[Federal Register: January 28, 2010 (Volume 75, Number 18)]
[Rules and Regulations]
[Page 4655-4682]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
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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
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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 information to another government agency instead of the
NPDB does not fulfill an entity's obligations under section 1921.
Section 1921 does not provide an exclusion from reporting to the NPDB
for organizations that may report to other government agencies.
Comment: One commenter stated that at least a dozen organizations
would meet the definition of a private accreditation entity and
requested that HRSA ensure these organizations comply equally with
section 1921 reporting requirements.
Response: HRSA agrees with the commenter and expects entities that
are required to report to the NPDB will do so in accordance with
section 1921 requirements. In addition, HRSA will monitor compliance
with these reporting requirements as it does currently with NPDB and
HIPDB reporting requirements.
6. Voluntary Surrender
Comment: We received several comments concerning the voluntary
surrender of a license and a notice of an investigation. These
commenters raised concerns regarding the nexus between a notice of
investigation and a subsequent voluntary license surrender to imply
either wrongdoing or negligence. One commenter recommended that
``notification of investigation'' be stricken from the definition of
voluntary surrender.
Response: The NPDB is primarily a flagging system intended to
facilitate a comprehensive review of the credentials of a health care
practitioner, physician, dentist or entity. An NPDB reported action
serves to alert users that a careful review of the past actions of a
health care practitioner, physician, dentist or entity may be prudent.
NPDB information is intended to be used in combination with information
from other sources, which is consistent with the prevailing credential
verification and professional review standards within the healthcare
delivery industry.
We disagree with the comment requesting that voluntary surrenders
after notification of an investigation be excluded from the voluntary
surrender definition. In an effort to ease the reporting burden and to
make the information contained in both the HIPDB and NPDB as useful as
possible for queriers, HRSA has attempted to make the reporting
requirements under the HIPDB and NPDB as uniform as possible. The
definition of voluntary surrender is based on the definition currently
used in the HIPDB. In addition, reporting voluntary surrenders after
notification of investigation eliminates a loophole in which a health
care practitioner, physician, or dentist surrenders his or her license
to avoid possible disciplinary proceedings and a subsequent report to
the Data Banks. If these voluntary surrenders are not reported to the
NPDB, health care practitioners, with potentially questionable
histories, would be able to move from state-to-state without detection.
Therefore, HRSA has maintained the ``notification of investigation''
language in the final rule.
It is important to note that the definition of the term ``voluntary
surrender'' applies only to State licensing actions reported under
section 1921 and does not apply to actions reported under the HCQIA. To
avoid confusion among entities that report surrenders under the HCQIA,
such as hospitals reporting surrenders of clinical privileges, we have
modified this term as it appears in Sec. 60.3 of the regulations, from
``voluntary surrender'' to ``voluntary surrender of license.''
Comment: We received several comments supporting the exclusion of
non-disciplinary voluntary surrenders from the proposed rule. One
commenter requested that the reporting requirement for exclusion of
late license renewals be more plainly stated.
Response: A State licensing authority's determination that a health
care practitioner, physician, or dentist or entity has voluntarily
surrendered his, her or its license because of non-payment or belated
payment of renewal fees would not be reportable unless the surrender
occurred after a notification of investigation, was done in exchange
for a decision by the licensing authority to cease an investigation, or
otherwise satisfies the requirements of the voluntary surrender
definition. We attempted to maintain consistency with the HIPDB
definition of ``voluntary surrender'' and the HIPDB exclusion of non-
renewals for non-payment of fees. While there are some slight
differences in language between the two regulations, we view these two
definitions as containing the same requirements.
Comment: One commenter requested clarification that a voluntary
surrender of a license will not preclude a State licensing authority
from continuing or initiating a disciplinary action.
Response: A State's reporting obligations under section 1921 have
no impact on the State's authority to continue or curtail disciplinary
action, which is dependent upon the State's rules.
Comment: We received several comments recommending that HRSA
clarify the differences between ``involuntary surrenders'' and
``voluntary surrenders.'' One commenter suggested that HRSA establish a
clear distinction between truly voluntary license surrenders,
involuntary license surrenders and license revocations, with separate
definitions and reporting categories for each. The commenter urged HRSA
to make mandatory reporting of information on all voluntary or
involuntary surrenders and
[[Page 4668]]
non-renewals of licenses, including those occasioned by non-payment of
licensure fees, a change to inactive status, or due to retirement.
Response: We disagree with these comments. Section 1921 and section
1128E both require reporting of any loss of license, including a loss
for the reason of a voluntary surrender. During the public comment
period for the section 1128E proposed rule, we received public comments
concerning this same definition of voluntary surrender. Commenters,
particularly licensing authorities, expressed concern regarding the
volume of reports that would have to be submitted if all surrenders of
license--including those due to retirement or non-payment of fees--were
reportable and the value of these non-disciplinary related surrenders
to queriers. At that time, it was determined that voluntary surrenders
for reasons such as retirement and non-payment of licensure renewal
fees would provide little value to Data Bank users and that such
actions would not be collected. Distinctions between voluntary and
involuntary surrenders have not been an issue for those reporting such
actions to the HIPDB, and we do not think such distinctions are
warranted at this time. To ensure consistency between section 1921 and
HIPDB reporting requirements, we will maintain this definition of
voluntary surrender for both Data Banks.
Comment: One commenter expressed concern about a potential conflict
between the reporting of a negative action or finding that under State
law is publicly available information and a ``voluntary surrender after
a notification of investigation or a formal official request'' to
surrender the license. The commenter believed that many reportable
voluntary surrenders may be based on non-public investigative
information and, therefore, not reportable. The commenter requested
clarification of the definition of a reportable voluntary surrender to
include surrenders regardless of whether they are based upon a
notification of investigation, or request, or agreement that is
publicly available.
Response: We believe there is no conflict between reporting a
negative action or finding that is publicly available and a voluntary
surrender that is based on information that is not publicly available.
