Privacy Act of 1974; Report of New System of Records, 52133-52140 [E7-17907]
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Background and Brief Description
Cyanobacteria (blue-green algae) can
be found in terrestrial, fresh, brackish,
or marine water environments. Some
species of cyanobacteria produce toxins
that may cause acute or chronic
illnesses (including neurotoxicity,
hepatotoxicity, and skin irritation) in
humans and animals (including other
mammals, fish, and birds). A number of
human health effects, including
gastroenteritis, respiratory effects, skin
irritations, allergic responses, and liver
damage, are associated with the
ingestion of or contact with water
containing cyanobacterial blooms.
Although the balance of evidence, in
conjunction with data from laboratory
animal research, suggests that
cyanobacterial toxins are responsible for
a range of human health effects, there
have been few epidemiologic studies of
this association.
During August 2006, we conducted
our first study to assess exposure to
microcystins in recreational waters with
a bloom of Microcystis aeruginosa. We
recruited 104 people who gave informed
consent to participate. Ninety seven
people did their recreational activities
on Lake 1, which had a confirmed M.
aeruginosa bloom, and 7 others did
normally be doing these activities, even
in the presence of a bloom. We may
recruit people who train for organized
swimming events (e.g., triathlons) in
lakes. In addition, we will recruit 50
study participants from lakes with no
blooms as a comparison group to assess
the health effects associated with
recreational activities on ‘‘clean’’ lakes.
Study participants will be asked to sign
a consent form, complete a symptom
survey before and after doing their
recreational water activities, provide
one 10-ml whole blood sample after
their recreational activities, and
complete a telephone symptom survey
8–10 days after doing study activities.
The purpose of the new data
collection is to continue assessing the
public health impact of exposure to the
cyanobacterial toxins, microcystins,
during recreational activities. We will
examine the extent of human exposure
to microcystins present in recreational
waters and associated aerosols and
whether serum levels of microcystins
can be used as a biomarker of exposure.
There is no cost to the respondents
other than their time. The total
estimated annualized burden hours are
69.
their activities on Lake 2, which had no
bloom. Study participants completed a
pre-activity questionnaire, a postactivity questionnaire, provided a 10-ml
blood sample, and completed a
telephone symptom survey 7–10 days
after exposure. The concentrations of
microcystins in Lake 1 ranged from 2 to
5 ug/L and in Lake 2 were all below the
limit of detection (LOD). When we
designed the study, we calculated that
a person exposed to recreationallygenerated aerosols from water
containing 10 ug/L of microcystins
should have levels of microcystins in
their blood. However, the microcystin
concentrations in Lake 2 were below the
LOD and in Lake 1 were actually 2ug/
L to 5ug/L, much lower than we
anticipated based on data from the
previous week. Thus, the recreational
exposures were not likely high enough
for us to quantify microcystins in blood
and the serum samples were all below
the LOD for microcystins.
For the new data collection, we will
conduct two separate studies in
different lakes. In total, we will recruit
200 study participants who are at risk
for swallowing water or inhaling spray
(i.e., water skiers, jet skiers, people
sailing small boats) and who would
ESTIMATED ANNUALIZED BURDEN HOURS
Number of respondents
Forms
Number of responses per
respondent
125
100
100
100
1
1
1
1
Screening questionnaire ..............................................................................................................
Consent and pre-exposure questionnaire ...................................................................................
Post-exposure questionnaire .......................................................................................................
10-day post exposure questionnaire ...........................................................................................
Dated: September 6, 2007.
Maryam I. Daneshvar,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. E7–17962 Filed 9–11–07; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
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Privacy Act of 1974; Report of New
System of Records
Department of Health and
Human Services (HHS), Centers for
Medicare & Medicaid Services (CMS).
AGENCY:
Notice of a New System of
Records.
ACTION:
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SUMMARY: In accordance with the
requirements of the Privacy Act of 1974,
CMS is proposing to establish a new
system of records (SOR) titled,
‘‘Performance Measurement and
Reporting System (PMRS),’’ System No.
09–70–0584. PMRS will serve as a
master system of records to assist in
projects that provide transparency in
health care on a broad-scale enabling
consumers to compare the quality and
price of health care services so that they
can make informed choices among
individual physicians, practitioners and
providers of services. In cooperation
with local or regional public-private
collaborative stakeholders; individuals
assigned to provider groups; insurance
and provider associations; government
agencies; employers; accrediting and
quality organizations; Chartered Value
Exchanges (CVE), data aggregators, and
other community leaders who are
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Average burden per response
(in hours)
5/60
10/60
15/60
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committed to improving the quality of
services, CMS is laying the foundation
for pooling and analyzing information
about the quality of medical services
and performance provided by
physicians and health care providers.
PMRS will further assist in developing
existing strategies to improve health
care quality including transparency of
cost and/or price information, quality
and utilization information; and patient
safety for Medicare beneficiaries by
collecting and aggregating data, by
measuring performance at the
individual physician level, and by
reporting meaningful information to
Medicare beneficiaries in order to make
informed choices and improve
outcomes.
Pursuant to the ‘‘routine use’’
promulgated under this system of
records notice, CMS or a non-Quality
Improvement Organization (non-QIO)
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contractor would make the individual
physician-level performance
measurement results available to
Medicare beneficiaries by posting it on
a public Web site and by various other
methods of data dissemination. If local
Web sites are used by a local or regional
collaborative, CMS would have links to
these Web sites on its main Web site.
This information would be made
available for the purpose of, and in a
manner that would promote more
informed choices by Medicare
beneficiaries among their Medicare
coverage options (i.e., the Medicare
Advantage, local or regional plans
offered in their area, and original feefor-service Medicare). The routine uses
established with this system contain a
proper explanation as to the need for the
disclosure provisions and provide
clarity to CMS’s intention to disclose
individual-specific information
contained in this system.
The primary purpose of this system is
to support the collection, maintenance,
and processing of information
promoting the effective, efficient, and
economical delivery of health care
services, and promoting the quality of
services of the type for which payment
may be made under title XVIII by
allowing for the establishment and
implementation of performance
measures, and the provision of feedback
to physicians. Information in this
system will also be disclosed to: (1)
Support regulatory, reimbursement, and
policy functions performed for the
Agency or by a contractor, consultant, or
a CMS grantee; (2) assist another Federal
and/or state agency, agency of a state
government, or an agency established by
state law; (3) promote more informed
choices by Medicare beneficiaries
among their Medicare group options by
making physician performance
measurement information available to
Medicare beneficiaries through a Web
site and other forms of data
dissemination; (4) provide CVEs and
data aggregators with information that
will assist in generating single or multipayer performance measurement results
to promote transparency in health care
to members of their community; (5)
assist individual physicians,
practitioners, providers of services,
suppliers, laboratories, and others
health care professionals who are
participating in health care transparency
projects; (6) assist individuals or
organizations with projects that provide
transparency in health care on a broadscale enabling consumers to compare
the quality and price of health care
services; or for research, evaluation, and
epidemiological projects related to the
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prevention of disease or disability;
restoration or maintenance of health or
for payment purposes; (7) assist Quality
Improvement Organizations; (8) support
litigation involving the agency; and (9)
combat fraud, waste, and abuse in
certain health benefits programs. We
have provided background information
about this new system in the
‘‘Supplementary Information’’ section
below. Although the Privacy Act
requires only that CMS provide an
opportunity for interested persons to
comment on the proposed routine uses,
CMS invites comments on all portions
of this notice. See ‘‘EFFECTIVE DATES’’
section for comment period.
EFFECTIVE DATES: CMS filed a new
system report with the Chair of the
House Committee on Government
Reform and Oversight, the Chair of the
Senate Committee on Homeland
Security & Governmental Affairs, and
the Administrator, Office of Information
and Regulatory Affairs, Office of
Management and Budget (OMB) on 9/
05/2007. To ensure that all parties have
adequate time in which to comment, the
new system, including routine uses, will
become effective 30 days from the
publication of the notice, or 40 days
from the date it was submitted to OMB
and Congress, whichever is later, unless
CMS receives comments that require
alterations to this notice.
ADDRESSES: The public should address
comments to: CMS Privacy Officer,
Division of Privacy Compliance,
Enterprise Architecture and Strategy
Group, Office of Information Services,
CMS, Room N2–04–27, 7500 Security
Boulevard, Baltimore, Maryland 21244–
1850. Comments received will be
available for review at this location, by
appointment, during regular business
hours, Monday through Friday from 9
a.m. to 3 p.m., eastern time zone.
FOR FURTHER INFORMATION CONTACT:
Aucha Prachanronarong, Health
Insurance Specialist, Division of
Ambulatory Care and Measure
Management, Quality Measurement and
Health Assessment Group, Office of
Clinical Standards and Quality, CMS,
Room C1–23–14, 7500 Security
Boulevard, Baltimore, Maryland 21244–
1850. The telephone number is (410)
786–1879 or contact
Aucha.Prachanronarong@cms.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Value-driven Health Care Initiative is
designed to achieve four cornerstones:
Interoperable health information
technology (HIT); transparency of price
information; transparency of quality
information; and the use of incentives to
promote high-quality and cost-efficient
health care. Regional/local public-
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private collaboration is essential to the
success of this Initiative. As such, the
Initiative is encouraging the growth of
regional public-private collaboratives
that will be chartered by the Agency for
Health Research and Quality (AHRQ) to
support and achieve the four
cornerstones. Only mature, sustainable,
multi-stakeholder entities that are
committed to achieving the four
cornerstones, including publicly
reporting physician-level and other
provider performance measurement
information and facilitating the use of
this information to improve the quality
and efficiency of health care delivery,
will become Chartered Value Exchanges
(CVE).
Provided they meet certain criteria
established by CMS and disclosure is
consistent with the Privacy Act, the
Health Insurance Portability and
Accountability Act (HIPAA) Privacy
Rule and other applicable laws, CMS
will provide CVEs with patient deidentified Medicare-inclusive
individual physician-level performance
measurement results. CMS also may
provide physician and patient
identifiable protected health claims data
information to data aggregators that are
HIPAA business associates of CMS
(including working with providers,
payers, or other HIPAA covered entities)
for purposes for generating these results.
