National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners: Reporting on Adverse and Negative Actions, 4656-4682 [2010-1514]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• Health Resources and Services Administration

[Federal Register Volume 75, Number 18 (Thursday, January 28, 2010)]
[Rules and Regulations]
[Pages 4656-4682]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-1514]



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Part III





Department of Health and Human Services





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Health Resources and Services Administration



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45 CFR Part 60



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

Federal Register / Vol. 75, No. 18 / Thursday, January 28, 2010 / 
Rules and Regulations

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration

45 CFR Part 60

RIN 0906-AA57


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 (HRSA), HHS.

ACTION: Final rule.

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SUMMARY: This final rule revises existing regulations under sections 
401 through 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 (MMPPPA), and as amended by the Omnibus 
Budget Reconciliation Act of 1990 (OBRA).
    The MMPPPA, along with certain additional provisions in the OBRA, 
was designed to protect program beneficiaries from unfit health care 
practitioners, and otherwise improve the anti-fraud provisions of 
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: This rule is effective March 1, 2010.

FOR FURTHER INFORMATION CONTACT: Mr. Darryl Gray, Director, Division of 
Practitioner Data Banks, Bureau of Health Professions, Health Resources 
and Services Administration (HRSA), Parklawn Building, 5600 Fishers 
Lane, Room 8-103, Rockville, MD 20857; telephone number: (301) 443-
2300.

SUPPLEMENTARY INFORMATION:

I. Background

A. 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, 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; Drug Enforcement 
Administration (DEA) adverse actions; Department of Health and Human 
Services (HHS), Office of the Inspector General (OIG) Medicare and 
Medicaid exclusions; and medical malpractice payments made for the 
benefit of any health care practitioner. Groups that have access to 
this information 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, DEA, HHS OIG, professional societies with formal 
peer review, and hospitals and other health care entities (such as 
health maintenance organizations).

B. Section 1921 of the Social Security Act

    On March 21, 2006, the Health Resources and Services Administration 
published a proposed rule in the Federal Register (71 FR 14135) 
designed to implement section 1921 of the Social Security Act (herein 
referred to as section 1921), as amended by section 5(b) of the MMPPPA, 
and as amended by the OBRA. Section 1921 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, or a private 
accreditation entity has finalized against a health care practitioner 
or 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 peer review 
organizations (referred to as QIOs) as 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. 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. 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.

C. Section 1128E of the Social Security Act

    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. The statute requires the Secretary to avoid duplicating 
the reporting requirements established for the NPDB. This data bank is 
known as the Healthcare Integrity and Protection Data Bank (HIPDB). The 
HIPDB began collecting reports in November 1999 concerning actions 
taken on or after August 21, 1996.

D. Distinctions Between the NPDB and the HIPDB

    Although section 422 of the HCQIA and sections 1921 and 1128E have 
overlapping components, they have unique elements, including 
differences

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in types of reportable adverse actions as well as differences in types 
of individuals or entities with access to the information. For example, 
private-sector hospitals have access to information reported under the 
HCQIA and section 1921, but not under section 1128E. The two tables 
below illustrate the similarities and differences among the HCQIA, 
section 1921, and section 1128E. Table 1, Description of Statutory 
Provisions, summarizes the specific provisions of each of the three 
statutes. Table 2, Description of Data Banks, compares the HIPDB with 
the NPDB (as expanded by section 1921).
    Section 1921 expands State reporting of licensure actions taken 
against physicians and dentists to the NPDB. This expansion matches the 
State reporting requirements to the HIPDB under section 1128E. 
Currently, the HCQIA limits NPDB reporting by medical and dental 
licensing authorities only to those adverse actions related to 
professional competence or professional conduct, but these authorities 
must report all actions to the HIPDB. The change will make the 
reporting of adverse actions by all State licensure and certification 
authorities nearly identical for both the NPDB and HIPDB. No current 
NPDB reporting requirements will be changed for hospitals, other health 
care entities, professional societies, DEA, HHS OIG, or medical 
malpractice payers.
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E. Maximum Coordination Between the NPDB and the 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 is 
implementing these regulations in a manner to avoid the need for an 
entity that must report information to both the NPDB and the HIPDB to 
file two reports. We have made significant efforts to develop these 
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 Web-based system that will sort the appropriate actions 
into the HIPDB, the NPDB or both. The required adjustments to the 
reporting system are made easier because both Data Banks are operated 
through a consolidated electronic system. For consistency and clarity, 
we have made minor edits to the regulations. For example, we replaced 
references to ``the Data Bank'' with ``the NPDB'' throughout the 
regulations, and modified references to types of report subjects who 
may dispute the accuracy of a report to include health care entities.

