[Federal Register: January 6, 2006 (Volume 71, Number 4)]
[Notices]
[Page 937-941]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06ja06-58]
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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), Centers 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 SOR titled, ``Medicare
Bariatric Surgery System (MBSS), System No. 09-70-0570.'' National
coverage determinations (NCDs) are determinations made by the Secretary
of HHS with respect to whether or not a particular item or service is
covered nationally under title XVIII of the Social Security Act (the
Act) section 1869(f)(1)(B). In order to be covered by Medicare, an item
or service must fall within one or more benefit categories contained
within Part A or Part B, and must not be otherwise excluded from
coverage. Moreover, with limited exceptions, the expenses incurred for
items or services must be ``reasonable and necessary for the diagnosis
or treatment of illness or injury or to improve the functioning of a
malformed body member,'' section 1862(a)(1)(A). CMS has determined that
the evidence is adequate to conclude that bariatric surgery is
reasonable and necessary in several patient groups where certain
criteria for these patients have been met. The reasonable and necessary
determination requires that patients meet the MBSS criteria set forth
in the decision memorandum and are consistent with the trials
discussed. Bariatric surgery is reasonable and necessary only when
facilities performing the surgery have full accreditation based on
standards equivalent to or exceeding the CMS minimum standards.
Collection of data elements related to bariatric surgery allows that
determination to be made.
The purpose of this system is to provide reimbursement for
bariatric surgery, and assist in the collection of data on patients
receiving bariatric surgery, for a data collection process to assure
patient safety and protection, and to determine that the bariatric
surgery is reasonable and necessary. Information retrieved from this
system will also be disclosed to: (1) Support regulatory,
reimbursement, and policy functions performed within the agency or by a
contractor or consultant; (2) assist another Federal or state agency
with information to 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) 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; (4)
support constituent requests made to a congressional representative;
(5) support litigation involving the agency; and (6) combat fraud and
abuse in certain Federally-funded health benefits programs. We have
provided background information about the modified 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 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 Governmental Affairs, and the Administrator, Office of
Information and Regulatory Affairs, Office of Management and Budget
(OMB) on 12/29/2005. We will not disclose any information under a
routine use until 30 days after publication. 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, 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 daylight time.
FOR FURTHER INFORMATION CONTACT: Rosemarie Hakim, Epidemiologist,
Office of Clinical Standards and Quality, CMS, Mail Stop C1-09-06, 7500
Security Boulevard, Baltimore, Maryland 21244-1849. She may be
contacted via telephone at (410) 786-3934, or via e-mail at
Rosemarie.Hakim@cms.hhs.gov.
SUPPLEMENTARY INFORMATION: Obesity is a growing epidemic in the United
States with over 60% of the population classified as overweight or
obese. One form of treatment for obesity is bariatric surgery. In May
2005 CMS began a reconsideration of the NCD on BS for Medicare
beneficiaries submitted by the American Society for bariatric surgery,
the American Obesity Association, and others. The requestors included
the following bariatric surgery procedures in their request for
reconsideration: (1) Roux-en-y Gastric Bypass, (2) Biliopancreatic
Diversion, (3) Laparoscopic Adjustable Gastric Banding, and (4)
Vertical Gastric Banding. CMS has determined that the evidence is
adequate to conclude that bariatric surgery is reasonable and necessary
for Medicare beneficiaries who have a Body Mass Index >= 35, at least
one co-morbidity related to morbid obesity, and have been unsuccessful
with medical treatment for obesity.
I. Description of the Proposed System of Records
A. Statutory and Regulatory Basis for SOR
The statutory authority for linking coverage decisions to the
collection of additional data is derived from section 1862(a)(1)(A) of
the Act, which states that Medicare may not provide payment for items
and services unless they are ``reasonable and necessary'' for the
treatment of illness or injury. In some cases, CMS will determine that
an item or service is only reasonable and necessary when specific data
collections accompany the provisions of the service. In these cases,
the collection of data is required to ensure that the care provided to
individual patients will improve health outcomes.
[[Page 938]]
B. Collection and Maintenance of Data in the System
The data collection should include baseline patient
characteristics. The information collected will include but is not
limited to: Name, address, telephone number, Health Insurance Claim
Number (HICN), geographic location, race/ethnicity, gender, and date of
birth, as well as, background information relating to Medicare or
Medicaid issues.
II. Agency Policies, Procedures, and Restrictions on the Routine Use
A. Agency Policies, Procedures, and Restrictions on the Routine Use
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 MBSS 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 MBSS. 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 provide reimbursement
for bariatric surgery, and assist in the collection of data on patients
receiving bariatric surgery, for a data collection process to assure
patient safety and protection, and to determine that the bariatric
surgery is reasonable and necessary.
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 agency contractors or consultants who have been engaged by
the agency to assist in the performance of a service related to this
system 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 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 consultant 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 or consultant from using or disclosing the information
for any purpose other than that described in the contract and requires
the contractor or consultant to return or destroy all information at
the completion of the contract.
2. To another Federal or state agency to:
a. Provide reimbursement for bariatric surgery, and assist in the
collection of data on patients receiving bariatric surgery for a data
collection process to assure patient safety and protection, and to
determine that the bariatric surgery is reasonable and necessary,
b. Contribute to the accuracy of CMS's proper payment of Medicare
benefits, and/or
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.