Voluntary surrenders are reportable even if the underlying reasons for
the surrender are not public information. However, voluntary surrenders
relating to retirement, non-payment of licensure renewal fees, and
change to inactive status, if there is not an investigation in
progress, are not reportable.
We did not receive any comments on the definitions of the terms
``affiliated or associated,'' ``organization type,'' or ``Quality
Improvement Organization.''
How Information Must Be Reported (Sec. 60.4)
Comment: We received several comments supporting the integration of
the electronic reporting and querying system for the NPDB and the
HIPDB, which enables reporting entities to submit a single adverse
action to both Data Banks, as appropriate. One commenter, however,
questioned the need for two systems if all of the information is
automatically sent to both with a single query or report submission.
Response: The NPDB and the HIPDB are separate and distinct
repositories, with different types of reportable actions contained in
each, as well as different sets of authorized queriers. However, this
distinction notwithstanding, the NPDB and the HIPDB form one integrated
system. Within this integrated system, an action reportable to both the
NPDB, including section 1921 and the HIPDB, will only need to be
reported once. The system will subsequently store the report according
to the appropriate statutory authority. Additionally, an eligible
querier that is registered to have access to information under both
Data Banks can query for information through a single request.
When Information Must Be Reported (Sec. 60.5)
Comment: One commenter stated the 15-day timeframe to report to a
State is not a reasonable amount of time for reporting information. We
also received comments expressing concern over the need to report to
individual States rather than directly to the NPDB.
Response: We feel that the 15-day timeframe is a reasonable amount
of time for reporting information. Currently, health care entities have
15 days to report actions to the Data Banks. This procedure has been in
place since the implementation of the NPDB and we have not received
notice of any concerns from users. Consequently, we feel it is
appropriate to use this timeframe with section 1921. Further, since the
development of electronic reporting technology, entities now submit
reports directly to the NPDB using the Data Bank's electronic reporting
system. The Data Banks' electronic reporting system enables reporting
entities to satisfy reporting obligations to State licensing
authorities by automatically providing a copy of the report for
submission via mail or fax to the appropriate State Board.
Comment: One commenter requested clarification of the penalties for
failure to report to the NPDB.
Response: Current regulations specify the penalties for failing to
report information to the NPDB under the HCQIA. For State licensing
authorities that fail to report licensing actions, Sec. 60.8 (c)
states that ``[i]f, 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. 60.9'' (redesignated as Sec. 60.11). There are
no additional penalties specified under section 1921 for failure to
report.
Reporting Errors, Omissions, and Revisions (Sec. 60.6)
Comment: One commenter questioned how HRSA would handle reports on
hospital subjects that changed ownership or discontinued operation or
services. The commenter suggested that HRSA should specify how a report
would be updated when the information is no longer meaningful given a
change in hospital circumstances.
Response: The Data Banks provide several methods to update
identifying information. If the subject of a report determines that
reported information concerning the subject is no longer accurate, the
subject should first contact the reporting entity to request that the
entity submit a correction report with the updated information. Also,
the subject may provide more current information, such as a name
change, to the Data Banks. In addition, the subject may submit a
subject statement for the report. This statement could note the change
in ownership or other change in status since the report was filed.
However, reporting entities are responsible for ensuring the accuracy
of the information contained in any report they submit.
Reporting Licensure Actions Taken by Boards of Medical Examiners (Sec.
60.8)
Comment: Two commenters requested that Sec. Sec. 60.8 and 60.9 of
the NPDB regulations be revised to include other health care
practitioners in addition to physicians and dentists. These commenters
requested that adverse clinical privileges actions taken against other
health care practitioners be made mandatory instead of voluntary. One
commenter stated that the current regulations do not adequately protect
consumers and health care facilities
[[Page 4669]]
from health care practitioners who have had actions taken against their
licenses or clinical privileges.
Response: As indicated in the proposed rule, the current
regulations governing the NPDB, which are not expanded or modified by
section 1921, are not subject to review and comment. Consequently,
neither the reporting requirements for licensure actions taken by
Boards of Medical Examiners under Sec. 60.8 nor the reporting
requirements for clinical privileges under Sec. 60.9 (redesignated as
Sec. 60.11) are not expanded or modified by section 1921 and,
therefore, are not subject to review and comment. The reporting
requirement of the new Sec. 60.9 (as added by section 1921) requires
the reporting of adverse licensure actions taken against health care
practitioners, physicians, dentists, and entities (health care
facilities). This revision to the NPDB enhances consumer protection and
patient safety.
Reporting Licensure Actions Taken by States (Sec. 60.9)
Comment: Two commenters requested information about the types of
licensure actions to be reported to the NPDB and the HIPDB. One
commenter asked whether data elements used for reporting to the NPDB
and the HIPDB will have the same definitions and whether the NPDB and
HIPDB will use the same violation and action codes for reporting.
Another asked for examples of the new types of licensure actions to be
collected by the NPDB and also requested that nominal or ministerial
acts or omissions not be reported.
Response: State licensing authorities will use the same reporting
formats, data element definitions, and code lists they currently use
for reporting licensure actions to the HIPDB for reporting section 1921
licensure actions. Examples of NPDB licensure actions that will be
reportable under section 1921 that are not currently reportable under
the HCQIA include formal or official actions, such as revocations,
suspensions and reprimands that are not based solely on professional
competence or conduct. Under section 1921, the NPDB also will collect
publicly available negative actions or findings, including fines or
citations for reasons related to the delivery of health care services
or taken with another action. HRSA will provide additional examples of
reportable actions in forthcoming policy guidance.
In keeping with our commitment to maintain consistency between NPDB
and HIPDB reporting formats, we are changing the status of the data
element ``Amount of Monetary Penalty'' from ``if known'' to
``mandatory'' when the reported action consists of a monetary penalty.
This field is mandatory on the HIPDB reporting format for monetary
penalties reported by State licensing agencies and was inadvertently
listed as ``if known'' in the proposed rule.
