Agency Information Collection Activities: Submission for OMB Review; Comment Request, 63657-63659 [2019-24929]
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Federal Register / Vol. 84, No. 222 / Monday, November 18, 2019 / Notices
program, known as the Voluntary
Prescription Drug Benefit Program. As
required by 42 CFR 423.32(a) and (b), a
Part D-eligible individual who wishes to
enroll in a Medicare prescription drug
plan (PDP) may enroll during the
enrollment periods specified in
§ 423.38, by completing an enrollment
form with the PDP, or enrolling through
other mechanisms CMS determines are
appropriate. Form Number: CMS–10718
(OMB control number: 0938–New);
Frequency: Yearly; Affected Public:
State, Local, or Tribal Governments;
Number of Respondents: 14,749,256;
Total Annual Responses: 14,749,256;
Total Annual Hours: 10,324,481. (For
policy questions regarding this
collection contact Deme Umo at (410)
786–8854.)
5. Type of Information Collection
Request: Revision with change of a
currently approved collection; Title of
Information Collection: Notice of Denial
of Medicare Prescription Drug Coverage;
Use: The purpose of this notice is to
provide information to enrollees when
prescription drug coverage has been
denied, in whole or in part, by their Part
D plans. The notice must be readable,
understandable, and state the specific
reasons for the denial. The notice must
also remind enrollees about their rights
and protections related to requests for
prescription drug coverage and include
an explanation of both the standard and
expedited redetermination processes
and the rest of the appeal process.
CMS requests approval of changes to
a currently approved collection under
section 1860D–4(g)(1) of the Social
Security Act which requires Part D plan
sponsors that deny prescription drug
coverage to provide a written notice of
the denial to the enrollee. The written
notice must include a statement, in
understandable language, of the reasons
for the denial and a description of the
appeals process.
Medicare beneficiaries who are
enrolled in a Part D plan will be
informed of adverse decisions related to
their prescription drug coverage and
their right to appeal these decisions.
The notice provides all ways that the
beneficiary can file an appeal under one
section. The Part D instructions have
also been revised to include a paragraph
informing providers that in the case that
a request for a coverage determination is
denied under Part B due to step therapy
requirements, a different notice should
be given.
This denial notice is primarily issued
to Part D plan enrollees (Medicare
beneficiaries) and is most commonly
sent to enrollees by mail. Relying on
electronic transmission of this notice to
beneficiaries is impractical. Plans are
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17:41 Nov 15, 2019
Jkt 250001
required by regulation to maintain a
website by which beneficiaries can
request an appeal. In this version of the
notice, website information is more
prominently displayed. Form Number:
CMS–10146 (OMB control number:
0938–0976); Frequency: Yearly; Affected
Public: State, Local, or Tribal
Governments; Number of Respondents:
525; Total Annual Responses:
2,887,866; Total Annual Hours: 721,967.
(For policy questions regarding this
collection contact Sara Klotz at (410)
786–1984.)
63657
1. On page 56193, second column,
third full paragraph, last line, the email
address ‘‘Leah.Cromwell@cms.hhs.gov’’
is corrected to read ‘‘Leah.Cromwell1@
cms.hhs.gov’’.
Dated: November 4, 2019.
Kate Goodrich.
Director, Center for Clinical Standards and
Quality, Chief Medical Officer, Centers for
Medicare & Medicaid Services.
[FR Doc. 2019–24934 Filed 11–15–19; 8:45 am]
BILLING CODE 4120–01–P
Dated: November 13, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2019–24930 Filed 11–15–19; 8:45 am]
BILLING CODE 4120–01–P
[Document Identifier CMS–10611, CMS–R–
282 and CMS–R–235]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare & Medicaid
Services
[CMS–3392–CN]
Medicare Program; Request for
Nominations for Members for the
Medicare Evidence Development &
Coverage Advisory Committee;
Correction
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Correction notice.
AGENCY:
This document corrects a
typographical error that appeared in the
notice published in the Federal Register
on October 21, 2019 entitled ‘‘Request
for Nominations for Members for the
Medicare Evidence Development &
Coverage Advisory Committee.’’
DATES: This correcting document is
effective on November 15, 2019.
FOR FURTHER INFORMATION CONTACT:
Leah Cromwell, (410) 786–2243.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background and Summary of Errors
In FR Doc. 2019–22947 of October 21,
2019 (84 FR 56193), there was a
typographical error that is identified in
the FOR FURTHER INFORMATION CONTACT
section.
