[Federal Register Volume 71, Number 212 (Thursday, November 2, 2006)]
[Notices]
[Pages 64527-64530]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-18452]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services


Privacy Act of 1974; Report of a New System of Records

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

ACTION: Notice of a new system of records (SOR).

-----------------------------------------------------------------------

SUMMARY: In accordance with the requirements of the Privacy Act of 
1974, we are proposing to establish a new system titled, ``Evaluation 
of Drug Usage Under the Staff Time and Resource Intensity Verification 
Study (STRIVE), System No. 09-70-0595.'' Section 1888(e)(G) of the 
Social Security Act (the Act) authorizes the Secretary of HHS to 
provide for payment adjustments to the skilled nursing facility (SNF) 
prospective payment system (PPS) through a resident classification 
system established by the Secretary that accounts for the relative 
resource utilization of different patient types. The case mix 
adjustment shall be based on resident assessment data and other data 
the Secretary considers appropriate. To accomplish this task, CMS is 
currently undertaking a national nursing home time study known as 
STRIVE, of which this data will be a part.
    The purpose of this system is to collect and maintain during the 
STRIVE time study individually identifiable information on selected 
beneficiaries' medication utilization while in a nursing home, skilled 
nursing facility or swing bed hospital. Information retrieved from this 
system may be disclosed to: (1) Support regulatory, reimbursement, and 
policy functions performed within the agency or by a contractor, 
grantee, or consultant. We have provided background information about 
the 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 Date section for 
comment period.

DATES: Effective Date: CMS filed a new SOR 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 October 27, 2006. To ensure that all 
parties have adequate time in which to comment, the new system will 
become effective 30 days from the publication of the notice, or 40 days 
from the date it was submitted to OMB and the Congress, whichever is 
later. We may defer implementation of this system or one or more of the 
routine use statements listed below if we receive comments that 
persuade us to defer implementation.

ADDRESSES: The public should address comment to the CMS Privacy 
Officer, Division of Privacy Compliance, Enterprise Architecture and 
Strategy Group, Office of Information Services, Mail-stop 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.-3 
p.m., eastern time.

FOR FURTHER INFORMATION CONTACT: Julie Stankivic, Division of 
Institutional Post Acute Care, Chronic Care Policy Group, Center for 
Medicare Management, Mail Stop C5-06-27, Centers for Medicare & 
Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1849. 
She can be reached by telephone at 410-786-5725, or via e-mail at 
[email protected].

SUPPLEMENTARY INFORMATION: Section 4008(k) of the Omnibus 
Reconciliation Act of 1990 (Public Law (Pub. L.) 101-508) required the 
Secretary to develop a proposal either to modify the then-current 
system under which SNFs received payment for extended care services 
under Part A of the Medicare program or to replace such a system with a 
system under which such payment would be made on the basis of a 
prospectively determined rate. In developing a proposal for the new 
system, the Secretary was required to ``provide for adjustments to 
prospectively determined rates to account for changes in a facility's 
case mix, volume of cases, and the development of new technologies and 
standards for medical practice.'' Section 4432 of the Balanced Budget 
Act of 1997 (Pub. L. 105-33) mandated a PPS for all SNFs for cost 
reporting periods beginning on or after July 1, 1998.
    Resident drug data may enable CMS to recalibrate the weights 
associated with the provision of non-therapy ancillary services to 
residents in SNFs and swing bed hospitals subject to the SNF PPS. In 
order to adjust the rates to account for changes in a facility's case 
mix, volume of cases and development of new technologies and standards 
of

[[Page 64528]]

medical practice, CMS must recalibrate the weights associated with the 
amount of time that nursing home staff spend caring for residents, as 
well as other elements of resident care. To do this, CMS has contracted 
with the Iowa Foundation for Medicare Care to conduct a study of staff 
time commonly referred to as STRIVE. This is the first national nursing 
home time study undertaken in the U.S. since 1997. As part of this 
process, CMS believes that collecting data on medication utilization in 
nursing homes is critical to analyzing the impact of the provision of 
non-therapy ancillary services to residents in SNFs and swing bed 
hospitals subject to the PPS.

