80_FR_49395 80 FR 49237 - Privacy Act of 1974: Report of New System of Records

80 FR 49237 - Privacy Act of 1974: Report of New System of Records

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services

Federal Register Volume 80, Issue 158 (August 17, 2015)

Page Range49237-49240
FR Document2015-20224

In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new SOR titled, ``CMS Risk Adjustment Suite of Systems (RASS),'' System No. 09-70-0508. Payments to Medicare Advantage (MA) organizations, Part D sponsors, and Program of All Inclusive Care for the Elderly (PACE) organizations (collectively referred to as ``MA organizations and other entities'') are adjusted based on the health status of enrolled Medicare beneficiaries (``enrollees''). RASS is established to receive, process, and store the data used to risk-adjust payments based on enrollee health status. The data will be used specifically to develop risk adjustment models and to calculate the risk score for each enrollee. Each MA organization and other entity must submit data to CMS in accordance with CMS regulations and instructions. ``Risk adjustment data'' refers to data submitted in two separate formats: comprehensive data equivalent to Medicare fee-for-service data (often referred to as encounter data); and data in abbreviated formats (often referred to as RAPS data). The MA risk adjustment data addressed by this SOR includes RAPS data submitted by a MA organization in an abbreviated format, as referenced at Sec. 422.310(d)(1), and similar abbreviated risk adjustment data submitted by other MA organizations and other entities. Encounter data has a separate SOR (System No. 09-70-0506).

Federal Register, Volume 80 Issue 158 (Monday, August 17, 2015)
[Federal Register Volume 80, Number 158 (Monday, August 17, 2015)]
[Notices]
[Pages 49237-49240]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-20224]


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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 New System of Records (SOR).

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

SUMMARY: In accordance with the requirements of the Privacy Act of 
1974, we are proposing to establish a new SOR titled, ``CMS Risk 
Adjustment Suite of Systems (RASS),'' System No. 09-70-0508. Payments 
to Medicare Advantage (MA) organizations, Part D sponsors, and Program 
of All Inclusive Care for the Elderly (PACE) organizations 
(collectively referred to as ``MA organizations and other entities'') 
are adjusted based on the health status of enrolled Medicare 
beneficiaries (``enrollees''). RASS is established to receive, process, 
and store the data used

[[Page 49238]]

to risk-adjust payments based on enrollee health status. The data will 
be used specifically to develop risk adjustment models and to calculate 
the risk score for each enrollee.
    Each MA organization and other entity must submit data to CMS in 
accordance with CMS regulations and instructions. ``Risk adjustment 
data'' refers to data submitted in two separate formats: comprehensive 
data equivalent to Medicare fee-for-service data (often referred to as 
encounter data); and data in abbreviated formats (often referred to as 
RAPS data). The MA risk adjustment data addressed by this SOR includes 
RAPS data submitted by a MA organization in an abbreviated format, as 
referenced at Sec.  422.310(d)(1), and similar abbreviated risk 
adjustment data submitted by other MA organizations and other entities. 
Encounter data has a separate SOR (System No. 09-70-0506).

DATES: Effective 30 days after publication. Written comments should be 
submitted on or before the effective date. HHS/CMS/CM may publish an 
amended system of records notice (SORN) in light of any comments 
received.

ADDRESSES: The public should address comments to: CMS Privacy Officer, 
Division of Security, Privacy Policy & Governance, Information Security 
& Privacy Group, Office of Enterprise Information, CMS, 7500 Security 
Boulevard, Baltimore, MD 21244-1870, Mailstop: N1-24-08, Office: (410) 
786-5357, email: [email protected]. 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: Risk Adjustment Mailbox Coordinator, 
Division of Encounter Data and Risk Adjustment Operations, Medicare 
Plan Payment Group, Center for Medicare, CMS, Mail Stop C1-13-07, 7500 
Security Boulevard, Baltimore, Maryland 21244-1850. The email is 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background on the Risk Adjustment Suite of Systems (RASS)

    The new RASS system of records is being established to cover data 
used to create risk adjustment scores needed to risk-adjust payments to 
Medicare and Medicaid provider entities, based on beneficiary 
demographics and health status. Risk-adjusted payments will implement 
reformatory provisions of the Social Security Act at sections 1853(a), 
1860D-15(c), and 1894(d)(2) (42 U.S.C. 1395w-23, 1395w-115, and 
1395eee), intended to collect and accurately calculate scores based on 
a beneficiary's demographics and health status. RASS will cover data 
housed in two existing information systems: The Risk Adjustment 
Processing System (RAPS), and the Risk Adjustment System (RAS). RAS 
will contain data extracted from RAPS and from two other IT systems 
(CME and NMUD), as more fully explained below:
    [cir] RAPS will receive abbreviated current risk adjustment data, 
consisting of diagnosis data about each beneficiary and the 
beneficiary's health care provider type, submitted by the relevant 
payee entity through the Front-End Risk Adjustment System (FERAS); RAPS 
will use the data to create an enrollee diagnosis data file for each 
beneficiary (See Categories of Records for data elements).
    [cir] RAS will extract the enrollee diagnosis data files from RAPS 
and will receive current demographic, enrollment and diagnoses data and 
past medical history data for each enrollee from two other CMS systems 
(CME and NMUD); RAS will use the RAPS, CME, and NMUD data to calculate 
risk factors and create a Risk Adjustment Factor (RAF) file, containing 
the risk score of each beneficiary:
    [ssquf] Common Medicare Environment (CME): RAS will extract current 
individual demographic and enrollment data about each enrollee (See 
Categories of Records for data elements).
    [ssquf] National Claims History files housed in the National 
Medicare Utilization Database (NMUD): RAS will extract current Medicare 
Fee-for-service (FFS) diagnoses information submitted on Inpatient, 
Outpatient, and Physician claims for each enrollee (See Categories of 
Records for data elements).
    [cir] RAS will transmit the Risk Adjustment Factor (RAF) file 
created in RAS to CMS' payment processing system for purposes of 
calculating and adjusting payments to payee entities, as follows:
    [ssquf] CMS pays MA organizations on a monthly prospective amount 
for each beneficiary enrolled (enrollee) in a Part C plan.
    [ssquf] CMS pays Part D sponsors a monthly prospective amount that 
reflects the plan sponsor's estimate of the revenue needed to cover a 
plan's costs for the risk portion of basic prescription drug coverage. 
The direct subsidy is adjusted based on the beneficiary's risk score, 
which reflects expected prescription drug expenditures for the coverage 
year (relative to a national average of 1.0), based on demographic and 
health status information for that person.
    [ssquf] CMS pays PACE organizations a monthly capitation amount 
based on the Part A and Part B payment rates established for purposes 
of payment to Medicare Advantage organizations pursuant to 1894(d)(2). 
CMS will ensure that payments take into account the comparative frailty 
of PACE enrollees relative to the general Medicare population.
    In addition to providing the file used to calculate risk adjustment 
payments, the RASS also provides reports for CMS based on the analysis 
of RAF files and other criteria; these reports include MA plan file 
submission transactions (acceptance rates, rejection rates, error 
rates, etc.) on a daily, weekly, monthly, and quarterly basis.

