[Federal Register: October 2, 2006 (Volume 71, Number 190)]
[Notices]
[Page 57968-57972]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02oc06-72]
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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).
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SUMMARY: In accordance with the requirements of the Privacy Act of
1974, we are proposing to establish a new system titled, ``Rural
Hospice Demonstration (RHD), System No. 09-70-0563.'' The program is
mandated by Sec. 409 of the Medicare Prescription Drug Improvement and
Modernization Act of 2003 (MMA) (Public Law (Pub. L.) 108-173), which
was enacted into law on December 8, 2003, and amended Title XVIII of
the Social Security Act (the Act). Section 409 authorizes the Secretary
of HHS (the Secretary) to conduct a demonstration project for the
delivery of hospice care to Medicare beneficiaries in rural areas.
Under the demonstration, Medicare beneficiaries who are unable to
receive hospice care at home for lack of an appropriate caregiver are
provided such care in a facility of 20 or fewer beds that offers,
within its walls, the full range of services provided by hospice
programs.
In order for a hospice organization or agency to participate in
this demonstration, it must be Medicare certified and meet all of the
Medicare Conditions of Participation as described in subparts C
(General Provisions), D (Core Services), and E (Other Services) of 42
CFR 418, except it shall not be required to offer services outside the
facility or meet the 20 percent inpatient cap requirements of section
1861(dd)(2) (A) (iii) of the Act.
The purpose of this system is to collect and maintain a person-
level view of identifiable data of Medicare beneficiaries who
participate in the rural hospice demonstrations. Information retrieved
from this system may be disclosed to: (1) Support regulatory,
reimbursement, and policy functions performed within the agency or by a
contractor, consultant, or grantee; (2) assist another Federal or State
agency with information to contribute to the accuracy of CMS's proper
payment of Medicare benefits, enable such agency to administer a
Federal health benefits program, or to enable such agency to fulfill a
requirement of Federal statute or regulation that implements a health
benefits program funded in whole or in part with Federal funds; (3)
support an individual or organization for a research project or in
support of an evaluation project related to the prevention of disease
or disability, the restoration or maintenance of health, or payment
related projects; (4) support litigation involving the agency; and (5)
combat fraud, waste, and abuse in certain Federally-funded health
benefits programs. We have provided background information about this
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.
DATES: Effective Date: CMS filed a 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 September 26, 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: Cindy Massuda, Project Officer,
Division of Deliver System Demonstration, Office of Research
Development & Information, Mail Stop C4-18-03, Centers for Medicare &
Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1849.
She can be reached by telephone at 410-786-0652 or e-mail
Cindy.Massuda@cms.hhs.gov.
[[Page 57969]]
SUPPLEMENTARY INFORMATION: The demonstration will be offered to up to
three hospice programs and will not exceed a period of 5 years. The
demonstration will test whether provisions of hospice services provided
by a demonstration hospice program to Medicare beneficiaries who lack
an appropriate caregiver and who reside in rural areas results in wider
access, improved hospice services, benefits to the community, and a
sustainable pattern of care. Hospice provides palliative care to
individuals who have a terminal illness with a prognosis of 6 months or
less. The care is provided typically in the individual's home or place
of residence with family members present.
Individuals who lack family or someone to serve as the primary
caregiver need proportionately more support from hospice staff. Due to
long distances and difficult terrain, it can be particularly difficult
to provide the Medicare hospice benefit efficiently in rural areas.
There may be situations where the hospice benefit could be provided to
beneficiaries who would not otherwise be able to receive these services
if the location of hospice care is altered.
This demonstration will allow a hospice with up to 20 beds to
provide all levels of hospice services within its walls to individuals
who reside in rural areas and lack an appropriate caregiver, while not
having to provide services outside of the hospice facility or comply
with the 20-percent cap on inpatient care days.
