Agency Information Collection Activities: Submission for OMB Review; Comment Request, 734-737 [2019-00411]
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questions regarding this collection,
contact Bilal Farrakh at 410–786–4456.)
6. Type of Information Collection
Request: New collection (Request for a
new OMB control number); Title of
Information Collection: Testing of Web
Survey Design and Administration for
CMS Experience of Care Surveys; Use:
This collection is a new generic
clearance request which encompasses
an array of research activities to add
web administration protocols to a series
of surveys conducted by the Centers for
Medicare & Medicaid Services (CMS).
This request seeks burden hours to
allow CMS and its contractors to
conduct cognitive in-depth interviews,
focus groups, pilot tests, and usability
studies to support a variety of
methodological studies around web
modes of data collection for programs
such as the Emergency Department
Experience of Care (EDPEC), Fee-forService (FFS) Consumer Assessment of
Healthcare Providers and Systems
(CAHPS), Hospital CAHPS (HCAHPS),
Medicare Advantage and Prescription
Drug (MA & PDP) CAHPS, Home Health
(HH) CAHPS, Hospice CAHPS, InCenter Hemodialysis (ICH) CAHPS, the
Health Outcomes Survey (HOS), and the
Medicare Advantage and Part D Plan
Disenrollment Reasons surveys.
Providers. Form Number: CMS–10694
(OMB control number: 0938-New);
Frequency: Yearly; Affected Public:
Business or other for-profits, Not-forProfit Institutions; Number of
Respondents: 75,250; Total Annual
Responses: 75,250; Total Annual Hours:
17,000. (For policy, questions regarding
this collection contact Elizabeth H.
Goldstein at 410–786–6665.)
7. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Medicare
Current Beneficiary Survey; Use: CMS is
the largest single payer of health care in
the United States. The agency plays a
direct or indirect role in administering
health insurance coverage for more than
120 million people across the Medicare,
Medicaid, CHIP, and Exchange
populations. A critical aim for CMS is
to be an effective steward, major force,
and trustworthy partner in supporting
innovative approaches to improving
quality, accessibility, and affordability
in healthcare. CMS also aims to put
patients first in the delivery of their
health care needs.
The Medicare Current Beneficiary
Survey (MCBS) is the most
comprehensive and complete survey
available on the Medicare population
and is essential in capturing data not
otherwise collected through our
operations. The MCBS is an in-person,
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nationally-representative, longitudinal
survey of Medicare beneficiaries that we
sponsor and is directed by the Office of
Enterprise Data and Analytics (OEDA).
The survey captures beneficiary
information whether aged or disabled,
living in the community or facility, or
serviced by managed care or fee-forservice. Data produced as part of the
MCBS are enhanced with our
administrative data (e.g. fee-for-service
claims, prescription drug event data,
enrollment, etc.) to provide users with
more accurate and complete estimates of
total health care costs and utilization.
The MCBS has been continuously
fielded for more than 26 years,
encompassing over 1 million interviews
and more than 100,000 survey
participants. Respondents participate in
up to 11 interviews over a four year
period. This gives a comprehensive
picture of health care costs and
utilization over a period of time.
The MCBS continues to provide
unique insight into the Medicare
program and helps CMS and our
external stakeholders better understand
and evaluate the impact of existing
programs and significant new policy
initiatives. In the past, MCBS data have
been used to assess potential changes to
the Medicare program. For example, the
MCBS was instrumental in supporting
the development and implementation of
the Medicare prescription drug benefit
by providing a means to evaluate
prescription drug costs and out-ofpocket burden for these drugs to
Medicare beneficiaries. Beginning in
2020, this proposed revision to the
clearance will add a few new measures
to existing questionnaire sections. The
revisions will result in a slight decrease
in respondent burden of 4%, due to
fewer projected completed cases each
round. Form Number: CMS–P–0015A
(OMB control number: 0938–0568);
Frequency: Occasionally; Affected
Public: Business or other for-profits and
Not-for-profit institutions; Number of
Respondents: 13,656; Total Annual
Responses: 35,998; Total Annual Hours:
42,610. (For policy questions regarding
this collection contact William Long at
410–786–7927.)
Dated: January 28, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2019–00433 Filed 1–30–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–R–262, CMS–
224–14, CMS–R–240, CMS–10164, CMS–
2552–10, CMS–R–306, CMS–10684, CMS–
10237, CMS–10524 and CMS–10511]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
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.
DATES: Comments on the collection(s) of
information must be received by the
OMB desk officer by March 4, 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
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/
SUMMARY:
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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) 786–1326.
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: Contract Year
2020 Plan Benefit Package (PBP)
Software and Formulary Submission;
Use: CMS requires that MA and PDP
organizations submit a completed Plan
Benefit Package (PBP) and formulary as
part of the annual bidding process.