II. The Privacy Act

    The Privacy Act governs the collection, maintenance, use, and 
dissemination of certain information about individuals by agencies of 
the Federal Government.
    A ``SOR'' is a group of any records under the control of a Federal 
agency from which information about individuals is retrieved by name or 
other personal identifier. The Privacy Act requires each agency to 
publish in the Federal Register notice of the existence and character 
of each SOR that the agency maintains. The System of Records Notice 
(SORN) identifies or describes the laws authorizing the system to be 
maintained; the types and sources of records in the system; the 
categories of individuals to whom the records pertain; the purposes for 
which the records are used within the agency; the routine uses for 
which a record maybe disclosed to parties outside the agency without 
the individual's prior, written consent; agency policies and procedures 
for safeguarding, storing, retrieving, accessing, retaining, and 
disposing of the records; the procedures for an individual to follow to 
make notification, access, and amendment requests to the System 
Manager; and whether the SOR is exempt from certain Privacy Act 
requirements.
System Number:
    09-70-0508

System Name:
    CMS Risk Adjustment Suite of Systems (RASS), HHS/CMS/CM.

Security Classification:
    Unclassified.

System Location:
    RASS (RAS/RAPS) Location: CMS Data Center, 7500 Security Boulevard, 
North Building, First Floor, Baltimore, Maryland 21244-1850.

[[Page 49239]]

Categories of Individuals Covered by the System:
    Information collected and maintained in this system pertains to: 
(1) Medicare beneficiaries enrolled in a Part C MA plan, MA-PD plan, 
PDP or PACE organization (``enrollees'') and (2) the health care 
provider(s), supplier(s), physician(s), or other practitioner(s) 
(``Providers'') who provide health care items and services to these 
enrollees.

Categories of Records in the System:
    The MA plans, MA-PDs, PDPs and PACE organizations (``MA 
organizations and other entities'') receive the data from the providers 
which is then submitted to RAPS via FERAS. The data received from the 
MA organizations and other entities are primarily diagnosis data 
extracted from claims information. Additional FFS and utilization data 
regarding those submissions are received from the CME and NCH data 
systems to complete the enrollee data requirements.
    Records will consist of the risk score for each enrollee and the 
data used to calculate the score, contained in Risk Adjustment Factor 
(RAF) files created in CMS' Risk Adjustment System (RAS), using data 
extracted from three other CMS IT systems:
     RAPS data: Diagnosis data files containing abbreviated 
current diagnosis data submitted by payee entities to CMS's Risk 
Adjustment Processing System (RAPS):
    [cir] Health Insurance Claim Number (HICN)
    [cir] Provider Type
    [cir] Service From Date
    [cir] Service Through Date
    [cir] Plan Number (MAO contract number)
    [cir] Diagnosis Code
    [cir] Diagnosis Delete Date
    [cir] RAS Diagnosis Indicator
    [cir] NCH Category Equitable BIC
    [cir] Accrete Data
    [cir] Delete Plan Number
    [cir] Submitter ID
    [cir] Daily File Code, and
    [cir] Delete File Code
     CME data: Current demographic and enrollment data from 
CMS's Common Medicare Environment (CME):
    [cir] Beneficiary Link Key Partition number
    [cir] Beneficiary Link Identifier
    [cir] Health Insurance Claim Number (HICN)
    [cir] Beneficiary Social Security Number
    [cir] Beneficiary Birth Date
    [cir] Beneficiary Death Date
    [cir] Beneficiary Sex Code
    [cir] Beneficiary Race Code
    [cir] Beneficiary First Name
    [cir] Beneficiary Middle Name
    [cir] Beneficiary Last Name
     NCH data: Current diagnosis data [and past medical history 
data] from National Claims History Files in CMS's National Medicare 
Utilization Database (NMUD):
    [cir] Health Insurance Claim Number (HICN)
    [cir] NCH Category Equitable BIC
    [cir] Diagnosis code
    [cir] Service Through Date
    [cir] Service From Date
    [cir] Beneficiary Link Identifier
    [cir] Provider Number

Authority for Maintenance of the System:
    This system was established pursuant to sections 1853(a), 1860D-
15(c), and 1894(d)(2)of the Social Security Act (42 U.S.C. 1395w-23, 
1395w-115, 1395eee).

