9/11/2017 1 Action Items for Long Term Care Compliance Programs Under the New ROPs 2017 MHA Fall Convention and Trade Show Todd J. Selby Hall, Render, Killian, Heath & Lyman 1512 Larimer Street, Suite 300 Writer Square Denver, CO 80202 What Will We Cover? 2 • Understand the regulatory requirements for Skilled Nursing Facility (SNF) compliance programs as mandated by the Final Requirements of Participation (RoPs). • Identify risks common to SNFs and benefits of a compliance program. • Utilize your compliance program as a quality improvement tool. • Identify action items corresponding with the seven elements of a compliance plan as identified by the Office of Inspector General (OIG). Origin of SNF Compliance Programs 3 • Section 6102(b)(1) of the ACA required: Nursing Facilities (NFs) and SNFs to have an effective compliance and ethics program in place by March 23, 2013. March 23, 2013 deadline was not enforced by Centers for Medicare & Medicaid Services (CMS) pending final regulations. Regulations “may” include model compliance program. October 4, 2016 new RoPs were published. Included NEW Section 483.85, Compliance and Ethics Program. Phase 3 of RoPs effective November 28, 2019.
Transcript
9/11/2017
1
Action Items for Long Term Care Compliance Programs Under the New
ROPs
2017 MHA Fall Convention and Trade Show
Todd J. Selby
Hall, Render, Killian, Heath & Lyman
1512 Larimer Street, Suite 300
Writer Square
Denver, CO 80202
What Will We Cover?
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• Understand the regulatory requirements for Skilled Nursing Facility (SNF) compliance programs as mandated by the Final Requirements of Participation (RoPs).
• Identify risks common to SNFs and benefits of a compliance program.
• Utilize your compliance program as a quality improvement tool.
• Identify action items corresponding with the seven elements of a compliance plan as identified by the Office of Inspector General (OIG).
Origin of SNF Compliance Programs
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• Section 6102(b)(1) of the ACA required:
Nursing Facilities (NFs) and SNFs to have an effective compliance and ethics program in place by March 23, 2013.
March 23, 2013 deadline was not enforced by Centers for Medicare & Medicaid Services (CMS) pending final regulations. Regulations “may” include model compliance program.
October 4, 2016 new RoPs were published. Included NEW Section 483.85, Compliance and Ethics Program.
Phase 3 of RoPs effective November 28, 2019.
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Section 6102 Specific Mandates
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• The compliance program must be “Reasonably designed, implemented and enforced so that it will be effective in preventing and detecting criminal, civil and administrative violators under the Act and in promoting quality of care.”
Other Sources of Compliance Guidance for SNFs
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• March 2000, OIG Compliance Guidance
• September 30, 2008 Federal Register / Supplemental Compliance Program Guidance
Supplemental Guidance was published in response to significant changes in the nursing home industry regarding delivery of services, changes in reimbursement, and new risk areas.
• September 23, 2010 Federal Register / Compliance Plans for Providers and Suppliers
Other Sources of Compliance Guidance for SNFs
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• RoPs
• CMS Manual Guidance and Transmittals
• Industry Resources (AHCA, LeadingAge, State Associations)
• Program for Evaluating Payment Patterns Electronic Report (PEPPER)
• OIG Workplan
• Surveys
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NEW RoP 483.85, Compliance and Ethics Program
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New Definitions
• Compliance and Ethics Program
• High Level Personnel
• Operating Organization
NEW RoP 483.85, Compliance and Ethics Program
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Required Components of Compliance and Ethics Program
• Written compliance standards, policies, and procedures.
• Designate compliance and ethics program contact for reporting of suspected violations.
NEW RoP 483.85, Compliance and Ethics Program
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• Alternate method of anonymous reporting without fear of retribution.
• Disciplinary standards setting out consequences of compliance violations.
• Assign high-level personnel to oversee the compliance and ethics program.
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NEW RoP 483.85, Compliance and Ethics Program
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• Sufficient resources and authority given to designated individuals.