While the demonstration provider will not have to meet the limit on
inpatient care days or provide care outside of the facility, it will
not alter the level of care requirements for general inpatient care. In
order to provide general inpatient care to hospice patients, a hospice
participating in the demonstration must assure that the need for
general inpatient care is met according to Medicare guidelines. The
demonstration will test whether hospice services provided by a facility
that does not meet the limit on inpatient care days or provide services
outside of the facility for hospice individuals residing in rural areas
who lack an appropriate caregiver results in wider access, improved
hospice services, benefits to the rural community, and a sustainable
pattern of care.
The demonstration is designed for a demonstration hospice to
provide the full range of services within its facility to Medicare
beneficiaries who reside in rural areas and lack an appropriate
caregiver. If a demonstration hospice provides care to any patient who
either lives outside a rural area or has an appropriate caregiver, then
the hospice must comply with all of Medicare hospice requirements at
Sec. 1861(dd) of the SSA for these patients since they are not
considered part of the demonstration.
I. Description of the Proposed System of Records
A. Statutory and Regulatory Basis for SOR
The statutory authority for this system is given under the
provisions of Sec. 409 of the Medicare Prescription Drug Improvement,
and Modernization Act of 2003 and Sec. 1861(dd) of the Social Security
Act. This program is codified at Title 42 United States Code 1395x
(dd).
B. Collection and Maintenance of Data in the System
This system will collect and maintain individually identifiable and
other data collected on Medicare beneficiaries and their providers who
provide service to such beneficiaries who participate in this
demonstration. Data will be collected from Medicare administrative and
claims records, patient medical charts, physician records, and via
survey instruments administered to beneficiaries and providers. The
collected information will include, but is not limited to Medicare
claims and eligibility data, name, address, telephone number, health
insurance claims number, race/ethnicity, gender, date of birth,
provider name, unique provider identification number, medical record
number, as well as clinical, demographic, health/well-being, family
and/or caregiver contact information, and background information
relating to Medicare issues.
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 RHD 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 RHD.
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
a person-level view of identifiable data of Medicare beneficiaries who
participate in the rural hospice demonstrations.
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:
1. To support 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
[[Page 57970]]
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 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.
2. To assist another Federal or State agency to:
a. Contribute to the accuracy of CMS's proper payment of Medicare
benefits;
b. 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
c. Assist Federal/State Medicaid programs within the State.
Other Federal or State agencies, in their administration of a
Federal health program, may require RHD information in order to support
evaluations and monitoring of Medicare claims information of
beneficiaries, including proper reimbursement for services provided.
3. To assist an individual or organization for a research project
or in support of an evaluation project related to the prevention of
disease or disability, the restoration or maintenance of health, or
payment related projects.
The RHD data will provide for research or support of evaluation
projects and a broader, longitudinal, national perspective of the
status of 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
policies that govern their care.
4. 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, and occasionally when
another party is involved in litigation and CMS 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.
5. To assist a CMS contractor (including, but not necessarily
limited to, 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, and abuse in such
program.
We contemplate disclosing information under this routine use only
in situations in which CMS may enter into a contractual, grantee,
cooperative agreement or consultant relationship with a third party to
assist in accomplishing CMS functions relating to the purpose of
combating fraud, waste, and abuse. CMS occasionally contracts out
certain of its functions or makes grants or cooperative agreements when
doing so would contribute to effective and efficient operations. CMS
must be able to give a contractor, grantee, consultant or other legal
agent whatever information is necessary for the agent to fulfill its
duties. In these situations, safeguards are provided in the contract
prohibiting the agent from using or disclosing the information for any
purpose other than that described in the contract and requiring the
agent to return or destroy all information.
6. 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, and 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, and abuse in such programs.
Other agencies may require RHD information for the purpose of
combating fraud, waste, and abuse in such Federally-funded programs.
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
because of the small size, use of this information could allow for the
deduction of the identity of the beneficiary).
IV. Safeguards
CMS has safeguards in place for authorized users and monitors of
such users to ensure against excessive or 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
[[Page 57971]]
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: September 19, 2006.
