[Federal Register Volume 75, Number 228 (Monday, November 29, 2010)]
[Notices]
[Pages 73095-73101]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-29952]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Privacy Act of 1974; Report of New System of Records
AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of
Health and Human Services (HHS).
ACTION: Notice of a New System of Records.
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SUMMARY: In accordance with the requirements of the Privacy Act of
1974, CMS is establishing a new system of records (SOR) titled,
``Medicare and Medicaid Electronic Health Record (EHR) Incentive
Program National Level Repository'' System No. 09-70-0587. The final
rule for the Medicare and Medicaid EHR Incentive Program implements the
provisions of the American Recovery and Reinvestment Act of 2009 (the
Recovery Act) (Pub. L. 111-5). Specifically, Title IV of Division B of
the Recovery Act amends Titles XVIII and XIX of the Social Security Act
(the Act) by establishing incentive payments to eligible professionals
(EPs), eligible hospitals and critical access hospitals (CAHs) and
Medicare Advantage (MA) Organizations participating in Medicare and
Medicaid programs that adopt and successfully demonstrate meaningful
use of certified electronic health record (EHR) technology. These
Recovery Act provisions, together with Title XIII of Division A of the
Recovery Act, may be cited as the ``Health Information Technology for
Economic and Clinical Health Act,'' or the ``HITECH Act.''
The final rule specified the initial criteria EPs, eligible
hospitals and CAHs, and MA Organizations must meet in order to qualify
for an incentive payment; calculation of the incentive payment amounts;
payment adjustments under Medicare for covered professional services
and inpatient hospital services provided by EPs, eligible hospitals and
CAHs failing to demonstrate meaningful use of certified EHR technology
beginning in 2015; and other program participation requirements. Also,
the Office of the National Coordinator for Health Information
Technology (ONC) issued a closely related final rule that specified the
initial set of standards, implementation specifications, and
certification criteria for certified EHR technology. ONC has also
issued a separate final rule on the establishment of certification
programs for health information technology (HIT).
To register for the Medicare and Medicaid EHR Incentive Program,
EPs,
[[Page 73096]]
eligible hospitals and CAHs, and MA Organizations will be required to
provide the following information: Name, National Provider Identifier
(NPI), business address and business phone for each EP, eligible
hospital or CAH; Taxpayer Identification Number (TIN) to which the EP,
eligible hospital or CAH wants the incentive payment to be made; For
EPs, whether they choose to participate in the Medicare EHR Incentive
Program or the Medicaid EHR Incentive Program; For eligible hospitals
and CAHs, their CMS Certification Number (CCN); and other information
as specified by CMS. EPs, eligible hospitals and CAHs will also have
the option to provide their e-mail address at the time of registration.
MA Organizations will be required to provide their contract number on
behalf of their MA-affiliated EPs and hospitals. At this time,
participation in the Medicare and Medicaid EHR Incentive Programs is
voluntary for EPs, eligible hospitals and CAHs.
Per section 1886(n)(4)(B) of the Act, as added by section 4102(c)
of the HITECH Act, the Secretary will post on the Internet Web site of
the Centers for Medicare & Medicaid Services, in an easily
understandable format, a list of the names, business addresses, and
business phone numbers of the Medicare EPs, eligible hospitals and CAHs
who are meaningful EHR users in the Medicare EHR Incentive Program.
Sections 1853(m)(5) and 1853(l)(7) of the Act, as added by sections
4101(c) and 4102(c) of the HITECH Recovery Act, require the Secretary
to post the same information for EPs and eligible hospitals
participating in the MA program as would be required if they were in
the Medicare FFS program. Additionally, the Secretary must post the
names of the qualifying MA Organizations receiving the incentive
payment or payments. The routine uses established with this system
contain a proper explanation as to the need for the disclosure
provisions and provide clarity to CMS' intention to disclose provider-
specific information contained in this system.
The primary purpose of this system, called the National Level
Repository or NLR, is to collect, maintain, and process information
that is required for the Medicare and Medicaid EHR Incentive Program.