During this process, organizations
prepare their proposed plan benefit
packages for the upcoming contract year
and submit them to CMS for review and
approval. The plan benefit package
submission consists of the Plan Benefit
Package (PBP) software, formulary file,
and supporting documentation, as
necessary. MA and PDP organizations
use the PBP software to describe their
organization’s plan benefit packages,
including information on premiums,
cost sharing, authorization rules, and
supplemental benefits. They also
generate a formulary to describe their
list of drugs, including information on
prior authorization, step therapy,
tiering, and quantity limits.
Additionally, CMS uses the PBP and
formulary data to review and approve
the plan benefit packages proposed by
each MA and PDP organization. This
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allows CMS to review the benefit
packages in a consistent way across all
submitted bids during with incredibly
tight timeframes. This data is also used
to populate data on Medicare Plan
Finder, which allows beneficiaries to
access and compare Medicare
Advantage and Prescription Drug plans.
Form Number: CMS–R–262 (OMB
control number 0938–0763); Frequency:
Yearly; Affected Public: Private Sector,
Business or other for-profits and Notfor-profit institution; Number of
Respondents: 570; Total Annual
Responses: 6,760; Total Annual Hours:
65,354.50 (For policy questions
regarding this collection contact Kristy
Holtje at 410–786–2209.)
2. Title of Information Collection:
Federal Qualified Health Center Cost
Report; Type of Information Collection
Request: Extension of a currently
approved collection; Use: Under the
authority of sections 1815(a) and
1833(e) of the Act, CMS requires that
providers of services participating in the
Medicare program submit information
to determine costs for health care
services rendered to Medicare
beneficiaries. Furthermore, these
sections of the Act provide that no
Medicare payments will be made to a
provider unless it furnishes the
information. CMS requires that
providers follow reasonable cost
principles under 1861(v)(1)(A) of the
Act when completing the Medicare cost
report. Under the regulations at 42 CFR
413.20 and 413.24, CMS defines
adequate cost data and requires cost
reports from providers on an annual
basis. The Form CMS–224–14 cost
report is needed to determine a
provider’s reasonable cost incurred in
furnishing medical services to Medicare
beneficiaries and to calculate the FQHC
settlement amount. These providers,
paid under the FQHC prospective
payment system (PPS), may receive
reimbursement outside of the PPS for
Medicare reimbursable bad debts and
pneumococcal and influenza vaccines.
The FQHC cost report is also used for
rate setting and payment refinement
activities, including developing a FQHC
market basket. Additionally, the
Medicare Payment Advisory
Commission (MedPAC) uses the FQHC
Medicare cost report data to calculate
Medicare margins, to formulate
recommendations to Congress regarding
the FQHC PPS, and to conduct
additional analysis of the FQHC PPS.
Form Number: CMS–224–14 (OMB
control number: 0938–1298); Frequency:
Yearly; Affected Public: State, Local, or
Tribal Governments; Number of
Respondents: 2,240; Number of
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735
Responses: 2,240; Total Annual Hours:
129,920. (For questions regarding this
collection contact Julie Stankivic at
(410) 786–5725.)
3. Type of Information Collection
Request: Reinstatement of a previously
approved collection; Title of
Information Collection: Prospective
Payments for Hospital Outpatient
Services; Use: Section 1833(t) of the Act,
as added by section 4523 of the
Balanced Budget Act of 1997 (the BBA)
requires the Secretary to establish a
prospective payment system (PPS) for
hospital outpatient services. Successful
implementation of an outpatient PPS
requires that CMS distinguish facilities
or organizations that function as
departments of hospitals from those that
are freestanding, so that CMS can
determine which services should be
paid under the OPPS, the clinical
laboratory fee schedule, or other
payment provisions applicable to
services furnished to hospital
outpatients. Information from the
reports required under sections
413.65(b)(3) and (c) is needed to make
these determinations. In addition,
section 1866(b)(2) of the Act authorizes
hospitals and other providers to impose
deductible and coinsurance charges for
facility services, but does not allow such
charges by facilities or organizations
which are not provider-based.
Implementation of this provision
requires that CMS have information
from the required reports, so it can
determine which facilities are providerbased. Form Number: CMS–R–240
(OMB control number: 0938–0798);
Frequency: Yearly; Affected Public:
Private Sector (Business or other forprofits, Not-for-Profit Institutions);
Number of Respondents: 750; Total
Annual Responses: 13,649,150; Total
Annual Hours: 680,920 (For policy
questions regarding this collection
contact Emily Lipkin at 410–786–3633.)