• Effectively communicate compliance standards, policies, and procedures to staff. (volunteers, contracted staff, etc.)
NEW RoP 483.85, Compliance and Ethics Program
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• Mandatory Training.
• Consistent enforcement and proper response to violations of standards, policies, and procedures.
Components for Operating Organizations with Five or More Facilities
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• Mandatory Annual Training Program.
• Designated Compliance Officer (CO).
Reports directly to governing body.
Not subordinate to general counsel, CEO, CFO, or COO.
• Compliance Liaisons at Each Facility.
• Annual Review of Compliance and Ethics Program.
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Action Items for SNFs
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• Review current compliance policies and procedures and revise as necessary.
• Comply with definition of high level personnel.
Action Items for SNFs
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• Designate compliance contact or compliance officer, if five or more facilities.
• Compliance liaisons, if five or more facilities.
• Create an anonymous reporting mechanism.
Action Items for SNFs
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• Conduct training, including volunteers and contract staff.
• Annual review, if more than five facilities.
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July 2017, Health Care Fraud Takedown
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• Largest fraud takedown in history.
• 412 defendants charged.
• $1.3 Billion in false billings.
• 295 exclusion notices to physicians and nurses.
• Also involved 30 Medicaid Fraud Units.
• Utilized 350 OIG agents and over 1,000 law enforcement.
DOJ Health Care Fraud and Abuse Program, FY 2016
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• $2.5 Billion in judgments and settlements.
• $3.5 Billion taking into account recoveries from previous years.
• $17.9 Billion in recoveries from 2009-2016.
• 975 criminal health care fraud investigations.
• 930 civil health care fraud investigations.
OIG Health Care Fraud and Abuse Program, FY 2016
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• 765 criminal actions related to Medicare and Medicaid.
• 690 civil actions related to Medicare and Medicaid.
• 3,365 individuals and entities excluded from federal health care programs.
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Why Have a Compliance Program?
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• Highly regulated industry: Requirements of Participation, Fraud and Abuse, employment laws, labor laws, HIPAA, False Claims Act, etc.
• Heightened scrutiny: OIG, Heat Task Force, Zone Program Integrity Contractors (ZPICs), Recovery Audit Contractors (RACs), MICs, MACs, Medicaid Recovery Audit Contractors, etc.
Why Have a Compliance Program?
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Many Reasons:
• Government expects you to have one.
• Cost of compliance is cheaper than cost of violations.
Why Have a Compliance Program?
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• They can lead to reduced consequences in the event of a violation.
• May avoid imposition of Corporate Integrity Agreement.
• The U.S. Sentencing Guidelines specifically mandate lesser criminal sanctions for organizations with “effective compliance programs.”
• One state has mandated compliance plans for Medicaid providers.
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Why Have a Compliance Program?
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In addition, a compliance program can:
• Identify problems before they get too large.
• Prevent problems.
• Give employees a chance to come to you before taking other action, such as filing a qui tam lawsuit.
What is an Effective Compliance Plan?
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• IMPORTANT: OIG’s compliance guidance is NOT a compliance plan.
• Copying the guidance and putting it on a shelf does not mean you have a compliance plan.
What is an Effective Compliance Plan?
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• OIG states that compliance programs are not “one size fits all.”
• It is okay if your compliance program differs from your colleagues.
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The Seven Elements of Compliance
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• OIG guidance materials consistently cite the following basic elements:
1. Written Standards and Procedures2. Oversight3. Education and Training4. Monitoring and Auditing 5. Reporting6. Enforcement and Discipline7. Response and Prevention
• OIG’s Compliance Guidance describes them somewhat differently, but they are the same elements.
The Seven Elements of Compliance
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1. Standards and Procedures
• The first element requires your compliance program to be in writing. If it is not in writing, it is not a compliance program.
• RECOMMENDED: All compliance policies and procedures assembled in a single manual. Easy to use. Easy to reference. Easy to provide to OIG and others.
