Kusserow on Compliance: CMS ‘guts’ SNF/LTC compliance program mandates

– CMS “bows” to industry pressure

– Objective standards replaced by subjective ones

– Designated compliance officer not to be required

– No contact person to whom “people may report suspected violations”

 

A new CMS proposed rule—“Medicare & Medicaid Programs; Requirements for Long-Term Care Facilities: Regulatory Provisions to Promote Efficiency and Transparency”—proposes to roll back and remove many compliance program related requirements for long term care facilities (LTC) participating in Medicare/Medicaid. The Proposed modifications include removing many of the compliance program requirements adopted in 2016 on the basis that they are not expressly required by statute. The stated purpose of the proposed changes is to reduce administrative burdens. This flies in the face of increased identification by CMS, OIG, GAO, DOJ, and Congress of legal and regulatory compliance violations by LTC facilities.

Enhanced compliance programs were a way of addressing these ongoing problems. Among the requirements removed were (1) designation of a compliance officer; (2) designation of a compliance liaison for operating organizations with five or more facilities; (3) annual reviews of the compliance program; (4) having an identified person to whom individuals may report suspected violations.

CMS now proposes that a LTC organization develop, implement, and maintain an effective compliance and ethics program most appropriate for size and type of the organization. This should include written compliance standards, policies, and procedures that are reasonably capable of reducing the prospect of criminal, civil, and administrative violations. The new standards are far less objective and rely more on subjective concepts that are vague and difficult to substantiate, using terms like “reasonable” and “sufficient.”  Other CMS expectations for facilities include:

  1. Providing sufficient resources for operation of the compliance program.
  2. Designating a high-level person for overall compliance program responsibility with appropriate authority to assure compliance with the regulations.
  3. Taking reasonable steps to achieve compliance with program’s standards, policies, procedures, including monitoring and auditing that is reasonably designed to detect criminal, civil, and administrative violations.
  4. Having in place and publicizing a reporting system whereby anyone could report violations by others within the organization without fear of retribution.
  5. Ensuring consistent enforcement and discipline of standards, policies, and procedures.
  6. Effectively communicating compliance standards, policies, and procedures in compliance mandatory training.
  7. Taking reasonable steps to respond detected violations and to prevent similar violations in the future.

The new CMS proposed compliance program standards are significantly different from standards issued by the U.S. Department of Justice in April 2019—new DOJ evaluation of corporate compliance program guidelineswhich are designed to be used in making prosecutorial decisions and in determining penalty guidelines. Before CMS proposed to rescind many of its previously published standards for compliance programs, the DOJ and CMS standards were consistent.

 

 

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

Kusserow on Compliance: Questions board-level compliance committees should be asking

HHS OIG compliance guidance calls for a Board-level committee to oversee the Compliance Program (CP). The HHS Inspector General noted that the best boards are those that are active, questioning, and exercise (constructive) skepticism in their oversight, asking probing questions about the compliance program. Boards need to know what type of questions they should be asking, and compliance officers should assist them with this problem. However, compliance officers in turn should be prepared to provide full and complete answers to them. The OIG and American Health Lawyers Association developed specific suggested questions that Board’s should be asking in their jointly produced “Corporate Responsibility and Corporate Compliance: A Resource for Health Care Boards of Directors” and “Corporate Responsibility and Health Care Quality (2007): A Resource for Health Care Boards of Directors”. The following are drawn from these advisory documents:

  1. Does the compliance officer have sufficient authority to implement the CP?
  2. What is the level of resources necessary to properly implement and operate the CP?
  3. Has the compliance officer been given the sufficient resources to carry out the mission?
  4. Have compliance-related responsibilities been delegated across all levels of management?
  5. What evidence is there that all employees are held equally accountable for compliance?
  6. How has the code been incorporated into corporate policies across the organization?
  7. What evidence is there that the code is understood and accepted across organization?
  8. Has management taken affirmative steps to publicize importance of code to employees?
  9. Have compliance-related policies been developed that address compliance risk areas?
  10. Are there policies/procedures for CP operation and how they should be reviewed/updated?
  11. What kind of document management ensures compliance-related documents are up to date?
  12. What is the scope of compliance-related education and training?
  13. What evidence is there of the effectiveness of CP training?
  14. What measures enforce training mandates and provide remedial training?
  15. What evidence is available that employees understand compliance expectations?
  16. How are compliance risks identified?
  17. What is the evidence that identified compliance risks are being addressed?
  18. Is the board being kept up to date on regulatory and industry compliance risks?
  19. How is the compliance program structured to address such risks?
  20. How are “at risk” operations assessed from a compliance perspective?
  21. Is conformance with the CP periodically evaluated?
  22. Does the CP undergo periodical independent evaluation of its effectiveness?
  23. What is the process for the evaluation and responding to suspected compliance violations?
  24. What kind of training is provided to those who conduct investigation of reported violations?
  25. How do the CO, HRM, and legal counsel coordinate in resolving compliance issues?
  26. What are the policies to ensure preservation of relevant CP documents and information?
  27. What policies address protection of “whistleblowers” and those accused of misconduct?
  28. What are the results of ongoing compliance monitoring by all program managers?
  29. How is ongoing compliance auditing being performed and by whom?
  30. How often is sanction-screening conducted and with what results?
  31. Are results from sanction-screening included in a signed report by the responsible parties?
  32. Has the CP been evaluated for effectiveness by a qualified independent reviewer?
  33. What evidence regarding effectiveness of hotline operation and follow-up investigations?
  34. What are the metrics being used to evidence CP effectiveness?
  35. What are the results of an independent review and assessment of the CP?

