§ 61.10 - Reporting exclusions from participation in Federal or State health care programs.  


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  • (a) Who must report. Federal and State Government agencies must report health care providers, suppliers, or practitioners excluded from participating in Federal or State health care programs, including exclusions that were made in a matter in which there was also a settlement that is not reported because no findings or admissions of liability have been made (regardless of whether the exclusion is the subject of a pending appeal) .

    (b) Entities described in paragraph (a) of this section must report the following information:

    (1) If the subject is an individual, personal identifiers, including:

    (i) Name;

    (ii) Social Security Number (or ITIN);

    (iii) Home address or address of record;

    (iv) Sex; and

    (v) Date of birth.

    (2) If the subject is an individual, that individual's employment or professional identifiers, including:

    (i) Organization name and type;

    (ii) Occupation and specialty, if applicable; and

    (iii) National Provider Identifier (NPI), when issued by theCenters for Medicare & Medicaid Services (CMS).

    (3) If the subject is an organization, identifiers, including:

    (i) Name;

    (ii) Business address;

    (iii) Federal Employer Identification Number (FEIN), or Social Security Number (or ITIN) when used by the subject as a Taxpayer Identification Number (TIN);

    (iv) The NPI, when issued by CMS; and

    (v) Type of organization.

    (4) For all subjects:

    (i) A narrative description of the acts or omissions and injuries upon which the reported action was based;

    (ii) Classification of the acts or omissions in accordance with a reporting code adopted by the Secretary;

    (iii) Classification of the action taken in accordance with a reporting code adopted by the Secretary, and the amount of any monetary penalty resulting from the reported action;

    (iv) The date the action was taken, its effective date and duration;

    (v) If the action is on appeal;

    (vi) Name of the agency taking the action;

    (vii) Name and address of the reporting entity; and

    (viii) The name, title and telephone number of the responsible official submitting the report on behalf of the reporting entity.

    (c) Entities described in paragraph (a) of this section should report, if known, the following information:

    (1) If the subject is an individual, personal identifiers, including:

    (i) Other name(s) used;

    (ii) Other address;

    (iii) FEIN, when used by the individual as a TIN;

    (iv) Name of each professional school attended and year of graduation; and

    (v) If deceased, date of death.

    (2) If the subject is an individual, that individual's employment or professional identifiers, including:

    (i) State professional license (including professional registration and certification) number(s), field(s) of licensure, and the name(s) of the State or Territory in which the license is held;

    (ii) Other numbers assigned by Federal or State agencies, to include, but not limited to Drug Enforcement Administration (DEA) registration number(s), Unique Physician Identification Number(s) (UPIN), and Medicaid and Medicare provider number(s);

    (iii) Name(s) and address(es) of any health care entity with which the subject is affiliated or associated; and

    (iv) Nature of the subject's relationship to each associated or affiliated health care entity.

    (3) If the subject is an organization, identifiers, including:

    (i) Other name(s) used;

    (ii) Other address(es) used;

    (iii) Other FEIN(s) or Social Security Numbers(s) (or ITINs) used;

    (iv) Other NPI(s) used;

    (v) State license (including registration and certification) number(s) and the name(s) of the State or territory in which the license is held;

    (vi) Other numbers assigned by Federal or State agencies, to include, but not limited to Drug Enforcement Administration (DEA) registration number(s), Clinical Laboratory Improvement Act (CLIA) number(s), Food and Drug Administration (FDA) number(s), and Medicaid and Medicare provider number(s);

    (vii) Names and titles of principal officers and owners;

    (viii) Name(s) and address(es) of any health care entity with which the subject is affiliated or associated; and

    (ix) Nature of the subject's relationship to each associated or affiliated health care entity.

    (4) For all subjects:

    (i) If the subject will be automatically reinstated; and

    (ii) The date of appeal, if any.

    (d) Sanctions for failure to report. The Secretary will provide for publication of a public report that identifies those Government agencies that have failed to report information on exclusions or debarments as required to be reported under this section.