45 C.F.R. Subpart B—Reporting of Information
Title 45 - Public Welfare
Information must be reported to the HIPDB as required under §§61.6, 61.7, 61.8, 61.9, 61.10, 61.11 and 61.15 in such form and manner as the Secretary may prescribe. (a) Information required under §§61.7, 61.8, 61.9, 61.10 and 61.11 must be submitted to the HIPDB— (1) Within 30 calendar days from the date the final adverse action was taken or the date when the reporting entity became aware of the final adverse action; or (2) By the close of the entity's next monthly reporting cycle, whichever is later. (b) The date the final adverse action was taken, its effective date and duration of the action would be contained in the information reported to the HIPDB under §§61.7, 61.8, 61.9, 61.10 and 61.11. (a) If errors or omissions are found after information has been reported, the reporter must send an addition or correction to the HIPDB. The HIPDB will not accept requests for readjudication of the case. (b) A reporter that reports information on licensure, criminal convictions, civil or administrative judgments, exclusions, or adjudicated actions or decisions under §§61.7, 61.8, 61.9, 61.10 or 61.11 also must report any revision of the action originally reported. Revisions include, but are not limited to, reversal of a criminal conviction, reversal of a judgment or other adjudicated decisions or whether the action is on appeal, and reinstatement of a license. (c) The subject will receive a copy of all reports, including revisions and corrections to the report. (d) Upon receipt of a report, the subject— (1) Can accept the report as written; (2) May provide a statement to the HIPDB that will be permanently appended to the report, either directly or through a designated representative (The HIPDB will distribute the statement to queriers, where identifiable, and to the reporting entity and the subject of the report. The HIPDB will not edit the statement; only the subject can, upon request, make changes to the statement); or (3) May follow the dispute process in accordance with §61.15. (a) What actions must be reported. Federal and State licensing and certification agencies must report to the HIPDB the following final adverse actions that are taken against a health care provider, supplier, or practitioner (regardless of whether the final adverse action is the subject of a pending appeal)— (1) Formal or official actions, such as revocation or suspension of a license or certification agreement or contract for participation in Federal or State health care programs (and the length of any such suspension), reprimand, censure or probation; (2) Any other loss of the license or loss of the certification agreement or contract for participation in Federal or State health care programs, or the right to apply for, or renew, a license or certification agreement or contract of the provider, supplier, or practitioner, whether by operation of law, voluntary surrender, non-renewal (excluding nonrenewals due to nonpayment of fees, retirement, or change to inactive status), or otherwise; and (3) Any other negative action or finding by such Federal or State agency that is publicly available information. (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 Individual Taxpayer Identification Number (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; (iii) National Provider Identifier (NPI), when issued by theCenters for Medicare & Medicaid Services (CMS); (iv) Name of each professional school attended and year of graduation; and (v) With respect to the State professional license (including professional certification and registration) on which the reported action was taken, the license number, the field of licensure, and the name of the State or territory in which the license is held. (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; (v) Type of organization; and (vi) With respect to the State license (including certification and registration) on which the reported action was taken, the license and the name of the State or territory in which the license is held. (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; and (iv) If deceased, date of death. (2) If the subject is an individual, that individual's employment or professional identifiers, including: (i) Other State professional license 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 (or ITIN) used; (iv) Other NPI(s) used; (v) Other State license 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 a publication of a public report that identifies those Government agencies that have failed to report information on adverse actions as required to be reported under this section. [64 FR 57758, Oct. 26, 1999, as amended at 69 FR 33868, June 17, 2004] (a) Who must report. Federal and State prosecutors must report criminal convictions against health care providers, suppliers, and practitioners related to the delivery of a health care item or service (regardless of whether the conviction 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 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) Name and location of court or judicial venue in which the action was taken; (iv) Docket or court file number; (v) Type of action taken; (vi) Statutory offense(s) and count(s); (vii) Name of primary prosecuting agency (or the plaintiff in civil actions); (viii) Date of sentence or judgment; (ix) Length of incarceration, detention, probation, community service or suspended sentence; (x) Amounts of any monetary judgment, penalty, fine, assessment or restitution; (xi) Other sentence, judgment or orders; (xii) If the action is on appeal; (xiii) Name and address of the reporting entity; and (xiv) 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; and (iii) FEIN, when used by the individual as a TIN. (2) If the subject is an individual, that individual's employment or professional identifiers, including: (i) State professional license (including professional certification and registration) 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 certification and registration) 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) Prosecuting agency's case number; (ii) Investigative agencies involved; (iii) Investigative agencies case of file number(s); and (iv) 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 criminal convictions as required to be reported under this section. [64 FR 57758, Oct. 26, 1999, as amended at 69 FR 33868, June 17, 2004] (a) Who must report. Federal and State attorneys and health plans must report civil judgments against health care providers, suppliers, or practitioners related to the delivery of a health care item or service (regardless of whether the civil judgment is the subject of a pending appeal). If a Government agency is party to a multi-claimant civil judgment, it must assume the responsibility for reporting the entire action, including all amounts awarded to all the claimants, both public and private. If there is no Government agency as a party, but there are multiple health plans as claimants, the health plan which receives the largest award must be responsible for reporting the total action for all parties. (b) Entities described in paragraph (a) of this section must report the information as required in §61.8(b). (c) Entities described in paragraph (a) of this section should report, if known the information as described in §61.8(c). (d) Sanctions for failure to report. Any health plan that fails to report information on a civil judgment required to be reported under this section will be subject to a civil money penalty (CMP) of not more than $25,000 for each such adverse action not reported. Such penalty will be imposed and collected in the same manner as CMPs under subsection (a) of section 1128A of the Act. The Secretary will provide for publication of a public report that identifies those Government agencies that have failed to report information on civil judgments as required to be reported under this section. (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. [64 FR 57758, Oct. 26, 1999, as amended at 69 FR 33869, June 17, 2004] (a) Who must report. Federal and State governmental agencies and health plans must report other adjudicated actions or decisions as defined in §61.3 related to the delivery, payment or provision of a health care item or service against health care providers, suppliers, and practitioners (regardless of whether the other adjudicated action or decision is subject to a pending appeal). (b) Entities described in paragraph (a) of this section must report the information as required in §61.10(b). (c) Entities described in paragraph (a) of this section should report, if known the information as described in §61.10(c). (d) Sanctions for failure to report. Any health plan that fails to report information on an other adjudicated action or decision required to be reported under this section will be subject to a civil money penalty (CMP) of not more than $25,000 for each such action not reported. Such penalty will be imposed and collected in the same manner as CMPs under subsection (a) of section 1128A of the Act. The Secretary will provide for publication of a public report that identifies those Government agencies that have failed to report information on other adjudicated actions as required to be reported under this section.
Title 45: Public Welfare
PART 61—HEALTHCARE INTEGRITY AND PROTECTION DATA BANK FOR FINAL ADVERSE INFORMATION ON HEALTH CARE PROVIDERS, SUPPLIERS AND PRACTITIONERS
Subpart B—Reporting of Information
§ 61.4 How information must be reported.
§ 61.5 When information must be reported.
§ 61.6 Reporting errors, omissions, revisions or whether an action is on appeal.
§ 61.7 Reporting licensure actions taken by Federal or State licensing and certification agencies.
§ 61.8 Reporting Federal or State criminal convictions related to the delivery of a health care item or service.
§ 61.9 Reporting civil judgments related to the delivery of a health care item or service.
§ 61.10 Reporting exclusions from participation in Federal or State health care programs.
§ 61.11 Reporting other adjudicated actions or decisions.
