[Federal Register Volume 77, Number 31 (Wednesday, February 15, 2012)]
[Proposed Rules]
[Pages 9138-9161]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-3014]
[[Page 9137]]
Vol. 77
Wednesday,
No. 31
February 15, 2012
Part V
Department of Health and Human Services
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45 CFR Parts 60 and 61
National Practitioner Data Bank; Proposed Rule
Federal Register / Vol. 77, No. 31 / Wednesday, February 15, 2012 /
Proposed Rules
[[Page 9138]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
45 CFR Parts 60 and 61
RIN 0906-AA87
National Practitioner Data Bank
AGENCY: Health Resources and Services Administration (HRSA), HHS.
ACTION: Notice of proposed rulemaking.
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SUMMARY: This proposed rule revises existing regulations under sections
401-432 of the Health Care Quality Improvement Act of 1986 and section
1921 of the Social Security Act, governing the National Practitioner
Data Bank, to incorporate statutory requirements under section 6403 of
the Patient Protection and Affordable Care Act of 2010 (Affordable Care
Act), Public Law 111-148. The Department of Health and Human Services
(HHS) also is removing Title 45 of the Code of Federal Regulations
(CFR) part 61, which implemented the Healthcare Integrity and
Protection Data Bank.
Section 6403 of the Affordable Care Act, the statutory authority
for this regulatory action, was designed to eliminate duplicative data
reporting and access requirements between the Healthcare Integrity and
Protection Data Bank (established under section 1128E of the Social
Security Act) and the National Practitioner Data Bank. Section 6403 of
the Affordable Care Act requires the Secretary to establish a
transition period to transfer all data in the Healthcare Integrity and
Protection Data Bank to the National Practitioner Data Bank, and, once
completed, to cease operations of the Healthcare Integrity and
Protection Data Bank. Information previously collected and disclosed
through the Healthcare Integrity and Protection Data Bank will then be
collected and disclosed through the National Practitioner Data Bank.
This regulatory action consolidates the collection and disclosure of
information from both data banks into one part of the CFR.
DATES: We invite comments on this proposed rule. To be considered,
submit comments on or before April 16, 2012.
Addresses and Mode of Transmission for Comments: You may submit
comments in one of three ways, as listed below. The first is the
preferred method. To avoid duplication, please submit your comments in
only one of these ways.
1. Federal eRulemaking Portal. You may submit comments
electronically to http://www.regulations.gov. Click on the link
``Submit a comment'' and enter the file code `` HRSA-0906-
AA87'' in the ID field. Submit your actual comments as an attachment to
your message or cover letter. (Attachments should be in Microsoft Word
or WordPerfect; however, we prefer Microsoft Word.)
2. By regular, express or overnight mail. You may mail written
comments to the following address only: Health Resources and Services
Administration, Department of Health and Human Services, Attention:
HRSA Regulations Officer, Parklawn Building Rm. 14-101, 5600 Fishers
Lane, Rockville, MD 20857. Please allow sufficient time for mailed
comments to be received before the close of the comment period.
3. Delivery by hand (in person or by courier). If you prefer, you
may deliver your written comments before the close of the comment
period to the same address: Parklawn Building Room 14-101, 5600 Fishers
Lane, Rockville, MD 20857. Please call (301) 443-1785 in advance to
schedule your arrival with one of our HRSA Regulations Office staff
members.
Because of staffing and resource limitations, and to ensure that no
comments are misplaced, we cannot accept comments by facsimile (FAX)
transmission.
In commenting, please refer to file code HRSA-0906-AA87.
Comments received on a timely basis will be available for public
inspection as they are received in Room 14-101 of the Health Resources
and Services Administration, 5600 Fishers Lane, Rockville, MD., on
Monday through Friday of each week from 8:30 a.m. to 5:00 p.m. (phone:
301-443-1785).
We will consider all comments we receive by the date and time
specified in the Dates section of this preamble, and will respond to
the comments in the preamble of the final rule.
FOR FURTHER INFORMATION CONTACT: Cynthia Grubbs, Director, Division of
Practitioner Data Banks, Bureau of Health Professions, Health Resources
and Services Administration, Parklawn Building, 5600 Fishers Lane, Room
8-103, Rockville, MD 20857; telephone number: (301) 443-2300.
SUPPLEMENTARY INFORMATION:
I. Background
A. Legal Authorities Governing the Data Banks
The paragraphs below provide a summary of the legal authorities
governing the National Practitioner Data Bank and the Healthcare
Integrity and Protection Data Bank.
(1.) The Health Care Quality Improvement Act of 1986 (42 U.S.C. 11101
et seq.)
The National Practitioner Data Bank (NPDB) was established by the
Health Care Quality Improvement Act of 1986 (HCQIA), as amended (42
U.S.C. 11101 et seq.). The HCQIA authorizes the NPDB to collect reports
of adverse licensure actions against physicians and dentists (including
revocations, suspensions, reprimands, censures, probations, and
surrenders); adverse clinical privileges actions against physicians and
dentists; adverse professional society membership actions against
physicians and dentists; Drug Enforcement Administration (DEA)
certification actions; Medicare/Medicaid exclusions; and medical
malpractice payments made for the benefit of any health care
practitioner. Organizations that have access to this data system
include hospitals, other health care entities that have formal peer
review processes and provide health care services, State medical or
dental boards and other health care practitioner State boards.
Individual practitioners may self-query. Information under the HCQIA is
reported by medical malpractice payers, State medical and dental
boards, professional societies with formal peer review, and hospitals
and other health care entities (such as health maintenance
organizations).
(2.) Section 1921 of the Social Security Act (42 U.S.C. 1396r-2) (Prior
to the Passage of the Affordable Care Act)
Section 1921 of the Social Security Act (herein referred to as
section 1921), as amended by section 5(b) of the Medicare and Medicaid
Patient and Program Protection Act of 1987, Public Law 100-93, and as
amended by the Omnibus Budget Reconciliation Act of 1990, Public Law
101-508, expanded the scope of the NPDB. Section 1921 requires each
State to adopt a system for reporting to the Secretary certain adverse
licensure actions taken against health care practitioners and 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 had taken
against a health care practitioner or health care entity.
Groups with access to this information include all organizations
eligible to query the NPDB under the HCQIA (hospitals, other health
care entities that have formal peer review and provide health care
services, State
[[Page 9139]]
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, certain law enforcement agencies, and
utilization and quality control Quality Improvement Organizations
(QIOs). Individual health care practitioners and entities may self-
query. Information under section 1921 is reported by State licensing
and certification authorities, peer review organizations, and private
accreditation entities.
Final regulations implementing section 1921 were issued on January
28, 2010 (75 FR 4656). The NPDB began collecting and disclosing section
1921 information on March 1, 2010.
(3.) Section 1128E of the Social Security Act (42 U.S.C. 1320a-7e)
(Prior to the Passage of the Affordable Care Act)
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,
directed 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
practitioners, providers, or suppliers. This data bank is known as the
Healthcare Integrity and Protection Data Bank (HIPDB). Section 1128E
required Federal and State government agencies and health plans to
report to the HIPDB the following final adverse actions: Licensing and
certification actions; criminal convictions and civil judgments related
to the delivery of health care services; exclusions from Federal or
State health care programs; and other adjudicated actions or decisions.
Federal and State government agencies and health plans have access to
this information. Individual practitioners, providers, and suppliers
may self-query the HIPDB.
The HIPDB began collecting reports in November 1999. Requirements
of both HCQIA and section 1921 overlap with the requirements under
section 1128E, although each law has unique characteristics, including
differences in the types of reportable actions and the types of
agencies, entities, and officials with access to information. For
example, all three reporting schemes require the reporting of State
licensure actions. The HCQIA, however, only requires the reporting of
licensure actions taken against physicians and dentists that are based
on professional competence or conduct. In contrast, sections 1921 and
1128E do not have a requirement that reportable adverse licensure
actions be based on professional competence or conduct and also differ
in the types of subjects reported. In addition, sections 1921 and 1128E
authorize access to many of the same types of agencies, organizations,
and officials. For example, both statutes authorize access by law
enforcement agencies, agencies that administer or pay for health care
services or programs, and State licensing authorities. Private-sector
hospitals and health care service providers are only able to access
information reported under the HCQIA and section 1921, but not under
section 1128E.
(4.) Section 6403 of the Patient Protection and Affordable Care Act of
2010
Section 6403 of the Patient Protection and Affordable Care Act of
2010 (hereinafter referred to as section 6403), Public Law 111-148,
amends sections 1921 and 1128E to eliminate duplication between the
HIPDB and the NPDB, and requires the Secretary to establish a
transition period for transferring data collected in the HIPDB to the
NPDB and to cease HIPDB operations. Information previously collected
and disclosed through the HIPDB will then be collected and disclosed
through the NPDB. No new data elements have been added as a result of
section 6403. All actions currently reported in the NPDB and HIPDB will
be reported to the NPDB.
All security standards that are currently in place to protect the
confidentiality of information in the Data Banks will be retained. HRSA
follows the National Institute of Standards and Technology (NIST)
security guidelines. More specifically, the Data Bank has extensive
operational, management, and technical controls that ensure the
security of the system and protect the data in the system. The Data
Bank contains information classified under the Privacy Act that is
considered personally identifiable information (PII). On an annual
basis, the Data Bank conducts a detailed security review process that
tests the effectiveness of the security controls to ensure the PII in
the system remains safe. Finally, every three years, the Data Bank is
Certified and Accredited (C&A) as a requirement to have an Authority to
Operate (ATO), in order to function as a Federal system.
The specific amendments section 6403 makes to sections 1921 and
1128E are described in greater detail in the paragraphs below.
Subsection (a) of section 6403 amends section 1128E to require
reporting to the NPDB instead of the HIPDB. Subsection (a) also
eliminates requirements in section 1128E related to reporting by State
agencies; conforms the requirements for reporting Federal licensing and
certification actions to those that apply to State agencies under
section 1921; provides that the information reported pursuant to
section 1128E will be available to the agencies, entities, and
officials authorized to access information reported pursuant to section
1921; and authorizes the Secretary to establish reasonable fees for the
disclosure of the information, with no exception from the fee for
Federal government agencies. Finally, subsection (a) requires the
Secretary, in implementing the amendments to section 1128E, to provide
for the maximum appropriate coordination between part B of the HCQIA
and section 1921.
Subsection (b) of section 6403 adds to section 1921 the State
agency reporting requirements that were eliminated from section 1128E
by subsection (a). These State actions, taken against health care
practitioners, providers, and suppliers, include State licensing and
certification actions, State health care-related criminal convictions
and civil judgments, exclusions from State health care programs, and
other adjudicated actions or decisions. Subsection (b) also conforms
the requirements for reporting State licensing and certification
actions to those that apply to Federal agencies under section 1128E and
makes amendments to expand the data access provisions of section
1921(b) so that entities that were authorized to access final adverse
action information reported to the HIPDB by State agencies under
section 1128E will retain access to that information when it is
reported to the NPDB under section 1921. Subsection (b) also adds new
provisions under section 1921 that are modeled on similar provisions in
section 1128E. These new provisions require the Secretary to disclose
reported information to a subject of a report and establish other
requirements designed to ensure that the information reported pursuant
to section 1921 is accurate; authorize the Secretary to establish or
approve reasonable fees for the disclosure of information reported
pursuant to section 1921; and provide protection against liability in a
civil action for entities reporting information as required by section
1921 (so long as such entities have no knowledge of the falsity of the
information). Subsection
[[Page 9140]]
(b) also provides definitions for the following terms: (1) ``State
licensing or certification agency;'' (2) ``State law or fraud
enforcement agency;'' and (3) ``final adverse action.'' Finally,
subsection (b) requires the Secretary, in implementing the amendments
to section 1921, to provide for the maximum appropriate coordination
with HCQIA and section 1128E.
Subsection (c) of section 6403 amends section 1128C of the Social
Security Act regarding the HHS Office of Inspector General's
responsibilities with respect to section 1128E by deleting the HHS
Office of Inspector General's responsibility to provide for the
reporting and disclosure of certain final adverse actions against
health care providers, suppliers, or practitioners pursuant to the data
collection system established under section 1128E. Subsection (d)
establishes requirements for a transition process; authorizes the
Department of Veterans Affairs to access, free of charge for one year,
information that was formerly reported only to the HIPDB; describes the
availability of additional funds for the transition process, if
necessary; and includes the effective date for the section.
Effectively, in addition to transferring HIPDB data and operations
to the NPDB, section 6403 transfers all section 1128E reporting
requirements by State agencies to section 1921, thereby eliminating
duplication in certain State agency reporting requirements under both
statutes, while leaving Federal agency and health plan reporting
requirements under the authority of section 1128E. Section 6403 also
creates a common list of queriers for section 1921 and section 1128E
data. There are exceptions to this common querier list. Hospitals and
other health care entities, professional societies, and QIOs have
access to section 1128E data as well as licensing and certification
actions under section 1921, but have no additional access to data as a
result of section 6403. By maintaining many of the same reporting
requirements and by maintaining different levels of access depending on
who is requesting information in section 6403, Congress further
indicated its intent that, despite the transition of HIPDB operations
to the NPDB, original reporting and querying requirements remain the
same to the greatest extent possible, while ensuring the maximum
coordination among the three statutes. Section 6403 does not affect
reporting requirements or query access under the HCQIA, so existing
requirements under the HCQIA for hospitals, other health care entities,
professional societies, or medical malpractice payers will not change.
The reporting and querying requirements of sections 1921 and 1128E,
as amended by section 6403, are described in greater detail below.