Purpose(s) of the System:
    Records will be used within the agency to develop risk adjustment 
models and to calculate the risk score for each Medicare beneficiary 
enrolled in the Medicare health plan. The risk score will be reported 
to the system that CMS uses to process payments, and ultimately will be 
used to adjust payments to MA organizations, Part D sponsors, and PACE 
organizations, based on beneficiary health status. (Note that payment 
records are not covered under this system of records.)
    Information retrieved from this SOR will be used for the following 
purposes:
 To determine the risk adjustment factors used to adjust 
payments to MA organizations and other entities, as required under 42 
CFR 422.304(a) and (c), 423.329 and 460.180
 to update risk adjustment models
 to calculate Medicare Disproportionate Share Hospital (DSH) 
percentages
 to conduct quality review and improvement activities for 
Medicare coverage purposes
 to conduct evaluations and other analysis to support the 
Medicare program (including demonstrations)
 to support public health initiatives and other health care-
related research
 for activities to support the administration of the Medicare 
program
 for activities conducted to support program integrity
 for purposes authorized by applicable law

Routine Uses of Records Maintained in the System, Including Categories 
or Users and the Purposes of Such Uses:
    Records may be disclosed to parties outside HHS, without the 
individual record subject's prior, written consent, for the following 
purposes:
    1. To determine the risk adjustment factors used to adjust 
payments, as required under Sec. Sec.  422.304(a) and (c), 423.329, and 
460.180, to update risk adjustment models, to calculate Medicare DSH 
percentages, to conduct quality review and improvement activities, for 
Medicare coverage purposes, to conduct evaluations and other analysis 
to support the Medicare program (including demonstrations) and to 
support public health initiatives, for activities conducted to support 
program integrity, and for purposes authorized by applicable law.
    2. To support CMS contractors, consultants, or grantees that have 
been contracted by the Agency when necessary to assist in 
accomplishment of a CMS function relating to the purposes for this 
system or a purpose listed in paragraph 1.
    3. To support an individual or organization for research to support 
the Medicare program and public health initiatives, and otherwise 
related to health care, such as evaluation or epidemiological projects 
related to the prevention of disease or disability, the restoration or 
maintenance of health, or for understanding and improving payment 
projects.
    4. To provide information to the U.S. Department of Justice (DOJ), 
a court, or an 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 State 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 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.
    6. To assist another Federal agency or an instrumentality of any 
governmental jurisdiction within or under the control of the United 
States (including any state or local governmental agency), that

[[Page 49240]]

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.
    7. To assist Medicare Advantage organizations, Part D Sponsors and 
PACE organizations with improving the quality of required risk 
adjustment data obtained from the provider that furnished the item or 
service. CMS will be analyzing the data received and advising MA 
organizations, Part D Sponsors and PACE organizations of trends and 
data analysis results to help improve the accuracy and completeness of 
data received from the provider.
    8. To assist appropriate Federal agencies and CMS contractors and 
consultants that have a need to know the information for the purpose of 
assisting CMS' efforts to respond to a suspected or confirmed breach of 
the security or confidentiality of information maintained in this 
system of records, provided that the information disclosed is relevant 
and necessary for that assistance.

    Note:  CMS may disclose information from this system of records, 
without the individual record subject's consent, for any of the 
following purposes referenced directly in the Privacy Act: 5 U.S.C. 
552a(b)(1), (3)-(8), and (12). CMS must also disclose information 
from this system of records, without the individual record subject's 
consent, for any of the following purposes referenced directly in 
the Privacy Act: 5 U.S.C. 552a(b)(2), and (b)(9)-(11).

Additional Provisions Affecting Routine Use Disclosures:
    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 PHI 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 
that is not directly identifiable, except 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 could, because of 
the small size, use this information to deduce the identity of the 
beneficiary).

    Note: Information collected or obtained under Sec.  1860D-15 
(i.e., risk adjustment data used to pay Part D plan sponsors) will 
be used and disclosed only in accordance with the statutory 
limitations under Sec.  1860D-15(f)(2).

POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, 
AND DISPOSING OF RECORDS IN THE SYSTEMStorage:
    Archived records will be stored on magnetic tapes. Data that is 
currently in use is stored in the RAPS database.

Retrievability:
    Records will be retrieved by National Provider Identifier (NPI), 
beneficiary provider name, or beneficiary Health Insurance Claim 
Number.

Safeguards:
    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. Access to 
records in the RASS will be limited to CMS personnel and contractors 
through password security, encryption, firewalls, and secured operating 
system(s).

Retention and Disposal:
    Records (i.e., enrollee diagnosis data files created in RAPS, and 
Risk Adjustment Factor (RAF) files created in RAS) will be maintained 
for a period of up to 10 years after date of creation. Any such records 
that are needed longer, such as to resolve claims and audit exceptions 
or to prosecute fraud, will be retained until such matters are 
resolved. Enrollee claims records are currently subject to a document 
preservation order and will be preserved indefinitely pending further 
notice from the U.S. Department of Justice (DOJ).

System Manager and Address:
    Director, Division of Encounter Data and Risk Adjustment 
Operations, Medicare Plan Payment Group, Center for Medicare, CMS, 7500 
Security Boulevard, Baltimore, Maryland 21244-1850.

Notification Procedure:
    Individuals (i.e., the beneficiary or provider) wishing to know if 
this system contains records about them should write to the system 
manager and include pertinent personally identifiable information 
(encrypted and properly transmitted) to be used for retrieval of their 
records (i.e., NPI or Health Insurance Claim Number).

Record Access Procedure:
    Individuals seeking access to records about them in this system 
should follow the same instructions indicated under ``Notification 
Procedure'' and reasonably specify the record content being sought. 
(These procedures are in accordance with Department regulation 45 CFR 
5b.5(a)(2)).

Contesting Record Procedures:
    Individuals seeking to contest the content of information about 
them in this system should follow the same instructions indicated under 
``Notification Procedure.'' The request should: reasonably identify the 
record and specify the information being contested; state the 
corrective action sought; and provide the reasons for the correction, 
with supporting justification. (These procedures are in accordance with 
Department regulation 45 CFR 5b.7.)

Record Source Categories:
    RASS processes data extracted from RAPS and RAS IT systems to 
calculate the risk scores used to adjust payments to Medicare Advantage 
organizations, Part D plan sponsors and PACE plans. RAS receives the 
most current data for each Medicare Part C and Part D beneficiary from 
the following sources: RAPS, Common Medicare Environment (CME) also 
known as Medicare Beneficiary Database (MBD/CME), and National Medicare 
Utilization Database (NMUD). RAPS receives risk adjustment data from MA 
organizations and other entities defined above.

Systems Exempted from Certain Provisions of the Act:
    None.