The patient de-identified results will be
calculated using Medicare claims data
based on consensus-based measures as
determined by CMS, including but not
limited to quality, efficiency and
utilization metrics. Available results
may include single payer (i.e., Medicare
only and private payer only
performance measurement results) and/
or multi-payer (i.e., results generated
from merging or aggregating Medicare
results with other private payer results)
patient de-identified, individual
physician-level performance
measurement results. CMS also plans to
make the patient de-identified and
individual physician-level performance
measurement results available to
Medicare beneficiaries, and others that
meet CMS requirements for disclosure.
CMS also has implemented a pilot
project known as, ‘‘The Better Quality
Information to Improve Care for
Medicare Beneficiaries (BQI) Project’’ to
develop a model for data aggregation,
quality measurement, and public
reporting. Through the BQI project, each
pilot collaborative, as a QIO
subcontractor, is aggregating private
claims data with Medicare claims data
and, in some cases, Medicaid claims
data to produce single payer and/or
multi-payer, patient de-identified,
individual physician-level performance
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measurement results using quality
measures that are approved by CMS.
These performance measurement results
will be made available to Medicare
beneficiaries by CMS or a CMS
contractor.
In addition, as required by the Tax
Relief and Health Care Act of 2006, CMS
is implementing a voluntary Physician
Quality Reporting Initiative (PQRI).
Under PQRI, eligible professionals who
choose to participate and successfully
report on a designated set of quality
measures for services paid under the
Medicare Physician Fee Schedule and
provided to Medicare beneficiaries
under the traditional fee-for-service
program, may earn a bonus payment
subject to a cap. Participating eligible
professionals whose Medicare patients
in the traditional fee-for-service program
fit the specifications of the PQRI quality
measures will report the corresponding
appropriate Common Procedural
Terminology (CPT) Category II codes or
G-codes on their claims. In the future,
CMS may publicly release the
performance information that is
reported by physicians pursuant to
PQRI.
I. Description of the Proposed System of
Records
A. Statutory and Regulatory Basis for
System
Authority for the collection,
maintenance, and disclosures from this
system is given under provisions of
§§ 1152, 1153(c), 1153(e), 1154, 1160,
1851(d) and 1862(g) of the Social
Security Act; § 101 of the Tax Relief and
Health Care Act of 2006; and §§ 901,
912, and 914 of the Public Health
Service Act.
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B. Collection and Maintenance of Data
in the System
The system contains single and multipayer, patient de-identified, individual
physician-level performance
measurement results as well as, patient
identifiable clinical and claims
information provided by individual
physicians, practitioners and providers
of services, individuals assigned to
provider groups, insurance and provider
associations, government agencies,
accrediting and quality organizations,
and others who are committed to
improving the quality of physician
services. This system contains the
patient’s or beneficiary’s name, sex,
health insurance claim number (HIC),
Social Security Number (SSN), address,
date of birth, medical record number(s),
prior stay information, provider name
and address, physician’s name, and/or
identification number, date of
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admission or discharge, other health
insurance, diagnosis, surgical
procedures, and a statement of services
rendered for related charges and other
data needed to substantiate claims. The
system contains provider
characteristics, prescriber identification
number(s), assigned provider number(s)
(facility, referring/servicing physician),
and national drug code information,
total charges, and Medicare payment
amounts.
II. Agency Policies, Procedures, and
Restrictions on Routine Uses
A. The Privacy Act permits us to
disclose information without an
individual’s consent/authorization if the
information is to be used for a purpose
that is compatible with the purpose(s)
for which the information was collected.
Any such disclosure of data is known as
a ‘‘routine use.’’ The government will
only release PMRS information that can
be associated with an individual as
provided for under ‘‘Section III.
Proposed Routine Use Disclosures of
Data in the System.’’ Both identifiable
and non-identifiable data may be
disclosed under a routine use.
We will only disclose the minimum
individually identifiable data necessary
to achieve the purpose of PMRS. CMS
has the following policies and
procedures concerning disclosures of
information that will be maintained in
the system. In general, disclosure of
information from the system will be
approved only for the minimum
information necessary to accomplish the
purpose of the disclosure and only after
CMS:
1. Determines that the use or
disclosure is consistent with the reason
that the data is being collected, e.g., to
collect, maintain, and process
information promoting the effective,
efficient, and economical delivery of
health care services, and promoting the
quality of services of the type for which
payment may be made under title XVIII;
2. Determines that:
a. The purpose for which the
disclosure is to be made can only be
accomplished if the record is provided
in individually identifiable form;
b. The purpose for which the
disclosure is to be made is of sufficient
importance to warrant the effect and/or
risk on the privacy of the individual that
additional exposure of the record might
bring; and
c. There is a reasonable probability
that the proposed use of the data would
in fact accomplish the stated purpose(s)
of the disclosure.
3. Requires the information recipient
to:
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a. Establish reasonable administrative,
technical, and physical safeguards to
prevent unauthorized use of disclosure
of the record(s);
b. Remove or destroy the information
that allows the individual to be
identified at the earliest time; and
c. Generally agree to not use or
disclose the information for any purpose
other than the stated purpose under
which the information was disclosed.
4. Determines that the data are valid
and reliable.
III. Proposed Routine Use Disclosures
of Data in the System
A. Entities Who May Receive
Disclosures Under Routine Use
These routine uses specify
circumstances, in addition to those
provided by statute in the Privacy Act
of 1974, under which CMS may release
information from the PMRS without the
consent/authorization of the individual
to whom such information pertains.
Each proposed disclosure of information
under these routine uses will be
evaluated to ensure that the disclosure
is legally permissible, including but not
limited to ensuring that the purpose of
the disclosure is compatible with the
purpose for which the information was
collected. We propose to establish the
following routine use disclosures of
information maintained in the system:
1. To support Agency contractors,
consultants, or CMS grantees who have
been engaged by the Agency to assist in
accomplishment of a CMS function
relating to the purposes for this SOR
and who need to have access to the
records in order to assist CMS.
We contemplate disclosing
information under this routine use only
in situations in which CMS may enter
into a contractual or similar agreement
with a third party to assist in
accomplishing a CMS function relating
to purposes for this SOR.
CMS occasionally contracts out
certain of its functions when doing so
would contribute to effective and
efficient operations. CMS must be able
to give a contractor, consultant, or CMS
grantee whatever information is
necessary for the contractor or
consultant to fulfill its duties. In these
situations, safeguards are provided in
the contract/similar agreement
prohibiting the contractor, consultant,
or grantee from using or disclosing the
information for any purpose other than
that described in the contract/similar
agreement and requires the contractor,
consultant, or grantee to return or
destroy all information at the
completion of the contract.
2. Pursuant to agreements with CMS
to assist another Federal or state agency,
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agency of a state government, or an
agency established by state law to:
a. Contribute to projects that provide
transparency in health care on a broadscale enabling consumers to compare
the quality and price of health care
services,
b. Contribute to the accuracy of CMS’s
proper payment of Medicare benefits,
c. Enable such agency to administer a
Federal health benefits program, or as
necessary to enable such agency to
fulfill a requirement of a Federal statute
or regulation that implements a health
benefits program funded in whole or in
part with Federal funds, and/or
d. Assist Federal/state Medicaid
programs which may require PMRS
information for purposes related to this
system.
Other Federal or state agencies in
their administration of a Federal health
program may require PMRS information
in order to support evaluations and
monitoring of Medicare claims
information of beneficiaries, including
proper reimbursement for services
provided.
3. To assist in making the individual
physician-level performance
measurement results available to
Medicare beneficiaries, through a Web
site and other forms of data
dissemination, in order to promote more
informed choices by Medicare
beneficiaries among their Medicare
coverage options.
This information would be made
available to Medicare beneficiaries for
the purpose of, and in a manner that
would promote more informed choices
by Medicare beneficiaries among their
Medicare coverage options (i.e., the
Medicare Advantage local or Regional
plans offered in their area, and original
fee-for-service Medicare).
4. To provide Chartered Value
Exchanges (CVE) and data aggregators
with information that will assist in
generating single or multi-payer
performance measurement results that
will assist beneficiaries in making
informed choices among individual
physicians, practitioners and providers
of services; enable consumers to
compare the quality and price of health
care services; and assist in providing
transparency in health care at the local
level if CMS:
a. Determines that the use or
disclosure does not violate legal
limitations under which the record was
provided, collected, or obtained;
b. Determines that the purpose for
which the disclosure is to be made:
(1) Is of sufficient importance to
warrant the effect and/or risk on the
privacy of the individual that additional
exposure of the record might bring, and
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(2) There is reasonable probability
that the objective for the use would be
accomplished;
c. Requires the recipient of the
information to establish reasonable
administrative, technical, and physical
safeguards to prevent unauthorized use
or disclosure of the record;
d. Make no further use or disclosure
of the record except:
(1) For use in another project
providing transparency in health care,
under these same conditions, and with
written authorization of CMS; and
(2) When required by law.
e. Secures a written statement
attesting to the information recipient’s
understanding of and willingness to
abide by these provisions. CVEs and
data aggregators should complete a Data
Use Agreement (CMS Form 0235) in
accordance with current CMS policies.
The disclosure of PMRS information
to CVEs or data aggregators will support
the generation of single or multi-payer
performance measurement results that
will provide a more comprehensive
view of physician performance for
Medicare beneficiaries. Both identifiable
physician level information and patient
de-identified information may be made
available to CVEs to enable them to
provide transparency in health care on
a local level. Identifiable physician and
patient level information may be
provided to data aggregators that are
HIPAA business associates of CMS to
conduct CMS’ health care operations
(including working with other
providers, payers, or other HIPAA
covered entities to generate single and
multi-payer performance information).
5. To assist individual physicians,
practitioners, providers of services,
suppliers, laboratories, and other health
care professionals who are participating
in health care transparency projects.
PMRS data will be released to the
individual physician only on those
individuals who received services
ordered or provided by the individual
physician and shall be limited to claims
and utilization data necessary to
perform that specific project function
whose information was provided for the
PMRS project. Individual physicians,
practitioners, providers of services,
suppliers, laboratories, and other health
care professionals require PMRS
information for the purpose of direct
feedback with respect to their
individual patients on a non-aggregated
basis.
PMRS information is needed in order
to support evaluations, establish the
validity of evidence, or to verify the
accuracy of information presented by
the individual physician as it concerns
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the patient’s entitlement to benefits and
for services provided.