II. Summary of the Proposed Rule

    The proposed regulations published on March 21, 2006, were 
developed to revise existing NPDB regulations at 45 CFR part 60 by 
adding section 1921 requirements for reporting of specific data 
elements to and procedures for obtaining this information from the 
NPDB. Certain sections of the existing NPDB regulations are consistent 
with section 1921 requirements. Specifically, the following provisions 
apply to NPDB and the section 1921 component of NPDB: (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 significant section 1921 additions are 
described below and are listed according to the sections of the 
regulations that they affect.
     Sec.  60.3 Definitions.
    In the proposed rule, we set forth definitions for the statutory 
terms ``formal proceeding,'' ``negative action or finding,'' ``peer 
review organization,'' ``private accreditation entity,'' ``Quality 
Improvement Organization,'' and ``voluntary surrender.'' Because of the 
statutory distinctions between peer review organizations and QIOs and 
differences in the missions of those organizations, we proposed to 
exclude QIOs from the definition of the term ``peer review 
organization.'' We also proposed definitions for certain terms 
established in HIPDB regulations to enhance coordination between the 
NPDB and the HIPDB in areas where overlapping requirements exist. These 
terms are ``affiliated or associated,'' ``organization name,'' and 
``organization type.''
     Sec.  60.5 When information must be reported.
    The proposed regulations sought to amend this section of the 
existing NPDB regulations 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 that are to be reported 
in accordance with section 1921.
     Sec.  60.7 Reporting medical malpractice payments.
    We revised paragraph (c) of this section to link the potential 
civil money penalty for each violation of the NPDB's confidentiality 
provisions to the amount set in 42 CFR 1003.103(c), which establishes 
the amount of a civil money penalty that may be imposed by the 
Inspector General for such a violation. Currently this section 
authorizes a civil money penalty of up to $11,000 for each violation.
     Sec.  60.8 Reporting licensure actions taken by Boards of 
Medical Examiners.
    For consistency with reporting requirements for States in the newly 
proposed Sec.  60.9, we proposed to revise paragraph (b)(10) of this 
section to require the reporting of the description of an action taken 
by a Board to include the duration of a non-permanent action.
     Sec.  60.9 Reporting licensure actions taken by States. 
(New)
    We proposed to redesignate the current Sec.  60.9 as Sec.  60.11, 
and add a new Sec.  60.9 to implement the reporting requirements of 
section 1921. In proposed Sec.  60.9, we addressed the reporting of 
licensure actions taken by State licensing authorities resulting from a 
formal proceeding. We proposed to include any formal or official 
proceeding held before the authority, organization or entity taking the 
action to provide maximum flexibility.
    Section 1921 specifically requires the reporting of a health care 
practitioner who, or entity that, 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 proposed that voluntary surrenders and 
licensure non-renewals due to non-payment 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.
    We proposed defining the phrase ``any negative action or finding'' 
by a State licensing authority to mean any action or finding that is 
publicly available and rendered by a licensing or certification 
authority. The definition excluded 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.
    Reportable actions, by statute, must be based on the result of 
formal proceedings. Thus, events unrelated to such proceedings would be 
excluded.
    We also proposed a list of ``mandatory'' data elements, as well as 
other data elements that should be reported to the NPDB ``if known.''
     Sec.  60.10 Reporting negative actions or findings taken 
by peer review organizations or private accreditation entities. (New)
    We proposed to redesignate the current 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 that a 
peer review organization or private accreditation entity has concluded

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against a health care practitioner or health care entity (both as 
defined in Sec.  60.3), respectively.
    With respect to reporting by private accreditation entities, we 
proposed that private accreditation entities be required to report 
determinations of less than full accreditation that indicate a 
substantial risk to the safety of a patient or patients or quality of 
health care services.
    We also proposed peer review organizations be required to report 
any recommendation to sanction a practitioner.
     Sec.  60.13 Requesting information from the NPDB. 
[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 proposed to redesignate the current Sec.  60.11 as Sec.  60.13 and 
revise the redesignated Sec.  60.13, paragraph (a), entitled, ``Who may 
request information and what information may be available,'' to clarify 
to whom information in the NPDB and section 1921 would be made 
available. Information reported under Sec. Sec.  60.7, 60.8 and 60.11 
is available only to those entities that have access to the information 
under the HCQIA (e.g., hospitals and other health care entities, and 
State licensing boards). Information reported under Sec. Sec.  60.9 and 
60.10 is available to organizations authorized to receive section 1921 
information, which includes all organizations eligible to query the 
NPDB under the HCQIA and new organizations specified in section 1921 
(e.g., Federal and State health care programs, law enforcement 
agencies, and QIOs).
     Sec.  60.14 Fees applicable to requests for information. 
[Redesignated]
    We proposed to redesignate the current 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 cover 
the full costs of operating the NPDB. Additionally, we made 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.
     Sec.  60.15 Confidentiality of NPDB. [Redesignated]
    In accordance with 42 CFR 1003.103(c), the Department's OIG has 
raised the CMP for each violation of the NPDB's confidentiality 
provisions from up to $10,000 to up to $11,000. Therefore, we proposed 
to revise paragraph (b) to reflect this change.

III. Summary and Response to Public Comments

    The proposed rule set forth a 60-day public comment period, ending 
May 22, 2006. HRSA received 33 public comments from State licensing 
authorities and their associations; associations representing 
physicians, dentists and other health care practitioners; associations 
representing health insurers; hospitals, other health care entities, 
and their associations; private accreditation organizations; private 
citizens; and private attorneys. Based on review of the statute and the 
assessment of public comments received, we believe the final 
regulations to implement section 1921 fully and adequately balance the 
Department's concerns with those expressed by the commenting public.
    Set forth below is an overview of the various comments and 
recommendations received and our responses to those concerns. In the 
preamble of the proposed rule, we requested comments concerning two 
specific areas. The first area concerned QIOs and peer review 
organizations. We asked for comments related to our proposed exemption 
of QIOs from reporting under section 1921, the proposed definition of a 
peer review organization, potential reportable events by peer review 
organizations and their relationships with other entities, the public 
or private status of peer review organizations, and the types of 
practitioners and entities they review. The second area concerned 
private accreditation entities and any potential limitations on their 
abilities to report under section 1921. The comments addressing these 
specific issues are included in the appropriate sections of the 
regulations below. Section IV of this preamble sets forth a summary of 
the specific revisions and clarifications to be made to the final 
regulations as a result of those comments.

