Currentintegrated_home_care_servicesPolicy LC3027ALL1019-A
Compliance Policy for Contracted Healthcare Providers and Third Parties
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This document sets Humana's compliance program requirements for contracted healthcare providers, their employees, and downstream entities supporting Humana's Medicare and/or Medicaid products; it requires organizations to implement or provide a materially similar compliance program and related assurances.
Policy Summary
Payerintegrated_home_care_services
PolicyCompliance Policy for Contracted Healthcare Providers and Third Parties
Policy CodePolicy LC3027ALL1019-A
Change TypeMinimal clarifications from 2024
Effective DateJan 1, 2025
Last ReviewJan 1, 2025
Next Review DateN/A
Key ActionProvide assurance that your organization has and distributes a materially similar compliance program to employees and third parties supporting Humana's Medicare and/or Medicaid products.
SourceLink
POLICY UPDATE CHANGES
No material clinical or coverage changes in this revision.
7elements listed
90training distribution timeframe (days)
Monthlyexclusion screening frequency
24/7reporting availability
10records retention (years)
Compliance Program Coverage Criteria
inv-01: Compliance program element requirements
Key elements and operational requirements for an effective compliance program that contracted organizations must follow or demonstrate they have materially similar practices for.
Element I - Written Policies: Maintain written policies, procedures and standards of conduct that are formally documented, reviewed no less than every 3 years, revised/approved as needed, and retained for at least 10 years; supporting procedures must adhere to the same review and approval cadence.
Element II - Compliance Contact and Oversight: Designate a compliance contact (and appropriate compliance officer/committee or high-level oversight) authorized to respond to requests for compliance program assurance and to support oversight activities.
Element III - Training and Education: Provide effective, tracked training and education covering compliance policies, standards of conduct, and FWA (and Medicaid topics when applicable); require completion within 90 days of hire/contract and annually thereafter; retain training records (including tracking logs, attendance, topics, and certifications) and be able to demonstrate or attest that training requirements have been fulfilled.
Element IV - Lines of Communication: Establish effective methods to receive, record, respond to, and track reports of suspected or detected noncompliance or FWA, including offering anonymous reporting and widely communicating methods and non-retaliation protections; ensure reporting mechanisms are available 24/7 and provide access to a designated compliance resource.
Element V - Disciplinary Standards: Implement and communicate well‑publicized disciplinary standards that describe expectations, examples of violative conduct, and appropriate disciplinary actions; communicate these standards on an ongoing basis (not only at initial or annual training).
Element VI/VII - Monitoring, Auditing and Response: Implement routine monitoring and auditing, monitoring/auditing work plans, government exclusion list reviews, conflict-of-interest processes, and a system for prompt response to compliance issues; ensure mechanisms to assess compliance risks and take corrective actions.
Appendices and Resources: Refer to appendices for resources and a summary of applicable laws and regulations to support implementation of the compliance program.
inv-02: Compliance program criteria
Required compliance program elements and operational expectations for organizations supporting Humana.
Policies and procedures: Maintain written policies and standards of conduct that are formally documented, reviewed at least every three years, revised/approved as needed, retained for at least 10 years, and distributed to employees, contractors, and downstream entities within 90 days of hire/contract, upon updates, and annually thereafter; content must be materially similar to Humana's policy and Ethics Every Day guidance.
Compliance officer and oversight: Designate qualified personnel (compliance officer/contact) and a compliance committee or equivalent oversight structure to fulfill compliance obligations and respond to assurance requests from Humana.
Training and education: Provide tracked general compliance and FWA training (including Medicaid topics when applicable); require completion within 90 days of hire/contract and annually thereafter; retain training records for at least 10 years; be prepared to provide proof or organizational-level attestations to Humana on request.
Reporting mechanisms: Maintain systems to receive, record, respond to, and track reports of suspected noncompliance or FWA, offer anonymous reporting, widely communicate reporting methods and non-retaliation policy, ensure 24/7 availability, and offer at least one organizational reporting option in addition to Humana's channels.
Monitoring and auditing: Conduct ongoing monitoring and auditing and report to leadership; implement timely corrective actions when necessary and cooperate with Humana oversight activities.