The Seven Elements of Compliance Standards and Procedures (cont.)
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• Important. In many cases, the OIG will want to see what actions are being taken to achieve compliance. This means providing a copy of your policies and procedures.
• Other benefits:
o Proof you have a compliance program.o Proof that you followed it.o Can lead OIG to not impose a C.I.A. later.
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The Seven Elements of ComplianceStandards and Procedures (cont.)
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• Written standards and procedures provide a:
o Clear statement of your commitment to, and expectation of, compliance.
o Guidance to your employees on compliance.
o Continuity, your response does not change as staff changes.
The Seven Elements of ComplianceStandards and Procedures (cont.)
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• Policies and procedures also provide:
o Resource for employees to consult when compliance issues arise.
o Training tool – written policies and procedures can be used to train employees on compliance.
The Seven Elements of ComplianceStandards and Procedures (cont.)
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• Must Include a Code of Conduct
o A code of conduct is a general statement of how employees, contractors and agents are expected to act as employees of the company.
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The Seven Elements of ComplianceStandards and Procedures (cont.)
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• Code of Conduct
o The OIG states that a code of conduct should “not only address compliance with statutes and regulations, but should also set forth broad principles that guide employees in conducting business professionally and properly.”
The Seven Elements of ComplianceStandards and Procedures (cont.)
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• Code of Conduct – Contents
o Should start with a statement regarding commitment to compliance and conducting business ethically, honestly and with integrity. May specify “all aspects” of operations.
o Should make the SNF’s emphasis on compliance clear, including a statement regarding compliance with governing laws and zero tolerance for violations.
The Seven Elements of ComplianceStandards and Procedures (cont.)
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• Providing Code of Conduct to Employees:
o Employees must receive and read standards.
o Supervisor should explain and answer questions.
o Employee should sign an attestation that they received and understood the policies.
o Employees should understand that violation leads to discipline.
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The Seven Elements of Compliance Standards and Procedures (cont.)
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Board of Directors: Because policies and procedures are a statement of the SNFs attitude towards compliance, they should include a statement from the Board of Directors.
Common Practice: Begin policies and procedures manual with resolution of the Board outlining the Board’s commitment to compliance.
The Seven Elements of ComplianceStandards and Procedures (cont.)
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NON-RETALIATION
Must have a policy on non-retaliation. Employees must know that they will not be punished for reporting non-compliance, etc.
Non-retaliation policy should also make it clear that employees who do engage in retaliation will be punished. This should specifically include that they may be terminated.
The Seven Elements of ComplianceStandards and Procedures (cont.)
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Need to address both Medicare and Medicaid compliance. The issues are not always the same.
It is also important to note that standards and procedures will evolve over time.
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The Seven Elements of Compliance
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2. Oversight
• Your compliance plan must have oversight.
The Seven Elements of Compliance Oversight (cont.)
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CO’s authority: This is important. Staff needs to understand that the CO has the ability to make requests, assign tasks, etc. It will be hard for CO to implement program if staff thinks they can safely ignore them.
The Seven Elements of ComplianceOversight (cont.)
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Who should be your CO? Choose carefully.
• Demonstrates leadership.• Reputation for honesty and integrity.(Trusted)• Experience in long term care.• Familiarity with regulations and operations.• Experience with project management/strong organizational skills.• Can maintain confidences and secrets.• CAN COMMUNICATE WELL.
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The Seven Elements of ComplianceOversight (cont.)
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• CO Job Description
o Have a written job description. It will spell out the CO’s responsibilities.
The Seven Elements of ComplianceOversight (cont.)
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• CO Reports to Board:
o Not just when there is a complaint or issue.o Routine reports.o Create “dashboards” that show current status and compare with
previous reports.o Show trends – number of complaints, number of investigations,
results, paybacks, etc.o Budget: show board how resources are used and where
resources are lacking.
The Seven Elements of Compliance
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3. Education and Training
• Training is arguably the most important part of your compliance program. This is how you communicate standards, requirements, etc. to your employees.