I. Description of the Proposed System of Records

A. Statutory and Regulatory Basis for SOR

    The statutory authority for this system is given under Section 
1888(e)(G) of the Social Security Act.

B. Collection and Maintenance of Data in the System

    This system will collect and maintain individually identifiable and 
other data collected by CMS and its contractors on Medicare 
participants and providers of service who are participating in STRIVE, 
in order to analyze relevant data to create adjustments based upon a 
resident classification system established by the Secretary that 
accounts for the relative resource utilization of different patient 
types. The collected information will include, but is not limited to: 
Facility name, Federal provider identification number, facility 
national provider identifier, beneficiary name, social security number, 
health insurance claim number, gender, date of birth, NDC Code, drug 
name, drug strength, dosage form (drops (gtts), gram (gm), etc.), 
quantity dispensed or returned, date drug dispensed or returned, dose 
and frequency, routine or PRN, compound code, and cost data if 
available.

II. Agency Policies, Procedures, and Restrictions on the Routine Use

    A. The Privacy Act permits us to disclose information without an 
individual's consent 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 STRIVE 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 collect the minimum personal data necessary to 
achieve the purpose of STRIVE.
    CMS has the following policies and procedures concerning 
disclosures of information that will be maintained in the system. 
Disclosure of information from the system will be approved only to the 
extent 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 and maintain 
individually identifiable information on selected beneficiaries' 
medication utilization while in a nursing home, skilled nursing 
facility, or swing bed hospital.
    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 strong probability that the proposed use of the data 
would in fact accomplish the stated purpose(s).
    3. Requires the information recipient to:
    a. Establish administrative, technical, and physical safeguards to 
prevent unauthorized use of disclosure of the record;
    b. Remove or destroy, at the earliest time, all patient-
identifiable information; and
    c. 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. The Privacy Act allows us to disclose information without an 
individual's consent 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 compatible use of data is known as a ``routine 
use.'' The proposed routine uses in this system meet the compatibility 
requirement of the Privacy Act. We are proposing to establish the 
following routine use disclosures of information maintained in the 
system:
    5. To agency contractors, consultants or grantees, who have been 
engaged by the agency to assist in the performance of a service related 
to this collection and who need to have access to the records in order 
to perform the activity.
    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 CMS function 
relating to purposes for this system.
    CMS believes that the disclosure of medication utilization data may 
enable CMS to better account for the relative resource utilization of 
different patient types for the purpose of updating SNF PPS.
    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 grantee whatever information 
is necessary for the contractor or consultant to fulfill its duties. In 
these situations, safeguards are provided in the contract prohibiting 
the contractor, consultant or grantee from using or disclosing the 
information for any purpose other than that described in the contract 
and requires the contractor, consultant or grantee to return or destroy 
all information at the completion of the contract.

B. Additional Provisions 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)).
    In addition, our policy will be to prohibit release even of data 
not directly identifiable, except pursuant to one of the routine uses 
or if required by law, if we determine there is a possibility that an 
individual can be identified through implicit deduction based on small 
cell sizes (instances where the patient population is so small that an 
individual could, because of the small size, use this information to 
deduce the identity of the beneficiary).

IV. Safeguards

    CMS has safeguards in place for authorized users and monitors such 
users to ensure against excessive or unauthorized use. Personnel having 
access to the system have been trained

[[Page 64529]]

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 may apply 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 Proposed System of Records on Individual Rights

    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. Data in this 
system will be subject to the authorized releases in accordance with 
the routine uses identified in this system of records.
    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 of patients whose data are 
maintained in this system. 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 information relating to individuals.

    Dated: October 24, 2006.
John R. Dyer,
Chief Operating Officer, Centers for Medicare & Medicaid Services.
SYSTEM NO. 09-70-0595

SYSTEM NAME:
    ``Evaluation of Drug Usage Under the Staff Time and Resource 
Intensity Verification Study (STRIVE),'' HHS/CMS/CMM.