Information in this system will also be disclosed to: (1) Support
regulatory, incentive payments and policy functions such as evaluation
and reporting, whether performed by the Agency or by an Agency
contractor or consultant; (2) assist another Federal and/or state
agency, agency of a state government, or an agency established by state
law; (3) assist in making the individual physician-level participation
data available through an Agency website and by various other means of
data dissemination; (4) assist the Department's Office of the National
Coordinator of Health Information Technology's (ONC's) grantees for the
purpose of supporting ``eligible professional'' (EP) adoption and
meaningful use of certified EHR technology; (5) support litigation
involving the Agency; (6) combat fraud, waste, and abuse in certain
health benefits programs, and (7) assist in a response to a suspected
or confirmed breach of the security or confidentiality of information.
We have provided background information about this new system in the
``Supplementary Information'' section below. Although the Privacy Act
requires only that CMS provide an opportunity for interested persons to
comment on the proposed routine uses, CMS invites comments on all
portions of this notice. See ``Effective Dates'' section for
information about the comment period.
DATES: Effective Dates: CMS filed a new system report with the Chair of
the House Committee on Government Reform and Oversight, the Chair of
the Senate Committee on Homeland Security & Governmental Affairs, and
the Administrator, Office of Information and Regulatory Affairs, Office
of Management and Budget (OMB) on November 29, 2010. To ensure that all
parties have adequate time in which to comment, the new system,
including routine uses, will become effective 30 days from the
publication of the notice, or 40 days from the date it was submitted to
OMB and Congress, whichever is later, unless CMS receives comments that
require alterations to this notice.
ADDRESSES: The public should address comments to: CMS Privacy Officer,
Division of Information Security and Privacy Management, Enterprise
Architecture and Strategy Group, Office of Information Services, CMS,
Room N1-24-08, 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 zone.
FOR FURTHER INFORMATION CONTACT: Rachel Maisler, Health Insurance
Specialist, Office of E-Health Standards and Services, CMS, 7500
Security Boulevard, Mail-stop: S2-26-17, Baltimore, MD 21244-1850.
Office: 410-786-5754, Facsimile: 410-786-1347, E-mail address:
[email protected].
SUPPLEMENTARY INFORMATION: Sections 4101(a), 4102(a) and 4102(a)(2) of
the HITECH Act respectively add sections 1848(o), 1886(n) and
1814(l)(A)(3) to the Act to limit incentive payments in the Medicare
Fee-for-service (FSS) EHR incentive program to an EP, eligible hospital
or CAH that is a ``meaningful EHR user.'' Sections 4101(c) and 4102(c)
of the HITECH Act respectively adds sections 1853(l) and 1853(m) which
outline the application of incentive payments for certain MA-affiliated
EPs and MA-affiliated hospitals. Section 4201(a)(2) of the HITECH Act
added section 1903(t) to the Act to limit incentive payments in the
Medicaid context to EPs, as defined at section 1903(t)(2)(A), who meet
the requirements of 1903(t). As described in our final rule discussed
below, these eligible professionals can receive an incentive payment
for adoption or utilization of, or upgrade to, certified EHR technology
in 2011, and can receive incentive payments in certain subsequent years
if they demonstrate meaningful use of certified EHR technology.
In sections 1848(o)(2)(A) and 1886(n)(3) of the Act, the Congress
specified three types of requirements for meaningful use in the
Medicare context: (1) Use of certified EHR technology in a meaningful
manner; (2) that the certified EHR technology is connected in a manner
that provides for the electronic exchange of health information to
improve the quality of care; and (3) that, in using certified EHR
technology, the provider submits to the Secretary information on
clinical quality measures and such other measures selected by the
Secretary.
In our final rule on the EHR incentive program, we stated that we
are not limited to collecting only information pertaining to Medicare
and Medicaid beneficiaries. Therefore, in our final rule, we require
that, in order to demonstrate meaningful use, an EP, eligible hospital
or CAH, or MA Organization must report aggregate information on
clinical quality measures for all patients to whom clinical quality
measures apply. As explained in the final rule for EHR incentive
payments, for the 2011 payment year, we use an attestation methodology
for the submission of summary information on clinical quality measures
as a condition of demonstrating meaningful use of certified EHR
technology.
