Agency Information Collection Activities: Submission for OMB Review; Comment Request, 57151-57154 [2021-22444]
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eligible hospitals and critical access
hospitals (CAHs), and Medicare
Advantage (MA) organizations
participating in the Medicare and
Medicaid programs that adopt and
successfully demonstrate meaningful
use of certified EHR technology
(CEHRT). These Recovery Act
provisions, together with Title XIII of
Division A of the Recovery Act, may be
cited as the ‘‘Health Information
Technology for Economic and Clinical
Health Act’’ or the ‘‘HITECH Act.’’
The HITECH Act created incentive
programs for EPs and eligible hospitals,
including CAHs, in the Medicare Feefor-Service (FFS), MA, and Medicaid
programs that successfully demonstrate
meaningful use of certified EHR
technology. In their first payment year,
Medicaid EPs and eligible hospitals
could adopt, implement, or upgrade to
certified EHR technology. It also
allowed for negative payment
adjustments in the Medicare FFS and
MA programs starting in 2015 for EPs,
eligible hospitals, and CAHs
participating in Medicare that are not
meaningful users of CEHRT. The
Medicaid Promoting Interoperability
Program did not authorize negative
payment adjustments, but its
participants were eligible for positive
incentive payments.
In CY 2017, we began collecting data
from eligible hospitals and CAHs to
determine the application of the
Medicare payment adjustments. At this
time, Medicare eligible professionals no
longer reported to the EHR Incentive
Program, as they began reporting under
the Merit-based Incentive Payment
System (MIPS). This information
collected was also used to make
incentive payments to eligible hospitals
and critical access hospitals in Puerto
Rico.
In the FY 2019 IPPS/LTCH PPS Final
Rule (83 FR 41634), we focused on
reducing burden on eligible hospitals
and CAHs. We finalized a new scoring
methodology for eligible hospitals and
CAHs, removing the requirement to
report on and meet the threshold for all
objectives and measures. This approach
required an eligible hospital or CAH to
meet the requirements on six measures,
with scoring based on performance.
This approach reduced burden by
decreasing the amount of time needed to
report on measures. Additionally, we
finalized two new optional opioid
measures and one new care
coordination measure to help address
the opioid epidemic and improve
interoperability.
In the FY 2020 IPPS/LTCH Final Rule
(84 FR 42591), we established the EHR
Reporting Period to be a minimum of
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any continuous 90-day period in CY
2021 for new and returning participants
(eligible hospitals and CAHs) in the
Medicare Promoting Interoperability
Program attesting to CMS, as well as
finalizing the removal of the Electronic
Prescribing Objective’s Verify Opioid
Treatment Agreement measure
beginning with the EHR reporting
period in CY 2020.
In the FY 2021 IPPS/LTCH PPS Final
Rule (85 FR 58966), we are finalizing as
proposed changes that we believe will
continue to be a low reporting burden
on eligible hospitals and CAHs in the
Medicare Promoting Interoperability
Program while incentivizing the
advanced use of CEHRT to support
health information exchange,
interoperability, advanced quality
measurement, and maximizing clinical
effectiveness and efficiencies. These
finalized changes include continuing an
EHR reporting period of a minimum of
any continuous 90-day period in CY
2022, and maintaining the Query of
PDMP measure as optional and worth 5
bonus points in CY 2021.
In the FY 2022 IPPS/LTCH PPS
Proposed Rule (86 FR 25628), we
proposed changes that we believe will
continue to be a low reporting burden
on eligible hospitals and CAHs in the
Medicare Promoting Interoperability
Program while incentivizing the
advanced use of CEHRT to support
health information exchange,
interoperability, advance quality
measurement, and maximize clinical
effectiveness and efficiencies. The
proposals include continuing an EHR
reporting period of a minimum of any
continuous 90-day period in CY 2023,
maintaining the Query of PDMP
measure as optional but worth 10 bonus
points in CY 2022, the addition of a new
Health Information Exchange BiDirectional Exchange measure
beginning in CY 2022 as an optional
alternative to the two existing measures,
a requirement of reporting 4 specific
Public Health and Clinical Data
Exchange Objective measures, the
inclusion of a new SAFER Guides
measure attestation response, and to
adopt two new eCQMs to the Medicare
Promoting Interoperability Program’s
eCQM measure set beginning with the
reporting period in CY 2023 (in addition
to removing three eCQMs from the
measure set beginning with the
reporting period in CY 2024, in
alignment with the finalized changes to
the Hospital IQR Program. In the FY
2022 IPPS/LTCH PPS Final Rule (86 FR
45460 through 45498), we finalized
these proposals. We did not finalize a
proposal to update the Provide Patients
Electronic Access to their Health
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57151
Information measure to include a data
retention requirement; however, this
proposal would not have affected our
information collection burden estimate.