We disagree with the suggestion to exclude actions that are based
on ``nominal or ministerial acts or omissions.'' Implementing this
suggestion would likely lead to uneven interpretation among States and
create a discrepancy between section 1921 and HIPDB definitions. We
have limited the reporting of certain types of negative actions or
findings, such as administrative fines or citations, and corrective
action plans, to those either based on the delivery of health care
services or taken with another action. We believe these limitations
would ensure that meaningful actions are reported, which appears to be
the commenter's goal, while maintaining as much consistency as possible
with the HIPDB.
Comment: Concerning information reported on all subjects, one
commenter expressed uncertainty over the purpose of collecting the
narrative description of acts or omissions. The commenter noted that,
for purposes of flagging individuals for additional scrutiny, a
narrative is not needed, and that it was not practical for use in
research.
Response: As specified in both the HCQIA and 1128E, ``a description
of the acts or omissions or other reasons for the action'' is
information that must be reported to the NPDB and the HIPDB. In
instances in which the statute clearly defines a requirement, HRSA does
not have the authority to make any modifications. In order to maintain
consistency between the NPDB and section 1921, we have retained the
narrative description on the reporting format for section 1921. In
addition, we believe a narrative description adds value to a flagging
system. The narrative description is critical to understanding the
reasons for and importance of a particular action for subsequent
reviewers of the report as well as the subject of the report, who has a
right to challenge the accuracy of the report.
Comment: One commenter urged HRSA to include, within the scope of
the proposed regulations, a requirement for mandatory reporting of
prescribing psychologists, including a specific NPDB data reporting
category.
Response: To the extent that prescribing psychologists meet the
definition of a ``health care practitioner,'' they are subject to
reports under section 1921.
Comment: One commenter questioned whether a State licensing
authority can take an action against a practitioner's license when the
action is based on another State licensing authority determination.
Response: Section 1921 does not supersede the ability of a State to
take an action against a practitioner or entity. States may take
actions for any reason permitted in their own laws and regulations.
Reporting Negative Actions or Findings Taken by Peer Review
Organizations or Private Accreditation Entities (Sec. 60.10)
Comment: One commenter requested that the Secretary limit
accreditation report content to the information collected during the
accreditation process so that accreditation entities can avoid costly
software changes. Another commenter noted that certain accreditation
entities post accreditation status on their Web sites, making
additional reporting unnecessary.
Response: HRSA disagrees with these comments. We continue to
believe the data elements selected for inclusion under section 1921 are
essential for users to properly identify entities that are subjects of
reports in the Data Bank and to understand the nature of the actions
taken against them. We believe the required information should be
available from information contained in existing records compiled
during the review process. The NPDB makes available an electronic
reporting format that can be completed online at the Data Banks' secure
Web-based reporting site. A reporting entity that makes information
available in other public formats has not met its statutory reporting
obligations under section 1921.
Comment: Several commenters expressed concern about the reporting
process. One commenter stated that it is unclear what specifically must
be reported since the proposed rule includes discretionary and
mandatory data elements (Sec. 60.9).
Response: The mandatory data elements are listed in Sec. 60.9(b).
The electronic system will not accept a report that does not include
these data elements. Data elements to be reported ``if known'' are
listed in Sec. 60.9(c). The inclusion of these data elements enhances
the matching process between a query and a reported subject and
provides additional information to aid users' understanding of the
reported incident.
Comment: One commenter requested that the Secretary modify the
regulations to require private accreditation entities to report their
[[Page 4670]]
negative actions or findings to all State agencies responsible for
licensing hospitals and health care entities.
Response: Adopting such a reporting requirement for private
accreditation entities is unnecessary and would be overly burdensome.
Queriers, including State licensing authorities, will have access to
negative actions and findings reported by accreditation entities
through the NPDB, which is a national repository.
Comment: Two commenters expressed concern about the reporting of a
narrative description of the act or omission upon which the reported
action was based. The commenters requested that HRSA provide detailed
guidance on the type of information to be included in this narrative
description.
Response: A narrative description of the act(s) or omission(s)
should contain sufficient specificity to allow a knowledgeable Data
Bank querier to clearly understand what led to the reported action or
finding and the seriousness of the act(s) or omission(s). Narrative
information also should be supported by written documentation, such as
official findings, orders or minutes. HRSA has provided examples of
acceptable narrative descriptions on the NPDB Web site (npdb-
hipdb@hrsa.gov), along with guidance on how to write an acceptable
narrative description and will continue to provide information as
needed.
Comment: One commenter expressed concern that the proposed Sec.
60.10 does not include the requirement that the reported action must be
the result of formal proceedings (as defined in Sec. 60.3) and
requested that this omission be corrected in the final rule.
Response: The requirement that an action must be the result of a
formal proceeding was omitted in error and has been included in the
final rule.
Comment: One commenter asked whether a hospital would be required
to report its own accreditation recommendations.
Response: Section 1921 does not require hospitals or other health
care entities to self-report accreditation recommendations. In general,
only the entity that takes a reportable action or finding must report
the action or finding to the NPDB. The subject of the reportable action
does not report the action.
Requesting Information From the NPDB (Sec. 60.13) [Redesignated]
Comment: Several commenters questioned whether a hospital is
authorized to query on nurses and other health care practitioners who
are employed by the hospital. They believed the proposed rule only
authorizes hospitals to query on individuals on the medical staff or
those who hold clinical privileges. Another commenter questioned
whether hospitals had access to section 1921 information at all.
Response: Section 1921 information is available to hospitals.
Section 1921(b)(6) of the Social Security Act states that this
information is available to ``hospitals and other health care entities
* * * with respect to physicians or other licensed health care
practitioners that have entered into, or may be entering into, an
employment or affiliation relationship with, or have applied for
clinical privileges or appointments to the medical staff of, such
hospitals or other health care entities * * *'' The other licensed
health care practitioners include individuals in professions such as
nursing and physical therapy.
Comment: Several commenters expressed concern that private
accreditation entities are not authorized to query and receive section
1921 information, which would support their evaluations of a health
care entity's performance. Other commenters supported public access to
NPDB information.
