Mastectomy Facility Accreditation Guide

October 2023


Claims and Billing Compliance (CB)

The Claims and Billing Compliance Standards are designed to support your business’ compliance with billing guidelines set by the Centers for Medicare and Medicaid Services and the Office of the Inspector General. You are expected to develop a compliance program that encompasses the spirit of the OIG’s Compliance Program Guidance for the Durable Medical Equipment, Prosthetics, Orthotics and Supply Industry.

The Standards parallel the five critical elements presented in the OIG’s Guidance:

  • You establish a claims and billing compliance program based upon formal policies and procedures that prevent inappropriate billing.
  • A qualified and trained individual is responsible for maintaining the compliance program and oversees that the program is administered consistently.
  • Appropriate staff is properly trained and educated on claims development and billing procedures in order to effectively manage the claims process and minimize the submission of improper claims.
  • Auditing and monitoring mechanisms are implemented to ensure consistent compliance and identify areas of improvement.
  • Written employment criteria and disciplinary guidelines are implemented for all billing and claims staff.


You must administer a claims and billing compliance program with written policies, procedures and standards that describe your compliance with federal and state policies.


Your compliance program must include written policies and procedures that address:

  • Appointing a compliance officer
  • Billing monitoring and auditing procedures
  • Chart audits—including the frequency and number of audits you’ll do
  • The procedures you follow if errors are found and what corrective actions you have taken
  • Education of your billing staff
  • Identifying and dealing with fraud and abuse


You must designate a qualified and trained individual to be responsible for maintaining the claims and billing compliance program.


You must indicate in your policy which specific staff member is responsible for claims and billing and document their qualifications and training with a job description, meeting minutes, attendance logs, course certificates or in-service agendas.


You must provide claims development and billing education for all staff involved with or responsible for, claims and billing. You must have documentation that you have implemented practices to prevent and control fraud, waste and abuse.


You or your designated staff members must be educated and trained in claims development and billing particular to job duties and responsibilities related to the compliance program. You must document this education with meeting minutes, attendance logs, course certificates or in-service agendas. Use the Billing Education Documentation form in the online Resource Kit to document this information.


You must establish ongoing file auditing and monitoring policies and procedures for clinical and financial records to ensure consistent compliance with all applicable federal, state and private payer healthcare plans.


You must annually write an evaluation of the results of the file auditing and monitoring compliance program and act on any necessary changes.


You must have meeting minutes, patient records and/or other documentation to reflect ongoing monitoring and auditing of the claims and billing compliance program. You must have documentation of audit reports and if necessary, the corrective actions you have taken. Use the Billing and Coding Error Report in the online Resource Kit to record your findings.

Your auditing policy should specifically indicate the number or percentage of charts you will audit. Outline how often you will conduct an audit (we recommend at least annually).

Minimally, your chart audit should consist of the following:

  • Documentation of the current prescription
  • That the quantities dispensed match the prescription
  • A signed and dated delivery receipt.

Delivery receipt date is the actual date the items were received by the patient or the mail/ship date.


You must have written policies and procedures that ensure investigations of suspected or actual noncompliance are handled appropriately and any necessary corrective action is taken.


You must have a plan that addresses how you conduct internal investigations of suspected noncompliance. This plan should include:

  • A time limit for closing an investigation of suspected claims and billing noncompliance
  • Options for corrective action after determining that an act of noncompliance has occurred, including disciplinary action, a review of existing policies and procedures and employee training
  • An indication of when it would be necessary to conduct a noncompliance investigation by an outside, independent investigator
  • An indication of how and when to refer an act of noncompliance to CMS or law enforcement authorities
  • An indication of when to report the suspected noncompliance to ABC as required by the Code of Professional Responsibility