Kusserow on Compliance: Time for Compliance Program evaluation

  1. Have a 2021 workplan focusing on improving the Compliance Program
  2. Not having independent evaluations is evidence of lack of program effectiveness
  3. DOJ & OIG: Identifying & addressing weaknesses evidences program effectiveness

With 2020 coming to an end, it is time to look forward to the New Year and plan ways to identify areas for improvement of the Compliance Program, building off of results of independent evaluations. Both the OIG and DOJ stress the importance of evidencing Compliance Program (“CP”) effectiveness and that all programs are in progress, never completed. They see compliance officers identifying weakness and gaps that lead to improvements as positive evidence of an effective program. The DOJ “Evaluation of Corporate Compliance Programs” notes that there will always be ways the program can be improved and enhanced. The DOJ, in its 2020 Compliance Program Evaluation Guidelines noted: “One hallmark of an effective compliance program is its capacity to improve and evolve. The actual implementation of controls in practice will necessarily reveal areas of risk and potential adjustment.”  The DOJ highlights the importance of effective implementation and evaluation measures” to determine whether the compliance program a “paper program” or one that is fully “implemented, reviewed, and revised, as appropriate, in an effective manner.” DOJ prosecutors are directed to ask: Does the company evaluate periodically the effectiveness of the organization’s compliance program?” Regular, rigorous, and consistent review of compliance programs is now the expectation.  The OIG calls for ongoing monitoring and independent ongoing auditing of Compliance Programs to evidence continuous improvement.

There are three general ways for independent evaluations: (1) a complete compliance program evaluation; (2) a compliance program gap analysis; or (3) an independently developed and administered employee survey of compliance knowledge, attitude and perceptions.

  1. Compliance Program effectiveness evaluations is recognized by experts as by far the best method to evidence how well the program is functioning. It measures outcome by conducting a 360-degree evaluation that includes: (a) full document examination and review; (b) on site review and testing of operations in action; and (c) interviews of Board members, executives, selective key staff, and focus group meetings. If done properly, the resulting reports with be 60 to 100 pages that include findings, observations, along with recommendations and suggestions for program improvement.
  2. Compliance program gap analysis is about half of the cost or less than a full compliance program evaluation, but the reduction of costs is matched by the diminished value of results. It is primarily a document “checklist” review, focusing on output metrics, rather than outcome metrics related to program effectiveness. It is best used with organizations with new or incomplete programs, desiring assistance in identifying elements needed to complete development of their program.  It can identify gaps for inexperienced compliance officers but lacks details by which this can be accomplished.
  3. Independently developed, validated, and administered compliance surveys of employees is the least expensive means, at a fraction of the cost for either of the two other methods, for evidencing and benchmarking compliance program effectiveness. The use of surveys has long been advocated by regulatory bodies, including in the Federal Sentencing Guidelines, OIG Compliance Program Guidance and DOJ guidelines. These organizations advise using surveys of employees to gauge how well the program is functioning. Surveys that are anchored in a large database of organization, permit benchmarking an organization to the universe. Compliance knowledge surveys test knowledge of the compliance program structure and operations and can provide very credible empirical evidence of the advancement of program knowledge, understanding and effectiveness. Compliance culture surveys focuses on employee beliefs, attitudes, and perception concerning compliance, useful in measuring the extent to which individuals, coworkers, supervisors, and leaders demonstrate commitment to compliance. Both types of surveys should be considered as they are useful in benchmarking and measuring change in the compliance environment over a period and provide different dimensions and perspectives on a compliance program.

For more information on the difference in scope of work between a full compliance program evaluation and a gap analysis, send your queries to Richard Kusserow at rkussserow@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 LinkedIn.

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Copyright © 2020 Strategic Management Services, LLC. Published with permission.

Kusserow on Compliance: OIG reports top unimplemented recommendations

The HHS Office of Inspector General (OIG) Top Unimplemented Recommendations: Solutions to Reduce Fraud, Waste, and Abuse in HHS Programs is an annual OIG publication. These recommendations, if implemented, are ones that would most positively impact HHS programs in terms of cost savings, program effectiveness and efficiency, and public health and safety. All were derived from audits and evaluations issued through December 31, 2019, which predated the COVID-19 public health emergency. Fourteen of the 25 were related to Medicare and Medicaid. The recommendations called for CMS to:

  1. Take actions to ensure that incidents of potential abuse or neglect of Medicare beneficiaries are identified and reported.
  2. Reevaluate the inpatient rehabilitation facility payment system, which could include seeking legislative authority to make any changes necessary to more closely align inpatient rehabilitation facility payment rates and costs.
  3. Seek legislative authority to comprehensively reform the hospital wage index system.
  4. Seek legislative authority to implement least costly alternative policies for Part B drugs under appropriate circumstances.
  5. Provide consumers with additional information about hospices’ performance via Hospice Compare.
  6. Continue to work with the Accredited Standards Committee X12 to ensure that medical device-specific information is included on claim forms and require hospitals to use certain condition codes for reporting device replacement procedures.
  7. Analyze the potential impacts of counting time spent as an outpatient toward the three-night requirement for skilled nursing facility (SNF) services so that beneficiaries receiving similar hospital care have similar access to these services.
  8. Provide targeted oversight of Medicare Advantage organizations (MAOs) that had risk adjusted payments resulting from unlinked chart reviews for beneficiaries who had no service records in the 2016 encounter data.
  9. Require MAOs to submit ordering and referring provider identifiers for applicable records in the encounter data.
  10. Develop and execute a strategy to ensure that Part D does not pay for drugs that should be covered by the Part A hospice benefit.
  11. Ensure that States’ reporting of national Medicaid data is complete, accurate, and timely.
  12. Collaborate with partners to develop strategies for improving rates of follow-up care for children treated for attention deficit hyperactivity disorder (ADHD).
  13. Develop policies and procedures to improve the timeliness of recovering Medicaid overpayments and recover uncollected amounts identified by OIG’s audits.
  14. Identify States that have limited availability of behavioral health services and develop strategies and share information to ensure that Medicaid managed care enrollees have timely access to these services.

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 LinkedIn.

Subscribe to the Kusserow on Compliance Newsletter

Copyright © 2020 Strategic Management Services, LLC. Published with permission.

Kusserow on Compliance: 2020 DOJ compliance program guidelines on continuous improvement and use of data

The DOJ released an update to its Compliance Guidance, intended to assist prosecutors in making informed decisions about whether a company’s compliance program was effective at the time of an offense. It emphasizes the importance of using data and technology to support compliance efforts, including assisting with continuous updates of a compliance program and assessing the adequacy and effectiveness of it at the time of the offense, charging decision, and case resolution. Many of the changes involve adding questions about a company’s ability to learn from its own experience through, among other things, the use of data and technology. The guidance asks whether companies:

  1. Engage in periodic reviews limited to a “snapshot” in time, or one based on continuous access to operational data across functions?
  2. Incorporated “lessons learned” through a “process for tracking and incorporating into its periodic risk assessment” information acquired both internally and from other similarly situated companies?
  3. Update policies/procedures and if they provide enough data to allow for effective monitoring and testing their effectiveness?
  4. Publish policy documents in a searchable format for easy reference and access?
  5. Can track access to specific policies/procedures to understand which are attracting the most attention from employees?
  6. Have means for employees to ask questions arising out of training?
  7. Have evaluated extent to which training has had an impact on employee behavior or operations?
  8. Engage in continuous ongoing monitoring and improving reporting mechanisms?
  9. Periodically test[s] hotline effectiveness, and track reports from inception to conclusion?
  10. Effectively communicate compliance requirements to employees during compliance education and training?

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 LinkedIn.

Subscribe to the Kusserow on Compliance Newsletter

Copyright © 2020 Strategic Management Services, LLC. Published with permission.

Kusserow on Compliance: OIG response plan—four goals for the COVID-19 Crisis

The HHS Office of Inspector General (OIG) has identified four goals to respond to the COVID-19 Pandemic: protecting people, protecting funds, protecting infrastructure, and promoting effectiveness. The OIG set out its framework in the OIG Strategic Plan: Oversight of COVID-19 Response and Recovery.

PROTECT PEOPLE. The OIG plans for this goal include to: (1) issue guidance on its administrative fraud enforcement authorities related to delivering needed patient care; (2) conduct rapid-cycle reviews of conditions affecting HHS beneficiaries or health care providers; (3) inform/support response efforts; (4) help ensure continuity of HHS operations during the public health emergency; (5) identify and investigate fraud and scams that endanger HHS beneficiaries and the public; (6) alert the public to fraud schemes related to COVID-19; and (7) assess the impacts of HHS programs on the health and safety in the acquisition, management, and distribution of COVID-19 tests and vaccine and treatment research and development.

PROTECT FUNDS. HHS was appropriated $251 billion for COVID-19 response and recovery—to prevent, prepare for, and respond to coronavirus, along with funds from other appropriations. The OIG plans for this  goal include: (1) reviewing of oversight, management, and internal controls for awarding, disbursement, and use of funds; (2) assessing whether recipients met requirements; (3) mitigating major risks that cut across program and agency boundaries; (4) ensuring that intended purposes of funds granted are being used properly; (5) identifying and investigating suspected fraud and exercising OIG’s administrative enforcement authorities; (6) identifying program integrity vulnerabilities and recommend safeguards; and (7) providing alerts to potential fraud risks or schemes to steal funds.

PROTECT INFRASTRUCTURE. Objectives for this goal include: (1) protecting the security and integrity of IT systems and health technology; (2) identifying IT vulnerabilities and incidents, mitigating threats, and restoring IT services; and (3) focusing on identifying and investigating cybersecurity vulnerabilities related to COVID-19 response.

PROMOTE EFFECTIVENESS. The OIG’s plans for this goal include: (1) focusing on COVID-19 efforts to identify successful practices and lessons learned from the emergency preparedness and response; (2) reviewing pandemic preparedness planning to identify how preparedness funding was spent; and (3) assessing COVID-19 impact on HHS programs and beneficiaries, including expanded telehealth in 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 LinkedIn.

Subscribe to the Kusserow on Compliance Newsletter

Copyright © 2020 Strategic Management Services, LLC. Published with permission.