We note the previously approved PRA
package under OMB control number
0938–1278 reflecting updates to
information collection burden estimates
based on policies finalized in the FY
2021 IPPS/LTCH PPS Final Rule
include information collection burden
estimates for 2021, which is the last year
for including Medicaid eligible
providers, eligible hospitals, and CAHs
in the burden estimate as the Medicaid
Promoting Interoperability Program
concludes December 31, 2021.
Therefore, this PRA request for
information collection burden in 2022
does not include any burden under the
Medicaid Promoting Interoperability
Program. Form Number: CMS–10552
(OMB control number: 0938–1278);
Frequency: Annually; Affected Public:
State, Local or Private Government;
Business and for-profit and Not-forprofit; Number of Respondents: 3,300;
Total Annual Responses: 3,300; Total
Annual Hours: 21,450. For policy
questions regarding this collection,
contact Jessica Warren at 410–786–
7519.)
Dated: October 8, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2021–22448 Filed 10–13–21; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–372(S), CMS–
10305, CMS–10148, CMS–10784, CMS–
10715, CMS–10768, CMS–R–43 and CMS–
10417]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, Health and Human
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
SUMMARY:
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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.
Comments on the collection(s) of
information must be received by the
OMB desk officer by November 15,
2021.
DATES:
Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
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-andGuidance/Legislation/Paperwork
ReductionActof1995/PRA-Listing.html.
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
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ADDRESSES:
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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: Revision of a currently
approved collection; Title of
Information Collection: Annual Report
on Home and Community Based
Services Waivers and Supporting
Regulations; Use: We use this report to
compare actual data to the approved
waiver estimates. In conjunction with
the waiver compliance review reports,
the information provided will be
compared to that in the Medicaid
Statistical Information System (MSIS)
(CMS–R–284; OMB control number:
0938–0345) report and FFP claimed on
a state’s Quarterly Expenditure Report
(CMS–64; OMB control number: 0938–
1265), to determine whether to continue
the state’s home and community-based
services waiver. States’ estimates of cost
and utilization for renewal purposes are
based upon the data compiled in the
CMS–372(S) reports. Form Number:
CMS–372(S) (OMB control number:
0938–0272); Frequency: Yearly; Affected
Public: State, Local, or Tribal
Governments; Number of Respondents:
48; Total Annual Responses: 253; Total
Annual Hours: 11,132. (For policy
questions regarding this collection
contact Ralph Lollar at 410–786–0777.)
2. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Medicare Part C
and Part D Data Validation (42 CFR
422.516(g) and 423.514(j)); Use: Sections
1857(e) and 1860D–12 of the Social
Security Act (‘‘the Act’’) authorize CMS
to establish information collection
requirements with respect to MAOs and
Part D sponsors. Section 1857(e)(1) of
the Act requires MAOs to provide the
Secretary of the Department of Health
and Human Services (DHHS) with such
information as the Secretary may find
necessary and appropriate. Section
1857(e)(1) of the Act applies to
Prescription Drug Plans (PDPs) as
indicated in section1860D–12. Pursuant
to statutory authority, CMS codified
these information collection
requirements in regulation at
§§ 422.516(g) Validation of Part C
Reporting Requirements, and 423.514(j)
Validation of Part D Reporting
Requirements respectively.
Data collected via Medicare Part C
and Part D reporting requirements are
an integral resource for oversight,
monitoring, compliance and auditing
activities necessary to ensure quality
provision of Medicare benefits to
beneficiaries. CMS uses the findings
collected through the data validation
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process to substantiate the data reported
via Medicare Part C and Part D reporting
requirements. Data validation provides
CMS with assurance that plan-reported
data are credible and consistently
collected and reported by Part C and D
SOs. CMS uses validated data to
respond to inquiries from Congress,
oversight agencies, and the public about
Part C and D SOs. The validated data
also allows CMS to effectively monitor
and compare the performance of SOs
over time. Validated plan-reported data
may be used for Star Ratings, Display
measures and other performance
measures. Additionally, SOs can take
advantage of the DV process to
effectively assess their own performance
and make improvements to their
internal operations and reporting
processes. Form Number: CMS–10305
(OMB control number: 0938–1115);
Frequency: Yearly; Affected Public:
State, Local, or Tribal Governments;
Number of Respondents: 761; Total
Annual Responses: 761; Total Annual
Hours: 20,945. (For policy questions
regarding this collection contact
Chanelle Jones at 410–786–8008.)
3. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: HIPAA
Administrative Simplification (NonPrivacy/Security) Complaint Form; Use:
The Secretary of Health and Human
Services (HHS), hereafter known as
‘‘The Secretary,’’ codified 45 CFR parts
160 and 164 Administrative
Simplification provisions that apply to
the enforcement of the Health Insurance
Portability and Accountability Act of
1996 Public Law 104–191 (HIPAA). The
provisions address rules relating to the
investigation of non-compliance of the
HIPAA Administrative Simplification
code sets, unique identifiers, operating
rules, and transactions. 45 CFR 160.306,
Complaints to the Secretary, provides
for investigations of covered entities by
the Secretary. Further, it outlines the
procedures and requirements for filing a
complaint against a covered entity.
Anyone can file a complaint if he or
she suspects a potential violation.
Persons believing that a covered entity
is not utilizing the adopted
Administrative Simplification
provisions of HIPAA are voluntarily
requested to file a complaint with CMS
via the Administrative Simplification
Enforcement and Testing Tool (ASETT)
online system, by mail, or by sending an
email to the HIPAA mailbox at
hipaacomplaint@cms.hhs.gov.
Information provided on the standard
form will be used during the
investigation process to validate non-
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compliance of HIPAA Administrative
Simplification provisions.
This standard form collects
identifying and contact information of
the complainant, as well as the
identifying and contact information of
the filed against entity (FAE). This
information enables CMS to respond to
the complainant and gather more
information if necessary, and to contact
the FAE to discuss the complaint and
CMS’ findings. Form Number: CMS–
10148 (OMB control number: 0938–
0948); Frequency: Occasionally;
Affected Public: Private sector, Business
or Not-for-profit institutions, State,
Local, or Tribal Governments, Federal
Government, Not-for-profits institutions;
Number of Respondents: 21; Total
Annual Responses: 21; Total Annual
Hours: 12. (For policy questions
regarding this collection contact Cecily
Austin at 410–786–0895.)
4. Type of Information Collection
Request: New collection (Request for a
new OMB control); Title of Information
Collection: The Home Health Care
CAHPS® Survey (HHCAHPS) Mode
Experiment; Use: The reporting of
quality data by HHAs is mandated by
Section 1895(b)(3)(B)(v)(II) of the Social
Security Act (‘‘the Act’’). This statute
requires that ‘‘each home health agency
shall submit to the Secretary such data
that the Secretary determines are
appropriate for the measurement of
health care quality. Such data shall be
submitted in a form and manner, and at
a time, specified by the Secretary for
purposes of this clause.’’ HHCAHPS
data are mandated in the Medicare
regulations at 42 CFR 484.250(a), which
requires HHAs to submit HHCAHPS
data to meet the quality reporting
requirements of section 1895(b)(3)(B)(v)
of the Act. This collection of
information is necessary to be able to
test updates to the HHCAHPS survey
and administration protocols.
CMS proposes to conduct a mode
experiment with the main goal of testing
the effects of a web-based mode on
response rates and scores as an addition
to the three currently approved modes
(OMB Control Number: 0938–1370). The
addition of a web mode will give HHAs
an alternative or an addition to the use
of mail and telephone modes. CMS is
also interested in testing a revised,
shorter version of the HHCAHPS survey,
based on feedback from patients and
stakeholders.
The data collected from the
HHCAHPS Survey mode experiment
will be used for the following purposes:
• Test the shortened survey
instrument, including several new
items;
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• Compare survey responses across
the four proposed modes to determine if
adjustments are needed to ensure that
data collection mode does not influence
results; and
• Determine if and by how much
patient characteristics affect the
patients’ rating of the care they receive
and adjust results based on those
factors.
The mode experiment is designed to
examine the effects of the shortened
survey on response rates and scores and
to provide precise adjustment estimates
for survey items and composites on the
shortened survey instrument.
Information from this mode experiment
will help CMS determine whether an
additional mode of administration (i.e.,
Web data collection) should be included
and a shortened survey instrument
should be used in the current national
implementation of the HHCAHPS
Survey. Form Number: CMS–10784
(OMB control number: 0938-New);
Frequency: Annually; Affected Public:
Individuals or Households; Number of
Respondents: 6,280; Total Annual
Responses: 6,280; Total Annual Hours:
1,049. (For policy questions regarding
this collection contact Lori E. Teichman
at 410–786–6684.)
5. Type of Information Collection
Request: New collection (Request for a
new OMB control number); Title of
Information Collection: Transparency in
Coverage; Use: The final rules titled
‘‘Transparency in Coverage,’’ published
November 12, 2020 (85 FR 72158),
establish requirements for group health
plans and health insurance issuers
offering non-grandfathered coverage in
the individual and group markets to
disclose to a participant, beneficiary, or
enrollee (or an authorized representative
on behalf of such individual) the
consumer-specific estimated costsharing liability for covered items or
services from a particular provider,
thereby allowing a participant,
beneficiary, or enrollee to obtain an
accurate estimate and understanding of
their potential out-of-pocket expenses
and to effectively shop for covered items
and services. Plans and issuers are
required to make such information
available for covered items and services
through an internet-based self-service
tool, and, if requested, in paper form.