For the Medicaid incentive program, as stated in our final rule,
for their first year of payment, providers are not required to
demonstrate meaningful use, and may receive an incentive payment by
demonstrating adoption,
[[Page 73097]]
implementation, or upgrade to certified EHR technology. We expect that,
for 2011, the majority of Medicaid providers will receive an incentive
payment through this pathway. In their second, third, fourth, fifth and
sixth payment year, Medicaid EPs and hospitals will be required to
demonstrate meaningful use of certified EHR technology to qualify for
an incentive payment.
As stated in our final rule, we will use a phased approach for
meaningful use criteria, based on currently available technology
capabilities and provider practice experience. We refer to the initial
meaningful use criteria as ``Stage 1.'' In the final rule, we require
that EPs, eligible hospitals and CAHs, including MA-affiliated EPs and
hospitals, demonstrate that they satisfy all the required meaningful
use objectives and associated measures of the Stage 1 criteria during
the reporting period for 2011 through attestation in order to receive
incentive payments. In addition, we require that EPs, eligible
hospitals and CAHs, and MA Organizations attest to the accuracy and
completeness of the numerators and denominators for each of the
applicable measures, and that the information submitted includes
information on all patients to whom the measure applies.
To qualify as a meaningful EHR user for 2011, we require that EPs,
eligible hospitals, or CAHs demonstrate that they meet all of the
required meaningful use objectives and the associated measures using
certified EHR technology. In order to receive an incentive payment, all
EPs, eligible hospitals and CAHs must register for the program in the
NLR and then attest that they have successfully demonstrated meaningful
use of certified EHR technology after the completion of their EHR
reporting period, which is defined at 75 FR 44566.
Section 1848(o)(3)(D) of the Act requires the Secretary to list, in
an easily understandable format, the names, business addresses, and
business phone numbers of the Medicare EPs for being meaningful EHR
users under the Medicare FFS program on the Internet web site of CMS.
Section 1886(n)(4)(B) of the Act requires the Secretary to list, in an
easily understandable format, the names and other relevant data as
determined appropriate, of eligible hospitals and CAHs who are
meaningful EHR users under the Medicare FFS program, on the CMS
Internet web site. Sections 1853(m)(5) and 1853(I)(7) of the Act
require the Secretary to post the same information for EPs and eligible
hospitals in the MA program as would be required if they were in the
Medicare FFS program. Therefore, we collect the information necessary
to post the name, business address and business phone numbers of all
EPs, eligible hospitals and CAHs participating in the Medicare FFS and
MA EHR Incentive Program,, and post this information on our Internet
web site. The routine uses established with this system contain a
proper explanation as to the need for the disclosure provisions and
provide clarity to CMS' intention to disclose provider-specific
information contained in this system.
I. Description of the Proposed System of Records
A. Statutory and Regulatory Basis for System
Authority for the collection, maintenance, and disclosures from
this system is provided under Sec. Sec. 1848(o), 1886(m), 1848(l), and
1853(m) of the Social Security Act which were added by the HITECH Act,
respectively authorize incentive payments for EPs, eligible hospitals,
CAHs and MA Organizations that successfully demonstrate meaningful use
of certified EHR technology. Sections 1903(a)(3) and 1903(t) of the
Social Security Act provides authority for the Medicaid EHR Incentive
Program. These provisions are implemented by 75 FR 44314 and 42 CFR
parts 412, 413, 422, collectively known as the Medicare and Medicaid
Programs; Electronic Health Record Incentive Program; Final Rule.
