[Federal Register Volume 74, Number 72 (Thursday, April 16, 2009)]
[Notices]
[Pages 17672-17676]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-8736]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services


Privacy Act of 1974; Notice of Modified System of Records

AGENCY: Department of Health and Human Services (HHS), Centers for 
Medicare & Medicaid Services (CMS).

ACTION: Notice of a modified system of records.

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SUMMARY: In accordance with the requirements of the Privacy Act of 
1974, CMS is proposing to make minor amendments to an existing system 
of records (SOR) titled, ``Performance Measurement and Reporting System 
(PMRS),'' System No. 09-70-0584, published at 72 Federal Register 52133 
(September 12, 2007), as amended by 73 Federal Register 80412 (December 
31, 2008). PMRS serves 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 other providers of services. We are 
making minor amendments to PMRS to include an additional legal 
authority: Section 109 of the Tax Relief and Health Care Act of 2006 
(TRHCA) (Pub. L. 109-432). Section 109 of the TRHCA amended Section 
1833(t) of the Social Security Act (42 U.S.C. 1395l(t)). This section 
mandates the establishment of a program for quality data reporting for 
hospital outpatient services and allow for the establishment of a 
program to require quality data reporting for ambulatory surgical 
center services. Accordingly, CMS is adding section 109 of TRCHA (42 
U.S.C. 1395l(t)) and section 1833(t) of the Act to the PMRS' legal 
authority section.
    The primary purpose of this system is explained in 72 FR 52133 
(2007) and 73 FR 80412 (2008). We have provided background information 
about this modified system in the SUPPLEMENTARY INFORMATION section 
below.

DATES: Effective Dates: The minor amendments contained in this notice 
are effective upon publication in the Federal Register.

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

[[Page 17673]]

Boulevard, Baltimore, Maryland 21244-1850. The telephone number is 
(410) 786-1879 or contact <a href="/cdn-cgi/l/email-protection#abeadec8c3ca85fbd9cac8c3cac5d9c4c5cad9c4c5ccebc8c6d885c3c3d885ccc4dd"><span class="__cf_email__" data-cfemail="e5a490868d84cbb59784868d848b978a8b84978a8b82a5868896cb8d8d96cb828a93">[email protected]</span></a>. For 
further information on this system as it relates to Hospital Outpatient 
Quality Data Reporting, please contact Anita Bhatia, Health Insurance 
Specialist, Division of Quality Improvement Policy for Acute Care, 
Quality Improvement Group, Office of Clinical Standards and Quality, 
CMS, Room C1-23-14, 7500 Security Boulevard, Baltimore, Maryland 21244-
1850. The telephone number is (410) 786-7236 or contact 
<a href="/cdn-cgi/l/email-protection#f7b6999e8396d9b59f96839e96b7949a84d99f9f84d9909881"><span class="__cf_email__" data-cfemail="4607282f322768042e27322f2706252b35682e2e3568212930">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: As required by TRHCA, CMS implemented a 
Hospital Outpatient Quality Data Reporting Program (HOP QDRP). Under 
the HOP QDRP, providers who successfully submit quality data on a 
designated set of quality measures receive the full annual market 
basket update rather than an update reduced by two percent. As a part 
of this program, CMS or its contractors may request a limited number of 
physician and patient-identifiable patient records to validate the 
accuracy of information submitted under the program. In this notice, 
CMS is adding this legal authority (section 1833(t) of the Social 
Security Act; 109 of division B of the Tax Relief and Health Care Act 
of 2006) to the Authority section of the PMRS SOR notice.

I. Description of the Modified System of Records

A. Statutory and Regulatory Basis for System

    The ``Authority'' section of PMRS system of records notice is 
amended to read: Authority for the collection, maintenance, and 
disclosures from this system is given under provisions of sections 
1152, 1153 (c), 1153(e), 1154, 1160, 1833(t), 1848(k), 1848(m), 1851(d) 
and 1862(g) of the Social Security Act; sections 101 and 109 of 
division B of the Tax Relief and Health Care Act of 2006; section 101 
of the Medicare, Medicaid, and SCHIP Extension Act of 2007, sections 
131 and 132 of MIPPA, and sections 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

    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 agency policies, procedures, and restriction on 
routine uses for the PMRS were published in the Federal Register on 
September 12, 2007. See 72 FR 52133 (Sept. 12, 2007) for further 
information.

III. Routine Use Disclosures of Data in the System

    For further information on the routine uses for the PMRS, please 
see 72 FR 52133 and 80 FR 80412.

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 Modified System on the Rights of Individuals

    CMS proposes to amend 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 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: April 8, 2009.
Michelle Snyder,
Acting Deputy Administrator, Centers for Medicare & Medicaid Services.

SYSTEM No.:
    09-70-0584.

[[Page 17674]]

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, practitioner or other provider-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, practitioner, and other providers 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 sections 1152, 1153(c), 
1153(e), 1154, 1160, 1833(t), 1848(k), 1848(m), 1851(d) and 1862(g) of 
the Social Security Act; sections 101 and 109 of division B of the Tax 
Relief and Health Care Act of 2006; section 101 of the Medicare, 
Medicaid, and SCHIP Extension Act of 2007, sections 131 and 132 of 
MIPPA, and sections 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 to promote the delivery of 
high quality, efficient, effective 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, provision of 
feedback to physicians, and public reporting of performance 
information. 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 website 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) and (10) combat fraud, waste, 
and abuse in certain health benefits programs.

ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES 
OR 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 
website 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 
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

[[Page 17675]]

    (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 others 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 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.
    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 FR 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 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

[[Page 17676]]

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. E9-8736 Filed 4-15-09; 8:45 am]
BILLING CODE 4120-03-P


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