A. Section-by-Section Analysis of Issues

The National Practitioner Data Bank (Sec.  60.1)
    Comment: We received several comments that addressed the 
distinctions among the HCQIA, section 1921 and section 1128E. 
Commenters expressed difficulty understanding the specific reporting 
requirements, access to the information authorized by section 1921, and 
the additional changes that would occur under section 1921.
    Response: The distinctions among the HCQIA, section 1921, and 
section 1128E are found in Table 1, Description of Statutory 
Provisions, in the preamble. Section 1921 will not increase the 
reporting burden on State licensing authorities because these entities 
currently report adverse actions to the NPDB and/or the HIPDB. 
Specifically, the HCQIA requires the reporting of licensure actions 
based on professional conduct or competence only against physicians and 
dentists, whereas sections 1921 and 1128E require the reporting of all 
licensure actions taken against all health care practitioners. Also, 
sections 1921 and 1128E require the reporting of adverse licensure 
actions taken against certain health care organizations. Existing NPDB 
reporting requirements for hospitals, other health care entities, 
professional societies, and medical malpractice payers are not affected 
by section 1921.
    Entities that are eligible to query the NPDB will continue to query 
as they always have and will gain access to additional information 
under section 1921. New queriers, such as government health care 
programs and law enforcement agencies, that gain access to the NPDB 
through section 1921 eligibility (i.e., queriers who did not already 
have NPDB eligibility), will only have access to information reported 
under section 1921. These new queriers will not have access to the NPDB 
information reported under the HCQIA. Most of these new section 1921 
queriers already have access to HIPDB information. Currently, private-
sector hospitals do not have access to HIPDB information, which 
includes adverse licensure actions taken against health care 
practitioners other than physicians and dentists, as well as licensure 
actions taken against physicians and dentists that are not related to 
professional competence or conduct. Under section 1921, private-sector 
hospitals will have access to all licensure actions taken against 
health care practitioners, including physicians and dentists.
Applicability of These Regulations (Sec.  60.2)
    Comment: We received several comments supporting the NPDB's 
expansion under section 1921, particularly with respect to collecting 
licensure actions on all health care practitioners. However, we also 
received

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several comments expressing concern over NPDB's expansion under section 
1921 to collect actions taken against health care entities. Citing the 
wording of the statute's first paragraph, which refers to peer review 
organizations and private accreditation entities reviewing the services 
provided by health care practitioners, one commenter questioned NPDB's 
authority to collect peer review and accreditation organization actions 
taken against health care entities. Other commenters questioned the 
authority of the NPDB to collect any type of action taken against 
health care entities because the NPDB was originally authorized to 
collect actions taken against health care practitioners only. These 
commenters also questioned the value of collecting reports on health 
care entities.
    Response: In 1987, Congress authorized the Secretary to collect 
adverse actions taken by licensing agencies against health care 
practitioners and health care entities in the MMPPPA. In 1990, Congress 
expanded this requirement through OBRA to include reporting of negative 
actions and findings by peer review organizations, and private 
accreditation entities. The statute, as amended, requires the 
collection of information from formal proceedings ``concluded against a 
health care practitioner or entity [emphasis added] by any authority of 
the State * * * responsible for the licensing of health care 
practitioners (or any peer review organization or private accreditation 
entity reviewing the services provided by heath care practitioners) or 
entities.''
    Second, section 1921(a)(1)(D) of the Social Security Act requires 
the collection of ``any negative action or finding by such authority, 
organization, or entity regarding the practitioner or entity.'' This 
language clearly indicates that the action taken by the licensing 
authority, peer review organization or private accreditation entity may 
be against a health care practitioner or health care entity.
    Finally, private accreditation entities, which are not operated by 
a unit of State or Federal government, accredit health care facilities, 
not individuals. Therefore, while their work may include reviewing the 
services provided by health care practitioners, these entities 
ultimately make determinations about health care facilities' 
qualifications and their ability to provide quality health care.
    While the statute clearly authorizes the Secretary to collect 
actions taken against health care practitioners and health care 
entities, the proposed rule limited reporting of peer review 