John R. Dyer,
Chief Operating Officer, Centers for Medicare & Medicaid Services.
SYSTEM NO. 09-70-0563
System Name:
``Rural Hospice Demonstration (RHD),'' HHS/CMS/ORDI.
Security Classification:
Level Three Privacy Act Sensitive Data.
System Location:
CMS Data Center, 7500 Security Boulevard, North Building, First
Floor, Baltimore, Maryland 21244-1850, and at various contractor
locations.
Categories of Individuals Covered by the System:
This system will collect and maintain individually identifiable and
other data collected on Medicare beneficiaries and their providers who
provide service to such beneficiaries who participate in this
demonstration.
Categories of Records in the System:
Data will be collected from Medicare administrative and claims
records, patient medical charts, physician records, and via survey
instruments administered to beneficiaries and providers. The collected
information will include, but is not limited to Medicare claims and
eligibility data, name, address, telephone number, health insurance
claims number, race/ethnicity, gender, date of birth, provider name,
unique provider identification number, medical record number, as well
as clinical, demographic, health/well-being, family and/or caregiver
contact information, and background information relating to Medicare
issues.
Authority for Maintenance of the System:
The statutory authority for this system is given under the
provisions of Sec. 409 of the Medicare Prescription Drug Improvement,
and Modernization Act of 2003 and Sec. 1861(dd) of the Social Security
Act. This program is codified at Title 42 United States Code 1395x
(dd).
Purpose(s) of the System:
The purpose of this system is to collect and maintain a person-
level view of identifiable data of Medicare beneficiaries who
participate in the rural hospice demonstrations. Information retrieved
from this system may be disclosed to: (1) Support regulatory,
reimbursement, and policy functions performed within the agency or by a
contractor, consultant, or grantee; (2) assist another Federal or State
agency with information to contribute to the accuracy of CMS's proper
payment of Medicare benefits, enable such agency to administer a
Federal health benefits program, or to enable such agency to fulfill a
requirement of Federal statute or regulation that implements a health
benefits program funded in whole or in part with Federal funds; (3)
support an individual or organization for a research project or in
support of an evaluation project related to the prevention of disease
or disability, the restoration or maintenance of health, or payment
related projects; (4) support litigation involving the agency; and (5)
combat fraud, waste, and abuse in certain Federally-funded health
benefits programs.
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 support 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.
2. To assist another Federal or State agency to:
a. Contribute to the accuracy of CMS's proper payment of Medicare
benefits;
b. 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
c. Assist Federal/State Medicaid programs within the State.
3. To support an individual or organization for a research project
or in support of an evaluation project related to the prevention of
disease, disability, or quality care projects, the restoration or
maintenance of health, and payment related projects.
4. 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.
5. To assist a CMS contractor (including, but not necessarily
limited to, fiscal intermediaries and carriers) that assists in the
administration of a CMS-administered health benefits
[[Page 57972]]
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, and
abuse in such program.
6. 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, and 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, and abuse in such programs.
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
because of the small size, use of this information could allow for the
deduction of the identity of the beneficiary).
Policies and Practices for Storing, Retrieving, Accessing, Retaining,
and Disposing of Records in the System:
Storage:
All records are stored on electronic media.
Retrievability:
The collected data are retrieved by an individual identifier; e.g.,
beneficiary name or HICN, and unique provider identification number.
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 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 25
years. 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 Deliver Systems Demonstration, Office of
Research Development and Information, Mail Stop C4-18-03, 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, provider's tax
identification number, national provider number, and for verification
purposes, or 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:
Information maintained in this system will be collected from
physicians volunteering to participate in the RHD. Additional data will
be collected from Medicare claims payment records.
Systems Exempted from Certain Provisions of the Act:
None.
[FR Doc. E6-16107 Filed 9-29-06; 8:45 am]
BILLING CODE 4120-03-P