[Federal Register Volume 71, Number 54 (Tuesday, March 21, 2006)]
[Proposed Rules]
[Pages 14135-14149]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-2686]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration

45 CFR Part 60

RIN 0906-AA43


National Practitioner Data Bank for Adverse Information on 
Physicians and Other Health Care Practitioners: Reporting on Adverse 
and Negative Actions

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Notice of proposed rulemaking.

-----------------------------------------------------------------------

SUMMARY: This proposed rule would revise existing regulations under 
sections 401-432 of the Health Care Quality Improvement Act of 1986, 
governing the National Practitioner Data Bank for Adverse Information 
on Physicians and Other Health Care Practitioners, to incorporate 
statutory requirements under section 1921 of the Social Security Act, 
as amended by section 5(b) of the Medicare and Medicaid Patient and 
Program Protection Act of 1987, and as amended by the Omnibus Budget 
Reconciliation Act of 1990.
    The Medicare and Medicaid Patient and Program Protection Act of 
1987, along with certain additional provisions in the Omnibus Budget 
Reconciliation Act of 1990, was designed to protect program 
beneficiaries from unfit health care practitioners, and otherwise 
improve the anti-fraud provisions of the Medicare and State health care 
programs. Section 1921, the statutory authority upon which this 
regulatory action is based, requires each State to adopt a system of 
reporting to the Secretary of Health and Human Services (the Secretary) 
certain adverse licensure actions taken against health care 
practitioners and health care entities licensed or otherwise authorized 
by a State (or a political subdivision thereof) to provide health care 
services. It also requires each State to report any negative actions or 
findings that a State licensing authority, peer review organization, or 
private accreditation entity has concluded against a health care 
practitioner or health care entity.

DATES: Comments on this proposed rule are invited. To be considered, 
comments must be received by May 22, 2006.

ADDRESSES: Written comments should be addressed to the Associate 
Administrator, Bureau of Health Professions (BHPr), Health Resources 
and Services Administration, Room 8-05, Parklawn Building, 5600 Fishers 
Lane, Rockville, Maryland 20857. Additionally, comments may be sent via 
e-mail to [email protected]. All comments received will be 
available for public inspection and copying at the Practitioner Data 
Banks Branch, Office of Workforce Evaluation and Quality Assurance, 
BHPr, Parklawn Building, 5600 Fishers Lane, Room 8-103, Rockville, MD 
20857, weekdays (Federal holidays excepted) between the hours of 8:30 
a.m. and 5 p.m. Comments also may be sent through the Federal 
eRulemaking Portal: http://www.regulations.gov. Follow instructions for 
submitting comments.

FOR FURTHER INFORMATION CONTACT: Mr. Mark S. Pincus, Chief, 
Practitioner Data Banks Branch, Office of Workforce Evaluation and 
Quality Assurance, Bureau of Health Professions, Health Resources and 
Services Administration, Parklawn Building, 5600 Fishers Lane, Room 8-
103, Rockville, MD 20857; telephone number: (301) 443-2300.

SUPPLEMENTARY INFORMATION:

I. Background

The Health Care Quality Improvement Act of 1986

    The National Practitioner Data Bank (NPDB) was established by the 
Health Care Quality Improvement Act (HCQIA) of 1986, as amended (42 
U.S.C. 11101 et seq.). The NPDB contains reports of adverse licensure 
actions against physicians and dentists (including revocations, 
suspensions, reprimands,

[[Page 14136]]

censures, probations, and surrenders for quality of care purposes 
only); adverse clinical privilege actions against physicians and 
dentists; adverse professional society membership actions against 
physicians and dentists; and medical malpractice payments made for the 
benefit of any health care practitioner. Groups that have access to 
this data system include hospitals, other health care entities that 
conduct peer review and provide health care services, State Medical or 
Dental Boards and other health care practitioner State boards. 
Individual practitioners can self-query. The reporting of information 
under the NPDB is limited to medical malpractice payers, State Medical 
and Dental Boards, professional societies with formal peer review, and 
hospitals and other health care entities (such as health maintenance 
organizations).
    The current regulations governing the NPDB which are not expanded 
or modified by section 1921 are not subject to review or comment under 
this Notice of Proposed Rulemaking, e.g., current reporting 
requirements for medical malpractice payers, current eligible entities 
which may query the NPDB.

Section 1921 of the Social Security Act

    Section 1921 of the Social Security Act (herein referred to as 
section 1921), as amended by section 5(b) of the Medicare and Medicaid 
Patient and Program Protection Act of 1987, Public Law 100-93, and as 
amended by the Omnibus Budget Reconciliation Act of 1990, Public Law 
101-508, expands the scope of the NPDB. Section 1921 requires each 
State to adopt a system of reporting to the Secretary certain adverse 
licensure actions taken against health care practitioners and health 
care entities by any authority of the State responsible for the 
licensing of such practitioners or entities. It also requires each 
State to report any negative action or finding that a State licensing 
authority, a peer review organization (except as noted below), or a 
private accreditation entity has concluded against a health care 
practitioner or health care entity.
    Groups that have access to this information include all 
organizations eligible to query the NPDB under the HCQIA (hospitals, 
other health care entities that conduct peer review and provide health 
care services, State Medical or Dental Boards and other health care 
practitioner State boards), other State licensing authorities, agencies 
administering Federal health care programs, including private entities 
administering such programs under contract, State agencies 
administering or supervising the administration of State health care 
programs, State Medicaid fraud control units, and certain law 
enforcement agencies, and utilization and quality control Quality 
Improvement Organizations (QIOs) as defined in Part B of title XI of 
the Social Security Act and appropriate entities with contracts under 
section 1154-3(a)(4)(C) of the Social Security Act. Individual health 
care practitioners and entities can self-query. The reporting of 
information under section 1921 is limited to State licensing and 
certification authorities, peer review organizations, and private 
accreditation entities.
    The Department has determined that the statutory language 
establishing reporting requirements at section 1921(a)(1) is unclear 
with respect to whether utilization and quality control peer review 
organizations (PROs) and their successor entities Quality Improvement 
Organizations (QIOs) are required to report to the NPDB.
    Section 1921(a)(1) refers to reporting of proceedings by ``any peer 
review organization''. Yet, section 1921(b)(4), when discussing who may 
have access to information, refers to ``utilization and quality control 
peer review organizations described in Part B of title XI * * *'' This 
indicates that the earlier reference to ``any peer review 
organization'' does not refer to ``utilization and quality control peer 
review organizations described in Part B of title XI * * *''
    We are proposing therefore that the reporting requirements at 
section 1921(a) not apply to QIOs. We are requesting specific comment 
on this choice. We based this decision on several factors. First, the 
critical mission of the QIO program is its focus on maintaining 
collaborative relationships with providers and practitioners to improve 
the quality of health care services delivered to Medicare 
beneficiaries. The reporting of QIO sanction recommendations to the 
NPDB will significantly interfere with the progress that has been made 
towards this goal and will substantially reduce the ability of QIOs to 
carry out their statutory and contractual obligations.
    Second, we believe that the established QIO process allows that 
these actions will ultimately be reported to the NPDB. A QIO is 
required in regulation to disclose information that displays practice 
or performance patterns of a practitioner or institution to Federal and 
State agencies that are responsible for the investigation of fraud and 
abuse of the Medicare or Medicaid programs or that are responsible for 
licensing and certification of practitioners and entities. In addition, 
the QIO must disclose sanction reports directly to the Office of the 
Inspector General and, if requested, CMS, and provide notice to the 
State medical board or other appropriate licensing boards for other 
practitioners when it submits a report and recommendations to the OIG. 
Finally, the QIO must disclose, upon request, and may disclose without 
a request, sanction reports to State and Federal agencies responsible 
for the identification, investigation, or prosecution of fraud and 
abuse.
    We are also concerned that QIO reporting may create misconceptions 
about the meaning of QIO sanction recommendations if reported to the 
NPDB. This is based on the fact that a sanction recommendation made by 
the QIO is only a recommendation, and may or may not trigger further 
action by the OIG or a State licensing board.
    Furthermore, when the OIG does not impose the recommended sanction, 
the QIO continues to monitor the performance of the affected party. If 
a QIO sanction recommendation results in OIG imposition of an exclusion 
from Medicare/Medicaid, that information is reported to the NPDB. If a 
QIO sanction recommendation results in a licensure action by a State 
licensing board, that information is reported to the NPDB as well.
    Section 1921 requires ``any peer review organization'' to report to 
the NPDB. As proposed, the QIOs and other organizations used by the CMS 
to support the QIO program are not required to report to the NPDB. 
However, as proposed, all other peer review organizations are still 
required to do so. We are also aware of other types of peer review 
organizations or peer review organization-like entities (public and 
private) which are not linked to the QIO program. It is unclear what 
negative actions these entities take, what negative findings they make, 
or to whom recommendations are presented. Thus, we request that 
reviewers, particularly peer review organizations which are not QIOs or 
supporting the QIO program, carefully review this portion of the 
proposed regulation. Specifically, reviewers are requested to provide 
comments regarding, but not limited to, the proposed definition of a 
peer review organization, potential reportable events, relationships 
with other entities, public or private status, and types of 
practitioners and entities reviewed.
    Section 1921 requires that private accreditation organizations 
report actions to the NPDB. We request that the public carefully review 
this portion of the proposed rule and provide

[[Page 14137]]

comments on any limitation on reporting that may apply to these 
organizations.