B. Collection and Maintenance of Data in the System
The National Level Repository (NLR) contains information on
eligible professionals who receive Medicare incentives as meaningful
users of certified EHR technology. Information in the NLR will be
populated from other CMS systems, including the Provider Enrollment,
Chain, and Ownership System (PECOS) and the National Plan & Provider
Enumeration System (NPPES). The NLR will contain provider name,
National Provider Identifier (NPI), business address and phone number,
Taxpayer Identification Number (TIN) to which the EP, eligible hospital
or CAH, or MA Organization wants the incentive payment to be made, and,
for EPs, whether they choose to participate in the Medicare EHR
Incentive Program or the Medicaid EHR Incentive Program. For eligible
hospitals and CAHs, their CCN will also be included. For MA
Organizations, their CMS contract number will be included. For
providers participating in the Medicaid EHR Incentive Program, it will
include the State in which they choose to participate. Additionally,
EPs, eligible hospitals and CAHs will have the option to provide an e-
mail address for inclusion in the system. At this time, participation
in the Medicare and Medicaid EHR Incentive Program is voluntary for
EPs, eligible hospitals and CAHs.
II. Agency Policies, Procedures, and Restrictions On Routine Uses
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 information collected in the NLR that
can be associated with an individual EP as provided for under ``Section
III. Proposed Routine Use Disclosures of Data in the System.''
Identifiable data may be disclosed under a routine use.
We will only disclose the minimum provider-level data necessary to
achieve the purpose of the Medicare and Medicaid EHR Incentive Program.
CMS has the following policies and procedures concerning disclosures of
information that will be maintained in the system. These policies do
not apply to Routine Use No. 3 for this system. In general, disclosure
of information from the system will be approved only for the minimum
information necessary to accomplish the purpose of the disclosure and
only after CMS:
1. Determines that the use or disclosure is consistent with the
reason that the data is being collected, e.g., to collect, maintain,
and process information promoting the nationwide health information
technology infrastructure that allows for the electronic use and
exchange of information.
2. Determines that:
a. The purpose of the disclosure can only be accomplished if the
record is provided in an 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 provider 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;
[[Page 73098]]
b. Remove or destroy at the earliest time all individually-
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. 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 Medicare and Medicaid EHR Incentive
Program without the consent 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 or consultants who have been
engaged by the Agency to assist in accomplishment of a CMS function
relating to the purposes for this SOR and who need to have access to
the records in order to assist CMS.
We contemplate disclosing information under this routine use only
in situations in which CMS may enter into a contractual or similar
agreement with a third party to assist in accomplishing a CMS function
relating to purposes for this SOR.
CMS occasionally contracts out certain of its functions when doing
so would contribute to effective and efficient operations. CMS must be
able to give a contractor 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 assist another Federal or state agency, agency of a state
government, or an agency established by state law pursuant to
agreements with CMS to:
a. Contribute to the accuracy of CMS's proper incentive payment to
Medicare and Medicaid EHR Incentive Program participants, and
b. Assist Federal/state Medicaid programs which may require
Medicare and Medicaid EHR Incentive Program information for purposes
related to this system.
c. Assist other Federal agencies that have the authority to perform
collection of debts owed to the Federal government.
Other Federal or state agencies in their administration of a
Federal health program may require EHR Incentive Program information in
order to support evaluations and monitoring of various aspects of the
Medicare and Medicaid EHR Incentive payments.
2. To assist in making the information for EPs, eligible hospitals
and CAHs, and MA Organizations that receive Medicare EHR incentive
payments through the new payment contractor, available through a public
web site. If local websites are used by a local or regional
collaborative, CMS would have links to these Web sites on its main Web
site.
This information would be posted for the purpose of, and in a
manner that would promote the use of EHRs by EPs, eligible hospitals
and CAHs, and MA Organizations to Medicare and Medicaid beneficiaries.
3. To assist the Department's Office of the National Coordinator of
Health Information Technology's (ONC's) grantees for the purpose of
supporting ``eligible professional'' (EP) adoption and meaningful use
of certified EHR technology.
We contemplate disclosing information under this routine use only
in situations in which CMS may be asked to provide necessary
information to ONC grantees, also referred to as Health Information
Technology Regional Extension Centers (RECs) to assist in accomplishing
an ONC function relating to support for ``eligible professional'' (EP)
adoption of, meaningful use of certified EHR technology, and provider
support.