organization actions or findings to those against health care 
practitioners only--not health care entities. We made this decision 
because it is our understanding that peer review organizations are 
primarily involved with evaluating the quality of patient care 
practices or services ordered or performed by health care 
practitioners. Peer review organizations under section 1921 would only 
be evaluating the performance of health care practitioners and not the 
specific performance of a health care facility. In addition, it is the 
health care facility that would be contracting with the peer review 
organization, so we do not believe the peer review organization would 
be in a position to recommend a sanction against the facility with 
which it contracts. Reporting by a peer review organization is limited 
to the discovery of practices by an individual physician, dentist or 
other practitioner that are so serious that they warrant a sanction 
recommendation by the peer review organization to the appropriate 
health care facility or other authority.
    Comment: Several commenters stated that information required to be 
reported by section 1921 is not reflective of the quality of health 
care provided by health care practitioners. One commenter expressed 
concern over the professional and economic impact of having a report in 
the NPDB.
    Response: Section 1921 does not limit reporting to only those 
actions judged by the reporting entity to be based on the quality of 
the health care services provided. The statute requires the reporting 
of specified actions that result from formal proceedings. The NPDB is a 
national repository of actions taken by mandated reporters. We 
understand that there may be a professional or economic impact as a 
result of an action taken against a health care practitioner who, or 
entity that, is reported to the NPDB. However, the NPDB is primarily an 
alert or flagging system. The information in the NPDB is intended to be 
used as a resource to assist authorized queriers in conducting an 
extensive independent investigation of the qualifications of a health 
care practitioner or entity. The NPDB is simply a conduit for 
information on actions taken and reported by authorized entities.
    Comment: Two commenters stated that before the section 1921 
regulations are implemented, HRSA should fully implement the 
recommendations from the Government Accountability Office's (GAO) 2000 
report on the NPDB titled, ``National Practitioner Data Bank: Major 
Improvements Are Needed to Enhance Data Bank's Reliability.''
    Response: The implementation of section 1921 is the final action 
needed to fully implement the recommendations from the GAO's 2000 
report. By the end of 2004, HRSA had satisfactorily addressed the GAO's 
recommendations with the exception of including the adverse licensure 
actions taken against nurses and other non-physicians healthcare 
practitioners.
Definitions (Sec.  60.3)
    Comment: We received two comments requesting clarification of 
current NPDB definitions. One commenter stated that the definition of 
the term ``physician'' should include doctors of podiatric medicine, 
and the other requested clarification of the term ``health care 
entity'' as used in these regulations.
    Response: The terms ``physician'' and ``health care entity'' are 
defined under the HCQIA and are clarified in existing NPDB regulations 
in Sec.  60.3. A doctor of podiatric medicine is not included in the 
term ``physician,'' which is defined by statute as a doctor of medicine 
or osteopathy legally authorized to practice medicine or surgery by a 
State (or who, without authority, holds himself or herself out to be so 
authorized), but is considered a ``health care practitioner.'' Section 
1921 requires the Secretary to provide the maximum appropriate 
coordination with the HCQIA when implementing this statute. Therefore, 
we have an obligation to be consistent with existing definitions and 
are unable to make the requested change.
    Throughout these regulations, we use the terms ``health care 
practitioners, physicians, dentists and entities'' to describe the full 
range of subjects of a section 1921 report. Our approach to describing 
section 1921 report subjects differs slightly from the statutory 
language of section 1921 ``health care practitioners and entities.'' We 
adopted this approach because we relied on existing NPDB definitions. 
These existing definitions, however, do not work seamlessly with each 
section 1921 provision. The existing NPDB definition of ``health care 
practitioner'' specifically excludes physicians and dentists, which are 
defined separately. We, therefore, refer throughout these regulations 
to ``health care practitioners, physicians, and dentists'' to remedy 
this difference between the HCQIA and section 1921.
    We use the current NPDB definition of ``health care entity'' to 
define the range of organizations that may be subjects of a report 
under section 1921. This definition, however, is used in the HCQIA to 
specify certain organizations that are authorized to report and receive 
information under the HCQIA. The current definition includes hospitals 
and other health care entities that provide health care services and

