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.

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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.

Kusserow on Compliance: Compliance risk assessment factors

 Testing compliance controls is a major compliance responsibility. This needs to be done at a program, department, or operational function area level. The responsible program manager or department head should be responsible for conducting her own risk assessments, as part of her ongoing monitoring responsibilities. The following are some risk factors that could exist in any program operation and could increase the risk of non-compliance. 

  1. What is the attitude of the program/department manager toward compliance controls?
  2. How committed and diligent is the manager toward ongoing monitoring duties?
  3. How well are policies and procedures kept up to date with changes in rule and regulations?
  4. Is there documentation & communication of organizational structure/mission & functions?
  5. Are all new hires carefully screened for their credentials and for any history of sanctions?
  6. Are all employees trained on written compliance controls, policies, and procedures?
  7. Has there been careful delegation and communication of authority for the management train?
  8. How well controlled is the administration of contracts, interaction with vendors/providers?
  9. Is the level of staffing appropriate to meet requirements of work?
  10. How is the management of confidential or sensitive material handled?
  11. How has the potential for conflicts of interest been addressed?
  12. What documentation is there for identified errors or irregularities?
  13. Do the managers periodically document and report errors and actions taken to correct them?
  14. Do employee standards and evaluations include compliance?
  15. What kinds of controls over automated data (computers/laptops, cell phones)?
  16. What steps have been taken to protect data security?

 

For more information on the subject of compliance risk assessments and evaluation, contact Kashish Parikh-Chopra, JD at kchopra@strategicm.com or (703) 535-1413.

 

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: Meeting sanction checking mandates

As the HHS Inspector General, I created what is now referred to as the List of Excluded Individuals and Entities (LEIE) that was followed by OIG compliance guidance documents which call for checking employees, physicians, vendors, and contractors against the LEIE. The OIG considers all claims and costs associated with an excluded party as potentially false and fraudulent and can lead to significant financial penalties and more. The OIG Special Advisory Bulletin on the Effect of Exclusion provides very useful information in assessing this risk area. CMS mandates, as a condition of enrollment, providers may not employ or contract with individuals or entities that are excluded from participation in any federal health care program and call for checking not only against the LEIE, but also the General Service Administration’s (GSA) Excluded Parties List System (EPLS), now part of the System for Award Management (SAM). CMS further called upon State Medicaid Directors to establish their own sanction data base and requires providers to check it on a monthly basis. To date, 40 states have moved to establish their own Medicaid sanction lists with other states in the process of doing the same. This has increased the sanction screening burden exponentially, not only for the compliance office but other departments as well. HR often has responsibility of sanction checking new hires and periodically current employees. Procurement is also affected because they handle the screening of vendors and contractors. The Medical Credentialing Office must ensure checking on physicians who have been granted staff privileges.  Other federal sanction databases worth screening are maintained by the DEA and FDA, as well as the Department of the Treasury Office of Foreign Assets Control (OFAC) Terrorist Watch List.

Daniel Peake, of the Compliance Resource Center (CRC), works with clients to provide a variety of CRC services that includes providing sanction checking services, as well as the investigation and resolution of potential hits. He noted that the time and resources necessary for developing and maintaining a search engine, along with regularly collecting and updating sanction information from many databases is not very cost effective. This high cost of using internal resources to develop and manage the sanction checking has resulted in the great majority of health care entities subscribing to a vendor service that provides a search engine to their established databases. Vendors can afford the high cost of maintaining the currency of the data because they amortize the costs over many clients. The problem is that that vendor quality, cost, and reliability can vary enormously.  From experience, he offered the following tips for those considering a vendor:

 

Tips on choosing a vendor search engine service

  1. Know the cost up front with a fixed rate, not based upon per click searches.
  2. Contract should permit cancelling without cause at any time, if dissatisfied.
  3. Ensure vendor has liability insurance ($ 1 to 3 million preferably).
  4. Determine other services included (e.g. policy templates, regulatory updates, etc.).
  5. Determine how much “help desk” assistance is available to resolve potential hits.

 

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