2. Instructions
• CMS (the Center for Medicare and Medicaid Services, is a Federal agency that
provides oversight of Medicare, Medicaid and Children's Health Insurance
Program) requires Medicare Advantage Prescription Drug Plans (MA-PDs) to
incorporate effective compliance training and education for all first tier,
downstream and related entities (FDRs) into their Compliance Programs.
• The first half of these slides provide information regarding CarePoint Health Plans
Medicare Compliance Program Requirements for FDRs pursuant to your contract
with CarePoint Health Plans. These requirements are consistent with the CMS
Compliance Program Guidelines (Chapter 9 of the PDB Manual/Chapter 21 of the
MMC Manual).
• The second half of this FDR compliance training includes information on CarePoint
Health Plans Medicare Compliance Program. FDRs may use these slides for their
annual compliance training. Using these slides is not required. FDRs may also elect
to develop their own compliance training materials or use materials provided by
another Medicare Advantage Organization or Part D Plan Sponsor, consistent with
your contract with CarePoint Health Plans.
3. Instructions
• At the time of contracting and at least annually, you will be required to
attest to your compliance with the CarePoint Health Plans Medicare
Compliance Program Requirements for FDRs. You will need to complete
the Annual Medicare Compliance Program Attestation and return the
signed original to CarePoint Health Plans.
• CarePoint Health Plans reserves the right to perform an audit of your
compliance program. FDRs may be asked to provide policies and
procedures regarding their compliance program, compliance training
materials used for compliance training , attendance logs that demonstrate
all employees have received the training, and any other documentation
demonstrating the effectiveness of the compliance program.
4. Welcome to FDR
Compliance Training
• This training is comprised of two sections:
1) A review of CarePoint Health Plans Medicare Compliance Program Requirements
for FDRs
• Consistent with CMS' Compliance Program Guidelines (Chapter 9 of the PDB
Manual/Chapter 21 of the MMC Manual).
• As outlined in your agreement with CarePoint Health Plans and described in your
Annual Medicare Compliance Attestation
2) An overview of CarePoint Health Plans Medicare Compliance Program, including:
• Overview of CarePoint Health Plans Principles of Professional Conduct
• How to report compliance violations and who to contact with Medicare
compliance questions
• CarePoint Health Plans Non-Retaliation Policy
• Possible disciplinary/corrective actions for non-compliance or fraud
5. What is the definition
of an FDR
Downstream Entity is 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 CarePoint
Health Plans or applicant and a first tier entity. These written arrangements continue
down to the level of the ultimate provider of both health and administrative services.
First Tier Entity is any party that enters into a written arrangement, acceptable to
CMS, with an MAO or Part D plan CarePoint Health Plans or applicant to provide
administrative services or health care services to a Medicare eligible individual under
the MA program or Part D program.
Related entity means any entity that is related to an MAO or Part D CarePoint Health
Plans by common ownership or control and
1. Performs some of the MAO or Part D plan CarePoint Health Plans management
functions under contract or delegation;
2. Furnishes services to Medicare enrollees under an oral or written agreement; or
3. Leases real property or sells materials to the MAO or Part D plan CarePoint Health
Plans at a cost of more than $2,500 during a contract period.
6. Examples
of FDRs
• Management service organizations (MSOs),
• Provider groups, hospitals, skilled nursing facilities,
• Pharmacy benefit managers (PBMs),
• Marketing firms, field marketing organizations,
• Claims processing and adjustment companies,
• Temporary employment agencies, and others.
• The following is not considered an FDR:
– A real estate broker whose business relationship with CarePoint
Health Plans is limited to the office space rentals
7. Why is compliance
training for FDRs important?
• CarePoint Health Plans has entered into a contracts with its FDRs to
perform certain functions that would otherwise be the responsibility
of CarePoint Health Plans.
• While CarePoint Health Plans may contract with FDRs to perform
certain functions on its behalf, CarePoint Health Plans maintains
ultimate responsibility for fulfilling the terms and conditions of its
contract(s) with CMS and for meeting the Medicare program
requirements, including the Compliance Program requirements.
• CMS has the authority to hold CarePoint Health Plans accountable
for any failure to meet the program requirements, even if the failure is
due to its FDRs' conduct.
• Both CarePoint Health Plans and its FDRs may be subject to liability
under civil and/or criminal laws, such as the False Claims Act or the
Anti-Kickback statute for fraud perpetrated in the administration or
delivery of Parts C and D benefits.
8. General CarePoint Medicare
Compliance Requirements for FDRs
• All FDRs to whom CarePoint Health Plans has delegated responsibilities
related to its core functions under its Medicare contracts with CMS are
required to be in compliance with all applicable laws, rules and regulations
with respect to Parts C and D delegated responsibilities.