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, or occasionally when
another party is involved in litigation and CMS's policies or
operations could be affected by the outcome of the litigation, CMS
would be able to disclose information to the DOJ, court, or
adjudicatory body involved.
5. To assist a CMS contractor (including, but not limited to
Medicare Administrative Contractors, fiscal intermediaries, and
carriers) that assists in the administration of a CMS-administered
health benefits program, or to a grantee of a CMS-administered grant
program, when disclosure is deemed reasonably necessary by CMS to
prevent, deter, discover, detect, investigate, examine, prosecute, sue
with respect to, defend against, correct, remedy, or otherwise combat
fraud, waste or abuse in such program.
We contemplate disclosing information under this routine use only
in situations in which CMS may enter into a contract or grant with a
third party to assist in accomplishing CMS functions relating to the
purpose of combating fraud, waste or abuse.
CMS occasionally contracts out certain of its functions when doing
so would contribute to effective and efficient operations. CMS must be
able to give a contractor or grantee whatever information is necessary
for the contractor or grantee to fulfill its duties. In these
situations, safeguards are provided in the contract prohibiting the
contractor or grantee from using or disclosing the information for any
purpose other than that described in the contract or grant and
requiring the contractor or grantee 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 or abuse in a health benefits program funded in whole or in part
by Federal funds, when disclosure is deemed reasonably necessary by CMS
to prevent, deter, discover, detect, investigate, examine, prosecute,
sue with respect to, defend against, correct, remedy, or otherwise
combat fraud, waste or abuse in such programs.
Other agencies may require Medicare and Medicaid EHR Incentive
Program information for the purpose of
[[Page 73099]]
combating fraud, waste or abuse in such Federally-funded programs.
7. To assist appropriate Federal agencies and Department
contractors that have a need to know the information for the purpose of
assisting the Department's efforts to respond to a suspected or
confirmed breach of the security or confidentiality of information
maintained in this system of records, and the information disclosed is
relevant and unnecessary for the assistance.
Other Federal agencies and contractors may require EHR Incentive
Program information for the purpose of assisting in a respond to a
suspected or confirmed breach of the security or confidentiality of
information.
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 E-Government Act of 2002, the Clinger-
Cohen Act of 1996; the Medicare Modernization Act of 2003, and the
corresponding implementing regulations. OMB Circular A-130, Management
of Federal Resources, Appendix III, Security of Federal Automated
Information Resources also applies. Federal, HHS, and CMS policies and
standards include but are not limited to: All pertinent National
Institute of Standards and Technology publications; the HHS Information
Systems Program Handbook and the CMS Information Security Handbook.
V. Effects of the New System On the Rights of Individuals
CMS proposes to establish this system in accordance with the
principles and requirements of the Privacy Act and will collect, use,
and disseminate information only as prescribed therein. We will only
disclose the minimum personal data necessary to achieve the purpose of
the data collection and the routine uses contained in this notice.
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: November 16, 2010.
Michelle Snyder,
Deputy Chief Operating Officer, Centers for Medicare & Medicaid
Services.
SYSTEM No. 09-70-0587
SYSTEM NAME:
``Medicare and Medicaid Electronic Health Record (EHR) Incentive
Program National Level Repository'' HHS/CMS/OESS.
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 National Level Repository (NLR) contains information on
eligible professionals who receive Medicare incentives as meaningful
users of certified EHR technology.