Response: The Secretary is not authorized to provide private
accreditation entities, other organizations, or the general public
access to NPDB information.
Comment: We received several comments questioning the range of law
enforcement agencies permitted to query the NPDB under the proposed
rule. In particular, commenters questioned the inclusion in the
proposed rule of certain law enforcement agencies, such as the Nuclear
Regulatory Commission and the U.S. Chief of Postal Inspector, not
specifically included in the statute. One commenter noted that law
enforcement access to section 1921 information would deter
participation in quality and risk management procedures. We also
received comments requesting that subjects of reports be informed when
law enforcement agencies receive a copy of their report, and that law
enforcement agencies should be required to state the purpose of their
query and not use the NPDB to circumvent standard criminal
investigative procedures.
Response: Section 1921(b) of the Social Security Act authorizes the
Secretary to release information collected under the statute to ``the
Attorney General and such other law enforcement officials as the
Secretary deems appropriate.'' The list provided in the proposed rule
of agencies authorized to receive section 1921 information under these
provisions is not considered to be exhaustive. Each of the listed
agencies, however, meets the qualifications described in the statute.
For example, the U.S. Chief of Postal Inspector and State law
enforcement agencies play a major role in investigating health care
fraud and abuse in government health care programs. The Nuclear
Regulatory Commission enforces regulations governing the medical use of
nuclear materials and also licenses physicians, clinical laboratories
and hospitals to possess and use nuclear byproduct materials. These
agencies will not have access to professional review actions or medical
malpractice information in the NPDB, but only section 1921 reports, so
we do not believe their access should have any impact on quality and
risk management activities.
Currently, all NPDB and HIPDB queriers are required to provide a
reason for their information request on a particular subject. Also, the
system records the name of each querying entity that has requested and
received a copy of a report, information that is available to the
subject of that report upon request, with the exception of queries
submitted by law enforcement agencies to the HIPDB. Consistent with
what was done with the HIPDB, HRSA will be seeking an exemption to
protect from release law enforcement queries for section 1921
information. This is necessary in order to protect the confidentiality
and integrity of investigations by law enforcement.
Confidentiality of National Practitioner Data Bank Information (Sec.
60.15)
Comment: One commenter expressed concern that NPDB information may
be misused or misinterpreted. The commenter stated that punishment for
improper access to or use of NPDB information should be greater than
the penalties for failing to report mandatory actions. Other commenters
expressed concern that information may be stored in the wrong Data Bank
and requested assurances that Data Bank information is secure.
Response: Information reported to the NPDB is considered
confidential and access to and use of the information is restricted. As
stated in Sec. 60.15, ``persons who, and entities which, receive
information from the NPDB either directly or from another party must
use it solely with respect to the purpose for which it was provided.''
Both improper use of and access to the NPDB may result in a CMP of up
to $11,000 for each violation.
[[Page 4671]]
The NPDB and the HIPDB are required by statute to coordinate
reporting and querying. Reported information is and will continue to be
contained only in the legally authorized Data Bank(s) as determined by
report content. Additionally, when the Data Banks receive a query on a
subject, the system searches for and releases information stored in the
NPDB and the HIPDB based on the querying entity's statutory authority
to access that information. Eligible entities that register with the
Data Banks must certify their authority as a reporter and querier under
each of the relevant statutes governing the Data Banks. Authorized
users interact with the Data Banks over a secure Web-based server that
uses the latest technology, along with various implementation measures,
to provide a secure environment for querying, reporting, and data
storage. Some of these security features include firewall protection
and encryption of transmitted data to prevent unauthorized access, as
well as the use of unique passwords for data entry and retrieval. The
system security plan is reviewed and updated annually to address
changes in guidance or industry standards needed to continue providing
secrecy and privacy for the system. In addition, every three years the
NPDB-HIPDB is required under the Federal Information System Management
Act (FISMA) to conduct and renew the system's Certification and
Accreditations (C&A). The C&A process involves convening a panel of
information technology professionals who conduct a security risk
assessment, security test and evaluation, technical vulnerability
assessment, and a Continuity of Operation Plan (COOP) exercise.
How To Dispute the Accuracy of National Practitioner Data Bank
Information (Sec. 60.16)
Comment: Several commenters raised concerns that the proposed
regulations did not include provisions for practitioners to rebut
information in NPDB reports. Other commenters expressed concern over
subjects' due process rights and requested that the Secretary provide
health care practitioners meaningful opportunities to dispute the
accuracy of claims reported to the NPDB and require the removal of
inaccurate reports. One of the commenters stated that a subject who
discovered incorrect or inaccurate information in the NPDB should have
a right to require the NPDB or the reporting entity to correct the
error.
Response: The NPDB currently has in place multiple levels of
safeguards to protect and ensure the accuracy of a report. Subjects may
dispute the accuracy of information provided in reports to the NPDB.
These safeguards will not change under section 1921.
Comment: One commenter stated that additional protections for
health care practitioners other than physicians and dentists should be
in place, such that an opportunity to dispute the accuracy of their
information reported to the NPDB should be guaranteed before the
information is submitted to the NPDB.
Response: The NPDB's safeguards to protect and ensure the accuracy
of reports apply equally to all types of practitioners. All subjects of
a report are treated equally and fairly by the Data Banks once a report
is submitted. We do not have the statutory authority to review the
merits of adverse actions taken by reporting entities. We can only
review (1) if the report is legally required or permitted to be filed,
and (2) if the report accurately depicts the action taken and the
reporter's basis for the action. Although we understand the comment,
the statute is clear that the Data Bank's responsibility is to receive
and disclose information expeditiously and in accordance with statute.
B. Other Issues Raised
1. Implementation Schedule
Comment: We received two comments regarding the requirement to
report all actions occurring since the enactment of section 1921. These
commenters expressed concern about the extra burden State licensing
agencies would face by having to report information dating back fifteen
years and questioned the accuracy and availability of such information
across States. One commenter questioned whether subjects of reports
dating back to 1992 would have access to information to enable them to
dispute reported actions, if necessary. One commenter requested that
HRSA only require the reporting of actions taken on or after the
publication date of the regulations.
