Tough Questions Under the CMS Compliance Program Guidelines
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1 Tough Questions Under the CMS Compliance Program Guidelines Elizabeth Lippincott, Esq. Lippincott Law Firm PLLC HCCA Managed Care Compliance Conference February 25, 2013 Paulette Wunsch, Esq. Vice President & Chief Integrity and Compliance Officer Florida Blue Tough Questions When do you voluntarily selfreport compliance problems? How do you ensure the Compliance Officer has the right level of authority? How do you determine if a vendor is a first tier or downstream entity? 1
2 Tough Question #1 When do you voluntarily self-report compliance problems? Self-Reporting is Voluntary as a Matter of Law Self-reporting not required by Social Security Act Self-reporting of FWA and Medicare program compliance is voluntary. Compliance Program Guidelines (CPGs), Past efforts to make self-reporting mandatory by regulation have not been finalized. Ex. Federal Register, Vol. 72, No. 233 (Dec. 5, 2007) at
3 Voluntary Self-Reporting is Strongly Advised by CMS CMS nonetheless strongly encourages self-reporting as an important practice in maintaining an effective compliance program. CPGs, The word should is used to indicate expectations created by this guidance. CPGs, 10 Plan sponsor should have procedures to voluntarily self-report potential fraud or misconduct... as part of an effective compliance program. 42 C.F.R (b)(vi)(G)(3) Thinking About Your Organization s Relationship with CMS Regulator Customer 3
4 Sometimes the Decision to Report is Relatively Straightforward Overpayments by government to plan sponsor Report and return within 60 days of identification Social Security Act 1128J(d) Element #7 of an Effective Compliance Program appropriate corrective action includes repayment of overpayments. 42 CFR (b) Fraud, Waste & Abuse (FWA) CMS strongly encourages self-reporting of actual and potential FWA, CPGs Process and timeline for reporting to MEDIC Even if dollar amounts are small Where do you draw the line? Harder decisions: program non-compliance situations with no overpayment or FWA Do you report everything? Case by case Factors to consider 4
5 Additional Factors to Consider Beneficiary impact Isolated or systemic Severity of issue or incident When incident occurred Discussion Hypothetical 1 Your enrollment area informs you (Compliance Officer) that monthly enrollment reports submitted to CMS for payment last month on a plan with 150,000+ members erroneously included three members who should have been disenrolled due to death. The enrollment director says that she has corrected it and hopes that it will be enough to fix this going forward. She confides in you that she is concerned that if this is reported to CMS, it might lead them to uncover other irregularities. Do you notify CMS? 5
6 Discussion Hypothetical #2 The director of appeals comes to your office to disclose that last month, two of the eighty-seven appeals decision letters that his department issued were late due to an employee s illness. In one case, the letter was a day late, and in the other, it was four days late. These were not expedited appeals. He is wondering if this should be reported to the CMS Account Manager. Tough Question #2 How do you ensure the Compliance Officer (CO) has the right level of authority? 6
7 CMS Requirements and Recommendations CPGs, Musts Report directly to CEO Express authority to provide unfiltered, inperson reports to CEO and governing body Reports not routed through GC, CFO, or COO An employee of plan sponsor, parent, or corporate affiliate Shoulds Full-time position Dedicated Medicare CO (strongly recommended) Training and/or experience working with MA and Part D programs and with regulatory authorities CMS Best Practices CPGs, Executive sessions with CO and governing body Independent, no operational role that could lead to self-policing If separate Medicare CO, allow that person to attend governing body meetings and make in-person reports Require governing body approval before terminating compliance officer CO is a member of senior management 7
8 Indicators of Authority In-person reports to governing body Regular one-onone meetings with CEO Relationship with Chair of Audit Committee Decides on what is reported to regulators Has voice in prioritizing compliance capability funding Hired and fired by governing body or committee chair Indicators of Authority Involved in acquisition due diligence Direct contact with vendor or joint venture executives to assure oversight Executive level title Voice in employee sales compensation to assure production goals are balanced with quality/compliance metrics Ability to communicate with all employees, high visibility and an open door policy that is used by employees Chair a compliance committee with leaders that are authorized to make decisions 8
9 Tough Question #3 How do you determine if a vendor is a first tier or downstream entity? Definitions First Tier Entity - any party that enters into a written arrangement, acceptable to CMS, with an MAO or Part D plan sponsor or applicant to provide administrative services or health care services to a Medicare eligible individual under the MA program or Part D program. Downstream Entity - any party that enters into a written arrangement, acceptable to CMS, with persons or entities involved with the MA benefit or Part D benefit, below the level of the arrangement between an MAO or applicant or a Part D plan sponsor or applicant and a first tier entity. 42 C.F.R and 423.4; CPGs, 20 9
10 Guidance on Identifying FDRs Entities to whom the sponsor has delegated administrative or health care service function relating to the sponsor s Medicare Parts C and D contracts (emphasis added). CPGs, 40 Not contracts that do not relate to the sponsor s Medicare functions, such as a real estate brokerage contract (emphasis added). CPGs, 40 Section 40 of CPGs does not incorporate the regulatory definitions concept of administrative services or health care services to a Medicare eligible individual under the MA Part D program (emphasis added). 42 C.F.R and 423.4; CPGs, 20 Guidance on Identification Process from 40 of CPGs Requires an analysis of all of the circumstances. Sponsors should have clearly defined processes and criteria to evaluate all vendors. Method left to discretion of plan sponsor Some use committee with legal, compliance, and business owner representatives. Note: Document process and when decisions are made for each vendor. 10
11 Questions to Ask from CPGs Function vendor will perform? Something sponsor must do under contract, law, regs, guidance? Direct enrollee impact? Written or oral interaction with enrollees? Questions to Ask from CPGs Access to beneficiary information or personal health information Decision making authority or strict direction from sponsor? In a position to commit FWA? Risk of harm to enrollees, program compliance, or FWA? 11
12 Selected Examples from CPGs Sales and marketing Applications processing Claims administration, processing and coverage adjudication Licensing and credentialing Hotline operations Bid preparation Discussion Hypothetical #1 Your plan s marketing area plans to hire a new firm to help develop written advertising materials and TV and radio spots. They will be working on commercial and Medicare lines of business. All materials will go through your internal compliance review process before they are finalized. The vendor will not have authority to release anything to the media before it is approved by your internal marketing and compliance teams. In fact, they will be providing the advertisements to your organization for distribution. Will this advertising vendor be an FDR? 12
13 Discussion Hypothetical #2 Your organization outsources printing and fulfillment of enrollment materials, including the fall distribution of Annual Notices of Change and Evidences of Coverage to current members. The contract specifies the deadlines for each mailing, requires detailed reporting on each mailing, and imposes performance penalties for any untimeliness. The contract leaves the vendor no discretion as to when items are mailed or the contents of the mailings. Is this vendor an FDR? Discussion Hypothetical #3 Your organization uses an actuarial firm to assist with bid preparation, but your internal staff are involved in bid development and review the bid before it is submitted. Is the actuarial firm an FDR? 13
14 Elizabeth Lippincott, Esq. Lippincott Law Firm PLLC Paulette Wunsch, Esq. Vice President & Chief Integrity and Compliance Officer Florida Blue Please contact us to request permission before using material from this presentation in another document or resource. This presentation is for educational purposes only, and it does not contain legal advice. Nothing in this presentation should be used as a substitute for the advice of a qualified health lawyer retained by your organization or for researching requirements in applicable laws, regulations, and guidance. 14
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