Agency Information Collection Activities: Submission for OMB Review; Comment Request, 7306-7308 [2020-02357]
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7306
Federal Register / Vol. 85, No. 26 / Friday, February 7, 2020 / Notices
You may submit comments
on this paperwork notice to the Office
of Management and Budget, Attn: Desk
Officer for OGE, via fax at 202–395–
6974 or email at OIRA_Submission@
omb.eop.gov. (Include reference to
‘‘OGE Form 201 paperwork comment’’
in the subject line of the message).
FOR FURTHER INFORMATION CONTACT:
Grant Anderson at the U.S. Office of
Government Ethics; telephone: 202–
482–9318; TTY: 800–877–8339; FAX:
202–482–9237; Email: ganderso@
oge.gov. An electronic copy of the OGE
Form 201 version used to manually
submit access requests to OGE or other
executive branch agencies by mail or
FAX is available in the Forms Library
section of OGE’s website at https://
www.oge.gov. A paper copy may also be
obtained, without charge, by contacting
Mr. Anderson. An automated version of
the OGE Form 201, also available on
OGE’s website, enables the requester to
electronically fill out, submit and
receive access to copies of the public
financial disclosure reports certified by
the U.S. Office of Government Ethics.
SUPPLEMENTARY INFORMATION:
Title: Request to Inspect or Receive
Copies of Executive Branch Personnel
Public Financial Disclosure Reports or
Other Covered Records.
Agency Form Number: OGE Form
201.
OMB Control Number: 3209–0002.
Type of Information Collection:
Extension with modifications of a
currently approved collection.
Type of Review Request: Regular.
Respondents: Individuals requesting
access to executive branch public
financial disclosure reports and other
covered records.
Estimated Annual Number of
Respondents: 7,600.
Estimated Time per Response: 10
minutes.
Estimated Total Annual Burden:
1,300 hours.
Abstract: The OGE Form 201 collects
information from, and provides certain
information to, persons who seek access
to OGE Form 278 Public Financial
Disclosure Reports, including OGE
Form 278–T Periodic Transaction
Reports, and other covered records. The
form reflects the requirements of the
Ethics in Government Act, subsequent
amendments pursuant to the
Representative Louise McIntosh
Slaughter Stop Trading on
Congressional Knowledge Act, and
OGE’s implementing regulations that
must be met by a person before access
can be granted. These requirements
include the address of the requester, as
well as any other person on whose
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ADDRESSES:
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behalf a record is sought, and
acknowledgement that the requester is
aware of the prohibited uses of
executive branch public disclosure
financial reports. See 5 U.S.C. appendix
105(b) and (c) and 402 (b)(1) and 5 CFR
2634.603(c) and (f). Executive branch
departments and agencies are
encouraged to use the OGE Form 201 for
individuals seeking access to public
financial disclosure reports and other
covered documents. OGE permits
departments and agencies to use or
develop their own forms as long as the
forms collect and provide all of the
required information.
OGE recently revised its OGE/GOVT–
1, Executive Branch Personnel Public
Financial Disclosure Reports and Other
Name-Retrieved Ethics Program Records
system of records. The revisions were
published in the Federal Register on
September 9, 2019, and went into effect
on November 8, 2019. The revisions
included several new and modified
routine uses. The information collected
on the OGE Form 201 is maintained in
the OGE/GOVT–1 Governmentwide
system of records, and the form contains
a Privacy Act statement referencing
OGE/GOVT–1 as required by section
(e)(3) of the Privacy Act. Accordingly,
OGE proposes to update the Privacy Act
statement in accordance with changes to
the OGE/GOVT–1 system of records.
This change will have no material effect
on the burden to filers.
On January 15, 2020, OGE published
a final rule making inflationary
adjustments to the Ethics in
Government Act civil monetary
penalties in accordance with the Federal
Civil Penalties Inflation Adjustment Act
Improvements Act of 2015. Pursuant to
these changes, the penalty for misuse of
public reports is now $20,489.
Accordingly, OGE proposes to update
the penalty amount stated on the Form
201, in the paragraph above the
applicant’s signature. This change will
have no material effect on the burden to
filers.
