[Code of Federal Regulations]
[Title 45, Volume 1]
[Revised as of October 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 45CFR60.9]

[Page 138-140]
 
                        TITLE 45--PUBLIC WELFARE
 
                           AND HUMAN SERVICES
 
PART 60--NATIONAL PRACTITIONER DATA BANK FOR ADVERSE INFORMATION ON 
PHYSICIANS AND OTHER HEALTH CARE PRACTITIONERS--Table of Contents
 
                   Subpart B--Reporting of Information
 
Sec. 60.9  Reporting adverse actions on clinical privileges.

    (a) Reporting to the Board of Medical Examiners--(1) Actions that 
must be reported and to whom the report must be made. Each health care 
entity must report to the Board of Medical Examiners in the State in 
which the health care entity is located the following actions:
    (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 entity relating to possible incompetence or improper 
professional conduct, or
    (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.

[[Page 139]]

    (2) Voluntary reporting on other health care practitioners. A health 
care entity may report to the Board of Medical Examiners information as 
described in paragraph (a)(3) of this section concerning actions 
described in paragraph (a)(1) in this section with respect to other 
health care practitioners.
    (3) What information must be reported. The health care entity must 
report the following information concerning actions described in 
paragraph (a)(1) of this section with respect to the physician or 
dentist:
    (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) Drug Enforcement Administration 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 Federal Register and after an opportunity 
for public comment.
    (b) Reporting by the Board of Medical Examiners to the National 
Practitioner Data Bank. Each Board must report, in accordance with 
Sec.Sec. 60.4 and 60.5, the information reported to it by a health care 
entity and any known instances of a health care entity's failure to 
report information as required under paragraph (a)(1) of this section. 
In addition, each Board must simultaneously report this information to 
the appropriate State licensing board in the State in which the health 
care entity is located, if the Board is not such licensing board.
    (c) Sanctions--(1) Health care entities. If the Secretary has reason 
to believe that a health care entity has substantially failed to report 
information in accordance with Sec. 60.9, the Secretary will conduct an 
investigation. If the investigation shows that the health care entity 
has not complied with Sec. 60.9, the Secretary will provide the entity 
with a written notice describing the noncompliance, giving the health 
care entity an opportunity to correct the noncompliance, and stating 
that the entity may request, within 30 days after receipt of such 
notice, a hearing with respect to the noncompliance. The request for a 
hearing must contain a statement of the material factual issues in 
dispute to demonstrate that there is cause for a hearing. These issues 
must be both substantive and relevant. The hearing will be held in the 
Washington, DC, metropolitan area. The Secretary will deny a hearing if:
    (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 Federal Register. In 
such case, the immunity protections provided under section 411(a) of the 
Act will not apply to the health care entity for professional review 
activities that occur during the 3-year period beginning 30 days after 
the date of publication of the entity's name in the Federal Register.
    (2) Board of Medical Examiners. If, after notice of noncompliance 
and providing opportunity to correct noncompliance, the Secretary 
determines that a Board has failed to report information in accordance 
with paragraph (b) of this section, the Secretary will

[[Page 140]]

designate another qualified entity for the reporting of this 
information.

(Approved by the Office of Management and Budget under control number 
0915-0126)

[54 FR 42730, Oct. 17, 1989, as amended at 59 FR 61555, Dec. 1, 1994]