6. To assist an individual or
organization with projects that provide
transparency in health care on a broadscale enabling consumers to compare
the quality and price of health care
services; or for research, evaluation, and
epidemiological projects related to the
prevention of disease or disability;
restoration or maintenance of health or
for payment purposes if CMS:
a. Determines that the use or
disclosure does not violate legal
limitations under which the record was
provided, collected, or obtained;
b. Determines that the purpose for
which the disclosure is to be made:
(1) Cannot be reasonably
accomplished unless the record is
provided in individually identifiable
form,
(2) Is of sufficient importance to
warrant the effect and/or risk on the
privacy of the individual that additional
exposure of the record might bring, and
(3) There is reasonable probability
that the objective for the use would be
accomplished;
c. Requires the recipient of the
information to:
(1) Establish reasonable
administrative, technical, and physical
safeguards to prevent unauthorized use
or disclosure of the record, and
(2) Remove or destroy the information
that allows the individual to be
identified at the earliest time at which
removal or destruction can be
accomplished consistent with the
purpose of the project, unless the
recipient presents an adequate
justification of a research or health
nature for retaining such information,
and
(3) Make no further use or disclosure
of the record except:
(a) For disclosure to a properly
identified person, for purposes of
providing transparency in health care
enabling consumers to compare the
quality and price of health care services
so that they can make informed choices
among individual physicians,
practitioners and providers of services;
(b) In emergency circumstances
affecting the health or safety of any
individual;
(c) For use in another research project,
under these same conditions, and with
written authorization of CMS;
(d) For disclosure to a properly
identified person for the purpose of an
audit related to the research project, if
information that would enable research
subjects to be identified is removed or
destroyed at the earliest opportunity
consistent with the purpose of the audit;
or
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(e) When required by law.
d. Secures a written statement
attesting to the information recipient’s
understanding of and willingness to
abide by these provisions. Researchers
should complete a Data Use Agreement
(CMS Form 0235) in accordance with
current CMS policies.
PMRS data will provide data for
projects that provide transparency in
health care on a broad-scale enabling
consumers to compare the quality and
price of health care services; and
research evaluation; and
epidemiological projects with a broader,
longitudinal, national perspective of the
status of health care provided to
Medicare beneficiaries. CMS anticipates
that many researchers will have
legitimate requests to use these data in
projects that could ultimately improve
the care provided to Medicare
beneficiaries and the policy that governs
the care.
7. To support Quality Improvement
Organizations (QIO) in connection with
review of claims, or in connection with
studies or other review activities
conducted pursuant to Part B of Title XI
of the Act and in performing affirmative
outreach activities to individuals for the
purpose of establishing and maintaining
their entitlement to Medicare benefits or
health insurance plans.
QIOs will work to implement quality
improvement programs, provide
consultation to CMS, its contractors,
and to state agencies. QIOs will assist
the state agencies in related monitoring
and enforcement efforts, assist CMS and
intermediaries in program integrity
assessment, and prepare summary
information for release to CMS.
8. To support the Department of
Justice (DOJ), court, or adjudicatory
body when:
a. The Agency or any component
thereof, or
b. Any employee of the Agency in his
or her official capacity, or
c. Any employee of the Agency in his
or her individual capacity where the
DOJ has agreed to represent the
employee, or
d. The United States Government,
is a party to litigation or has an interest
in such litigation, and by careful review,
CMS determines that the records are
both relevant and necessary to the
litigation and that the use of such
records by the DOJ, court or
adjudicatory body is compatible with
the purpose for which the agency
collected the records.
Whenever CMS is involved in
litigation, or occasionally when another
party is involved in litigation and CMS’s
policies or operations could be affected
by the outcome of the litigation, CMS
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would be able to disclose information to
the DOJ, court, or adjudicatory body
involved.
9. To assist a CMS contractor
(including, but not limited to MACs,
fiscal intermediaries and carriers) that
assists in the administration of a CMSadministered health benefits program,
or to a grantee of a CMS-administered
grant program, when disclosure is
deemed reasonably necessary by CMS to
prevent, deter, discover, detect,
investigate, examine, prosecute, sue
with respect to, defend against, correct,
remedy, or otherwise combat fraud,
waste or abuse in such program.
We contemplate disclosing
information under this routine use only
in situations in which CMS may enter
into a contract or grant with a third
party to assist in accomplishing CMS
functions relating to the purpose of
combating fraud, waste or abuse.
CMS occasionally contracts out
certain of its functions when doing so
would contribute to effective and
efficient operations. CMS must be able
to give a contractor or grantee whatever
information is necessary for the
contractor or grantee to fulfill its duties.
In these situations, safeguards are
provided in the contract prohibiting the
contractor or grantee from using or
disclosing the information for any
purpose other than that described in the
contract and requiring the contractor or
grantee to return or destroy all
information.
10. To assist another Federal agency
or to an instrumentality of any
governmental jurisdiction within or
under the control of the United States
(including any state or local
governmental agency), that administers,
or that has the authority to investigate
potential fraud, waste or abuse in a
health benefits program funded in
whole or in part by Federal funds, when
disclosure is deemed reasonably
necessary by CMS to prevent, deter,
discover, detect, investigate, examine,
prosecute, sue with respect to, defend
against, correct, remedy, or otherwise
combat fraud, waste or abuse in such
programs.
Other agencies may require PMRS
information for the purpose of
combating fraud, waste or abuse in such
Federally-funded programs.
B. Additional Circumstances Affecting
Routine Use Disclosures
To the extent this system contains
Protected Health Information (PHI) as
defined by HHS regulation ‘‘Standards
for Privacy of Individually Identifiable
Health Information’’ (45 CFR Parts 160
and 164, Subparts A and E) 65 Fed. Reg.
82462 (12–28–00). Disclosures of such
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PHI that are otherwise authorized by
these routine uses may only be made if,
and as, permitted or required by the
‘‘Standards for Privacy of Individually
Identifiable Health Information.’’ (See
45 CFR 164–512 (a) (1)).
IV. Safeguards
CMS has safeguards in place for
authorized users and monitors such
users to ensure against unauthorized
use. Personnel having access to the
system have been trained in the Privacy
Act and information security
requirements. Employees who maintain
records in this system are instructed not
to release data until the intended
recipient agrees to implement
appropriate management, operational
and technical safeguards sufficient to
protect the confidentiality, integrity and
availability of the information and
information systems and to prevent
unauthorized access.
This system will conform to all
applicable Federal laws and regulations
and Federal, HHS, and CMS policies
and standards as they relate to
information security and data privacy.
These laws and regulations include but
are not limited to: the Privacy Act of
1974; the Federal Information Security
Management Act of 2002; the Computer
Fraud and Abuse Act of 1986; the
Health Insurance Portability and
Accountability Act of 1996; the EGovernment Act of 2002, the ClingerCohen Act of 1996; the Medicare
Modernization Act of 2003, and the
corresponding implementing
regulations. OMB Circular A–130,
Management of Federal Resources,
Appendix III, Security of Federal
Automated Information Resources also
applies. Federal, HHS, and CMS
policies and standards include but are
not limited to: all pertinent National
Institute of Standards and Technology
publications; the HHS Information
Systems Program Handbook and the
CMS Information Security Handbook.
V. Effects of the New System on the
Rights of Individuals
CMS proposes to establish this system
in accordance with the principles and
requirements of the Privacy Act and will
collect, use, and disseminate
information only as prescribed therein.
We will only disclose the minimum
personal data necessary to achieve the
purpose of PMRS.
Disclosure of information from the
system will be approved only to the
extent necessary to accomplish the
purpose of the disclosure. CMS has
assigned a higher level of security
clearance for the information
maintained in this system in an effort to
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provide added security and protection
of data in this system.
CMS will take precautionary
measures to minimize the risks of
unauthorized access to the records and
the potential harm to individual privacy
or other personal or property rights.
CMS will collect only that information
necessary to perform the system’s
functions. In addition, CMS will make
disclosure from the proposed system
only with consent of the subject
individual, or his/her legal
representative, or in accordance with an
applicable exception provision of the
Privacy Act. CMS, therefore, does not
anticipate an unfavorable effect on
individual privacy as a result of the
disclosure of information relating to
individuals.
Dated: September 4, 2007.
Charlene Frizzera,
Chief Operating Officer, Centers for Medicare
& Medicaid Services.
SYSTEM No. 09–70–0584
SYSTEM NAME:
• ‘‘Performance Measurement and
Reporting System (PMRS),’’ HHS/CMS/
OCSQ
SECURITY CLASSIFICATION:
Level Three Privacy Act Sensitive
SYSTEM LOCATION:
CMS Data Center, 7500 Security
Boulevard, North Building, First Floor,
Baltimore, Maryland 21244–1850 and at
various contractor sites.
CATEGORIES OF INDIVIDUALS COVERED BY THE
SYSTEM:
The system contains single and multipayer, patient de-identified, individual
physician-level performance
measurement results as well as, clinical
and claims information provided by
individual physicians, practitioners and
providers of services, individuals
assigned to provider groups, insurance
and provider associations, government
agencies, accrediting and quality
organizations, and others who are
committed to improving the quality of
physician services.
jlentini on PROD1PC65 with NOTICES
CATEGORIES OF RECORDS IN THE SYSTEM:
This system contains the patient’s or
beneficiary’s name, sex, health
insurance claim number (HIC), Social
Security Number (SSN), address, date of
birth, medical record number(s), prior
stay information, provider name and
address, physician’s name, and/or
identification number, date of
admission or discharge, other health
insurance, diagnosis, surgical
procedures, and a statement of services
rendered for related charges and other
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data needed to substantiate claims. The
system contains provider
characteristics, prescriber identification
number(s), assigned provider number(s)
(facility, referring/servicing physician),
and national drug code information,
total charges, and Medicare payment
amounts.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
Authority for the collection,
maintenance, and disclosures from this
system is given under provisions of
§§ 1152, 1153 (c), 1153(e), 1154, 1160,
1851 (d) and 1862 (g) of the Social
Security Act; § 101 of the Tax Relief and
Health Care Act of 2006; and §§ 901,
912, and 914 of the Public Health
Service Act.