On page 56193, we inadvertently
made a typographical error in the email
address of the Medicare Evidence
Development & Coverage Advisory
Committee (MEDCAC) coordinator.
II. Correction of Errors
In FR Doc. 2019–22947 of October 21,
2019 (84 FR 56193), make the following
corrections:
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Centers for Medicare & Medicaid
Services
Centers for Medicare &
Medicaid Services, HHS.
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995
(PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, and to allow
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the burden estimate or any
other aspect of this collection of
information, including the necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions, the accuracy of
the estimated burden, ways to enhance
the quality, utility, and clarity of the
information to be collected, and the use
of automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
SUMMARY:
Comments on the collection(s) of
information must be received by the
OMB desk officer by December 18, 2019.
ADDRESSES: When commenting on the
proposed information collections,
please reference the document identifier
or OMB control number. To be assured
consideration, comments and
recommendations must be received by
the OMB desk officer via one of the
DATES:
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63658
Federal Register / Vol. 84, No. 222 / Monday, November 18, 2019 / Notices
following transmissions: OMB, Office of
Information and Regulatory Affairs,
Attention: CMS Desk Officer, Fax
Number: (202) 395–5806 OR, Email:
OIRA_submission@omb.eop.gov.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ website address at
website address at https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.html.
1. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
2. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
William Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. The term ‘‘collection of
information’’ is defined in 44 U.S.C.
3502(3) and 5 CFR 1320.3(c) and
includes agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires federal agencies
to publish a 30-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension or
reinstatement of an existing collection
of information, before submitting the
collection to OMB for approval. To
comply with this requirement, CMS is
publishing this notice that summarizes
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: Extension without change of a
currently approved collection; Title of
Information Collection: Medicare
Outpatient Observation Notice (MOON);
Use: On August 6, 2015, Congress
enacted the Notice of Observation
Treatment and Implication for Care
Eligibility Act (NOTICE Act) Public Law
114–42, amending Section 1866(a)(1) of
the Social Security Act (the Act) (42
U.S.C. 1395cc(a)(1)), by adding a new
subparagraph (Y). The NOTICE Act
requires hospitals and CAHs to provide
written notification and oral
explanation to individuals who receive
observation services as outpatients for
more than 24 hours.
The MOON is a standardized notice
delivered to persons entitled to
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17:41 Nov 15, 2019
Jkt 250001
Medicare benefits under Title XVIII of
the Act who receive more than 24 hours
of observation services, informing them
that their hospital stay is outpatient and
not inpatient, and the implications of
being an outpatient. This information
collection applies to beneficiaries in
Original Medicare and enrollees in
Medicare health plans.
The Medicare Outpatient Observation
Notice (MOON) serves as the written
notice component of this mandatory
notification process. The standardized
content of the MOON includes all
informational elements required by
statute, in language understandable to
beneficiaries, and fulfils the regulatory
requirements at 42 CFR part 489.20(y).
The MOON is not given every time
items and services are furnished in a
hospital or CAH. Rather, hospitals are
only required to deliver the MOON to
individuals receiving observation
services as outpatients for more than 24
hours. Form Number: CMS–10611
(OMB control number: 0938–1308);
Frequency: Yearly; Affected Public:
State, Local, or Tribal Governments;
Number of Respondents: 4,373; Total
Annual Responses: 946,209; Total
Annual Hours: 236,552. (For policy
questions regarding this collection
contact Janet Miller at Janet.Miller@
cms.hhs.gov.)
2. Type of Information Collection
Request: Revision with change of a
currently approved collection; Title of
Information Collection: Health Plan
Appeals and Grievance Data Collection
and Reporting Requirements, Data
Disclosure Requirements under section
422.111; Use: Part 422 of Title 42 of the
Code of Federal Regulations (CFR)
distinguishes between certain
information a Medicare Advantage (MA)
organization must provide to each
enrollee (on an annual basis) and
information that the MA organization
must disclose to any MA eligible
individual (upon request). This
requirement can be found in
§ 1852(c)(2)(C) of the Social Security Act
and in 42 CFR 422.111(c)(3) which
states that MA organizations must
disclose information pertaining to the
number of disputes, and their
disposition in the aggregate, with the
categories of grievances and appeals, to
any individual eligible to elect an MA
organization who requests this
information.