 

More information regarding available tools and resources available to assist in answering these questions, 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.

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

Kusserow on Compliance: New OIG Work Plan items

The HHS Office of Inspector General (OIG) recently issued updates to its Active Work Plan (Work Plan). The Work Plan outlines ongoing and planned audits and evaluations for the fiscal year and beyond. Recent additions related to Medicare/Medicaid include the following:

  1. Medicare Part D Rebates Related to Drugs Dispensed by 340B Pharmacies. Drug manufacturers often do not pay for Medicare Part D prescription rebates filled at 340B-covered entities and contract pharmacies because the manufacturer already provides a discount on the drug. The OIG will conduct a study to determine the potential rebate savings if Part B program sponsors and manufacturers could agree on eligible prescriptions filled at 340B pharmacies that receive rebates.

 

  1. Characteristics of Part D Beneficiaries at Serious Risk of Opioid Misuse or Overdose. An OIG data brief found that about 71,000 Medicare Part D beneficiaries were at serious risk of opioid misuse or overdose in 2017. The OIG will study: (1) the characteristics of these beneficiaries, including their demographics and diagnoses; (2) the opioid utilization of these beneficiaries; and (3) the extent to which these beneficiaries have had adverse health effects related to opioids and any overdose incidents.

 

  1. Ensuring Dual-Eligible Beneficiaries’ Access to Drugs Under Part D: Mandatory Review.

Part D plans that meet certain limitations have the discretion to include different Part D drugs and drug utilization tools in their formularies. Under the Affordable Care Act, the OIG conducts an annual study to review the extent to which Part D sponsors’ formularies include drugs commonly used by Medicaid and Medicare Part D beneficiaries.

 

  1. Nursing Facility Staffing: Reported Levels and CMS Oversight. CMS uses the Payroll Based Journal auditable daily staffing data to analyze staffing patterns and populate the staffing component of the Nursing Home Compare website. It aids the public determine the results of health and safety inspections, quality of care at nursing facilities, and staffing. The OIG will issue two reports to: (1) describe nursing staffing levels that facilities report to the Payroll-Based Journal; and (2) examine CMS efforts to ensure data accuracy and improve resident quality of care.

 

  1. Medicare Part B Payments for Podiatry and Ancillary Services. Medicare Part B covers podiatry services for medically necessary treatment of foot injuries, diseases, or other medical conditions affecting the foot, ankle, or lower leg. It does not cover routine foot-care services unless they are: (1) necessary and integral part of otherwise covered services; (2) for the treatment of warts on the foot; (3) in the presence of a systemic condition or conditions; or (4) for the treatment of infected toenails. The OIG will review Part B payments to determine whether podiatry and ancillary services were medically necessary and supported in accordance with Medicare requirements.

 

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: The relationship between an Interim Compliance Officer and the CEO

Getting the right start is the best way to have a good return on investment

Catie Heindel, J.D., a highly experienced compliance consultant who has served as an Interim Compliance Officer, notes it is increasingly common for healthb care organizations to seek a temporary compliance officer to cover a gap. Though the rationale behind hiring an interim compliance officer is different for every organization, the ultimate goal is usually the same—to provide high quality and efficient compliance program leadership that will reduce exposure to unwanted risks and problems. Preparation and communication with staff to introduce the person selected to act in an interim capacity is very important to having a successful result from the engagement.

Ensuring a successful hiring decision really needs the personal involvement of the CEO. The OIG compliance guidance stresses that the compliance officer should report directly to the CEO. This sentiment also applies to Interim Compliance Officers; and the best return on investment for having someone move in and successfully temporarily fill a compliance officer gap is for the CEO to establish a direct reporting relationship. It is also helpful for everyone involved if the CEO personally provides a detailed background briefing on the organization that includes:

  • management structure;
  • mission/vision;
  • why the person was engaged;
  • expectations for the engagement; and
  • their role in the organization.

Upon arrival, the CEO should ensure there is a proper “on-boarding” process that includes personally introducing the interim compliance professional to the executive leadership, key program managers, legal counsel, HRM, and Board members. This interaction, from the outset, sets the right tone and will help to ensure that the interim is in lockstep with the CEO.  Furthermore, this empowerment exercise will permit the interim to move more quickly in gathering the reins of the compliance program and guard against having anything fall “beneath the cracks”.  It will also help the interim compliance professional to “hit the ground” running immediately and begin productive work.

For more information regarding engaging and preparing Interim Compliance Officers, Catie Heindel can be contacted at www.cheindel@strategicm.com, or via phone at (847) 707-9830.

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.