The internet-based self-service tool must
allow participants, beneficiaries, or
enrollees to search for cost-sharing
information for a covered item or
service by inputting the name of a
specific in-network provider in
conjunction with a billing code or
descriptive term, as well as other
relevant factors such as location of
service, facility name, or dosage. In
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addition, the final rules require that the
tool allow the user to refine and reorder
search results based on geographic
proximity of in-network providers. For
covered items and services provided by
out-of-network providers, the tool must
provide the out-of-network allowed
amount, percentage of billed charges, or
other rates that provide a reasonably
accurate estimate of the amount a plan
or issuer will pay by allowing
consumers to input a billing code,
descriptive code, or other relevant
factor, such as location.
The final rules also require plans and
issuers to publicly disclose applicable
rates with in-network providers,
including negotiated rates; historical
data outlining the different billed
charges and allowed amounts a plan or
issuer has paid for covered items or
services, including prescription drugs,
furnished by out-of-network providers;
and negotiated rates and historical net
prices for covered prescription drugs
furnished by in-network providers
through three machine-readable files (an
In-network Rate File, Allowed Amount
File, and Prescription Drug File). The
machine-readable files must be posted
publicly on an internet website and
updated on a monthly basis. Form
Number: CMS–10715 (OMB control
number: 0938–1372); Frequency:
Frequently; Affected Public: Public and
Private sectors; Number of Respondents:
908; Total Annual Responses: 74,460;
Total Annual Hours: 28,618,546. (For
policy questions regarding this
collection contact Russell Tipps at 301–
492–4371.)
6. Type of Information Collection
Request: New collection (Request for a
new OMB control number); Title of
Information Collection: The ESRD
Network Peer Mentoring Program; Use:
The End Stage Renal Disease (ESRD)
Network Peer Mentoring Program is a
voluntary program designed to provide
patient peer support to people with
kidney disease. In part, the peer support
is beneficial because patients can give
each other something most practitioners
do not have: Lived experience with
kidney disease. The support and
perspective of someone who has ‘‘been
there’’ can help people better cope with
their circumstances.
The ESRD Network Peer Mentoring
Program is a partnership between
dialysis facilities, ESRD Networks, and
patient peer mentors and mentees that
wish to engage in the program. The peer
mentoring program is organized and
published with educational
opportunities for peer mentors and
mentees, provides resources, and
includes a complementary toolkit for
ESRD Networks and dialysis facilities to
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promote and operationalize the
program.
Program applicants are people with
ESRD who: (1) Are adults over the age
of 18; have been receiving in-center or
home dialysis or have been transplanted
for at least six months; actively engage
in the care plan; consistently
demonstrate leadership qualities at
facility Quality Assurance &
Performance Improvement (QAPI)
meetings, Lobby Days, and other facility
activities; and wish to be a peer mentor;
or (2) are over 18 years of age; are newly
diagnosed patients but have been on incenter dialysis for at least six months;
are looking for peer support to help
them transition to their new reality; and
are known as a peer mentee.
To participate in the ESRD Network
Peer Mentoring Program, peer mentors
and mentees will complete an online
application form stored in Confluence.
The application serves to validate the
peer mentor or peer mentee interest in
the ESRD Network Peer Mentoring
Program. Information collection is
important to the process of pairing peer
mentors and mentees with similarly
lived experience and interests with their
kidney disease. In addition, the
application collects information about
the peers’ interest in kidney disease,
treatment modality, age range, preferred
gender recognition, and attitudes toward
their kidney disease diagnosis. It also
supports aligning hobbies, and genders
to support best matched peers with each
other. Form Number: CMS–10768 (OMB
control number: 0938–NEW);
Frequency: Once; Affected Public:
Individuals and Households; Number of
Respondents: 75; Total Annual
Responses: 75; Total Annual Hours: 19.
(For policy questions regarding this
collection, contact Lisa Rees at 816–
426–6353.)
7. Type of Information Collection
Request: Revision of a previously
approved collection; Title of
Information Collection: Conditions of
Coverage for Portable X-ray Suppliers
and Supporting Regulations; Use: The
requirements contained in this
information collection request are
classified as conditions of participation
or conditions for coverage. Portable Xrays are basic radiology studies
(predominately chest and extremity Xrays) performed on patients in skilled
nursing facilities, residents of long-term
care facilities and homebound patients.