Celeste Dade-Vinson,
Health Insurance Specialist, Centers for Medicare & Medicaid Services.
[FR Doc. 2015-20224 Filed 8-14-15; 8:45 am]
 BILLING CODE 4120-03-P



                                                                               Federal Register / Vol. 80, No. 158 / Monday, August 17, 2015 / Notices                                                   49237

                                                  Proposed Project                                        Boston and Cincinnati. In these two                       younger children with a focus on
                                                    The Green Housing Pilot Study (New                    cities, renovations sponsored by the                      newborns–3 years. Having a larger age
                                                  Orleans)—New—National Center for                        Department of Housing and Urban                           range of children in the study will
                                                  Environmental Health (NCEH), Centers                    Development (HUD) had already been                        improve the estimates of how
                                                  for Disease Control and Prevention                      scheduled. By selecting sites in which                    environmental exposures inside and
                                                  (CDC).                                                  renovations were already scheduled to                     outside of their homes can occur during
                                                                                                          occur, CDC has leveraged the                              different life stages of childhood, a
                                                  Background and Brief Description                        opportunity to collect survey and                         critical period of life when the immune
                                                     The Centers for Disease Control and                  biomarker data from residents, and to                     system and other organ systems are still
                                                  Prevention (CDC) seeks a new three-year                 collect environmental measurements in                     developing.
                                                  OMB approval for the Green Housing                      homes to evaluate associations between                       The Pilot will be implemented by
                                                  Pilot Study (New Orleans) or ‘‘Pilot’’ of               green housing and health.                                 incorporating it into the Green Housing
                                                  additional components to be tested at                      Several objectives will be evaluated
                                                                                                                                                                    study schedule. Data collection methods
                                                  the New Orleans site for the main Green                 during the Pilot:
                                                                                                             (1) Identify and characterize factors                  include: (1) Time-activity pattern
                                                  Housing Study (OMB No. 0920–0906,
                                                                                                          affecting children’s exposures to                         questionnaire of children, administered
                                                  Expiration 10/31/2017). The goal of the
                                                                                                          chemical ingredients from consumer                        to mothers/primary caregivers; (2)
                                                  Pilot is to apply novel approaches to
                                                                                                          products found in their everyday                          collection of air, soil, dust samples from
                                                  study exposures to various indoor
                                                                                                          environment to support the data and                       the respondent’s home; and (3)
                                                  pollutants in children ranging in age
                                                                                                          modeling needs of the exposure                            collection of blood, urine, toenails
                                                  from newborn–12 years. The
                                                  information collected will help                         components of EPA’s national research                     clippings, and feces from the
                                                  scientists better understand time-                      programs;                                                 respondent’s eligible children.
                                                  activity patterns of children that affect                  (2) Evaluate the Pilot data metrics for                   We hypothesize that a better
                                                  exposures to chemical and biological                    incorporation in and enhancement of                       estimation of exposure pathways will
                                                  agents in their residential environments,               CDC’s ability to understand the                           improve exposure modeling for the
                                                  and improve estimates of exposure for                   relationship between environmental                        current and the future Green Housing
                                                  children.                                               exposures and asthma;                                     Study sites, and influence future
                                                     Results from this Pilot will inform                     (3) Compare multimedia                                 research in environmental health.
                                                  future Green Housing Study sites and                    measurements and survey data between                      Although children are considered
                                                  will potentially reduce participant time                pre- and post-renovation time points in                   participants, the respondents to all
                                                  burden by collecting some                               green and non-green low-income                            questionnaires are the mothers/primary
                                                  questionnaires electronically. This                     housing to assess exposure related                        caregivers; no children will fill out
                                                  study directly supports the Healthy                     changes in the residence and                              questionnaires.
                                                  People 2020 Healthy Homes’ health                       participants due to renovation activities.
                                                                                                             Like the other Green Housing Study                        The respondents are 64 mothers/
                                                  protection goal of the CDC. This
                                                                                                          sites, data will be collected from 64                     primary caregivers of enrolled children;
                                                  investigation is consistent with CDC’s
                                                                                                          households. Study participants are                        or approximately 21 respondents each
                                                  Health Protection Research Agenda,
                                                  which calls for research to identify the                children with asthma and their mothers/                   year. There is no cost to the respondents
                                                  major environmental causes of disease                   primary caregivers living in HUD-                         other than their time to participate in
                                                  and disability and related risk factors.                subsidized housing that has either                        the study.
                                                     In 2011, CDC funded the first two                    received a green renovation or is a non-                     The total estimated annual burden
                                                  study sites for the Green Housing Study,                green home. This Pilot will also enroll                   hours for the Pilot is 56 hours.

                                                                                                         ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                                                       Average
                                                                                                                                                                                       Number of
                                                                                                                                                                    Number of                        burden per
                                                               Type of respondents                                           Form name                                               responses per
                                                                                                                                                                   respondents                        response
                                                                                                                                                                                       respondent      (in hrs.)

                                                  Mothers/Primary Caregivers of Enrolled Chil-           Time/Activity Questionnaire ...........................       21                 4            40/60
                                                   dren.



                                                  Leroy A. Richardson,                                    DEPARTMENT OF HEALTH AND                                  SUMMARY:   In accordance with the
                                                  Chief, Information Collection Review Office,            HUMAN SERVICES                                            requirements of the Privacy Act of 1974,
                                                  Office of Scientific Integrity, Office of the                                                                     we are proposing to establish a new
                                                  Associate Director for Science, Office of the           Centers for Medicare & Medicaid                           SOR titled, ‘‘CMS Risk Adjustment
                                                  Director, Centers for Disease Control and               Services                                                  Suite of Systems (RASS),’’ System No.
                                                  Prevention.                                                                                                       09–70–0508. Payments to Medicare
                                                  [FR Doc. 2015–20191 Filed 8–14–15; 8:45 am]             Privacy Act of 1974: Report of New                        Advantage (MA) organizations, Part D
                                                  BILLING CODE 4163–18–P                                  System of Records                                         sponsors, and Program of All Inclusive
mstockstill on DSK4VPTVN1PROD with NOTICES