Disciplinary standards: Communicate and apply disciplinary standards on an ongoing basis; failure to report suspected concerns can result in disciplinary action up to termination of contract or employment.
Third-party/subcontractor obligations: Train subcontractors on combating FWA or require them to assure they receive such training; require downstream entities and third parties to adhere to comparable policies and procedures and to be covered by compliant written agreements.
Security and privacy: Ensure security and privacy of information in accordance with applicable federal and state requirements (not limited to HIPAA/HITECH).
Examples of reportable conduct: Includes falsifying enrollment, false statements to obtain funds, providing inaccurate diagnosis coding, identity misuse to defraud.
Humana reporting channels: Humana's Ethics Help Line, web, email, and Special Investigations referral contacts are available for reporting suspected FWA.
inv-03: Operational compliance criteria
Operational requirements and expectations for Humana-contracted organizations regarding compliance program elements, monitoring, disciplinary standards, response procedures, and subcontractor controls.
Reporting channels: Provide mechanisms for reporting suspected or detected noncompliance and FWA to Humana (phone, web, email, Special Investigations) and maintain organizational reporting processes to enable timely initial review and action.
Disciplinary action and notification: When noncompliance is identified, initiate disciplinary action which may include corrective action plans or termination; notify Humana of findings and subsequent actions in a timely manner via the organization's compliance resource(s).
Dissemination of standards: Maintain well‑publicized disciplinary standards and ongoing communications (eg, newsletters, staff meetings, intranet, posters) that describe expectations, examples of violative conduct, and corresponding actions (retraining, corrective action, removal or termination).
Monitoring and auditing cooperation: Implement routine monitoring and auditing; respond timely to Humana oversight requests and provide documentation, attestations, and cooperate with audits including facility inspections and records review.
Exclusion screening: Screen employees and subcontractors against OIG and SAM exclusion lists prior to hire/contract and at least monthly thereafter; promptly remove excluded individuals/entities from supporting Humana business and retain screening records for at least 10 years.
Conflicts of interest: Maintain a process to assess conflicts of interest and determine removal or approval to continue work; comply with Humana requests for conflict information or removal actions.
Investigation timing and confidentiality: Conduct an inquiry as quickly as possible and no later than two weeks after identifying potential noncompliance or FWA; maintain confidentiality and documentation of reported issues and retain related records for 10 years.
Reporting to plan sponsors and cooperation: Report confirmed violations related to contracted functions and subsequent actions to plan sponsors; cooperate with investigations and retain documentation for 10 years.
Subcontracting notifications and offshore reporting: Notify Humana prior to subcontracting any services related to functions performed for Humana; ensure compliant written agreements are in place; report offshore subcontractors that handle Humana Medicare PHI to CMS via Humana within 30 days of contract signature.
Medicaid offshoring: Recognize that Medicaid-related offshoring may be prohibited by certain states and must be pre‑approved by Humana on a state-by-state basis.
Legal framework: This policy references federal laws and guidance (eg, CMS Part C/D rules, False Claims Act, Anti-Kickback Statute, Stark, HIPAA/HITECH, FCPA, civil monetary penalties) that underpin compliance expectations.
inv-04: CMS data use and compliance requirements
Data handling and compliance obligations when CMS data is accessed under a DUA.
Purpose limitation: Use, disclosure, or reuse of CMS data is limited to the purposes specified in the CMS Data Use Agreement (DUA) or as otherwise authorized by CMS.
Need-to-know and minimum necessary: Access to CMS data must be limited to individuals on a need-to-know basis and to the minimum amount of data necessary to accomplish the permitted purpose(s).
Safeguards: Establish administrative, technical, and physical safeguards for storage and disclosure of CMS data to protect confidentiality and prevent unauthorized access or use.
Legal counsel and references: Consult legal counsel to determine when the CMS DUA applies to your organization; follow CMS and HHS guidance and applicable federal regulations; maintain annual review/update and approval of compliance policies per 42 C.F.R. §§ 422.503(b)(4)(vi)(B) and 423.504(b)(4)(vi)(B).