B. Section 1921 as Amended by Section 6403
As amended by section 6403, section 1921 requires each State to
have in effect a system of reporting licensure and certification
actions taken against a health care practitioner or entity by a State
licensing or certification agency. Section 6403 defines a State
licensing or certification agency to include State licensing
authorities, peer review organizations, and private accreditation
entities. Licensing and certification actions include certain adverse
actions taken by a State licensing authority as well as any negative
action or finding that a State licensing authority, a peer review
organization, or a private accreditation entity has concluded against a
health care practitioner or entity. Each State also must have in effect
a system of reporting information with respect to any final adverse
action (not including settlements in which no findings of liability
have been made) taken against a health care practitioner, provider, or
supplier by a State law or fraud enforcement agency. These final
adverse actions include criminal convictions or civil judgments in
State court related to the delivery of health care services, exclusions
from participation in a State health care program, and any other
adjudicated action or decision. In addition, final adverse actions
include any licensure or certification action taken against a supplier
by a State licensing or certification agency. Section 1921 information
is now available to agencies administering Federal health care
programs, including private entities administering such programs under
contract; State licensing or certification agencies, and Federal
agencies responsible for the licensing and certification of health care
practitioners, providers, and suppliers; State agencies administering
or supervising the administration of State health care programs; health
plans; State law or fraud enforcement agencies; and the U.S. Attorney
General and other law enforcement officials as the Secretary deems
appropriate. In addition, QIOs, as well as hospitals, professional
societies, and other health care entities have access to ``licensure
and certification actions'' reported under section 1921. These entities
do not have access to ``final adverse actions'' added to section 1921
by section 6403. Potential subjects of section 1921 reports, including
health care practitioners, health care entities, providers, and
suppliers, may self-query.
C. Section 1128E, as Amended by Section 6403
Section 6403 amends section 1128E to require the Secretary to
maintain a national health care fraud and abuse data collection program
under this section for the reporting of certain final adverse actions
against health care practitioners, providers, and suppliers. The
Secretary shall furnish the information collected under section 1128E
to the NPDB. Federal government agencies and health plans are required
to report to the NPDB the following final adverse actions: licensing
and certification actions; criminal convictions and civil judgments in
Federal or State court related to the delivery of health care services;
exclusions from Federal health care programs; and other adjudicated
actions or decisions.
The information collected under section 1128E shall be available
from the National Practitioner Data Bank to all agencies, authorities,
and officials which are authorized under the amended section 1921
access provisions. However, under the section 1921 access provisions,
hospitals, other health care entities, professional societies, and QIOs
are only authorized to receive certain section 1921 information.
Individual practitioners, providers, and suppliers may self-query the
NPDB to receive section 1128E information.
The table below further illustrates the impact that section 6403
has on current data bank requirements, presenting the requirements for
the HCQIA, section 1921 and 1128E before the passage of section 6403,
and the proposed requirements after passage of section 6403.
The table is only a summary of the statutory reporting and querying
requirements before and after passage of section 6403. All elements in
the table, including definitions of terms used, are detailed in various
sections of this proposed rule.
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Table 1--Data Banks Statutory Requirements Before and After Passage of
Section 6403*
------------------------------------------------------------------------
Statutory requirements before Reporting/querying requirements
passage of Section 6403 after passage of Section 6403
------------------------------------------------------------------------
WHO REPORTS? WHO REPORTS?
HCQIA (NPDB) HCQIA (NPDB)
[ssbox]Medical malpractice payers [ssbox]Medical malpractice payers
[ssbox]Boards of Medical/Dental [ssbox]Boards of Medical/Dental
Examiners Examiners
[ssbox]Hospitals and other [ssbox]Hospitals and other health
healthcare entities care entities
[ssbox]Professional societies with [ssbox]Professional societies with
formal peer review formal peer review
[ssbox]Drug Enforcement [ssbox]Drug Enforcement
Administration Administration
[ssbox]Health and Human Services-- [ssbox]Health and Human Services-
Office of Inspector General Office of Inspector General
...................................
SECTION 1921 (NPDB) SECTION 1921 (NPDB)
[ssbox]Peer review organizations [ssbox]Peer review organizations
[ssbox]Private accreditation [ssbox]Private accreditation
organizations organizations
[ssbox]State authorities that [ssbox]State authorities that
license practitioners and entities license or certify practitioners,
entities, providers, suppliers
[ssbox]State law or fraud
enforcement agencies
...................................
SECTION 1128E (HIPDB) SECTION 1128E (NPDB)
[ssbox]Federal and State government [ssbox]Federal government agencies
agencies (including State law or [ssbox]Health plans
fraud enforcement agencies)
[ssbox]Health plans
------------------------------------------------------------------------
WHAT INFORMATION IS REPORTED? WHAT INFORMATION IS REPORTED?
HCQIA (NPDB) HCQIA (NPDB)
[ssbox]Medical malpractice payments [ssbox]Medical malpractice payments
[ssbox]Adverse licensure actions [ssbox]Adverse licensure actions
(physicians/dentists): (physicians/dentists):
--revocation, suspension, --revocation, suspension,
reprimand, probation, surrender, reprimand, probation, surrender,
censure censure
[ssbox]Adverse clinical privileges [ssbox]Adverse clinical privileges
actions (primarily physicians/ actions (primarily physicians/
dentists) dentists)
[ssbox]Adverse professional society [ssbox]Adverse professional society
membership (primarily physicians/ membership (primarily physicians/
dentists) dentists)
[ssbox]DEA certification actions [ssbox]DEA certification actions
[ssbox]Medicare/Medicaid exclusions [ssbox]Medicare/Medicaid exclusions
SECTION 1921 (NPDB) SECTION 1921 (NPDB)
[ssbox]Licensing actions [ssbox]Licensing or certification
(practitioners and entities): actions (practitioners, entities,
--revocation, reprimand, censure, providers, and suppliers):
suspension, probation --revocation, reprimand, censure,
--any dismissal or closure of the suspension, probation
proceedings by reason of --any dismissal or closure of the
surrendering the license or proceedings by reason of
leaving the State or jurisdiction surrendering the license or
--any other loss of the license leaving the State or jurisdiction
--any negative action or finding by --any other loss of, or loss of the
a State licensing authority, peer right to apply for, or renew a
review organization, or private license
accreditation entity --any negative action or finding by
a State licensing or certification
authority, peer review
organization, or private
accreditation entity
[ssbox]Health care-related civil
judgments in State court
(practitioners, providers,
suppliers)
[ssbox]Health care-related State
criminal convictions
(practitioners, providers,
suppliers)
[ssbox]Exclusions from State health
care programs (practitioners,
providers, suppliers)
[ssbox]Other adjudicated actions or
decisions (practitioners,
providers, suppliers)
...................................
SECTION 1128E (HIPDB) SECTION 1128E (NPDB)
[ssbox]Licensing and certification [ssbox]Federal licensing/
actions (practitioners, providers, certification actions
and suppliers): (practitioners, providers, and
--revocation, reprimand, suppliers):
suspension, censure, probation; --revocation, reprimand, censure,
--any other loss of license, or suspension, probation
right to apply for, or renew, a --any dismissal or closure of the
license, whether by voluntary proceedings by reason of
surrender, non-renewability, or surrendering the license or
otherwise leaving the State or jurisdiction
--any other negative action or --any other loss of, or right to
finding that is publicly available apply for, or renew, a license,
information whether by voluntary surrender,
[ssbox]Health care-related civil non-renewability, or otherwise
judgments in Federal or State --any negative action or finding
court (practitioners, providers, that is publicly available
suppliers) information
[ssbox]Health care-related Federal [ssbox]Health care-related civil
or State criminal convictions judgments in Federal or State
(practitioners, providers, court (practitioners, providers,
suppliers) suppliers)
[ssbox]Exclusions from Federal or [ssbox]Health care-related Federal
State health care programs or State criminal convictions
(practitioners, providers, (practitioners, providers,
suppliers) suppliers)
[ssbox]Other adjudicated actions or [ssbox]Exclusions from Federal
decisions (practitioners, health care programs
providers, suppliers) (practitioners, providers,
suppliers)
[ssbox]Other adjudicated actions or
decisions (practitioners,
providers, suppliers)
------------------------------------------------------------------------
[[Page 9142]]
WHO CAN QUERY? WHO CAN QUERY?
HCQIA (NPDB) HCQIA (NPDB)
[ssbox]Hospitals [ssbox]Hospitals
[ssbox]Other health care entities [ssbox]Other health care entities
with formal peer review with formal peer review
[ssbox]Professional societies with [ssbox]Professional societies with
formal peer review formal peer review
[ssbox]Boards of Medical/Dental [ssbox]Boards of Medical/Dental
Examiners Examiners
[ssbox]Other health care [ssbox]Other health care
practitioner State licensing practitioner State licensing
boards boards
[ssbox]Plaintiff's attorney/pro se [ssbox]Plaintiff's attorney/pro se
plaintiffs (limited circumstances) plaintiffs (limited circumstances)
[ssbox]Health care practitioners [ssbox]Health care practitioners
(self-query) (self-query)
[ssbox]Researchers (statistical [ssbox]Researchers (statistical
data only) data only)
SECTION 1921 (NPDB) SECTION 1921 and SECTION 1128E
(NPDB)
[ssbox]Hospitals and other health [ssbox]Hospitals and other health
care entities (HCQIA) care entities (HCQIA)**
[ssbox]Professional societies with [ssbox]Professional societies with
formal peer review formal peer review**
[ssbox]Quality Improvement [ssbox]Quality Improvement
Organizations Organizations**
[ssbox]State licensing agencies [ssbox]State licensing or
that license practitioners and certification agencies that
entities license or certify practitioners,
[ssbox]Agencies administering entities, providers, or suppliers
Federal health care programs, or [ssbox]Agencies administering
their contractors (including those providing payment
[ssbox]State agencies administering for services) Federal health care
State health care programs programs and their contractors
[ssbox]State Medicaid fraud control [ssbox]State agencies administering
units State health care programs
[ssbox]U.S. Comptroller General [ssbox]Federal agencies that
[ssbox]U.S. Attorney General and license or certify practitioners,
other law enforcement providers, suppliers
[ssbox]Health care practitioners/ [ssbox]Health plans
entities (self-query) [ssbox]State law or fraud
[ssbox]Researchers (statistical enforcement agencies (including
data only) State Medicaid fraud control
units)
SECTION 1128E (HIPDB) [ssbox]U.S. Comptroller General
[ssbox]Federal and State government [ssbox]U.S. Attorney General and
agencies other Federal law enforcement
[ssbox]Health plans [ssbox]Health care practitioners,
[ssbox]Health care practitioners/ entities, providers, suppliers
providers/suppliers (self-query) (self-query)
[ssbox]Researchers (statistical [ssbox]Researchers (statistical
data only) data only).
------------------------------------------------------------------------
* For NPDB requirements, the term ``practitioners'' is used throughout
this table to mean ``practitioners, physicians, dentists.''
** Under Section 1921, these entities only have access to reported
licensing or certification actions, which is consistent with these
entities' access prior to passage of the Affordable Care Act.
D. Maximum Coordination When Implementing Section 6403
Sections 6403(a)(3) and 6403(b)(4) require the Secretary to provide
for the maximum appropriate coordination among HCQIA, section 1921, and
section 1128E when implementing the provisions of section 6403. We have
made significant efforts to develop this proposed rule in a manner that
minimizes the burden on reporters. Reporters previously responsible for
reporting adverse actions to both the NPDB and HIPDB only needed to
submit one report per action, provided that reporting was done through
the Department's web-based system that sorted the appropriate actions
into the HIPDB, the NPDB, or both. Similarly, under the revised
regulations, reporters will only need to submit one report per action.
Congress's mandate that the Secretary provide for the maximum
appropriate coordination among the statutes makes it necessary, in
certain cases, to make slight modifications when combining sometimes
overlapping statutory requirements. These instances are described in
the paragraphs below, and in the discussion of the proposed regulatory
definitions.
E. Terms Used To Describe Subjects of Reports Under Section 1921 and
1128E
We clarified statutory language used to describe report subjects in
several ways. First, we used the term ``health care practitioner,
physician, and dentist'' throughout these regulations to refer to
``health care practitioner'' report subjects for sections 1921 and
1128E. We are clarifying that the ``health care practitioner'' report
subjects under both sections 1921 and 1128E include health care
practitioners, physicians, and dentists to help ensure consistency in
the merged data, as the NPDB definition of ``health care practitioner''
excludes physicians and dentists whereas the HIPDB definition includes
physicians and dentists. The definitions for physician and dentist are
provided for separately and therefore they are included as report
subjects.
Second, we clarified statutory language with respect to report
subjects by consistently using the term ``entity, provider, and
supplier'' in referring to section 1921 entity report subjects. Both
original and amended section 1921 reporting requirements include
certain adverse actions taken against a ``health care practitioner or
entity,'' and NPDB regulations use the HCQIA definition of ``health
care entity'' to define the range of these report subjects. It is clear
from the context of section 6403 that the use of the term ``entity''
also includes ``supplier'' subjects. Specifically, section 6403(b),
which added the disclosure and correction provision in section 1921(d),
refers only to ``health care practitioner'' and ``entity'' report
subjects. It is not reasonable to conclude that Congress intended to
prevent providers and suppliers from having access to their own reports
or being able to dispute a report, while giving that ability to health
care practitioners and entities. Although the provision only uses the
terms practitioner and entity it must be read broadly to keep the
Congressional intent of not making significant changes to current
reporting and querying requirements. Therefore, we apply this provision
to all section 1921 report subjects, including health care
practitioners, physicians, dentists, entities, providers, and
suppliers.
Finally, the proposed rule sometimes refers to ``practitioner,
physician, dentist, provider, and supplier'' as one grouping. The
manner in which the regulation defines supplier may be read to include
physicians and dentists. In the proposed rule, where physicians
[[Page 9143]]
and dentists are specified, but other suppliers are not, it is intended
that other suppliers are not included in those instances. Where
suppliers are mentioned along with physicians and dentists, the intent
is not to imply that suppliers do not include physicians and dentists,
but that all terms were included for the sake of clarity.
F. Sanction Authority
HIPDB regulations include sanctions against Federal and State
agencies and health plans for failure to report as required. For
Federal and State government agencies, the Secretary provides for
publication of a public report that identifies those agencies that have
failed to report information as required. Health plans that fail to
report information as required under section 1128E are subject to a
civil money penalty of up to $25,000 for each action not reported.