The appeals and grievance data form
is an OMB approved form for use by
Medicare Advantage organizations to
disclose grievance and appeal data,
upon request, to individuals eligible to
elect an MA organization. By utilizing
the form, MA organizations will meet
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
the disclosure requirements set forth in
regulations at 42 CFR 422.111(c)(3).
In an effort to identify opportunities
to reduce burden for this collection, we
compared data provided by plans to
CMS in Part C reporting requirements
(OMB 0938–1054) with the
requirements to provide aggregate
grievance and appeals data to MA
eligible beneficiaries. We found that
data reported to CMS in the Part C
reporting requirements was data that
would meet the disclosure requirements
at § 1852(c)(2)(C) of the Social Security
Act and 42 CFR 422.111(c).
We are proposing to revise this form
by allowing plans to use data collected
for Part C reporting requirements (OMB
0938–1054) that also meet requirements
for this collection. This change merges
and aligns the collection and reporting
periods, so MA plans do not need to
keep two separate sets of data and
reports each year.
For CMS Part C reporting
requirements, data is collected
quarterly, but only reported annually.
To match this and reduce plan burden,
CMS is revising this form to use the data
reported annually to CMS, and that data
be valid for one year versus creating a
new report every six months. Further,
data provided to enrollees would be
consistent with data provided to CMS.
Form Number: CMS–R–282 (OMB
control number: 0938–0778); Frequency:
Yearly; Affected Public: State, Local, or
Tribal Governments; Number of
Respondents: 733; Total Annual
Responses: 59,133; Total Annual Hours:
5,405. (For policy questions regarding
this collection contact Staci Paige at
410–786–2045.)
3. Type of Information Collection
Request: Reinstatement with change of a
currently approved collection; Title of
Information Collection: Data Use
Agreement (DUA) Form; Use: The
Privacy Act of 1974 allows for
discretionary releases of data
maintained in Privacy Act protected
systems of records under § 552a(b)
(Conditions of Disclosure). The mandate
to account for disclosures of data under
the Privacy Act is found at
§ 552a(c)(Accounting of Certain
Disclosures). This section states that
certain information must be maintained
regarding disclosures made by each
agency. This information is: Date,
Nature, Purpose, and Name/Address of
Recipient. Section 552a(e) sets the
overall Agency Requirements that each
agency must meet in order to maintain
records under the Privacy Act.
The Data Use Agreement (DUA) form
is needed as part of the review of each
CMS data request to ensure compliance
with the requirements of the Privacy Act
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Federal Register / Vol. 84, No. 222 / Monday, November 18, 2019 / Notices
for disclosures that contain PII. The
DUA form also provides data requestors
and custodians with a formal means to
agree to the data protection and
destruction statutory and regulatory
requirements of CMS’ PII data.
When entities, such as academic,
federal or state agency researchers or
CMS contractors request CMS PII/PHI
data, they enter into a Data Use
Agreement (DUA) with CMS. The DUA
stipulates that the recipient of CMS data
must properly protect the data
according to all applicable data security
standards and also provide for its
appropriate destruction at the
completion of the project/study or the
expiration date of the DUA. The DUA
form enables the data recipient and
CMS to document the request and
approval for release of CMS data. Form
Number: CMS–R–235 (OMB control
number: 0938–0734); Frequency: Yearly;
Affected Public: State, Local, or Tribal
Governments; Number of Respondents:
9,200; Total Annual Responses: 9,200;
Total Annual Hours: 2,900. (For policy
questions regarding this collection
contact Kari A Gaare at 410–786–8612.)
Dated: November 13, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2019–24929 Filed 11–15–19; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–1835]
Smallpox (Variola Virus) Infection:
Developing Drugs for Treatment or
Prevention; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry entitled
‘‘Smallpox (Variola Virus) Infection:
Developing Drugs for Treatment or
Prevention.’’ The purpose of this
guidance is to assist sponsors in the
clinical development of drugs for
treating or preventing smallpox (variola
virus) infection. This guidance finalizes
the draft guidance of the same name
issued on July 11, 2018.
DATES: The announcement of the
guidance is published in the Federal
Register on November 18, 2019.
