CMS Pub. 100-10, ch. 9, § 9005

Unless otherwise noted, statutory cites are to the Act). This section is based on, and

interprets the following authority:

§1156(a) identifies the obligations of health care practitioners and other persons (e.g.,

hospitals or other health care facilities, organizations, or agencies) who provide or order

healthcare services for which payment may be made under the Medicare or State health

care programs.

§1156(b) (1) requires that the QIO provide the practitioner or other person with notice, an

opportunity for discussion, and if appropriate, the opportunity to enter into and complete a

Corrective Action Plan.

§1156(b) provides the sanctions for a violation of the obligations in §1156(a), including

exclusion for a period of no less than 1 year or payment of an amount of up to$10,000 for

each instance in which improper or unnecessary services were furnished, ordered, or

prescribed, if appropriate).

§1156 (b)(5) (added by §4095 of the Omnibus Budget Reconciliation Act of 1987 (as

amended by §401(c)(1) of PL No. 101-597) establishes certain pre-exclusion appeal rights

for practitioners or other persons located in rural health professional shortage areas or in

counties with a population of less than 70,000 people.

42 CFR §480.139 governs disclosure of QIO deliberations.

42 CFR §1001.1901 provides the scope and effect of exclusions from Federal health care

programs of individuals and entities under Title 42 of the Code of Federal Regulations,

including certain exceptions to exclusions.

42 CFR §1001.3001-3005 describes the reinstatement process for excluded individuals

who request reinstatement to OIG.

42 CFR §1004.10 describes the statutory obligations of practitioners and other persons

who furnish services or order services.

42 CFR §1004.20 explains sanction actions that may be taken upon a finding by a QIO of

a violation of the obligations of §1156(a) and 42 CFR §1004.10.

42 CFR §1004.30 explains the basic responsibilities of a QIO in connection with

compliance by a practitioner or other person with §1156(a) and 42 CFR §1004.10.

42 CFR §1004.40 describes the actions a QIO must take when a violation of 42 CFR

§1004.10 is identified, including identifying the type of violation, obligations involved, the

situation or circumstances involved, suggested method for correcting the situation (if

appropriate), and rights of practitioners or other persons.

42 CFR §1004.40(b)(6) identifies the right of the practitioner or other person to request a

meeting with the QIO and the parameters of such a meeting.

42 CFR §1004.50 describes the QIO’s responsibilities when meeting with a practitioner

or other person who has been notified of a violation pursuant to §1004.4.

42 CFR §1004.60 describes the actions a QIO must take and certain requirements it must

meet when it affirms, modifies, or resolves its findings about a violation.

42 CFR §1004.70 describes the action a QIO must take on final finding of a violation if

the finding is not resolved to the QIO’s satisfaction as specified in 42 CFR §1004.60(a),

including submission of a report to OIG and providing notice to the practitioner or other

person.

42 CFR §1004.80 governs the QIO report to OIG for any violations identified by the QIO

that have not been resolved.

42 CFR §1004.90 requires the QIO to provide specific recommendations based on

documentation provided to OIG for consideration.

42 CFR §1004.100 describes OIG responsibilities upon receipt of the QIO report and

provides for an exclusion, as recommended by the QIO, to take effect after 120 days if

OIG does not make a determination.

42 CFR §1004.110 specifies the requirements for the issuance of the Notice of Sanction,

including an opportunity for the practitioner or other person to elect to notify patients.

42 CFR §§1004.120 – 1004.130 address the exclusion and reinstatement.

42 CFR §1004.140 provides for the limited appeal rights.