While section 6403 transfers State agency reporting requirements from
section 1128E to section 1921, we plan to maintain existing sanction
authority (publication of a public report) for those State agencies
that are required to report licensure and certification actions,
exclusions from State health care programs, criminal convictions and
civil judgments in a State court, and other adjudicated actions or
decisions. Further, we plan to maintain existing sanction authority, as
stated above, and which currently exists in section 1128E, for those
Federal agencies that fail to report. These sanctions are currently
part of the agency's compliance plan, and we are attempting to maintain
consistency between current and future Data Bank operational policy.
G. Authorization Dates for Collecting Reports
The authorization dates for collecting adverse actions under
section 1921 and section 1128E are based on the original legislation
for the requirements and are unchanged by the passage of section 6403.
Amendments made by section 6403 represent a reorganization of existing
statutory requirements and not an imposition of new actions. Therefore,
the passage section 6403 does not affect reporters' obligations to
report action back to the dates currently in use for the system.
Actions taken by State agencies transferred from section 1128E to
section 1921 will retain their original authorization dates.
H. Limitations on the Scope of Public Comment
The current regulations governing the NPDB which are not expanded
or modified by section 6403 are not subject to review or comment under
this Notice of Proposed Rulemaking, e.g., reporting requirements for
medical malpractice payers, and eligible entities that may query the
NPDB under the authority of the HCQIA.
II. Provisions of the Proposed Rule
We describe the proposed amendments below according to the sections
of the regulations which they affect.
Sec. 60.1 The National Practitioner Data Bank
The proposed rule amends this section by incorporating the
statutory provisions for section 1128E of the Social Security Act.
Sec. 60.2 Applicability of These regulations
The proposed rule amends this section by revising the reporting
requirements to include those organizations and agencies required to
report under section 1921 and section 1128E (both as amended by section
6403).
Sec. 60.3 Definitions
The proposed rule adds existing definitions from the HIPDB
regulations as well as new statutory definitions to this section.
Because this proposed rule combines requirements already specified in
current NPDB and HIPDB regulations, it was necessary to modify the
regulatory definitions for certain terms or combine similar regulatory
definitions for the same term. In one instance, for the term ``Act,'' a
definition is deleted in its entirety. We believe this approach is
consistent with the mandate that the Secretary provide for the maximum
appropriate coordination among the HCQIA, section 1921, and section
1128E. This proposed rule also clarifies new statutory definitions.
These clarifications merely provide additional examples of the scope of
the definitions.
As a result, we propose to add the following new terms to this
section, which are in the current HIPDB regulations:
Civil judgment means a court-ordered action rendered in a Federal
or State court proceeding, other than a criminal proceeding. This
reporting requirement does not include consent judgments that have been
agreed upon and entered to provide security for civil settlements in
which there was no finding or admission of liability.
The term ``civil judgment'' is currently defined in the HIPDB
regulations, and we have not modified this existing definition.
Criminal conviction means a conviction as described in section
1128(i) of the Social Security Act.
The term ``criminal conviction'' is currently defined in the HIPDB
regulations, and we have not modified this existing definition.
Exclusion means a temporary or permanent debarment of an individual
or entity from participation in any Federal or State health-related
program, in accordance with which items or services furnished by such
person or entity will not be reimbursed under any Federal or State
health-related program.
The term ``exclusion'' is currently defined in the HIPDB
regulations, and we have not modified this existing definition.
Federal government agency includes, but is not limited to:
(a) The U.S. Department of Justice;
(b) The U.S. Department of Health and Human Services;
(c) Federal law enforcement agencies, including law enforcement
investigators;
(d) Any other Federal agency that either administers or provides
payment for the delivery of health care services, including, but not
limited to the U.S. Department of Defense and the U.S. Department of
Veterans Affairs; and
(e) Federal agencies responsible for the licensing and
certification of health care practitioners, physicians, dentists,
providers, and suppliers.
The definition of the term ``government agency'' is set forth in
section 1128E(g)(3) of the Social Security Act to describe the range of
Federal government agencies that are required to report under section
1128E (as revised by section 6403). These proposed rules refer to the
section 1128E term, ``government agencies,'' as ``Federal government
agencies'' to provide clarification between the Federal agencies
required to report under section 1128E and certain State agencies
(which are defined separately) that must report under section 1921.
These proposed rules specify that the definition includes, but is not
limited to, those agencies listed.
Health care provider means, for the purposes of this part, a
provider of services as defined in section 1861(u) of the Social
Security Act; any health care organization (including a health
maintenance organization, preferred provider organization, or group
medical practice) that provides health care services and follows a
formal peer review process for the purpose of furthering quality health
care, and any other health care organization that, directly or through
contracts, provides health care services.
[[Page 9144]]
The term ``health care provider'' is currently defined in HIPDB
regulations. We slightly modified this definition by replacing the
phrase ``means a provider'' with ``means, for purposes of this part, a
provider'' to avoid any confusion with the manner that Medicare defines
such term.
Health care supplier means, for the purposes of this part, a
provider of medical and other health care services as described in
section 1861(s) of the Social Security Act; or any individual or
entity, other than a provider, who furnishes, whether directly or
indirectly, or provides access to, health care services, supplies,
items, or ancillary services (including, but not limited to, durable
medical equipment suppliers, manufacturers of health care items,
pharmaceutical suppliers and manufacturers, health record services such
as medical, dental, and patient records, health data suppliers, and
billing and transportation service suppliers). The term also includes
any individual or entity under contract to provide such supplies,
items, or ancillary services; health plans as defined in this section
(including employers that are self-insured); and health insurance
producers (including, but not limited to agents, brokers, solicitors,
consultants, and reinsurance intermediaries).
The term ``health care supplier'' is currently defined in HIPDB
regulations. We slightly modified this definition by replacing the
phrase ``means a provider'' with ``means, for purposes of this part, a
provider'' to avoid any confusion with the manner that Medicare defines
such term.
Health plan means, for the purposes of this part, a plan, program,
or organization that provides health benefits, whether directly,
through insurance, reimbursement, or otherwise, and includes but is not
limited to:
(a) A policy of health insurance;
(b) A contract of a service benefit organization;
(c) A membership agreement with a health maintenance organization
or other prepaid health plan;
(d) A plan, program, agreement, or other mechanism established,
maintained, or made available by a self-insured employer or group of
self-insured employers, a health care practitioner, physician, dentist,
provider, or supplier group, third-party administrator, integrated
health care delivery system, employee welfare association, public
service group, or organization or professional association;
(e) An insurance company, insurance service, or insurance
organization that is licensed to engage in the business of selling
health care insurance in a State and which is subject to State law
which regulates health insurance; and
(f) An organization that provides benefit plans whose coverage is
limited to outpatient prescription drugs.
The term ``health plan'' is currently defined in the HIPDB
regulations. We slightly modified this definition by replacing the
phrase ``practitioner, provider, or supplier'' with the phrase ``health
care practitioner, physician, dentist, provider, or supplier.'' We
slightly modified this definition by replacing the phrase ``means a
plan'' with ``means, for purposes of this part, a plan'' to avoid any
confusion with the HIPAA definition. Additionally, we broadened the
definition to respond to an expressed need to include stand-alone
prescription drug plans, like those offered under the Medicare Part D
program.
Other adjudicated actions or decisions means formal or official
final actions taken against a health care practitioner, physician,
dentist, provider, or supplier by a Federal governmental agency, a
State law or fraud enforcement agency, or a health plan; which include
the availability of a due process mechanism, and are based on acts or
omissions that affect or could affect the payment, provision or
delivery of a health care item or service. For example, a formal or
official final action taken by a Federal governmental agency, a State
law or fraud enforcement agency, or a health plan may include, but is
not limited to, personnel-related actions such as suspensions without
pay, reductions in pay, reductions in grade for cause, terminations, or
other comparable actions. A hallmark of any valid adjudicated action or
decision is the availability of a due process mechanism. The fact that
the subject elects not to use the due process mechanism provided by the
authority bringing the action is immaterial, as long as such a process
is available to the subject before the adjudicated action or decision
is made final. In general, if an adjudicated action or decision follows
an agency's established administrative procedures (which ensure that
due process is available to the subject of the final adverse action),
it would qualify as a reportable action under this definition. This
definition specifically excludes clinical privileging actions taken by
Federal government agencies or State law and fraud enforcement agencies
and similar paneling decisions made by health plans. This definition
does not include overpayment determinations made by Federal or State
government programs, their contractors or health plans; and it does not
include denial of claims determinations made by Federal government
agencies, State law or fraud enforcement agencies, or health plans. For
health plans that are not government entities, an action taken
following adequate notice and the opportunity for a hearing that meets
the standards of due process set out in section 412(b) of the HCQIA (42
U.S.C. 11112(b)) also would qualify as a reportable action under this
definition.
The term ``other adjudicated actions or decisions'' is currently
defined in HIPDB regulations. To reflect a change in terminology made
by section 6403, we modified this definition by replacing the term,
``State government agency'' with ``State law or fraud enforcement
agency'' when referring to those State agencies that take ``other
adjudicated actions or decisions.''
State law or fraud enforcement agency includes, but is not limited
to:
(a) A State law enforcement agency;
(b) A State Medicaid fraud control unit (as defined in section
1903(q) of the Social Security Act); and
(c) A State agency administering (including those providing payment
for services) or supervising the administration of a State health care
program (as defined in section 1128(h) of the Social Security Act).
Section 6403(b)(3) added the term ``State law or fraud enforcement
agency'' in section 1921(g)(2) of the Social Security Act to describe
those State agencies (in addition to State licensing or certification
agencies) that were formerly required to report final adverse actions
under section 1128E and that are now required to report those actions
under section 1921. We added ``a State agency administering (including
those providing payment for services) a State health care program'' as
an example of an agency that would report exclusions from State health
care programs. These State agencies also would take certain other
adjudicated actions or decisions defined in the regulations, such as
``personnel-related actions,'' when providing health care services
through State-owned hospitals and other facilities. Because these
agencies have a role in investigating and preventing health care fraud
and abuse, they were included in the definition.
State licensing or certification agency includes, but is not
limited to, any authority of a State (or of a political subdivision
thereof) responsible for the licensing or certification of health care
practitioners, physicians, dentists, (or any peer review organization,
or private accreditation entity reviewing the services provided by
health care practitioners, physicians, or dentists), health care
entities, providers, or
[[Page 9145]]
suppliers. Examples of such State agencies include Departments of
Professional Regulation, Health, Social Services (including State
Survey and Certification and Medicaid Single State agencies), Commerce,
and Insurance.
Section 6403(b)(3) amended section 1921 by adding the term ``State
licensing or certification agency.'' This term, which is defined in
section 1921(g)(1) of the Social Security Act, is intended to combine
two categories of current NPDB and HIPDB reporters: (1) State agencies
responsible for licensing health care practitioners and entities (also
referred to in NPDB regulations as ``State licensing and certification
authorities''), peer review organizations, and private accreditation
entities (all of which currently report to the NPDB under section
1921); and (2) State agencies responsible for the licensing and
certification of health care practitioners, providers, and suppliers
(which report to the HIPDB under section 1128E). We also clarified the
definition by providing examples from the HIPDB regulations of the
scope of State agencies that license or certify health care
practitioners, physicians, dentists, health care entities, providers,
and suppliers.
In addition to the new terms we propose to add in this section, we
also propose to slightly amend the definitions of the following
existing terms. These amendments are necessary to ensure the maximum
appropriate coordination among requirements for the HCQIA, and sections
1921 and 1128E of the Social Security Act.
Board of Medical Examiners, or Board means a body or subdivision of
such body which is designated by a State for the purpose of licensing,
monitoring, and disciplining physicians or dentists. This term includes
a Board of Osteopathic Examiners or its subdivision, a Board of
Dentistry or its subdivision, or an equivalent body as determined by
the State. Where the Secretary, pursuant to section 423(c)(2), of the
HCQIA (42 U.S.C. 11112(c)) has designated an alternate entity to carry
out the reporting activities of Sec. 60.12 due to a Board's failure to
comply with Sec. 60.8, the term Board of Medical Examiners or
``Board'' refers to this alternate entity.
For this definition, we deleted the reference to ``the Act'' and
inserted the complete statutory reference for the HCQIA. This change
was necessary to avoid confusion among the different statutes governing
NPDB operations.
Health care entity means, for purposes of this part:
(a) A hospital;
(b) An entity that provides health care services, and engages in
professional review activity through a formal peer review process for
the purpose of furthering quality health care, or a committee of that
entity; or
(c) A professional society or a committee or agent thereof,
including those at the national, State, or local level, of physicians,
dentists, or other health care practitioners that engages in
professional review activity through a formal peer review process, for
the purpose of furthering quality health care.
For purposes of paragraph (b) of this definition, an entity
includes: a health maintenance organization which is licensed by a
State or determined to be qualified as such by the Department of Health
and Human Services; and any group or prepaid medical or dental practice
which meets the criteria of paragraph (b).
To avoid any confusion with the manner that Medicare defines such
terms, we replaced the phrase ``health care entity means'' with
``health care entity means, for the purposes of this part.''
Health care practitioner, licensed health care practitioner,
licensed practitioner, or practitioner means an individual other than a
physician or dentist, who is licensed or otherwise authorized by a
State to provide health care services (or any individual who, without
authority, holds himself or herself out to be so licensed or
authorized).
The current NPDB and HIPDB definitions for the term ``health care
practitioner'' have slight differences, although both Data Banks
ultimately collect information on the same range of practitioners.
First, the NPDB definition excludes physicians and dentists because the
HCQIA provides separate definitions for physicians and dentists.
Conversely, the HIPDB definition for ``health care practitioner''
includes physicians and dentists. Second, the HIPDB definition includes
individuals who, without authority, hold themselves out to be licensed
or authorized. While this language regarding individuals who hold
themselves out to be licensed or authorized is not explicitly stated in
the original NPDB definition of ``health care practitioner,'' it is
included in the NPDB definitions for ``physician'' and ``dentist,'' and
has been part of NPDB ``health care practitioner'' definition in
reporting guidance since the NPDB began operations. A final difference
in the two regulatory definitions is that the HIPDB definition also
refers to the terms ``licensed health care practitioner,'' ``licensed
practitioner,'' and ``practitioner.''
