Kusserow on Compliance: Documentary pillars supporting effective compliance programs

16 key documents described

Critical to an effective Compliance Program (CP) is reinforcing it with key documents that provide the supporting pillars. The following describes some of most important compliance program documents:

  1. Code of Conduct. This can be viewed as the Constitution for the organization and should be distributed to all covered persons.
  2. Charters for the Executive and Board Level Oversight Committees. These should establish oversight and support for the CP and define roles and responsibilities.
  3. Compliance Officer Charter/Position Description. It is important to formally describe the role of this position, responsibilities, reporting relationship to the CEO and Board, etc.
  4. Protocols Between the Compliance Office and Legal Counsel, HR, Internal Audit, etc. Many functions overlap or intersect with the Compliance Office. Working relationships need to be defined to avoid “turf issues.”
  5. Compliance Education and Training Policy. This should describe the development and implementation of regular, effective education and training programs for all affected parties, and describe general topics covered, frequency of training, and how you will document completion of the training.
  6. Hotline Charter/Policy. There needs to be a document that establishes a process to receive complaints and how they will be handled. It should describe how individuals can report concerns and ask questions or request guidance.
  7. Policies Addressing Ongoing Monitoring of High-Risk Areas. This is for program managers on their responsibilities to monitor their risk areas, develop and implement written guidance to their staff, training of the staff on how to comply and verify they are following the instructions properly.
  8. Policies Addressing Ongoing Auditing of High-Risk Area. These should address independent reviews of high-risk areas to verify and validate ongoing monitoring is operating the way it should and assist in the reduction of identified problem areas.
  9. Policies Governing Internal Investigations. Outline of the general steps that will be taken to investigate a report of possible problems; and documentation of results.
  10. Policies Addressing Non-Engagement of Sanctioned Individuals and Entities. This should state that there will be no engaging, contracting with, accepting referrals or prescriptions from those that are sanctioned, excluded or debarred from federal and state health care programs.
  11. Conflicts of Interest Policy. This should require all potential conflicts of interest be disclosed and provide a method for addressing them.
  12. Anonymity and Confidentiality Report Policies. Employees should be allowed to report potential wrongdoing anonymously and policy should protect the identity of those who request confidentiality.
  13. Non-Retaliation Policy. This should address protection against retaliation of those reporting potential wrongdoing.
  14. Document Policy Management and Retention. This should outline document retention and destruction requirements and should address electronically maintained documents.
  15. Credentialing and License Policy. This should address which individuals must maintain licensure and state that make clear no engagement or contract individuals and entities that are not properly licensed. It should define verification procedures.
  16. Disclosure of Overpayments and Violations of Law and Regulations Polices. Overpayments are common and sometime there is identification of wrongdoing. Strict rules should govern when and under what circumstances disclosures to outside parties is required.

These are only a starting point. All policies should be reviewed on an annual basis and updated as necessary. This includes eliminating policies that are no longer appropriate or relevant and writing new ones. All policies should be written in a template that permits you to document when a policy was last reviewed and when it was last changed.

For more information on this topic contact Marvin Mills (mmills@complianceresource.com) at the Compliance Resource Center that maintains over 1,000 compliance-related policy templates.

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: Board members must meet their compliance obligations

Both the DOJ and OIG have been moving to make board members more accountable for meeting fiduciary duties and obligations in overseeing the Compliance Program. The OIG has long called for a top-down compliance program, beginning at the board level. The OIG and American Health Lawyers Association published “Corporate Responsibility and Corporate Compliance: A resource for Health Care Boards of Directors” that sets forth how these obligations should be met. These standards are being included in Corporate Integrity Agreements that mandate personal attestations from board members regarding the effectiveness of the Compliance Program.

Traditionally, Outside Directors were the primary watchdogs of any board that oversaw of the audit, compliance, and compensation committees, rather than directors from the management of the enterprise. An Independent Director should not be affiliated with the organization as an adviser, auditor or consultant or have personal services contract(s) with the Company. One type of Independent Director that should be on the board is one that is also “compliance literate,” meaning having intimate knowledge of compliance as result of having been a compliance officer, an attorney who has dealt with compliance issues, experience as a compliance consultant, etc. They should have the requisite knowledge and skills to be able to critically evaluate the information and needs relating to the Compliance Program. If not already done, it is advisable for Compliance Officers to work on educating the board on their fiduciary obligations and the merits of having a compliance literate board member.