SUMMARY:
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17:41 Nov 15, 2019
Jkt 250001
You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
ADDRESSES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–D–1835 for ‘‘Smallpox (Variola
Virus) Infection: Developing Drugs for
Treatment or Prevention.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
PO 00000
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63659
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of this guidance to the Division
of Drug Information, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT:
Jeffrey Murray, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6360,
Silver Spring, MD 20993–0002, 301–
796–1500.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a final guidance for industry entitled
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]]>Agencies
[Federal Register Volume 84, Number 222 (Monday, November 18, 2019)]
[Notices]
[Pages 63657-63659]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24929]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier CMS-10611, CMS-R-282 and CMS-R-235]
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
AGENCY: Centers for Medicare & Medicaid Services, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is
announcing an opportunity for the public to comment on CMS' intention
to collect information from the public. Under the Paperwork Reduction
Act of 1995 (PRA), federal agencies are required to publish notice in
the Federal Register concerning each proposed collection of
information, including each proposed extension or reinstatement of an
existing collection of information, and to allow a second opportunity
for public comment on the notice. Interested persons are invited to
send comments regarding the burden estimate or any other aspect of this
collection of information, including the necessity and utility of the
proposed information collection for the proper performance of the
agency's functions, the accuracy of the estimated burden, ways to
enhance the quality, utility, and clarity of the information to be
collected, and the use of automated collection techniques or other
forms of information technology to minimize the information collection
burden.
DATES: Comments on the collection(s) of information must be received by
the OMB desk officer by December 18, 2019.
ADDRESSES: When commenting on the proposed information collections,
please reference the document identifier or OMB control number. To be
assured consideration, comments and recommendations must be received by
the OMB desk officer via one of the
[[Page 63658]]
following transmissions: OMB, Office of Information and Regulatory
Affairs, Attention: CMS Desk Officer, Fax Number: (202) 395-5806 OR,
Email: [email protected].
To obtain copies of a supporting statement and any related forms
for the proposed collection(s) summarized in this notice, you may make
your request using one of following:
1. Access CMS' website address at website address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.
1. Email your request, including your address, phone number, OMB
number, and CMS document identifier, to [email protected].
2. Call the Reports Clearance Office at (410) 786-1326.
FOR FURTHER INFORMATION CONTACT: William Parham at (410) 786-4669.
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from
the Office of Management and Budget (OMB) for each collection of
information they conduct or sponsor. The term ``collection of
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and
includes agency requests or requirements that members of the public
submit reports, keep records, or provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires
federal agencies to publish a 30-day notice in the Federal Register
concerning each proposed collection of information, including each
proposed extension or reinstatement of an existing collection of
information, before submitting the collection to OMB for approval. To
comply with this requirement, CMS is publishing this notice that
summarizes the following proposed collection(s) of information for
public comment:
1. Type of Information Collection Request: Extension without change
of a currently approved collection; Title of Information Collection:
Medicare Outpatient Observation Notice (MOON); Use: On August 6, 2015,
Congress enacted the Notice of Observation Treatment and Implication
for Care Eligibility Act (NOTICE Act) Public Law 114-42, amending
Section 1866(a)(1) of the Social Security Act (the Act) (42 U.S.C.
1395cc(a)(1)), by adding a new subparagraph (Y). The NOTICE Act
requires hospitals and CAHs to provide written notification and oral
explanation to individuals who receive observation services as
outpatients for more than 24 hours.
The MOON is a standardized notice delivered to persons entitled to
Medicare benefits under Title XVIII of the Act who receive more than 24
hours of observation services, informing them that their hospital stay
is outpatient and not inpatient, and the implications of being an
outpatient. This information collection applies to beneficiaries in
Original Medicare and enrollees in Medicare health plans.
The Medicare Outpatient Observation Notice (MOON) serves as the
written notice component of this mandatory notification process. The
standardized content of the MOON includes all informational elements
required by statute, in language understandable to beneficiaries, and
fulfils the regulatory requirements at 42 CFR part 489.20(y).
The MOON is not given every time items and services are furnished
in a hospital or CAH. Rather, hospitals are only required to deliver
the MOON to individuals receiving observation services as outpatients
for more than 24 hours. Form Number: CMS-10611 (OMB control number:
0938-1308); Frequency: Yearly; Affected Public: State, Local, or Tribal
Governments; Number of Respondents: 4,373; Total Annual Responses:
946,209; Total Annual Hours: 236,552. (For policy questions regarding
this collection contact Janet Miller at [email protected].)