[[Page 4663]]

perform formal peer review activities for the purpose of furthering 
quality health care. The definition, however, also includes 
professional societies that conduct formal peer review activities for 
the purpose of furthering quality health care. We do not believe that 
professional societies fit the definition of subjects of section 1921 
reports, and, for the following reasons, we do not intend to collect 
actions against professional societies under this statute. First, 
section 1921(a)(1)(A) through (C) requires the reporting of any adverse 
action taken by a licensing authority, any dismissals or closures of 
licensing proceedings, or any other loss of a license. To our 
knowledge, licensing authorities do not license, nor do they take 
licensure actions against, professional societies. Therefore, we do not 
expect any licensure reports on professional societies. Second, section 
1921(a)(1)(D) requires the reporting of any negative action or finding 
by a licensing authority, peer review organization or private 
accreditation entity. Under section 1921, private accreditation 
entities, by definition, evaluate the quality of health care services 
provided by a health care entity, measure the health care entity's 
performance, assign that entity a level of accreditation, conduct 
periodic reviews of the quality of health care provided by the entity, 
and report to the NPDB certain final determinations that affect the 
entity's accreditation status. We are unaware of any professional 
societies that directly provide health care services and that would 
contract with a private accreditation entity to perform these defined 
functions. Current NPDB guidance defines a professional society as a 
membership association of physicians, dentists, or other health care 
practitioners that follows a formal peer review process for the purpose 
of furthering quality health care. Therefore, we do not believe that 
professional societies could be the subjects of private accreditation 
entity reports. Because only health care practitioners, physicians, and 
dentists will be the subjects of peer review organization reports, 
professional societies will not be the subjects of these section 1921 
reports either.
1. Formal Proceeding
    Comment: Three commenters expressed concern over the broad nature 
of the definition of formal proceeding. These commenters stated that 
the definition gives too much discretion and not enough guidance to 
reporting entities; does not differentiate between informal and formal 
proceedings; will generate large volumes of report information with 
little value; and, will be difficult to enforce.
    Response: While HRSA crafted the proposed definition of ``formal 
proceeding'' to allow the different types of reporters the maximum 
flexibility in determining the processes they will follow in conducting 
their proceedings, we agree that the current definition is too broad 
and should provide more guidance. As a result, we changed the 
definition of ``formal proceeding'' to include proceedings that are 
taken by entities or organizations that maintain defined rules, 
policies, or procedures for such proceedings. We believe this 
definition of ``formal proceeding'' provides reporters with enough 
information to be able to distinguish between informal and formal 
proceedings. In determining whether a process is formal, we are only 
concerned with the presence of defined rules, policies or procedures 
and not whether the rules, policies and procedures have been strictly 
adhered to. To the extent disputes arise regarding whether a process is 
formal (for instance during the Secretarial Review process), the NPDB 
will not generally examine whether the defined rules, policies or 
procedures have been followed.
    Comment: Two commenters asked why the due process requirements for 
a ``formal peer review process'' under 42 U.S.C. 11112 do not apply to 
adverse actions reported under section 1921. We received other comments 
requesting that we include a due process provision in the ``formal 
proceeding'' definition. These commenters stated that the proposed 
definition does not ensure due process protections for health care 
practitioners reported under section 1921.
    Response: The provision under 42 U.S.C. 11112 cited by several 
commenters refers to due process standards for professional review 
activities undertaken at a hospital or other health care entity. 
Hospital and other health care entity professional review activities 
must meet these standards if the entities wish to avail themselves of 
the Federal liability protections described in 42 U.S.C. 11111. These 
standards do not affect the NPDB reporting requirements. Therefore, it 
is consistent for these standards not to apply to section 1921 
reporting requirements.
    While the professional review provisions under 42 U.S.C. 11111 do 
not apply to section 1921, as several commenters noted, licensing 
agencies operating under State law must provide due process protections 
for those they regulate. Therefore, it is the formal proceedings 
conducted by private accreditation and peer review organizations that 
appear to be of greatest concern. To address this concern, we have 
modified the definitions of ``peer review organization'' and ``private 
accreditation entity'' to include provisions regarding the presence of 
due process mechanisms. If a peer review organization or private 
accreditation entity does not make due process available, the entity 
does not meet the respective definition. As stated earlier, the NPDB is 
concerned only with the presence of due process mechanisms, i.e., 
defined rules, policies or procedures and not whether the rules, 
policies and procedures have been strictly adhered to.
    Comment: One commenter requested that HRSA modify the definition of 
formal proceeding to include proceedings ``taken at the request of'' a 
State licensing or certification authority, peer review organization or 
private accreditation entity.
    Response: Section 1921 does not include the authority to collect 
actions taken or findings made by organizations or bodies other than 
those specified in the statute.
2. Negative Action or Finding
    We received 20 comments concerning the definition of negative 
action or finding by a State licensing authority, peer review 
organization, or private accreditation entity. We organized these 
comments according to the reporting requirements of the three sections 
of the definition: private accreditation organization, peer review 
organization, and State licensing authority.
    Comment: The majority of comments concerning negative actions or 
findings reported by private accreditation entities (i.e., receipt of 
less than full accreditation from a private accreditation entity that 
indicates a substantial risk to patient safety and health care quality) 
suggested the elimination or limitation of the reporting requirement 
for private accreditation entities. Several commenters stated that the 
adoption of the proposed rule would have an adverse effect on health 
care quality because it would deter facilities from participating in 
accreditation programs, which are primarily voluntary. Two commenters 
compared the role of private accreditation organizations to that of 
QIOs and supported their exemption from reporting based on the same 
rationale used to exempt QIOs. Others, citing the dynamic nature of the 
accreditation process in which preliminary or conditional decisions can 
change quickly, recommended

[[Page 4664]]