 

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: Compliance officer best practice tips

The ever increasing health care regulatory and enforcement environment increases the challenge for compliance officers. It is not enough to develop the seven standard elements of a compliance program. Compliance officers must persuade the organization to adopt those elements by changing the culture of the organization. This requires a lot of effort. It can be called preaching or selling—it amounts to the same thing. The following are suggested tips:

  1. Obtain independent evidence of compliance program improvement by periodically having independent experts evaluate its effectiveness and offer suggestions for improvements.

 

  1. Maintain ongoing metrics to benchmark progress of the compliance program effectiveness, such as using a compliance culture or knowledge survey that evidences improvements from one period to another.

 

  1. Do not compromise principle in the face of skepticism and sometimes resistance with leadership, and those who consider compliance to be a distraction to their job. Once you begin to “cave in” to their unreasonable disagreements, it creates a pathway to ineffectiveness.

 

  1. Educate management on the benefits of compliance in assisting in reducing risks that could give rise to liabilities and loss of reputation. The challenge of selling the message is ongoing.

 

  1. Sell the importance, value, and benefits of the program to the board, leadership, and the rank and file employees. Also sell the consequences not having an effective program. Gaining “buy-in” by the executive leadership and Board is the best path for the compliance officer to be effective.

 

  1. To be truly successful, compliance officers must reach and convince first line managers to carry the compliance message to their subordinates, by word and example. What they say and what attitudes they project to their staff is far more powerful than pronouncements from “on high.”

 

  1. Rank and file must see compliance as responsive to their concerns and this means actively and promptly investigating and resolving matters raised by the work force in a competent professional manner. Also, the compliance officer needs to be visible and available to hear what concerns people have; as such, it is good to walk around and talk to people about their jobs, thoughts, concerns, etc. This is all part of selling the program.

 

  1. Successful compliance officers seek cooperation and coordination of effort, not competition, with other functions that overlap with compliance, such as HR, Legal Counsel, and Internal Audit. If these functions engage in turf battles, it will negatively impact the effectiveness of the compliance program. A lot of benefit can come from developing protocols (policy documents) that establish working relationships and methods of cooperative effort.

 

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 © 202o Strategic Management Services, LLC. Published with permission.

Kusserow on Compliance: Effective hotline programs

All healthcare organizations need confidential compliance communication channels. First and foremost among them is a hotline. By definition, all effective compliance programs should have a hotline. It is an important avenue of communication between employees and management, in that it permits employees to report sensitive matters outside the normal supervisory channels.  The reality is that developing and monitoring a hotline is a critical part of any effective compliance program. It provides an avenue of communication that permits employees to report sensitive matters outside the normal supervisory channels. The compliance officer bears the responsibility of constantly reviewing and improving the effectiveness of the hotline operation.  The US Sentencing Commission, the HHS Office of Inspector General (OIG), and Department of Justice (DOJ) all call for having a hotline, as well as other authorities, including the Sarbanes-Oxley Act for publicly traded companies and the federal courts in connection with unlawful harassment. Failure to establish positive internal compliance reporting channels often results in reporting externally to the OIG and DOJ from “whistleblowers.” The challenge is establishing effective internal compliance communication. Today, it is the exception to find organizations trying to manage a hotline function internally. The fact is that any advantage of internally operated hotlines is more than off-set by the disadvantages.

From a practical standpoint, it simply is not cost effective to operate a hotline 24/7 internally.  Even those that decide to operate and manage the function in house are confronted with a number of challenges—it is extremely inefficient, costly and seldom meets any minimum standards. Hotline numbers will need to be “backstopped” against tracing and all caller identification systems have to be blocked. People answering the calls in house should not be highly visible to the work force. Confidence comes from neither party being known to the other. Hotline vendors have the training and experience to handle complainants. Callers are generally nervous and afraid and knowing they are providing information to an outside party generally is reassuring. They always raise the question of whether anonymity is truly offered and whether employees will ever sufficiently trust calling an employee. It has become the standard practice for organizations to outsource their hotline to a vendor.  However, evaluating those providing the best service at the right price is a challenge. The following are questions that can be used to determine a properly qualified vendor. Those failing key tests should be avoided as they may prove to be a future liability.