On November 25, 2019, OGE
published a first round notice of its
intent to request approval for the
modified OGE Form 201, Request to
Inspect or Receive Copies of Executive
Branch Personnel Public Financial
Disclosure Reports or Other Covered
Records. See 84 FR 64895. OGE received
no responses to that notice.
Request for Comments: Agency and
public comment is again invited
specifically on the need for and
practical utility of this information
collection, the accuracy of OGE’s
burden estimate, the enhancement of
quality, utility, and clarity of the
information collected, and the
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minimization of burden (including the
use of information technology). The
comments will become a matter of
public record.
Approved: February 3, 2020.
Emory Rounds,
Director, U.S. Office of Government Ethics.
[FR Doc. 2020–02396 Filed 2–6–20; 8:45 am]
BILLING CODE 6345–03–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–3427, CMS–
10709, CMS–10631 and CMS–10466]
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 9, 2020.
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
SUMMARY:
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jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 85, No. 26 / Friday, February 7, 2020 / Notices
Number: (202) 395–5806 OR, Email:
OIRA_submission@omb.eop.gov.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ website address at
website address at https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.html.
1. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
2. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
William Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. The term ‘‘collection of
information’’ is defined in 44 U.S.C.
3502(3) and 5 CFR 1320.3(c) and
includes agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires federal agencies
to publish a 30-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension or
reinstatement of an existing collection
of information, before submitting the
collection to OMB for approval. To
comply with this requirement, CMS is
publishing this notice that summarizes
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: Reinstatement with change of a
previously approved collection; Title of
Information Collection: End Stage Renal
Disease Application and Survey and
Certification Report; Use: Part I of this
form is a facility identification and
screening measurement used to initiate
the certification and recertification of
ESRD facilities. Part II is completed by
the Medicare/Medicaid State survey
agency to determine facility compliance
with ESRD conditions for coverage.
Form Number: CMS–3427 (OMB control
number: 0938–0360); Frequency: Every
three years; Affected Public: Private
sector (Business or other for-profit and
Not-for profit institutions); Number of
Respondents: 7,493; Total Annual
Responses: 2,473; Total Annual Hours:
824. (For policy questions regarding this
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collection contact Jennifer Milby at 410–
786–8828).
2. Type of Information Collection
Request: New collection (Request for a
new OMB control number); Title of
Information Collection: Hospital Survey
for Specified Covered Outpatient Drugs
(SCODs); Use: In the CY 2018 OPPS/
ASC payment system final rule with
comment period, CMS finalized a policy
to adjust payment for separately payable
outpatient drugs acquired by eligible
hospitals at discounted rates under
HRSA’s 340B program from Average
Sales Price (ASP) plus 6 percent to ASP
minus 22.5 percent. According to 42
U.S.C. 256b, eligible hospitals include
those with a Medicare Disproportionate
Share Hospital adjustment of greater
than 11.75 percent, Children’s
Hospitals, Critical Access Hospitals,
Cancer Hospitals, Rural Referral Centers
and Sole Community Hospitals. The
340B program sets a ceiling on the price
that covered entities pay for outpatient
drugs. The 340B ceiling price refers to
the maximum amount that a
manufacturer can charge a covered
entity for the purchase of a 340B
covered outpatient drug. The 340B
ceiling price is statutorily defined as the
Average Manufacturer Price (AMP)
reduced by the rebate percentage, which
is commonly referred to as the Unit
Rebate Amount (URA).
On December 27, 2018, the United
States District Court for the District of
Columbia ruled that the Secretary of the
Department of Health & Human Services
exceeded his statutory authority to
adjust payment rates under the Hospital
Outpatient Prospective Payment System
(OPPS) for separately payable, 340Bacquired drugs. See American Hospital
Ass’n v. Azar, 348 F. Supp. 3d 62, 82–
83 (D.D.C. 2018), appeal pending, Nos.
19–5048 & 19–5198 (D.C. Cir.). The
Court reasoned, in part, that the
Secretary had not collected the
necessary data to set payment rates
based on acquisition costs. The
government disagrees with that ruling
and has appealed. Nonetheless, in the
event that the ruling is affirmed, CMS
believes that it is important to begin
obtaining acquisition costs for specified
covered outpatient drugs to set payment
rates based on cost for 340B-acquired
drugs when they are furnished by
certain covered entity hospitals.