                                                                                                                                                                    Care for the Elderly (PACE)
                                                                                                          AGENCY:  Centers for Medicare &
                                                                                                                                                                    organizations (collectively referred to as
                                                                                                          Medicaid Services (CMS), Department
                                                                                                                                                                    ‘‘MA organizations and other entities’’)
                                                                                                          of Health and Human Services (HHS)
                                                                                                                                                                    are adjusted based on the health status
                                                                                                          ACTION:Notice of New System of                            of enrolled Medicare beneficiaries
                                                                                                          Records (SOR).                                            (‘‘enrollees’’). RASS is established to
                                                                                                                                                                    receive, process, and store the data used


                                             VerDate Sep<11>2014   16:57 Aug 14, 2015   Jkt 235001   PO 00000   Frm 00040    Fmt 4703   Sfmt 4703    E:\FR\FM\17AUN1.SGM    17AUN1


                                                  49238                        Federal Register / Vol. 80, No. 158 / Monday, August 17, 2015 / Notices

                                                  to risk-adjust payments based on                        intended to collect and accurately                      D CMS pays PACE organizations a
                                                  enrollee health status. The data will be                calculate scores based on a beneficiary’s             monthly capitation amount based on the
                                                  used specifically to develop risk                       demographics and health status. RASS                  Part A and Part B payment rates
                                                  adjustment models and to calculate the                  will cover data housed in two existing                established for purposes of payment to
                                                  risk score for each enrollee.                           information systems: The Risk                         Medicare Advantage organizations
                                                     Each MA organization and other                       Adjustment Processing System (RAPS),                  pursuant to 1894(d)(2). CMS will ensure
                                                  entity must submit data to CMS in                       and the Risk Adjustment System (RAS).                 that payments take into account the
                                                  accordance with CMS regulations and                     RAS will contain data extracted from                  comparative frailty of PACE enrollees
                                                  instructions. ‘‘Risk adjustment data’’                  RAPS and from two other IT systems                    relative to the general Medicare
                                                  refers to data submitted in two separate                (CME and NMUD), as more fully                         population.
                                                  formats: comprehensive data equivalent                  explained below:                                        In addition to providing the file used
                                                  to Medicare fee-for-service data (often                   Æ RAPS will receive abbreviated                     to calculate risk adjustment payments,
                                                  referred to as encounter data); and data                current risk adjustment data, consisting              the RASS also provides reports for CMS
                                                  in abbreviated formats (often referred to               of diagnosis data about each beneficiary              based on the analysis of RAF files and
                                                  as RAPS data). The MA risk adjustment                   and the beneficiary’s health care                     other criteria; these reports include MA
                                                  data addressed by this SOR includes                     provider type, submitted by the relevant              plan file submission transactions
                                                  RAPS data submitted by a MA                             payee entity through the Front-End Risk               (acceptance rates, rejection rates, error
                                                  organization in an abbreviated format,                  Adjustment System (FERAS); RAPS will                  rates, etc.) on a daily, weekly, monthly,
                                                  as referenced at § 422.310(d)(1), and                   use the data to create an enrollee                    and quarterly basis.
                                                  similar abbreviated risk adjustment data                diagnosis data file for each beneficiary
                                                                                                                                                                II. The Privacy Act
                                                  submitted by other MA organizations                     (See Categories of Records for data
                                                  and other entities. Encounter data has a                elements).                                               The Privacy Act governs the
                                                  separate SOR (System No. 09–70–0506).                     Æ RAS will extract the enrollee                     collection, maintenance, use, and
                                                  DATES: Effective 30 days after                          diagnosis data files from RAPS and will               dissemination of certain information
                                                  publication. Written comments should                    receive current demographic,                          about individuals by agencies of the
                                                  be submitted on or before the effective                 enrollment and diagnoses data and past                Federal Government.
                                                  date. HHS/CMS/CM may publish an                         medical history data for each enrollee                   A ‘‘SOR’’ is a group of any records
                                                  amended system of records notice                        from two other CMS systems (CME and                   under the control of a Federal agency
                                                  (SORN) in light of any comments                         NMUD); RAS will use the RAPS, CME,                    from which information about