Section 1128E of the Social Security Act

    The Secretary recognizes that the reporting requirements of both 
section 422 of the HCQIA and section 1921 overlap with the requirements 
under section 1128E of the Social Security Act (herein referred to as 
section 1128E), as added by section 221(a) of the Health Insurance 
Portability and Accountability Act of 1996, Public Law 104-191. Section 
1128E directs the Secretary to establish and maintain a national health 
care fraud and abuse data collection program for the reporting and 
disclosing of certain final adverse actions taken against health care 
providers, suppliers or practitioners. This data bank is known as the 
Healthcare Integrity and Protection Data Bank (HIPDB). The HIPDB began 
collecting reports in November 1999.

Distinctions Between the NPDB and the HIPDB

    Although section 422 of the HCQIA and sections 1921 and 1128E have 
overlapping components, we note that the statutes have unique 
characteristics, including differences in the types of reportable 
adverse actions and individuals or entities with access to adverse 
action information. For example, the HCQIA allows for the reporting of 
licensure actions based on professional conduct and competence only 
against physicians and dentists, whereas sections 1921 and 1128E allow 
for reporting of all licensure actions against all health care 
practitioners. Hospitals have access under the HCQIA and section 1921, 
but not under section 1128E. The chart below illustrates the 
differences among the HCQIA, section 1921, and section 1128E.
    Section 1921 requires that reporting of licensure actions taken 
against physicians and dentists to the NPDB be expanded, which will 
match the reporting requirements of HIPDB. Currently, the HCQIA limits 
reporting by medical and dental boards only to those adverse actions 
related to professional competence or professional conduct. The change 
will make the reporting of adverse actions by all State licensure and 
certification authorities identical for both the NPDB and HIPDB. There 
will be no increased reporting burden for the medical and dental 
boards. No current NPDB reporting requirements will be changed for 
hospitals, other health care entities, professional societies, or 
medical malpractice payers.

------------------------------------------------------------------------
 
-------------------------------------------------------------------------
                                  HCQIA
------------------------------------------------------------------------
Who Reports?
   Medical malpractice payers
   Boards of Medical/Dental Examiners
   Hospitals
   Other health care entities
   Professional societies with formal peer review
What Information Is Avaialble?
   Medical malpractice payments (all health care practitioners)
   Adverse licensure actions (physicians/dentist)
  --Revocation, suspension, reprimand, probation, surrender, censure
   Adverse clinical privilege actions (primarily physicians/
   dentists)
   Adverse professional society membership (primarily physicians/
   dentists)
Who Can Query?
   Hospitals
   Other health care entities with formal peer review
   Professional societies with formal peer review
   Boards of Medical/Dental Examiners
   Other health care practitioners State licensing boards
   Plaintiff's attorney/pro se plaintiffs (plaintiffs
   representing themselves, limited circumstances)
   Health care practitioners (self-query)
   Researchers (statistical data only)
------------------------------------------------------------------------
                              Section 1921
------------------------------------------------------------------------
Who Reports?
   State health care practitioner licensing boards
   State health care entity licensing boards
   Peer review organizations
   Private accreditation organizations
What Information Is Available?
   Any adverse licensure actions (practitioners/entities)
  --Revocation, reprimand, censure, suspension (including length),
   probation
  --Any dismissal or closure of the proceedings by reason of the
   practitioner or entity surrendering the license or leaving the State
   or jurisdiction
  --Any other loss of the license
   Any negative action or finding by a State licensing
   authority, peer review organization, or private accreditation
   organization concluded against a health care practitioner or entity
Who Can Query?
   Hospitals and other health care entities (Title IV)
   Professional societies with formal peer review
   State health care practitioner/entity licensing boards
   Agencies administering Federal health care programs, or their
   contractors
   State agencies administering State health care programs
   Quality Improvement Organizations
   State Medicaid Fraud Control Units
   U.S. Comptroller General
   U.S. Attorney General and other law enforcement
   Health care practitioners/entities (self-query)
   Researchers (statistical data only)
------------------------------------------------------------------------
                              Section 1128E
------------------------------------------------------------------------
Who Reports?
   Federal and State Government Agencies
   Health Plans
What Information Is Avaialble?
   Licensing and certification actions (practitioners,
   providers, and suppliers) revocation, reprimand, suspension
   (including length), censure, probation; any other loss of license, or
   right to apply for, or renew, a license of the provider, supplier, or
   practitioner, whether by voluntary surrender, non-renewability, or
   otherwise and; any other negative action or finding that is publicly
   available information
   Health care-related civil judgments (practitioners,
   providers, and suppliers)
   Health care-related criminal convictions (practitioners,
   providers, and suppliers)
   Exclusions from Federal or State health care programs
   (practitioners, providers, and suppliers)
   Other adjudicated actions or decisions (practitioners,
   providers, and suppliers)
Who Can Query?
   Federal and State Government Agencies
   Health Plans
   Health care practitioners/providers/suppliers (self-query)
   Researchers (statistical data only)
------------------------------------------------------------------------
                                  HIPDB
------------------------------------------------------------------------
Who Reports?
   Federal and State Government Agencies
   Health Plans
What Information Is Available?
   Licensing and certification actions (practitioners,
   providers, and suppliers) revocation, reprimand, suspension
   (including length), censure, probation voluntary surrender, any other
   negative action or finding by a Federal or State licensing or
   certification agency that is publicly available information
   Health care-related civil judgments (practitioners,
   providers, and suppliers)
   Health care-related criminal convictions (practitioners,
   providers and suppliers)
   Exclusions from Federal or State health care programs
   (practitioners, providers, and suppliers)
   Other adjudicated actions or decisions (practitioners,
   providers, and suppliers)
Who Can Query?
   Federal and State Government Agencies
   Health Plans
   Health care practitioners/providers/suppliers (self-query)
   Researchers (statistical data only)
------------------------------------------------------------------------
                              Expanded NPDB
------------------------------------------------------------------------
Who Reports?
   Medical malpractice payers
   State health care practitioner licensing and certification
   authorities (including medical and dental boards)
   Hospitals
   Other health care entities with formal peer review (HMO's,
   group practices, managed care organizations)

[[Page 14138]]

 
   Professional societies with formal peer review
   State entity licensing and certification authorities
   Peer review organizations
   Private accreditation organizations
What Information Is Available?
   Medical malpractice payments (all health care practitioners)
   Any adverse licensure actions (all practitioners or entities)
    --Revocation, reprimand, censure, suspension, probation
    --Any dismissal or closure of the proceedings by reason of the
     practitioner or entity surrendering the license or leaving the
     State or jurisdiction
    --Any other loss of license
   Adverse clinical privileging actions
   Adverse professional society membership actions
   Any negative action or finding by a State licensing or
   certification authority
   Peer review organization negative actions or finding against
   a health care practitioner or entity
   Private accreditation organization negative actions or
   findings against a health care practitioner or entity
Who Can Query?
   Hospitals
   Other health care entities, with formal peer review
   Professional societies with formal peer review
   State health care practitioner licensing and certification
   authorities (including medical and dental boards)
   State entity licensing and certification authorities*
   Agencies or contractors administering Federal health care
   programs*
   State agencies administering State health care programs*
   State Medicaid Fraud Units*
   U.S. Comptroller General*
   U.S. Attorney General and other law enforcement*
   Health care practitioners (self query)
   Plaintiff's attorney/pro se plaintiffs (under limited
   circumstances)**
   Quality Improvement Organizations*
   Researchers (statistical data only)
------------------------------------------------------------------------
* Eligible to receive only those reports authorized by section 1921.
** Eligible to receive only those reports authorized by HCQIA.

Maximum Coordination Between the NPDB and HIPDB

    Section 1921 requires the Secretary to provide for the maximum 
appropriate coordination in the implementation of its reporting 
requirements with those of section 422 of the HCQIA. The Secretary also 
is proposing to implement this regulation in a manner to avoid the need 
for an entity which must report information to both the NPDB and the 
HIPDB to file two reports. We have made significant efforts to develop 
these proposed regulations in a manner that minimizes the burden on 
reporters. Therefore, reporters responsible for reporting the final 
adverse actions to both the NPDB and HIPDB will be required only to 
submit one report per action, provided that reporting is made through 
the Department's consolidated reporting mechanism that will sort the 
appropriate actions into the HIPDB, NPDB or both. The required 
adjustments to the reporting mechanism are made easier because both 
data banks are operated through the same contractor and managed by 
HRSA.

