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.

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

Kusserow on Compliance: Board compliance expertise needed to protect against liabilities

– OIG “White Papers” and CIAs are must-reads for compliance officer

– CIA board member certification mandates is a “game changer”

– Boards need “compliance literate” members

– Compliance officers should not wait for boards’ engagement of experts

Government regulators have advised for decades that effective Compliance Programs begin at the top with the Board and cascade down through the executive leadership and the compliance officer to all employees. The OIG and American Health Lawyers Association (AHLA) issued three communications that underscore the Board compliance duties and responsibilities. The most recent is “Practical Guidance for Health Care Governing Boards on Compliance Oversight” which advised Boards to have compliance expertise available to make sure they meet all fiduciary duties and obligations in overseeing corporate compliance.

Carrie Kusserow, with 20 years experience as a compliance officer and consultant who brought organizations through CIA mandates, has found the Practical Guidance particularly significant.  It calls for Boards to engage Compliance Experts to assist them in meeting their obligations and it is noteworthy that it provides almost identical language to the language used in CIAs regarding Boards’ use of Compliance Experts. In cases where the OIG finds that the Board has not been providing the proper oversight of the compliance program, the OIG really nails the organization down in the CIA mandates, which now require personal certifications of board members. She suggests that Compliance Officers should review recent CIAs to learn what the OIG considers as best practices for a Board in engaging a Compliance Expert to be on call for advisory services.

Steve Forman, a CPA with more than twenty years experience as a Compliance Officer, compliance consultant, and has been engaged on many occasions as Board Compliance Expert.  He notes that the CIA mandates for Boards to engage a Compliance Expert because most board compliance oversight lacks members who are experts in compliance. Whereas Board Audit Committees always include “financially literate” members, most Board committees providing compliance program oversight lack members who are “compliance literate.” The result is relatively few boards have with anyone with compliance expertise to assist in proper oversight and support for the Compliance Program. His best advice for Boards is to include someone who is “compliance literate” that knows what questions to be asked and assess program effectiveness.

For more information on this subject, contact Carrie Kusserow (ckusserow@strategicm.com)

 

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: 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: Countdown to mandated nursing facility compliance programs

– Only months remain to evidence having an effective compliance program

– Many have a lot to do before state agencies begin their assessments

– Nursing homes lag behind hospitals in compliance program development

Tom Herrmann, J.D., served over 20 years in the OIG’s Office of Counsel and for the past ten years has been a compliance consultant, specializing in nursing home compliance programs. He explained that the Affordable Care Act included a mandate that skilled nursing facilities and nursing homes adopt and implement an effective compliance and ethics program as a condition of participation in the Medicare and Medicaid programs with a November 28, 2018 deadline established in regulations issued by CMS. At that time, State survey agencies will begin assessing nursing facility development and implementation of an effective compliance and ethics program, as a condition for participation in the Medicare and Medicaid programs. Reviews will be conducted under the CMS State Operation Manual “Guidance to Surveyors for Long Term Care Facilities”.  The new mandate parallels the HHS OIG Compliance Program Guidance for Nursing Facilities with its identified seven elements of an effective compliance program. Those that followed the OIG guidance will have little problem in meeting the new mandate, but those who did not, have only months to come into compliance. Based on his experience, he believes that facilities have a lot to do to come into compliance before state agencies begin their assessments, as many have delayed or limited resources for compliance program development.   He suggests that the most cost effective method to begin catching up to have a compliance expert perform a gap analysis to identify elements needed for the compliance program and how be able to evidence program effectiveness. A gap analysis should provide a “road map” and step-by-step plan for bringing a facility into compliance with the mandates. Those that have already implemented their compliance program should consider having an effectiveness evaluation conducted to experts that follow the review protocols that will be used by government auditors.

For more information about meeting the standards of these new mandates, Tom Herrmann may be reached at thermmann@strategicm.com or at (703) 535-1410.

 

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.