Kusserow on Compliance: Engaging experts to supplement and assist compliance offices

Most compliance offices are swamped with work. Sometimes it is a periodic rush to meet some urgency, while at other times there is just too much to be done with too little to meet all challenges in the ever-changing regulatory and enforcement environment. There are three broad ways to handle the load: (1) insource, so that all compliance office work is handled in-house, using consultants only occasionally for advisory services or evaluation of the compliance program; (2) outsource the compliance program to designated or interim compliance officers as a temporary solution for maintaining continuity, using an expert to be the interim compliance officer; or (3) cosource by using on-call experts to supplement the compliance office with specific duties or assignments.

Suzanne Castaldo, J.D., an expert on the subject, notes that many smaller organizations cannot justify the cost and burdens of supporting the program in-house and outsource it entirely to a designated compliance officer, who most often is a part-time engaged expert. The HHS Office of the Inspector General (OIG) recognized the use of designated compliance officers who may serve in that capacity for several organizations. Taking this approach should entail engaging experts on a part-time basis. If a full-time person can be afforded, then using this approach doesn’t make sense. The benefits include bringing the experience of many organizations to the entity that could ill afford to develop in-house.

Kashish Chopra, J.D., MBA, CHC, has served as an interim compliance officer and makes the point that in this day and age, with such a rapidly evolving regulatory and enforcement environment, health care organizations cannot afford to take the chance on having a gap in the compliance office. Having an expert on a short-term engagement can take over the reins of the program while a permanent replacement is found.

Jillian Bower, a highly experienced consultant has been instrumental in providing supplemental support to compliance officers. She noted that cosourcing has evolved as a “middle ground” between insourcing and outsourcing and has also been recognized by the OIG as a useful solution when expertise and resources are limited. It involves using experts on an ongoing basis to supplement limited staff resources to carry out part of their workload. It offers the advantage of the compliance officer maintaining control and direction of the program. Cosourcing can help bridge the gap in a manner that does not compromise the flexibility to easily return to a position where the Compliance Office can reassume full operation and end cosourcing at any time, when staffing issues are resolved. It is hiring piecemeal as needed. Common cosourcing may be using a consultant as a HIPAA privacy and/or security officer, conducting ongoing monitoring/auditing, performing enterprise risk management/analysis, engaging a statistical data claims analyst expert to determine error rates, hotline operations management, compliance investigations/training, reviewing arrangements with referral sources, and managing the sanction screening operations.

The fact is that there are options for consideration when a compliance program is being stretched beyond its capability to meet challenges or where a gap takes place among key compliance staff.

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

Kusserow on Compliance: Tips for getting the most from your CIA

This was the title of a section in a presentation by Laura Ellis, HHS Office of Inspector General (OIG) Senior Counsel, at the recent Health Care Compliance Association (HCCA) Compliance Institute, where she explained that the settlement process is very lengthy, and that compliance officers should spend that time period preparing for what is to come. Even before matters are referred to the OIG for settlement negotiations, the matter will have been with the Department of Justice (DOJ) for a long time.  It is only after the DOJ turns matters over to the OIG that the agency determines whether or not a corporate integrity agreement (CIA) is necessary, and if so, what terms and condition should be included in the agreement.  Ellis stated that negotiations with the OIG may take up to a year before a CIA emerges.   It is during this rather long lead-up period that the compliance officer should be very busy preparing for what is to come.  Ellis offered a number of suggestions for the compliance officer to follow while this process is underway, including:

Thomas Herrmann, J.D., was previously responsible for negotiating CIAs on behalf of the OIG and in providing monitors with a number of years’ consulting experience, working with more than a dozen clients with CIAs and as an Independent Review Organization (IRO). He agreed with the Ellis statement about the long lead time before a CIA is signed, and that the compliance officer should not waste that valuable time.  Once executed, the clock begins ticking and a lot has to be accomplished in a relatively short time.   Among the most important tasks needing immediate attention is finding and vetting potential outside experts to be the IRO and, in some cases, compliance experts for the Board and quality monitors. The responsibility for selecting these experts lies with the organization, not the OIG.  This may take a lot of time and warrants serious consideration as in all likelihood, the organization will have them for five years.  A mistake in selection will come back to haunt the organization and may aggravate matters with the OIG.  The compliance officer should be very much involved in finding and selecting the right experts with the right expertise.   The more experience the firm selected has in performing this type of work, the less likely there will be problems.  An experienced firm won’t have the learning curve of an inexpert firm that oftentimes adds cost to the engagement and results in poor reports to the OIG.  For an organization that is already in hot water with the DOJ and OIG, this kind of complicating matter is not wanted.