• If your officers, employees, agents, and subcontractors are not aware of your policies and procedures, the policies and procedures are pointless.
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The Seven Elements of ComplianceEducation and Training (cont.)
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• Training must be ongoing. Rules change, standards change, risks change, your policies and procedures change. This requires your training to be ongoing and changing.
• Amount of training may differ depending upon position, fraud and abuse risk, etc.
• Higher risk departments should receive more training.
The Seven Elements of ComplianceEducation and Training (cont.)
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Risk areas for additional education and training include:
• Duplication of services.• Failing to adhere to RoPs.• Failing to return overpayments – bigger issue today.• Falsified documentation.• Resident Abuse.• Joint ventures.
The Seven Elements of ComplianceEducation and Training (cont.)
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Prove Training Occurred: Track training topics.
• Keep copies of training materials, handouts, PowerPoint, etc.
• Keep copy of ongoing training schedule. (Shows overall plan/effort regarding how you address specific topics.)
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The Seven Elements of Compliance
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4. Monitoring and Auditing
• OIG considers an ongoing evaluation process to be a “critical to a successful compliance program.”
• Your program should include regular, periodic compliance audits.
• OIG recommends maintaining copies of audit reports, including non-compliance.
The Seven Elements of ComplianceMonitoring and Auditing (cont.)
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• Monitoring - usually refers to “real-time” compliance verification. Can also be used to refer to auditing performed by interested individuals.
• Auditing - usually refers to “after the fact” compliance monitoring. Can also be used to refer to compliance verification performed by disinterested parties.
The Seven Elements of ComplianceMonitoring and Auditing (cont.)
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• Your compliance policies and procedures should require the compliance officer to develop an audit plan for the year.
• An audit plan is tool that outlines where you will apply limited auditing resources.
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The Seven Elements of ComplianceMonitoring and Auditing (cont.)
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Identifying Risk Areas.
• There are a number of sources:o OIG Annual Workplan.o OIG semi-annual report.o MedPAC report.o Previous year’s audit findings.o Prior survey reports.o External Audit results.o Management/Department Heads.
The Seven Elements of ComplianceMonitoring and Auditing (cont.)
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Prioritizing Risk Areas.
• The purpose of this step is to determine which compliance risks are of most concern. This is not an exact science.
• The primary goal is to determine which areas are more pressing so that the appropriate areas are dealt with.
• The goal is to identify problems before the government, so you are looking to identify the areas that are most likely to lead to problems.
The Seven Elements of ComplianceMonitoring and Auditing (cont.)
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Prioritizing Risk Areas
• The CO can involve other department heads and leaders in the risk assessment process.
• Involving the department heads in the assessment provides other perspectives on the risks facing the agency.
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The Seven Elements of ComplianceMonitoring and Auditing (cont.)
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Determine what to audit.
• You cannot monitor everything. This process ought to help you effectively apply limited resources.
The Seven Elements of ComplianceMonitoring and Auditing (cont.)
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• Auditors should have expertise/understanding of program requirements, billing requirements, etc.
• They need to understand what they are looking at and be able to identify an error.
The Seven Elements of ComplianceMonitoring and Auditing (cont.)
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• Audit should result in a written report. The report should explain the findings, the cause of any violations, etc.
• These written reports will be used by the CO to report to the Board.
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The Seven Elements of ComplianceMonitoring and Auditing (cont.)
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• Once you have the audit results, you need to address them.
• A deviation due to legitimate, explainable circumstances may require little or no response.
The Seven Elements of Compliance
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5. Reporting
• Widely viewed as providing a means for staff to report to management, but reporting is not just about having an anonymous complaint mechanism.
The Seven Elements of ComplianceReporting (cont.)
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• The OIG refers to reporting as “developing effective lines of communication”.
• Open lines of communication between CO and personnel is very important to building a culture of compliance.
• Open communication requires CO reporting to personnel as well as personnel reporting non-compliance to CO.
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The Seven Elements of ComplianceReporting (cont.)
