CMS Pub. 100-16, ch. 11, § 20.3

Compliance with Policies

(Rev. 79, Issued 02-17-06, Effective Date 02-17-06)

The organization should monitor compliance through analysis of complaints or

grievances, requests to change providers, enrollee satisfaction surveys, rapid

disenrollment surveys, and other sources of enrollee input. Issues in compliance should

be addressed through education or counseling of the staff or providers or other corrective

action, and information on compliance with the policies should be considered during the

recredentialing and staff evaluation process and within the quality improvement program.

The organization ensures compliance with Federal and State laws affecting the rights of

enrollees.

Applicable Federal laws include, but are not limited to:

• Federal laws and regulations designed to prevent or ameliorate fraud, waste, and

abuse to include but not limited to:

- Applicable provisions of Federal criminal law;

- The False Claims Act (31 U. S.C. 3729 et seq.);

- The Anti-Kickback statute (§1128B(b) of the Act); and

• HIPAA administrative simplification rules at 45 CFR Parts 160, 162, and 164.

In general, agencies other than CMS or the State Medicaid Agency enforce these laws,

and reviews conducted under these standards will not include detailed assessment of an

organization's compliance. However, CMS or States will report any observed violations

and refer any enrollee complaints to the appropriate agency for resolution.

The organization must include provisions relating to compliance with Federal and State

laws in subcontracts with providers. Assessment of compliance should be included in the

organization's credentialing procedures to the extent feasible and appropriate. For

example, if site visits to individual providers' offices are conducted, they should include a

general assessment of physical accessibility. Compliance issues identified may be

addressed through the organization's Quality Improvement Program.

Each MA contract is for a period of at least 12 months. The contract is effective on the

date specified in the contract between the MA organization and CMS.

An MA organization's MA contract with CMS will contain a provision specifying

inspection and auditing rights, along with CMS' rights to inspect or evaluate the quality,

appropriateness, and timeliness of services performed under the contract; CMS' rights to

inspect or evaluate the facilities of the organization when evidence of the need to do so

exists; and CMS' right to inspect books, contracts, and records of the MA organization

that pertain to the organization's ability to bear financial risk, perform services, and

determine amounts payable.

An MA organization's MA contract will contain a severability provision that provides

that upon CMS' request: (1) The contract will be amended to exclude any MA plan or

State-licensed entity specified by CMS, and (2) A separate contract would be deemed to

be in place for the plan removed from the MA contract, when such a request is made.

An MA organization's MA contract will contain a provision stating that any regulations

or policy statements issued by CMS after the date on which final bid proposals must be

submitted for a calendar year, and which create significant new operational costs of

which the MA organization did not have reasonable notice prior to such date, will not

become effective before the next contract year for which these requirements can be taken

into account in making bid submissions, unless earlier implementation is required by

statute or in connection with litigation challenging CMS” policies.

NOTE: MA organizations offering prescription drug benefits under Part D must

follow the fraud, waste, and abuse requirements at 42 CFR Part 423.

Please see §423.504(b)(4)(vi)(H) for these requirements.