To reconcile these differences in definitional language, while
still maintaining the statutory requirements, we made two changes to
the NPDB definition. First, we expanded the original NPDB term of
``health care practitioner'' to include the additional terms used in
the HIPDB definition (i.e., ``licensed health care practitioner,
licensed practitioner, or practitioner''). Second, we included in the
definition individuals who, without authority, hold themselves out to
be licensed or authorized. Although this proposed definition excludes
physicians and dentists (and the original HIPDB definition does not),
we refer to ``health care practitioners, physicians, and dentists''
throughout these proposed rules to ensure that the statutory
requirements are fulfilled.
Hospital means, for purposes of this part, an entity described in
paragraphs (1) and (7) of section 1861(e) of the Social Security Act.
To avoid any confusion with the manner that Medicare defines such
terms, we replaced the phrase ``means an entity'' with ``means, for
purposes of this part, an entity.''
Negative action or finding by a Federal or State licensing or
certification 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 Federal or State
licensing or certification authority, including but not limited to,
limitations on the scope of practice, liquidations, injunctions, and
forfeitures. This definition also includes final adverse actions
rendered by a Federal or State licensing or certification authority,
such as exclusions, revocations, or suspension of license or
certification, that occur in conjunction with settlements in which no
finding of liability has been made (although such a settlement itself
is not reportable under the statute). This definition excludes
administrative fines or citations and corrective action plans and other
personnel actions, unless they are:
[[Page 9146]]
(1) Connected to the delivery of health care services, or
(2) Taken in conjunction with other adverse licensure or
certification actions such as revocation, suspension, censure,
reprimand, probation, or surrender.
To date, we have allowed reporting entities to apply their own
specific definition of negative action or finding. This provides States
and other reporting entities the flexibility to interpret their own
statutes and governing policies to meet the reporting requirements of
the NPDB and HIPDB. We have also received comments from reporting
entities that suggest a need for a more formal definition of negative
finding. We welcome comments that address the definition of any
negative action or finding, specifically comments that clarify the
definition of negative finding.
Both NPDB and the HIPDB regulations defined the term ``negative
action or finding.'' The NPDB definition was limited to negative
actions or findings by peer review organizations, private accreditation
entities, and State authorities that license (including licensure and
certification) health care practitioners and entities. The HIPDB
definition included negative actions or findings by Federal or State
agencies responsible for the licensing or certification of health care
practitioners, providers, and suppliers. Our proposed definition
incorporates language from the HIPDB definition to ensure that the NPDB
will collect the full range of section 1921 and section 1128E reporting
requirements for Federal and State licensing and certification
authorities.
In addition, we slightly modified language in the original HIPDB
definition regarding the reporting of administrative fines or
citations, and corrective action plans and other personnel actions, to
make it consistent with existing section 1921 language. Under our
proposed definition, administrative fines or citations, and corrective
action plans and personnel actions, must be reported if they are either
(1) related to the delivery of health care services or (2) taken with
another reportable action. The ``or'' replaces the ``and'' in the
original HIPDB definition. While this change may slightly expand the
reporting requirements for certain Federal agencies, we believe it is
fully consistent with Congress's efforts to otherwise harmonize Federal
and State licensure and certification reporting requirements.
Peer review organization means, for purposes of this part, 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. We slightly modified this definition by changing ``means an
organization'' to ``means, for the purposes of this part, an
organization'' to avoid confusion with the definition of this term in
Section 1152 of the Social Security Act.
Physician means, for purposes of this part, 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). We slightly modified this definition by changing ``means a
doctor'' to ``means, for the purposes of this part, a doctor'' to avoid
confusion with the definition of this term used in Section 1861(r) of
the Social Security Act.
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, provider, or supplier;
(b) Measures a health care entity's, provider's, or supplier'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, provider, or
supplier; and
(d) Has due process mechanisms available to health care entities,
providers, or suppliers.
In the current NPDB regulations, private accreditation entities are
limited to those that accredit health care entities. The definition
excludes private accreditation entities that accredit health care
practitioners. While the term ``entities,'' with respect to subjects of
section 1921 reports, is now understood to include providers and
suppliers (and the term ``suppliers'' includes individuals as well as
organizations), it is still our understanding that accreditation
organizations only accredit organizations and business entities, and
not individuals. Therefore it is our expectation that, under the
limited reporting requirements that apply to accreditation
organizations, private accreditation entities would only report
organizations and business entities. To the extent that an
accreditation organization also accredits sole proprietorships and
takes reportable actions against them, we anticipate that these sole
proprietorships would be reported to the NPDB as organization, and not
as individual, subjects.
Voluntary surrender of license or certification means a surrender
made after a notification of investigation or a formal official request
by a Federal or State licensing or certification authority for a health
care practitioner, physician, dentist, health care entity, provider, or
supplier, to surrender the license or certification (including
certification agreements or contracts for participation in Federal or
State health care programs). The definition also includes those
instances where a health care practitioner, physician, dentist, health
care entity, provider, or supplier voluntarily surrenders a license or
certification (including program participation agreements or contracts)
in exchange for a decision by the licensing or certification 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.
Both the NPDB and the HIPDB regulations included definitions for
``voluntary surrender.'' The HIPDB regulations referred to this term as
``voluntary surrender,'' while the NPDB regulations used the term
``voluntary surrender of license.'' In these proposed rules, we refer
to this term as ``voluntary surrender of license or certification'' for
two reasons. First, the revised term clarifies the scope of voluntary
surrenders to be reported under sections 1921 and 1128E (i.e., Federal
and State licensing and certification actions). Second, the change will
prevent confusion among organizations that report surrenders of
clinical privileges under the HCQIA.
The NPDB and HIPDB regulatory definitions for voluntary surrender
were nearly identical with respect to voluntary surrenders of State
licensure. However, the HIPDB definition also contained language with
respect to surrender of Federal licensure, as well as Federal and State
certification (including certification agreements or contracts for
participation in Federal or State health care programs). This
additional HIPDB language was included in the NPDB definition to ensure
that original HIPDB reporting requirements remained unchanged.
[[Page 9147]]
In addition to the definitions we have added or clarified, we also
propose to eliminate the term ``Act'' from section 60.3. We chose this
approach to avoid confusion when referencing the different statutes
governing NPDB operations. NPDB regulations currently define ``Act'' as
the Health Care Quality Improvement Act of 1986, title IV of Public Law
99-660, as amended. HIPDB regulations define ``Act'' as the Social
Security Act. We instead reference each of these statutes (as well as
other governing statutes) by name where they appear in the regulations.
We also propose to use the NPDB definition for the term, ``State,''
as it relates to all requirements under the HCQIA and sections 1921 and
1128E. Both NPDB and HIPDB regulations include a definition for
``State,'' however, they differ in that the NPDB definition includes
two additional territories (American Samoa and the Northern Mariana
Islands) that are not part of the HIPDB definition. While this change
to the original HIPDB regulatory definition may slightly modify
requirements for certain organizations, this should not be overly
burdensome as these territories have reported few, if any, actions in
the past. We believe the simplicity of this change outweighs the very
slight potential increase in burden based on the addition of these two
territories. Furthermore, the NPDB definition of ``State'' is included
in statute, while the HIPDB definition is not. Therefore, the Secretary
has greater flexibility to conform the definition to that of the NPDB.
Sec. 60.4 How Information Must Be Reported
We propose to amend this section by changing the reference to
``Sec. 60.11'' to read ``Sec. 60.12'' and including references to the
newly added Sec. Sec. 60.10, 60.11, 60.13, 60.14, 60.15, and 60.16. We
also remove the reference to reporting to the Board of Medical
Examiners.
Sec. 60.5 When Information Must Be Reported
We propose to amend this section of the existing NPDB regulations
by:
a. Revising the introductory text of this section to include
references to the newly added Sec. Sec. 60.10, 60.13, 60.14, 60.15,
and 60.16 and redesignated Sec. Sec. 60.11 and 60.12;
b. Adding the August 21, 1996 legacy reporting date for section
1128E actions; and
c. Removing paragraphs (a)-(d) and replacing them with a list of
reportable actions. This list reflects the combination of reporting
categories from the NPDB and the HIPDB regulations.
The proposed rule brings the HIPDB reporting time frame in line
with the NPDB and eliminates references from the current HIPDB
regulation to reporting by the close of an entity's next monthly
reporting cycle. The proposed rule also eliminates from the current
NPDB regulation the requirement for reporting within a 15-day window
for those entities that have a dual obligation to report to a State
authority. Thus all reports must be made within 30-calendar days from
the date the final adverse action was taken. This rule also clarifies
the State reporting obligations for persons or entities responsible for
submitting malpractice payments (Sec. 60.7), negative actions or
findings (Sec. 60.11), and adverse actions (Sec. 60.12). Reports for
these three categories are submitted directly to the NPDB and a copy of
the report must be mailed to the appropriate State licensing or
certification agency. This has been the operational practice of the
NPDB since 1990 and fulfills the statutory State reporting obligation
for these reporters.
Sec. 60.6 Reporting Errors, Omissions, Revisions or Whether an Action
Is on Appeal
We propose to amend this section by:
a. Revising the title to include reporting of whether an action is
on appeal. This information currently must be reported for final
adverse actions specified in HIPDB regulations;
b. Revising the first and last sentences in paragraph (b) to
include the requirement to report revisions to actions for all
licensure and certification actions, criminal convictions, civil
judgments, exclusions, and other adjudicated actions or decisions. The
HIPDB regulations require reporting of revisions to these actions;
c. Revising the third sentence of paragraph (b) to include the
requirement to report when an action is on appeal for licensure and
certification actions, criminal convictions, civil judgments,
exclusions, and other adjudicated actions; and
d. Adding a new sentence at the end of paragraph (a) and new
paragraphs (c) and (d) to clarify current data bank policy regarding
notifying subjects of a report and the steps subjects may take to
ensure the information reported is accurate. These clarifications
generally are included in HIPDB regulations, but the same policy has
applied to the NPDB as well.
Sec. 60.7 Reporting Medical Malpractice Payments
(We propose no changes to this section.)
Sec. 60.8 Reporting Licensure Actions Taken by Boards of Medical
Examiners
We propose to amend this section by revising the reference to
``Sec. 60.11'' in the last sentence of paragraph (c) to read ``Sec.
60.12.'' This change reflects the fact that Sec. 60.11 was
redesignated as Sec. 60.12 in these proposed rules. We are also adding
``Individual Tax Identification Number (ITIN)'' to Sec. 60.8(b)(4)
after the word Social Security Number.
Sec. 60.9 Reporting Licensure and Certification Actions Taken by States
We propose to amend Sec. 60.9 to reflect the changes made by
section 6403 to the section 1921 licensure action reporting
requirements by State agencies. The title of this section was revised
to include licensure and certification actions, as required under
section 6403(b)(1)(A)(i). The term ``certification'' has two distinct
meanings in the current NPDB and HIPDB regulations. First, in both sets
of regulations, ``certification'' is related to licensure. Licensure
includes certification and other forms of authorization to provide
health care services, and, based on their individual laws and
requirements, States may ``license,'' ``certify,'' or ``register''
certain types of health care practitioners, health care entities,
providers, or suppliers. For example, States may certify nurse's aides.
Second, in section 1128E and the HIPDB regulations, the term
``certification'' is also used to refer to certification of a health
care practitioner, provider, or supplier to participate in a Federal or
State health care program. In this context, certification includes
certification agreements and contracts for participation in a
government health care program. State certification actions such as
termination of a hospital's Medicaid participating provider agreement
or contract are now being reported to the NPDB under this part.
We also propose to modify paragraphs (a) and (b) to reflect the
range of subjects reported under this section to include health care
practitioners, physicians, dentists, health care entities, providers,
and suppliers. In addition, we propose to amend paragraphs (a)(1)
through (a)(4) to reflect changes to those reporting requirements made
by section 6403(b)(1)(A), which intended to harmonize State licensure
and certification action reporting requirements with Federal licensure
and certification action reporting
[[Page 9148]]
requirements under section 1128E. To reflect the fact that section 6403
transfers State licensure and certification action reporting
requirements from section 1128E to section 1921, we propose the
following changes to ensure that the original reporting requirements
from the HIPDB regulations remain unchanged. First, we amended language
in paragraphs (a)(1) through (4) to clarify the range of reportable
licensure and certification actions with respect to a license,
certification agreement, or contract for participation in State health
care programs. Second, in paragraph (c)(4)(ii), which was previously a
reserved field, we added a data element for the date of any appeal.
Third, we added paragraph (e) to incorporate the sanctions for failure
to report that were included in the HIPDB regulations for State
licensure and certification actions. Finally, we are also adding
``Individual Tax Identification Number (ITIN)'' to Sec. 60.9(b)(1)(ii)
after the word Social Security Number.
Sec. 60.10 Reporting Licensure and Certification Actions Taken by
Federal Agencies
We propose to redesignate Sec. 60.10 as Sec. 60.11, and add a new
Sec. 60.10 to implement the reporting requirements for Federal
licensure and certification agencies. These agencies must report to the
NPDB the following final adverse actions that are taken against a
health care practitioner, physician, dentist, provider, or supplier
(regardless of whether the final adverse action is the subject of a
pending appeal):
(a) Formal or official actions, such as revocation or suspension of
a license or certification agreement or contract for participation in
Federal health care programs (and the length of any such suspension),
reprimand, censure, or probation;
(b) Any dismissal or closure of the proceedings by reason of the
health care practitioner, physician, dentist, provider, or supplier
surrendering their license or certification agreement or contract for
participation in Federal health care programs, or leaving the State or
jurisdiction;
(c) Any other loss of the license or loss of the certification
agreement or contract for participation in a Federal health care
program, or the right to apply for, or renew, a license or
certification agreement or contract of the health care practitioner,
physician, dentist, provider, or supplier, whether by operation of law,
voluntary surrender, nonrenewal (excluding nonrenewals due to
nonpayment of fees, retirement, or change to inactive status), or
otherwise; and
(d) Any other negative action or finding by such Federal agency
that is publicly available information.