Carrie Kusserow has over 15 years’ compliance officer and consultant experience, and was brought in to be the compliance officer to an organization under a CIA while Laura Ellis was the monitor. Kusserow echoes Ellis’ advice to organizations to take steps to “get the most out of the money” expended on these resources. The more expert they are in the health care sector, the better.  The more experience the individuals assigned to do the work have, particularly experience with the OIG, the better.   The one thing to avoid is hiring an IRO and then paying it to learn about the type of work being done by the organization or how to interact with the OIG. Having top-notch experts can impart considerable added value from prior experience of doing this kind of work. She also pointed out that once these outside experts are engaged, there is another lag period before they begin their work and again when they present reports on the results of their work.  It is a huge mistake to allow these gap periods to elapse without doing serious preparation work.  It is important to begin planning at the earliest date for what is needed to meet CIA terms and conditions, which will assist in this effort, and development of a project plan for execution.   The planning process and timelines for meeting CIA requirements will have to take into account when reports by the IRO, and possibly the compliance expert, are due to the OIG.

Steve Forman, CPA, has over 35 years’ experience, having served as both as a compliance officer and as an IRO many times, and as a compliance expert four times under a CIA. He advises compliance officers that one step that cannot be undertaken too soon is getting the Executive/Management Compliance Committee and Board Compliance Committee involved. They need to understand fully in practical and operational terms their personal obligations, along with what is needed from them to meet CIA obligations.   He also strongly recommends at the first indication that a CIA may be in the future to begin reviewing posted agreements on the OIG website, especially those that involve similar types of organizations.   One point of caution is that the OIG has been changing CIAs significantly as to new requirements, conditions, and certifications by board members and executives. Information derived from these reviews should be translated into a plan of action to ensure the organization is in tune with what the OIG will expect.  He strongly suggests that compliance officers consider engage compliance experts to do two things:

  1. Have the compliance program conduct an independent evaluation and act on findings and recommendations. Having such a report with evidence of correcting any deficiencies can be invaluable evidence to the OIG in making a determination as to whether a CIA is necessary and, if so, mitigating terms and conditions. It will be looking for this evidence.
  2. Once a CIA is executed, immediately engage experts to conduct a mock audit to test the terms and conditions that must be met under the CIA and to have them addressed before the IRO or compliance expert under the CIA begins work.

Taking these two steps can avoid a lot of problems, expenditures and complications under a CIA. The OIG takes evidence of independent experts serious. That is why they rely upon them as IROs, Compliance Experts, and Quality Monitors.

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

Kusserow on Compliance: Compliance officers should have active roles in CIA negotiations

Laura Ellis, HHS Office of Inspector General (OIG) Senior Counsel, has a reputation for managing the most difficult and complicated corporate integrity agreements (CIAs) on behalf of the OIG. At the recent Health Care Compliance Association (HCCA) Compliance Institute, she urged compliance officers not to sit on the sidelines while a CIA is being negotiated with the OIG.   They should be actively involved in all facets of negotiation and should not wait to be involved until the agreement is signed and put into effect. She reminded everyone that once the CIA is signed, the compliance officer will be the face of the company to the OIG, not the attorneys.   From years of experience, she has found attorneys negotiating terms and conditions of a CIA often don’t have the operational experience to fully understand all the implications of what is being committed to in terms and obligation. As a result, it is not uncommon for attorneys to come back to the OIG after a CIA has been executed to try to renegotiate points.   This is triggered as result of management and the compliance officer realizing what is involved in meeting the terms and condition.   Ellis stated that the OIG is not inclined to reopen CIA negotiations.  The mistake was not having the compliance officer on the front end of negotiations and present during the negotiation process.  As the CIA settlement process takes shape, the compliance officer needs to:

  • be part of the negotiations;
  • review and comment on all drafts;
  • create a basic plan from the draft to determine what it takes to meet obligations;
  • conduct a min-gap assessment of what it takes to do what the CIA would require;
  • begin work on implementation strategies; and
  • start the process to determine resource needs to meet obligations.