PURPOSE (S) OF THE SYSTEM:
The primary purpose of this system is
to support the collection, maintenance,
and processing of information
promoting the effective, efficient, and
economical delivery of health care
services, and promoting the quality of
services of the type for which payment
may be made under title XVIII by
allowing for the establishment and
implementation of performance
measures, and the provision of feedback
to physicians. Information in this
system will also be disclosed to: (1)
Support regulatory, reimbursement, and
policy functions performed for the
Agency or by a contractor, consultant, or
a CMS grantee; (2) assist another Federal
and/or state agency, agency of a state
government, or an agency established by
state law; (3) promote more informed
choices by Medicare beneficiaries
among their Medicare group options by
making physician performance
measurement information available to
Medicare beneficiaries through a Web
site and other forms of data
dissemination; (4) provide Charted
Value Exchanges (CVE) and data
aggregators with information that will
assist in generating single or multi-payer
performance measurement results to
promote transparency in health care to
members of their community; (5) assist
individual physicians, practitioners,
providers of services, suppliers,
laboratories, and other health care
professionals who are participating in
health care transparency projects; (6)
assist individuals or organizations with
projects that provide transparency in
health care on a broad-scale, enabling
consumers to compare the quality and
price of health care services; or for
research, evaluation, and
epidemiological projects related to the
prevention of disease or disability;
restoration or maintenance of health or
for payment purposes; (7) assist Quality
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Improvement Organizations; (8) support
litigation involving the agency; and (9)
combat fraud, waste, and abuse in
certain health benefits programs
ROUTINE USES OF RECORDS MAINTAINED IN THE
SYSTEM, INCLUDING CATEGORIES OF USERS AND
THE PURPOSES OF SUCH USES:
A. Entities Who May Receive
Disclosures Under Routine Use. These
routine uses specify circumstances, in
addition to those provided by statute in
the Privacy Act of 1974, under which
CMS may release information from the
PMRS without the consent/
authorization of the individual to whom
such information pertains. Each
proposed disclosure of information
under these routine uses will be
evaluated to ensure that the disclosure
is legally permissible, including but not
limited to ensuring that the purpose of
the disclosure is compatible with the
purpose for which the information was
collected. We propose to establish the
following routine use disclosures of
information maintained in the system:
1. To support Agency contractors,
consultants, or CMS grantees who have
been engaged by the Agency to assist in
accomplishment of a CMS function
relating to the purposes for this SOR
and who need to have access to the
records in order to assist CMS.
2. Pursuant to agreements with CMS
to assist another Federal or state agency,
agency of a state government, or an
agency established by state law to:
a. Contribute to projects that provide
transparency in health care on a broadscale enabling consumers to compare
the quality and price of health care
services,
b. Contribute to the accuracy of CMS’s
proper payment of Medicare benefits,
c. Enable such agency to administer a
Federal health benefits program, or as
necessary to enable such agency to
fulfill a requirement of a Federal statute
or regulation that implements a health
benefits program funded in whole or in
part with Federal funds, and/or
d. Assist Federal/state Medicaid
programs which may require PMRS
information for purposes related to this
system.
3. To assist in making the individual
physician-level performance
measurement results available to
Medicare beneficiaries, through a Web
site and other forms of data
dissemination, in order to promote more
informed choices by Medicare
beneficiaries among their Medicare
coverage options.
4. To provide Chartered Value
Exchanges (CVE) and data aggregators
with information that will assist in
generating single or multi-payer
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performance measurement results that
will assist beneficiaries in making
informed choices among individual
physicians, practitioners and providers
of services; enable consumers to
compare the quality and price of health
care services; and assist in providing
transparency in health care at the local
level if CMS:
a. Determines that the use or
disclosure does not violate legal
limitations under which the record was
provided, collected, or obtained;
b. Determines that the purpose for
which the disclosure is to be made:
(1) Is of sufficient importance to
warrant the effect on and/or risk to the
privacy of the individual that additional
exposure of the record might bring, and
(2) There is reasonable probability
that the objective for the use would be
accomplished;
c. Requires the recipient of the
information to establish reasonable
administrative, technical, and physical
safeguards to prevent unauthorized use
or disclosure of the record,
d. Make no further use or disclosure
of the record except:
(1) For use in another project
providing transparency in health care,
under these same conditions, and with
written authorization of CMS;
(2) When required by law.
e. Secures a written statement
attesting to the information recipient’s
understanding of and willingness to
abide by these provisions. CVEs and
data aggregators should complete a Data
Use Agreement (CMS Form 0235) in
accordance with current CMS policies.
5. To assist individual physicians,
practitioners, providers of services,
suppliers, laboratories, and other health
care professionals who are participating
in health care transparency projects.
6. To assist an individual or
organization with projects that provide
transparency in health care on a broad
scale, enabling consumers to compare
the quality and price of health care
services; or for research, evaluation, and
epidemiological projects related to the
prevention of disease or disability;
restoration or maintenance of health or
for payment purposes if CMS:
a. Determines that the use or
disclosure does not violate legal
limitations under which the record was
provided, collected, or obtained;
b. Determines that the purpose for
which the disclosure is to be made:
(1) Cannot be reasonably
accomplished unless the record is
provided in individually identifiable
form,
(2) Is of sufficient importance to
warrant the effect and/or risk on the
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18:43 Sep 11, 2007
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privacy of the individual that additional
exposure of the record might bring, and
(3) There is reasonable probability
that the objective for the use would be
accomplished;
c. Requires the recipient of the
information to:
(1) Establish reasonable
administrative, technical, and physical
safeguards to prevent unauthorized use
or disclosure of the record, and
(2) Remove or destroy the information
that allows the individual to be
identified at the earliest time at which
removal or destruction can be
accomplished consistent with the
purpose of the project, unless the
recipient presents an adequate
justification of a research or health
nature for retaining such information,
and
(3) Make no further use or disclosure
of the record except:
(a) For disclosure to a properly
identified person, for purposes of
providing transparency in health care
enabling consumers to compare the
quality and price of health care services
so that they can make informed choices
among individual physicians,
practitioners and providers of services;
(b) In emergency circumstances
affecting the health or safety of any
individual;
(c) For use in another research project,
under these same conditions, and with
written authorization of CMS;
(d) For disclosure to a properly
identified person for the purpose of an
audit related to the research project, if
information that would enable research
subjects to be identified is removed or
destroyed at the earliest opportunity
consistent with the purpose of the audit;
or
(e) When required by law.
d. Secures a written statement
attesting to the information recipient’s
understanding of and willingness to
abide by these provisions. Researchers
should complete a Data Use Agreement
(CMS Form 0235) in accordance with
current CMS policies.
7. To support Quality Improvement
Organizations (QIO) in connection with
review of claims, or in connection with
studies or other review activities
conducted pursuant to Part B of Title XI
of the Act and in performing affirmative
outreach activities to individuals for the
purpose of establishing and maintaining
their entitlement to Medicare benefits or
health insurance plans.
8. To support the Department of
Justice (DOJ), court, or adjudicatory
body when:
a. The Agency or any component
thereof, or
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52139
b. Any employee of the Agency in his
or her official capacity, or
c. Any employee of the Agency in his
or her individual capacity where the
DOJ has agreed to represent the
employee, or
d. The United States Government,
is a party to litigation or has an
interest in such litigation, and by careful
review, CMS determines that the
records are both relevant and necessary
to the litigation and that the use of such
records by the DOJ, court or
adjudicatory body is compatible with
the purpose for which the agency
collected the records.
9. To assist a CMS contractor
(including, but not limited to MACs,
fiscal intermediaries and carriers) that
assists in the administration of a CMSadministered health benefits program,
or to a grantee of a CMS-administered
grant program, when disclosure is
deemed reasonably necessary by CMS to
prevent, deter, discover, detect,
investigate, examine, prosecute, sue
with respect to, defend against, correct,
remedy, or otherwise combat fraud,
waste or abuse in such program.
10. To assist another Federal agency
or an instrumentality of any
governmental jurisdiction within or
under the control of the United States
(including any state or local
governmental agency), that administers,
or that has the authority to investigate
potential fraud, waste or abuse in a
health benefits program funded in
whole or in part by Federal funds, when
disclosure is deemed reasonably
necessary by CMS to prevent, deter,
discover, detect, investigate, examine,
prosecute, sue with respect to, defend
against, correct, remedy, or otherwise
combat fraud, waste or abuse in such
programs.
B. Additional Circumstances
Affecting Routine Use Disclosures. To
the extent this system contains
Protected Health Information (PHI) as
defined by HHS regulation ‘‘Standards
for Privacy of Individually Identifiable
Health Information’’ (45 CFR Parts 160
and 164, Subparts A and E) 65 Fed. Reg.
82462 (12–28–00). Disclosures of such
PHI that are otherwise authorized by
these routine uses may only be made if,
and as, permitted or required by the
‘‘Standards for Privacy of Individually
Identifiable Health Information.’’ (See
45 CFR 164–512(a)(1)).
POLICIES AND PRACTICES FOR STORING,
RETRIEVING, ACCESSING, RETAINING, AND
DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
Records are stored on both tape
cartridges (magnetic storage media) and
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in a DB2 relational database
management environment (DASD data
storage media).
RETRIEVABILITY:
Information is most frequently
retrieved by HICN, provider number
(facility, physician, IDs), service dates,
and beneficiary state code.
SAFEGUARDS:
CMS has safeguards in place for
authorized users and monitors such
users to ensure against unauthorized
use. Personnel having access to the
system have been trained in the Privacy
Act and information security
requirements. Employees who maintain
records in this system are instructed not
to release data until the intended
recipient agrees to implement
appropriate management, operational
and technical safeguards sufficient to
protect the confidentiality, integrity and
availability of the information and
information systems and to prevent
unauthorized access.
This system will conform to all
applicable Federal laws and regulations
and Federal, HHS, and CMS policies
and standards as they relate to
information security and data privacy.
