CMS Pub. 100-16, ch. 21, § 50.3.1

42 C.F.R. §§ 422.503(b)(4)(vi)(C), 423.504(b)(4)(vi)(C)

The sponsor’s employees (including temporary workers and volunteers), and governing

body members, must, at a minimum, receive general compliance training within 90 days

of initial hiring, and annually thereafter. The following are examples of how sponsors

may satisfy the general compliance training requirements:

• Classroom training;

• Online training modules; or

• Attestations that employees have read and received the sponsor’s Standards of

Conduct and/or compliance policies and procedures.

Sponsors must be able to demonstrate that their employees have fulfilled these training

requirements. Examples of proof of training may include copies of sign-in sheets,

employee attestations and electronic certifications from the employees taking and

completing the training.

Sponsors must ensure that general compliance information is communicated to their

FDRs. The sponsor’s compliance expectations can be communicated through

distribution of the sponsor’s Standards of Conduct and/or compliance policies and

procedures to FDRs’ employees. Distribution may be accomplished through Provider

Guides, Business Associate Agreements or Participation Manuals, etc.

Sponsors should review and update, if necessary, the general compliance training

whenever there are material changes in regulations, policy or guidance, and at least

annually.

The following are examples of topics the general compliance training program should

communicate:

• A description of the compliance program, including a review of compliance

policies and procedures, the Standards of Conduct, and the sponsor’s commitment

to business ethics and compliance with all Medicare program requirements;

• An overview of how to ask compliance questions, request compliance

clarification or report suspected or detected noncompliance. Training should

emphasize confidentiality, anonymity, and non-retaliation for compliance related

questions or reports of suspected or detected noncompliance or potential FWA;

• The requirement to report to the sponsor actual or suspected Medicare program

noncompliance or potential FWA;

• Examples of reportable noncompliance that an employee might observe;

• A review of the disciplinary guidelines for non-compliant or fraudulent behavior.

The guidelines will communicate how such behavior can result in mandatory

retraining and may result in disciplinary action, including possible termination

when such behavior is serious or repeated or when knowledge of a possible

violation is not reported;

• Attendance and participation in compliance and FWA training programs as a

condition of continued employment and a criterion to be included in employee

evaluations;

• A review of policies related to contracting with the government, such as the laws

addressing gifts and gratuities for Government employees;

• A review of potential conflicts of interest and the sponsor’s system for disclosure

of conflicts of interest;

• An overview of HIPAA/HITECH, the CMS Data Use Agreement (if applicable),

and the importance of maintaining the confidentiality of personal health

information;

• An overview of the monitoring and auditing process; and

• A review of the laws that govern employee conduct in the Medicare program.

See Appendix B for other examples of laws and regulations that may be discussed in

training.