Further, we are substituting the acronym ``ITIN'' in place of the
word ``Individual Tax Identification Number'' in Sec. 60.10(b)(1)(ii).
Sec. 60.11 Reporting Negative Actions or Findings Taken by Peer Review
Organizations or Private Accreditation Entities [Redesignated]
We propose to redesignate Sec. 60.11 as Sec. 60.12 and add
redesignated Sec. 60.10 as Sec. 60.11. In accordance with the changes
to the scope of ``entity'' report subjects required by section 6403, we
propose to amend paragraph (a) of this section to include the reporting
of health care practitioners, physicians, dentists, health care
entities, providers, and suppliers. While peer review organizations
will continue to report negative actions or findings taken against
health care practitioners, physicians, or dentists, private
accreditation entities are required to report actions taken against
health care entities, providers, or suppliers. Paragraph (a) is revised
to reflect that the reporting entity, (i.e., peer review organization
or private accreditation entity) not the State, must submit reports
directly to the NPDB and then provide a copy of the report to the
appropriate State licensing or certification authority by mail. The
remaining paragraphs (b)--(d) are accordingly modified to reflect this
reporting scheme.
Sec. 60.12 Reporting Adverse Actions Taken Against Clinical Privileges.
[Redesignated]
We propose to redesignate Sec. 60.12 as Sec. 60.17 and add
redesignated Sec. 60.11 as Sec. 60.12. As done with Sec. 60.11, the
reporting scheme under paragraph (a) is revised to reflect that health
care entities send reports directly to the NPDB and provide a copy of
the report to the State Board of Medical Examiners.
Further, we propose to slightly modify the heading of Sec.
60.12(a) to read ``Reporting by Health Care Entities to the NPDB.''
Sec. 60.13 Reporting Federal or State Criminal Convictions Related to
the Delivery of a Health Care Item or Service
We propose to redesignate Sec. 60.13 as Sec. 60.18, and add a new
Sec. 60.13 to implement the requirements of section 6403. Under this
provision, Federal and State prosecutors are required to report
criminal convictions against health care practitioners, physicians,
dentists, providers, or suppliers related to the delivery of a health
care item or service (regardless of whether the conviction is the
subject of a pending appeal).
Sec. 60.14 Reporting Civil Judgments Related to the Delivery of a
Health Care Item or Service
We propose to redesignate Sec. 60.14 as Sec. 60.19, and add a new
Sec. 60.14 to implement the requirements of section 6403. Under this
provision Federal and State attorneys and health plans must report
civil judgments against health care practitioners, physicians,
dentists, providers, or suppliers related to the delivery of a health
care item or service (regardless of whether the civil judgment is the
subject of a pending appeal).
Sec. 60.15 Reporting Exclusions From Participation in Federal or State
Health Care Programs
We propose to redesignate Sec. 60.15 as Sec. 60.20, and add a new
Sec. 60.15 to implement the requirements of section 6403. Under this
provision, Federal government agencies and State law and fraud
enforcement agencies must report health care practitioners, physicians,
dentists, providers, and suppliers excluded from participating in
Federal or State health care programs, including exclusions resulting
from a settlement that is not reported because no findings or
admissions of liability have been made (regardless of whether the
exclusion is the subject of a pending appeal).
Sec. 60.16 Reporting Other Adjudicated Actions or Decisions
We propose to redesignate Sec. 60.16 as Sec. 60.21, and add a new
Sec. 60.16 to implement the requirements of section 6403. Under this
provision, Federal government agencies, State law and fraud enforcement
agencies, and health plans must report other adjudicated actions or
decisions as defined in Sec. 60.3 related to the delivery, payment or
provision of a health care item or service against health care
practitioners, physicians, dentists, providers, and suppliers
(regardless of whether the other adjudicated action or decision is
subject to a pending appeal).
Sec. 60.17 Information Which Hospitals Must Request From the National
Practitioner Data Bank [Redesignated]
As previously noted, we propose redesignating Sec. 60.12 as Sec.
60.17.
[[Page 9149]]
Sec. 60.18 Requesting Information From the National Practitioner Data
Bank [Redesignated]
We propose to redesignate Sec. 60.13 as Sec. 60.18. We propose to
amend Sec. 60.18, paragraph (a) of the existing NPDB regulations to
clarify to whom information under the HCQIA as well as the amended
sections 1921 and 1128E components of the NPDB would be made available
by:
a. Redesignating Sec. 60.13 as Sec. 60.18 to implement the
requirements of section 6403;
b. Revising the reference to ``Sec. 60.11'' in paragraph (a)(1) to
read ``Sec. 60.12;''
c. Revising the reference to ``Sec. 60.12'' in paragraph (a)(1)(v)
to read ``Sec. 60.17;''
d. Adding the references to include Sec. Sec. 60.10, 60.11, 60.13,
60.14, 60.15, and 60.16 in paragraph (a)(2);
e. Revising paragraph (a)(2)(i) to include the following language
in parentheses after the word administering: ``including those
providing payment for services;''
f. Replacing the text in paragraphs (a)(2), (ii), (iv), (v), (vi),
and (vii) to reflect the revised list of entities which may receive
information reported under Sec. Sec. 60.9, 60.10, 60.11, 60.13, 60.14,
60.15 and 60.16; and
g. Inserting paragraph (a)(2)(viii).
Based on section 6403 amendments, State licensing or certification
agencies and Federal agencies responsible for the licensing and
certification of health care practitioners, physicians, dentists,
providers and suppliers are authorized to query the NPDB under section
1921 and 1128E. We understand the statutory language to limit query
access to those State licensing and certification agencies that license
or certify health care practitioners, physicians, dentists, entities,
providers, or suppliers. These agencies would include only authorities
of the State responsible for licensure or certification and would
exclude peer review organizations and private accreditation entities.
Such an interpretation of the statutory language is consistent with the
goal of maintaining existing NPDB and HIPDB reporting and querying
requirements to the greatest extent possible.
Consistent with section 6403 language, hospitals and other health
care entities, professional societies, and QIOs will have access to
section 1921 information reported in Sec. Sec. 60.9 and 60.11, and
section 1128E information reported in Sec. Sec. 60.10, 60.13, 60.14,
60.15, and 60.16. Access to the section 1921 information for these
groups was not affected by the passage of section 6403. Section 6403
expands the access that these groups have with respect to Federal
information under section 1128E.
Sec. 60.19 Fees Applicable to Requests for Information [Redesignated]
We propose to amend redesignated Sec. 60.19(a) to reflect, based
on section 6403 amendments, the full range of subjects that will be
sent a copy of a report submitted about them.
Sec. 60.20 Confidentiality of National Practitioner Data Bank
information [Redesignated]
We propose to slightly amend redesignated Sec. 60.20 so that it
reflects the limitations on disclosure provisions based on current NPDB
and HIPDB regulatory language. These confidentiality requirements would
apply to all information obtained from the NPDB.
Sec. 60.21 How To Dispute the Accuracy of National Practitioner Data
Bank Information [Redesignated]
The dispute process for the NPDB and the HIPDB is identical,
however, HIPDB regulations currently provide a more detailed account of
the process than do the NPDB regulations. Therefore, we are proposing
to amend this section to include the HIPDB regulatory provisions for
disputing the accuracy of data bank information.
Sec. 60.22 Immunity
Section 6403 added a provision to section 1921 that provides
reporters of NPDB information immunity from liability in a civil action
filed by the subject of a report, unless the individual, entity, or
authorized agent submitting the report has actual knowledge of the
falsity of the information contained in the report. HIPDB regulations
also contain a similar immunity provision. We propose to add this
provision, which will apply to all individuals who, and entities and
authorized agents that, report information to the NPDB.
III. Implementation Schedule
Reporting requirements have been established through Title IV of
the Health Care Quality Improvement Act of 1986, Section 1921 of the
Social Security Act, as amended by the Omnibus Budget Reconciliation
Act of 1990, and Section 1128E of the Social Security Act as added by
Section 221(a) of the Health Insurance Portability and Accountability
Act of 1996, and through their respective regulatory procedures. As a
result, most reporters and queriers have submitted information to and
received information from the NPDB and the HIPDB since 1996. A few
reporters, accreditation organizations, and peer review organizations,
have submitted information to the NPDB since 2010.
As a result of Section 6403 of the Patient Protection and
Affordable Care Act of 2010, the HIPDB will cease to function. Data
contained in the HIPDB will be transferred to the NPDB, along with the
reporting and querying functions. Therefore, we will announce through
the issuance of notice(s) in the Federal Register when the merged
system will be open for reporting and querying. Further, the
announcement will identify when and how information will be available
from the NPDB. A revised reporting form will be used to accommodate
system integration functions when this form is approved by the Office
of Management and Budget in accordance with the Paperwork Reduction Act
of 1995.
IV. Regulatory Impact Statement
A. Regulatory Analysis
This proposed rule is technical in nature. It involves transferring
data reporting requirements under 45 CFR part 61 for the Healthcare
Integrity and Protection Data Bank (HIPDB) to 45 CFR part 60 for the
National Practitioner Data Bank (NPDB), another data bank receiving
like reports. The result of this transfer does not increase the
regulatory burden on affected entities; it alleviates duplication.
1. Executive Orders 12866 and 13563
Executive Orders 13563 and 12866 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Executive
Order 13563 emphasizes the importance of quantifying both costs and
benefits, of reducing costs, of harmonizing rules, and of promoting
flexibility. This rule has been designated a ``significant regulatory
action'' although not economically significant, under section 3(f) of
Executive Order 12866. Accordingly, the rule has been reviewed by the
Office of Management and Budget.
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
[[Page 9150]]
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. The purpose of the proposed rule is to
eliminate duplication between the HIPDB and the NPDB. The NPDB will
serve as the sole repository for all information previously captured in
the HIPDB. This will not substantially alter reporting requirements.
Therefore 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 agencies to assess anticipated costs and
benefits for any rulemaking that may result in an annual expenditure of
$136 million or more by State, local, or tribal governments, or the
private sector. HRSA has determined that this rule does not impose any
additional mandates on State, local, or tribal governments, or the
private sector, that will result in an annual expenditure of $136
million or more. A full analysis under the UMRA is not necessary.
4. Executive Order 13132--Federalism
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule imposing
substantial direct requirements or costs on State and local
governments, preempts State law, or otherwise has Federalism
implications. In reviewing this proposed rule under the threshold
criteria of Executive Order 13132, the Secretary has determined that
this rule will not significantly affect the rights, roles, and
responsibilities of State or local governments because the actions that
are already reported under HIPDB are merely shifting to the NPDB.
B. Paperwork Reduction Act
This proposed rule does not add any new reporter categories, but
information-collection requirements may be expanded for some reporters.
For instance, the proposed rule interprets statutory references to
``entity'' reporting subjects under the amended section 1921 to include
``health care providers and suppliers.'' As a result, accreditation
entities will now be required to report actions taken against providers
and suppliers in addition to those subjects that meet the definition of
a ``health care entity.'' However, these sorts of expansions are subtle
and will not significantly alter the current requirements under the
HIPDB and NPDB regulations. The NPDB and HIPDB regulations contain
information collection requirements that have been approved by OMB
under the Paperwork Reduction Act of 1995 (PRA) and assigned control
numbers 0915-0126 and 0915-0239, respectively.
The only impact of the merging of 45 CFR Part 61 with 45 CFR Part
60 is to eliminate duplication and streamline internal operations. By
combining two data banks into a single data bank, the need to capture
like information in two data bases is eliminated.
Dated: January 11, 2012.
Mary K. Wakefield,
Administrator, Health Resources and Services Administration.
Approved: February 3, 2012.
Kathleen Sebelius,
Secretary.
List of Subjects
45 CFR Part 60
Claims, Fraud, Health, Health maintenance organizations (HMOs),
Health professions, Hospitals, Insurance companies, Malpractice,
Reporting and recordkeeping requirements.
45 CFR Part 61
Billing and transportation services, Durable medical equipment
suppliers and manufacturers, Health care insurers, Health maintenance
organizations (HMOs), Health professions, Home health care agencies,
Hospitals, Pharmaceutical suppliers and manufacturers, Reporting and
recordkeeping requirements, Skilled nursing facilities.
For the reasons set forth in the preamble, HHS proposes to revise
45 CFR parts 60 and 61 as follows:
PART 60--NATIONAL PRACTITIONER DATA BANK
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.
2. The Table of Contents for part 60 is revised to read as follows:
Subpart A--General Provisions
Sec.
60.1 The National Practitioner Data Bank.
60.2 Applicability of these regulations.
60.3 Definitions.
Subpart B--Reporting of Information
Sec.
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 and certification actions taken by States.
60.10 Reporting licensure and certification actions taken by Federal
agencies.
60.11 Reporting negative actions or findings taken by peer review
organizations or private accreditation entities.
60.12 Reporting adverse actions taken against clinical privileges.
60.13 Reporting Federal or State criminal convictions related to the
delivery of a health care item or service.
60.14 Reporting civil judgments related to the delivery of a health
care item or service.
60.15 Reporting exclusions from participation in Federal or State
health care programs.
60.16 Reporting other adjudicated actions or decisions.
Subpart C--Disclosure of Information by the National Practitioner Data
Bank
Sec.
60.17 Information which hospitals must request from the National
Practitioner Data Bank.
60.18 Requesting information from the National Practitioner Data
Bank.
60.19 Fees applicable to requests for information.
60.20 Confidentiality of National Practitioner Data Bank
information.
60.21 How to dispute the accuracy of National Practitioner Data Bank
information.
60.22 Immunity.
3. Revise part 60 to read as follows:
Subpart A--General Provisions
Sec. 60.1 The National Practitioner Data Bank
The Health Care Quality Improvement Act of 1986 (HCQIA), as
amended, title IV of Public Law 99-660 (42 U.S.C. 11101 et seq.)
(hereinafter referred to as ``title IV''), 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
(hereinafter referred to as ``section 1921''), as amended, (42 U.S.C.