These laws and regulations include but
are not limited to: the Privacy Act of
1974; the Federal Information Security
Management Act of 2002; the Computer
Fraud and Abuse Act of 1986; the
Health Insurance Portability and
Accountability Act of 1996; the EGovernment Act of 2002, the ClingerCohen Act of 1996; the Medicare
Modernization Act of 2003, and the
corresponding implementing
regulations. OMB Circular A–130,
Management of Federal Resources,
Appendix III, Security of Federal
Automated Information Resources also
applies. Federal, HHS, and CMS
policies and standards include but are
not limited to: all pertinent National
Institute of Standards and Technology
publications; the HHS Information
Systems Program Handbook and the
CMS Information Security Handbook.
jlentini on PROD1PC65 with NOTICES
RETENTION AND DISPOSAL:
Records are maintained with
identifiers for all transactions after they
are entered into the system for a period
of 20 years. Records are housed in both
active and archival files. All claimsrelated records are encompassed by the
document preservation order and will
be retained until notification is received
from the Department of Justice.
SYSTEM MANAGER AND ADDRESS:
Director, Quality Measurement and
Health Assessment Group, Office of
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Clinical Standards and Quality, CMS,
Room C1–23–14, 7500 Security
Boulevard, Baltimore, Maryland 21244–
1850.
NOTIFICATION PROCEDURE:
For purpose of notification, the
subject individual should write to the
system manager who will require the
system name, and the retrieval selection
criteria (e.g., HICN, Provider number,
etc.).
RECORD ACCESS PROCEDURE:
For purpose of access, use the same
procedures outlined in Notification
Procedures above. Requestors should
also reasonably specify the record
contents being sought. (These
procedures are in accordance with
Department regulation 45 CFR
5b.5(a)(2)).
CONTESTING RECORD PROCEDURES:
The subject individual should contact
the system manager named above, and
reasonably identify the record and
specify the information to be contested.
State the corrective action sought and
the reasons for the correction with
supporting justification. (These
procedures are in accordance with
Department regulation 45 CFR 5b.7).
RECORD SOURCE CATEGORIES:
Medicare Beneficiary Database (09–
70–0536), National Claims History File
(09–70–0558), and private physicians,
private providers, laboratories, other
providers and suppliers who are
participating in health care transparency
projects sponsored by the Agency.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS
OF THE ACT:
None.
[FR Doc. E7–17907 Filed 9–11–07; 8:45 am]
BILLING CODE 4120–03–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0230]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Information From
United States Processors That Export
to the European Community
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
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information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by October 12,
2007.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974, or e-mailed to
baguilar@omb.eop.gov. All comments
should be identified with the OMB
control number 0910–0320. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Information From U.S. Processors That
Export to the European Community—
(OMB Control Number 0910–0320)—
Extension
The European Community (EC) is a
group of 27 European countries that
have agreed to harmonize their
commodity requirements to facilitate
commerce among member states. EC
legislation for intra-EC trade has been
extended to trade with non-EC
countries, including the United States.
For certain food products, including
those listed in this document, EC
legislation requires assurances from the
responsible authority of the country of
origin that the processor of the food is
in compliance with applicable
regulatory requirements.
FDA requests information from
processors that export certain animalderived products (e.g., shell eggs, dairy
products, game meat, game meat
products, animal casings, and gelatin) to
the EC. FDA uses the information to
maintain lists of processors that have
demonstrated current compliance with
U.S. requirements and provides the lists
to the EC quarterly. Inclusion on the list
is voluntary. EC member countries refer
to the lists at ports of entry to verify that
products offered for importation to the
EC from the United States are from
processors that meet U.S. regulatory
requirements. Products processed by
firms not on the lists are subject to
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Agencies
[Federal Register Volume 72, Number 176 (Wednesday, September 12, 2007)]
[Notices]
[Pages 52133-52140]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-17907]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Privacy Act of 1974; Report of New System of Records
AGENCY: Department of Health and Human Services (HHS), Centers for
Medicare & Medicaid Services (CMS).
ACTION: Notice of a New System of Records.
-----------------------------------------------------------------------
SUMMARY: In accordance with the requirements of the Privacy Act of
1974, CMS is proposing to establish a new system of records (SOR)
titled, ``Performance Measurement and Reporting System (PMRS),'' System
No. 09-70-0584. PMRS will serve as a master system of records to assist
in projects that provide transparency in health care on a broad-scale
enabling consumers to compare the quality and price of health care
services so that they can make informed choices among individual
physicians, practitioners and providers of services. In cooperation
with local or regional public-private collaborative stakeholders;
individuals assigned to provider groups; insurance and provider
associations; government agencies; employers; accrediting and quality
organizations; Chartered Value Exchanges (CVE), data aggregators, and
other community leaders who are committed to improving the quality of
services, CMS is laying the foundation for pooling and analyzing
information about the quality of medical services and performance
provided by physicians and health care providers. PMRS will further
assist in developing existing strategies to improve health care quality
including transparency of cost and/or price information, quality and
utilization information; and patient safety for Medicare beneficiaries
by collecting and aggregating data, by measuring performance at the
individual physician level, and by reporting meaningful information to
Medicare beneficiaries in order to make informed choices and improve
outcomes.
Pursuant to the ``routine use'' promulgated under this system of
records notice, CMS or a non-Quality Improvement Organization (non-QIO)
[[Page 52134]]
contractor would make the individual physician-level performance
measurement results available to Medicare beneficiaries by posting it
on a public Web site and by various other methods of data
dissemination. If local Web sites are used by a local or regional
collaborative, CMS would have links to these Web sites on its main Web
site. This information would be made available for the purpose of, and
in a manner that would promote more informed choices by Medicare
beneficiaries among their Medicare coverage options (i.e., the Medicare
Advantage, local or regional plans offered in their area, and original
fee-for-service Medicare). The routine uses established with this
system contain a proper explanation as to the need for the disclosure
provisions and provide clarity to CMS's intention to disclose
individual-specific information contained in this system.
The primary purpose of this system is to support the collection,
maintenance, and processing of information promoting the effective,
efficient, and economical delivery of health care services, and
promoting the quality of services of the type for which payment may be
made under title XVIII by allowing for the establishment and
implementation of performance measures, and the provision of feedback
to physicians. Information in this system will also be disclosed to:
(1) Support regulatory, reimbursement, and policy functions performed
for the Agency or by a contractor, consultant, or a CMS grantee; (2)
assist another Federal and/or state agency, agency of a state
government, or an agency established by state law; (3) promote more
informed choices by Medicare beneficiaries among their Medicare group
options by making physician performance measurement information
available to Medicare beneficiaries through a Web site and other forms
of data dissemination; (4) provide CVEs and data aggregators with
information that will assist in generating single or multi-payer
performance measurement results to promote transparency in health care
to members of their community; (5) assist individual physicians,
practitioners, providers of services, suppliers, laboratories, and
others health care professionals who are participating in health care
transparency projects; (6) assist individuals or organizations with
projects that provide transparency in health care on a broad-scale
enabling consumers to compare the quality and price of health care
services; or for research, evaluation, and epidemiological projects
related to the prevention of disease or disability; restoration or
maintenance of health or for payment purposes; (7) assist Quality
Improvement Organizations; (8) support litigation involving the agency;
and (9) combat fraud, waste, and abuse in certain health benefits
programs. We have provided background information about this new system
in the ``Supplementary Information'' section below. Although the
Privacy Act requires only that CMS provide an opportunity for
interested persons to comment on the proposed routine uses, CMS invites
comments on all portions of this notice. See ``Effective Dates''
section for comment period.
EFFECTIVE DATES: CMS filed a new system report with the Chair of the
House Committee on Government Reform and Oversight, the Chair of the
Senate Committee on Homeland Security & Governmental Affairs, and the
Administrator, Office of Information and Regulatory Affairs, Office of
Management and Budget (OMB) on 9/05/2007. To ensure that all parties
have adequate time in which to comment, the new system, including
routine uses, will become effective 30 days from the publication of the
notice, or 40 days from the date it was submitted to OMB and Congress,
whichever is later, unless CMS receives comments that require
alterations to this notice.
ADDRESSES: The public should address comments to: CMS Privacy Officer,
Division of Privacy Compliance, Enterprise Architecture and Strategy
Group, Office of Information Services, CMS, Room N2-04-27, 7500
Security Boulevard, Baltimore, Maryland 21244-1850. Comments received
will be available for review at this location, by appointment, during
regular business hours, Monday through Friday from 9 a.m. to 3 p.m.,
eastern time zone.
FOR FURTHER INFORMATION CONTACT: Aucha Prachanronarong, Health
Insurance Specialist, Division of Ambulatory Care and Measure
Management, Quality Measurement and Health Assessment Group, Office of
Clinical Standards and Quality, CMS, Room C1-23-14, 7500 Security
Boulevard, Baltimore, Maryland 21244-1850. The telephone number is
(410) 786-1879 or contact Aucha.Prachanronarong@cms.hhs.gov.
SUPPLEMENTARY INFORMATION: The Value-driven Health Care Initiative is
designed to achieve four cornerstones: Interoperable health information
technology (HIT); transparency of price information; transparency of
quality information; and the use of incentives to promote high-quality
and cost-efficient health care. Regional/local public-private
collaboration is essential to the success of this Initiative. As such,
the Initiative is encouraging the growth of regional public-private
collaboratives that will be chartered by the Agency for Health Research
and Quality (AHRQ) to support and achieve the four cornerstones. Only
mature, sustainable, multi-stakeholder entities that are committed to
achieving the four cornerstones, including publicly reporting
physician-level and other provider performance measurement information
and facilitating the use of this information to improve the quality and
efficiency of health care delivery, will become Chartered Value
Exchanges (CVE).
Provided they meet certain criteria established by CMS and
disclosure is consistent with the Privacy Act, the Health Insurance
Portability and Accountability Act (HIPAA) Privacy Rule and other
applicable laws, CMS will provide CVEs with patient de-identified
Medicare-inclusive individual physician-level performance measurement
results. CMS also may provide physician and patient identifiable
protected health claims data information to data aggregators that are
HIPAA business associates of CMS (including working with providers,
payers, or other HIPAA covered entities) for purposes for generating
these results. The patient de-identified results will be calculated
using Medicare claims data based on consensus-based measures as
determined by CMS, including but not limited to quality, efficiency and
utilization metrics. Available results may include single payer (i.e.,
Medicare only and private payer only performance measurement results)
and/or multi-payer (i.e., results generated from merging or aggregating
Medicare results with other private payer results) patient de-
identified, individual physician-level performance measurement results.
CMS also plans to make the patient de-identified and individual
physician-level performance measurement results available to Medicare
beneficiaries, and others that meet CMS requirements for disclosure.