                                                  received.                                               and NMUD data to calculate risk factors               individuals is retrieved by name or
                                                                                                          and create a Risk Adjustment Factor                   other personal identifier. The Privacy
                                                  ADDRESSES: The public should address                                                                          Act requires each agency to publish in
                                                                                                          (RAF) file, containing the risk score of
                                                  comments to: CMS Privacy Officer,                       each beneficiary:                                     the Federal Register notice of the
                                                  Division of Security, Privacy Policy &                     D Common Medicare Environment                      existence and character of each SOR
                                                  Governance, Information Security &                      (CME): RAS will extract current                       that the agency maintains. The System
                                                  Privacy Group, Office of Enterprise                     individual demographic and enrollment                 of Records Notice (SORN) identifies or
                                                  Information, CMS, 7500 Security                         data about each enrollee (See Categories              describes the laws authorizing the
                                                  Boulevard, Baltimore, MD 21244–1870,                    of Records for data elements).                        system to be maintained; the types and
                                                  Mailstop: N1–24–08, Office: (410) 786–                     D National Claims History files                    sources of records in the system; the
                                                  5357, email: walter.stone@cms.hhs.gov.                  housed in the National Medicare                       categories of individuals to whom the
                                                  Comments received will be available for                 Utilization Database (NMUD): RAS will                 records pertain; the purposes for which
                                                  review at this location, by appointment,                extract current Medicare Fee-for-service              the records are used within the agency;
                                                  during regular business hours, Monday                   (FFS) diagnoses information submitted                 the routine uses for which a record
                                                  through Friday from 9 a.m.–3 p.m.,                      on Inpatient, Outpatient, and Physician               maybe disclosed to parties outside the
                                                  Eastern Time zone.                                      claims for each enrollee (See Categories              agency without the individual’s prior,
                                                  FOR FURTHER INFORMATION CONTACT: Risk                   of Records for data elements).                        written consent; agency policies and
                                                  Adjustment Mailbox Coordinator,                            Æ RAS will transmit the Risk                       procedures for safeguarding, storing,
                                                  Division of Encounter Data and Risk                     Adjustment Factor (RAF) file created in               retrieving, accessing, retaining, and
                                                  Adjustment Operations, Medicare Plan                    RAS to CMS’ payment processing                        disposing of the records; the procedures
                                                  Payment Group, Center for Medicare,                     system for purposes of calculating and                for an individual to follow to make
                                                  CMS, Mail Stop C1–13–07, 7500                           adjusting payments to payee entities, as              notification, access, and amendment
                                                  Security Boulevard, Baltimore,                          follows:                                              requests to the System Manager; and
                                                  Maryland 21244–1850. The email is                          D CMS pays MA organizations on a                   whether the SOR is exempt from certain
                                                  Riskadjustment@cms.hhs.gov.                             monthly prospective amount for each                   Privacy Act requirements.
                                                  SUPPLEMENTARY INFORMATION:                              beneficiary enrolled (enrollee) in a Part
                                                                                                          C plan.                                               System Number:
                                                  I. Background on the Risk Adjustment                       D CMS pays Part D sponsors a                         09–70–0508
                                                  Suite of Systems (RASS)                                 monthly prospective amount that
                                                                                                                                                                SYSTEM NAME:
                                                     The new RASS system of records is                    reflects the plan sponsor’s estimate of
                                                  being established to cover data used to                 the revenue needed to cover a plan’s                    CMS Risk Adjustment Suite of
                                                  create risk adjustment scores needed to                 costs for the risk portion of basic                   Systems (RASS), HHS/CMS/CM.
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                                                  risk-adjust payments to Medicare and                    prescription drug coverage. The direct                SECURITY CLASSIFICATION:
                                                  Medicaid provider entities, based on                    subsidy is adjusted based on the                        Unclassified.
                                                  beneficiary demographics and health                     beneficiary’s risk score, which reflects
                                                  status. Risk-adjusted payments will                     expected prescription drug expenditures               SYSTEM LOCATION:
                                                  implement reformatory provisions of the                 for the coverage year (relative to a                    RASS (RAS/RAPS) Location: CMS
                                                  Social Security Act at sections 1853(a),                national average of 1.0), based on                    Data Center, 7500 Security Boulevard,
                                                  1860D–15(c), and 1894(d)(2) (42 U.S.C.                  demographic and health status                         North Building, First Floor, Baltimore,
                                                  1395w–23, 1395w–115, and 1395eee),                      information for that person.                          Maryland 21244–1850.