1396r-2) expanded the requirements under the NPDB and requires each
State to adopt a system of reporting to the Secretary adverse licensure
or certification actions taken against health care practitioners,
physicians, dentists, health care entities, providers, and suppliers,
as well as certain final adverse actions taken by State law and
[[Page 9151]]
fraud enforcement agencies against health care practitioners,
physicians, dentists, providers, and suppliers. Section 1128E of the
Social Security Act (hereinafter referred to as ``section 1128E''), as
amended, (42 U.S.C. 1320a-7e) authorizes the Secretary to implement a
national healthcare fraud and abuse data collection program for the
reporting and disclosing of certain final adverse actions taken by
Federal government agencies and health plans against health care
practitioners, physicians, dentists, providers, and suppliers.
Information from section 1921 and section 1128E is to be reported and
distributed through the NPDB. The regulations in this part set forth
the reporting and disclosure requirements for the NPDB, as well as
procedures to dispute the accuracy of information contained in the
NPDB.
Sec. 60.2 Applicability of these regulations.
The regulations in this part establish reporting requirements
applicable to hospitals, health care entities, Boards of Medical
Examiners, professional societies of physicians, dentists, or other
health care practitioners which take adverse licensure or professional
review actions; State licensing or certification authorities, peer
review organizations, and private accreditation entities that take
licensure or certification actions or negative actions or findings
against health care practitioners, physicians, dentists, health care
entities, providers, or suppliers; entities (including insurance
companies) making payments as a result of medical malpractice actions
or claims; Federal government agencies, State law and fraud enforcement
agencies and health plans that take final adverse actions against
health care practitioners, physicians, dentists, providers, and
suppliers. They also establish procedures to enable individuals or
entities to obtain information from the NPDB or to dispute the accuracy
of NPDB information.
Sec. 60.3 Definitions.
Adversely affecting means reducing, restricting, suspending,
revoking, or denying clinical privileges or membership in a health care
entity.
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.
Board of Medical Examiners, or Board, means a body or subdivision
of such body which is designated by a State for the purpose of
licensing, monitoring, and disciplining physicians or dentists. This
term includes a Board of Osteopathic Examiners or its subdivision, a
Board of Dentistry or its subdivision, or an equivalent body as
determined by the State. Where the Secretary, pursuant to section
423(c)(2) of the HCQIA (42 U.S.C. 11112(c)), has designated an
alternate entity to carry out the reporting activities of Sec. 60.12
due to a Board's failure to comply with Sec. 60.8, the term Board of
Medical Examiners or Board refers to this alternate entity.
Civil judgment means a court-ordered action rendered in a Federal
or State court proceeding, other than a criminal proceeding. This
reporting requirement does not include Consent Judgments that have been
agreed upon and entered to provide security for civil settlements in
which there was no finding or admission of liability.
Clinical privileges means the authorization by a health care entity
to a physician, dentist or other health care practitioner for the
provision of health care services, including privileges and membership
on the medical staff.
Criminal conviction means a conviction as described in section
1128(i) of the Social Security Act.
Dentist means a doctor of dental surgery, doctor of dental
medicine, or the equivalent who is legally authorized to practice
dentistry by a State (or who, without authority, holds himself or
herself out to be so authorized).
Exclusion means a temporary or permanent debarment of an individual
or entity from participation in any Federal or State health-related
program, in accordance with which items or services furnished by such
person or entity will not be reimbursed under any Federal or State
health-related program.
Federal government agency includes, but is not limited to:
(a) The U.S. Department of Justice;
(b) The U.S. Department of Health and Human Services;
(c) Federal law enforcement agencies, including law enforcement
investigators;
(d) Any other Federal agency that either administers or provides
payment for the delivery of health care services, including, but not
limited to the U.S. Department of Defense and the U.S. Department of
Veterans Affairs; and
(e) Federal agencies responsible for the licensing and
certification of health care practitioners, physicians, dentists,
providers, and suppliers.
Formal peer review process means the conduct of professional review
activities through formally adopted written procedures which provide
for adequate notice and an opportunity for a hearing.
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.
Health care entity means, for purposes of this part:
(a) A hospital;
(b) An entity that provides health care services, and engages in
professional review activity through a formal peer review process for
the purpose of furthering quality health care, or a committee of that
entity; or
(c) A professional society or a committee or agent thereof,
including those at the national, State, or local level, of physicians,
dentists, or other health care practitioners that engages in
professional review activity through a formal peer review process, for
the purpose of furthering quality health care.
For purposes of paragraph (b) of this definition, an entity
includes: a health maintenance organization which is licensed by a
State or determined to be qualified as such by the Department of Health
and Human Services; and any group or prepaid medical or dental practice
which meets the criteria of paragraph (b).
Health care practitioner, licensed health care practitioner,
licensed practitioner, or practitioner means an individual other than a
physician or dentist, who is licensed or otherwise authorized by a
State to provide health care services (or any individual who, without
authority, holds himself or herself out to be so licensed or
authorized).
Health care provider means, for purposes of this part, a provider
of services as defined in section 1861(u) of the Social Security Act;
any organization (including a health maintenance organization,
preferred provider organization or group medical practice) that
provides health care services and follows a formal peer review process
for the purpose of furthering quality health care, and any other
organization that, directly or through contracts, provides health care
services.
Health care supplier means, for purposes of this part, a provider
of medical and other health care services as described in section
1861(s) of the Social Security Act; or any individual or entity, other
than a provider, who
[[Page 9152]]
furnishes, whether directly or indirectly, or provides access to,
health care services, supplies, items, or ancillary services
(including, but not limited to, durable medical equipment suppliers,
manufacturers of health care items, pharmaceutical suppliers and
manufacturers, health record services [such as medical, dental, and
patient records], health data suppliers, and billing and transportation
service suppliers). The term also includes any individual or entity
under contract to provide such supplies, items, or ancillary services;
health plans as defined in this section (including employers that are
self-insured); and health insurance producers (including but not
limited to agents, brokers, solicitors, consultants, and reinsurance
intermediaries).
Health plan means, for purposes of this part, a plan, program or
organization that provides health benefits, whether directly, through
insurance, reimbursement or otherwise, and includes but is not limited
to:
(a) A policy of health insurance;
(b) A contract of a service benefit organization;
(c) A membership agreement with a health maintenance organization
or other prepaid health plan;
(d) A plan, program, agreement, or other mechanism established,
maintained, or made available by a self-insured employer or group of
self-insured employers, a health care practitioner, physician, dentist,
provider, or supplier group, third-party administrator, integrated
health care delivery system, employee welfare association, public
service group or organization or professional association;
(e) An insurance company, insurance service or insurance
organization that is licensed to engage in the business of selling
health care insurance in a State and which is subject to State law
which regulates health insurance; and
(f) An organization that provides benefit plans whose coverage is
limited to outpatient prescription drugs.
Hospital means, for purposes of this part, an entity described in
paragraphs (1) and (7) of section 1861(e) of the Social Security Act.
Medical malpractice action or claim means a written complaint or
claim demanding payment based on a physician's, dentist's, or other
health care practitioner's provision of or failure to provide health
care services, and includes the filing of a cause of action based on
the law of tort, brought in any State or Federal Court or other
adjudicative body.
Negative action or finding by a Federal or State licensing or
certification 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 also includes final adverse actions rendered by a Federal or
State licensing or certification authority, such as exclusions,
revocations, or suspension of license or certification, that occur in
conjunction with settlements in which no finding of liability has been
made (although such a settlement itself is not reportable under the
statute). This definition excludes administrative fines or citations
and corrective action plans and other personnel actions, unless they
are:
(1) Connected to the delivery of health care services, or
(2) Taken in conjunction with other adverse 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.
Other adjudicated actions or decisions means formal or official
final actions taken against a health care practitioner, physician,
dentist, provider, or supplier by a Federal governmental agency, a
State law or fraud enforcement agency, or a health plan; which include
the availability of a due process mechanism, and are based on acts or
omissions that affect or could affect the payment, provision, or
delivery of a health care item or service. For example, a formal or
official final action taken by a Federal governmental agency, a State
law or fraud enforcement agency, or a health plan may include, but is
not limited to, a personnel-related action such as suspensions without
pay, reductions in pay, reductions in grade for cause, terminations, or
other comparable actions. A hallmark of any valid adjudicated action or
decision is the availability of a due process mechanism. The fact that
the subject elects not to use the due process mechanism provided by the
authority bringing the action is immaterial, as long as such a process
is available to the subject before the adjudicated action or decision
is made final. In general, if an ``adjudicated action or decision''
follows an agency's established administrative procedures (which ensure
that due process is available to the subject of the final adverse
action), it would qualify as a reportable action under this definition.
This definition specifically excludes clinical privileging actions
taken by Federal government agencies or State law and fraud enforcement
agencies and similar paneling decisions made by health plans. This
definition does not include overpayment determinations made by Federal
or State government programs, their contractors or health plans; and it
does not include denial of claims determinations made by Federal
government agencies, State law or fraud enforcement agencies, or health
plans. For health plans that are not Government entities, an action
taken following adequate notice and the opportunity for a hearing that
meets the standards of due process set out in section 412(b) of the
HCQIA (42 U.S.C. 11112(b)) also would qualify as a reportable action
under this definition.
Peer review organization means, for purposes of this part, 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.
Physician means, for purposes of this part, 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).
[[Page 9153]]
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, provider, or supplier;
(b) Measures a health care entity's, provider's, or supplier'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, provider, or
supplier; and
(d) Has due process mechanisms available to health care entities,
providers, or suppliers.
Professional review action means an action or recommendation of a
health care entity:
(a) Taken in the course of professional review activity;
(b) Based on the professional competence or professional conduct of
an individual physician, dentist, or other health care practitioner
which affects or could affect adversely the health or welfare of a
patient or patients; and
(c) Which adversely affects or may adversely affect the clinical
privileges or membership in a professional society of the physician,
dentist, or other health care practitioner.
(d) This term excludes actions which are primarily based on:
(1) The physician's, dentist's, or other health care practitioner's
association, or lack of association, with a professional society or
association;
(2) The physician's, dentist's, or other health care practitioner's
fees or the physician's, dentist's, or other health care practitioner's
advertising or engaging in other competitive acts intended to solicit
or retain business;
(3) The physician's, dentist's, or other health care practitioner's
participation in prepaid group health plans, salaried employment, or
any other manner of delivering health services whether on a fee-for-
service or other basis;
(4) A physician's, dentist's, or other health care practitioner's
association with, supervision of, delegation of authority to, support
for, training of, or participation in a private group practice with, a
member or members of a particular class of health care practitioner or
professional; or
(5) Any other matter that does not relate to the competence or
professional conduct of a physician, dentist, or other health care
practitioner.
Professional review activity means an activity of a health care
entity with respect to an individual physician, dentist, or other
health care practitioner:
(a) To determine whether the physician, dentist, or other health
care practitioner may have clinical privileges with respect to, or
membership in, the entity;
(b) To determine the scope or conditions of such privileges or
membership; or
(c) To change or modify such privileges or membership.
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 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.
Secretary means the Secretary of Health and Human Services and any
other officer or employee of the Department of Health and Human
Services to whom the authority involved has been delegated.
State means the fifty States, the District of Columbia, Puerto
Rico, the Virgin Islands, Guam, American Samoa, and the Northern
Mariana Islands.
State law or fraud enforcement agency includes, but is not limited
to:
(a) a State law enforcement agency;
(b) a State Medicaid fraud control unit (as defined in section
1903(q) of the Social Security Act); and
(c) a State agency administering (including those providing payment
for services) or supervising the administration of a State health care
program (as defined in section 1128(h) of the Social Security Act).
State licensing or certification agency includes, but is not
limited to, any authority of a State (or of a political subdivision
thereof) responsible for the licensing or certification of health care
practitioners, physicians, dentists (or any peer review organization or
private accreditation entity reviewing the services provided by health
care practitioners, physicians, or dentists), health care entities,
providers, or suppliers. Examples of such State agencies include
Departments of Professional Regulation, Health, Social Services
(including State Survey and Certification and Medicaid Single State
agencies), Commerce, and Insurance.
Voluntary surrender of license or certification means a surrender
made after a notification of investigation or a formal official request
by a Federal or State licensing or certification authority for a health
care practitioner, physician, dentist, health care entity, provider, or
supplier to surrender the license or certification (including
certification agreements or contracts for participation in Federal or
State health care programs). The definition also includes those
instances where a health care practitioner, physician, dentist, health
care entity, provider, or supplier voluntarily surrenders a license or
certification (including program participation agreements or contracts)
in exchange for a decision by the licensing or certification 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.
Subpart B--Reporting of Information
Sec. 60.4 How information must be reported.
Information must be reported to the NPDB as required under
Sec. Sec. 60.7, 60.8, 60.9, 60.10, 60.11, 60.12, 60.13, 60.14, 60.15
and 60.16 in such form and manner as the Secretary may prescribe.
Sec. 60.5 When information must be reported.
Information required under Sec. Sec. 60.7, 60.8, and 60.12 must be
submitted to the NPDB within 30 days following the action to be
reported, beginning with actions occurring on or after September 1,
1990; information required under Sec. 60.11 must be submitted to the
NPDB within 30 days following the action to be reported, beginning with
actions occurring on or after January 1, 1992; and information required
under Sec. Sec. 60.9, 60.10, 60.13, 60.14, 60.15, and 60.16 must be
submitted to the NPDB within 30 days following the action to be
reported, beginning with actions occurring on or after August 21, 1996.
[[Page 9154]]
Following is the list of reportable actions:
(a) Malpractice payments (Sec. 60.7);
(b) Licensure and certification actions (Sec. Sec. 60.8, 60.9, and
60.10);
(c) Negative actions or findings (Sec. 60.11);
(d) Adverse actions (Sec. 60.12);
(e) Health Care-related Criminal Convictions (Sec. 60.13);
(f) Health Care-related Civil Judgments (Sec. 60.14);
(g) Exclusions from Federal or State health care programs (Sec.
60.15); and
(h) Other adjudicated actions of decisions (Sec. 60.16).
