42 U.S.C. 11101-11152; 42 U.S.C. 1396r-2; 42 U.S.C. 1320a-7e
The Health Care Quality Improvement Act of 1986 (HCQIA), as amended, title IV of Public Law 99-660 (42 U.S.C. 11101
The regulations in this part establish reporting requirements applicable to hospitals, health care entities, Boards of Medical Examiners, and professional societies of health care practitioners which take adverse licensure or professional review actions; state licensing
(1) The U.S. Department of Justice;
(2) The U.S. Department of Health and Human Services;
(3) Federal law enforcement agencies, including law enforcement investigators;
(4) Any other Federal agency that either administers or provides payment for the delivery of health care services, including, but not limited to the U.S. Department of Defense and the U.S. Department of Veterans Affairs; and
(5) Federal agencies responsible for the licensing and certification of health care practitioners, providers, and suppliers.
(1) A hospital;
(2) An entity that provides health care services, and engages in professional review activity through a formal peer review process for the purpose of furthering quality health care, or a committee of that entity; or
(3) A professional society or a committee or agent thereof, including those at the national, state, or local level, of health care practitioners that engages in professional review activity through a formal peer review process, for the purpose of furthering quality health care.
(4) For purposes of paragraph (2) of this definition, an entity includes: a health maintenance organization which is licensed by a state or determined to be qualified as such by the Department of Health and Human Services; and any group or prepaid medical or dental practice which meets the criteria of paragraph (2).
(1) A policy of health insurance;
(2) A contract of a service benefit organization;
(3) A membership agreement with a health maintenance organization or other prepaid health plan;
(4) A plan, program, agreement, or other mechanism established, maintained, or made available by a self-insured employer or group of self-insured employers, a health care practitioner, provider, or supplier group, third-party administrator, integrated health care delivery system, employee welfare association, public service group or organization or professional association;
(5) An insurance company, insurance service, or insurance organization that is licensed to engage in the business of selling health care insurance in a state and which is subject to state law which regulates health insurance; and
(6) An organization that provides benefit plans whose coverage is limited to outpatient prescription drugs.
(1) A final determination of denial or termination of an accreditation status from a private accreditation entity that indicates a risk to the safety of a patient(s) or quality of health care services;
(2) Any recommendation by a peer review organization to sanction a health care practitioner; or
(3) Any negative action or finding that, under the state's law, is publicly available information and is rendered by a licensing or certification authority, including but not limited to, limitations on the scope of practice, liquidations, injunctions, and forfeitures. This definition also includes final adverse actions rendered by a Federal or state licensing or certification authority, such as exclusions, revocations, or suspension of license or certification, that occur in conjunction with settlements in which no finding of liability has been made (although such a settlement itself is not reportable under the statute). This definition excludes administrative fines or citations and corrective action plans and other personnel actions, unless they are:
(i) Connected to the delivery of health care services; or
(ii) Taken in conjunction with other adverse licensure or certification actions such as revocation, suspension, censure, reprimand, probation, or surrender.
(1) Evaluates and seeks to improve the quality of health care provided by a health care entity, provider, or supplier;
(2) Measures a health care entity's, provider's, or supplier's performance based on a set of standards and assigns a level of accreditation;
(3) Conducts ongoing assessments and periodic reviews of the quality of health care provided by a health care entity, provider, or supplier; and
(4) Has due process mechanisms available to health care entities, providers, or suppliers.
(1) Taken in the course of professional review activity;
(2) Based on the professional competence or professional conduct of an individual health care practitioner which affects or could affect adversely the health or welfare of a patient or patients; and
(3) Which adversely affects or may adversely affect the clinical privileges or membership in a professional society of the health care practitioner.