II. Provisions of the Proposed Rule

    We note that certain sections of the existing NPDB regulations 
satisfy section 1921 requirements for the NPDB and, therefore, are 
applicable to the section 1921 component of the NPDB. Specifically, the 
following provisions would apply: (1) The provisions in Sec.  60.6, 
pertaining to reporting errors, omissions, and revisions to an action 
previously reported to the NPDB; (2) the confidentiality provisions in 
the redesignated Sec.  60.15 (formerly Sec.  60.13); and (3) the 
provisions in the redesignated Sec.  60.16 (formerly Sec.  60.14), 
regarding procedures for disputing the accuracy of information in the 
NPDB. The proposed amendments are described below according to the 
sections of the regulations which they affect.

Section 60.3 Definitions

    We propose to add the following new terms to this section:
    Affiliated or associated refers to health care entities with which 
a subject of a report has a business or professional relationship. This 
includes, but is not limited to, organizations, associations, 
corporations, or partnerships. This also includes a professional 
corporation or other business entity composed of a single individual.
    Formal proceeding means a formal or official proceeding held before 
a State licensing or certification authority, peer review organization, 
or private accreditation entity. We believe that by defining ``formal 
proceeding'' in this manner, State licensing authorities, peer review 
organizations, and private accreditation entities will have maximum 
flexibility in determining the process they will follow in conducting 
such proceedings.
    Negative action or finding by a State licensing or credentialing 
authority, peer review organization, or private accreditation entity 
means:
    (a) Receipt of less than full accreditation from a private 
accreditation entity that indicates a substantial risk to the safety of 
patient care or quality of health care services and includes, but is 
not limited to, denial of accreditation or non-accreditation;
    (b) Any recommendation by a peer review organization to sanction a 
practitioner; or
    (c) 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 excludes administrative fines, or citations and corrective 
action plans, unless they are: (1) Connected to the delivery of health 
care services, and (2) taken in conjunction with other licensure or 
certification actions such as revocation, suspension, censure, 
reprimand, probation, or surrender.
    Organization name means the subject's business or employer at the 
time the underlying acts occurred. If more than one business or 
employer is applicable, the one most closely related to the underlying 
acts should be reported as the ``organization name'' with the others 
being reported as the ``affiliated or associated health care 
entities.''
    Organization type means a description of the nature of that 
business or employer.
    Peer review organization means an organization with the primary 
purpose of evaluating the quality of patient care practices or services 
ordered or performed by health care practitioners measured against 
objective criteria which define acceptable and adequate practice 
through an evaluation by a sufficient number of health practitioners in 
such area to assure adequate peer review.
    Private accreditation entity means an entity or organization, 
including but not limited to the Joint Commission on Accreditation of 
Healthcare Organizations, National Committee for Quality Assurance, 
Utilization Review Accreditation Commission, Commission on 
Accreditation of Rehabilitation Facilities, and the Community Health 
Accreditation Program, that:
    (a) Evaluates and seeks to improve the quality of health care 
providers by a health care entity;
    (b) Measures a health care entity's performance based on a set of 
standards and assigns a level of accreditation; and
    (c) Conducts ongoing assessments and periodic reviews of the 
quality of health care provided by a health care entity.
    We believe that this definition of ``private accreditation entity'' 
is necessary in order to include voluntary reviews by all outside 
accrediting organizations.

[[Page 14139]]

    Quality Improvement Organization means an entity defined in part B 
of title XI of the Social Security Act and appropriate entities with 
contracts under section 1154(a)(4)(C) of the Social Security Act.
    A utilization and quality control Quality Improvement Organization 
(as defined in part B of title XI of the Social Security Act) means an 
entity which--

    ``(1)(A) 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 (B) 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 it governing 
body.''

    Voluntary surrender means a surrender made after a notification of 
investigation or a formal official request by a State licensing 
authority for a health care practitioner or entity to surrender a 
license. The definition also includes those instances where a health 
care practitioner or entity voluntarily surrenders a license in 
exchange for a decision by the licensing authority to cease an 
investigation or similar proceeding, or in return for not conducting an 
investigation or proceeding, or in lieu of a disciplinary action.
    Section 1921 specifically requires the reporting of a health care 
practitioner or entity who voluntarily surrenders a license. Based on 
extensive discussions with various State licensing authorities, we have 
been advised that the voluntary surrender and non-renewal of licensure 
are used by Federal and State health care programs as a means to 
exclude questionable health care practitioners and entities from 
participation. These voluntary surrenders and non-renewal actions, if 
not reported to the NPDB, would result in allowing health care 
practitioners or entities to move from State to State without 
detection. We also recognize that many voluntary surrenders are not a 
result of the types of adverse actions that are intended for inclusion 
in the NPDB. Therefore, we are proposing that voluntary surrenders and 
licensure non-renewals due to nonpayment of licensure fees, changes to 
inactive status and retirements be excluded from reporting to the NPDB 
unless they are taken in combination with a revocation, suspension, 
reprimand, censure, or probation, in which case they would be 
reportable actions.

Section 60.5 When Information Must Be Reported

    We are proposing to amend this section by:
    1. Revising the introductory text of this section to include 
references to the newly added Sec. Sec.  60.9 and 60.10 and 
redesignated Sec.  60.11;
    2. Revising paragraph (b), ``Licensure Actions (Sec.  60.8 and 
Sec.  60.9),'' to refer specifically to the State Board of Medical 
Examiners and to clarify the requirements made in new Sec.  60.9;
    3. Revising the reference to ``Sec.  60.9'' in the title and the 
third sentence of paragraph (d) to read ``Sec.  60.11''; and
    4. Adding a new paragraph, ``Negative Action or Finding (Sec.  
60.10),'' to provide a new category of actions which are to be reported 
pursuant to section 1921.

Section 60.7 Reporting Medical Malpractice Payments

    In accordance with 42 CFR 1003.103(c), the Department's Office of 
Inspector General has raised the civil money penalty for each failure 
to report a medical malpractice payment from up to $10,000 to up to 
$11,000. Therefore, we propose to revise paragraph (c) to reflect this 
factual change.

Section 60.8 Reporting Licensure Actions Taken by Boards of Medical 
Examiners

    We propose to revise paragraph (b)(10) of this section, to make it 
consistent with the reporting requirements for States in the newly 
proposed Sec.  60.9, to require the reporting of the description of an 
action taken by a Board, to include the duration of a nonpermanent 
action.

Section 60.9 (New) Reporting Licensure Actions Taken by States

    We propose to redesignate Sec.  60.9 as Sec.  60.11, and add a new 
Sec.  60.9 to implement the reporting requirements of section 1921. 
Under this provision, each State, through the system adopted for 
reporting such information in section 1921(a)(1), would report directly 
to the NPDB.
    The following actions resulting from formal proceedings would be 
reported:
    1. Any adverse action taken by the licensing authority of the State 
resulting from a formal proceeding, including revocation or suspension 
of a license (and the length of any such suspension), reprimand, 
censure or probation;
    2. Any dismissal or closure of a formal proceeding due to the 
practitioner or entity surrendering the license or the practitioner 
leaving the State or jurisdiction;
    3. Any other loss of the license of the practitioner or entity, 
whether by operation of law, voluntary surrender or non-renewal 
(excluding those due to nonpayment of licensure renewal fees, 
retirement, or change to inactive status), or otherwise; and
    4. Any negative action or finding by such authority, organization, 
or entity regarding the practitioner or entity.
    Reportable actions, by statute, must be based on the result of 
formal proceedings. Thus, events unrelated to such proceedings would be 
excluded.

Section 60.10 (New) Reporting Negative Actions or Findings Taken by 
Peer Review Organizations or Private Accreditation Entities

    We are proposing to redesignate Sec.  60.10 as Sec.  60.12 and add 
a new Sec.  60.10 to implement the reporting requirements of section 
1921. Under this provision, each State is required to adopt a system of 
reporting to the NPDB any negative action or finding which a peer 
review organization or private accreditation entity has concluded 
against a health care practitioner or health care entity (both as 
defined in Sec.  60.3).