4. Type of Information Collection
Request: Reinstatement of a previously
approved collection; Title of
Information Collection: Medicare EDI
Enrollment Form and EDI Registration;
Use: The Congress, recognizing the need
to simplify the administration of health
care transactions, enacted the Health
Insurance Portability and
Accountability Act of 1996 (HIPAA),
Public Law 104–191, on August 21,
1996. Title II, Subtitle F of this
legislation directs the Secretary of the
Department of Health and Human
Services to develop unique standards
for specified electronic transactions and
code sets for those transactions. The
purpose of this Subtitle is to improve
the Medicare and Medicaid programs in
particular and the efficiency and
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effectiveness of the health care industry
in general through the establishment of
standards and requirements to facilitate
the electronic transmission of certain
health information. This Subtitle also
requires that the Secretary adopt
standards for financial and
administrative transactions, and data
elements for those transactions to enable
health information to be exchanged
electronically. The Standards for
Electronic Transactions final rule, 45
CFR part 162 subpart K 162.1101
through subpart R 162.1802, (hereinafter
referred to as ‘‘Transactions Rule’’)
published August 17, 2000 adopted
standards for health care transactions
and code sets. Subsequent to the
Transactions Rule, CMS–0003–P and
CMS–0005–P proposed modifications to
the adopted standards essential to
permit initial implementation of the
standards throughout the entire
healthcare industry.
Currently, Medicare contractors have
a process in place to enroll providers for
electronic billing and other EDI
transactions. In support of the HIPAA
Transactions Rule, the purpose of this
Paperwork Reduction Act (PRA) request
is to establish a common form that is
sufficient to address all HIPAA
transactions. Form Number: CMS–10164
(OMB control number: 0938–0983);
Frequency: Hourly; Affected Public:
Private Sector (Business or other forprofits, Not-for-Profit Institutions);
Number of Respondents: 193,268;
Number of Responses: 193,268; Total
Annual Hours: 64,423. (For policy
questions regarding this collection,
contact Matt Klischer at 410–786–7488.)
5. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Hospitals and
Health Care Complex Cost Report; Use:
Under the authority of sections 1815(a)
and 1833(e) of the Act, CMS requires
that providers of services participating
in the Medicare program submit
information to determine costs for
health care services rendered to
Medicare beneficiaries. CMS requires
that providers follow reasonable cost
principles under 1861(v)(1)(A) of the
Act when completing the Medicare cost
report. Under the regulations at 42 CFR
413.20 and 413.24, CMS defines
adequate cost data and requires cost
reports from providers on an annual
basis. The Form CMS–2552–10 cost
report is needed to determine a
provider’s reasonable cost incurred in
furnishing medical services to Medicare
beneficiaries and calculate the hospital
settlement amounts. These providers,
paid under the inpatient prospective
payment system (IPPS) and the
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outpatient prospective payment system
(OPPS), may receive reimbursement
outside of the PPS for hospital-specific
adjustments such as Medicare
reimbursable bad debts,
disproportionate share, uncompensated
care, direct and indirect medical
education costs, and organ acquisition
costs. The Form CMS–2552–10 cost
report is also used for rate setting and
payment refinement activities,
including developing a hospital market
basket. Additionally, the Medicare
Payment Advisory Commission
(MedPAC) uses the hospital cost report
data to calculate Medicare margins, to
formulate recommendations to Congress
regarding the IPPS and OPPS, and to
conduct additional analysis of the IPPS
and OPPS. Form Number: CMS–2552–
10 (OMB control number: 0938–0050);
Frequency: Yearly; Affected Public:
Private Sector (Business or other Forprofit and Not-for-profit institutions),
State, Local and Tribal Governments,
Federal Government; Number of
Respondents: 6,088; Total Annual
Responses: 6,088; Total Annual Hours:
4,097,224. (For policy questions
regarding this collection contact Gail
Duncan at 410–786–7278.)
6. Type of Information Collection
Request: Reinstatement of a previously
approved collection; Title of
Information Collection: Use of Restraint
and Seclusion in Psychiatric Residential
Treatment Facilities (PRTFs) for
Individuals Under Age 21 and
Supporting Regulations; Use:
Psychiatric residential treatment
facilities are required to report deaths,
serious injuries and attempted suicides
to the State Medicaid Agency and the
Protection and Advocacy Organization.
They are also required to provide
residents the restraint and seclusion
policy in writing, and to document in
the residents’ records all activities
involving the use of restraint and
seclusion. Form Number: CMS–R–306
(OMB control number: 0938–0833);
Frequency: Occasionally; Affected
Public: Private sector (Business or other
for-profits); Number of Respondents:
390; Total Annual Responses:
1,466,823; Total Annual Hours: 449,609.
(For policy questions regarding this
collection contact Kirsten Jensen at 410–
786–8146.)
7. Type of Information Collection
Request: New collection (request for a
new OMB control number); Title of
Information Collection: 21st Century
Cures Act Section 12002 IMD Study;
Use: The Act requires that HHS conduct
a study of the effects of the 2016
Medicaid Managed Care final rule’s
provisions that clarified policy on
coverage of IMD services in lieu of other
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covered services. The survey is needed
to help answer the 5 mandated study
questions. The collected data will be
used by CMS develop a Report to
Congress as required by the Act. Form
Number: CMS–10684 (OMB Control
Number: 0938–TBD); Frequency: Yearly;
Affected Public: State, Local, or Tribal
Governments; Number of Respondents:
43; Number of Responses: 43; Total
Annual Hours: 86. (For questions
regarding this collection contact Laura
Snyder at (410) 786–3198.)
8. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Medicare
Advantage Application—Part C and
1876 Cost Plan Expansion Application
Regulations under 42 CFR 422 (Subpart
K) & 417.400; Use: The Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA)
Public Law 108–173 established the
Medicare Prescription Drug Benefit
Program (Part D) and made revisions to
the provisions of Medicare Part C,
governing what is now called the
Medicare Advantage (MA) program
(formerly Medicare+Choice). The MMA
directed that important aspects of the
new Medicare Prescription Drug Benefit
Program under Part D be similar to and
coordinated with regulations for the MA
program. The MMA changes made
managed care more accessible, efficient,
and attractive to beneficiaries seeking
options to meet their needs.
This information collection includes
the process for organizations wishing to
provide healthcare services under MA
plans. These organizations must
complete an application annually (if
required), file a bid, and receive final
approval from CMS. The MA
application process has two options for
applicants that include (1) request for
new MA product or (2) request for
expanding the service area of an existing
product. CMS utilizes the application
process as the means to review, assess
and determine if applicants are
compliant with the current
requirements for participation in the
MA program and to make a decision
related to contract award. This
collection process is the only
mechanism for organizations to
complete the required MA application
process. CMS will collect and review
information under the solicitation of
Part C applications for the various
health plan product types described in
the Background section above. CMS will
use the information to determine
whether the applicants meet the
requirements to become an MA
organization and are qualified to
provide a particular type of MA plan.
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The application process is open to all
health plans that want to participate in
the MA program. The application is
distinct and separate from the bid
process, and CMS issues a
determination on the application prior
to bid submissions, or before the first
Monday in June. Form Number: CMS–
10137 (OMB control number: 0938–
0935); Frequency: Annually; Affected
Public: Private Sector (Business or other
for-profits, Not-for-Profit Institutions);
Number of Respondents: 380; Total
Annual Responses: 400; Total Annual
Hours: 6,106. (For policy questions
regarding this collection contact Keith
Penn-Jones, at 410–786–3104.)
9. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Medicare
Program; Prior Authorization Process for
Certain Durable Medical Equipment,
Prosthetic, Orthotics, and Supplies
(DMEPOS); Use: The CMS has had
longstanding concerns about the
improper payments related to DMEPOS
items. The Department of Health and
Human Services’ Office of the Inspector
General and the U.S. Government
Accountability Office have published
multiple reports indicating questionable
billing practices by suppliers,
inappropriate Medicare payments, and
questionable utilization of DMEPOS
items. The fiscal year (FY) 2017
Medicare FFS program improper
payment rate for the Durable Medical
Equipment, Prosthetics, Orthotics, and
Supplies (DMEPOS) was 44.6%,
accounting for over $3.7 billion in
projected improper payments. The CMS
has implemented several initiatives in
recent years to address these issues,
such as the DMEPOS Competitive
Bidding Program, as well as heightened
screening of suppliers, as authorized by
the Affordable Care Act. In addition to
those actions, CMS is continuing the use
of prior authorization in fee for service
Medicare. Prior authorization is a
process through which a request for
provisional affirmation of coverage is
submitted for review before an item is
rendered to a Medicare patient and
before a claim is submitted for payment.
Prior authorization helps make sure that
applicable Medicare coverage, payment,
and coding rules are met before item(s)
are rendered. Prior to furnishing the
item to the beneficiary and prior to
submitting the claim for processing, a
requester must submit a prior
authorization request that includes
evidence that the item complies with all
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applicable Medicare coverage, coding,
and payment rules. Consistent with
§ 414.234(d), such evidence must
include the order, relevant information
from the beneficiary’s medical record,
and relevant supplier-produced
documentation. After receipt of all
applicable required Medicare
documentation, CMS or one of its
review contractors will conduct a
medical review and communicate a
decision that provisionally affirms or
non-affirms the request. A provisional
affirmative decision is a preliminary
finding that a future claim submitted to
Medicare for the DMEPOS item likely
meets Medicare’s coverage, coding, and
payment requirements. Suppliers who
receive a non-affirmative decision have
unlimited resubmission opportunities.
Form Number: CMS–10524 (OMB
control number: 0938–1293); Frequency:
Occasionally; Affected Public: Private
Sector (Business or other for-profits,
Not-for-Profit Institutions); Number of
Respondents: 321,551; Total Annual
Responses: 321,551; Total Annual
Hours: 160,775.68 (For policy questions
regarding this collection contact Yuliya
Cook at (410) 786–0157.)