(4) This term excludes actions which are primarily based on:
(i) The health care practitioner's association, or lack of association, with a professional society or association;
(ii) The health care practitioner's fees or the health care practitioner's advertising or engaging in other competitive acts intended to solicit or retain business;
(iii) The health care practitioner's participation in prepaid group health plans, salaried employment, or any other manner of delivering health services whether on a fee-for-service or other basis;
(iv) A health care practitioner's association with, supervision of, delegation of authority to, support for, training of, or participation in a private group practice with, a member or members of a particular class of health care practitioner or professional; or
(v) Any other matter that does not relate to the competence or professional conduct of a health care practitioner.
(1) To determine whether the health care practitioner may have clinical privileges with respect to, or membership in, the entity;
(2) To determine the scope or conditions of such privileges or membership; or
(3) To change or modify such privileges or membership.
(1)(i) Is composed of a substantial number of the licensed doctors of medicine and osteopathy engaged in the practice of medicine or surgery in the area and who are representative of the practicing physicians in the area, designated by the Secretary under section 1153, with respect to which the entity shall perform services under this part, or
(ii) Has available to it, by arrangement or otherwise, the services of a sufficient number of licensed doctors of medicine or osteopathy engaged in the practice of medicine or surgery in such area to assure that adequate peer review of the services provided by the various medical specialties and subspecialties can be assured;
(2) Is able, in the judgment of the Secretary, to perform review functions required under section 1154 in a manner consistent with the efficient and effective administration of this part and to perform reviews of the pattern of quality of care in an area of medical practice where actual performance is measured against objective criteria which define acceptable and adequate practice; and
(3) Has at least one individual who is a representative of consumers on its governing body.
(1) A state law enforcement agency;
(2) A state Medicaid fraud control unit (as defined in section 1903(q) of the Social Security Act); and
(3) A state agency administering (including those providing payment for services) or supervising the administration of a state health care program (as defined in section 1128(h) of the Social Security Act).
Information must be reported to the NPDB as required under §§ 60.7, 60.8, 60.9, 60.10, 60.11, 60.12, 60.13, 60.14, 60.15 and 60.16 in such form and manner as the Secretary may prescribe.
Information required under §§ 60.7, 60.8, and 60.12 must be submitted to the NPDB within 30 days following the action to be reported, beginning with actions occurring on or after September 1, 1990; information required under § 60.11 must be submitted to the NPDB within 30 days following the action to be reported, beginning with actions occurring on or after January 1, 1992; and information required under §§ 60.9, 60.10, 60.13, 60.14, 60.15, and 60.16 must be submitted to the NPDB within 30
(a) Malpractice payments (§ 60.7);
(b) Licensure and certification actions (§§ 60.8, 60.9, and 60.10);
(c) Negative actions or findings (§ 60.11);
(d) Adverse actions (§ 60.12);
(e) Health Care-related Criminal Convictions (§ 60.13);
(f) Health Care-related Civil Judgments (§ 60.14);
(g) Exclusions from Federal or state health care programs (§ 60.15); and
(h) Other adjudicated actions of decisions (§ 60.16).
(a) Persons and entities are responsible for the accuracy of information which they report to the NPDB. If errors or omissions are found after information has been reported, the person or entity which reported it must send an addition or correction to the NPDB and, in the case of reports made under § 60.12 of this part, also to the Board of Medical Examiners, as soon as possible. The NPDB will not accept requests for readjudication of the case by the NPDB, and will not examine the underlying merits of a reportable action.
(b) An individual or entity which reports information on licensure or certification, negative actions or findings, clinical privileges, criminal convictions, civil or administrative judgments, exclusions, or adjudicated actions or decisions under §§ 60.8, 60.9, 60.10, 60.11, 60.12, 60.13, 60.14, 60.15, or 60.16 must also report any revision of the action originally reported. Revisions include, but are not limited to, reversal of a professional review action or reinstatement of a license. In the case of actions reported under §§ 60.9, 60.10, 60.13, 60.14, 60.15 or 60.16, revisions also include whether an action is on appeal. Revisions are subject to the same time constraints and procedures of §§ 60.5, 60.8, 60.9, 60.10, 60.11, 60.12, 60.13, 60.14, 60.15, or 60.16 as applicable to the original action which was reported.