Persons or entities responsible for submitting reports of
malpractice payments (Sec. 60.7), negative actions or findings (Sec.
60.11), or adverse actions (Sec. 60.12) must additionally provide to
their respective State authorities a copy of the report they submit to
the NPDB.
Sec. 60.6 Reporting errors, omissions, revisions or whether an action
is on appeal.
(a) Persons and entities are responsible for the accuracy of
information which they report to the NPDB. If errors or omissions are
found after information has been reported, the person or entity which
reported it must send an addition or correction to the NPDB and in the
case of reports made under Sec. 60.12, also to the Board of Medical
Examiners, as soon as possible. The NPDB will not accept requests for
readjudication of the case by the NPDB, and will not examine the
underlying merits of a reportable action.
(b) An individual or entity which reports information on licensure
or certification, negative actions or findings, clinical privileges,
criminal convictions, civil or administrative judgments, exclusions, or
adjudicated actions or decisions under Sec. Sec. 60.8, 60.9, 60.10,
60.11, 60.12, 60.13, 60.14, 60.15, or 60.16 must also report any
revision of the action originally reported. Revisions include, but are
not limited to, reversal of a professional review action or
reinstatement of a license. In the case of actions reported under
Sec. Sec. 60.9, 60.10, 60.13, 60.14, 60.15 or 60.16, revisions also
include whether an action is on appeal. Revisions are subject to the
same time constraints and procedures of Sec. Sec. 60.5, 60.8, 60.9,
60.10, 60.11, 60.12, 60.13, 60.14, 60.15, or 60.16 as applicable to the
original action which was reported.
(c) The subject will be sent a copy of all reports, including
revisions and corrections to the report.
(d) Upon receipt of a report, the subject:
(1) Can accept the report as written;
(2) May provide a statement to the NPDB that will be permanently
appended to the report, either directly or through a designated
representative; (The NPDB will distribute the statement to queriers,
where identifiable, and to the reporting entity and the subject of the
report. Only the subject can, upon request, make changes to the
statement. The NPDB will not edit the statement; however the NPDB
reserves the right to redact personal indentifying and offensive
language that does not change the factual nature of the statement.) or
(3) May follow the dispute process in accordance with Sec. 60.21.
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,
(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.
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,
[[Page 9155]]
(4) The physician's or dentist's Social Security number or
Individual Tax Identification Number (ITIN), if known, and if obtained
in accordance with section 7 of the Privacy Act of 1974 (5 U.S.C. 552a
note),
(5) 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. 60.12.
Sec. 60.9 Reporting licensure and certification 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, health
care entity, provider, or supplier (all 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 or certification
authority of the State as a result of a formal proceeding, including
revocation or suspension of a license, or certification agreement or
contract for participation in a State health care program (and the
length of any such suspension), reprimand, censure, or probation;
(2) Any dismissal or closure of the formal proceeding by reason of
the health care practitioner, physician, dentist, health care entity,
provider, or supplier surrendering the license or certification
agreement or contract for participation in a State health care program,
or leaving the State or jurisdiction;
(3) Any other loss of license or loss of the certification
agreement or contract for participation in a State health care program,
or the right to apply for, or renew, a license or certification
agreement or contract of the health care practitioner, physician,
dentist, health care entity, provider or supplier, whether by operation
of law, voluntary surrender, nonrenewal (excluding nonrenewals due to
nonpayment of fees, retirement, or change to inactive status), or
otherwise.
(4) Any negative action or finding by such authority, organization,
or entity regarding the health care practitioner, physician, dentist,
health care entity, provider, or supplier.
(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 an individual, personal identifiers,
including:
(i) Name;
(ii) Social Security Number or ITIN, if known, and if obtained in
accordance with section 7 of the Privacy Act of 1974 (5 U.S.C. 552a
note);
(iii) Home address or address of record;
(iv) Sex; and
(v) Date of birth.
(2) If the subject is an individual, employment or professional
identifiers, including:
(i) Organization name and type;
(ii) Occupation and specialty, if applicable;
(iii) National Provider Identifier (NPI);
(iv) Name of each professional school attended and year of
graduation; and
(v) With respect to the professional license (including
professional certification and registration) on which the reported
action was taken, the license number, the field of licensure, and the
name of the State or Territory in which the license is held.
(3) If the subject is an organization, identifiers, including:
(i) Name;
(ii) Business address;
(iii) Federal Employer Identification Number (FEIN), or Social
Security Number when used by the subject as a Taxpayer Identification
Number (TIN);
(iv) The NPI;
(v) Type of organization; and
(vi) With respect to the license (including certification and
registration) on which the reported action was taken, the license and
the name of the State or Territory in which the license is held.
(4) For all subjects:
(i) A narrative description of the acts or omissions and injuries
upon which the reported action was based;
(ii) Classification of the acts or omissions in accordance with a
reporting code adopted by the Secretary;
(iii) Classification of the action taken in accordance with a
reporting code adopted by the Secretary, and the amount of any monetary
penalty resulting from the reported action;
(iv) The date the action was taken, its effective date and
duration;
(v) Name of the agency taking the action;
(vi) Name and address of the reporting entity; and
(vii) The name, title and telephone number of the responsible
official submitting the report on behalf of the reporting entity.
(c) What information may be reported, if known. Reporting entities
described in paragraph (a) of this section may voluntarily report, if
known, the following information:
(1) If the subject is an individual, personal identifiers,
including:
(i) Other name(s) used;
(ii) Other address;
(iii) FEIN, when used by the individual as a TIN; and
(iv) If deceased, date of death.
(2) If the subject is an individual, employment or professional
identifiers, including:
(i) Other State professional license number(s), field(s) of
licensure, and the name(s) of the State or Territory in which the
license is held;
(ii) Other numbers assigned by Federal or State agencies,
including, but not limited to 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 an organization, identifiers, including:
(i) Other name(s) used;
(ii) Other address(es) used;
(iii) Other FEIN(s) or Social Security Number(s) used;
(iv) Other NPI(s) used;
(v) Other State license number(s) and the name(s) of the State or
Territory in which the license is held;
(vi) Other numbers assigned by Federal or State agencies,
including, but not limited to Drug Enforcement Administration (DEA)
registration
[[Page 9156]]
number(s), Clinical Laboratory Improvement Act (CLIA) number(s), Food
and Drug Administration (FDA) number(s), and Medicaid and Medicare
provider number(s);
(vii) Names and titles of principal officers and owners;
(viii) Name(s) and address(es) of any health care entity with which
the subject is affiliated or associated; and
(ix) Nature of the subject's relationship to each associated or
affiliated health care entity.
(4) For all subjects:
(i) Whether the subject will be automatically reinstated.
(ii) The date of appeal, if any.
(d) 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.
(e) Sanctions for failure to report. The Secretary will provide for
a publication of a public report that identifies failures to report
information on adverse actions as required to be reported under this
section.
Sec. 60.10 Reporting Federal licensure and certification actions.
(a) What actions must be reported. Federal licensing and
certification agencies must report to the NPDB the following final
adverse actions that are taken against a health care practitioner,
physician, dentist, provider, or supplier (regardless of whether the
final adverse action is the subject of a pending appeal):
(1) Formal or official actions, such as revocation or suspension of
a license or certification agreement or contract for participation in
Federal health care programs (and the length of any such suspension),
reprimand, censure or probation,
(2) Any dismissal or closure of the proceedings by reason of the
health care practitioner, physician, dentist, provider, or supplier
surrendering their license or certification agreement or contract for
participation in Federal health care programs, or leaving the State or
jurisdiction,
(3) Any other loss of the license or loss of the certification
agreement or contract for participation in Federal health care
programs, or the right to apply for, or renew, a license or
certification agreement or contract of the health care practitioner,
physician, dentist, provider, or supplier, whether by operation of law,
voluntary surrender, nonrenewal (excluding nonrenewals due to
nonpayment of fees, retirement, or change to inactive status), or
otherwise, and
(4) Any other negative action or finding by such Federal agency
that is publicly available information.
(b) What information must be reported. Each Federal agency
described in paragraph (a) must report the following information:
(1) If the subject is an individual, personal identifiers,
including:
(i) Name;
(ii) Social Security Number or ITIN;
(iii) Home address or address of record;
(iv) Sex; and
(v) Date of birth.
(2) If the subject is an individual, employment or professional
identifiers, including:
(i) Organization name and type;
(ii) Occupation and specialty, if applicable;
(iii) National Provider Identifier (NPI);
(iv) Name of each professional school attended and year of
graduation; and
(v) With respect to the State professional license (including
professional certification and registration) on which the reported
action was taken, the license number, the field of licensure, and the
name of the State or Territory in which the license is held.
(3) If the subject is an organization, identifiers, including:
(i) Name;
(ii) Business address;
(iii) Federal Employer Identification Number (FEIN), or Social
Security Number (or ITIN) when used by the subject as a Taxpayer
Identification Number (TIN);
(iv) The NPI;
(v) Type of organization; and
(vi) With respect to the State license (including certification and
registration) on which the reported action was taken, the license and
the name of the State or Territory in which the license is held.
(4) For all subjects:
(i) A narrative description of the acts or omissions and injuries
upon which the reported action was based;
(ii) Classification of the acts or omissions in accordance with a
reporting code adopted by the Secretary;
(iii) Classification of the action taken in accordance with a
reporting code adopted by the Secretary, and the amount of any monetary
penalty resulting from the reported action;
(iv) The date the action was taken, its effective date and
duration;
(v) Name of the agency taking the action;
(vi) Name and address of the reporting entity; and
(vii) The name, title, and telephone number of the responsible
official submitting the report on behalf of the reporting entity.
(c) What information may be reported, if known. Reporting entities
described in paragraph (a) of this section may voluntarily report, if
known, the following information:
(1) If the subject is an individual, personal identifiers,
including:
(i) Other name(s) used;
(ii) Other address;
(iii) FEIN, when used by the individual as a TIN; and
(iv) If deceased, date of death.
(2) If the subject is an individual, employment or professional
identifiers, including:
(i) Other State professional license number(s), field(s) of
licensure, and the name(s) of the State or Territory in which the
license is held;
(ii) Other numbers assigned by Federal or State agencies,
including, but not limited to 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 an organization, identifiers, including:
(i) Other name(s) used;
(ii) Other address(es) used;
(iii) Other FEIN(s) or Social Security Number(s) used;
(iv) Other NPI(s) used;
(v) Other State license number(s) and the name(s) of the State or
Territory in which the license is held;
(vi) Other numbers assigned by Federal or State agencies,
including, but not limited to 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) The date of appeal, if any.
(d) Sanctions for failure to report. The Secretary will provide for
a publication
[[Page 9157]]
of a public report that identifies those agencies that have failed to
report information on adverse actions as required to be reported under
this section.
Sec. 60.11 Reporting negative actions or findings taken by peer
review organizations or private accreditation entities.
(a) What actions must be reported. Peer review organizations and
private accreditation entities are required to report any negative
actions or findings (as defined in Sec. 60.3) which are taken against
a health care practitioner, physician, dentist, health care entity,
provider, or supplier to the NPDB and provide a copy to the appropriate
State licensing or certification agency. The health care practitioner,
physician, dentist, health care entity, provider, or supplier 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 peer review
organization and private accreditation entity must report the
information as required in Sec. 60.9(b).
(c) What information may be reported, if known: Each peer review
organization and private accreditation entity should report, if known,
the information as described in Sec. 60.9(c).
(d) Access to documents. Each peer review organization and private
accreditation entity 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.
Sec. 60.12 Reporting adverse actions taken against clinical
privileges.
(a) Reporting by health care entities to the NPDB.
(1) Actions that must be reported and to whom the report must be
made. Each health care entity must report to the NPDB and provide a
copy of the 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 NPDB 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,
(v) Date of birth,
(vi) Name of each professional school attended and year of
graduation,
(vii) For each professional license: the license number, the field
of licensure, and the name of the State or Territory in which the
license is held,
(viii) Drug Enforcement Administration registration number, if
known,
(ix) A description of the acts or omissions or other reasons for
privilege loss, or, if known, for surrender,
(x) Action taken, date the action was taken, and effective date of
the action, and
(xi) Other information as required by the Secretary from time to
time after publication in the Federal Register and after an opportunity
for public comment.
(b) Reporting by the Board of Medical Examiners to the NPDB. Each
Board must report 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 of Medical Examiners 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 of Medical Examiners 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 three-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 of Medical Examiners 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.
Sec. 60.13 Reporting Federal or State criminal convictions related to
the delivery of a health care item or service.
(a) Who must report. Federal and State prosecutors must report
criminal convictions against health care practitioners, physicians,
dentists, providers, and suppliers related to the delivery of a health
care item or service (regardless of whether the conviction is the
subject of a pending appeal).
[[Page 9158]]
(b) Entities described in paragraph (a) of this section must report
the following information:
(1) If the subject is an individual, personal identifiers,
including:
(i) Name;
(ii) Social Security Number (or ITIN) (States must report this
information, if known, and if obtained in accordance with section 7 of
the Privacy Act of 1974);
(iii) Home address or address of record;
(iv) Sex; and
(v) Date of birth.
(2) If the subject is an individual, that individual's employment
or professional identifiers, including:
(i) Organization name and type;
(ii) Occupation and specialty, if applicable; and
(iii) National Provider Identifier (NPI).
(3) If the subject is an organization, identifiers, including:
(i) Name;
(ii) Business address;
(iii) Federal Employer Number (FEIN), or Social Security Number (or
ITIN) when used by the subject as a Taxpayer Identification Number
(TIN);
(iv) The NPI; and
(v) Type of organization.
(4) For all subjects:
(i) A narrative description of the acts or omissions and injuries
upon which the reported action was based;
(ii) Classification of the acts or omissions in accordance with a
reporting code adopted by the Secretary;
(iii) Name and location of court or judicial venue in which the
action was taken;
(iv) Docket or court file number;
(v) Type of action taken;
(vi) Statutory offense(s) and count(s);
(vii) Name of primary prosecuting agency (or the plaintiff in civil
actions);
(viii) Date of sentence or judgment;
(ix) Length of incarceration, detention, probation, community
service, or suspended sentence;
(x) Amounts of any monetary judgment, penalty, fine, assessment, or
restitution;
(xi) Other sentence, judgment, or orders;
(xii) If the action is on appeal;
(xiii) Name and address of the reporting entity; and
(xiv) The name, title, and telephone number of the responsible
official submitting the report on behalf of the reporting entity.