Section 60.13 Requesting Information From the National Practitioner 
Data Bank [Redesignated]

    Under the statute, section 1921 data would be released for the 
purpose of determining the fitness of an individual to provide health 
care services and to protect the health and safety of individuals 
receiving health care through programs administered by the requesting 
entities, as well as to protect the fiscal integrity of these programs. 
We propose to redesignate Sec.  60.11 as Sec.  60.13 and revise 
redesignated Sec.  60.13, paragraph (a), entitled ``Who may request 
information and what information may be available.'', to clarify to 
whom information in the HCQIA and section 1921 components of the NPDB 
would be made available as outlined below:
    (1) Information reported under Sec. Sec.  60.7, 60.8, and 60.11 is 
available only to:
    (i) A hospital that requests information concerning a physician,

[[Page 14140]]

dentist or other health care practitioner who is on its medical staff 
(courtesy or otherwise) or has clinical privileges at the hospital;
    (ii) A physician, dentist, or other health care practitioner who 
requests information concerning himself or herself;
    (iii) A State Medical Board of Examiners or other State authority 
that licenses physicians, dentists, or other health care practitioners;
    (iv) A health care entity which has entered or may be entering into 
an employment or affiliation relationship with a physician, dentist, or 
other health care practitioner, or to which the physician, dentist, or 
other 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 physician, dentist, or other 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 Sec.  60.12(a), 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, which 
does not permit the identification of any individual or entity. (For 
example, researchers can use statistical information to identify the 
total number of physicians with adverse licensure actions or medical 
malpractice payments in a specific State.)
    (2) Information reported under Sec. Sec.  60.9 and 60.10 is 
available only to the agencies, authorities, and officials listed below 
that request information on licensure disciplinary actions and any 
other negative actions or findings concerning an individual health care 
practitioner or entity. 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.
    (a) Agencies administering Federal health care programs, including 
private entities administering such programs under contract;
    (b) Authorities of States (or political subdivisions thereof) which 
are responsible for licensing health care practitioners and entities;
    (c) State agencies administering or supervising the administration 
of State health care programs (as defined in 42 U.S.C. 1128(h));
    (d) State Medicaid fraud control units (as defined in 42 U.S.C. 
1903(q));
    (e) Law enforcement officials and agencies such as:
    (1) United States Attorney General;
    (2) United States Chief Postal Inspector;
    (3) United States Inspectors General;
    (4) United States Attorneys;
    (5) United States Comptroller General;
    (6) United States Drug Enforcement Administration;
    (7) United States Nuclear Regulatory Commission;
    (8) Federal Bureau of Investigation; and
    (9) State law enforcement agencies, which include, but are not 
limited to, State Attorneys General.
    (f) Utilization and quality control Quality Improvement 
Organizations (QIOs) described in part B of title XI and appropriate 
entities with contracts under section 1154(a)(4)(C) of the Social 
Security Act with respect to eligible organizations reviewed under the 
contracts;
    (g) Hospitals and other health care entities (as defined in section 
431 of HCQIA), with respect to physicians or other licensed health care 
practitioners that 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 health care 
entities;
    (h) A physician, dentist, or other health care practitioner who, 
and an entity which, requests information concerning himself, herself, 
or itself; and
    (i) A person or entity requesting statistical information, in a 
form which does not permit the identification of any individual or 
entity. (For example, researchers can use statistical information to 
identify the total number of nurses with adverse licensure actions in a 
specific State. Similarly, researchers can use statistical information 
to identify the total number of health care entities denied 
accreditation.)

Section 60.14 Fees Applicable to Requests for Information 
[Redesignated]

    We propose to redesignate Sec.  60.12 as Sec.  60.14 and to revise 
redesignated Sec.  60.14. Section 1921 expands the scope of the NPDB by 
permitting additional entities to query regarding adverse licensure 
actions and certain other negative actions or findings. As provided in 
the annual HHS Appropriations Acts, the Department's authority for 
charging user fees (in addition to the basic authority) under section 
427(b)(4) of the HCQIA applies to all requests for information from the 
NPDB and is set in amounts sufficient to recover the full costs of 
operating the NPDB. Additionally, we are making technical changes to 
this section in order to comply with Office of Management and Budget 
(OMB) Circular A-25 governing the Federal policy regarding fees 
assessed for Government services.

Section 60.15 Confidentiality of National Practitioner Data Bank 
Information [Redesignated]

    In accordance with 42 CFR 1003.103(c), the Department's Office of 
Inspector General has raised the civil money penalty for each violation 
of the NPDB's confidentiality provisions from up to $10,000 to up to 
$11,000. Therefore, we propose to revise paragraph (b) to reflect this 
change.

III. Implementation Schedule

    The Omnibus Budget Reconciliation Act of 1990 required each State 
to have a system available, as of January 1, 1992, for the reporting of 
adverse action information on health care practitioners and health care 
entities. Therefore, we will announce through the issuance of notice(s) 
in the Federal Register a schedule when States are to begin reporting 
to, and when information will be available from, the NPDB. Reporters 
responsible for reporting final adverse actions to both the NPDB and 
the HIPDB will be asked to submit the report only once, provided 
reporting is made through the new consolidated reporting mechanism. The 
system is being configured to sort the appropriate actions into the 
NPDB, HIPDB, or both.

IV. Regulatory Impact Statement

A. Regulatory Analysis

    The Office of Management and Budget (OMB) has reviewed this 
proposed rule in accordance with the provisions of Executive Order 
12866 and the Regulatory Flexibility Act of 1980 (RFA) (5 U.S.C. 601-
612), and the Small Business Regulatory Enforcement Act of 1996, Public 
Law 104-121, which amended the RFA, and has determined that it does not 
meet the criteria for an economically significant regulatory action. In 
accordance with the Unfunded Mandates Reform Act of 1995 (UMRA), Public 
Law 104-4, we have determined that this rule does not

[[Page 14141]]

impose any mandates on State, local or tribal governments, or the 
private sector that will result in an annual expenditure of $110 
million or more, and that a full analysis under the Act is not 
required.
1. Executive Order 12866
    HRSA has examined the economic implications of this proposed rule 
as required by Executive Order 12866. Executive Order 12866 directs 
agencies to assess all costs and benefits of available regulatory 
alternatives and, when regulation is necessary, to select regulatory 
approaches that maximize net benefits (including potential economic, 
environmental, public health and safety, and other advantages; 
distributive impacts; and equity). Executive Order 12866 classifies a 
rule as significant if it meets any one of a number of specified 
conditions, including: Having an annual effect on the economy of $100 
million, adversely affecting a sector of the economy in a material way, 
adversely affecting competition, or adversely affecting jobs. A 
regulation is also considered a significant regulatory action if it 
raises novel legal or policy issues.
    HRSA (for example) concludes that this proposed rule is a 
significant regulatory action under the Executive Order since it raises 
novel legal and policy issues under section 3(f)(4). HRSA concludes, 
however, that this proposed rule does not meet the significance 
threshold of $100 million effect on the economy in any one year under 
section 3(f)(1). HRSA requests comments regarding this determination, 
and invites commenters to submit any relevant data that will assist the 
agency in estimating the impact of this rulemaking.
    Consistent with section 1921, these proposed regulations identify 
certain data elements for reporting that are mandatory and specify 
other discretionary data elements for reporting. Many of the mandatory 
and discretionary data elements set forth in this proposed rulemaking 
are already collected and maintained on a routine basis for a variety 
of purposes by reporting entities, and should not result in additional 
costs or in new and significant burdens. After consulting with State 
representatives, we now know that States routinely collect and maintain 
much of this information. Many licensing boards also routinely collect 
and report much of this information to their national organizations 
such as the National Council of State Boards of Nursing, Federation of 
Chiropractic Licensing Boards, American Association of State Social 
Work Boards, Federation of State Medical Boards and the Association of 
State and Provincial Psychology Boards. State Survey and Certification 
agencies also are required to report adverse information to CMS 
regarding certain health care entities. This information is already 
reported to the HIPDB under section 1128E. Actions that are already 
reported under section 1128E will only need to be reported once; the 
system will automatically route these reports to both Data Banks. 
Private accreditation entities also collect and maintain information on 
the Internet regarding health care entities that have been denied 
accreditation or are not accredited. We are unaware of any professional 
review organizations, which would be required to report, which maintain 
information regarding recommendations on the Internet. Since we 
recognize that some classes of reporters may not collect or maintain 
the full array of data elements contemplated for inclusion into the 
NPDB (e.g., other name (s) used or a DEA registration number), we are 
classifying certain data elements to be reported if known. We intend 
not to impose new or added burdens on reporters and are proposing to 
give reporters the option of omitting certain discretionary data 
elements that they do not maintain or to which they do not have access. 
We invite you to comment on appropriateness of providing the option to 
omit reporting certain discretionary data elements and as classifying 
certain data elements ``to be reported if known.''
2. Regulatory Flexibility Act
    The Regulatory Flexibility Act (RFA) and the Small Business 
Regulatory Enforcement and Fairness Act of 1996, which amended the RFA, 
require HRSA to analyze options for regulatory relief of small 
businesses. For purposes of the RFA, small entities include small 
businesses, nonprofit organizations, and government agencies. In 
accordance with the Regulatory Flexibility Act, if a rule has a 
significant economic effect on a substantial number of small entities, 
the Secretary must specifically consider the economic effect of the 
rule on small entities and analyze regulatory options that could lessen 
the impact of the rule. For purposes of this rule, we have defined 
small entities as peer review organizations, private accreditation 
entities and local health care practitioner and entity licensing 
boards; individuals and States are not included in this definition of 
small entities. We have determined that both the burden and costs 
associated with reporting to the NPDB will be minimal. According to the 
leading accrediting bodies (e.g., Joint Commission on Accreditation of 
Healthcare Organizations, National Committee for Quality Assurance, 
Utilization Review Accreditation Commission and Commission on 
Accreditation of Rehabilitation Facilities), accreditation entities 
take approximately 100 negative findings or actions per year against 
health care practitioners or health care entities. We have little 
information on the potential volume of reporting by peer review 
organizations. We estimate that the number of reports will be small, 
but this is an issue that we believe can be better addressed after the 
review of public comments, however, we have provided an estimate of 100 
reports per year. On this basis, we have determined that the data 
collection process will not have a significant impact on local 
government agencies, peer review organizations, private accreditation 
entities, and that this rule will not have a major effect on the 
economy or on Federal or State expenditures.
    We estimate that the costs to entities which must report to the 
NPDB under section 1921 and those that opt to query under section 1921 
will not approach the threshold of a major rule. In the burden estimate 
table which follows, the total cost of the rule to users is less than 
$300,000 annually. This cost estimate does not include the cost of 
queries which the entity may file. The major reason for the low cost is 
that the majority of categories of reporters and potential queriers are 
already interacting with the NPDB and/or the HIPDB. These users are 
already familiar with the operation and procedures of the Data Banks. 
For instance the State Boards are currently reporting to the NPDB and/
or the HIPDB. Reports required under section 1921 will be the same as 
those currently being made and filing one report, in most cases, will 
meet the reporting obligation for NPDB, HIPDB and section 1921 of the 
enhanced NPDB. Hospitals and other health care entities are currently 
querying the NPDB regarding physicians and dentists, for these entities 
there would only be a small increase in administrative costs if they 
began to query on other hospital personnel such as nurses. Thus, the 
Secretary certifies that these proposed regulations will not have a 
significant impact on a substantial number of small entities.
3. Unfunded Mandates Reform Act
    Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) 
(Pub. L. 104-4) requires that agencies assess anticipated costs and 
benefits for any rulemaking that may result in an annual expenditure of 
$110 million or