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                                                                               Federal Register / Vol. 80, No. 158 / Monday, August 17, 2015 / Notices                                            49239

                                                  CATEGORIES OF INDIVIDUALS COVERED BY THE                  Æ Beneficiary Last Name                                1. To determine the risk adjustment
                                                  SYSTEM:                                                   • NCH data: Current diagnosis data                  factors used to adjust payments, as
                                                     Information collected and maintained                 [and past medical history data] from                  required under §§ 422.304(a) and (c),
                                                  in this system pertains to: (1) Medicare                National Claims History Files in CMS’s                423.329, and 460.180, to update risk
                                                  beneficiaries enrolled in a Part C MA                   National Medicare Utilization Database                adjustment models, to calculate
                                                  plan, MA–PD plan, PDP or PACE                           (NMUD):                                               Medicare DSH percentages, to conduct
                                                  organization (‘‘enrollees’’) and (2) the                  Æ Health Insurance Claim Number                     quality review and improvement
                                                  health care provider(s), supplier(s),                   (HICN)                                                activities, for Medicare coverage
                                                  physician(s), or other practitioner(s)                    Æ NCH Category Equitable BIC                        purposes, to conduct evaluations and
                                                  (‘‘Providers’’) who provide health care                   Æ Diagnosis code                                    other analysis to support the Medicare
                                                  items and services to these enrollees.                    Æ Service Through Date                              program (including demonstrations) and
                                                                                                            Æ Service From Date                                 to support public health initiatives, for
                                                  CATEGORIES OF RECORDS IN THE SYSTEM:                                                                          activities conducted to support program
                                                                                                            Æ Beneficiary Link Identifier
                                                     The MA plans, MA–PDs, PDPs and                         Æ Provider Number                                   integrity, and for purposes authorized
                                                  PACE organizations (‘‘MA organizations                                                                        by applicable law.
                                                  and other entities’’) receive the data                  AUTHORITY FOR MAINTENANCE OF THE SYSTEM:                 2. To support CMS contractors,
                                                  from the providers which is then                          This system was established pursuant                consultants, or grantees that have been
                                                  submitted to RAPS via FERAS. The data                   to sections 1853(a), 1860D–15(c), and                 contracted by the Agency when
                                                  received from the MA organizations and                  1894(d)(2)of the Social Security Act (42              necessary to assist in accomplishment of
                                                  other entities are primarily diagnosis                  U.S.C. 1395w–23, 1395w–115, 1395eee).                 a CMS function relating to the purposes
                                                  data extracted from claims information.                                                                       for this system or a purpose listed in
                                                                                                          PURPOSE(S) OF THE SYSTEM:                             paragraph 1.
                                                  Additional FFS and utilization data
                                                  regarding those submissions are                           Records will be used within the                        3. To support an individual or
                                                  received from the CME and NCH data                      agency to develop risk adjustment                     organization for research to support the
                                                  systems to complete the enrollee data                   models and to calculate the risk score                Medicare program and public health
                                                  requirements.                                           for each Medicare beneficiary enrolled                initiatives, and otherwise related to
                                                     Records will consist of the risk score               in the Medicare health plan. The risk                 health care, such as evaluation or
                                                  for each enrollee and the data used to                  score will be reported to the system that             epidemiological projects related to the
                                                  calculate the score, contained in Risk                  CMS uses to process payments, and                     prevention of disease or disability, the
                                                  Adjustment Factor (RAF) files created in                ultimately will be used to adjust                     restoration or maintenance of health, or
                                                  CMS’ Risk Adjustment System (RAS),                      payments to MA organizations, Part D                  for understanding and improving
                                                  using data extracted from three other                   sponsors, and PACE organizations,                     payment projects.
                                                  CMS IT systems:                                         based on beneficiary health status. (Note                4. To provide information to the U.S.
                                                     • RAPS data: Diagnosis data files                    that payment records are not covered                  Department of Justice (DOJ), a court, or
                                                  containing abbreviated current                          under this system of records.)                        an adjudicatory body when (a) the
                                                  diagnosis data submitted by payee                         Information retrieved from this SOR                 Agency or any component thereof, or (b)
                                                  entities to CMS’s Risk Adjustment                       will be used for the following purposes:              any employee of the Agency in his or
                                                  Processing System (RAPS):                               • To determine the risk adjustment                    her official capacity, or (c) any
                                                     Æ Health Insurance Claim Number                        factors used to adjust payments to MA               employee of the Agency in his or her
                                                  (HICN)                                                    organizations and other entities, as                individual capacity where the DOJ has
                                                     Æ Provider Type                                        required under 42 CFR 422.304(a) and                agreed to represent the employee, or (d)
                                                     Æ Service From Date                                    (c), 423.329 and 460.180                            the United State Government, is a party
                                                     Æ Service Through Date                               • to update risk adjustment models                    to litigation or has an interest in such
                                                     Æ Plan Number (MAO contract                          • to calculate Medicare                               litigation, and by careful review, CMS
                                                  number)                                                   Disproportionate Share Hospital                     determines that the records are both
                                                     Æ Diagnosis Code                                       (DSH) percentages                                   relevant and necessary to the litigation
                                                     Æ Diagnosis Delete Date                              • to conduct quality review and                       and that the use of such records by the
                                                     Æ RAS Diagnosis Indicator                              improvement activities for Medicare                 DOJ, court, or adjudicatory body is
                                                     Æ NCH Category Equitable BIC                           coverage purposes                                   compatible with the purpose for which
                                                     Æ Accrete Data                                       • to conduct evaluations and other                    the agency collected the records.
                                                     Æ Delete Plan Number                                   analysis to support the Medicare                       5. To assist a CMS contractor
                                                     Æ Submitter ID                                         program (including demonstrations)                  (including, but not limited to Medicare
                                                     Æ Daily File Code, and                               • to support public health initiatives                Administrative Contractors, fiscal
                                                     Æ Delete File Code                                     and other health care-related research              intermediaries, and carriers) that assists
                                                     • CME data: Current demographic                      • for activities to support the                       in the administration of a CMS-
                                                  and enrollment data from CMS’s                            administration of the Medicare                      administered health benefits program,
                                                  Common Medicare Environment (CME):                        program                                             or to a grantee of a CMS-administered
                                                     Æ Beneficiary Link Key Partition                     • for activities conducted to support                 grant program, when disclosure is
                                                  number                                                    program integrity                                   deemed reasonably necessary by CMS to
                                                     Æ Beneficiary Link Identifier                        • for purposes authorized by applicable               prevent, deter, discover, detect,
                                                     Æ Health Insurance Claim Number                        law                                                 investigate, examine, prosecute, sue
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                                                  (HICN)                                                                                                        with respect to, defend against, correct,
                                                     Æ Beneficiary Social Security Number                 ROUTINE USES OF RECORDS MAINTAINED IN THE             remedy, or otherwise combat fraud,
                                                     Æ Beneficiary Birth Date                             SYSTEM, INCLUDING CATEGORIES OR USERS AND             waste or abuse in such program.
                                                     Æ Beneficiary Death Date                             THE PURPOSES OF SUCH USES:                               6. To assist another Federal agency or
                                                     Æ Beneficiary Sex Code                                 Records may be disclosed to parties                 an instrumentality of any governmental
                                                     Æ Beneficiary Race Code                              outside HHS, without the individual                   jurisdiction within or under the control
                                                     Æ Beneficiary First Name                             record subject’s prior, written consent,              of the United States (including any state
                                                     Æ Beneficiary Middle Name                            for the following purposes:                           or local governmental agency), that


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                                                  49240                        Federal Register / Vol. 80, No. 158 / Monday, August 17, 2015 / Notices