CMS also has implemented a pilot project known as, ``The Better
Quality Information to Improve Care for Medicare Beneficiaries (BQI)
Project'' to develop a model for data aggregation, quality measurement,
and public reporting. Through the BQI project, each pilot
collaborative, as a QIO subcontractor, is aggregating private claims
data with Medicare claims data and, in some cases, Medicaid claims data
to produce single payer and/or multi-payer, patient de-identified,
individual physician-level performance
[[Page 52135]]
measurement results using quality measures that are approved by CMS.
These performance measurement results will be made available to
Medicare beneficiaries by CMS or a CMS contractor.
In addition, as required by the Tax Relief and Health Care Act of
2006, CMS is implementing a voluntary Physician Quality Reporting
Initiative (PQRI). Under PQRI, eligible professionals who choose to
participate and successfully report on a designated set of quality
measures for services paid under the Medicare Physician Fee Schedule
and provided to Medicare beneficiaries under the traditional fee-for-
service program, may earn a bonus payment subject to a cap.
Participating eligible professionals whose Medicare patients in the
traditional fee-for-service program fit the specifications of the PQRI
quality measures will report the corresponding appropriate Common
Procedural Terminology (CPT) Category II codes or G-codes on their
claims. In the future, CMS may publicly release the performance
information that is reported by physicians pursuant to PQRI.
I. Description of the Proposed System of Records
A. Statutory and Regulatory Basis for System
Authority for the collection, maintenance, and disclosures from
this system is given under provisions of Sec. Sec. 1152, 1153(c),
1153(e), 1154, 1160, 1851(d) and 1862(g) of the Social Security Act;
Sec. 101 of the Tax Relief and Health Care Act of 2006; and Sec. Sec.
901, 912, and 914 of the Public Health Service Act.
B. Collection and Maintenance of Data in the System
The system contains single and multi-payer, patient de-identified,
individual physician-level performance measurement results as well as,
patient identifiable clinical and claims information provided by
individual physicians, practitioners and providers of services,
individuals assigned to provider groups, insurance and provider
associations, government agencies, accrediting and quality
organizations, and others who are committed to improving the quality of
physician services. This system contains the patient's or beneficiary's
name, sex, health insurance claim number (HIC), Social Security Number
(SSN), address, date of birth, medical record number(s), prior stay
information, provider name and address, physician's name, and/or
identification number, date of admission or discharge, other health
insurance, diagnosis, surgical procedures, and a statement of services
rendered for related charges and other data needed to substantiate
claims. The system contains provider characteristics, prescriber
identification number(s), assigned provider number(s) (facility,
referring/servicing physician), and national drug code information,
total charges, and Medicare payment amounts.
II. Agency Policies, Procedures, and Restrictions on Routine Uses
A. The Privacy Act permits us to disclose information without an
individual's consent/authorization if the information is to be used for
a purpose that is compatible with the purpose(s) for which the
information was collected. Any such disclosure of data is known as a
``routine use.'' The government will only release PMRS information that
can be associated with an individual as provided for under ``Section
III. Proposed Routine Use Disclosures of Data in the System.'' Both
identifiable and non-identifiable data may be disclosed under a routine
use.
We will only disclose the minimum individually identifiable data
necessary to achieve the purpose of PMRS. CMS has the following
policies and procedures concerning disclosures of information that will
be maintained in the system. In general, disclosure of information from
the system will be approved only for the minimum information necessary
to accomplish the purpose of the disclosure and only after CMS:
1. Determines that the use or disclosure is consistent with the
reason that the data is being collected, e.g., to collect, maintain,
and process information promoting the effective, efficient, and
economical delivery of health care services, and promoting the quality
of services of the type for which payment may be made under title
XVIII;
2. Determines that:
a. The purpose for which the disclosure is to be made can only be
accomplished if the record is provided in individually identifiable
form;
b. The purpose for which the disclosure is to be made is of
sufficient importance to warrant the effect and/or risk on the privacy
of the individual that additional exposure of the record might bring;
and
c. There is a reasonable probability that the proposed use of the
data would in fact accomplish the stated purpose(s) of the disclosure.
3. Requires the information recipient to:
a. Establish reasonable administrative, technical, and physical
safeguards to prevent unauthorized use of disclosure of the record(s);
b. Remove or destroy the information that allows the individual to
be identified at the earliest time; and
c. Generally agree to not use or disclose the information for any
purpose other than the stated purpose under which the information was
disclosed.
4. Determines that the data are valid and reliable.
III. Proposed Routine Use Disclosures of Data in the System
A. Entities Who May Receive Disclosures Under Routine Use
These routine uses specify circumstances, in addition to those
provided by statute in the Privacy Act of 1974, under which CMS may
release information from the PMRS without the consent/authorization of
the individual to whom such information pertains. Each proposed
disclosure of information under these routine uses will be evaluated to
ensure that the disclosure is legally permissible, including but not
limited to ensuring that the purpose of the disclosure is compatible
with the purpose for which the information was collected. We propose to
establish the following routine use disclosures of information
maintained in the system:
1. To support Agency contractors, consultants, or CMS grantees who
have been engaged by the Agency to assist in accomplishment of a CMS
function relating to the purposes for this SOR and who need to have
access to the records in order to assist CMS.
We contemplate disclosing information under this routine use only
in situations in which CMS may enter into a contractual or similar
agreement with a third party to assist in accomplishing a CMS function
relating to purposes for this SOR.
CMS occasionally contracts out certain of its functions when doing
so would contribute to effective and efficient operations. CMS must be
able to give a contractor, consultant, or CMS grantee whatever
information is necessary for the contractor or consultant to fulfill
its duties. In these situations, safeguards are provided in the
contract/similar agreement prohibiting the contractor, consultant, or
grantee from using or disclosing the information for any purpose other
than that described in the contract/similar agreement and requires the
contractor, consultant, or grantee to return or destroy all information
at the completion of the contract.
2. Pursuant to agreements with CMS to assist another Federal or
state agency,
[[Page 52136]]
agency of a state government, or an agency established by state law to:
a. Contribute to projects that provide transparency in health care
on a broad-scale enabling consumers to compare the quality and price of
health care services,
b. Contribute to the accuracy of CMS's proper payment of Medicare
benefits,
c. Enable such agency to administer a Federal health benefits
program, or as necessary to enable such agency to fulfill a requirement
of a Federal statute or regulation that implements a health benefits
program funded in whole or in part with Federal funds, and/or
d. Assist Federal/state Medicaid programs which may require PMRS
information for purposes related to this system.
Other Federal or state agencies in their administration of a
Federal health program may require PMRS information in order to support
evaluations and monitoring of Medicare claims information of
beneficiaries, including proper reimbursement for services provided.
3. To assist in making the individual physician-level performance
measurement results available to Medicare beneficiaries, through a Web
site and other forms of data dissemination, in order to promote more
informed choices by Medicare beneficiaries among their Medicare
coverage options.
This information would be made available to Medicare beneficiaries
for the purpose of, and in a manner that would promote more informed
choices by Medicare beneficiaries among their Medicare coverage options
(i.e., the Medicare Advantage local or Regional plans offered in their
area, and original fee-for-service Medicare).
4. To provide Chartered Value Exchanges (CVE) and data aggregators
with information that will assist in generating single or multi-payer
performance measurement results that will assist beneficiaries in
making informed choices among individual physicians, practitioners and
providers of services; enable consumers to compare the quality and
price of health care services; and assist in providing transparency in
health care at the local level if CMS:
a. Determines that the use or disclosure does not violate legal
limitations under which the record was provided, collected, or
obtained;
b. Determines that the purpose for which the disclosure is to be
made:
(1) Is of sufficient importance to warrant the effect and/or risk
on the privacy of the individual that additional exposure of the record
might bring, and
(2) There is reasonable probability that the objective for the use
would be accomplished;
c. Requires the recipient of the information to establish
reasonable administrative, technical, and physical safeguards to
prevent unauthorized use or disclosure of the record;
d. Make no further use or disclosure of the record except:
(1) For use in another project providing transparency in health
care, under these same conditions, and with written authorization of
CMS; and
(2) When required by law.
e. Secures a written statement attesting to the information
recipient's understanding of and willingness to abide by these
provisions. CVEs and data aggregators should complete a Data Use
Agreement (CMS Form 0235) in accordance with current CMS policies.
The disclosure of PMRS information to CVEs or data aggregators will
support the generation of single or multi-payer performance measurement
results that will provide a more comprehensive view of physician
performance for Medicare beneficiaries. Both identifiable physician
level information and patient de-identified information may be made
available to CVEs to enable them to provide transparency in health care
on a local level. Identifiable physician and patient level information
may be provided to data aggregators that are HIPAA business associates
of CMS to conduct CMS' health care operations (including working with
other providers, payers, or other HIPAA covered entities to generate
single and multi-payer performance information).
5. To assist individual physicians, practitioners, providers of
services, suppliers, laboratories, and other health care professionals
who are participating in health care transparency projects.
PMRS data will be released to the individual physician only on
those individuals who received services ordered or provided by the
individual physician and shall be limited to claims and utilization
data necessary to perform that specific project function whose
information was provided for the PMRS project. Individual physicians,
practitioners, providers of services, suppliers, laboratories, and
other health care professionals require PMRS information for the
purpose of direct feedback with respect to their individual patients on
a non-aggregated basis.
PMRS information is needed in order to support evaluations,
establish the validity of evidence, or to verify the accuracy of
information presented by the individual physician as it concerns the
patient's entitlement to benefits and for services provided.
