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.

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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.

Kusserow on Compliance: The cost-benefit of engaging interim compliance officers

Carrie Kusserow is COO for Strategic Management, which provides interim compliance officers (ICOs) for health care organizations. She noted that in making the decision about engaging an ICO, close consideration should be given to the return on investment (ROI). In fact, most decisions of this type are made around this time of the year, as organization begin thinking about revitalizing their compliance program in the New Year. The best results from engaging ICOs come from having several different related tasks in a single engagement. First and foremost is managing the program. However, that by itself may not gain the best ROI. She recommends that the ICO engagement include cost avoidance from incidents and event that could give rise to liabilities. Part of this task would be include a “gap analysis” on the status of the program.  Another task should be to help define what is needed in the recruitment of a permanent compliance officer. Also, before the ICO leaves, it is highly advisable to have a full report provided to the executive leadership and board on what was found with regards to the program and anything needed to ensure that it operates in a manner to achieve the desired outcome.  Additionally, the ICO can assist in identifying the education, skills, leadership experience and personality needed in the permanent replacement.

Kashish Parikh-Chopra, J.D., MBA, CHC, CHPC notes that a growing number of health care provider organizations have been turning to her firm to find an Interim Compliance Officer (ICO) to fill temporary vacancies, evaluate status of the compliance program, and mentor current compliance office staff.  Her firm, Strategic Management provides such services with individuals who have all the necessary experience, technical skills, proven leadership and personality to properly fit into the senior management team. Often, executive leadership or the Board decides it is necessary to engage an expert to make improvements or to keep operations running smoothly and addressing issues, while the organization searches for the right permanent candidate. It also provides a fresh set of professional eyes examining and testing the compliance program for any potential deficiencies. By including these evaluations and reporting requirements in the ICO engagement, the organization receives a benefit, which if contracted for separately, would cost twice as much. What this means is that for the cost of a full compliance program evaluation, the ICO would also manage the program for the gap period.

 

For more on Interim Compliance Officers, Kashish Parikh-Chopra can be reached at kchopra@strategicm.com or via telephone at (703) 535-1413.  Also visit https://compliance.com/services/interim-compliance-officer/ or see Journal of Health Care Compliance at https://compliance.com/publications/understanding-the-role-of-an-interim-compliance-officer/

 

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: Meeting long term care compliance program legal mandates

The Patient Protection and Affordable Care Act (ACA) included a mandate that long term care (LTC) skilled nursing facilities (SNFs) and nursing homes adopt and implement an effective compliance and ethics program as a condition of participation in the Medicare and Medicaid programs. Facilities have until November 28, 2019 to meet the compliance program requirements. At that time, state survey agencies will begin assessing facility compliance with implementation of an effective compliance and ethics program following the CMS State Operation Manual “Guidance to Surveyors for Long Term Care Facilities.”  CMS requires annual review of its compliance and ethics program to ensure that modifications are made to reflect changes in laws, regulations, and to reduce violations.

Tom Herrmann, J.D., served over 20 years in the OIG Office of Counsel and for the past ten years has been a compliance consultant, specializing in nursing home compliance programs. He explains that the new mandate parallels the HHS OIG Compliance Program Guidance for Nursing Facilities and those that followed the guidance will have little problem in meeting the new mandate, but those who didn’t have only months to come into compliance. For those organizations with weak programs, he suggests the most cost effective method to begin catching up is 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 by experts to verify it will meet mandated standards.

Kash Chopra, J.D., has assisted many smaller LTC organizations in answering the challenge of meeting the mandate challenge by providing Designated Compliance Officers (DCOs) that assume the responsibility of being the Compliance Officer, including the building and managing of the program. The OIG recognizes using DCOs when the wide range of compliance responsibilities become a serious problem for smaller organizations and a full time Compliance Officer is unaffordable. The OIG’s position is that “For those companies that have limited resources, the compliance function could be outsourced to an expert in compliance.”  The OIG further recognize that an outsourced party can provide services on a part time basis.  Using highly experienced experts can lower fixed costs, reduce staff loads, and avoid using someone who is less qualified. Also, most of the work can be done remotely. Using an outside expert part-time, can accomplish more than a lesser experienced full time employee. She advises comparing the cost of hiring a compliance officer against that of a part time expert acting as the DCO.

For more information on this subject, Kash Chopra can be reached at kchopra@strategicm.com or via telephone at (703) 535-1413. Also see https://compliance.com/blog/contracting-compliance-program/

 

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.