The acquisition cost data hospitals
submit in response to this survey will be
used to help determine payment
amounts for drugs acquired under the
340B program. We want to ensure that
the Medicare program pays for specified
covered outpatient drugs purchased
under the 340B program at amounts that
approximate what hospitals actually pay
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7307
to acquire the drugs. This will ensure
that the Medicare program uses taxpayer
dollars prudently while maintaining
beneficiary access to these drugs and
allowing beneficiary cost-sharing to be
based on the amounts hospitals actually
pay to acquire the drugs. Form Number:
CMS–10709 (OMB control number:
0938–New); Frequency: Occasionally;
Affected Public: Business or other forprofits and Not-for-profits, State, Local,
or Tribal Governments; Number of
Respondents: 1,338; Total Annual
Responses: 1,338; Total Annual Hours:
64,224. (For policy questions regarding
this collection contact Steven Johnson at
410–786–3332.)
3. Type of Information Collection
Request: Revision with change of a
currently approved collection; Title of
Information Collection: The PACE
Organization Application Process in 42
CFR part 460; Use: The Programs of AllInclusive Care for the Elderly (PACE)
consist of pre-paid, capitated plans that
provide comprehensive health care
services to frail, older adults in the
community who are eligible for nursing
home care according to State standards.
PACE organizations (PO) must provide
all Medicare and Medicaid covered
services; financing of this model is
accomplished through prospective
capitation of both Medicare and
Medicaid payments. Upon approval of a
PACE application, CMS executes a
3-way program agreement with the
applicant entity and the applicable State
Administering Agency (SAA). CMS
regulations at 42 CFR 460.98(b)(2)
require a PO to provide PACE services
in at least the PACE center, the home,
and inpatient facilities. The PACE
center is the focal point for the delivery
of PACE services; the center is where
the interdisciplinary team (IDT) is
located, services are provided, and
socialization occurs with staff that is
consistent and familiar to participants.
Collection of this information is
mandated by statute under sections
1894(f) and 1934(f) of the Act and at 42
CFR part 460, subpart B, which
addresses the PO application and
waiver process. In general, PACE
services are provided through a PO. An
entity wishing to become a PO must
submit an application to CMS that
describes how the entity meets all the
requirements in the PACE program. An
entity’s application must be
accompanied by an assurance from the
SAA of the State in which the PO is
located.
CMS recently issued a final PACE rule
(CMS–4168–F), effective August 2,
2019, which updates and modernizes
the PACE program. This final rule
codifies CMS’ existing practice of
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Federal Register / Vol. 85, No. 26 / Friday, February 7, 2020 / Notices
relying on automated review systems for
processing initial applications to
become a PACE organization and
expansion applications for existing
PACE organizations. In addition, the
final rule will modify the PACE
regulations to eliminate the need for
PACE organizations to request waivers
for a number of the most commonly
waived provisions. This latter change is
expected to reduce burden and improve
efficiency for POs, state administering
agencies, and CMS.
In addition to codifying the current
automated processes for the submission
and review of both initial and service
area expansion applications, this rule
modifies existing regulatory provisions
and requirements. As a result, certain
attestations associated with the
application are no longer applicable,
and others need to be updated to reflect
updated regulatory requirements. We
are also making minor tweaks to certain
document upload requirements for
clarification purposes based on
experience reviewing applications.
Form Number: CMS–10631 (OMB
control number: 0938–1326); Frequency:
Yearly; Affected Public: State, Local, or
Tribal Governments; Number of
Respondents: 72; Total Annual
Responses: 109; Total Annual Hours:
7,226. (For policy questions regarding
this collection contact Debbie Vanhoven
at 410–786–6625.)
4. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Patient
Protection and Affordable Care Act;
Exchange Functions: Eligibility for
Exemptions; Use: The data collection
and reporting requirements in ‘‘Patient
Protection and Affordable Care Act;
Exchange Functions: Eligibility for
Exemptions; Miscellaneous Minimum
Essential Coverage Provisions’’ (78 FR
39494—July 1, 2013)), address federal
requirements that states must meet with
regard to the Exchange minimum
function of performing eligibility
determinations and issuing certificates
of exemption from the shared
responsibility payment. In the final
regulation, CMS addresses standards
related to eligibility, including the
verification and eligibility
determination process, eligibility
redeterminations, options for states to
rely on HHS to make eligibility
determinations for certificates of
exemption, and reporting. Form
Number: CMS–10466 (OMB control
number: 0938–1190); Frequency:
Occasionally; Affected Public: Private
Sector (Businesses or other for-profits);
Number of Respondents: 45,060; Total
Annual Responses: 45,060; Total
Annual Hours: 12,150. (For policy
questions regarding this collection
contact Katherine Bentley at 301–492–
5209.)
Dated: February 3, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2020–02357 Filed 2–5–20; 4:15 pm]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Tribal Budget and Narrative
Justification Template (New Collection)
Office of Child Support
Enforcement; Administration for
Children and Families; HHS.
ACTION: Request for public comment.
AGENCY:
The Office of Child Support
Enforcement (OCSE), Administration for
Children and Families (ACF), U.S.
Department of Health and Human
Services (HHS), is proposing to collect
expenditure estimates for the Tribal
Child Support Enforcement Program
through an optional financial reporting
SUMMARY:
form, Tribal Budget and Narrative
Justification Template. This optional
template is designed for tribes operating
an approved Tribal Child Support
Enforcement Program to use in
preparing their annual budget and
narrative justification estimates in
accordance with the tribal child support
enforcement regulations.
DATES: Comments due within 60 days of
publication. In compliance with the
requirements of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
the Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
ADDRESSES: Copies of the proposed
collection of information can be
obtained and comments may be
forwarded by emailing infocollection@
acf.hhs.gov. Alternatively, copies can
also be obtained by writing to the
Administration for Children and
Families, Office of Planning, Research
and Evaluation, 330 C Street SW,
Washington, DC 20201, Attn: ACF
Reports Clearance Officer. All requests,
emailed or written, should be identified
by the title of the information collection.
SUPPLEMENTARY INFORMATION:
Description: To receive child support
funding under 45 CFR part 309, tribes
and tribal organizations must submit the
financial forms described in 45 CFR
309.130(b) and other forms as the
Secretary may designate, due no later
than August 1 annually. The optional
Tribal Budget and Narrative Justification
Template will help to improve
efficiency and establish uniformity and
consistency in the annual budget
submission and review process. Tribes
may use the Excel or Word version of
the template to submit the required
financial information.
Respondents: Tribes and tribal
organizations administering a Tribal
Child Support Enforcement Program
under title IV–D of the Social Security
Act.
ANNUAL BURDEN ESTIMATES
Total
number of
respondents
Instrument
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Tribal Budget and Narrative Justification—Excel ................
Tribal Budget and Narrative Justification—Word ................
Estimated Total Annual Burden
Hours: 1,000.
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
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17:42 Feb 06, 2020
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Total
number of
responses per
respondent
50
10
3
3
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
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Average
burden hours
per response
16
20
Total
burden hours
2,400
600
Annual
burden hours
800
200
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
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]]>Agencies
[Federal Register Volume 85, Number 26 (Friday, February 7, 2020)]
[Notices]
[Pages 7306-7308]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02357]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-3427, CMS-10709, CMS-10631 and CMS-10466]
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
AGENCY: Centers for Medicare & Medicaid Services, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is
announcing an opportunity for the public to comment on CMS' intention
to collect information from the public. Under the Paperwork Reduction
Act of 1995 (PRA), federal agencies are required to publish notice in
the Federal Register concerning each proposed collection of
information, including each proposed extension or reinstatement of an
existing collection of information, and to allow a second opportunity
for public comment on the notice. Interested persons are invited to
send comments regarding the burden estimate or any other aspect of this
collection of information, including the necessity and utility of the
proposed information collection for the proper performance of the
agency's functions, the accuracy of the estimated burden, ways to
enhance the quality, utility, and clarity of the information to be
collected, and the use of automated collection techniques or other
forms of information technology to minimize the information collection
burden.
DATES: Comments on the collection(s) of information must be received by
the OMB desk officer by March 9, 2020.
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
[[Page 7307]]
Number: (202) 395-5806 OR, Email: [email protected].
