Notice2021-22444
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Primary source
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Published
October 14, 2021
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 196 (Thursday, October 14, 2021)</title>
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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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
[[Page 57152]]
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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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: <a href="https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html">https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html</a>.
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
<a href="/cdn-cgi/l/email-protection#375f5e47565654585a475b565e594377545a44195f5f4419505841"><span class="__cf_email__" data-cfemail="8be3e2fbeaeae8e4e6fbe7eae2e5ffcbe8e6f8a5e3e3f8a5ece4fd">[email protected]</span></a>. Information provided on the standard form
will be used during the investigation process to validate non-
[[Page 57153]]
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:
<bullet> Test the shortened survey instrument, including several
new items;
<bullet> 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
<bullet> 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
[[Page 57154]]
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
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