Response: In Sec. 60.5, the NPDB regulations state that
information must be submitted beginning with actions occurring on or
after January 1, 1992. However, while we recognize the commenters'
concerns, we strongly encourage each reporter to submit actions
occurring on or after January 1, 1992. To assist in reducing the burden
on State licensing agencies, we will offer State agencies two options
for submitting legacy HIPDB reports (August 21, 1996, forward) to the
NPDB. One option is, with the States' permission, for HRSA to provide
copies to the NPDB of all actions previously reported to the HIPDB that
fall under the section 1921 requirements. The second option is for the
State agencies to resubmit all legacy HIPDB reports (August 21, 1996,
forward) to the NPDB under section 1921. We also recognize the report
subjects' concerns regarding their ability to dispute reports of
actions taken more than a decade ago. However, the dispute resolution
process (Secretarial review) is available to determine whether an
action is reportable under applicable law and regulations. The process
also determines whether the report accurately describes the reporter's
action and reasons for the action as stated in the reporter's decision
documents or in a public record, such as board orders.
2. Immunity Provisions of the HCQIA
Comment: One commenter recommended extending the immunity from
liability protections (under 42 U.S.C. 11111) to all individuals
reporting information concerning a health care practitioner, physician,
dentist or entity under section 1921.
Response: Part A of Title IV (42 U.S.C. 11111) provides that the
professional review bodies of hospitals and other health care entities,
and persons serving on or otherwise assisting such bodies, are offered,
in certain circumstances, immunity from private damages in civil suits
under Federal or State law. It does not apply to reporting licensure
actions or medical malpractice payments under the HCQIA, nor does it
apply to section 1921 reporting. HRSA is unable to extend this immunity
without a statutory amendment.
3. Paperwork Reduction Act Statement
Comment: One commenter expressed concern that section 1921 would
create an increased burden on State licensing and certification
agencies.
Response: Section 1921 does not create a new reporting burden for
State licensing authorities. State licensure reporting requirements
under section 1921 are essentially identical to those already being
reported under the HIPDB. Because of the Data Banks' integrated
reporting and querying system, State licensing agencies will only need
to submit a licensing action once. The system will subsequently store
the report according to statutory requirements in the NPDB, the HIPDB
or both.
Comment: One commenter stated that peer review organizations do not
have substantial resources and that the section 1921 reporting
requirement would be burdensome.
Response: Information required to be reported by peer review
organizations
[[Page 4672]]
should be minimal. We have received comments noting that peer review
organizations generally recommend areas of improvement and do not
recommend sanctions (the only type of reportable event for these
organizations). Therefore, we believe their reporting requirements will
not be overly burdensome.
Comment: One commenter stated that the proposed rule did not
account for additional staff time responding to a greater volume of
telephone calls resulting from increased access to reported State
licensure discipline information.
Response: The licensing actions to be reported to the NPDB under
section 1921 have already been or are required to be reported to the
HIPDB. It is for this reason that we do not believe the volume of
telephone calls resulting from these reports would constitute an added
burden to State licensing boards.
Comment: One commenter recommended that HRSA amend the proposed
rule to allow State licensing agencies and private accreditation
entities that contract with and report to other Federal agencies to
determine among themselves which agency will report to the NPDB, to
further reduce reporting burden. This commenter expressed concern that
section 1921 would alter its existing reporting relationship with
another Federal agency.
Response: Statutes governing the NPDB and the HIPDB specifically
state who must report and what must be reported to each Data Bank. A
State licensing authority that takes a reportable action must report
the action to the NPDB and/or the HIPDB. The statute will not alter
existing reporting relationships between agencies or between agencies
and their contractors.
IV. Summary of Revisions in the Final Rule
Based on our review and response to the array of public comments,
and on the discretionary authority given to the Department under the
statute, we have made the revisions to the proposed regulations
outlined below. We believe these revisions will allow the NPDB to
collect and disseminate information under section 1921 in an effective
and efficient manner.
Section 60.2
We are modifying the proposed change to the first sentence
in Sec. 60.2 to read ``State licensing or certification authorities,
peer review organizations, and private accreditation entities that take
negative actions or findings against health care practitioners,
physicians, dentists, or entities.''
Section 60.3
We are revising the definition of the term ``formal
proceeding'' to read as follows: Formal Proceeding means a proceeding
held before a State licensing or certification authority, peer review
organization, or private accreditation entity that maintains defined
rules, policies, or procedures for such a proceeding.
We are modifying language in the definition of the term
``negative action or finding'' to limit the scope of actions or
findings reported by private accreditation organizations. The sentence
``Receipt of less than full accreditation from a private accreditation
entity that indicates a substantial risk to the safety of a patient(s)
or quality of health care services and includes, but is not limited to,
denial of accreditation or non-accreditation;'' is replaced by ``A
final determination of denial or termination of an accreditation status
from a private accreditation entity that indicates a risk to the safety
of a patient(s) or quality of health care services.''
To ensure clarity of the range of reportable subjects, we
are modifying the definition of the term ``negative action or finding''
to replace the sentence ``Any recommendation by a peer review
organization to sanction a practitioner.'' to read: ``Any
recommendation by a peer review organization to sanction a health care
practitioner, physician, or dentist.''
We are revising the following sentence in the definition
of the term ``negative action or finding:'' ``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.'' In this sentence, we are replacing the ``and'' in between
``connected to the delivery of health care services'' and ``taken in
conjunction with other licensure * * *'' with an ``or.'' Also in this
sentence, we are deleting the ``,'' in ``administrative fines, or
citations'' and adding a ``,'' after ``citations'' and before ``and
corrective action plans.''
After the first sentence in the definition of the term
``peer review organization,'' we are adding a requirement that to
qualify as a peer review organization for purposes of this rule, an
organization must have due process mechanisms. This sentence reads:
``The organization has due process mechanisms available to health care
practitioners, physicians, and dentists.'' We also are changing the
term ``health care practitioners'' in the first sentence to read
``health care practitioners, physicians, or dentists.''