6. To assist an individual or organization with projects that
provide transparency in health care on a broad-scale enabling consumers
to compare the quality and price of health care services; or for
research, evaluation, and epidemiological projects related to the
prevention of disease or disability; restoration or maintenance of
health or for payment purposes if CMS:
a. Determines that the use or disclosure does not violate legal
limitations under which the record was provided, collected, or
obtained;
b. Determines that the purpose for which the disclosure is to be
made:
(1) Cannot be reasonably accomplished unless the record is provided
in individually identifiable form,
(2) Is of sufficient importance to warrant the effect and/or risk
on the privacy of the individual that additional exposure of the record
might bring, and
(3) There is reasonable probability that the objective for the use
would be accomplished;
c. Requires the recipient of the information to:
(1) Establish reasonable administrative, technical, and physical
safeguards to prevent unauthorized use or disclosure of the record, and
(2) Remove or destroy the information that allows the individual to
be identified at the earliest time at which removal or destruction can
be accomplished consistent with the purpose of the project, unless the
recipient presents an adequate justification of a research or health
nature for retaining such information, and
(3) Make no further use or disclosure of the record except:
(a) For disclosure to a properly identified person, for purposes of
providing transparency in health care enabling consumers to compare the
quality and price of health care services so that they can make
informed choices among individual physicians, practitioners and
providers of services;
(b) In emergency circumstances affecting the health or safety of
any individual;
(c) For use in another research project, under these same
conditions, and with written authorization of CMS;
(d) For disclosure to a properly identified person for the purpose
of an audit related to the research project, if information that would
enable research subjects to be identified is removed or destroyed at
the earliest opportunity consistent with the purpose of the audit; or
[[Page 52137]]
(e) When required by law.
d. Secures a written statement attesting to the information
recipient's understanding of and willingness to abide by these
provisions. Researchers should complete a Data Use Agreement (CMS Form
0235) in accordance with current CMS policies.
PMRS data will provide data for projects that provide transparency
in health care on a broad-scale enabling consumers to compare the
quality and price of health care services; and research evaluation; and
epidemiological projects with a broader, longitudinal, national
perspective of the status of health care provided to Medicare
beneficiaries. CMS anticipates that many researchers will have
legitimate requests to use these data in projects that could ultimately
improve the care provided to Medicare beneficiaries and the policy that
governs the care.
7. To support Quality Improvement Organizations (QIO) in connection
with review of claims, or in connection with studies or other review
activities conducted pursuant to Part B of Title XI of the Act and in
performing affirmative outreach activities to individuals for the
purpose of establishing and maintaining their entitlement to Medicare
benefits or health insurance plans.
QIOs will work to implement quality improvement programs, provide
consultation to CMS, its contractors, and to state agencies. QIOs will
assist the state agencies in related monitoring and enforcement
efforts, assist CMS and intermediaries in program integrity assessment,
and prepare summary information for release to CMS.
8. To support the Department of Justice (DOJ), court, or
adjudicatory body when:
a. The Agency or any component thereof, or
b. Any employee of the Agency in his or her official capacity, or
c. Any employee of the Agency in his or her individual capacity
where the DOJ has agreed to represent the employee, or
d. The United States Government,
is a party to litigation or has an interest in such litigation, and by
careful review, CMS determines that the records are both relevant and
necessary to the litigation and that the use of such records by the
DOJ, court or adjudicatory body is compatible with the purpose for
which the agency collected the records.
Whenever CMS is involved in litigation, or occasionally when
another party is involved in litigation and CMS's policies or
operations could be affected by the outcome of the litigation, CMS
would be able to disclose information to the DOJ, court, or
adjudicatory body involved.
9. To assist a CMS contractor (including, but not limited to MACs,
fiscal intermediaries and carriers) that assists in the administration
of a CMS-administered health benefits program, or to a grantee of a
CMS-administered grant program, when disclosure is deemed reasonably
necessary by CMS to prevent, deter, discover, detect, investigate,
examine, prosecute, sue with respect to, defend against, correct,
remedy, or otherwise combat fraud, waste or abuse in such program.
We contemplate disclosing information under this routine use only
in situations in which CMS may enter into a contract or grant with a
third party to assist in accomplishing CMS functions relating to the
purpose of combating fraud, waste or abuse.
CMS occasionally contracts out certain of its functions when doing
so would contribute to effective and efficient operations. CMS must be
able to give a contractor or grantee whatever information is necessary
for the contractor or grantee to fulfill its duties. In these
situations, safeguards are provided in the contract prohibiting the
contractor or grantee from using or disclosing the information for any
purpose other than that described in the contract and requiring the
contractor or grantee to return or destroy all information.
10. To assist another Federal agency or to an instrumentality of
any governmental jurisdiction within or under the control of the United
States (including any state or local governmental agency), that
administers, or that has the authority to investigate potential fraud,
waste or abuse in a health benefits program funded in whole or in part
by Federal funds, when disclosure is deemed reasonably necessary by CMS
to prevent, deter, discover, detect, investigate, examine, prosecute,
sue with respect to, defend against, correct, remedy, or otherwise
combat fraud, waste or abuse in such programs.
Other agencies may require PMRS information for the purpose of
combating fraud, waste or abuse in such Federally-funded programs.
B. Additional Circumstances Affecting Routine Use Disclosures
To the extent this system contains Protected Health Information
(PHI) as defined by HHS regulation ``Standards for Privacy of
Individually Identifiable Health Information'' (45 CFR Parts 160 and
164, Subparts A and E) 65 Fed. Reg. 82462 (12-28-00). Disclosures of
such PHI that are otherwise authorized by these routine uses may only
be made if, and as, permitted or required by the ``Standards for
Privacy of Individually Identifiable Health Information.'' (See 45 CFR
164-512 (a) (1)).
IV. Safeguards
CMS has safeguards in place for authorized users and monitors such
users to ensure against unauthorized use. Personnel having access to
the system have been trained in the Privacy Act and information
security requirements. Employees who maintain records in this system
are instructed not to release data until the intended recipient agrees
to implement appropriate management, operational and technical
safeguards sufficient to protect the confidentiality, integrity and
availability of the information and information systems and to prevent
unauthorized access.
This system will conform to all applicable Federal laws and
regulations and Federal, HHS, and CMS policies and standards as they
relate to information security and data privacy. These laws and
regulations include but are not limited to: the Privacy Act of 1974;
the Federal Information Security Management Act of 2002; the Computer
Fraud and Abuse Act of 1986; the Health Insurance Portability and
Accountability Act of 1996; the E-Government Act of 2002, the Clinger-
Cohen Act of 1996; the Medicare Modernization Act of 2003, and the
corresponding implementing regulations. OMB Circular A-130, Management
of Federal Resources, Appendix III, Security of Federal Automated
Information Resources also applies. Federal, HHS, and CMS policies and
standards include but are not limited to: all pertinent National
Institute of Standards and Technology publications; the HHS Information
Systems Program Handbook and the CMS Information Security Handbook.
V. Effects of the New System on the Rights of Individuals
CMS proposes to establish this system in accordance with the
principles and requirements of the Privacy Act and will collect, use,
and disseminate information only as prescribed therein. We will only
disclose the minimum personal data necessary to achieve the purpose of
PMRS.
Disclosure of information from the system will be approved only to
the extent necessary to accomplish the purpose of the disclosure. CMS
has assigned a higher level of security clearance for the information
maintained in this system in an effort to
[[Page 52138]]
provide added security and protection of data in this system.
CMS will take precautionary measures to minimize the risks of
unauthorized access to the records and the potential harm to individual
privacy or other personal or property rights. CMS will collect only
that information necessary to perform the system's functions. In
addition, CMS will make disclosure from the proposed system only with
consent of the subject individual, or his/her legal representative, or
in accordance with an applicable exception provision of the Privacy
Act. CMS, therefore, does not anticipate an unfavorable effect on
individual privacy as a result of the disclosure of information
relating to individuals.
Dated: September 4, 2007.
Charlene Frizzera,
Chief Operating Officer, Centers for Medicare & Medicaid Services.
SYSTEM No. 09-70-0584
SYSTEM NAME:
``Performance Measurement and Reporting System (PMRS),''
HHS/CMS/OCSQ
SECURITY CLASSIFICATION:
Level Three Privacy Act Sensitive
SYSTEM LOCATION:
CMS Data Center, 7500 Security Boulevard, North Building, First
Floor, Baltimore, Maryland 21244-1850 and at various contractor sites.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
The system contains single and multi-payer, patient de-identified,
individual physician-level performance measurement results as well as,
clinical and claims information provided by individual physicians,
practitioners and providers of services, individuals assigned to
provider groups, insurance and provider associations, government
agencies, accrediting and quality organizations, and others who are
committed to improving the quality of physician services.
CATEGORIES OF RECORDS IN THE SYSTEM:
This system contains the patient's or beneficiary's name, sex,
health insurance claim number (HIC), Social Security Number (SSN),
address, date of birth, medical record number(s), prior stay
information, provider name and address, physician's name, and/or
identification number, date of admission or discharge, other health
insurance, diagnosis, surgical procedures, and a statement of services
rendered for related charges and other data needed to substantiate
claims. The system contains provider characteristics, prescriber
identification number(s), assigned provider number(s) (facility,
referring/servicing physician), and national drug code information,
total charges, and Medicare payment amounts.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
Authority for the collection, maintenance, and disclosures from
this system is given under provisions of Sec. Sec. 1152, 1153 (c),
1153(e), 1154, 1160, 1851 (d) and 1862 (g) of the Social Security Act;
Sec. 101 of the Tax Relief and Health Care Act of 2006; and Sec. Sec.
901, 912, and 914 of the Public Health Service Act.
PURPOSE (S) OF THE SYSTEM:
The primary purpose of this system is to support the collection,
maintenance, and processing of information promoting the effective,
efficient, and economical delivery of health care services, and
promoting the quality of services of the type for which payment may be
made under title XVIII by allowing for the establishment and
implementation of performance measures, and the provision of feedback
to physicians. Information in this system will also be disclosed to:
(1) Support regulatory, reimbursement, and policy functions performed
for the Agency or by a contractor, consultant, or a CMS grantee; (2)
assist another Federal and/or state agency, agency of a state
government, or an agency established by state law; (3) promote more
informed choices by Medicare beneficiaries among their Medicare group
options by making physician performance measurement information
available to Medicare beneficiaries through a Web site and other forms
of data dissemination; (4) provide Charted Value Exchanges (CVE) and
data aggregators with information that will assist in generating single
or multi-payer performance measurement results to promote transparency
in health care to members of their community; (5) assist individual
physicians, practitioners, providers of services, suppliers,
laboratories, and other health care professionals who are participating
in health care transparency projects; (6) assist individuals or
organizations with projects that provide transparency in health care on
a broad-scale, enabling consumers to compare the quality and price of
health care services; or for research, evaluation, and epidemiological
projects related to the prevention of disease or disability;
restoration or maintenance of health or for payment purposes; (7)
assist Quality Improvement Organizations; (8) support litigation
involving the agency; and (9) combat fraud, waste, and abuse in certain
health benefits programs
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
A. Entities Who May Receive Disclosures Under Routine Use. These
routine uses specify circumstances, in addition to those provided by
statute in the Privacy Act of 1974, under which CMS may release
information from the PMRS without the consent/authorization of the
individual to whom such information pertains. Each proposed disclosure
of information under these routine uses will be evaluated to ensure
that the disclosure is legally permissible, including but not limited
to ensuring that the purpose of the disclosure is compatible with the
purpose for which the information was collected. We propose to
establish the following routine use disclosures of information
maintained in the system:
1. To support Agency contractors, consultants, or CMS grantees who
have been engaged by the Agency to assist in accomplishment of a CMS
function relating to the purposes for this SOR and who need to have
access to the records in order to assist CMS.