narrowing the scope of reportable actions to include only final outcome 
determinations, such as a withdrawal or termination of accreditation 
status or a denial of accreditation status. One commenter requested 
that the actions be further limited to those actions due to an 
immediate threat or harm to patients, rather than the proposed 
``substantial risk to the safety of a patient or patients or quality of 
health care services.'' In addition, this commenter suggested the 
exclusion of actions based solely on administrative determinations.
    Response: Unlike QIOs, which were not specifically named as 
reporters in section 1921, the statute clearly requires private 
accreditation entities to report. HRSA, however, agrees that the 
collaborative and continuous nature of the accreditation process could 
prove difficult for private accreditation organizations by creating a 
potential for the submission of multiple reports on a health care 
entity that is not fully compliant with the particular private 
accreditation organization standards for reasons other than a threat to 
patient safety. Therefore, we modified this part of the negative action 
or finding definition to require the reporting of final determinations 
of denial or termination of an accreditation status that indicates a 
risk to the safety of a patient(s) or quality of health care services. 
We believe limiting private accreditation organization reporting to 
these final actions would streamline the reporting process, would not 
have a negative impact on voluntary accreditation efforts, and would 
meet section 1921 reporting requirements.
    By limiting reporting to those negative actions or findings that 
indicate a risk to patient safety or quality of health care services, 
we believe we have precluded the reporting of negative actions or 
findings based solely on administrative reasons. We disagree with the 
comment to modify the definition to reporting based on immediate threat 
or harm to a patient. This language is likely to result in uneven 
interpretation and reporting by accreditation entities and would 
severely limit reporting.
    We also changed the definition to require reporting of those final 
determinations that are based on ``a risk'' to patient safety as 
opposed to ``a substantial risk'' to ensure more uniform understanding 
and reporting of these actions as well as more consistent enforcement 
of the reporting requirement.
    Comment: With respect to negative actions or findings reported by 
private accreditation entities, one commenter expressed concern that 
reporting by private accreditation entities to the NPDB would undermine 
physician self-governance by reporting physician infractions unrelated 
to medical competence.
    Response: Under section 1921, private accreditation entities would 
only report final actions related to the accreditation of health care 
entities. Physicians, dentists, and other health care practitioners 
would not be subjects of these reports.
    Comment: Nine organizations raised concerns about the requirement 
for peer review organizations to report any negative actions or 
findings to the NPDB under section 1921. Several commenters stated that 
requiring the peer review committee to report sanctions would have a 
chilling effect on the peer review process in a hospital. The 
commenters stated that the peer review conducted by a hospital or 
professional society peer review committee is a confidential process 
and that these committees should be exempt from reporting under section 
1921. Another commenter stated that professional societies are not peer 
review organizations. One commenter stated that peer review 
organization reporting would not have an effect on the hospital peer 
review process.
    Response: Section 1921 requires the reporting of ``any negative 
action or finding'' by a peer review organization. Therefore, it would 
be inappropriate to exclude the reporting of ``any negative action or 
finding'' by peer review organizations. For purposes of section 1921 
reporting, the term ``peer review organization'' does not include the 
internal peer review committees of hospitals, professional societies, 
or other health care entities as defined in the current NPDB 
regulations. Peer review organizations are separate from the internal 
peer review committees of hospitals and professional societies. 
According to the definition, a peer review organization is an 
``organization'' whose primary purpose is to evaluate the quality of 
patient care and services against objective criteria that define 
acceptable and adequate practice through an evaluation by a sufficient 
number of health care practitioners to ensure adequate peer review. 
This requires that the peer review organization be a stand-alone 
organization separate from a hospital or other health care entity.
    Comment: Several commenters recommended limiting peer review 
organization reporting to recommended sanctions that indicate a 
substantial risk to patient safety or quality of care. Other commenters 
noted that State laws require peer review organizations to report more 
serious findings to State licensing agencies, making it likely that the 
NPDB would already capture this information in a subsequent licensure 
action. One commenter stated that peer review organizations that 
contract with health care facilities do not recommend sanctions; they 
recommend improvements.
    Response: We agree that peer review organizations identify and 
recommend opportunities for practitioner improvement and generally do 
not recommend sanctions. The health care entities themselves (e.g., 
their peer review committees or boards) would use this information to 
make the decision to sanction a health care practitioner. Further, we 
believe that a sanction recommended by a peer review organization would 
occur in extremely rare instances, likely when there is an immediate 
threat to patient health or safety. Consequently, we believe that we do 
not need to modify the negative action or finding definition as 
suggested by the commenter.
    Comment: Several commenters requested that reportable actions be 
limited to final actions that are afforded due process. They stated 
that, since peer review organizations make recommendations for action 
and the recommendations may be acted upon by another agency or 
organization, peer review organizations should not be required to 
report.
    Response: We agree that peer review organizations may make 
recommendations for another entity to take an action and do not take or 
enforce actions themselves. Therefore, they do not take final actions. 
The presence of a due process mechanism, however, is a hallmark of peer 
review organizations and private accreditation entities and can provide 
greater validity to the information reported. As stated earlier, we 
addressed this concern by modifying the definition of ``peer review 
organization'' to include provisions requiring the presence of due 
process mechanisms.
    Comment: One commenter requested clarification of the term 
``sanction'' as it relates to reporting sanctions recommended by peer 
review organizations.
    Response: In the context of section 1921, a sanction is a 
recommendation by a peer review organization concerning a health care 
practitioner, physician or dentist that, if adopted by the hospital or 
health care entity, would negatively affect the status of that 
individual. For example, if a peer review organization make a 
recommendation that, if adopted, would adversely affect the clinical 
privileges of a physician, the recommended sanction would be reportable 
to the NPDB.

[[Page 4665]]