(c) The subject will be sent 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 NPDB that will be permanently appended to the report, either directly or through a designated representative; (The NPDB will distribute the statement to queriers, where identifiable, and to the reporting entity and the subject of the report. Only the subject can, upon request, make changes to the statement. The NPDB will not edit the statement; however the NPDB reserves the right to redact personal identifying and offensive language that does not change the factual nature of the statement.); or
(3) May follow the dispute process in accordance with § 60.21.
(a)
(b)
(1) With respect to the health care practitioner for whose benefit the payment is made:
(i) Name,
(ii) Work address,
(iii) Home address, if known,
(iv) Social Security Number, if known, and if obtained in accordance with section 7 of the Privacy Act of 1974 (5 U.S.C. 552a note),
(v) Date of birth,
(vi) Name of each professional school attended and year of graduation,
(vii) For each professional license: the license number, the field of licensure, and the name of the state or territory in which the license is held,
(viii) Drug Enforcement Administration registration number, if known, and
(ix) Name of each hospital with which he or she is affiliated, if known;
(2) With respect to the reporting entity:
(i) Name and address of the entity making the payment,
(ii) Name, title, and telephone number of the responsible official submitting the report on behalf of the entity, and
(iii) Relationship of the reporting entity to the health care practitioner for whose benefit the payment is made;
(3) With respect to the judgment or settlement resulting in the payment:
(i) Where an action or claim has been filed with an adjudicative body, identification of the adjudicative body and the case number,
(ii) Date or dates on which the act(s) or omission(s) which gave rise to the action or claim occurred,
(iii) Date of judgment or settlement,
(iv) Amount paid, date of payment, and whether payment is for a judgment or a settlement,
(v) Description and amount of judgment or settlement and any conditions attached thereto, including terms of payment,
(vi) A description of the acts or omissions and injuries or illnesses upon which the action or claim was based,
(vii) Classification of the acts or omissions in accordance with a reporting code adopted by the Secretary, and
(viii) Other information as required by the Secretary from time to time after publication in the
(c)
(d)
(a)
(1) Which revokes or suspends (or otherwise restricts) a physician's or dentist's license,
(2) Which censures, reprimands, or places on probation a physician or dentist, or
(3) Under which a physician's or dentist's license is surrendered.
(b)
(1) The physician's or dentist's name,
(2) The physician's or dentist's work address,
(3) The physician's or dentist's home address, if known,
(4) The physician's or dentist's Social Security number or Individual Tax Identification Number (ITIN), if known, and if obtained in accordance with section 7 of the Privacy Act of 1974 (5 U.S.C. 552a note),
(5) National Provider Identifier (NPI),
(6) The physician's or dentist's date of birth,
(7) Name of each professional school attended by the physician or dentist and year of graduation,
(8) For each professional license, the physician's or dentist's license number, the field of licensure and the name of the state or territory in which the license is held,
(9) The physician's or dentist's Drug Enforcement Administration registration number, if known,
(10) A description of the acts or omissions or other reasons for the action taken,
(11) A description of the Board action, the date the action was taken, its effective date and duration,
(12) Classification of the action in accordance with a reporting code adopted by the Secretary, and
(13) Other information as required by the Secretary from time to time after publication in the
(c)
(a)
(1) Any adverse action taken by the licensing or certification authority of the state as a result of a formal proceeding, including revocation or suspension of a license, or certification agreement or contract for participation in a government health care program (and the length of any such suspension), reprimand, censure, or probation;
(2) Any dismissal or closure of the formal proceeding by reason of the health care practitioner, health care entity, provider, or supplier surrendering the license or certification agreement or contract for participation in a government health care program, or leaving the state or jurisdiction;
(3) Any other loss of license or loss of the certification agreement or contract for participation in a government health care program, or the right to apply for, or renew, a license or certification agreement or contract of the health care practitioner, health care entity, provider or supplier, whether by operation of law, voluntary surrender, nonrenewal (excluding non-renewals due to nonpayment of fees, retirement, or change to inactive status), or otherwise;
(4) Any negative action or finding by such authority, organization, or entity regarding the health care practitioner, health care entity, provider, or supplier.