2. Pursuant to agreements with CMS to assist another Federal or
state agency, agency of a state government, or an agency established by
state law to:
a. Contribute to projects that provide transparency in health care
on a broad-scale enabling consumers to compare the quality and price of
health care services,
b. Contribute to the accuracy of CMS's proper payment of Medicare
benefits,
c. Enable such agency to administer a Federal health benefits
program, or as necessary to enable such agency to fulfill a requirement
of a Federal statute or regulation that implements a health benefits
program funded in whole or in part with Federal funds, and/or
d. Assist Federal/state Medicaid programs which may require PMRS
information for purposes related to this system.
3. To assist in making the individual physician-level performance
measurement results available to Medicare beneficiaries, through a Web
site and other forms of data dissemination, in order to promote more
informed choices by Medicare beneficiaries among their Medicare
coverage options.
4. To provide Chartered Value Exchanges (CVE) and data aggregators
with information that will assist in generating single or multi-payer
[[Page 52139]]
performance measurement results that will assist beneficiaries in
making informed choices among individual physicians, practitioners and
providers of services; enable consumers to compare the quality and
price of health care services; and assist in providing transparency in
health care at the local level if CMS:
a. Determines that the use or disclosure does not violate legal
limitations under which the record was provided, collected, or
obtained;
b. Determines that the purpose for which the disclosure is to be
made:
(1) Is of sufficient importance to warrant the effect on and/or
risk to the privacy of the individual that additional exposure of the
record might bring, and
(2) There is reasonable probability that the objective for the use
would be accomplished;
c. Requires the recipient of the information to establish
reasonable administrative, technical, and physical safeguards to
prevent unauthorized use or disclosure of the record,
d. Make no further use or disclosure of the record except:
(1) For use in another project providing transparency in health
care, under these same conditions, and with written authorization of
CMS;
(2) When required by law.
e. Secures a written statement attesting to the information
recipient's understanding of and willingness to abide by these
provisions. CVEs and data aggregators should complete a Data Use
Agreement (CMS Form 0235) in accordance with current CMS policies.
5. To assist individual physicians, practitioners, providers of
services, suppliers, laboratories, and other health care professionals
who are participating in health care transparency projects.
6. To assist an individual or organization with projects that
provide transparency in health care on a broad scale, enabling
consumers to compare the quality and price of health care services; or
for research, evaluation, and epidemiological projects related to the
prevention of disease or disability; restoration or maintenance of
health or for payment purposes if CMS:
a. Determines that the use or disclosure does not violate legal
limitations under which the record was provided, collected, or
obtained;
b. Determines that the purpose for which the disclosure is to be
made:
(1) Cannot be reasonably accomplished unless the record is provided
in individually identifiable form,
(2) Is of sufficient importance to warrant the effect and/or risk
on the privacy of the individual that additional exposure of the record
might bring, and
(3) There is reasonable probability that the objective for the use
would be accomplished;
c. Requires the recipient of the information to:
(1) Establish reasonable administrative, technical, and physical
safeguards to prevent unauthorized use or disclosure of the record, and
(2) Remove or destroy the information that allows the individual to
be identified at the earliest time at which removal or destruction can
be accomplished consistent with the purpose of the project, unless the
recipient presents an adequate justification of a research or health
nature for retaining such information, and
(3) Make no further use or disclosure of the record except:
(a) For disclosure to a properly identified person, for purposes of
providing transparency in health care enabling consumers to compare the
quality and price of health care services so that they can make
informed choices among individual physicians, practitioners and
providers of services;
(b) In emergency circumstances affecting the health or safety of
any individual;
(c) For use in another research project, under these same
conditions, and with written authorization of CMS;
(d) For disclosure to a properly identified person for the purpose
of an audit related to the research project, if information that would
enable research subjects to be identified is removed or destroyed at
the earliest opportunity consistent with the purpose of the audit; or
(e) When required by law.
d. Secures a written statement attesting to the information
recipient's understanding of and willingness to abide by these
provisions. Researchers should complete a Data Use Agreement (CMS Form
0235) in accordance with current CMS policies.
7. To support Quality Improvement Organizations (QIO) in connection
with review of claims, or in connection with studies or other review
activities conducted pursuant to Part B of Title XI of the Act and in
performing affirmative outreach activities to individuals for the
purpose of establishing and maintaining their entitlement to Medicare
benefits or health insurance plans.
8. To support the Department of Justice (DOJ), court, or
adjudicatory body when:
a. The Agency or any component thereof, or
b. Any employee of the Agency in his or her official capacity, or
c. Any employee of the Agency in his or her individual capacity
where the DOJ has agreed to represent the employee, or
d. The United States Government,
is a party to litigation or has an interest in such litigation, and
by careful review, CMS determines that the records are both relevant
and necessary to the litigation and that the use of such records by the
DOJ, court or adjudicatory body is compatible with the purpose for
which the agency collected the records.
9. To assist a CMS contractor (including, but not limited to MACs,
fiscal intermediaries and carriers) that assists in the administration
of a CMS-administered health benefits program, or to a grantee of a
CMS-administered grant program, when disclosure is deemed reasonably
necessary by CMS to prevent, deter, discover, detect, investigate,
examine, prosecute, sue with respect to, defend against, correct,
remedy, or otherwise combat fraud, waste or abuse in such program.
10. To assist another Federal agency or an instrumentality of any
governmental jurisdiction within or under the control of the United
States (including any state or local governmental agency), that
administers, or that has the authority to investigate potential fraud,
waste or abuse in a health benefits program funded in whole or in part
by Federal funds, when disclosure is deemed reasonably necessary by CMS
to prevent, deter, discover, detect, investigate, examine, prosecute,
sue with respect to, defend against, correct, remedy, or otherwise
combat fraud, waste or abuse in such programs.
B. Additional Circumstances Affecting Routine Use Disclosures. To
the extent this system contains Protected Health Information (PHI) as
defined by HHS regulation ``Standards for Privacy of Individually
Identifiable Health Information'' (45 CFR Parts 160 and 164, Subparts A
and E) 65 Fed. Reg. 82462 (12-28-00). Disclosures of such PHI that are
otherwise authorized by these routine uses may only be made if, and as,
permitted or required by the ``Standards for Privacy of Individually
Identifiable Health Information.'' (See 45 CFR 164-512(a)(1)).
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
Records are stored on both tape cartridges (magnetic storage media)
and
[[Page 52140]]
in a DB2 relational database management environment (DASD data storage
media).
RETRIEVABILITY:
Information is most frequently retrieved by HICN, provider number
(facility, physician, IDs), service dates, and beneficiary state code.
SAFEGUARDS:
CMS has safeguards in place for authorized users and monitors such
users to ensure against unauthorized use. Personnel having access to
the system have been trained in the Privacy Act and information
security requirements. Employees who maintain records in this system
are instructed not to release data until the intended recipient agrees
to implement appropriate management, operational and technical
safeguards sufficient to protect the confidentiality, integrity and
availability of the information and information systems and to prevent
unauthorized access.
This system will conform to all applicable Federal laws and
regulations and Federal, HHS, and CMS policies and standards as they
relate to information security and data privacy. These laws and
regulations include but are not limited to: the Privacy Act of 1974;
the Federal Information Security Management Act of 2002; the Computer
Fraud and Abuse Act of 1986; the Health Insurance Portability and
Accountability Act of 1996; the E-Government Act of 2002, the Clinger-
Cohen Act of 1996; the Medicare Modernization Act of 2003, and the
corresponding implementing regulations. OMB Circular A-130, Management
of Federal Resources, Appendix III, Security of Federal Automated
Information Resources also applies. Federal, HHS, and CMS policies and
standards include but are not limited to: all pertinent National
Institute of Standards and Technology publications; the HHS Information
Systems Program Handbook and the CMS Information Security Handbook.
RETENTION AND DISPOSAL:
Records are maintained with identifiers for all transactions after
they are entered into the system for a period of 20 years. Records are
housed in both active and archival files. All claims-related records
are encompassed by the document preservation order and will be retained
until notification is received from the Department of Justice.
SYSTEM MANAGER AND ADDRESS:
Director, Quality Measurement and Health Assessment Group, Office
of Clinical Standards and Quality, CMS, Room C1-23-14, 7500 Security
Boulevard, Baltimore, Maryland 21244-1850.
NOTIFICATION PROCEDURE:
For purpose of notification, the subject individual should write to
the system manager who will require the system name, and the retrieval
selection criteria (e.g., HICN, Provider number, etc.).
RECORD ACCESS PROCEDURE:
For purpose of access, use the same procedures outlined in
Notification Procedures above. Requestors should also reasonably
specify the record contents being sought. (These procedures are in
accordance with Department regulation 45 CFR 5b.5(a)(2)).
CONTESTING RECORD PROCEDURES:
The subject individual should contact the system manager named
above, and reasonably identify the record and specify the information
to be contested. State the corrective action sought and the reasons for
the correction with supporting justification. (These procedures are in
accordance with Department regulation 45 CFR 5b.7).
RECORD SOURCE CATEGORIES:
Medicare Beneficiary Database (09-70-0536), National Claims History
File (09-70-0558), and private physicians, private providers,
laboratories, other providers and suppliers who are participating in
health care transparency projects sponsored by the Agency.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
[FR Doc. E7-17907 Filed 9-11-07; 8:45 am]
BILLING CODE 4120-03-P