Ellis also made the point that attitude matters once a CIA is in place, and compliance officers should work with the monitor in an open and honest way. A positive working relationship between the monitor and the compliance officer is to everyone’s best interest.  The earlier in the process that they get to know each other, the better.

Thomas Herrmann, J.D., was previously responsible on behalf of the OIG for negotiating CIAs and providing monitors, and subsequently gained many years of consulting experience working with more than a dozen clients with CIAs and as an independent review organization (IRO).  He says that what many fail to understand is that, although the OIG is involved in the Department of Justice (DOJ) settlement process, a different OIG attorney will be assigned as negotiator for the CIA.  Once the agreement is executed, it is passed on to a different OIG attorney to be the monitor to assure compliance with the terms of the CIA.   A very common mistake is for attorneys to deal with issues handled by someone earlier in the process, or in effect, re-litigate.  This is a big mistake.  The OIG will not re-litigate or interpret decisions made by the DOJ.  At the same time, the OIG monitor is definitely disinclined to deal with issues that were or should have been addressed with the OIG negotiator.  Herrmann goes on to explains that the OIG views the organization’s legal counsel as filling an adversarial role, but once things are executed, the OIG does not want to continue dealing with the advocate.  The focus of the relationship with the OIG should be on meeting the terms of the CIA. Herrmann sees it as a huge mistake for the legal counsel to continue making arguments or try to modify terms with the monitor, as this frequently leads to aggravation of matters and creates additional problems for the organization.  The monitor wants to deal with how the organization will meet its obligations, and that means working with the compliance officer to determine how the terms and conditions of the CIA will be fulfilled.  It behooves compliance officers to get to know their monitor as quickly as possible, evidence their commitment, and exhibit an attitude to work out what it takes to get the job done.

Carrie Kusserow has over 15 years’ compliance officer and consultant experience; in fact, she was brought in to be the compliance officer to an organization under a CIA while Laura Ellis was the monitor. Her experience with Ellis was precisely what Ellis explained during her presentation.   Maintaining the focus on meeting the obligations of the agreement is very important for credibility and permits ironing out of issues. By listening carefully and responding to Ellis’ questions openly in a forthright manner, Kusserow developed a very good working relationship.  This made work easier for everyone.  Compliance officers need to listen carefully to what the monitor expresses, working as needed and then immediately following up to report actions taken. The focus must stay on getting the job done to the satisfaction of the OIG.  It is also critical that the compliance officer at all times be “straight up” and honest with the OIG.  If this is done, then a bond of trust can be developed that can iron out details that are sure to arise. This can permit seeking non-adversarial clarification of terms and conditions. On the other hand, failing to develop a proper working relationship with the monitor can result in lack of understanding and increased work for everyone. As such, as soon as the CIA is signed, the compliance officer should come into direct contact with the OIG monitor.

Suzanne Castaldo, J.D., has worked both as a litigator and compliance consultant dealing with numerous organizations with CIAs. She confirmed what Ellis noted about attorneys negotiating with the OIG without active involvement of either management or the compliance officer. In almost every case, it has created avoidable issues.  She strongly recommends that anyone engaging a law firm to assist with CIA negotiations insist on including knowledgeable members of management and the compliance officer in all meetings with the OIG.  All terms that are being negotiated should be reviewed and assessed by them to understand all implications and resulting work obligations. Many attorneys will not find this to their liking and may argue against it.   However, not being part of this process reminds one of “arriving at the dance after it is over.”

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

 

Kusserow on Compliance: Codes of conduct part 2—16 tips for developing or revising codes

The code of conduct should be a statement of guiding principles for an organization with separate policies and procedures to provide more detailed guidance on how to meet them. It should be reviewed annually as part of ongoing monitoring to ensure it is current with applicable laws, regulations, policies, and standards.   Periodically, the code will need to be revised and updated.  The HHS Office of Inspector General (OIG) has provided a number of points it believes should be included in such a document.  It is worth reviewing them as part of either developing or revising the code.  The following are tips, considerations, and suggestions related to code development or revision.