Required Provider Actions and Reporting
Documentation Required
Provide assurance and distribute compliance materials
Organizations may be required to provide assurance that they understand and incorporate Humana's compliance components into their own compliance program or that they have a materially similar program; organizations must provide this publication or an updated, materially-similar document to all employees and third parties who support Humana's Medicare and/or Medicaid products.
- Provide organizational-level assurance when requested that your compliance program incorporates Humana's compliance components or is materially similar.
- Distribute this publication (or an updated, materially similar document) to all employees and third parties who support Humana's Medicare and/or Medicaid products as part of the contractual relationship.
Documentation Required
Retain training records and demonstrate completion
Maintain and be able to demonstrate completion of FWA and general compliance training for employees and downstream entities; training must be completed within 90 days of hire or contract and annually thereafter, and records must be retained for at least 10 years. Humana may request proof or organizational-level attestations of completion.
- Track training completion formally and retain training records (eg, attendance logs, topics covered, certifications) for a minimum of 10 years.
- Ensure FWA training covers required topics (laws/regulations related to MA and Part D FWA, obligations to have policies/procedures to address FWA, reporting processes, protections for reporters, and types of FWA relevant to your setting).
- Be prepared to provide documentation or an attestation to Humana upon request.
Note
Report suspected noncompliance and FWA to Humana
Report suspected or detected noncompliance and FWA to Humana using the prescribed channels; only report matters that pertain to Humana business.
- Phone: Ethics Help Line 1-877-5-THE-KEY (1-877-584-3539).
- Online: Ethics Help Line web reporting site www.ethicshelpline.com.
- Email: ethics@humana.com (Ethics Office).
- Special Investigations Referral: phone 1-800-614-4126, email siureferrals@humana.com, fax 1-920-339-3613.
- If your organization identifies noncompliance, initiate disciplinary action (which may include corrective action plans or termination) and notify Humana timely via your compliance resource(s).
- Do not report FWA that is unrelated to Humana business to Humana.
Denial Risk
Stark (Physician Self‑Referral) prohibition and guidance
The Physician Self‑referral (Stark) statute (42 U.S.C. § 1395nn) prohibits a physician from making referrals for certain Medicare‑payable designated health services to entities with which the physician (or an immediate family member) has a specified financial relationship unless an exception applies; the entity may not present claims to Medicare for such referred services.
- Be aware that specific statutory exceptions exist and CMS provides guidance on established exceptions (see CMS Physician Self‑Referral guidance).
- Ensure organizational billing and referral practices do not submit claims to Medicare for services improperly referred in violation of Stark.
Key Definitions
FDR and related entity definitions
FDR (First-Tier/Downstream/Related Entity)CMS term for a first-tier, downstream, or related entity supporting Humana's products and services — a contracted party performing business function(s) Humana is otherwise responsible for.
First Tier EntityCMS term for any entity having a direct contract with a Humana entity to provide covered services or perform a function related to Medicare/Medicaid-eligible individuals under a Humana-administered plan.
Downstream EntityCMS term for any party with an indirect written arrangement between a first-tier entity and a third party for providing a covered service or performing a function related to a Humana-administered Medicare, Medicare prescription drug, Medicaid, or dual plan; continues to the ultimate provider.
Related EntityCMS term for any entity related to Humana by common ownership or control.
Downstream entity
DefinitionDownstream entity: any party with an indirect written arrangement that exists between a first-tier entity and a third party for providing a covered service or performing a function related to a Humana-administered Medicare Advantage, Medicare prescription drug benefit, Medicaid and/or dual Medicare-Medicaid plan; this continues to the level of the ultimate provider.
ExampleAn organization contracted directly with Humana is a first-tier entity; hospitals and healthcare practitioners contracted with that organization as part of its network are downstream entities.
ObligationDownstream arrangements must be disclosed and monitored by first-tier entities as part of their compliance responsibilities to Humana.
FDR (first-tier, downstream, related entity)
DefinitionFDR: collective CMS term referring to first-tier, downstream, or related entities that support Humana by performing business functions Humana would otherwise perform; includes contracted parties and those acting on Humana's behalf.