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• If you have instilled a culture of compliance, employees will simply report problems to supervisors.
• Realistically, employees may not be willing to report for fear of retaliation, etc.
• Want to make it easy and “safe” to report, because if they do not report to you, they will report to someone else.
The Seven Elements of ComplianceReporting (cont.)
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• Telephone Hotlines. Cost is a factor: phone line, employee to monitor, etc. This may not be appropriate for small entities.
• Drop box - cheaper. Where is drop box? Can it be approached and utilized without being seen? Example. Security camera located near drop box.
• E-mail - requires some technical know-how.
The Seven Elements of ComplianceReporting (cont.)
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• Keep complaint log simple.
• Do not want too much information in the complaint log/hotline log, unless access is restricted.
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The Seven Elements of ComplianceReporting (cont.)
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After you receive a report:
• You should have clearly defined procedures for responding to a report of a violation. It should address investigating the complaint, documenting the investigation, resolving the problem.
• If your investigation confirms the report, you need to fix it.
The Seven Elements of ComplianceReporting (cont.)
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This is important. If a staff person comes forward to notify you of non-compliance, you may be investigating, but because they do not hear from you, they assume you are ignoring it. This may lead them to contacting the government or a lawyer.
The Seven Elements of ComplianceReporting (cont.)
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Ongoing CO/compliance department communication to the SNF provides another form of education and is part of instilling a “culture of compliance.” Some ideas:
• Compliance column in the company newsletter. This can include frequently asked questions.
• Send e-mail updates/reminders.
• Create posters.
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The Seven Elements of Compliance
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6. Enforcement and Discipline
• This is the other side of education. Your policies and procedures must address how you respond to violations of your policies and procedures.
The Seven Elements of ComplianceEnforcement and Discipline (cont.)
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Individuals who are involved in compliance violations must be disciplined. Not just staff, management and even officers:
• The OIG’s compliance guidance states that policies should address discipline that may be imposed upon corporate officersas well as managers, employees, and other health care professionals.
The Seven Elements of ComplianceEnforcement and Discipline (cont.)
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Do need to be careful that employees with similar violations receive similar punishments. Variations can lead to discrimination claims.
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The Seven Elements of ComplianceEnforcement and Discipline (cont.)
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Flexibility to proceed directly to termination is important. Some violations are so egregious that you cannot risk continuing to employ the individual.
Examples: submitting fraudulent documentation, paying kickbacks, etc.
The Seven Elements of ComplianceEnforcement and Discipline (cont.)
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DOCUMENT! DOCUMENT! DOCUMENT!
Documenting disciplinary action, is important to:
• Prove effective compliance program; or,• Respond to any wrongful termination claims.
The documentation of the discipline will be important in defeating a claim of discrimination. In some states it may also allow you to defeat a claim for unemployment.
The Seven Elements of Compliance
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7. Response and Prevention
• If a concern is raised, you must respond. Failing to respond will cause you more trouble.
• Response involves investigating to determine what happened, making any repayments and taking steps to prevent it from happening again.
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The Seven Elements of ComplianceResponse and Prevention (cont.)
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Response contains several steps:
• Investigate. Is there a problem?• Determine scope. How big is the problem?• Payback?• Fraud or other issue to report?• Fix the problem.• Audit to ensure problem stays fixed.
The Seven Elements of ComplianceResponse and Prevention (cont.)
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Your response should answer the following questions:
• Who was involved?
• What led to the violation?
• When did the violation start?
• How far back should we look?
The Seven Elements of ComplianceResponse and Prevention (cont.)
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If the problem was due to a failure of your policies andprocedures, you may need to:
Draft and implement new policies and procedures.
Revise old policies and procedures and implement revisions.
You will need to train staff on new/revised policies and procedures.
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Conclusion
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If you do have a compliance program, is it effective?
Effective compliance is more than simply a policy and procedure manual on your shelf, it is on ongoing effort to detect and prevent fraud and to instill a culture of compliance within your organization.