  1. Gain buy-in from the top. All codes need buy-in and support from the top, beginning with Board approval and personal involvement and support of the CEO. They should not only provide input to the process, but ultimately approve the result.
  2. Determine responsibility for code review and revision. Most codes are developed and reviewed under the leadership of the compliance officer and human resources management (HRM) with a cross section of key persons from the various operational areas. The compliance officer, HRM, and legal counsel should actively drive the process.
  3. Code will affect policy development. The code should be analogous to a Constitution that outlines basic principles; policies are like law and regulations that are consistent with the Constitution. The code should have direct contact with and influence over compliance policy development.
  4. Form a committee to assist in development/revision of the code. It is important to gain wide buy-in for the code. It is advisable to form a committee consisting of individuals across various operational areas.   Their views and input will go a long way in selling the code to the entire workforce. The committee can assist in determining format and content of the code and can be used to meet target deadlines for completion.  The committee should include the compliance officer, legal counsel, HRM, Health Insurance Portability and Accountability Act (HIPAA) (P.L. 104+191) privacy/security officers, and representatives from various operations.
  5. Develop a plan. Code development must follow a plan with timeframes for step completion and the respective roles for everyone involved in the process. All those involved in this effort needs to understand how it is going to function and the level of commitment necessary from them. The various development and approval steps, as well as timeframes for them, should be part of the plan.
  6. Consider using experts to facilitate the process. There is no need to reinvent the wheel. Code development or revision can be simplified, facilitated, and guided by compliance experts in this field. They can not only advise, but direct attention to key concepts that need to be included in the code, many of which have been outlined by the HHS OIG. They also have the advantage of avoiding turf issues that sometimes slow code making decisions.
  7. Decide upon size. The code should be a booklet, not a book. If the amount of content grows, employees’ attention to reading and absorbing the content declines. Detailed written guidance on complying with code provisions should be included in policies and procedures. Generally, codes should be about 20 pages or less.
  8. Establishing form and format. The best practice is to have each section in the code begin with an introductory statement of guiding principle, followed by bullet point standards in furtherance of that statement. Bullet points are easier for employees to follow than long narratives.
  9. Determine core content. Among the initial steps on Code development or revision is determining what is needed in terms of specific content. The code should address all stakeholders, including patients, employees, management, regulatory authorities, etc. The code should include a description of the compliance program and how to contact the compliance office via phone and email. It should also address regulatory and legal issues, including conflicts of interest, gifts and gratuities, high-risk areas, and compliance with the fraud statutes, including the Anti-Kickback Statute, Stark Law, etc.
  10. Address reporting of suspected problems. The code should clearly state that everyone has an affirmative duty to report any possible wrongdoing, along with a detailed outline of procedures for handling questions about compliance or ethical issues, and the channels by which they can report potential violations in confidence or anonymously without fear of retribution or retaliation. This includes provisions for how to report to the hotline.
  11. Decide on manner of dissemination. A decision needs to be made as to how the code will be made available to all covered persons, such as being posted on the organization’ s intranet, provided in hard copy with signature receipt, or a combination of both. If the code is not new, but one that has been revised, then steps need to be made to stop dissemination of the old version. The code should be addressed in all employee training sessions. In the case of compliance training, the code should be covered in some detail and copies of the code should be available at those sessions.
  12. Reference to policies and procedures. The code should be a document that sets for principles the way the Constitution does for the country, with policies providing more detailed written guidance, in the same way that laws and regulations do. Therefore, when the code is changed, revised, or updated, it is important to reference all policies to ensure they will be consistent with the code. Having a code and policies that conflict is a formula for migraines.
  13. Reading level. It is critical that the code be written at a level understandable by employees. Failure to do this can result in a document that cannot support adequately the compliance program goals of the organization. Finding the right reading level can be a challenge, as often there is a wide range of education, ranging from professional staff with graduate degrees to those without any degrees at all. The best practice is to try to create a document at the tenth grade reading level. The worst practice is to develop a document in legalese with footnotes to laws and regulations.
  14. Language. Many health care organizations have a significant percentage of their employees for whom English is a secondary language. The question to be determined therefore is whether the code should have versions in another language. If the decision is affirmative, care must be taken that the translation is very accurate, as nothing can create a bigger headache than multiple interpretations between documents in different languages.
  15. Date the document and formally rescind the old version. If a question arises concerning written guidance to employees, it is important to have evidence of what guidance was in place during the period in question.
  16.  Acknowledgement and attestation. There should be a form evidencing receipt of the code by covered persons, along with a form to be signed by the person attesting his or her understanding and compliance with the terms of the code. Such forms should be kept on file by HRM.

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.