The CoPs are based on criteria described
in the law, and are designed to ensure
that each portable X-ray supplier has
properly trained staff and provides the
appropriate type and level of care for
patients. The information collection
requirements described below are
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necessary to certify portable X-ray
suppliers wishing to participate in the
Medicare program. There are currently
506 portable X-ray suppliers
participating in the Medicare program.
On September 30, 2019 (84 FR 51732),
CMS updated the personnel
requirements for portable X-ray
technicians at 42 CFR 486.104(a), to
focus on the qualifications of the
individual performing services
removing school accreditation
requirements and simplifying the
structure of the requirements.
Additionally, CMS also revised the
requirements for referral of service at 42
CFR 486.106(a) for portable X-ray
requirements for orders. This change
removed the requirement that physician
or non-physician practitioner’s orders
for portable X-ray services must be
written and signed and replacing the
specific requirements related to the
content of each portable X-ray order
with a cross-reference to the
requirements at 42 CFR 410.32, which
also apply to portable X-ray services.
Form Number: CMS–R–43 (OMB
Control number: 0938–0338);
Frequency: Yearly; Affected Public:
Business or other for-profit and Not-forprofit institutions; Number of
Respondents: 506; Total Annual
Responses: 1,012; Total Annual Hours:
324. (For policy questions regarding this
collection contact James Cowher at 410–
786–1948.)
8. Title of Information Collection:
Medicare Fee-for-Service Prepayment
Review of Medical Records; Type of
Information Collection Request:
Revision of a currently approved
collection; Use: The Medical Review
program is designed to prevent
improper payments in the Medicare FFS
program. Whenever possible, Medicare
Administrative Contractors (MACs) are
encouraged to automate this process;
however, it may require the evaluation
of medical records and related
documents to determine whether
Medicare claims are billed in
compliance with coverage, coding,
payment, and billing policies.
Addressing improper payments in the
Medicare fee-for-service (FFS) program
and promoting compliance with
Medicare coverage and coding rules is a
top priority for the CMS. Preventing
Medicare improper payments requires
the active involvement of every
component of CMS and effective
coordination with its partners including
various Medicare contractors and
providers. The information required
under this collection is requested by
Medicare contractors to determine
proper payment, or if there is a
suspicion of fraud. Medicare contractors
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request the information from providers/
suppliers submitting claims for payment
when data analysis indicates aberrant
billing patterns or other information
which may present a vulnerability to the
Medicare program. Form Number:
CMS–10417 (OMB control number:
0938–0969); Frequency: Occasionally;
Affected Public: Private Sector, State,
Business, and Not-for Profits; Number of
Respondents: 485,632; Number of
Responses: 485,632; Total Annual
Hours: 242,816. (For questions regarding
this collection, contact Christine Grose
at (410–786–1362).
Dated: October 8, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2021–22444 Filed 10–13–21; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–6841]
Select Updates for Unique Device
Identification: Policy Regarding Global
Unique Device Identification Database
Requirements for Certain Devices;
Draft Guidance for Industry and Food
and Drug Administration Staff;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing the availability of the draft
guidance entitled ‘‘Select Updates for
Unique Device Identification: Policy
Regarding Global Unique Device
Identification Database Requirements
for Certain Devices; Draft Guidance for
Industry and Food and Drug
Administration Staff.’’ This draft
guidance explains that there are certain
class I devices for which FDA does not
intend to enforce Global Unique Device
Identification Database (GUDID)
submission requirements and describes
how a labeler of a class I device can
determine if its device is one of these
devices in the revised section III of this
draft guidance. When this draft
guidance is finalized, the updates in
section III of this draft guidance would
supersede the recommendations in
section III of the guidance ‘‘Unique
Device Identification: Policy Regarding
Compliance Dates for Class I and
Unclassified Devices and Certain
Devices Requiring Direct Marking’’
SUMMARY:
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[Federal Register Volume 86, Number 196 (Thursday, October 14, 2021)]
[Notices]
[Pages 57151-57154]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-22444]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-372(S), CMS-10305, CMS-10148, CMS-10784, CMS-
10715, CMS-10768, CMS-R-43 and CMS-10417]
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
AGENCY: Centers for Medicare & Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
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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
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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 November 15, 2021.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
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.
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: Revision of a currently
approved collection; Title of Information Collection: Annual Report on
Home and Community Based Services Waivers and Supporting Regulations;
Use: We use this report to compare actual data to the approved waiver
estimates. In conjunction with the waiver compliance review reports,
the information provided will be compared to that in the Medicaid
Statistical Information System (MSIS) (CMS-R-284; OMB control number:
0938-0345) report and FFP claimed on a state's Quarterly Expenditure
Report (CMS-64; OMB control number: 0938-1265), to determine whether to
continue the state's home and community-based services waiver. States'
estimates of cost and utilization for renewal purposes are based upon
the data compiled in the CMS-372(S) reports. Form Number: CMS-372(S)
(OMB control number: 0938-0272); Frequency: Yearly; Affected Public:
State, Local, or Tribal Governments; Number of Respondents: 48; Total
Annual Responses: 253; Total Annual Hours: 11,132. (For policy
questions regarding this collection contact Ralph Lollar at 410-786-
0777.)
2. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Medicare Part C
and Part D Data Validation (42 CFR 422.516(g) and 423.514(j)); Use:
Sections 1857(e) and 1860D-12 of the Social Security Act (``the Act'')
authorize CMS to establish information collection requirements with
respect to MAOs and Part D sponsors. Section 1857(e)(1) of the Act
requires MAOs to provide the Secretary of the Department of Health and
Human Services (DHHS) with such information as the Secretary may find
necessary and appropriate. Section 1857(e)(1) of the Act applies to
Prescription Drug Plans (PDPs) as indicated in section1860D-12.
Pursuant to statutory authority, CMS codified these information
collection requirements in regulation at Sec. Sec. 422.516(g)
Validation of Part C Reporting Requirements, and 423.514(j) Validation
of Part D Reporting Requirements respectively.
Data collected via Medicare Part C and Part D reporting
requirements are an integral resource for oversight, monitoring,
compliance and auditing activities necessary to ensure quality
provision of Medicare benefits to beneficiaries. CMS uses the findings
collected through the data validation process to substantiate the data
reported via Medicare Part C and Part D reporting requirements. Data
validation provides CMS with assurance that plan-reported data are
credible and consistently collected and reported by Part C and D SOs.
CMS uses validated data to respond to inquiries from Congress,
oversight agencies, and the public about Part C and D SOs. The
validated data also allows CMS to effectively monitor and compare the
performance of SOs over time. Validated plan-reported data may be used
for Star Ratings, Display measures and other performance measures.
Additionally, SOs can take advantage of the DV process to effectively
assess their own performance and make improvements to their internal
operations and reporting processes. Form Number: CMS-10305 (OMB control
number: 0938-1115); Frequency: Yearly; Affected Public: State, Local,
or Tribal Governments; Number of Respondents: 761; Total Annual
Responses: 761; Total Annual Hours: 20,945. (For policy questions
regarding this collection contact Chanelle Jones at 410-786-8008.)
3. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: HIPAA
Administrative Simplification (Non-Privacy/Security) Complaint Form;
Use: The Secretary of Health and Human Services (HHS), hereafter known
as ``The Secretary,'' codified 45 CFR parts 160 and 164 Administrative
Simplification provisions that apply to the enforcement of the Health
Insurance Portability and Accountability Act of 1996 Public Law 104-191
(HIPAA). The provisions address rules relating to the investigation of
non-compliance of the HIPAA Administrative Simplification code sets,
unique identifiers, operating rules, and transactions. 45 CFR 160.306,
Complaints to the Secretary, provides for investigations of covered
entities by the Secretary. Further, it outlines the procedures and
requirements for filing a complaint against a covered entity.
Anyone can file a complaint if he or she suspects a potential
violation. Persons believing that a covered entity is not utilizing the
adopted Administrative Simplification provisions of HIPAA are
voluntarily requested to file a complaint with CMS via the
Administrative Simplification Enforcement and Testing Tool (ASETT)
online system, by mail, or by sending an email to the HIPAA mailbox at
[email protected]. Information provided on the standard form
will be used during the investigation process to validate non-
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compliance of HIPAA Administrative Simplification provisions.
This standard form collects identifying and contact information of
the complainant, as well as the identifying and contact information of
the filed against entity (FAE). This information enables CMS to respond
to the complainant and gather more information if necessary, and to
contact the FAE to discuss the complaint and CMS' findings. Form
Number: CMS-10148 (OMB control number: 0938-0948); Frequency:
Occasionally; Affected Public: Private sector, Business or Not-for-
profit institutions, State, Local, or Tribal Governments, Federal
Government, Not-for-profits institutions; Number of Respondents: 21;
Total Annual Responses: 21; Total Annual Hours: 12. (For policy
questions regarding this collection contact Cecily Austin at 410-786-
0895.)
4. Type of Information Collection Request: New collection (Request
for a new OMB control); Title of Information Collection: The Home
Health Care CAHPS[supreg] Survey (HHCAHPS) Mode Experiment; Use: The
reporting of quality data by HHAs is mandated by Section
1895(b)(3)(B)(v)(II) of the Social Security Act (``the Act''). This
statute requires that ``each home health agency shall submit to the
Secretary such data that the Secretary determines are appropriate for
the measurement of health care quality. Such data shall be submitted in
a form and manner, and at a time, specified by the Secretary for
purposes of this clause.'' HHCAHPS data are mandated in the Medicare
regulations at 42 CFR 484.250(a), which requires HHAs to submit HHCAHPS
data to meet the quality reporting requirements of section
1895(b)(3)(B)(v) of the Act. This collection of information is
necessary to be able to test updates to the HHCAHPS survey and
administration protocols.