[[Page 14142]]

more by State, local, or tribal governments, or the private sector. In 
accordance with the UMRA, we have determined that the only costs (which 
we believe will not be significant) would include the ability to 
transmit the information electronically (e.g., Internet service) and 
additional staff hours needed to transmit information. We estimate an 
initial start-up cost of approximately $500 per private accreditation 
entity. For this reason, we have determined that this rule does not 
impose any mandates on State, local or tribal government or the private 
sector that will result in an annual expenditure of $110 million or 
more, and that a full analysis under the UMRA is not necessary.
4. Executive Order 13132
    Executive Order 13132, Federalism, establishes certain requirements 
that an agency must meet when it promulgates a rule that imposes 
substantial direct requirements or costs on State and local 
governments, preempts State law, or otherwise has federalism 
implications. In reviewing this proposed rule under the threshold 
criteria of Executive Order 13132, we have determined that this rule 
will not significantly affect the rights, roles, and responsibilities 
of State or local governments.

Paperwork Reduction Act of 1995

    The NPDB regulations contain information collection requirements 
that have been approved by OMB under the Paperwork Reduction Act of 
1995 and assigned control number 0915-0126.
    This proposed rule also contains information collection 
requirements. As required by the Paperwork Reduction Act of 1995 (44 
U.S.C. 3507(d)), we have submitted a copy of this proposed rule to OMB 
for its review of these information collection requirements.
    Collection of Information: National Practitioner Data Bank for 
Adverse Information on Physicians and Other Health Care Practitioners.
    Description: Information collected under Sec. Sec.  60.9 and 60.10 
of this proposed rule would be used by authorized parties, specified in 
the proposed rule, to determine the fitness of individuals to provide 
health care services, to protect the health and safety of individuals 
receiving health care through programs administered by the requesting 
agencies, and to protect the fiscal integrity of these programs. 
Information collected under Sec. Sec.  60.6 and 60.16 would be used to 
correct reports submitted to the NPDB. Information collected under 
Sec.  60.13 would be used to disseminate reports to individuals and 
entities eligible to query the NPDB.
    Description of Respondents: State government authorities 
responsible for licensing health care practitioners and health care 
entities, peer review organizations, and private accreditation entities 
reviewing the services of a health care practitioner or entity.
    Estimated Annual Reporting: We estimate that the public reporting 
burden for the proposed rule is 11,444 hours. Each State is required to 
adopt a system of reporting to the Secretary certain adverse licensure 
actions taken against health care practitioners and health care 
entities, and any other negative actions or findings by a State 
licensing authority, peer review organization, or private accreditation 
entity.
    The estimated annual reporting and querying burden is as follows:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                          Number of   Frequency of    Number of     Hours per      Burden                    Total  cost
                      Section No.                        respondents    response      responses     response        hours     Hourly  cost       \8\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Errors and Omissions 60.6 (a) \1\.....................            23             1            23        15 min             6           $25          $150
Revisions 60.6 (b) \1\................................             7             1             7        30 min             4            25           100
Licensure Actions 60.9 \2\............................             0             0             0             0             0             0             0
Negative Actions: Private Accreditation Entities 60.10             4            25           100        45 min            75            25         1,875
 \3\..................................................
Negative Actions: Peer review organizations 60.10 \3\.            25             4           100        45 min            75            25         1,875
Queries: Agencies administering Federal health care               10          25.5           255         5 min            21            25           525
 programs 60.13(a)(2)(i) \4\..........................
Queries: State Agencies 60.13(a)(2)(iii) \4\..........            51            20          1020         5 min            85            25         2,125
Queries: State Medicaid 60.13(a)(2)(iv) \4\...........            51            20          1020         5 min            85            25         2,125
Queries: Law Enforcement 60.13(a)(2)(v) \4\...........           262           .71           185         5 min            15            25           225
Queries: QIOs 60.13(a)(2)(vi) \4\.....................            51             5           255         5 min            21            25           525
Queries: Hospitals and other health care entities             10,930          10.5       114,765         5 min         9,564            25       239,000
 60.13(a)(2)(vii) \4\.................................
Self-Query 60.13(1)(b) \5\............................             0             0             0             0             0             0             0
Initial Request for Dispute of Report 60.16(b) \7\....            18             1            18        15 min             5            45           225
Practitioner Requests for Secretarial Review 60.16(b)              3             1             3       8 hours            24           200         4,800
 \7\..................................................
Subject Statements 60.16(b) \7\.......................            40             1            40        60 min            40           100         4,000
Entity Registration 60.3 \6\..........................         1,500             1         1,500        60 min         1,500            25        37,000
Entity Update 60.3 \6\................................           225             1           225         5 min            19            25           475
                                                       -------------------------------------------------------------------------------------------------

[[Page 14143]]