Who is includedFDR employees include individuals employed by, contracted with, or otherwise supporting an FDR (eg, healthcare providers, pharmacists, board members, committee members, volunteers, consultants).
Relation to HumanaFDRs perform functions in support of Humana's Medicare/Medicaid offerings and are subject to Humana oversight and contractual compliance requirements.
Audit
AuditA formal review of compliance with a particular set of internal criteria based on applicable laws and regulations.
PurposeTo confirm adherence to policies/procedures, assess corrective actions, and validate compliance with legal and contractual obligations.
Humana oversightHumana may conduct audits of first-tier entities including inspection of facilities, systems, books, procedures, and records related to contracted services.
downstream entities / offshore subcontractors
DefinitionDownstream entities/subcontractors: any party engaged by your organization to perform functions related to Humana business; subcontracting must be disclosed to Humana prior to engagement and covered by compliant written agreements.
Offshore subcontractors (PHI)Any offshore subcontractor that receives, processes, transfers, handles, stores, or accesses Humana Medicare member PHI must be reported to CMS via Humana within 30 days of contract signature.
Medicaid offshoringMedicaid-related offshoring may be prohibited by certain states and requires Humana pre-approval on a state-by-state basis.
reportable FWA examples
Falsified applicationsFalsify benefit/enrollment application(s).
False statements to obtain fundsUse false pretenses or make false statements to get money from the healthcare system.
Inaccurate codingProvide inaccurate diagnosis code information to payors.
Identity misuseUse the identifying information of another person with the intent to defraud.
Reporting scopeReportable FWA concerns must pertain to Humana-contracted work; matters not related to Humana business must not be reported to Humana.
CMS Data Use Agreement
DefinitionCMS Data Use Agreement (DUA): an agreement that restricts disclosure, use, and reuse of CMS-provided data to the purposes specified in the agreement and requires need-to-know and minimum-necessary access.
SafeguardsRequires establishment of administrative, technical, and physical safeguards to protect confidentiality and prevent unauthorized use or access.
Legal counselOrganizations must consult legal counsel to determine when/if the CMS DUA applies to them; a signed DUA provides CMS assurance of compliance with the Privacy Act, Privacy Rule, and CMS data release policies.
HITECH Act
HITECH ActFederal law that modifies HIPAA to promote adoption of health information technology, sets disclosure and security requirements for electronic health records, and establishes breach notification requirements for unsecured PHI.
ScopeAddresses use of electronic health records, incentives for adoption, disclosure requirements, and how to secure PHI appropriately.
ReferencePolicy references HITECH as part of overarching fraud, abuse, privacy and security provisions incorporated into Humana's compliance materials.
Fraud Enforcement and Recovery Act of 2009
Fraud Enforcement and Recovery Act of 2009Federal law that strengthens enforcement and recovery related to fraud in federal assistance programs, increases resources for investigation and prosecution, and facilitates recovery under the False Claims Act.
EffectImproves enforcement of fraud investigations and recovery of funds lost to fraud; made recovery under the False Claims Act easier.
Policy linkageReferenced in Humana's appendices as part of the statutory framework underpinning compliance expectations.
Stark statute
Stark Statute (42 U.S.C. § 1395nn)Physician Self‑referral ('Stark') Statute prohibits a physician from making referrals for certain designated health services payable by Medicare to an entity with which the physician (or an immediate family member) has a financial relationship (ownership, investment, or compensation), unless an exception applies.
Claims prohibitionThe statute also prohibits the entity from presenting or causing to be presented claims to Medicare (or billing another payer) for those referred services.
Further guidanceSpecific statutory exceptions and additional information are available from CMS (https://www.cms.gov/PhysicianSelfReferral/).
Policy Summary
Payerintegrated_home_care_services
PolicyCompliance Policy for Contracted Healthcare Providers and Third Parties
Policy CodePolicy LC3027ALL1019-A
Change TypeMinimal clarifications from 2024
Effective DateJan 1, 2025
Last ReviewJan 1, 2025
Next Review DateN/A
Key ActionProvide assurance that your organization has and distributes a materially similar compliance program to employees and third parties supporting Humana's Medicare and/or Medicaid products.
SourceLink
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