CMS proposes to conduct a mode experiment with the main goal of
testing the effects of a web-based mode on response rates and scores as
an addition to the three currently approved modes (OMB Control Number:
0938-1370). The addition of a web mode will give HHAs an alternative or
an addition to the use of mail and telephone modes. CMS is also
interested in testing a revised, shorter version of the HHCAHPS survey,
based on feedback from patients and stakeholders.
The data collected from the HHCAHPS Survey mode experiment will be
used for the following purposes:
Test the shortened survey instrument, including several
new items;
Compare survey responses across the four proposed modes to
determine if adjustments are needed to ensure that data collection mode
does not influence results; and
Determine if and by how much patient characteristics
affect the patients' rating of the care they receive and adjust results
based on those factors.
The mode experiment is designed to examine the effects of the
shortened survey on response rates and scores and to provide precise
adjustment estimates for survey items and composites on the shortened
survey instrument. Information from this mode experiment will help CMS
determine whether an additional mode of administration (i.e., Web data
collection) should be included and a shortened survey instrument should
be used in the current national implementation of the HHCAHPS Survey.
Form Number: CMS-10784 (OMB control number: 0938-New); Frequency:
Annually; Affected Public: Individuals or Households; Number of
Respondents: 6,280; Total Annual Responses: 6,280; Total Annual Hours:
1,049. (For policy questions regarding this collection contact Lori E.
Teichman at 410-786-6684.)
5. Type of Information Collection Request: New collection (Request
for a new OMB control number); Title of Information Collection:
Transparency in Coverage; Use: The final rules titled ``Transparency in
Coverage,'' published November 12, 2020 (85 FR 72158), establish
requirements for group health plans and health insurance issuers
offering non-grandfathered coverage in the individual and group markets
to disclose to a participant, beneficiary, or enrollee (or an
authorized representative on behalf of such individual) the consumer-
specific estimated cost-sharing liability for covered items or services
from a particular provider, thereby allowing a participant,
beneficiary, or enrollee to obtain an accurate estimate and
understanding of their potential out-of-pocket expenses and to
effectively shop for covered items and services. Plans and issuers are
required to make such information available for covered items and
services through an internet-based self-service tool, and, if
requested, in paper form. The internet-based self-service tool must
allow participants, beneficiaries, or enrollees to search for cost-
sharing information for a covered item or service by inputting the name
of a specific in-network provider in conjunction with a billing code or
descriptive term, as well as other relevant factors such as location of
service, facility name, or dosage. In addition, the final rules require
that the tool allow the user to refine and reorder search results based
on geographic proximity of in-network providers. For covered items and
services provided by out-of-network providers, the tool must provide
the out-of-network allowed amount, percentage of billed charges, or
other rates that provide a reasonably accurate estimate of the amount a
plan or issuer will pay by allowing consumers to input a billing code,
descriptive code, or other relevant factor, such as location.
The final rules also require plans and issuers to publicly disclose
applicable rates with in-network providers, including negotiated rates;
historical data outlining the different billed charges and allowed
amounts a plan or issuer has paid for covered items or services,
including prescription drugs, furnished by out-of-network providers;
and negotiated rates and historical net prices for covered prescription
drugs furnished by in-network providers through three machine-readable
files (an In-network Rate File, Allowed Amount File, and Prescription
Drug File). The machine-readable files must be posted publicly on an
internet website and updated on a monthly basis. Form Number: CMS-10715
(OMB control number: 0938-1372); Frequency: Frequently; Affected
Public: Public and Private sectors; Number of Respondents: 908; Total
Annual Responses: 74,460; Total Annual Hours: 28,618,546. (For policy
questions regarding this collection contact Russell Tipps at 301-492-
4371.)
6. Type of Information Collection Request: New collection (Request
for a new OMB control number); Title of Information Collection: The
ESRD Network Peer Mentoring Program; Use: The End Stage Renal Disease
(ESRD) Network Peer Mentoring Program is a voluntary program designed
to provide patient peer support to people with kidney disease. In part,
the peer support is beneficial because patients can give each other
something most practitioners do not have: Lived experience with kidney
disease. The support and perspective of someone who has ``been there''
can help people better cope with their circumstances.
The ESRD Network Peer Mentoring Program is a partnership between
dialysis facilities, ESRD Networks, and patient peer mentors and
mentees that wish to engage in the program. The peer mentoring program
is organized and published with educational opportunities for peer
mentors and mentees, provides resources, and includes a complementary
toolkit for ESRD Networks and dialysis facilities to
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promote and operationalize the program.