10. Type of Information Collection
Request: Reinstatement; Title of
Information Collection: Medicare
Coverage of Items and Services in FDA
Investigational Device Exemption
Clinical Studies—Revision of Medicare
Coverage; Use . Section 1862(m) of the
Social Security Act (and regulations at
42 CFR Subpart B (sections 405.201–
405.215) allows for payment of the
routine costs of care furnished to
Medicare beneficiaries in a Category A
investigational device exemption (IDE)
study and authorizes the Secretary to
establish criteria to ensure that Category
A IDE trials conform to appropriate
scientific and ethical standards.
Medicare does not cover the Category A
device itself because Category A
(Experimental) devices do not satisfy
the statutory requirement that Medicare
pay for devices determined to be
reasonable and necessary. Medicare may
cover Category B (Non-experimental)
devices, and associated routine costs of
care, if they are considered reasonable
and necessary and if all other applicable
Medicare coverage requirements are
met.
Under the current centralized review
process, interested parties (such as
study sponsors) that wish to seek
Medicare coverage related to Category A
or B IDE studies have a centralized
point of contact for submission, review
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and determination of Medicare coverage
IDE study requests. In order for CMS (or
its designated entity) to determine if the
Medicare coverage criteria are met, as
described in our regulations, CMS (or its
designated entity) must review
documents submitted by interested
parties or study sponsors. Such
information submitted will be a FDA
IDE approval letter, IDE study protocol,
IRB approval letter, National Clinical
Trials (NCT) number, and Supporting
materials as needed. Form Number:
CMS–10511 (OMB control number:
0938–1250); Frequency: Yearly; Affected
Public: Private Sector (Business or other
for-profits, Not-for-Profit Institutions);
Number of Respondents: 100; Total
Annual Responses: 100; Total Annual
Hours: 200. (For policy questions
regarding this collection contact Cheryl
Gilbreath at 410–786–5919.)
Dated: January 28, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2019–00411 Filed 1–30–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: State Self-Assessment Review
and Report.
OMB No.: 0970–0223.
Description: Section 454(15)(A) of the
Social Security Act, as amended by the
Personal Responsibility and Work
Opportunity Act of 1996, requires each
State to annually assess the performance
of its child support enforcement
program in accordance with standards
specified by the Secretary of the
Department of Health and Human
Services, and to provide a report of the
findings to the Secretary. This
information is required to determine if
States are complying with Federal child
support mandates and providing the
best services possible. The report is also
intended to be used as management tool
to help States evaluate their programs
and assess performance.
Respondents: State Child Support
Enforcement Agencies or Department/
Agency/Bureau responsible for Child
Support Enforcement in each State.
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[Federal Register Volume 84, Number 21 (Thursday, January 31, 2019)]
[Notices]
[Pages 734-737]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-00411]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-R-262, CMS-224-14, CMS-R-240, CMS-10164,
CMS-2552-10, CMS-R-306, CMS-10684, CMS-10237, CMS-10524 and CMS-10511]
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
AGENCY: Centers for Medicare & Medicaid 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
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 March 4, 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 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/
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PaperworkReductionActof1995/PRA-Listing.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) 786-1326.
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: Contract Year
2020 Plan Benefit Package (PBP) Software and Formulary Submission; Use:
CMS requires that MA and PDP organizations submit a completed Plan
Benefit Package (PBP) and formulary as part of the annual bidding
process. During this process, organizations prepare their proposed plan
benefit packages for the upcoming contract year and submit them to CMS
for review and approval. The plan benefit package submission consists
of the Plan Benefit Package (PBP) software, formulary file, and
supporting documentation, as necessary. MA and PDP organizations use
the PBP software to describe their organization's plan benefit
packages, including information on premiums, cost sharing,
authorization rules, and supplemental benefits. They also generate a
formulary to describe their list of drugs, including information on
prior authorization, step therapy, tiering, and quantity limits.
Additionally, CMS uses the PBP and formulary data to review and approve
the plan benefit packages proposed by each MA and PDP organization.
This allows CMS to review the benefit packages in a consistent way
across all submitted bids during with incredibly tight timeframes. This
data is also used to populate data on Medicare Plan Finder, which
allows beneficiaries to access and compare Medicare Advantage and
Prescription Drug plans. Form Number: CMS-R-262 (OMB control number
0938-0763); Frequency: Yearly; Affected Public: Private Sector,
Business or other for-profits and Not-for-profit institution; Number of
Respondents: 570; Total Annual Responses: 6,760; Total Annual Hours:
65,354.50 (For policy questions regarding this collection contact
Kristy Holtje at 410-786-2209.)
2. Title of Information Collection: Federal Qualified Health Center
Cost Report; Type of Information Collection Request: Extension of a
currently approved collection; Use: Under the authority of sections
1815(a) and 1833(e) of the Act, CMS requires that providers of services
participating in the Medicare program submit information to determine
costs for health care services rendered to Medicare beneficiaries.