• Consistent with the above requirement, FDRs should report all suspected,
potential or actual instances of Medicare program non-compliance and FWA
to CarePoint Health Plans.
• All Compliance Program Requirements apply to the FDR and the FDR's
employees, unless otherwise indicated.
– FDR Employees are defined as any person under control of the FDR (intern, volunteer,
consultant, temporary or permanent, full or part-time, regardless of payment) who has
contact with a Medicare beneficiary, orally or in writing, or a Medicare beneficiary's
information (such as claims, letters or medical records)
9. Requirements for
Exclusion Lists Reviews
• All FDRs must ensure monthly screening of HHS OIG List of Excluded
Individuals and Entities (LEIE list) exclusion and GSA debarment lists prior to
the hiring or contracting of any prospective, potential or actual new
employee, temporary employee, volunteer, consultant, governing body
member, or downstream and related entities, and monthly thereafter, to
ensure that none of these entities are excluded or become excluded from
participation in federal programs , as required by 42 CFR
§§422.503(b)(4)(vi)(F), 423.504(b)(4)(vi)(F), 42 CFR 1001.1901
– If an FDR should discover an excluded individual, the FDR should immediately
disclose this information to CarePoint Health Plans.
– All FDRs must ensure there are procedures to identify and prevent payment
for any item or service provided by an excluded person or entity
– FDRs and their employees must immediately disclose any exclusion or other
event that make them ineligible to perform work related to Federal Health
Care Programs.
10. Requirements for Reporting
Conflicts of Interest
• All FDRs are required to effectively screen both their senior management and
governing body for conflicts of interest with CarePoint Health Plans interests and
disclosure to CarePoint Health Plans upon identification of any Conflicts of Interest, at
the time of contracting and annually thereafter, as required by 42 CFR §§
422.503(b)(4)(vi)(A)(3), 423.504(b)(4)(vi)(A)(3).
• An effective conflicts of interest screening process may including the following:
– At time of hire/appointment and annually
– Ensuring the person has reviewed the organization's* conflict of interest policy
n Determining whether the person has disclosed any conflicts of interest, and
whether management has allowed the person to work despite the conflicts of
interest, or whether the conflicts of interest have been eliminated
*If the organization does not have its own conflicts of interest policy, the organization
may adopt CarePoint Health Plans conflicts of interest policy, which is easily available
in CarePoint Health Plans Standard of Conduct
11. Requirements for
Compliance Policies
• All FDRs are required to have and distribute compliance
policies (including a conflicts of interest policy and non-
intimidation, non-retaliation policy) and standards of conduct
annually and within 90 days of hire, and whenever compliance
policies and standards of conduct are updated/revised.
• All FDRs are required to have their employees sign that they
have read and agree to comply with written policies and
standards of conduct, within 90 days of hire and annually
thereafter.
• The FDR may use CarePoint Health Plans compliance materials
or compliance materials that are comparable
12. Requirements for
Compliance Policies
• CarePoint Health Plans need not review and approve the FDR's
compliance materials in advance to ensure consistency with CMS
requirements; however, CarePoint Health Plans will be held
accountable for ensuring that their FDRs have compliance
materials that meet CMS requirements.
• All FDRs should inform their employees that violation of
standards will result in appropriate disciplinary action, up to and
including termination of employment.
• All FDRs must encourage their employees' to ask compliance
questions and report potential instances of Medicare program
noncompliance and FWA confidentially or anonymously (if
desired) without fear of retaliation.
13. Requirements for
Compliance Training
• The FDR's Compliance Program must be
communicated using training and educational
materials, as required by 42 CFR §§
422.503(b)(4)(vi)(C),423.504(b)(4)(vi)(C)
• At a minimum, FDRs must conduct compliance
training, at the following times:
– Within 90 days of hire, for all new employees
– At the time of appointment for a new Chief
Executive, manager or governing body member
– Annually
14. Requirements for
Compliance Training
• CarePoint Health Plans requires that FDRs
administer specialized compliance training FDR
employees upon hire and annually thereafter.
This training should be based on issues posing a
compliance risk based on an individual's job
function, when an FDR employee is found to be
non-compliant and/or working in an area found
to be non-compliant or implicated in past
misconduct.
15. Requirements for
Maintaining Records
• The FDR should maintain records that demonstrate its
compliance with these Medicare Compliance Program
Requirements for FDRs
• Records should be maintained for no less than ten
(10) years
• Records may include compliance program materials,
training attendance logs and test results, FDR employee
attestations for completion of training
16. Requirements for
Corrective Action Plans
• For corrective actions related to misconduct or
program noncompliance by an FDR, all elements
of the corrective action are detailed in a written
agreement with the FDR.
