[Federal Register: September 12, 2007 (Volume 72, Number 176)]
[Notices]
[Page 52133-52140]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12se07-96]
-----------------------------------------------------------------------
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