    Comment: We received a wide range of comments concerning negative 
actions or findings taken by licensing and certification authorities 
(i.e., any negative action or finding that is publicly available, 
excluding 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). Several commenters stated the definition was 
too broad and would generate a large volume of reports with little 
value. They recommended that the definition be limited to actions or 
findings based on patient safety and quality of care issues, or based 
on professional competence or conduct. Conversely, other commenters 
thought the definition was too restrictive, gave licensing bodies too 
much latitude in deciding what to report, and would exclude important 
information regarding a practitioner's fitness to practice. One of 
these commenters stated that licensing boards have a unique role in 
consumer protection and that HRSA should modify the definition to 
include any action taken by a licensing authority that finds a 
violation of a statute or regulation and is a matter of public record. 
Another commenter requested that we modify the definition so that 
administrative fines or citations and corrective action plans are 
reportable if they are either related to the delivery of health care 
services or taken with another reportable action.
    Response: Section 1921 states that State licensing agencies must 
report ``any negative action or finding'' without any limitation other 
than the action or finding must result from a formal proceeding. We 
agree with commenters that further limiting reporting to negative 
actions or findings based on competence or conduct, or quality of care 
issues, would create a subjective standard that unnecessarily exempts 
important information and may lead to uneven interpretation and 
reporting by licensing agencies.
    After consideration of comments suggesting that the proposed 
definition is too restrictive and describing the unique consumer 
protection role played by State boards, we modified the definition 
regarding the reporting of administrative fines or citations, and 
corrective action plans. This modification includes the collection of 
those actions or findings if they are either (1) related to the 
delivery of health care services or (2) taken with another reportable 
action. The definition in the proposed rule mandated that both 
requirements be met. While we do not wish to collect administrative 
fines and citations, or corrective action plans that are imposed for 
reasons unrelated to health care delivery (such as a fine for failing 
to notify a board of an address change in a timely fashion), we believe 
that if such an action is related to the delivery of health care 
services by a health care practitioner, physician, dentist, or health 
care entity, it should be reported. Such an action or finding should 
not have to meet the additional requirement of being taken in 
conjunction with another action. This modification to the definition 
creates a slight difference with the HIPDB definition; however, we 
believe that this change is important to ensure that meaningful actions 
are not excluded from reporting.
    We disagree that the definition gives licensing authorities too 
much latitude in deciding which actions to report, as they are 
currently required to report any negative action or finding that is 
publicly available, with the previously stated exceptions for 
administrative fines or citations, and corrective action plans. These 
fines, citations and corrective action plans are limited to those 
related to health care delivery to ensure that they are meaningful to 
queriers. It is for this same reason we disagree with the proposal to 
require reporting of all violations of statute or regulation that are a 
matter of public record. In addition, we are obligated to try to 
maintain consistency with HIPDB reporting requirements, and this 
proposed definition would create a substantial difference between 
section 1921 and HIPDB State licensure reporting requirements.
    In addition to this change in the definition, HRSA is making a 
minor grammatical change to the definition. In the proposed definition, 
we misplaced a comma. That comma should have appeared after 
``administrative fines or citations,'' rather than between those two 
terms. In the final rule, we moved the comma to its intended place.
    Comment: One commenter stated that HRSA should limit reporting of 
licensure actions to final actions.
    Response: We disagree with this comment. HRSA's interaction with 
State licensure authorities revealed that, within the operation of 
State licensure authorities, there are instances when temporary 
actions, i.e., summary or emergency limitation or restriction on 
license, are necessary to prevent imminent danger to the public. 
Temporary actions are treated differently than other actions in that 
procedural rights of the practitioner are provided following the 
action, rather than preceding it. Further, HRSA opines that the 
reporting of temporary actions is in keeping with the purpose of the 
NPDB, which is to protect the public from the threat of incompetent 
practitioners continuing to practice without disclosure or discovery of 
previous damaging or incompetent performance. In addition, the statute 
does not limit licensure actions to those that are final actions. 
Currently, licensure actions reported to the NPDB are not limited to 
final actions.
    Comment: One commenter expressed concern about whether the negative 
action or finding definition would require licensing authorities to 
report the referral of a practitioner for impairment monitoring or 
participation in a diversion program. The commenter stated that HRSA 
should either withdraw the definition or clarify that such referrals 
are ``corrective actions,'' and agreed with another commenter that 
corrective actions should only be reported when taken with another 
reportable action.
    Response: Current policy guidance for reporting NPDB and HIPDB 
licensing and certification actions specifically excludes reporting of 
agreements that impose monitoring of a practitioner for a specific 
period of time, unless such monitoring constitutes a restriction of the 
practitioner's license or is considered to be a reprimand. Since we do 
not believe that the referral of a practitioner for impairment 
monitoring or participation in a diversion program are adverse actions 
under the statute and therefore not reportable, we will continue this 
policy under section 1921. It is up to each licensing authority to 
determine whether the actions they take are ``corrective actions,'' 
which, based on the definition change mentioned previously, are 
reportable if they are publicly available and are either related to the 
delivery of health care services or taken in conjunctions with another 
reportable action.
    Comment: One commenter recommended expanding the definition to 
include negative actions ``taken at the request of'' a licensing or 
certification authority.
    Response: Section 1921 does not include the authority to collect 
actions taken or findings made by organizations or bodies other than 
those specified in the statute.
    Comment: Two commenters requested that HRSA specify what types of 
negative actions or findings, particularly what types of administrative 
penalties, should be reported under the definition of negative action 
or finding.
    Response: The type of reportable negative action or finding by a 
State licensing authority includes any action

[[Page 4666]]