2. Type of Information Collection Request: Revision with change of
a currently approved collection; Title of Information Collection:
Health Plan Appeals and Grievance Data Collection and Reporting
Requirements, Data Disclosure Requirements under section 422.111; Use:
Part 422 of Title 42 of the Code of Federal Regulations (CFR)
distinguishes between certain information a Medicare Advantage (MA)
organization must provide to each enrollee (on an annual basis) and
information that the MA organization must disclose to any MA eligible
individual (upon request). This requirement can be found in Sec.
1852(c)(2)(C) of the Social Security Act and in 42 CFR 422.111(c)(3)
which states that MA organizations must disclose information pertaining
to the number of disputes, and their disposition in the aggregate, with
the categories of grievances and appeals, to any individual eligible to
elect an MA organization who requests this information.
The appeals and grievance data form is an OMB approved form for use
by Medicare Advantage organizations to disclose grievance and appeal
data, upon request, to individuals eligible to elect an MA
organization. By utilizing the form, MA organizations will meet the
disclosure requirements set forth in regulations at 42 CFR
422.111(c)(3).
In an effort to identify opportunities to reduce burden for this
collection, we compared data provided by plans to CMS in Part C
reporting requirements (OMB 0938-1054) with the requirements to provide
aggregate grievance and appeals data to MA eligible beneficiaries. We
found that data reported to CMS in the Part C reporting requirements
was data that would meet the disclosure requirements at Sec.
1852(c)(2)(C) of the Social Security Act and 42 CFR 422.111(c).
We are proposing to revise this form by allowing plans to use data
collected for Part C reporting requirements (OMB 0938-1054) that also
meet requirements for this collection. This change merges and aligns
the collection and reporting periods, so MA plans do not need to keep
two separate sets of data and reports each year.
For CMS Part C reporting requirements, data is collected quarterly,
but only reported annually. To match this and reduce plan burden, CMS
is revising this form to use the data reported annually to CMS, and
that data be valid for one year versus creating a new report every six
months. Further, data provided to enrollees would be consistent with
data provided to CMS. Form Number: CMS-R-282 (OMB control number: 0938-
0778); Frequency: Yearly; Affected Public: State, Local, or Tribal
Governments; Number of Respondents: 733; Total Annual Responses:
59,133; Total Annual Hours: 5,405. (For policy questions regarding this
collection contact Staci Paige at 410-786-2045.)
3. Type of Information Collection Request: Reinstatement with
change of a currently approved collection; Title of Information
Collection: Data Use Agreement (DUA) Form; Use: The Privacy Act of 1974
allows for discretionary releases of data maintained in Privacy Act
protected systems of records under Sec. 552a(b) (Conditions of
Disclosure). The mandate to account for disclosures of data under the
Privacy Act is found at Sec. 552a(c)(Accounting of Certain
Disclosures). This section states that certain information must be
maintained regarding disclosures made by each agency. This information
is: Date, Nature, Purpose, and Name/Address of Recipient. Section
552a(e) sets the overall Agency Requirements that each agency must meet
in order to maintain records under the Privacy Act.
The Data Use Agreement (DUA) form is needed as part of the review
of each CMS data request to ensure compliance with the requirements of
the Privacy Act
[[Page 63659]]
for disclosures that contain PII. The DUA form also provides data
requestors and custodians with a formal means to agree to the data
protection and destruction statutory and regulatory requirements of
CMS' PII data.
When entities, such as academic, federal or state agency
researchers or CMS contractors request CMS PII/PHI data, they enter
into a Data Use Agreement (DUA) with CMS. The DUA stipulates that the
recipient of CMS data must properly protect the data according to all
applicable data security standards and also provide for its appropriate
destruction at the completion of the project/study or the expiration
date of the DUA. The DUA form enables the data recipient and CMS to
document the request and approval for release of CMS data. Form Number:
CMS-R-235 (OMB control number: 0938-0734); Frequency: Yearly; Affected
Public: State, Local, or Tribal Governments; Number of Respondents:
9,200; Total Annual Responses: 9,200; Total Annual Hours: 2,900. (For
policy questions regarding this collection contact Kari A Gaare at 410-
786-8612.)
Dated: November 13, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2019-24929 Filed 11-15-19; 8:45 am]
BILLING CODE 4120-01-P