(b)
(1) If the subject is an individual, personal identifiers, including:
(i) Name,
(ii) Social Security Number or ITIN, if known, and if obtained in accordance with section 7 of the Privacy Act of 1974 (5 U.S.C. 552a note),
(iii) Home address or address of record,
(iv) Sex, and
(v) Date of birth.
(2) If the subject is an individual, employment or professional identifiers, including:
(i) Organization name and type,
(ii) Occupation and specialty, if applicable,
(iii) National Provider Identifier (NPI),
(iv) Name of each professional school attended and year of graduation, and
(v) With respect to the 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 when used by the subject as a Taxpayer Identification Number (TIN),
(iv) The NPI,
(v) Type of organization, and
(vi) With respect to the 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) Name of the agency taking the action,
(vi) Name and address of the reporting entity, and
(vii) The name, title and telephone number of the responsible official submitting the report on behalf of the reporting entity.
(c)
(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, 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, including, but not limited to 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 Number(s) 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, including, but not limited to 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) Whether the subject will be automatically reinstated.
(ii) The date of appeal, if any.
(d)
(e) Sanctions for failure to report. The Secretary will provide for a publication of a public report that identifies failures to report information on adverse actions as required to be reported under this section.
(a)
(1) Formal or official actions, such as revocation or suspension of a license or certification agreement or contract for participation in government health care programs (and the length of any such suspension), reprimand, censure or probation,
(2) Any dismissal or closure of the proceedings by reason of the health care practitioner, provider, or supplier surrendering their license or certification agreement or contract for participation in government health care programs, or leaving the state or jurisdiction,
(3) Any other loss of the license or loss of the certification agreement or contract for participation in government health care programs, or the right to apply for, or renew, a license or certification agreement or contract of the health care practitioner, provider, or supplier, whether by operation of law, voluntary surrender, nonrenewal (excluding non-renewals due to nonpayment of fees, retirement, or change to inactive status), or otherwise, and
(4) Any other negative action or finding by such Federal agency that is publicly available information.
(b)
(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, employment or professional identifiers, including:
(i) Organization name and type,
(ii) Occupation and specialty, if applicable,
(iii) National Provider Identifier (NPI),
(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,
(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) Name of the agency taking the action,
(vi) Name and address of the reporting entity, and
(vii) The name, title, and telephone number of the responsible official submitting the report on behalf of the reporting entity.
(c)
(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, 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, including, but not limited to 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 Number(s) 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, including, but not limited to 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) Whether the subject will be automatically reinstated.
(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 agencies that have failed to report information on adverse actions as required to be reported under this section.
(a)
(b)
(c)
(d)
(a)
(i) Any professional review action that adversely affects the clinical privileges of a physician or dentist for a period longer than 30 days,
(ii) Acceptance of the surrender of clinical privileges or any restriction of such privileges by a physician or dentist:
(A) While the physician or dentist is under investigation by the health care
(B) In return for not conducting such an investigation or proceeding, or
(iii) In the case of a health care entity which is a professional society, when it takes a professional review action concerning a physician or dentist.
(2)
(3)
(i) Name,
(ii) Work address,
(iii) Home address, if known,
(iv) Social Security Number, if known, and if obtained in accordance with section 7 of the Privacy Act of 1974,
(v) Date of birth,
(vi) Name of each professional school attended and year of graduation,
(vii) For each professional license: the license number, the field of licensure, and the name of the state or territory in which the license is held,
(viii) DEA registration number, if known,
(ix) A description of the acts or omissions or other reasons for privilege loss, or, if known, for surrender,
(x) Action taken, date the action was taken, and effective date of the action, and
(xi) Other information as required by the Secretary from time to time after publication in the
(b)
(c)
(i) The request for a hearing is untimely,
(ii) The health care entity does not provide a statement of material factual issues in dispute, or
(iii) The statement of factual issues in dispute is frivolous or inconsequential.