                                                  administers or that has the authority to                small size, use this information to                   pertinent personally identifiable
                                                  investigate potential fraud, waste or                   deduce the identity of the beneficiary).              information (encrypted and properly
                                                  abuse in a health benefits program                        Note: Information collected or obtained             transmitted) to be used for retrieval of
                                                  funded in whole or in part by Federal                   under § 1860D–15 (i.e., risk adjustment data          their records (i.e., NPI or Health
                                                  funds, when disclosure is deemed                        used to pay Part D plan sponsors) will be             Insurance Claim Number).
                                                  reasonably necessary by CMS to                          used and disclosed only in accordance with
                                                                                                          the statutory limitations under § 1860D–              RECORD ACCESS PROCEDURE:
                                                  prevent, deter, discover, detect,
                                                  investigate, examine, prosecute, sue                    15(f)(2).                                                Individuals seeking access to records
                                                  with respect to, defend against, correct,                                                                     about them in this system should follow
                                                  remedy, or otherwise combat fraud,                      POLICIES AND PRACTICES FOR STORING,                   the same instructions indicated under
                                                                                                          RETRIEVING, ACCESSING, RETAINING, AND                 ‘‘Notification Procedure’’ and
                                                  waste or abuse in such programs.
                                                                                                          DISPOSING OF RECORDS IN THE SYSTEMSTORAGE:            reasonably specify the record content
                                                     7. To assist Medicare Advantage
                                                                                                            Archived records will be stored on                  being sought. (These procedures are in
                                                  organizations, Part D Sponsors and
                                                                                                          magnetic tapes. Data that is currently in             accordance with Department regulation
                                                  PACE organizations with improving the
                                                                                                          use is stored in the RAPS database.                   45 CFR 5b.5(a)(2)).
                                                  quality of required risk adjustment data
                                                  obtained from the provider that                         RETRIEVABILITY:                                       CONTESTING RECORD PROCEDURES:
                                                  furnished the item or service. CMS will                   Records will be retrieved by National                  Individuals seeking to contest the
                                                  be analyzing the data received and                      Provider Identifier (NPI), beneficiary                content of information about them in
                                                  advising MA organizations, Part D                       provider name, or beneficiary Health                  this system should follow the same
                                                  Sponsors and PACE organizations of                      Insurance Claim Number.                               instructions indicated under
                                                  trends and data analysis results to help                                                                      ‘‘Notification Procedure.’’ The request
                                                  improve the accuracy and completeness                   SAFEGUARDS:
                                                                                                                                                                should: reasonably identify the record
                                                  of data received from the provider.                       Personnel having access to the system
                                                                                                                                                                and specify the information being
                                                     8. To assist appropriate Federal                     have been trained in the Privacy Act
                                                                                                                                                                contested; state the corrective action
                                                  agencies and CMS contractors and                        and information security requirements.
                                                                                                                                                                sought; and provide the reasons for the
                                                  consultants that have a need to know                    Employees who maintain records in this
                                                                                                                                                                correction, with supporting justification.
                                                  the information for the purpose of                      system are instructed not to release data
                                                                                                                                                                (These procedures are in accordance
                                                  assisting CMS’ efforts to respond to a                  until the intended recipient agrees to
                                                                                                                                                                with Department regulation 45 CFR
                                                  suspected or confirmed breach of the                    implement appropriate management,
                                                                                                                                                                5b.7.)
                                                  security or confidentiality of                          operational, and technical safeguards
                                                  information maintained in this system                   sufficient to protect the confidentiality,            RECORD SOURCE CATEGORIES:
                                                  of records, provided that the                           integrity and availability of the                       RASS processes data extracted from
                                                  information disclosed is relevant and                   information and information systems;                  RAPS and RAS IT systems to calculate
                                                  necessary for that assistance.                          and to prevent unauthorized access.                   the risk scores used to adjust payments
                                                                                                          Access to records in the RASS will be                 to Medicare Advantage organizations,
                                                     Note: CMS may disclose information from
                                                  this system of records, without the individual
                                                                                                          limited to CMS personnel and                          Part D plan sponsors and PACE plans.
                                                  record subject’s consent, for any of the                contractors through password security,                RAS receives the most current data for
                                                  following purposes referenced directly in the           encryption, firewalls, and secured                    each Medicare Part C and Part D
                                                  Privacy Act: 5 U.S.C. 552a(b)(1), (3)–(8), and          operating system(s).                                  beneficiary from the following sources:
                                                  (12). CMS must also disclose information                                                                      RAPS, Common Medicare Environment
                                                                                                          RETENTION AND DISPOSAL:
                                                  from this system of records, without the                                                                      (CME) also known as Medicare
                                                  individual record subject’s consent, for any               Records (i.e., enrollee diagnosis data
                                                                                                                                                                Beneficiary Database (MBD/CME), and
                                                  of the following purposes referenced directly           files created in RAPS, and Risk
                                                  in the Privacy Act: 5 U.S.C. 552a(b)(2), and                                                                  National Medicare Utilization Database
                                                                                                          Adjustment Factor (RAF) files created in
                                                  (b)(9)–(11).                                                                                                  (NMUD). RAPS receives risk adjustment
                                                                                                          RAS) will be maintained for a period of
                                                                                                                                                                data from MA organizations and other
                                                                                                          up to 10 years after date of creation. Any
                                                                                                                                                                entities defined above.
                                                  ADDITIONAL PROVISIONS AFFECTING ROUTINE USE             such records that are needed longer,
                                                  DISCLOSURES:                                            such as to resolve claims and audit                   SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS
                                                     This system contains Protected Health                exceptions or to prosecute fraud, will be             OF THE ACT:
                                                  Information (PHI) as defined by HHS                     retained until such matters are resolved.               None.
                                                  regulation ‘‘Standards for Privacy of                   Enrollee claims records are currently
                                                                                                          subject to a document preservation                    Celeste Dade-Vinson,
                                                  Individually Identifiable Health
                                                                                                          order and will be preserved indefinitely              Health Insurance Specialist, Centers for
                                                  Information’’ (45 CFR parts 160 and 164,
                                                                                                          pending further notice from the U.S.                  Medicare & Medicaid Services.
                                                  65 FR 82462 (12–28–00), subparts A and
                                                                                                          Department of Justice (DOJ).                          [FR Doc. 2015–20224 Filed 8–14–15; 8:45 am]
                                                  E). Disclosures of PHI authorized by
                                                                                                                                                                BILLING CODE 4120–03–P
                                                  these routine uses may only be made if,                 SYSTEM MANAGER AND ADDRESS:
                                                  and as, permitted or required by the
                                                                                                            Director, Division of Encounter Data
                                                  ‘‘Standards for Privacy of Individually
                                                                                                          and Risk Adjustment Operations,                       DEPARTMENT OF HEALTH AND
                                                  Identifiable Health Information.’’
                                                                                                          Medicare Plan Payment Group, Center                   HUMAN SERVICES
                                                     In addition, our policy will be to                   for Medicare, CMS, 7500 Security
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                                                  prohibit release even of data that is not               Boulevard, Baltimore, Maryland 21244–                 Food and Drug Administration
                                                  directly identifiable, except if required               1850.
                                                  by law, if we determine there is a                                                                            [Docket No. FDA–2000–D–0103]
                                                  possibility that an individual can be                   NOTIFICATION PROCEDURE:
                                                                                                                                                                Botanical Drug Development; Draft
                                                  identified through implicit deduction                     Individuals (i.e., the beneficiary or               Guidance for Industry; Availability
                                                  based on small cell sizes (instances                    provider) wishing to know if this system
                                                  where the patient population is so small                contains records about them should                    AGENCY:    Food and Drug Administration,
                                                  that individuals could, because of the                  write to the system manager and include               HHS.


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Document Created: 2015-12-15 11:06:39
Document Modified: 2015-12-15 11:06:39
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of New System of Records (SOR).
DatesEffective 30 days after publication. Written comments should be submitted on or before the effective date. HHS/CMS/CM may publish an amended system of records notice (SORN) in light of any comments received.
ContactRisk Adjustment Mailbox Coordinator, Division of Encounter Data and Risk Adjustment Operations, Medicare Plan Payment Group, Center for Medicare, CMS, Mail Stop C1-13-07, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. The email is [email protected]
FR Citation80 FR 49237 

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