SECURITY CLASSIFICATION:
    Level Three Privacy Act Sensitive Data.

SYSTEM LOCATION:
    Centers for Medicare & Medicaid Services (CMS) Data Center, 7500 
Security Boulevard, North Building, First Floor, Baltimore, Maryland 
21244-1850 and at various co-locations of CMS agents.

CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
    This system will collect and maintain individually identifiable and 
other data collected by CMS and its contractors on Medicare 
participants and providers of service who are participating in STRIVE, 
in order to analyze relevant data to create adjustments based upon a 
resident classification system established by the Secretary that 
accounts for the relative resource utilization of different patient 
types.

CATEGORIES OF RECORDS IN THE SYSTEM:
    The collected information will include, but is not limited to: 
Facility name, Federal provider identification number, facility 
national provider identifier, beneficiary name, social security number, 
health insurance claim number, gender, date of birth, NDC Code, drug 
name, drug strength, dosage form (drops (gtts), gram (gm), etc.), 
quantity dispensed or returned, date drug dispensed or returned, dose 
and frequency, routine or PRN, compound code, and cost data if 
available.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
    The statutory authority for this system is given under Section 
1888(e)(G) of the Social Security Act.

PURPOSE(S) OF THE SYSTEM:
    The purpose of this system is to collect and maintain during the 
STRIVE time study individually identifiable information on selected 
beneficiaries' medication utilization while in a nursing home, skilled 
nursing facility or swing bed hospital. Information retrieved from this 
system may be disclosed to: (1) support regulatory, reimbursement, and 
policy functions performed within the agency or by a contractor, 
grantee, or consultant.

ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES 
OR USERS AND THE PURPOSES OF SUCH USES:
    A. The Privacy Act allows us to disclose information without an 
individual's consent 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 compatible use of data is known as a ``routine 
use.'' The proposed routine uses in this system meet the compatibility 
requirement of the Privacy Act. We are proposing to establish the 
following routine use disclosures of information maintained in the 
system:
    1. To agency contractors, consultants or grantees, who have been 
engaged by the agency to assist in the performance of a service related 
to this collection and who need to have access to the records in order 
to perform the activity.
B. Additional Provisions 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)).
    In addition, our policy will be to prohibit release even of data 
not directly identifiable, except pursuant to one of the routine uses 
or if required by law, if we determine there is a possibility that an 
individual can be identified through implicit deduction based on small 
cell sizes (instances where the patient population is so small that an 
individual could, because of the small size, use this information to 
deduce the identity of the beneficiary).

POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, 
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
    All records will be stored electronically and on hard copy.

RETRIEVABILITY:
    The collected data are retrieved by an individual identifier; e.g., 
beneficiary name or HICN.

SAFEGUARDS:
    CMS has safeguards in place for authorized users and monitors such 
users to ensure against excessive or

[[Page 64530]]

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 may apply 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:
    CMS will retain information for a total period not to exceed 5 
years after the final report is released. All claims-related records 
are encompassed by the document preservation order and will be retained 
until notification is received from DOJ.

SYSTEM MANAGER AND ADDRESS:
    Director Division of Institutional Post Acute Care, Chronic Care 
Policy Group, Center for Medicare Management, Mail Stop C5-06-27, 
Centers for Medicare & Medicaid Services, 7500 Security Boulevard, 
Baltimore, MD 21244-1849.

NOTIFICATION PROCEDURE:
    For purpose of access, the subject individual should write to the 
system manager who will require the system name, employee 
identification number, tax identification number, national provider 
number, and for verification purposes, the subject individual's name 
(woman's maiden name, if applicable), HICN, and/or SSN (furnishing the 
SSN is voluntary, but it may make searching for a record easier and 
prevent delay).

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).

RECORDS SOURCE CATEGORIES:
    Data will be collected from OmniCare, pharmacies, nursing homes, 
and Long Term Care Minimum Data Set, System No. 09-70-1517.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
    None.
 [FR Doc. E6-18452 Filed 11-1-06; 8:45 am]
BILLING CODE 4120-03-P