We are adding a fourth element in the proposed definition
of ``private accreditation entity'' to include an entity that ``Has due
process mechanisms available to health care entities.'' We are also
deleting the ``and'' at the end of the statement ``Measures a health
care entity's performance based on a set of standards and assigns a
level of accreditation;'' and deleting the period at the end of the
statement ``Conducts ongoing assessments and periodic reviews of the
quality of health care provided by a health care entity'' and replacing
it with ``and.''
For clarification purposes, we are changing the term
``Voluntary surrender'' to ``Voluntary surrender of license.'' Also, in
the first and second sentences of the definition, we are changing the
phrase ``a health care practitioner or entity'' to read ``a health care
practitioner, physician, dentist, or entity.''
Section 60.9
In Sec. 60.9(a), we are changing the phrase ``a health
care practitioner or entity (both as defined in Sec. 60.3)'' to read
``a health care practitioner, physician, dentist, or entity (as defined
in Sec. 60.3).''
In Sec. 60.9(a)(2) through Sec. 60.9(a)(4), we are
changing the phrase ``practitioner or entity'' to read ``health care
practitioner, physician, dentist, or entity.''
In Sec. 60.9(a)(3) we are replacing the word
``nonpayment'' with ``non-payment.''
We are changing the phrase ``health care practitioner'' in
Sec. Sec. 60.9(b)(1), 60.9(b)(2), 60.9(c)(1), and Sec. 60.9(c)(2) to
read ``health care practitioner, physician, or dentist.''
We are deleting Sec. 60.9(c)(4)(ii), the requirement to
report the amount of any monetary penalty resulting from the reported
action ``if known,'' and adding that requirement to Sec.
60.9(b)(4)(iii). This change makes the reporting of this data element
mandatory instead of discretionary.
Section 60.10
We are adding a third sentence to Sec. 60.10(a) to state
that the actions taken must be as a result of formal proceedings (as
defined in Sec. 60.3).
In section Sec. 60.10(a), we are changing the phrase
``health care practitioner or health care entity'' to read ``health
care practitioner, physician, dentist, or entity.''
[[Page 4673]]
Section 60.13
To clarify the range of subjects that may be queried on,
we are changing the phrase ``individual health care practitioner or
entity'' in the first sentence of paragraph (a)(2) of Sec. 60.13 to
read: ``individual health care practitioner, physician, dentist, or
entity.''
We are changing the phrase ``licensing health care
practitioners and entities'' in Sec. 60.13(a)(2)(ii) to read
``licensing health care practitioners, physicians, dentists, and
entities.''
In 60.13(a)(2)(iv), we capitalized the phrase ``Medicaid
Fraud Control Units.''
Section 60.14
In Sec. 60.14(a), we are changing the sentence ``The
amount of such fees will be sufficient to recover the full costs of
operating the NPDB'' to read ``The amount of such fees will be
sufficient to cover the full costs of operating the NPDB.'' We are
changing the word ``recover'' to read ``cover'' for clarification.
V. Regulatory Impact Statement
A. Regulatory Analysis
OMB has reviewed this final 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 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 final 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.
Regulations are also considered a significant regulatory action if it
raises novel legal or policy issues.
The Office of Information and Regulatory Affairs (OIRA) has
designated this final rule a significant regulatory action under the
Executive Order since it raises novel legal and policy issues under
section 3(f)(4) of the Executive Order. OIRA concludes, however, that
this rule does not meet the significance threshold of $100 million
effect on the economy in any one year under section 3(f)(1).
Consistent with section 1921, these 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 final rule 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 understand that States routinely collect and
maintain much of this information. Many licensing boards routinely
collect and report much of this information to 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. In addition, State Survey and
Certification agencies are required to report adverse information to
CMS regarding certain health care entities. Moreover, this information
is reported to the HIPDB under section 1128E. Actions that are reported
under section 1128E will only need to be reported once; the NPDB-HIPDB
system will automatically route these reports to both Data Banks.
Further, private accreditation entities maintain information on
Internet Web sites regarding health care entities that have undergone
the accreditation survey process and their ensuing accreditation
status. We are unaware of any peer review organizations that make
available specific information relating to their reviews on their
organization's Web sites.
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 do not intend to impose new or added burdens on reporters and are
proposing to give reporters the option of omitting certain data
elements that they do not maintain or to which they do not have access.
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. Further,
in accordance with the RFA, 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. Therefore, 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 leading private accreditation entities,
(e.g., the Joint Commission, National Committee for Quality Assurance,
Utilization Review Accreditation Commission and Commission on
Accreditation of Rehabilitation Facilities), accreditation entities
take approximately 11 negative findings or actions per year against
health care entities. Based on a review of public comments, we estimate
the potential volume of reporting by peer review organizations to be
minimal. Most commenters that addressed the volume of such reports,
while not providing specific estimates, stated that peer review
organizations would rarely make the types of recommendations that would
be reportable under these regulations. 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 that 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 section 1921 to users
[[Page 4674]]
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 licensing authorities are currently
reporting to the NPDB and/or the HIPDB. Reports required under section
1921 will be the same as those currently being made to the HIPDB, and
filing one report, in almost all cases, will meet the reporting
obligation for the 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 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 more by State, local, or tribal governments, or the
private sector. In accordance with the UMRA, we have determined that
the only costs are those related to the ability to transmit the
information electronically (e.g., Internet service) and additional
staff hours needed to transmit information (which we believe will not
be significant). 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 final 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 because the actions that are to be reported under
section 1921 are already being reported to the HIPDB under 1128E.
B. 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 (PRA) and assigned control number 0915-0126.
This final rule also contains information collection requirements.
As required by the PRA [44 U.S.C. 3507(d)], we have submitted a copy of
this final 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 final rule would be used by authorized parties, specified in
the final 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, physicians,
dentists, and health care entities, peer review organizations, and
private accreditation entities reviewing the services of a health care
practitioner, physician, dentist, or entity.