In the event that the Secretary denies a hearing, the Secretary will send a written denial to the health care entity setting forth the reasons for denial. If a hearing is denied, or, if as a result of the hearing the entity is found to be in noncompliance, the Secretary will publish the name of the health care entity in the
(2)
(a)
(b)
(1) If the subject is an individual, personal identifiers, including:
(i) Name,
(ii) Social Security Number (or ITIN) (states must report this information, if known, and if obtained in accordance with section 7 of the Privacy Act of 1974),
(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).
(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, 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)
(1) If the subject is an individual, personal identifiers, including:
(i) Other name(s) used,
(ii) Other address(es), 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, including, but not limited to 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, including, but not limited to 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 or file number(s), and
(iv) The date of appeal, if any.
(d)
(e)
(a)
(b)
(c)
(d)
(e)
(a)
(b)
(1) If the subject is an individual, personal identifiers, including:
(i) Name,
(ii) Social Security Number (or ITIN) (state law and fraud enforcement agencies must report this information if known, and if obtained in accordance with section 7 of the Privacy Act of 1974),
(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).
(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, 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)
(1) If the subject is an individual, personal identifiers, including:
(i) Other name(s) used,
(ii) Other address(es),
(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, including, but not limited to 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, including, but
(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)
(e)
(a)
(b)
(c)
(d)
(e)
(a)
(1) At the time a health care practitioner applies for a position on its medical staff (courtesy or otherwise) or for clinical privileges at the hospital; and
(2) Every 2 years for any health care practitioner who is on its medical staff (courtesy or otherwise) or has clinical privileges at the hospital.
(b)
(c)
(a)
(1) Information reported under §§ 60.7, 60.8, and 60.12 of this part is available to:
(i) A hospital that requests information concerning a health care practitioner who is on its medical staff (courtesy or otherwise) or has clinical privileges at the hospital,
(ii) A health care practitioner who requests information concerning himself or herself,
(iii) A State Medical Board of Examiners or other state authority that licenses health care practitioners,
(iv) A health care entity which has entered or may be entering into an employment or affiliation relationship with a health care practitioner, or to which the health care practitioner has applied for clinical privileges or appointment to the medical staff,
(v) An attorney, or individual representing himself or herself, who has filed a medical malpractice action or claim in a state or Federal court or other adjudicative body against a hospital, and who requests information regarding a specific health care practitioner who is also named in the action or claim. This information will be disclosed only upon the submission of evidence that the hospital failed to request information from the NPDB, as required by § 60.17(a) of this part, and may be used solely with respect to litigation resulting from the action or claim against the hospital,
(vi) A health care entity with respect to professional review activity, and
(vii) A person or entity requesting statistical information, in a form which does not permit the identification of any individual or entity.
(2) Information reported under §§ 60.9, 60.10, 60.11, 60.13, 60.14, 60.15, and 60.16 of this part is available to the agencies, authorities, and officials listed below that request information on licensure or certification actions, any other negative actions or findings, or final adverse actions concerning an individual practitioner, health care entity, provider, or supplier. These agencies, authorities, and officials may obtain data for the purposes of determining the fitness of individuals to provide health care services, protecting the health and safety of individuals receiving health care through programs administered by the requesting agency, and protecting the fiscal integrity of these programs.