• The written agreement will include
ramifications if the FDR fails to implement the
corrective action satisfactorily.
17. How to Report
Compliance & FWA
Issues within your Organization
• FDRs of CarePoint Health Plans should have policies and procedures that
address Medicare program non- compliance and fraud, waste and abuse.
These policies and procedures should address the following:
– What situations may be considered red flags for fraud?
– What methods will be used to prevent and detect fraud, waste and abuse activities?
– How and who will investigate situations that are reported?
– How will employees report this information?
– How will employees be protected from retaliation should they report a potential issue?
– What corrective and/or disciplinary actions will be taken if fraud, waste or abuse occurs?
– How will employees receive education on these policies and procedures?
• FDRs of CarePoint Health Plans MUST report any potential fraud, waste or
abuse related to CarePoint Health Plans Part C and D lines of business to
CarePoint Health Plans (or if preferred, to an external agency). Instructions for
reporting to CarePoint Health Plans are included later within this training.
18. FDR’s Non-Intimidation,
Non-Retaliation
• FDRs are required to have a non-intimidation, non-retaliation policy, and to the
extent that an FDR does not have one, the FDR may choose to adopt CarePoint Health
Plans policy, which is easily available in CarePoint Health Plans Standards of Conduct.
• Below are recommended elements for inclusion in a Non-Intimidation, Non-
Retaliation policy:
• Employees should be encouraged to report any potential fraud, waste or abuse that
they know or think they know is occurring.
• Employees that do make a report must not be retaliated against for making the
report. This is true for good-faith reports. Employees that are found to have made a
report because they are disgruntled or have other inappropriate motivation may not
be afforded the same protections.
• Employees should be given a means to make a report anonymously if they choose.
This can be accomplished by using an anonymous hotline or a third party reporting
vendor.
• Employees that retaliate against another employee that has made a good-faith
report should be subject to corrective action up to and including termination.
19. FWA training
requirements for FDRs
• CMS has developed a standardized web-based Medicare Part C
and D FWA training and education module. The module is
available through the CMS Medicare Learning Network (MLN) at
http://www.cms.gov/Outreach-and-Education/Medicare-
Learning-Network-MLN/MLNProducts/WebBasedTraining.html
– Under "Related Links", at the bottom of the page, click on
"Web-Based Training (WBT) Courses". Click on Medicare
Parts C and D Fraud, Waste and Abuse Training
• The CMS standardized FWA training should be used by any FDR
who is NOT deemed and for whom CarePoint Health Plans has
not separately provided its own FWA training materials.
20. FWA training
requirements for FDRs
• FDRs who have met the FWA certification requirements
through enrollment into the Medicare program or accreditation
as a Durable Medical Equipment, Prosthetics, Orthotics, and
Supplies (DMEPOS) are deemed to have met the training and
educational requirements for fraud, waste, and abuse.
• No additional documentation beyond the documentation
necessary for proper credentialing is required to establish that
an FDR or employee of an FDR is deemed.
• However, even if "deemed" for FWA training, FDR's employees
still must have compliance training.
21. Compliance is
Your Responsibility
• All employees are held accountable for compliance,
from the top to the bottom of the organization
– Compliance is a part of your day-to-day responsibilities
– Managers must ensure that employees are fully trained in
all standards, policies and procedures
– Employees should request additional training to ensure
they are performing/behaving in compliant manner
22. Written
Policies and Procedures
• CMS requires CarePoint Health Plans to have written Standards
of Conduct.
• The Standards of Conduct and compliance policies reflect
CarePoint Health Plans commitment to integrity, ethical conduct
and legal/regulatory compliance.
• The Standards of Conduct communicates to our FDRs
– Compliance is everyone's responsibility from the top to the bottom of
the organization.
– How to deal with potential compliance issues.
– The responsibility to report violations of law, regulations, Medicare
program requirements fraud, waste and abuse (FWA) and any
Medicare Compliance Program Requirements to CarePoint Health
Plans.
23. Written
Policies and Procedures
• All entities contracted to perform work related to Medicare
programs must review CarePoint Health Plans Standards of
Conduct and policies and procedures or have appropriate
policies and procedures to address ethical conduct, as well as a
compliance program to address Medicare program non-
compliance and Fraud, Waste and Abuse.