Estimated Annual Reporting: We estimate that the public reporting
burden for the final rule is 10,429.48 hours. Each State is required to
adopt a system of reporting to the Secretary certain adverse licensure
actions taken against health care practitioners, physicians, dentists,
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 Number of
Section No. respondents of response responses Hours per response Burden hours Hourly cost Total cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
Errors and Omissions 60.6 (a) \1\.......... 23 1 23 15 min...................... 5.75 $25 $144
Revisions to Actions 60.6 (b) \1\.......... 7 1 7 30 min...................... 3.5 25 88
Licensure Actions 60.9 \2\................. 0 0 0 0........................... 0 0 0
Adverse Action 60.10 Private Accreditation 11 1 11 45 min...................... 8.25 25 206
Entities \3\.
Adverse Action 60.10 Peer Review 25 2 50 45 min...................... 37.50 25 938
Organizations \3\.
Queries: Agencies administering Federal 10 26 260 5 min....................... 21.66 25 542
health care programs 60.13 (a)(2)(i) \4\.
Queries: State Licensing Authorities 0 0 0 0........................... 0 0 0
60.13(a)(2)(ii) \4\.
Queries: State Agencies 60.13 (a)(2)(iii) 51 20 1020 5 min....................... 85 25 2,125
\4\.
Queries: State Medicaid 60.13 (a)(2)(iv) 51 20 1020 5 min....................... 85 25 2,125
\4\.
Queries: Law Enforcement 60.13 (a)(2)(v) 262 1 262 5 min....................... 21.83 25 546
\4\.
Queries: QIOs 60.13 (a)(2)(vi) \4\......... 51 5 255 5 min....................... 21.25 25 531
Queries: Hospitals and other health care 10,930 11 120,230 5 min....................... 10,019.16 25 250,479
entities 60.13 (a)(2)(vii) \4\.
Self-Query 60.11(a)(2) \5\................. 0 0 0 0........................... 0 0 0
Entity Registration 60.3 \6\............... 50 1 50 60 min...................... 50 25 1,250
Entity Update 60.3 \6\..................... 25 1 25 5 min....................... 2.08 25 52
Initial Request for Dispute of Report 18 1 18 15 min...................... 4.5 45 203
60.16(b) \7\.
[[Page 4675]]
Practitioner Requests for Secretarial 3 1 3 8 hours..................... 24 200 4,800
Review 60.16(b) \7\.
Subject Statements 60.16(b) \7\............ 40 1 40 60 min...................... 40 100 4,000
------------------------------------------------------------------------------------------------------------
Total.................................. 11,557 ........... 123,183 ............................ 10,429.48 ........... 268,029
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Although OMB has previously approved the burden under the 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, physicians, dentists, and health care entities are already 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 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 responsible for reporting the revision. 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 already 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 are 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, physicians, dentists, 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 already required to be reported to the HIPDB and were included in
the HIPDB regulations. This regulation, therefore, includes the burden estimates only for those negative actions or findings taken by peer review
organizations and private accreditation entities. We anticipate that there may be 25 peer review organizations that meet the definition proposed in
this NPRM. Comments on the proposed rule indicate that peer review organizations will not often take the type of action or finding required to be
reported in this regulation. Therefore, we estimate that on average these organizations would, at most, report a finding 2 times a year to the NPDB.
We estimate that, under Sec. 60.10, there will be approximately 11 private accreditation entities reporting on an average 2 times each during the
year to the NPDB for a total of 50 reports. We have identified 11 organizations that meet the definition of a private accreditation entity. We believe
that these entities will report an average of 11 actions per year. This estimation is based on changes in the final rule that limits reportable
actions to final terminations and denials of accreditation. 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, 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, physicians, dentists, and health care entities. Based on
current NPDB querying patterns, we estimate an approximate total of 123,183 new (section 1921--only) queries per year on health care practitioners,
physicians, dentists, and health care entities. The costs associated with preparing these queries are estimated at $25 per hour. This estimate
excludes queries by State licensing authorities. State licensing boards that license health care practitioners already have access to NPDB
information. Additionally, State licensing authorities that license health care practitioners and entities currently have access to the HIPDB, which
not only contains the new types of licensing reports collected under section 1921, but also contains a range of other types of adverse actions.
Because of the low volume of queries currently submitted by these authorities, we do not anticipate an increase in queries as a result of section 1921
implementation. All queries under section 1921 are voluntary.
\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, physicians, dentists, 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. All self-querying is voluntary.
\6\ To access the NPDB, entities are required to certify that they meet section 1921 reporting and/or querying requirements. Consequently, an eligible
entity must complete and submit an Entity Registration Form to the NPDB. Data 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. We estimate that an
additional 50 entities will register with the NPDB each year for the next 3 years for a total of 150 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 number, 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 150 new registrants, we estimate
that approximately 25 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, physician, dentist, 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 $45 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,
physician, dentist, 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, physician, or dentist 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.
[[Page 4676]]
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: September 9, 2009.
Mary K. Wakefield,
Administrator, Health Resources and Services Administration.
Dated: September 14, 2009.
Kathleen Sebelius,
Secretary, Department of Health and Human Services.
0
For the reasons set forth in the preamble, the Health Resources and
Services Administration amends 45 CFR part 60 as set forth below:
PART 60--NATIONAL PRACTITIONER DATA BANK FOR ADVERSE INFORMATION ON
PHYSICIANS AND OTHER HEALTH CARE PRACTITIONERS
0
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
0
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. The regulations in this part set
forth the reporting and disclosure requirements for the NPDB.
Sec. 60.2 [Amended]
0
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, physicians, dentists, 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.
0
4. Section 60.3 is amended by removing the reference to ``Sec. 60.9''
in the third sentence of the definition of ``Board of Medical
Examiners'' and adding ``Sec. 60.11'' in its place, and by adding the
following 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 of license'' in 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 proceeding held before a State licensing
or certification authority, peer review organization, or private
accreditation entity that maintains defined rules, policies, or
procedures for such a proceeding.