To obtain copies of a supporting statement and any related forms
for the proposed collection(s) summarized in this notice, you may make
your request using one of following:
1. Access CMS' website address at website address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.
1. Email your request, including your address, phone number, OMB
number, and CMS document identifier, to [email protected].
2. Call the Reports Clearance Office at (410) 786-1326.
FOR FURTHER INFORMATION CONTACT: William Parham at (410) 786-4669.
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from
the Office of Management and Budget (OMB) for each collection of
information they conduct or sponsor. The term ``collection of
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and
includes agency requests or requirements that members of the public
submit reports, keep records, or provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires
federal agencies to publish a 30-day notice in the Federal Register
concerning each proposed collection of information, including each
proposed extension or reinstatement of an existing collection of
information, before submitting the collection to OMB for approval. To
comply with this requirement, CMS is publishing this notice that
summarizes the following proposed collection(s) of information for
public comment:
1. Type of Information Collection Request: Reinstatement with
change of a previously approved collection; Title of Information
Collection: End Stage Renal Disease Application and Survey and
Certification Report; Use: Part I of this form is a facility
identification and screening measurement used to initiate the
certification and recertification of ESRD facilities. Part II is
completed by the Medicare/Medicaid State survey agency to determine
facility compliance with ESRD conditions for coverage. Form Number:
CMS-3427 (OMB control number: 0938-0360); Frequency: Every three years;
Affected Public: Private sector (Business or other for-profit and Not-
for profit institutions); Number of Respondents: 7,493; Total Annual
Responses: 2,473; Total Annual Hours: 824. (For policy questions
regarding this collection contact Jennifer Milby at 410-786-8828).
2. Type of Information Collection Request: New collection (Request
for a new OMB control number); Title of Information Collection:
Hospital Survey for Specified Covered Outpatient Drugs (SCODs); Use: In
the CY 2018 OPPS/ASC payment system final rule with comment period, CMS
finalized a policy to adjust payment for separately payable outpatient
drugs acquired by eligible hospitals at discounted rates under HRSA's
340B program from Average Sales Price (ASP) plus 6 percent to ASP minus
22.5 percent. According to 42 U.S.C. 256b, eligible hospitals include
those with a Medicare Disproportionate Share Hospital adjustment of
greater than 11.75 percent, Children's Hospitals, Critical Access
Hospitals, Cancer Hospitals, Rural Referral Centers and Sole Community
Hospitals. The 340B program sets a ceiling on the price that covered
entities pay for outpatient drugs. The 340B ceiling price refers to the
maximum amount that a manufacturer can charge a covered entity for the
purchase of a 340B covered outpatient drug. The 340B ceiling price is
statutorily defined as the Average Manufacturer Price (AMP) reduced by
the rebate percentage, which is commonly referred to as the Unit Rebate
Amount (URA).
On December 27, 2018, the United States District Court for the
District of Columbia ruled that the Secretary of the Department of
Health & Human Services exceeded his statutory authority to adjust
payment rates under the Hospital Outpatient Prospective Payment System
(OPPS) for separately payable, 340B-acquired drugs. See American
Hospital Ass'n v. Azar, 348 F. Supp. 3d 62, 82-83 (D.D.C. 2018), appeal
pending, Nos. 19-5048 & 19-5198 (D.C. Cir.). The Court reasoned, in
part, that the Secretary had not collected the necessary data to set
payment rates based on acquisition costs. The government disagrees with
that ruling and has appealed. Nonetheless, in the event that the ruling
is affirmed, CMS believes that it is important to begin obtaining
acquisition costs for specified covered outpatient drugs to set payment
rates based on cost for 340B-acquired drugs when they are furnished by
certain covered entity hospitals.
The acquisition cost data hospitals submit in response to this
survey will be used to help determine payment amounts for drugs
acquired under the 340B program. We want to ensure that the Medicare
program pays for specified covered outpatient drugs purchased under the
340B program at amounts that approximate what hospitals actually pay to
acquire the drugs. This will ensure that the Medicare program uses
taxpayer dollars prudently while maintaining beneficiary access to
these drugs and allowing beneficiary cost-sharing to be based on the
amounts hospitals actually pay to acquire the drugs. Form Number: CMS-
10709 (OMB control number: 0938-New); Frequency: Occasionally; Affected
Public: Business or other for-profits and Not-for-profits, State,
Local, or Tribal Governments; Number of Respondents: 1,338; Total
Annual Responses: 1,338; Total Annual Hours: 64,224. (For policy
questions regarding this collection contact Steven Johnson at 410-786-
3332.)