 
    Total.............................................        13,200  ............       119,516  ............        11,518  ............      295,025
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Although OMB has previously approved the burden under HCQIA for the reporting of errors and omissions to information previously reported to the
  NPDB, section 1921 will expand the scope of the NPDB to include all health care practitioners and health care entities. However, licensure actions
  reported to the NPDB regarding health care practitioners and health care entities are also reported to the HIPDB and, thus, were previously calculated
  in the burden estimates for the HIPDB. Therefore, the burden for correcting or revising NPDB licensure actions is not included in this regulation.
  Section 60.6 requires individuals and entities that report information to the NPDB to ensure the accuracy of the information. If there are any errors
  or omissions to the reports previously submitted to the NPDB, the individual or entity that submitted the report to the NPDB is also responsible for
  making the necessary correction or revision to the original report. If there is any revision to the action, the individual or entity that submitted
  the original report to the NPDB is also responsible for reporting revisions. Based upon corrections and revisions made under the HCQIA, we estimate
  that a total of 23 respondents will need to correct their reports each year and that a total of 7 respondents will need to revise actions originally
  reported each year. Based on experience with the NPDB, a correction is expected to take 15 minutes to complete and submit. A revision is expected to
  take somewhat longer (30 minutes) because it involves completing a portion of a new report form rather than just correcting the individual items that
  are in error. The costs associated with preparing corrections and revisions are estimated at $25 per hour.
\2\ Since Sec.   60.9 requires each State to adopt a system of reporting to the NPDB disciplinary licensure actions, the various licensing boards within
  each State will be required to report such actions directly to the State licensing authorities. These same licensing boards also are responsible for
  reporting such actions to the HIPDB. Therefore, we calculate the annual reporting burden for State licensing boards under the HIPDB and not this
  regulation. As a result, the reporting burden for State licensing boards is not included in this regulation. We estimate that under the HIPDB
  regulations 40,400 reports will be submitted to both the NPDB and the HIPDB each year, for an average of 187 reports per State licensing authority and
  22 reports per State licensing board. The costs associated with preparing licensure reports are estimated at $25 per hour. The cost estimates for this
  burden associated with the HIPDB.
\3\ Section 1921 requires each State to adopt a system of reporting to the NPDB any negative action or finding concluded against health care
  practitioners and health care entities by a State licensing authority, peer review organization, or private accreditation entity. The negative actions
  or findings taken by State licensing authorities are also required to be reported to the HIPDB and were included in the HIPDB regulations. Therefore,
  this regulation includes the burden estimates only for those negative actions or findings taken by peer review organizations and private accreditation
  entities. We speculate that there may be 25 professional review organizations that may meet the definition proposed in this NPRM. We estimate that
  each of these organizations may report a finding 4 times a year to the NPDB. The section of the NPRM that deals with professional review organizations
  and the associated public burden estimates may require substantial revision based on the public comments received. We estimate that, under Sec.
  60.10 there will be an average of 4 private accreditation entities reporting approximately 25 times each during the year to the NPDB for a total of
  100 reports. Based on experience with the NPDB, we estimate that it will take a peer review organization or a private accreditation entity 45 minutes
  to complete and submit an initial report. The costs associated with preparing reports are estimated at $25 per hour.
\4\ Although OMB has previously approved the burden under the HCQIA for querying the NPDB, section 1921 authorizes additional entities, such as State
  Medicaid fraud control units, utilization and quality control Quality Improvement Organizations, and certain law enforcement officials to query the
  NPDB for disciplinary licensure actions, and other negative actions or findings concluded against health care practitioners and health care entities.
  Based on current NPDB querying patterns, we estimate an approximate total of 117,500 new (section 1921-only) queries per year on health care
  practitioners and health care entities. The costs associated with preparing these queries are estimated at $25 per hour.
\5\ Currently, self queries by health care practitioners are automatically submitted to both the NPDB and the HIPDB, and we anticipate the same policy
  will be in effect for health care entities when section 1921 is implemented. Therefore, self queries submitted to the NPDB by health care
  practitioners and health care entities already are included in HIPDB burden estimates and are not included in this regulation. Since the burden and
  costs for preparation of self queries is contained in HIPDB no additional cost estimates are required by the implementation of section 1921.
\6\ To access the NPDB, entities are required to certify that they meet section 1921 reporting and/or querying requirements. An eligible entity also
  must complete and submit an Entity Registration Form to the NPDB. The information collected on this form provides the NPDB with essential information
  concerning the entity (e.g., name, address, and entity type). Eligible entities (e.g., State licensing agencies, hospitals, or managed care
  organizations) that have access to the HCQIA, section 1921 and section 1128E information will only be required to register once. All other eligible
  entities must complete and submit the Entity Registration Form. We estimate that an additional 1,500 entities will register with the NPDB each year
  for the next three years for a total of 4,500 entities. We estimate that it will take an entity 60 minutes to complete and submit the Entity
  Registration Form to the NPDB. The costs associated with preparing the registration and entity verification documents are estimated at $25 per hour.
 If there are any changes in the entity's name, address, telephone, entity type designation, or query and/or report point of contact, the entity
  representative must update the information on the Entity Registration Update Form and submit it to the NPDB. Of these 4,500 new registrants, we
  estimate that approximately 225 entities will need to update their organization's information each year. The costs associated with preparing the
  registration and entity verification documents are estimated at $25 per hour.
\7\ OMB has previously approved the burden under the HCQIA for disputing the factual accuracy of information in a report and requesting Secretarial
  review of the disputed report. Based on experience with the NPDB, we estimate that an additional 18 reports will be entered into the ``disputed
  status.'' We estimate that it will take a health care practitioner or health care entity 15 minutes to notify the NPDB to enter the report into
  ``disputed status.'' The costs associated with preparing an initial dispute request is estimated at approximately $50 per hour. Of the 18 disputed
  reports, we estimate that only 3 will be forwarded to the Secretary for review. We estimate that it will take a health care practitioner or entity 8
  hours to describe, in writing, which facts are in dispute and to gather supporting documentation related to the dispute. Based on experience with the
  NPDB and HIPDB we estimate the costs associated with preparing a request for Secretarial review at approximately $200 per hour. In addition, a health
  care practitioner who, or a health care entity that, is the subject of a report may submit a 2,000-character statement at any time after the NPDB has
  received the report. We estimate that an additional 40 practitioners and entities will submit statements to the NPDB. Based on previous experience, we
  estimate that each statement will take approximately 60 minutes to prepare. The cost estimate for preparation of statements is $100 per hour.
\8\ The costs presented in this table have been estimated based on whole hours. The cost estimates are for response preparation, and do not cover the
  costs per query (user fee) which will be assessed for each name submitted to the NPDB. The per hour cost estimates have been developed by using
  operational reports of organizations utilizing the NPDB and HIPDB.
 Request for Comment: In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public
  comment on proposed data collection projects, comments are invited on: (a) Whether the proposed collection of information is necessary for the proper
  performance of the functions of the Agency, including whether the information shall have practical utility; (b) the accuracy of the Agency's estimate
  of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and
  (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other
  forms of information technology.

    Written comments and recommendations concerning the proposed 
information collection requirements should be sent to: John Kraemer, 
Human Resources and Housing Branch, Office of Management and Budget, 
New Executive Office Building, Room 10235, Washington, DC 20503. 
Written comments must be received within 60 days of publication of this 
proposed regulation.

[[Page 14144]]

List of Subjects in 45 CFR Part 60

    Claims, Fraud, Health, Health maintenance organizations (HMOs), 
Health professions, Hospitals, Insurance companies, Malpractice, 
Reporting and recordkeeping requirements.

    Dated: June 7, 2005.
Elizabeth M. Duke,
Administrator, Health Resources and Services Administration.

    Approved: November 7, 2005.
Michael O. Leavitt,
Secretary of Health and Human Services.

    Accordingly, 45 CFR part 60 is proposed to be amended as set forth 
below:

PART 60--NATIONAL PRACTITIONER DATA BANK FOR ADVERSE INFORMATION ON 
PHYSICIANS AND OTHER HEALTH CARE PRACTITIONERS

    1. The authority citation for 45 CFR part 60 is revised to read as 
follows:

    Authority: 42 U.S.C. 11101-11152; 42 U.S.C. 1396r-2.

Subpart A--General Provisions

    2. Section 60.1 is revised to read as follows:


Sec.  60.1  The National Practitioner Data Bank.

    The Health Care Quality Improvement Act of 1986, as amended 
(HCQIA), title IV of Public Law 99-660 (42 U.S.C. 11101 et seq.), 
authorizes the Secretary to establish (either directly or by contract) 
a National Practitioner Data Bank (NPDB) to collect and release certain 
information relating to the professional competence and conduct of 
physicians, dentists and other health care practitioners. Section 1921 
of the Social Security Act (42 U.S.C. 1396r-2) (section 1921) requires 
each State to adopt a system of reporting to the Secretary adverse 
licensure actions taken against health care practitioners and entities. 
Section 1921 also requires States to report any negative action or 
finding which a State licensing authority, peer review organization, or 
private accreditation entity has concluded against a health care 
practitioner or entity. This information will be collected and released 
to authorized parties by the NPDB. These regulations set forth the 
reporting and disclosure requirements for the NPDB.


Sec.  60.2  [Amended]

    3. Section 60.2 is amended by adding the phrase ``State licensing 
authorities;'' after the phrase ``Boards of Medical Examiners;'' in the 
first sentence and by adding ``State licensing or certification 
authorities, peer review organizations, and private accreditation 
entities that take negative actions or findings against health care 
practitioners or entities;'' after the phrase ``professional review 
actions;'' in the first sentence; and by removing the phrase ``National 
Practitioner Data Bank'', wherever it appears, and adding the term 
``NPDB'' in its place.
    4. Section 60.3 is amended by revising the reference to ``Sec.  
60.9'' in the third sentence of the definition of ``Board of Medical 
Examiners'' to read ``Sec.  60.11''; and by adding the following terms 
and their definitions: ``Affiliated or associated'', ``Formal 
proceeding'', ``Negative action or finding'', ``Organization name'', 
``Organization type'', ``Peer review organization'', ``Private 
accreditation entity'', ``Quality Improvement Organization'', and 
``Voluntary surrender'', inserted in the appropriate alphabetical order 
to read as follows:


Sec.  60.3  Definitions.