Furthermore, these sections of the Act provide that no Medicare
payments will be made to a provider unless it furnishes the
information. CMS requires that providers follow reasonable cost
principles under 1861(v)(1)(A) of the Act when completing the Medicare
cost report. Under the regulations at 42 CFR 413.20 and 413.24, CMS
defines adequate cost data and requires cost reports from providers on
an annual basis. The Form CMS-224-14 cost report is needed to determine
a provider's reasonable cost incurred in furnishing medical services to
Medicare beneficiaries and to calculate the FQHC settlement amount.
These providers, paid under the FQHC prospective payment system (PPS),
may receive reimbursement outside of the PPS for Medicare reimbursable
bad debts and pneumococcal and influenza vaccines. The FQHC cost report
is also used for rate setting and payment refinement activities,
including developing a FQHC market basket. Additionally, the Medicare
Payment Advisory Commission (MedPAC) uses the FQHC Medicare cost report
data to calculate Medicare margins, to formulate recommendations to
Congress regarding the FQHC PPS, and to conduct additional analysis of
the FQHC PPS. Form Number: CMS-224-14 (OMB control number: 0938-1298);
Frequency: Yearly; Affected Public: State, Local, or Tribal
Governments; Number of Respondents: 2,240; Number of Responses: 2,240;
Total Annual Hours: 129,920. (For questions regarding this collection
contact Julie Stankivic at (410) 786-5725.)
3. Type of Information Collection Request: Reinstatement of a
previously approved collection; Title of Information Collection:
Prospective Payments for Hospital Outpatient Services; Use: Section
1833(t) of the Act, as added by section 4523 of the Balanced Budget Act
of 1997 (the BBA) requires the Secretary to establish a prospective
payment system (PPS) for hospital outpatient services. Successful
implementation of an outpatient PPS requires that CMS distinguish
facilities or organizations that function as departments of hospitals
from those that are freestanding, so that CMS can determine which
services should be paid under the OPPS, the clinical laboratory fee
schedule, or other payment provisions applicable to services furnished
to hospital outpatients. Information from the reports required under
sections 413.65(b)(3) and (c) is needed to make these determinations.
In addition, section 1866(b)(2) of the Act authorizes hospitals and
other providers to impose deductible and coinsurance charges for
facility services, but does not allow such charges by facilities or
organizations which are not provider-based. Implementation of this
provision requires that CMS have information from the required reports,
so it can determine which facilities are provider-based. Form Number:
CMS-R-240 (OMB control number: 0938-0798); Frequency: Yearly; Affected
Public: Private Sector (Business or other for-profits, Not-for-Profit
Institutions); Number of Respondents: 750; Total Annual Responses:
13,649,150; Total Annual Hours: 680,920 (For policy questions regarding
this collection contact Emily Lipkin at 410-786-3633.)
4. Type of Information Collection Request: Reinstatement of a
previously approved collection; Title of Information Collection:
Medicare EDI Enrollment Form and EDI Registration; Use: The Congress,
recognizing the need to simplify the administration of health care
transactions, enacted the Health Insurance Portability and
Accountability Act of 1996 (HIPAA), Public Law 104-191, on August 21,
1996. Title II, Subtitle F of this legislation directs the Secretary of
the Department of Health and Human Services to develop unique standards
for specified electronic transactions and code sets for those
transactions. The purpose of this Subtitle is to improve the Medicare
and Medicaid programs in particular and the efficiency and
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effectiveness of the health care industry in general through the
establishment of standards and requirements to facilitate the
electronic transmission of certain health information. This Subtitle
also requires that the Secretary adopt standards for financial and
administrative transactions, and data elements for those transactions
to enable health information to be exchanged electronically. The
Standards for Electronic Transactions final rule, 45 CFR part 162
subpart K 162.1101 through subpart R 162.1802, (hereinafter referred to
as ``Transactions Rule'') published August 17, 2000 adopted standards
for health care transactions and code sets. Subsequent to the
Transactions Rule, CMS-0003-P and CMS-0005-P proposed modifications to
the adopted standards essential to permit initial implementation of the
standards throughout the entire healthcare industry.
Currently, Medicare contractors have a process in place to enroll
providers for electronic billing and other EDI transactions. In support
of the HIPAA Transactions Rule, the purpose of this Paperwork Reduction
Act (PRA) request is to establish a common form that is sufficient to
address all HIPAA transactions. Form Number: CMS-10164 (OMB control
number: 0938-0983); Frequency: Hourly; Affected Public: Private Sector
(Business or other for-profits, Not-for-Profit Institutions); Number of
Respondents: 193,268; Number of Responses: 193,268; Total Annual Hours:
64,423. (For policy questions regarding this collection, contact Matt
Klischer at 410-786-7488.)
5. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Hospitals and
Health Care Complex Cost Report; Use: Under the authority of sections
1815(a) and 1833(e) of the Act, CMS requires that providers of services
participating in the Medicare program submit information to determine
costs for health care services rendered to Medicare beneficiaries. CMS
requires that providers follow reasonable cost principles under
1861(v)(1)(A) of the Act when completing the Medicare cost report.
Under the regulations at 42 CFR 413.20 and 413.24, CMS defines adequate
cost data and requires cost reports from providers on an annual basis.
The Form CMS-2552-10 cost report is needed to determine a provider's
reasonable cost incurred in furnishing medical services to Medicare
beneficiaries and calculate the hospital settlement amounts. These
providers, paid under the inpatient prospective payment system (IPPS)
and the outpatient prospective payment system (OPPS), may receive
reimbursement outside of the PPS for hospital-specific adjustments such
as Medicare reimbursable bad debts, disproportionate share,
uncompensated care, direct and indirect medical education costs, and
organ acquisition costs. The Form CMS-2552-10 cost report is also used
for rate setting and payment refinement activities, including
developing a hospital market basket. Additionally, the Medicare Payment
Advisory Commission (MedPAC) uses the hospital cost report data to
calculate Medicare margins, to formulate recommendations to Congress
regarding the IPPS and OPPS, and to conduct additional analysis of the
IPPS and OPPS. Form Number: CMS-2552-10 (OMB control number: 0938-
0050); Frequency: Yearly; Affected Public: Private Sector (Business or
other For-profit and Not-for-profit institutions), State, Local and
Tribal Governments, Federal Government; Number of Respondents: 6,088;
Total Annual Responses: 6,088; Total Annual Hours: 4,097,224. (For
policy questions regarding this collection contact Gail Duncan at 410-
786-7278.)
6. Type of Information Collection Request: Reinstatement of a
previously approved collection; Title of Information Collection: Use of
Restraint and Seclusion in Psychiatric Residential Treatment Facilities
(PRTFs) for Individuals Under Age 21 and Supporting Regulations; Use:
Psychiatric residential treatment facilities are required to report
deaths, serious injuries and attempted suicides to the State Medicaid
Agency and the Protection and Advocacy Organization. They are also
required to provide residents the restraint and seclusion policy in
writing, and to document in the residents' records all activities
involving the use of restraint and seclusion. Form Number: CMS-R-306
(OMB control number: 0938-0833); Frequency: Occasionally; Affected
Public: Private sector (Business or other for-profits); Number of
Respondents: 390; Total Annual Responses: 1,466,823; Total Annual
Hours: 449,609. (For policy questions regarding this collection contact
Kirsten Jensen at 410-786-8146.)
7. Type of Information Collection Request: New collection (request
for a new OMB control number); Title of Information Collection: 21st
Century Cures Act Section 12002 IMD Study; Use: The Act requires that
HHS conduct a study of the effects of the 2016 Medicaid Managed Care
final rule's provisions that clarified policy on coverage of IMD
services in lieu of other covered services. The survey is needed to
help answer the 5 mandated study questions. The collected data will be
used by CMS develop a Report to Congress as required by the Act. Form
Number: CMS-10684 (OMB Control Number: 0938-TBD); Frequency: Yearly;
Affected Public: State, Local, or Tribal Governments; Number of
Respondents: 43; Number of Responses: 43; Total Annual Hours: 86. (For
questions regarding this collection contact Laura Snyder at (410) 786-
3198.)
8. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Medicare
Advantage Application--Part C and 1876 Cost Plan Expansion Application
Regulations under 42 CFR 422 (Subpart K) & 417.400; Use: The Medicare
Prescription Drug, Improvement, and Modernization Act of 2003 (MMA)
Public Law 108-173 established the Medicare Prescription Drug Benefit
Program (Part D) and made revisions to the provisions of Medicare Part
C, governing what is now called the Medicare Advantage (MA) program
(formerly Medicare+Choice). The MMA directed that important aspects of
the new Medicare Prescription Drug Benefit Program under Part D be
similar to and coordinated with regulations for the MA program. The MMA
changes made managed care more accessible, efficient, and attractive to
beneficiaries seeking options to meet their needs.
This information collection includes the process for organizations
wishing to provide healthcare services under MA plans. These
organizations must complete an application annually (if required), file
a bid, and receive final approval from CMS. The MA application process
has two options for applicants that include (1) request for new MA
product or (2) request for expanding the service area of an existing
product. CMS utilizes the application process as the means to review,
assess and determine if applicants are compliant with the current
requirements for participation in the MA program and to make a decision
related to contract award. This collection process is the only
mechanism for organizations to complete the required MA application
process. CMS will collect and review information under the solicitation
of Part C applications for the various health plan product types
described in the Background section above. CMS will use the information
to determine whether the applicants meet the requirements to become an
MA organization and are qualified to provide a particular type of MA
plan.