 

Questions for hotline vendors

  1. Cost of Service. Does the vendor charge an established fixed rate or sliding rate based upon number of calls? Seek a fixed, not a variable rate, based upon number or time of calls. A good rule of thumb is that the cost of a hotline service should not exceed $1-3 per employee per year.

 

  1. Industry Focus. Can the vendor evidence having understanding and expertise of issues related to the health care industry? Failing to understand healthcare standards and regulatory matters limits the ability to properly debrief callers. Ask for a breakdown of the types of clients they serve by industries.

 

  1. Hours of Service. Does the vendor provide 24/7 service? If not, don’t use them.

 

  1. Call Centers. Does the vendor provide call services? If so, avoid them completely. Call centers provide outbound calls used to promote services and products. Others answer after hour services for businesses (doctors, plumbers, electricians, etc.) and relate messages to their clients. The people doing this are performing a clerical function and answering hotline calls requires more professional expertise. Furthermore, there is the risk of having calls interrupted by a call for some needing emergency service.

 

  1. Hotline Service Types. Does the vendor provide multiple levels of service for (a) receiving live operator calls and (b) a web-based reporting system that prompts individual complainants? One level alone is not enough.

 

  1. Avoiding Vendor Contract Traps. Does the contract permit cancellation at any time with a simple 30 day notice? If not, don’t use them. Staying with a vendor should be because of good service, not because of being locked into them by contract terms. If you have a current contract, check the termination clauses to see if cancelling a contract is cumbersome. If it is, ask to renegotiate the termination clause. If they decline, then take steps to follow termination procedures in the contract.

 

  1. Hotline Number. Does the vendor want to use their phone number? This is a common vendor trap to lock in users to their service. You advertise their number everywhere and to change would necessitate changing all the places you have advertise the number. Always use and own your own hotline number that can be pointed to a vendor.

 

  1. Language Translation. Does the vendor provide a language translation service to address non-English speakers?

 

  1. Check Vendor Background. What is the level of hotline experience among the ownership, management, and operation of the service?

 

  1. Length of Hotline Experience. How many years of experience can the vendor evidence in the management of hotline operations?

 

  1. Policies, Procedures, and Protocols. Does the vendor provide advice on developing operating protocols for following up an allegations and complaints received through the hotline?

 

  1. Business Associate Agreement (BAA). Does the vendor offer to sign a BAA to meet HIPAA protected health information (PHI) requirements for any patient related information received through the hotline? If they don’t know what that means, forget them.

 

  1. Timelines. Will the vendor agree to provide a full written report within one business day of receipt of the call and for urgent matters, immediate notification?

 

  1. Report Delivery Security. Does the vendor deliver call reports by the most secure means? It is critical to establish a secure call report submission process to a specific responsible party and to an alternate should the primary contact be unavailable? Any delivery of reports via fax or email lack necessary security. It is critical that reports are secured to protect those filing the report, as well as those who are subject of the report or mentioned in them. HIPAA PHI, proprietary and confidential data, and personnel information must be protected. Web-based reporting is the most secure with notification of a report being provided via email.

 

  1. Routine vs. Urgent Reporting. Does the vendor assist in establishing a process that alerts the primary contact to any urgent report received? A delay in reporting a serious issue could result in potential liabilities.

 

  1. Insurance. Does the vendor provide at least one to three million dollars liability coverage? If your vendor does not have this insurance, consider changing over to one that provides this assurance.

 

  1. Caller Contact Information. Does the vendor have procedures for providing callers with a means to call back without disclosing their identity?

 

  1. Personalized Service. Does the vendor provide the identity or identities of individuals available to respond to any issues or question that may arise, whether it relates to call reports, invoice issues, or providing general advice? Not having easy access to someone or having to go through a phone system moving you from one office to another before you find a stranger who may or may not be able to answer your questions can be frustrating. If possible, seek an identified accounts manager who will be responsible for any and all issues that arise under the contract.

 

  1. Training and Assistance. Does the vendor provide guidance on the best way to promote understanding of the hotline?

 

  1. Other Useful Benefits. Are there any other services or benefit provided under the contract? This would include such things as supporting policy and procedures for hotline management, poster templates, newsletters, etc. For smaller organizations, these benefits may exceed even the service fees paid to the vendor. Find out what they offer.

 

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 © 2017 Strategic Management Services, LLC. Published with permission.