* * * * *
    Affiliated or associated refers to health care entities with which 
a subject of a final adverse action has a business or professional 
relationship. This includes, but is not limited to, organizations, 
associations, corporations, or partnerships. This also includes a 
professional corporation or other business entity composed of a single 
individual.
* * * * *
    Formal proceeding means a formal or official proceeding held before 
a State licensing or certification authority, peer review organization, 
or private accreditation entity.
* * * * *
    Negative action or finding by a State licensing authority, peer 
review organization, or private accreditation entity means:
    (1) Receipt of less than full accreditation from a private 
accreditation entity that indicates a substantial risk to the safety of 
a patient or patients or quality of health care services and includes, 
but is not limited to, denial of accreditation or non-accreditation; or
    (2) Any recommendation by a peer review organization to sanction a 
practitioner.
    (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 excludes administrative fines, or citations and corrective 
action plans, unless they are:
    (i) Connected to the delivery of health care services; and
    (ii) Taken in conjunction with other licensure or certification 
actions such as revocation, suspension, censure, reprimand, probation, 
or surrender.
    Organization name means the subject's business or employer at the 
time the underlying acts occurred. If more than one business or 
employer is applicable, the one most closely related to the underlying 
acts should be reported as the ``organization name'', with the others 
being reported as ``affiliated or associated health care entities''.
    Organization type means a description of the nature of that 
business or employer.
    Peer review organization means an organization with the primary 
purpose of evaluating the quality of patient care practices or services 
ordered or performed by health care practitioners measured against 
objective criteria which define acceptable and adequate practice 
through an evaluation by a sufficient number of health practitioners in 
such area to assure adequate peer review. This definition excludes 
Quality Improvement Organizations (QIOs) funded by the Centers for 
Medicare & Medicaid Services (CMS) and other organizations used by CMS 
to support the QIO program.
* * * * *
    Private accreditation entity means an entity or organization that:
    (1) Evaluates and seeks to improve the quality of health care 
provided by a health care entity;
    (2) Measures a health care entity's performance based on a set of 
standards and assigns a level of accreditation; and
    (3) Conducts ongoing assessments and periodic reviews of the 
quality of health care provided by a health care entity.
* * * * *
    Quality Improvement Organization means a utilization and quality 
control Quality Improvement Organization (as defined in part B of title 
XI of the Social Security Act) means an entity which--

    ``(1)(A) 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 (B) 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

[[Page 14145]]

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 it governing 
body.''
* * * * *
    Voluntary surrender means a surrender made after a notification of 
investigation or a formal official request by a State licensing 
authority for a health care practitioner or entity to surrender a 
license. The definition also includes those instances where a health 
care practitioner or entity voluntarily surrenders a license in 
exchange for a decision by the licensing authority to cease an 
investigation or similar proceeding, or in return for not conducting an 
investigation or proceeding, or in lieu of a disciplinary action.
    5. Subpart B is revised as set forth below:


Subpart B--Reporting of Information

60.4 How information must be reported.
60.5 When information must be reported.
60.6 Reporting errors, omissions, and revisions.
60.7 Reporting medical malpractice payments.
60.8 Reporting licensure actions taken by Boards of Medical 
Examiners.
60.9 Reporting licensure actions taken by States.
60.10 Reporting negative actions or findings taken by peer review 
organizations or private accreditation entities.
60.11 Reporting adverse actions on clinical privileges.

Subpart B--Reporting of Information


Sec.  60.4  How information must be reported.

    Information must be reported to the NPDB or to a Board of Medical 
Examiners as required under Sec. Sec.  60.7, 60.8, and 60.11 in such 
form and manner as the Secretary may prescribe.


Sec.  60.5  When information must be reported.

    Information required under Sec. Sec.  60.7, 60.8, and 60.11 must be 
submitted to the NPDB within 30 days following the action to be 
reported, beginning with actions occurring after August 31, 1990, and 
information required under Sec. Sec.  60.9 and 60.10 must be submitted 
to the NPDB within 30 days following the action to be reported, 
beginning with actions occurring after December 31, 1991, as follows:
    (a) Malpractice Payments (Sec.  60.7). Persons or entities must 
submit information to the NPDB within 30 days from the date that a 
payment, as described in Sec.  60.7, is made. If required under Sec.  
60.7, this information must be submitted simultaneously to the 
appropriate State licensing board.
    (b) Licensure Actions (Sec.  60.8 and Sec.  60.9). The Board of 
Medical Examiners or other licensing or certifying authority of a State 
must submit information within 30 days from the date the licensure 
action was taken.
    (c) Negative Action or Finding (Sec.  60.10). Peer review 
organizations, or private accreditation entities must report any 
negative actions or findings to the State within 15 days from the date 
the action was taken or the finding was made. Each State, through the 
adopted system of reporting, must submit to the NPDB the information 
received from the peer review organization, or private accreditation 
entity within 15 days from the date on which it received this 
information.
    (d) Adverse Actions (Sec.  60.11). A health care entity must report 
an adverse action to the Board within 15 days from the date the adverse 
action was taken. The Board must submit the information received from a 
health care entity within 15 days from the date on which it received 
this information. If required under Sec.  60.11, this information must 
be submitted by the Board simultaneously 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.


Sec.  60.6  Reporting errors, omissions, and revisions.

    (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 or, in the 
case of reports made under Sec.  60.11, to the Board of Medical 
Examiners, as soon as possible.
    (b) An individual or entity which reports information on licensure, 
negative actions or findings or clinical privileges under Sec. Sec.  
60.8, 60.9, 60.10, or 60.11 must also report any revision of the action 
originally reported. Revisions include reversal of a professional 
review action or reinstatement of a license. Revisions are subject to 
the same time constraints and procedures of Sec. Sec.  60.5, 60.8, 
60.9, 60.10, and 60.11, as applicable to the original action which was 
reported. (Approved by the Office of Management and Budget under 
control number 0915-0126)


Sec.  60.7  Reporting medical malpractice payments.

    (a) Who must report. Each entity, including an insurance company, 
which makes a payment under an insurance policy, self-insurance, or 
otherwise, for the benefit of a physician, dentist or other health care 
practitioner in settlement of or in satisfaction in whole or in part of 
a claim or a judgment against such physician, dentist, or other health 
care practitioner for medical malpractice, must report information as 
set forth in paragraph (b) of this section to the NPDB and to the 
appropriate State licensing board(s) in the State in which the act or 
omission upon which the medical malpractice claim was based. For 
purposes of this section, the waiver of an outstanding debt is not 
construed as a ``payment'' and is not required to be reported.
    (b) What information must be reported. Entities described in 
paragraph (a) of this section must report the following information:
    (1) With respect to the physician, dentist or other 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,
    (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) 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 physician, 
dentist, or other 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,

[[Page 14146]]

    (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 Federal Register and after an opportunity 
for public comment.
    (c) Sanctions. Any entity that fails to report information on a 
payment required to be reported under this section is subject to a 
civil money penalty of up to $11,000 for each such payment involved. 
This penalty will be imposed pursuant to procedures at 42 CFR part 
1003.
    (d) Interpretation of information. A payment in settlement of a 
medical malpractice action or claim shall not be construed as creating 
a presumption that medical malpractice has occurred.


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

Sec.  60.8  Reporting licensure actions taken by Boards of Medical 
Examiners.

    (a) What actions must be reported. Each Board of Medical Examiners 
must report to the NPDB any action based on reasons relating to a 
physician's or dentist's professional competence or professional 
conduct--
    (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) Information that must be reported. The Board must report the 
following information for each action:
    (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, if known, 
and if obtained in accordance with section 7 of the Privacy Act of 
1974,
    (5) The physician's or dentist's date of birth,
    (6) Name of each professional school attended by the physician or 
dentist and year of graduation.
    (7) 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,
    (8) The physician's or dentist's Drug Enforcement Administration 
registration number, if known,
    (9) A description of the acts or omissions or other reasons for the 
action taken,
    (10) A description of the Board action, the date the action was 
taken, and its effective date and duration,
    (11) Classification of the action in accordance with a reporting 
code adopted by the Secretary, and
    (12) Other information as required by the Secretary from time to 
time after publication in the Federal Register and after an opportunity 
for public comment.
    (c) Sanctions. If, after notice of noncompliance and providing 
opportunity to correct noncompliance, the Secretary determines that a 
Board has failed to submit a report as required by this section, the 
Secretary will designate another qualified entity for the reporting of 
information under Sec.  60.11.


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

Sec.  60.9  Reporting licensure actions taken by States.

    (a) What actions must be reported. Each State is required to adopt 
a system of reporting to the NPDB actions, as listed below, which are 
taken against a health care practitioner or entity (both as defined in 
Sec.  60.3). The actions taken must be as a result of formal 
proceedings (as defined in Sec.  60.3). The actions which must be 
reported are:
    (1) Any adverse action taken by the licensing authority of the 
State as a result of a formal proceeding, including revocation or 
suspension of a license (and the length of any such suspension), 
reprimand, censure, or probation;
    (2) Any dismissal or closure of the formal proceeding by reason of 
the practitioner or entity surrendering the license, or the 
practitioner leaving the State or jurisdiction;
    (3) Any other loss of the license of the practitioner or entity, 
whether by operation of law, voluntary surrender (excluding those due 
to nonpayment of licensure renewal fees, retirement, or change to 
inactive status), or otherwise; and
    (4) Any negative action or finding by such authority, organization, 
or entity regarding the practitioner or entity.
    (b) What information must be reported. Each State must report the 
following information (not otherwise reported under Sec.  60.8):
    (1) If the subject is a health care practitioner, personal 
identifiers, including:
    (i) Name;
    (ii) Social Security Number, 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 a health care practitioner, employment or 
professional identifiers, including:
    (i) Organization name and type;
    (ii) Occupation and specialty, if applicable;
    (iii) National Provider Identifier (NPI), when issued by the 
Centers for Medicare & Medicaid Services (CMS);
    (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 a health care entity, 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, when issued by CMS;
    (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;
    (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

[[Page 14147]]

submitting the report on behalf of the reporting entity.
    (c) What information may be reported, if known: Entities described 
in paragraph (a) of this section may voluntarily report, if known, the 
following information:
    (1) If the subject is a health care practitioner, 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 a health care practitioner, 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 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 a health care entity, 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 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) Whether the subject will be automatically reinstated; and
    (ii) The amount of any monetary penalty resulting from the reported 
action.
    (d) Access to documents. Each State must provide the Secretary (or 
an entity designated by the Secretary) with access to the documents 
underlying the actions described in paragraphs (a)(1) through (4) of 
this section, as may be necessary for the Secretary to determine the 
facts and circumstances concerning the actions and determinations for 
the purpose of carrying out section 1921 of the Social Security Act.