Other Federal or state agencies in their administration of a
Federal health program may require MBSS information in order to provide
reimbursement for bariatric surgery, and assist in the collection of
data on patients receiving bariatric surgery for a data collection
process to assure patient safety and protection, and to determine that
the bariatric surgery is reasonable and necessary.
3. To 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 MBSS data will provide for research or in support of evaluation
projects, a broader, 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 policy that
governs the care.
4. To a member of Congress or to a Congressional staff member in
response to an inquiry of the Congressional office made at the written
request of the constituent about whom the record is maintained.
Beneficiaries sometimes request the help of a member of Congress in
resolving an issue relating to a matter before CMS. The member of
Congress then writes CMS, and CMS must be able to give sufficient
information to be responsive to the inquiry.
5. To 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
[[Page 939]]
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.
6. To 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 or abuse in such program.
We contemplate disclosing information under this routine use only
in situations in which CMS may enter into a contractual relationship or
grant with a third party to assist in accomplishing CMS functions
relating to the purpose of combating fraud and abuse.
CMS occasionally contracts out certain of its functions and makes
grants 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.
7. To 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
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 or abuse in such programs.
Other agencies may require MBSS information for the purpose of
combating fraud 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, 65 FR 82462 (12-28-00), Subparts A and E) 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.''
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
individuals who are familiar with the enrollees 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 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 (see item IV above) 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 the 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: December 27, 2005.
Lori Davis,
Acting Chief Operating Officer, Centers for Medicare & Medicaid
Services.
System No. 09-70-0570
System Name:
``Medicare Bariatric Surgery System (MBSS);'' HHS/CMS/OCSQ.
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 contractors.
Categories of Individuals Covered by the System:
CMS has determined that the evidence is adequate to conclude that
bariatric surgery is reasonable and necessary for Medicare
beneficiaries who have a Body Mass Index >= 35, at least one co-
morbidity related to morbid obesity, and have been unsuccessful with
medical treatment for obesity.
[[Page 940]]
Categories of Records in the System:
The data collection should include baseline patient
characteristics. The information collected will include but is not
limited to: name, address, telephone number, Health Insurance Claim
Number (HICN), geographic location, race/ethnicity, gender, and date of
birth, as well as, background information relating to Medicare or
Medicaid issues.
Authority for Maintenance of the System:
The statutory authority for linking coverage decisions to the
collection of additional data is derived from Sec. 1862(a)(1)(A) of the
Social Security Act (the Act), which states that Medicare may not
provide payment for items and services unless they are ``reasonable and
necessary'' for the treatment of illness or injury. In some cases, CMS
will determine that an item or service is only reasonable and necessary
when specific data collections accompany the provision of the service.
In these cases, the collection of data is required to ensure that the
care provided to individual patients will improve health outcomes.
Purpose(s) of the System:
The purpose of this system is to provide reimbursement for
bariatric surgery, and assist in the collection of data on patients
receiving bariatric surgery, for a data collection process to assure
patient safety and protection, and to determine that the bariatric
surgery is reasonable and necessary. Information retrieved from this
system will also be disclosed to: (1) Support regulatory,
reimbursement, and policy functions performed within the agency or by a
contractor or consultant; (2) assist another Federal or state agency
with information to 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) 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; (4)
support constituent requests made to a congressional representative;
(5) support litigation involving the agency; and (6) combat fraud and
abuse in certain Federally-funded health benefits programs.
Routine Uses of Records Maintained in the System, Including Categories
of 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 or consultants who have been engaged by
the agency to assist in the performance of a service related to this
system of records and who need to have access to the records in order
to perform the activity.
2. To another Federal or State agency to:
A. Provide reimbursement for bariatric surgery, and assist in the
collection of data on patients receiving bariatric surgery, for a data
collection process to assure patient safety and protection, and to
determine that the bariatric surgery is reasonable and necessary,
b. Contribute to the accuracy of CMS's proper payment of Medicare
benefits, and/or
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.
3. To 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. To a member of Congress or to a Congressional staff member in
response to an inquiry of the Congressional office made at the written
request of the constituent about whom the record is maintained.
5. To 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.
6. To 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 or abuse in such program.
7. To 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
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 or 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, 65 FR 82462 (12-28-00), subparts A and E. 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.''
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
individuals who are familiar with the enrollees 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 are stored electronically.
Retrievability:
The data are retrieved by an individual identifier i.e., name of
beneficiary or provider.
[[Page 941]]
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 of 6 years and 3
months. 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, Office of Clinical Standards and Quality, CMS, Room S2-
26-17, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.
Notification Procedure:
For the purpose of access, the subject individual should write to
the system manager who will require the system name, address, age,
gender, and for verification purposes, the subject individual's name
(woman's maiden name, if applicable).
Record Access Procedure:
For the purpose of access, use the same procedures outlines 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).
Contesting Records Procedures:
The subject individual should contact the system manager named
above and reasonable identify the records 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:
Records maintained in this system are derived from Carrier and
Fiscal Intermediary Systems of Records, Common Working File System of
Records, clinics, institutions, hospitals and group practices
performing the procedures, and outside registries and professional
interest groups.
Systems Exempted From Certain Provisions of the Act:
None.
[FR Doc. E5-8331 Filed 1-5-06; 8:45 am]
BILLING CODE 4120-03-P