* * * * *
Negative action or finding by a State licensing authority, peer
review organization, or private accreditation entity means:
(a) A final determination of denial or termination of an
accreditation status from a private accreditation entity that indicates
a risk to the safety of a patient(s) or quality of health care
services;
(b) Any recommendation by a peer review organization to sanction a
health care practitioner, physician, or dentist; 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, or
(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 ``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, physicians, or
dentists measured against objective criteria which define acceptable
and adequate practice through an evaluation by a sufficient number of
health practitioners in such an area to ensure adequate peer review.
The organization has due process mechanisms available to health care
practitioners, physicians, and dentists. This definition excludes
utilization and quality control peer review organizations described in
Part B of Title XI of the Social Security Act (referred to as QIOs) and
other organizations funded by the Centers for Medicare and Medicaid
Services (CMS) to support the QIO program.
* * * * *
Private accreditation entity means an entity or organization that:
(a) Evaluates and seeks to improve the quality of health care
provided 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;
(c) Conducts ongoing assessments and periodic reviews of the
quality of health care provided by a health care entity; and
(d) Has due process mechanisms available to health care entities.
* * * * *
Quality Improvement Organization means a utilization and quality
control peer review organization (as defined in part B of title XI of
the Social Security Act) that:
(a)(1) Is composed of a substantial number of the licensed doctors
of
[[Page 4677]]
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
(2) 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;
(b) 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
(c) Has at least one individual who is a representative of
consumers on its governing body.
* * * * *
Voluntary surrender of license means a surrender made after a
notification of investigation or a formal official request by a State
licensing authority for a health care practitioner, physician, dentist,
or entity to surrender a license. The definition also includes those
instances where a health care practitioner, physician, dentist, 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.
0
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 on or after September 1,
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 on or after January 1, 1992,
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 (5 U.S.C. 552a
note),
(v) Date of birth,
(vi) Name of each professional school attended and year of
graduation,
(vii) For each professional license: the license number, the field
of licensure, and the name of the State or Territory in which the
license is held,
[[Page 4678]]
(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,
(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 not to exceed the amount specified at 42 CFR
1003.103(c).
(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 U.S.C. 552a note),
(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, 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.
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, physician, dentist, or entity
(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 health care practitioner, physician, dentist, or entity
surrendering the license, or the practitioner leaving the State or
jurisdiction;
(3) Any other loss of the license of the health care practitioner,
physician, dentist, or entity, whether by operation of law, voluntary
surrender (excluding those due to non-payment 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 health care practitioner, physician, dentist,
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, physician, or
dentist, 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 (5 U.S.C. 552a
note);
(iii) Home address or address of record;
(iv) Sex; and
(v) Date of birth.
(2) If the subject is a health care practitioner, physician, or
dentist, 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)
[[Page 4679]]
on which the reported action was taken, the license and the name of the
State or Territory in which the license is held.
(4) For all subjects:
(i) A narrative description of the acts or omissions and injuries
upon which the reported action was based;
(ii) Classification of the acts or omissions in accordance with a
reporting code adopted by the Secretary;
(iii) Classification of the action taken in accordance with a
reporting code adopted by the Secretary, and the amount of any monetary
penalty resulting from the reported action;
(iv) The date the action was taken, its effective date and
duration;
(v) Name of the agency taking the action;
(vi) Name and address of the reporting entity; and
(vii) The name, title and telephone number of the responsible
official submitting the report on behalf of the reporting entity.
(c) 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, physician, or
dentist, 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, physician, or
dentist, 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.
(ii) [Reserved]
(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, physician, dentist, or entity by a peer review
organization or private accreditation entity. The health care
practitioner, physician, dentist, or entity must be licensed or
otherwise authorized by the State to provide health care services. The
actions taken must be as a result of formal proceedings (as defined in
Sec. 60.3).
(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 a 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 (5 U.S.C. 552a
note),
(v) Date of birth,
(vi) Name of each professional school attended and year of
graduation,
(vii) For each professional license: the license number, the field
of licensure, and the name of the State or Territory in which the
license is held,
(viii) Drug Enforcement Administration registration number, if
known,
(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
[[Page 4680]]
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 Secretary will
provide the entity with a written notice describing the noncompliance,
giving the health care entity an opportunity to correct the
noncompliance, and stating that the entity may request, within 30 days
after receipt of such notice, a hearing with respect to the
noncompliance. The request for a hearing must contain a statement of
the material factual issues in dispute to demonstrate that there is
cause for a hearing. These issues must be both substantive and
relevant. The hearing will be held in the Washington, DC, metropolitan
area. The Secretary will deny a hearing if:
(i) The request for a hearing is untimely,
(ii) The health care entity does not provide a statement of
material factual issues in dispute, or
(iii) The statement of factual issues in dispute is frivolous or
inconsequential.
In the event that the Secretary denies a hearing, the Secretary will
send a written denial to the health care entity setting forth the
reasons for denial. If a hearing is denied, or if as a result of the
hearing the entity is found to be in noncompliance, the Secretary will
publish the name of the health care entity in the Federal Register. In
such case, the immunity protections provided under section 411(a) of
the Act will not apply to the health care entity for professional
review activities that occur during the 3-year period beginning 30 days
after the date of publication of the entity's name in the Federal
Register.
(2) Board of Medical Examiners. If, after notice of noncompliance
and providing opportunity to correct noncompliance, the Secretary
determines that a Board has failed to report information in accordance
with paragraph (b) of this section, the Secretary will designate
another qualified entity for the reporting of this information.
(Approved by the Office of Management and Budget under control number
0915-0126)
0
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, physician, dentist, 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
[[Page 4681]]
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,
physicians, dentists, 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
(I) State law enforcement agencies, which include, but are not
limited to, State Attorneys General.
(vi) Utilization and quality control peer review 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 cover 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
must 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)
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
[[Page 4682]]
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. 2010-1514 Filed 1-27-10; 8:45 am]
BILLING CODE 4165-15-P