Sec.  60.10  Reporting negative actions or findings taken by peer 
review organizations or private accreditation entities.

    (a) What actions must be reported. Each State is required to adopt 
a system of reporting to the NPDB any negative actions or findings (as 
defined in Sec.  60.3) which are taken against a health care 
practitioner or health care entity by a peer review organization or 
private accreditation entity. The health care practitioner or health 
care entity must be licensed or otherwise authorized by the State to 
provide health care services.
    (b) What information must be reported. Each State must report the 
information as required in Sec.  60.9(b).
    (c) What information should be reported, if known: Each State 
should report, if known, the information as described in Sec.  60.9(c).
    (d) Access to documents. Each State must provide the Secretary (or 
an entity designated by the Secretary) with access to the documents 
underlying the actions described in this section as may be necessary 
for the Secretary to determine the facts and circumstances concerning 
the actions and determinations for the purpose of carrying out section 
1921 of the Social Security Act.


Sec.  60.11  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.
    (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 this section, the Secretary will 
conduct an investigation. If the investigation shows that the health 
care entity has not complied with this section, the

[[Page 14148]]

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. If a hearing is held, it will be 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.
    (2) 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.
    (3) 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 designate 
another qualified entity for the reporting of this information.

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

    6. Subpart C is revised as set forth below:


Subpart C--Disclosure of Information by the National Practitioner Data 
Bank

60.12 Information which hospitals must request from the National 
Practitioner Data Bank.
60.13 Requesting information from the National Practitioner Data 
Bank.
60.14 Fees applicable to requests for information.
60.15 Confidentiality of National Practitioner Data Bank 
information.
60.16 How to dispute the accuracy of National Practitioner Data Bank 
information.

Subpart C--Disclosure of Information by the National Practitioner 
Data Bank


Sec.  60.12  Information which hospitals must request from the National 
Practitioner Data Bank.

    (a) When information must be requested. Each hospital, either 
directly or through an authorized agent, must request information from 
the NPDB concerning a physician, dentist or other health care 
practitioner as follows:
    (1) At the time a physician, dentist or other 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 concerning any physician, dentist, or other 
health care practitioner who is on its medical staff (courtesy or 
otherwise), or has clinical privileges at the hospital.
    (b) Failure to request information. Any hospital which does not 
request the information as required in paragraph (a) of this section is 
presumed to have knowledge of any information reported to the NPDB 
concerning this physician, dentist or other health care practitioner.
    (c) Reliance on the obtained information. Each hospital may rely 
upon the information provided by the NPDB to the hospital. A hospital 
shall not be held liable for this reliance unless the hospital has 
knowledge that the information provided was false.


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

Sec.  60.13  Requesting information from the National Practitioner Data 
Bank.

    (a) Who may request information and what information may be 
available. Information in the NPDB will be available, upon request, to 
the persons or entities, or their authorized agents, as described 
below:
    (1) Information reported under Sec. Sec.  60.7, 60.8, and 60.11 is 
available to:
    (i) A hospital that requests information concerning a physician, 
dentist or other health care practitioner who is on its medical staff 
(courtesy or otherwise) or has clinical privileges at the hospital;
    (ii) A physician, dentist, or other health care practitioner who 
requests information concerning himself or herself;
    (iii) A State Medical Board of Examiners or other State authority 
that licenses physicians, dentists, or other health care practitioners;
    (iv) A health care entity which has entered or may be entering into 
an employment or affiliation relationship with a physician, dentist, or 
other health care practitioner, or to which the physician, dentist, or 
other 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 physician, dentist, or other 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 Sec.  60.12(a), 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 Sec. Sec.  60.9 and 60.10 is 
available to the agencies, authorities, and officials listed below that 
request information on licensure disciplinary actions and any other 
negative actions or findings concerning an individual health care 
practitioner or entity. 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 Federal health care programs, including 
private entities administering such programs under contract;
    (ii) Authorities of States (or political subdivisions thereof) 
which are responsible for licensing health care practitioners and 
entities;
    (iii) State agencies administering or supervising the 
administration of State health care programs (as defined in 42 U.S.C. 
1128(h));
    (iv) State Medicaid fraud control units (as defined in 42 U.S.C. 
1903(q));
    (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;
    (H) Federal Bureau of Investigation; and

[[Page 14149]]

    (I) State law enforcement agencies, which include, but are not 
limited to, State Attorneys General.
    (vi) Utilization and quality control Quality Improvement 
Organizations described in part B of title XI and appropriate entities 
with contracts under section 1154(a)(4)(C) of the Social Security Act 
with respect to eligible organizations reviewed under the contracts;
    (vii) Hospitals and other health care entities (as defined in 
section 431 of the HCQIA), with respect to physicians or other licensed 
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;
    (viii) A physician, dentist, or other health care practitioner who, 
and an entity which, requests information concerning himself, herself, 
or itself; and
    (ix) 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) Procedures for obtaining National Practitioner Data Bank 
information. Persons and entities may obtain information from the NPDB 
by submitting a request in such form and manner as the Secretary may 
prescribe. These requests are subject to fees as described in Sec.  
60.14.


Sec.  60.14  Fees applicable to requests for information.

    (a) Policy on Fees. The fees described in this section apply to all 
requests for information from the NPDB. The amount of such fees will be 
sufficient to recover the full costs of operating the NPDB. The actual 
fees will be announced by the Secretary in periodic notices in the 
Federal Register. However, for purposes of verification and dispute 
resolution at the time the report is accepted, the NPDB will provide a 
copy--at the time a report has been submitted, automatically, without a 
request and free of charge--of the record to the health care 
practitioner or entity who is the subject of the report and to the 
reporter.
    (b) Criteria for determining the fee. The amount of each fee will 
be determined based on the following criteria:
    (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) Assessing and collecting fees. The Secretary will announce 
through notice in the Federal Register from time to time the methods of 
payment of NPDB fees. In determining these methods, the Secretary will 
consider efficiency, effectiveness, and convenience for the NPDB users 
and the Department. Methods may include: Credit card; electronic fund 
transfer and other methods of electronic payment.


Sec.  60.15  Confidentiality of National Practitioner Data Bank 
information.

    (a) Limitations on disclosure. Information reported to the NPDB is 
considered confidential and shall not be disclosed outside the 
Department of Health and Human Services, except as specified in 
Sec. Sec.  60.12, 60.13, and 60.16. Persons who, and entities which, 
receive information from the NPDB either directly or from another party 
may use it solely with respect to the purpose for which it was 
provided. Nothing in this paragraph shall prevent the disclosure of 
information by a party which is authorized under applicable State law 
to make such disclosure.
    (b) Penalty for violations. Any person who violates paragraph (a) 
of this section shall be subject to a civil money penalty of up to 
$11,000 for each violation. This penalty will be imposed pursuant to 
procedures at 42 CFR part 1003.


Sec.  60.16  How to dispute the accuracy of National Practitioner Data 
Bank information.

    (a) Who may dispute National Practitioner Data Bank information. 
Any physician, dentist, or other health care practitioner or health 
care entity may dispute the accuracy of information in the NPDB 
concerning himself, herself or itself. The Secretary will routinely 
mail a copy of any report filed in the NPDB to the subject individual 
or entity.
    (b) Procedures for filing a dispute. The subject of the report may 
dispute the accuracy of the report within 60 days from the date on 
which the Secretary mails the report to the subject individual or 
entity. The procedures for disputing a report are:
    (1) Informing the Secretary and the reporting entity, in writing, 
of the disagreement, and the basis for it,
    (2) Requesting simultaneously that the disputed information be 
entered into a ``disputed'' status and be reported to inquirers as 
being in a ``disputed'' status, and
    (3) Attempting to enter into discussion with the reporting entity 
to resolve the dispute.
    (c) Procedures for revising disputed information. (1) If the 
reporting entity revises the information originally submitted to the 
NPDB, the Secretary will notify all entities to whom reports have been 
sent that the original information has been revised.
    (2) If the reporting entity does not revise the reported 
information, the Secretary will, upon request, review the written 
information submitted by both parties (the subject individual or entity 
and the reporting entity). After review, the Secretary will either--
    (i) If the Secretary concludes that the information is accurate, 
include a brief statement by the physician, dentist or other health 
care practitioner or health care entity describing the disagreement 
concerning the information, and an explanation of the basis for the 
decision that it is accurate, or
    (ii) If the Secretary concludes that the information is incorrect, 
send corrected information to previous inquirers.

[FR Doc. 06-2686 Filed 3-20-06; 8:45 am]
BILLING CODE 4160-15-P