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The application process is open to all health plans that want to
participate in the MA program. The application is distinct and separate
from the bid process, and CMS issues a determination on the application
prior to bid submissions, or before the first Monday in June. Form
Number: CMS-10137 (OMB control number: 0938-0935); Frequency: Annually;
Affected Public: Private Sector (Business or other for-profits, Not-
for-Profit Institutions); Number of Respondents: 380; Total Annual
Responses: 400; Total Annual Hours: 6,106. (For policy questions
regarding this collection contact Keith Penn-Jones, at 410-786-3104.)
9. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Medicare Program;
Prior Authorization Process for Certain Durable Medical Equipment,
Prosthetic, Orthotics, and Supplies (DMEPOS); Use: The CMS has had
longstanding concerns about the improper payments related to DMEPOS
items. The Department of Health and Human Services' Office of the
Inspector General and the U.S. Government Accountability Office have
published multiple reports indicating questionable billing practices by
suppliers, inappropriate Medicare payments, and questionable
utilization of DMEPOS items. The fiscal year (FY) 2017 Medicare FFS
program improper payment rate for the Durable Medical Equipment,
Prosthetics, Orthotics, and Supplies (DMEPOS) was 44.6%, accounting for
over $3.7 billion in projected improper payments. The CMS has
implemented several initiatives in recent years to address these
issues, such as the DMEPOS Competitive Bidding Program, as well as
heightened screening of suppliers, as authorized by the Affordable Care
Act. In addition to those actions, CMS is continuing the use of prior
authorization in fee for service Medicare. Prior authorization is a
process through which a request for provisional affirmation of coverage
is submitted for review before an item is rendered to a Medicare
patient and before a claim is submitted for payment. Prior
authorization helps make sure that applicable Medicare coverage,
payment, and coding rules are met before item(s) are rendered. Prior to
furnishing the item to the beneficiary and prior to submitting the
claim for processing, a requester must submit a prior authorization
request that includes evidence that the item complies with all
applicable Medicare coverage, coding, and payment rules. Consistent
with Sec. 414.234(d), such evidence must include the order, relevant
information from the beneficiary's medical record, and relevant
supplier-produced documentation. After receipt of all applicable
required Medicare documentation, CMS or one of its review contractors
will conduct a medical review and communicate a decision that
provisionally affirms or non-affirms the request. A provisional
affirmative decision is a preliminary finding that a future claim
submitted to Medicare for the DMEPOS item likely meets Medicare's
coverage, coding, and payment requirements. Suppliers who receive a
non-affirmative decision have unlimited resubmission opportunities.
Form Number: CMS-10524 (OMB control number: 0938-1293); Frequency:
Occasionally; Affected Public: Private Sector (Business or other for-
profits, Not-for-Profit Institutions); Number of Respondents: 321,551;
Total Annual Responses: 321,551; Total Annual Hours: 160,775.68 (For
policy questions regarding this collection contact Yuliya Cook at (410)
786-0157.)
10. Type of Information Collection Request: Reinstatement; Title of
Information Collection: Medicare Coverage of Items and Services in FDA
Investigational Device Exemption Clinical Studies--Revision of Medicare
Coverage; Use . Section 1862(m) of the Social Security Act (and
regulations at 42 CFR Subpart B (sections 405.201-405.215) allows for
payment of the routine costs of care furnished to Medicare
beneficiaries in a Category A investigational device exemption (IDE)
study and authorizes the Secretary to establish criteria to ensure that
Category A IDE trials conform to appropriate scientific and ethical
standards. Medicare does not cover the Category A device itself because
Category A (Experimental) devices do not satisfy the statutory
requirement that Medicare pay for devices determined to be reasonable
and necessary. Medicare may cover Category B (Non-experimental)
devices, and associated routine costs of care, if they are considered
reasonable and necessary and if all other applicable Medicare coverage
requirements are met.
Under the current centralized review process, interested parties
(such as study sponsors) that wish to seek Medicare coverage related to
Category A or B IDE studies have a centralized point of contact for
submission, review and determination of Medicare coverage IDE study
requests. In order for CMS (or its designated entity) to determine if
the Medicare coverage criteria are met, as described in our
regulations, CMS (or its designated entity) must review documents
submitted by interested parties or study sponsors. Such information
submitted will be a FDA IDE approval letter, IDE study protocol, IRB
approval letter, National Clinical Trials (NCT) number, and Supporting
materials as needed. Form Number: CMS-10511 (OMB control number: 0938-
1250); Frequency: Yearly; Affected Public: Private Sector (Business or
other for-profits, Not-for-Profit Institutions); Number of Respondents:
100; Total Annual Responses: 100; Total Annual Hours: 200. (For policy
questions regarding this collection contact Cheryl Gilbreath at 410-
786-5919.)
Dated: January 28, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2019-00411 Filed 1-30-19; 8:45 am]
BILLING CODE 4120-01-P