(c) Entities described in paragraph (a) of this section and each
State should report, if known, the following information:
(1) If the subject is an individual, personal identifiers,
including:
(i) Other name(s) used;
(ii) Other address; and
(iii) FEIN, when used by the individual as a TIN.
(2) If the subject is an individual, that individual's employment
or professional identifiers, including:
(i) State professional license (including professional
certification and registration) number(s), field(s) of licensure, and
the name(s) of the State or Territory in which the license is held;
(ii) Other numbers assigned by Federal or State agencies, to
include, 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 an organization, identifiers, including:
(i) Other name(s) used;
(ii) Other address(es) used;
(iii) Other FEIN(s) or Social Security Numbers(s) (or ITINs) used;
(iv) Other NPI(s) used;
(v) State license (including certification and registration)
number(s) and the name(s) of the State or Territory in which the
license is held;
(vi) Other numbers assigned by Federal or State agencies, to
include, 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) Prosecuting agency's case number;
(ii) Investigative agencies involved;
(iii) Investigative agencies case or file number(s); and
(iv) The date of appeal, if any.
(d) 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.
(e) Sanctions for failure to report. The Secretary will provide for
publication of a public report that identifies those agencies that have
failed to report information on criminal convictions as required to be
reported under this section.
Sec. 60.14 Reporting civil judgments related to the delivery of a
health care item or service.
(a) Who must report. Federal and State attorneys and health plans
must report civil judgments against health care practitioners,
physicians, dentists, providers, or suppliers related to the delivery
of a health care item or service (regardless of whether the civil
judgment is the subject of a pending appeal). If a Government agency is
party to a multi-claimant civil judgment, it must assume the
responsibility for reporting the entire action, including all amounts
awarded to all the claimants, both public and private. If there is no
Government agency as a party, but there are multiple health plans as
claimants, the health plan which receives the largest award must be
responsible for reporting the total action for all parties.
(b) What information must be reported. Entities described in
paragraph (a) of this section must report the information as required
in Sec. 60.13(b).
(c) What information may be reported, if known. Entities described
in paragraph (a) of this section should report, if known the
information as described in Sec. 60.13(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 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.
(e) Sanctions for failure to report. Any health plan that fails to
report information on a civil judgment required to be reported under
this section will be subject to a civil money penalty (CMP) of not more
than $25,000 for each such adverse action not reported. Such penalty
will be imposed and collected in the same manner as CMPs under
subsection (a) of section 1128A of the Social Security Act. The
Secretary will provide for publication of a public report that
identifies those Government agencies that have failed to report
information on civil judgments as required to be reported under this
section.
[[Page 9159]]
Sec. 60.15 Reporting exclusions from participation in Federal or
State health care programs.
(a) Who must report. Federal Government agencies and State law and
fraud enforcement agencies must report health care practitioners,
physicians, dentists, providers, or suppliers excluded from
participating in Federal or State health care programs, including
exclusions that were made in a matter in which there was also a
settlement that is not reported because no findings or admissions of
liability have been made (regardless of whether the exclusion is the
subject of a pending appeal).
(b) What information must be reported. Entities described in
paragraph (a) of this section must report the following information:
(1) If the subject is an individual, personal identifiers,
including:
(i) Name;
(ii) Social Security Number (or ITIN) (State law and fraud
enforcement agencies must report this information if known, and if
obtained in accordance with section 7 of the Privacy Act of 1974);
(iii) Home address or address of record;
(iv) Sex; and
(v) Date of birth.
(2) If the subject is an individual, that individual's employment
or professional identifiers, including:
(i) Organization name and type;
(ii) Occupation and specialty, if applicable; and
(iii) National Provider Identifier (NPI).
(3) If the subject is an organization, identifiers, including:
(i) Name;
(ii) Business address;
(iii) Federal Employer Identification Number (FEIN) or Social
Security Number (or ITIN) when used by the subject as a Taxpayer
Identification Number (TIN);
(iv) The NPI; and
(v) Type of organization.
(4) For all subjects:
(i) A narrative description of the acts or omissions and injuries
upon which the reported action was based;
(ii) Classification of the acts or omissions in accordance with a
reporting code adopted by the Secretary;
(iii) Classification of the action taken in accordance with a
reporting code adopted by the Secretary, and the amount of any monetary
penalty resulting from the reported action;
(iv) The date the action was taken, its effective date and
duration;
(v) If the action is on appeal;
(vi) Name of the agency taking the action;
(vii) Name and address of the reporting entity; and
(viii) The name, title, and telephone number of the responsible
official submitting the report on behalf of the reporting entity.
(c) Entities described in paragraph (a) of this section should
report, if known, the following information:
(1) If the subject is an individual, personal identifiers,
including:
(i) Other name(s) used;
(ii) Other address;
(iii) FEIN, when used by the individual as a TIN;
(iv) Name of each professional school attended and year of
graduation; and
(v) If deceased, date of death.
(2) If the subject is an individual, that individual's employment
or professional identifiers, including:
(i) State professional license (including professional registration
and certification) number(s), field(s) of licensure, and the name(s) of
the State or Territory in which the license is held;
(ii) Other numbers assigned by Federal or State agencies, to
include, 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 an organization, identifiers, including:
(i) Other name(s) used;
(ii) Other address(es) used;
(iii) Other FEIN(s) or Social Security Numbers(s) (or ITINs) used;
(iv) Other NPI(s) used;
(v) State license (including registration and certification)
number(s) and the name(s) of the State or territory in which the
license is held;
(vi) Other numbers assigned by Federal or State agencies, to
include, 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) If the subject will be automatically reinstated; and
(ii) The date of appeal, if any.
(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.
(e) Sanctions for failure to report. The Secretary will provide for
publication of a public report that identifies those Government
agencies that have failed to report information on exclusions or
debarments as required to be reported under this section.
Sec. 60.16 Reporting other adjudicated actions or decisions.
(a) Who must report. Federal Government agencies, State law or
fraud enforcement agencies, and health plans must report other
adjudicated actions or decisions as defined in Sec. 60.3 related to
the delivery, payment or provision of a health care item or service
against health care practitioners, physicians, dentists, providers, and
suppliers (regardless of whether the other adjudicated action or
decision is subject to a pending appeal).
(b) Entities described in paragraph (a) of this section must report
the information as required in Sec. 60.15(b).
(c) Entities described in paragraph (a) of this section should
report, if known, the information as described in Sec. 60.15(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 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.
(e) Sanctions for failure to report. Any health plan that fails to
report information on another adjudicated action or decision required
to be reported under this section will be subject to a civil money
penalty (CMP) of not more than $25,000 for each such action not
reported. Such penalty will be imposed and collected in the same manner
as CMPs under subsection (a) of section 1128A of the Social Security
Act. The Secretary will provide for publication of a public report that
identifies those Government agencies that have failed to report
information on other adjudicated actions as required to be reported
under this section.
[[Page 9160]]
Subpart C--Disclosure of Information by the National Practitioner
Data Bank
Sec. 60.17 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 two 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.
Sec. 60.18 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 60.12 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. 60.17(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, 60.10, 60.11,
60.13, 60.14, 60.15, and 60.16 is available to the agencies,
authorities, and officials listed below that request information on
licensure or certification actions, any other negative actions or
findings, or final adverse actions concerning an individual
practitioner, physician, dentist, health care entity, provider, or
supplier. These agencies, authorities, and officials may obtain data
for the purposes of determining the fitness of individuals to provide
health care services, protecting the health and safety of individuals
receiving health care through programs administered by the requesting
agency, and protecting the fiscal integrity of these programs.
(i) Agencies administering (including those providing payment for
services) Federal health care programs, including private entities
administering such programs under contract;
(ii) State licensing or certification agencies and Federal agencies
responsible for the licensing and certification of health care
practitioners, physicians, dentists, providers, or suppliers;
(iii) State agencies administering or supervising the
administration of State health care programs (as defined in 42 U.S.C.
1128(h));
(iv) State law or fraud enforcement agencies;
(v) Law enforcement officials and agencies such as:
(A) United States Attorney General;
(B) United States Chief Postal Inspector;
(C) United States Inspectors General;
(D) United States Attorneys;
(E) United States Comptroller General;
(F) United States Drug Enforcement Administration;
(G) United States Nuclear Regulatory Commission; or
(H) Federal Bureau of Investigation;
(vi) Utilization and quality control peer review organizations
described in part B of title XI and to appropriate entities with
contracts under section 1154(a)(4)(C) of the Social Security Act with
respect to eligible organizations reviewed under the contracts, but
only with respect to information provided pursuant to Sec. Sec. 60.9
and 60.11, as well as information provided pursuant to Sec. Sec.
60.13, 60.14, 60.15, and 60.16 by Federal agencies and health plans;
(vii) Hospitals and other health care entities (as defined in
section 431 of the Health Care Quality Improvement Act of 1986), 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, but only with respect to information provided pursuant
to Sec. Sec. 60.9 and 60.11, as well as information provided pursuant
to Sec. Sec. 60.13, 60.14, 60.15, and 60.16 by Federal agencies and
health plans;
(viii) health plans;
and
(ix) A health care practitioner, physician, dentist, health care
entity, provider, or supplier who requests information concerning
himself, herself, or itself; and
(x) A person or entity requesting statistical information, in a
form which does not permit the identification of any individual or
entity. (For example, researchers may use statistical information to
identify the total number of nurses with adverse licensure actions in a
specific State. Similarly, researchers may use statistical information
to identify the total number of health care entities denied
accreditation.)
(b) 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.
60.19.
Sec. 60.19 Fees applicable to requests for information.
(a) Policy on Fees. The fees described in this section apply to all
requests for information from the NPDB. The amount of such fees will be
sufficient to recover the full costs of operating the NPDB. The actual
fees will be announced by the Secretary in periodic notices in the
Federal Register. However, for purposes of verification
[[Page 9161]]
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, physician, dentist, entity, provider, or
supplier 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. 60.20 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. 60.17, 60.18, and 60.21. Persons and entities receiving
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 section will prevent the disclosure of information by a
party from its own files used to create such reports where disclosure
is otherwise authorized under applicable State or Federal law.
(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. 60.21 How to dispute the accuracy of National Practitioner Data
Bank information.
(a) Who may dispute the NPDB information. The NPDB will routinely
mail or transmit electronically to the subject a copy of the report
filed in the NPDB. In addition, as indicated in Sec. 60.18(a)(2)(ix),
the subject may also request a copy of such report. The subject of the
report or a designated representative may dispute the accuracy of a
report concerning himself, herself, or itself as set forth in paragraph
(b) of this section.
(b) Procedures for disputing a report with the reporting entity.
(1) If the subject disagrees with the reported information, the
subject must request in writing that the NPDB enter the report into
``disputed status.''
(2) The NPDB will send the report, with a notation that the report
has been placed in ``disputed status,'' to queriers (where
identifiable), the reporting entity and the subject of the report.
(3) The subject must attempt to enter into discussion with the
reporting entity to resolve the dispute. If the reporting entity
revises the information originally submitted to the NPDB, the NPDB will
notify the subject and all entities to whom reports have been sent that
the original information has been revised. If the reporting entity does
not revise the reported information, or does not respond to the subject
within 60 days, the subject may request that the Secretary review the
report for accuracy. The Secretary will decide whether to correct the
report within 30 days of the request. This time frame may be extended
for good cause. The subject also may provide a statement to the NPDB,
either directly or through a designated representative, that will
permanently append the report.
(c) Procedures for requesting a Secretarial review.
(1) The subject must request, in writing, that the Secretary review
the report for accuracy. The subject must return this request to the
NPDB along with appropriate materials that support the subject's
position. The Secretary will only review the accuracy of the reported
information, and will not consider the merits or appropriateness of the
action or the due process that the subject received.
(2) After the review, if the Secretary:
(i) Concludes that the information is accurate and reportable to
the NPDB, the Secretary will inform the subject and the NPDB of the
determination. The Secretary will include a brief statement
(Secretarial Statement) in the report that describes the basis for the
decision. The report will be removed from ``disputed status.'' The NPDB
will distribute the corrected report and statement(s) to previous
queriers (where identifiable), the reporting entity and the subject of
the report.
(ii) Concludes that the information contained in the report is
inaccurate, the Secretary will inform the subject of the determination
and direct the NPDB or the reporting entity to revise the report. The
Secretary will include a brief statement (Secretarial Statement) in the
report describing the findings. The NPDB will distribute the corrected
report and statement(s) to previous queriers (where identifiable), the
reporting entity and the subject of the report.
(iii) Determines that the disputed issues are outside the scope of
the Department's review, the Secretary will inform the subject and the
NPDB of the determination. The Secretary will include a brief statement
(Secretarial Statement) in the report describing the findings. The
report will be removed from ``disputed status.'' The NPDB will
distribute the report and the statement(s) to previous queriers (where
identifiable), the reporting entity and the subject of the report.
(iv) Determines that the adverse action was not reportable and
therefore should be removed from the NPDB, the Secretary will inform
the subject and direct the NPDB to void the report. The NPDB will
distribute a notice to previous queriers (where identifiable), the
reporting entity and the subject of the report that the report has been
voided.
Sec. 60.22 Immunity.
Individuals, entities or their authorized agents, and the NPDB
shall not be held liable in any civil action filed by the subject of a
report unless the individual, entity, or authorized agent submitting
the report has actual knowledge of the falsity of the information
contained in the report.
Title 45--Public Welfare
4. CHAPTER I--DEPARTMENT OF HEALTH AND HUMAN SERVICES
PART 61--[REMOVED]
4. Under the authority of 42 U.S.C. 1320a-7e, remove part 61.
[FR Doc. 2012-3014 Filed 2-14-12; 8:45 am]
BILLING CODE 4165-15-P