3. Type of Information Collection Request: Revision with change of
a currently approved collection; Title of Information Collection: The
PACE Organization Application Process in 42 CFR part 460; Use: The
Programs of All-Inclusive Care for the Elderly (PACE) consist of pre-
paid, capitated plans that provide comprehensive health care services
to frail, older adults in the community who are eligible for nursing
home care according to State standards. PACE organizations (PO) must
provide all Medicare and Medicaid covered services; financing of this
model is accomplished through prospective capitation of both Medicare
and Medicaid payments. Upon approval of a PACE application, CMS
executes a 3-way program agreement with the applicant entity and the
applicable State Administering Agency (SAA). CMS regulations at 42 CFR
460.98(b)(2) require a PO to provide PACE services in at least the PACE
center, the home, and inpatient facilities. The PACE center is the
focal point for the delivery of PACE services; the center is where the
interdisciplinary team (IDT) is located, services are provided, and
socialization occurs with staff that is consistent and familiar to
participants.
Collection of this information is mandated by statute under
sections 1894(f) and 1934(f) of the Act and at 42 CFR part 460, subpart
B, which addresses the PO application and waiver process. In general,
PACE services are provided through a PO. An entity wishing to become a
PO must submit an application to CMS that describes how the entity
meets all the requirements in the PACE program. An entity's application
must be accompanied by an assurance from the SAA of the State in which
the PO is located.
CMS recently issued a final PACE rule (CMS-4168-F), effective
August 2, 2019, which updates and modernizes the PACE program. This
final rule codifies CMS' existing practice of
[[Page 7308]]
relying on automated review systems for processing initial applications
to become a PACE organization and expansion applications for existing
PACE organizations. In addition, the final rule will modify the PACE
regulations to eliminate the need for PACE organizations to request
waivers for a number of the most commonly waived provisions. This
latter change is expected to reduce burden and improve efficiency for
POs, state administering agencies, and CMS.
In addition to codifying the current automated processes for the
submission and review of both initial and service area expansion
applications, this rule modifies existing regulatory provisions and
requirements. As a result, certain attestations associated with the
application are no longer applicable, and others need to be updated to
reflect updated regulatory requirements. We are also making minor
tweaks to certain document upload requirements for clarification
purposes based on experience reviewing applications. Form Number: CMS-
10631 (OMB control number: 0938-1326); Frequency: Yearly; Affected
Public: State, Local, or Tribal Governments; Number of Respondents: 72;
Total Annual Responses: 109; Total Annual Hours: 7,226. (For policy
questions regarding this collection contact Debbie Vanhoven at 410-786-
6625.)
4. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Patient
Protection and Affordable Care Act; Exchange Functions: Eligibility for
Exemptions; Use: The data collection and reporting requirements in
``Patient Protection and Affordable Care Act; Exchange Functions:
Eligibility for Exemptions; Miscellaneous Minimum Essential Coverage
Provisions'' (78 FR 39494--July 1, 2013)), address federal requirements
that states must meet with regard to the Exchange minimum function of
performing eligibility determinations and issuing certificates of
exemption from the shared responsibility payment. In the final
regulation, CMS addresses standards related to eligibility, including
the verification and eligibility determination process, eligibility
redeterminations, options for states to rely on HHS to make eligibility
determinations for certificates of exemption, and reporting. Form
Number: CMS-10466 (OMB control number: 0938-1190); Frequency:
Occasionally; Affected Public: Private Sector (Businesses or other for-
profits); Number of Respondents: 45,060; Total Annual Responses:
45,060; Total Annual Hours: 12,150. (For policy questions regarding
this collection contact Katherine Bentley at 301-492-5209.)
Dated: February 3, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2020-02357 Filed 2-5-20; 4:15 pm]
BILLING CODE 4120-01-P