or finding that is publicly available and rendered by a licensing or 
certification authority. Administrative fines or citations, and 
corrective action plans, are excluded unless they are: (1) Connected to 
the delivery of health care services or (2) taken in conjunction with 
other licensure or certification actions.
    Reportable actions, by statute, must be based on the result of 
formal proceedings and events unrelated to such proceedings would be 
excluded. The types of negative actions or findings likely will vary 
from State-to-State.
    Comment: With respect to all negative actions or findings reported 
under section 1921, one commenter requested that the Secretary limit 
all reportable negative actions and findings to those that last longer 
than 30 days. Such a restriction exists for clinical privileges actions 
reported to the NPDB under the HCQIA.
    Response: Under the HCQIA, only adverse actions against clinical 
privileges are limited to actions that last more than 30 days. This 
limitation does not apply to the other reportable actions under the 
NPDB. Consequently, section 1921 does not limit the reporting of 
negative actions or findings to any particular time period. To place a 
30-day restriction is not consistent with the statute and current NPDB 
and HIPDB reporting requirements for licensure and other actions.
3. Organization Name
    Comment: One commenter requested that HRSA clarify the nature of 
the employment organization relative to information that must be 
reported in Sec.  60.9. The commenter asked whether HRSA intended to 
collect the name of the employer at the time of the act or omission 
that led to the reported action.
    Response: This information is collected currently by both the NPDB 
and the HIPDB, and the intent is to collect the name of the employer of 
the physician, dentist, or other health care practitioner at the time 
of the act or omission that led to the reported action.
4. Peer Review Organization
    Comment: In response to our request for comments concerning peer 
review organizations, including the exemption of QIOs from reporting 
under section 1921, four commenters responded that QIOs should be 
exempt from the reporting requirements of section 1921(a)(1) based on 
the rationale provided in the NPRM. One commenter stated that if QIOs 
are, in fact, peer review organizations, they should not be exempted 
from reporting. The commenter, however, agreed that the rationale to 
exempt QIOs from reporting was reasonable. One commenter responded that 
QIOs should not be exempted from reporting, stating that if private 
accreditation organizations are required to report, then QIOs should be 
required to report as well.
    Response: Section 1921 does not specifically include QIOs in the 
peer review organization definition. 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 * * *'' (currently referred to as 
QIOs). This indicates that the earlier reference to ``any peer review 
organization'' does not refer to ``utilization and quality control peer 
review organizations'' as described in Part B of title XI.
    With respect to linking QIO reporting to private accreditation 
entity reporting, we disagree with this contention. Section 1921 
specifically requires that private accreditation entities report to the 
NPDB. The statute does not specifically require QIO reporting. In 
addition, the reporting of QIO sanction recommendations to the NPDB 
will significantly interfere with the critical mission of the QIO 
program, which focuses on maintaining collaborative relationships with 
providers and practitioners to improve the quality of health care 
services delivered to Medicare beneficiaries. Private accreditation 
entities do not have this specific mission.
    Based on these reasons and in light of the support for the QIO 
exclusion from this definition in the proposed rule, we have decided to 
maintain this exclusion in the final rule.
    Comment: Two commenters stated that the definition of ``peer review 
organization'' should be amended to include language assuring that peer 
review organizations reporting to the NPDB are those that provide due 
process to their physician participants and that a physician has had 
ample opportunity to appeal the peer review organization's findings. 
Additional provisions such as these would provide at least minimal 
assurance of the quality of information considered and the fairness of 
the fact-finding process.
    Response: We concur with these comments and have added language 
regarding the presence of due process to the definition. As stated 
earlier, while the professional review provisions under 42 U.S.C. 11111 
do not apply to section 1921, as several commenters noted, licensing 
agencies operating under State law must provide due process protections 
for those they regulate. Therefore, it is the formal proceedings 
conducted by peer review organizations and private accreditation that 
are of the greatest concern.
    To address this concern, we have modified the definitions of ``peer 
review organization'' and ``private accreditation entity'' to include 
provisions regarding the presence of due process mechanisms. If a peer 
review organization or private accreditation entity does not make due 
process available to practitioners and entities, respectively, the 
entity does not meet the definition.
    For purposes of reporting, the NPDB is only concerned with the 
presence of a due process mechanism and not whether due process has 
been strictly adhered to. To the extent disputes arise regarding 
whether due process has been provided (for instance during the 
Secretarial Review process), the NPDB will not generally examine 
whether the due process rules of any particular entity have been 
followed or the extent to which particular practitioners had access to 
such mechanisms.
    Comment: We received comments requesting that patient safety 
organizations (PSOs), as defined by the Patient Safety and Quality 
Improvement Act of 2005 (Patient Safety Act), and programs that are 
operated by payers (e.g., pay-for-performance or value-based purchasing 
programs), be excluded from the definition of peer review 
organizations. One commenter stated that the proposed rule was 
inconsistent with the Patient Safety Act and would hamper patient 
safety organization activities.
    Response: We do not feel that the rule is inconsistent with the 
Patient Safety Act nor will it hamper PSO activities. We do not believe 
that a specific exclusion from the definition of peer review 
organizations for patient safety organizations is necessary since we do 
not expect PSOs to take any reportable actions under this regulation. 
The only actions that a peer review organization must report to the 
NPDB are recommendations to sanction a health care practitioner, 
physician or dentist. By contrast, PSOs, defined in section 921(4) of 
the Public Health Service Act (42 U.S.C. 299b-21(4)), in order to 
properly carry out their mandatory patient safety activities in 
accordance with the Patient Safety Act, are to use data and reports 
they develop to ``encourage a culture of safety,'' which is understood 
to mean using the data they receive and develop into reports to create 
an environment in which errors and close calls will be readily reported 
by providers and thoroughly discussed

[[Page 4667]]

without fear of penalty or an increased risk of liability. Accordingly, 
it would be inconsistent with PSO commitments made to the Secretary 
pursuant to section 924(a) and 921(5) of the Public Health Service Act 
to make sanction recommendations regarding providers and therefore 
there would be no crossover with this regulation mandating peer review 
organization reporting responsibilities with the separate and distinct 
objectives and responsibilities of PSOs, as set forth in the Patient 
Safety Act.
    We also do not feel that an exception is appropriate for programs 
that are operated by payers. QIOs were excluded from the definition of 
peer review organization because of the statutory distinctions between 
peer review organizations and QIOs in section 1921 and differences in 
the missions of those organizations. There is no similar statutory 
distinction between peer review organizations and programs that are 
operated by payers in section 1921 and we do not feel that the mission 
of programs operated by payers justify such an exclusion as with QIOs.
5. Private Accreditation Entity
    Comment: We received two comments requesting clarification of this 
definition. One of these commenters asked HRSA to confirm that 
organizations that accredit educational programs do not meet the 
requirements of the ``private accreditation entity.'' The other 
commenter requested that organizations that accredit mammography 
screening facilities be exempted because a Federal accreditation 
program currently exists to regulate this type of accrediting 
organization.
    Response: The definition of the term ``private accreditation 
entity'' includes only those organizations that meet the requirements 
of the definition. Private accreditation entities are only required to 
report actions concerning health care entities. If a private 
accreditation entity accredits organizations other than those that meet 
the definition of the term ``health care entity,'' such as purely 
educational programs, then any actions taken against those 
organizations would not be reportable.
    Reporting in