CATEGORIES OF RECORDS IN THE SYSTEM:
The NLR will contain provider name, National Provider Identifier
(NPI), business address and phone number, Taxpayer Identification
Number (TIN) to which the EP, eligible hospital or CAH, or MA
Organization wants the incentive payment to be made, and, for EPs,
whether they choose to participate in the Medicare EHR Incentive
Program or the Medicaid EHR Incentive Program. For eligible hospitals
and CAHs, their CCN will also be included. For MA Organizations, their
CMS contract number will be included. For providers participating in
the Medicaid EHR Incentive Program, it will include the State in which
they choose to participate. Additionally, EPs, eligible hospitals and
CAHs will have the option to provide an e-mail address for inclusion in
the system. At this time, participation in the Medicare and Medicaid
EHR Incentive Program is voluntary for EPs, eligible hospitals and
CAHs.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
Authority for the collection, maintenance, and disclosures from
this system is provided under Sec. Sec. 1848(o), 1886(m), 1848(l), and
1853(m) of the Social Security Act which were added by the HITECH Act,
respectively authorize incentive payments for EPs, eligible hospitals,
CAHs and MA Organizations that successfully demonstrate meaningful use
of certified EHR technology. Sections 1903(a)(3) and 1903(t) of the
Social Security Act provides authority for the Medicaid EHR Incentive
Program. These provisions are implemented by 75 FR 44314 and 42 CFR
parts 412, 413, 422, collectively known as the Medicare and Medicaid
Programs; Electronic Health Record Incentive Program; Final Rule.
PURPOSE(S) OF THE SYSTEM:
The primary purpose of this system, called the National Level
Repository or NLR, is to collect, maintain, and process information
that is required for the Medicare and Medicaid EHR Incentive Program.
Information in this system will also be disclosed to: (1) Support
regulatory, incentive payments and policy functions such as evaluation
and reporting, whether performed by the Agency or by an Agency
contractor or consultant; (2) assist another Federal and/or state
agency, agency of a state government, or an agency established by state
law; (3) assist in making the individual physician-level participation
data available through an Agency website and by various other means of
data dissemination; (4) assist the Department's Office of the National
Coordinator of Health Information Technology's (ONC's) grantees for the
purpose of supporting ``eligible professional'' (EP) adoption and
meaningful use of certified EHR technology; (5) support litigation
involving the Agency; (6) combat fraud, waste, and abuse in certain
health
[[Page 73100]]
benefits programs, and (7) assist in a response to a suspected or
confirmed breach of the security or confidentiality of information.
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 EHRI without the consent 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. To assist another Federal or state agency, agency of a state
government, or an agency established by state law pursuant to
agreements with CMS to:
a. Contribute to the accuracy of CMS's proper incentive payment to
Medicare and Medicaid EHR Incentive Program participants, and
b. Assist Federal/state Medicaid programs which may require
Medicare and Medicaid EHR Incentive Program information for purposes
related to this system.
c. Assist other Federal agencies that have the authority to perform
collection of debts owed to the Federal government.
3. To assist in making the information for EPs, eligible hospitals
and critical access hospitals (CAHs), who receive EHR incentive
payments through the new payment contractor, available through a public
website. If local Web sites are used by a local or regional
collaborative, CMS would have links to these websites on its main
website.
4. To assist the Department's Office of the National Coordinator of
Health Information Technology's (ONC's) grantees for the purpose of
supporting ``eligible professional'' (EP) adoption and meaningful use
of certified EHR technology.
5. 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.
6. To assist a CMS contractor (including, but not 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 or abuse in such program.
7. 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.
8. To assist appropriate Federal agencies and Department
contractors that have a need to know the information for the purpose of
assisting the Department's efforts to respond to a suspected or
confirmed breach of the security or confidentiality of information
maintained in this system of records, and the information disclosed is
relevant and necessary for the assistance.
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 provider number
(facility, physician, IDs), service dates, and prescriber
identification number.
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 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 10 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, Office of E-Health Standards and Services, Centers for
Medicare & Medicaid Services, 7500 Security Blvd, Mail-stop: S2-26-17,
Baltimore, MD 21244-1850.
[[Page 73101]]
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., Provider number, SSN, 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:
Information in the National Level Repository will be populated from
other CMS systems of records, including the Provider Enrollment, Chain,
and Ownership System (PECOS) and the National Plan & Provider
Enumeration System (NPPES).
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
[FR Doc. 2010-29952 Filed 11-26-10; 8:45 am]
BILLING CODE 4120-01-P