24. What is Wrongdoing
Wrongdoing: Examples of wrongdoing, which may lead to
disciplinary and or corrective action, include but not limited to:
• Illegal or fraudulent activity
• Violations of law, regulations or CMS Medicare program
requirements
• Failing to disclose Conflicts of interest or failing report acts of
wrong-doing, including non- compliant, dishonest or unethical
conduct
• Violations of the Standards of Conduct and/ or company
policies
• Encouraging or assisting others in acts of non-compliance
25. What is Wrongdoing
• Failure to meet compliance program training requirements, or
other such requirements of CarePoint Health Plans Medicare
Compliance Program
• Knowingly submitting false reports of non-compliance
• Retaliation against an employee or contractor for their good
faith participation in the Medicare Compliance Program and/or
reporting FWA, non-compliance, or other acts of wrongdoing
This list above is provided as a guide to assist Associates in
identifying specific conduct that may constitute grounds for
disciplinary and/or corrective action, including termination of
employment, affiliation, appointment or contract; however, it is
not exhaustive.
26. Requirement to
Report Wrongdoing
• ALL FDRs (and their employees) are required to
report Wrongdoing, especially suspected Fraud
• FDR's board members, managers and employees may
report Wrongdoing related to CarePoint Health Plans to
the CarePoint Health Plans or to any external federal or
state law enforcement agency (for suspected cases of
fraud)
27. How to Report Wrongdoing
to CarePoint Health Plans
• All wrongdoing, including ethical issues, potential conflicts of interest,
potential compliance issues, fraud allegations, etc, may be reported to
CarePoint Health Plans using any of the following means:
• By calling or emailing CarePoint Health Plans Compliance Officer –
– Ajhezza Gonzalez (201) 432.2133 X103 agonzalez@carepoint.org
• By mail: Ajhezza Gonzalez, Compliance Officer, CarePoint Health Plans
Harborside Financial Center-Plaza Five-Suite 1510 Jersey City, NJ 07311
• Compliance Hotline: 1-888-671-6191
• (Completely anonymous unless you choose to give your name)
• Compliance Fax: 908-378-7846
• Compliance Email: compliance@carepoint.org
28. How to Report Suspected Fraud
to External Agency
• New Jersey Office of the Attorney General:
1-609-292-4925
• New Jersey Department of Banking and
Insurance, Frauds Bureau: 1-800-446-7467
• Call 1-800-MEDICARE or Call 1-800-HHS-TIPS
29. Responding to
Compliance Issues
• When you report a compliance issue to CarePoint Health
Plans, you may be asked a series of questions to assist in the
investigation. Please give as much detail as possible about the
issue.
• The Compliance Officer, or designee, thoroughly investigates
each report of an alleged violation of the
– Medicare Compliance Program
– Applicable federal and state laws and regulations and
Medicare program requirements
– CarePoint Health Plans standards of conduct, policies and
procedures
– Reports of Wrongdoing
30. Responding to
Compliance Issues
• Confirmed cases of violations will be handled as
follows
– Corrective actions will be implemented ASAP
– Self-reporting to government agencies,
involvement of legal counsel, if necessary
– To prevent future violations, there will be
immediate training and potentially a review of
policies and procedures to determine any needed
revisions
– Follow-up auditing and monitoring
31. Corrective
Actions
• Compliance violations and acts of Wrongdoing are subject to
corrective actions
• The CarePoint Health Plans Compliance Officer may request a
correction action plan (CAP) and/or recommend specific
corrective actions be implemented to remediate the compliance
violation or deficiency.
• Depending on the severity of the issue, the FDR may be
sanctioned and the contract may be terminated.
• For staff who are involved in the wrongdoing, the CarePoint
Health Plans Compliance Officer may request the corrective
actions include disciplinary action up to and including
termination of the individual(s).
32. CMS may impose Sanctions
against CarePoint
for Non-Compliance
• Notices of non-compliance
• Warning Letters
• Requests for Corrective Action Plans
• Suspension of Enrollment and Marketing
• Fines
Sanctions vary with the severity, repetition of
the deficiency and impact to members.
33. Auditing & Monitoring
• CarePoint Health Plans, or an organization on its behalf, may
conduct Annual Risk Assessments and Audits of its FDRs to
ensure FDRs are meeting requirements of the FDR's contract
• Internal Audits
– Although FDRs may conduct their own internal audits and provide
their annual audit plan and the results of their audits to CarePoint
Health Plans, CarePoint Health Plans reserves the right to conduct its
own audits (as required by CMS).
• CMS or other regulatory or enforcement agencies may conduct
their own audits
• All FDRs and their employees are expected to fully cooperate
with all auditing and monitoring activities.
34. CarePoint’s Non-Intimidation,
Non-Retaliation Policy
• CarePoint Health Plans will not discriminate or
retaliate against anyone or any FDR who, in
good faith, reports Wrongdoing, including
violations of laws or regulations, the Standards
of Conduct, or CarePoint Health Plans policies.
• Retaliation should be reported to the
Medicare Compliance Officer