Program applicants are people with ESRD who: (1) Are adults over
the age of 18; have been receiving in-center or home dialysis or have
been transplanted for at least six months; actively engage in the care
plan; consistently demonstrate leadership qualities at facility Quality
Assurance & Performance Improvement (QAPI) meetings, Lobby Days, and
other facility activities; and wish to be a peer mentor; or (2) are
over 18 years of age; are newly diagnosed patients but have been on in-
center dialysis for at least six months; are looking for peer support
to help them transition to their new reality; and are known as a peer
mentee.
To participate in the ESRD Network Peer Mentoring Program, peer
mentors and mentees will complete an online application form stored in
Confluence. The application serves to validate the peer mentor or peer
mentee interest in the ESRD Network Peer Mentoring Program. Information
collection is important to the process of pairing peer mentors and
mentees with similarly lived experience and interests with their kidney
disease. In addition, the application collects information about the
peers' interest in kidney disease, treatment modality, age range,
preferred gender recognition, and attitudes toward their kidney disease
diagnosis. It also supports aligning hobbies, and genders to support
best matched peers with each other. Form Number: CMS-10768 (OMB control
number: 0938-NEW); Frequency: Once; Affected Public: Individuals and
Households; Number of Respondents: 75; Total Annual Responses: 75;
Total Annual Hours: 19. (For policy questions regarding this
collection, contact Lisa Rees at 816-426-6353.)
7. Type of Information Collection Request: Revision of a previously
approved collection; Title of Information Collection: Conditions of
Coverage for Portable X-ray Suppliers and Supporting Regulations; Use:
The requirements contained in this information collection request are
classified as conditions of participation or conditions for coverage.
Portable X-rays are basic radiology studies (predominately chest and
extremity X-rays) performed on patients in skilled nursing facilities,
residents of long-term care facilities and homebound patients. The CoPs
are based on criteria described in the law, and are designed to ensure
that each portable X-ray supplier has properly trained staff and
provides the appropriate type and level of care for patients. The
information collection requirements described below are necessary to
certify portable X-ray suppliers wishing to participate in the Medicare
program. There are currently 506 portable X-ray suppliers participating
in the Medicare program.
On September 30, 2019 (84 FR 51732), CMS updated the personnel
requirements for portable X-ray technicians at 42 CFR 486.104(a), to
focus on the qualifications of the individual performing services
removing school accreditation requirements and simplifying the
structure of the requirements. Additionally, CMS also revised the
requirements for referral of service at 42 CFR 486.106(a) for portable
X-ray requirements for orders. This change removed the requirement that
physician or non-physician practitioner's orders for portable X-ray
services must be written and signed and replacing the specific
requirements related to the content of each portable X-ray order with a
cross-reference to the requirements at 42 CFR 410.32, which also apply
to portable X-ray services. Form Number: CMS-R-43 (OMB Control number:
0938-0338); Frequency: Yearly; Affected Public: Business or other for-
profit and Not-for-profit institutions; Number of Respondents: 506;
Total Annual Responses: 1,012; Total Annual Hours: 324. (For policy
questions regarding this collection contact James Cowher at 410-786-
1948.)
8. Title of Information Collection: Medicare Fee-for-Service
Prepayment Review of Medical Records; Type of Information Collection
Request: Revision of a currently approved collection; Use: The Medical
Review program is designed to prevent improper payments in the Medicare
FFS program. Whenever possible, Medicare Administrative Contractors
(MACs) are encouraged to automate this process; however, it may require
the evaluation of medical records and related documents to determine
whether Medicare claims are billed in compliance with coverage, coding,
payment, and billing policies. Addressing improper payments in the
Medicare fee-for-service (FFS) program and promoting compliance with
Medicare coverage and coding rules is a top priority for the CMS.
Preventing Medicare improper payments requires the active involvement
of every component of CMS and effective coordination with its partners
including various Medicare contractors and providers. The information
required under this collection is requested by Medicare contractors to
determine proper payment, or if there is a suspicion of fraud. Medicare
contractors request the information from providers/suppliers submitting
claims for payment when data analysis indicates aberrant billing
patterns or other information which may present a vulnerability to the
Medicare program. Form Number: CMS-10417 (OMB control number: 0938-
0969); Frequency: Occasionally; Affected Public: Private Sector, State,
Business, and Not-for Profits; Number of Respondents: 485,632; Number
of Responses: 485,632; Total Annual Hours: 242,816. (For questions
regarding this collection, contact Christine Grose at (410-786-1362).
Dated: October 8, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2021-22444 Filed 10-13-21; 8:45 am]
BILLING CODE 4120-01-P
