the same day as a related procedure
  14. Double and over-billing Medicare for services that lacked supporting documentation
  15. Improperly billing for radiation treatment without proper physician supervision
  16. Submitting false claims for magnetic resonance imaging (MRI) services
  17. Billing for services that were not documented in the patients’ medical records
  18. Billing twice for the same services
  19. Misrepresentation of the level of a service provided to increase reimbursement
  20. Routinely waived patient copayments as an inducement, then billing Medicare for them.
  21. Claims for services not performed, medically necessary, and/or properly documented
  22. Claims for services rendered to patients referred by physicians benefiting from referral
  23. Purchasing cancer treatments from unlicensed sources for oncology practice
  24. Diluting patients’ chemotherapy treatments and delivering in a manner designed to extend period of treatment time
  25. Claims for medically unnecessary or properly documented intensity-modulated radiation therapy (IMRT)
  26. Unsupported add-on claims for “special treatment procedures” and “specialty physics consults”
  27. Violating the Stark Laws and Anti-Kickback statute by rewarding referring physicians

 

Kusserow on Compliance: Overlap between physician-owned hospitals and distributers could result in violations of the Stark Laws and Anti-kickback Statute

The HHS Office of Inspector General (OIG) issued a new report about the limited available information to identify physicians who have concurrent ownership interests in physician owned distributors (PODs) and hospitals. The agency raised concerns about the lack of transparency among Medicare providers and the vendors that sell them implantable devices. Lack of transparency of ownership may prevent identification of providers who may be violating the referral and billing prohibitions of the Stark Law or the Anti-Kickback Statute (AKS). This problem may also have implications for patient safety and quality of care, in that physician ownership may affect physicians’ clinical decision making in performing surgeries or ability to choose a device in which they have a financial interest rather than another device that may be more appropriate for the patient.

This new report followed up on its October 2013 report (Spinal Devices Supplied by Physician Owned Distributors: Overview of Prevalence and Use), where it found that PODs supplied the devices used in nearly one in five spinal fusion surgeries that were billed to Medicare. CMS expressed continued interest and concern about the overlap between owners of physician-owned hospitals and PODs of spinal devices. The OIG examined the hospitals used in the prior report that self-identified as physician-owned and reported having purchased spinal devices from PODs. The report also used publicly available information (e.g. websites for hospitals and PODs, as well as state business registration websites) and information from CMS’s Provider Enrollment, Chain and Ownership System (PECOS) to attempt to determine whether a physician had an ownership interest in both a hospital and a POD that sold spinal devices to the hospital.

During data collection for the original report, 119 hospitals self-identified as having purchased spinal devices from PODs. Of these 119 hospitals, 12 self-identified as physician-owned and reported that they purchased spinal devices from 12 PODs. All of these hospitals self-identified as physician-owned on their web sites, and five of them identified physician-owners by name. The report also researched the ownership of the 12 PODs from which the 12 physician-owned hospitals reported having bought spinal devices. Two of these PODs identified physician-owners by name on their websites. The report identified the physician-owners of an additional three PODs from our review of state business registration websites and identified one physician who had an ownership interest in both a hospital and a POD that supplied spinal devices to that hospital. The OIG noted, however, that it is possible that additional physicians had such ownership interests that were not detected using what information it had available.

The results of the study demonstrate a need for increased transparency with regard to ownership information for PODs and, to a lesser extent, of hospitals. The Physician Payments Sunshine Act (Sunshine Act) requires manufacturers and group purchasing organizations to report to CMS any ownership and investment interests held by physicians. The OIG intends to monitor CMS’s implementation of the Sunshine Act and be on guard for those arrangements that may rise to a violation of law or regulations.

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 © 2015 Strategic Management Services, LLC. Published with permission.