(i) Agencies administering (including those providing payment for services) Federal health care programs, including private entities administering such programs under contract,
(ii) State licensing or certification agencies and Federal agencies responsible for the licensing and certification of health care practitioners, providers, or suppliers,
(iii) State agencies administering or supervising the administration of state health care programs (as defined in 42 U.S.C. 1128(h)),
(iv) State law or fraud enforcement agencies,
(v) Law enforcement officials and agencies such as:
(A) United States Attorney General,
(B) United States Chief Postal Inspector,
(C) United States Inspectors General;
(D) United States Attorneys,
(E) United States Comptroller General,
(F) United States Drug Enforcement Administration,
(G) United States Nuclear Regulatory Commission, or
(H) Federal Bureau of Investigation,
(vi) Utilization and quality control peer review organizations described in part B of title XI and to appropriate entities with contracts under section 1154(a)(4)(C) of the Social Security Act
(vii) Hospitals and other health care entities (as defined in section 431 of the Health Care Quality Improvement Act of 1986), with respect to health care practitioners who have entered (or may be entering) into employment or affiliation relationships with, or have applied for clinical privileges or appointments to the medical staff of such hospitals or other health care entities, but only with respect to information provided pursuant to §§ 60.9, 60.10, and 60.11, as well as information provided pursuant to §§ 60.13, 60.14, 60.15, and 60.16 by Federal agencies and health plans,
(viii) Health plans,
(ix) A health care practitioner, health care entity, provider, or supplier who requests information concerning himself, herself, or itself, and
(x) A person or entity requesting statistical information, in a form which does not permit the identification of any individual or entity. (For example, researchers may use statistical information to identify the total number of nurses with adverse licensure actions in a specific state. Similarly, researchers may use statistical information to identify the total number of health care entities denied accreditation.)
(b)
(a)
(b)
(1) Direct and indirect personnel costs, including salaries and fringe benefits such as medical insurance and retirement,
(2) Physical overhead, consulting, and other indirect costs (including materials and supplies, utilities, insurance, travel, and rent and depreciation on land, buildings, and equipment),
(3) Agency management and supervisory costs,
(4) Costs of enforcement, research, and establishment of regulations and guidance,
(5) Use of electronic data processing equipment to collect and maintain information—the actual cost of the service, including computer search time, runs and printouts, and
(6) Any other direct or indirect costs related to the provision of services.
(c)
(a)
(b)
(a)
(b)
(2) The NPDB will send the report, with a notation that the report has been placed in “disputed status,” to queriers (where identifiable), the reporting entity and the subject of the report.
(3) The subject must attempt to enter into discussion with the reporting entity to resolve the dispute. If the reporting entity revises the information originally submitted to the NPDB, the NPDB will notify the subject and all entities to whom reports have been sent that the original information has been revised. If the reporting entity does not revise the reported information, or does not respond to the subject within 60 days, the subject may request that the Secretary review the report for accuracy. The Secretary will decide whether to correct the report within 30 days of the request. This time frame may be extended for good cause. The subject also may provide a statement to the NPDB, either directly or through a designated representative that will permanently append the report.
(c)
(2) After the review, if the Secretary:
(i) Concludes that the information is accurate and reportable to the NPDB, the Secretary will inform the subject and the NPDB of the determination. The Secretary will include a brief statement (Secretarial Statement) in the report that describes the basis for the decision. The report will be removed from “disputed status.” The NPDB will distribute the corrected report and statement(s) to previous queriers (where identifiable), the reporting entity and the subject of the report.
(ii) Concludes that the information contained in the report is inaccurate, the Secretary will inform the subject of the determination and direct the NPDB or the reporting entity to revise the report. The Secretary will include a brief statement (Secretarial Statement) in the report describing the findings. The NPDB will distribute the corrected report and statement(s) to previous queriers (where identifiable), the reporting entity and the subject of the report.
(iii) Determines that the disputed issues are outside the scope of the Department's review, the Secretary will inform the subject and the NPDB of the determination. The Secretary will include a brief statement (Secretarial Statement) in the report describing the findings. The report will be removed from “disputed status.” The NPDB will
(iv) Determines that the adverse action was not reportable and therefore should be removed from the NPDB, the Secretary will inform the subject and direct the NPDB to void the report. The NPDB will distribute a notice to previous queriers (where identifiable), the reporting entity and the subject of the report that the report has been voided.
Individuals, entities or their authorized agents, and the NPDB shall not be held liable in any civil action filed by the subject of a report unless the individual, entity, or authorized agent submitting the report has actual knowledge of the falsity of the information contained in the report.