Agency Information Collection Activities: Proposed Collection; Comment Request, 13130-13132 [2018-06081]
Download as PDF
<![CDATA[
13130
Federal Register / Vol. 83, No. 59 / Tuesday, March 27, 2018 / Notices
should sunset, or whether the limited
wraparound pilot program should be
made permanent. Form Number: CMS–
10571 (OMB control number: 0938–
NEW); Frequency: Once; Affected
Public: Private Sector; Number of
Respondents: 8; Total Annual
Responses: 8; Total Annual Hours: 24.
(For policy questions regarding this
collection contact Usree
Bandyopadhyay at 410–786–6650.)
Dated: March 22, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2018–06082 Filed 3–26–18; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–10341, CMS–
10538, CMS–R–153, CMS–10561 and CMS–
10336]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services.
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 (the
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
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
burden estimates 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 must be received by
May 29, 2018.
ADDRESSES: When commenting, please
reference the document identifier or
amozie on DSK30RV082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:07 Mar 26, 2018
Jkt 244001
OMB control number. To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number ll, Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
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
https://www.cms.gov/Regulations-andGuidance/Legislation/
PaperworkReductionActof1995/PRAListing.html.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
William Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
CMS–10341 Affordable Care Act
Information and Collection
Requirements for Section 1115
Demonstration Projects
CMS–10538 Hospice Information for
Medicare Part D Plans
CMS–R–153 Medicaid Drug Use
Review (DUR) Program
CMS–10561 Essential Community
Provider Data Collection to Support
QHP Certification for PYs 2021–
2023
CMS–10336 Medicare and Medicaid
Programs; Electronic Health Record
Incentive Program
Under the PRA (44 U.S.C. 3501–
3520), federal agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
PO 00000
Frm 00012
Fmt 4703
Sfmt 4703
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
requires federal agencies to publish a
60-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.
Information Collection
1. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Section 1115
Demonstration Projects Regulations at
42 CFR 431.408, 431.412, 431.420,
431.424, and 431.428; Use: This
collection is necessary to ensure that
states comply with regulatory and
statutory requirements related to the
development, implementation and
evaluation of demonstration projects.
States seeking waiver authority under
Section 1115 are required to meet
certain requirements for public notice,
the evaluation of demonstration
projects, and reports to the Secretary on
the implementation of approved
demonstrations. Form Number: CMS–
10341 (OMB control number 0938–
1162); Frequency: Yearly and quarterly;
Affected Public: State, Local, or Tribal
Governments; Number of Respondents:
37; Total Annual Responses: 300; Total
Annual Hours: 24,092. (For policy
questions regarding this collection
contact Tonya Moore at 410–786–0019.)
2. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Hospice
Information for Medicare Part D Plans;
Use: The form would be completed by
the prescriber or the beneficiary’s
hospice, or if the prescriber or hospice
provides the information verbally to the
Part D sponsor, the form would be
completed by the sponsor. Information
provided on the form would be used by
the Part D sponsor to establish coverage
of the drug under Medicare Part D. Per
statute, drugs that are necessary for the
palliation and management of the
terminal illness and related conditions
are not eligible for payment under Part
D. The standard form provides a vehicle
for the hospice provider, prescriber or
sponsor to document that the drug
prescribed is ‘‘unrelated’’ to the
E:\FR\FM\27MRN1.SGM
27MRN1
amozie on DSK30RV082PROD with NOTICES
Federal Register / Vol. 83, No. 59 / Tuesday, March 27, 2018 / Notices
terminal illness and related conditions.
It also gives a hospice organization the
option to communicate a beneficiary’s
change in hospice status and care plan
to Part D sponsors. Form Number: CMS–
10538 (OMB control number 0938–
1269); Frequency: Occasionally;
Affected Public: Private sector (business
or other for-profits); Number of
Respondents: 424; Total Annual
Responses: 376,487; Total Annual
Hours: 31,374. (For policy questions
regarding this collection contact Shelly
Winston at 410–786–3694.)
3. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Medicaid Drug
Use Review (DUR) Program; Use: States
must provide for a review of drug
therapy before each prescription is filled
or delivered to a Medicaid patient. This
review includes screening for potential
drug therapy problems due to
therapeutic duplication, drug-disease
contraindications, drug-drug
interactions, incorrect drug dosage or
duration of drug treatment, drug-allergy
interactions, and clinical abuse/misuse.
Pharmacists must make a reasonable
effort to obtain, record, and maintain
Medicaid patient profiles. These profiles
must reflect at least the patient’s name,
address, telephone number, date of
birth/age, gender, history, e.g., allergies,
drug reactions, list of medications, and
pharmacist’s comments relevant to the
individual’s drug therapy.
The State must conduct RetroDUR
which provides for the ongoing periodic
examination of claims data and other
records in order to identify patterns of
fraud, abuse, inappropriate or medically
unnecessary care. Patterns or trends of
drug therapy problems are identified
and reviewed to determine the need for
intervention activity with pharmacists
and/or physicians. States may conduct
interventions via telephone,
correspondence, or face-to-face contact.
Annual reports are submitted to CMS
for the purposes of monitoring
compliance and evaluating the progress
of States’ DUR programs. The
information submitted by States is
reviewed and results are compiled by
CMS in a format intended to provide
information, comparisons and trends
related to States’ experiences with DUR.
The States benefit from the information
and may enhance their programs each
year based on State reported innovative
practices that are compiled by CMS
from the DUR annual reports. Form
Number: CMS–R–153 (OMB control
number: 0938–0659); Frequency: Yearly,
quarterly, and occasionally; Affected
Public: State, Local, or Tribal
Governments; Number of Respondents:
VerDate Sep<11>2014
18:07 Mar 26, 2018
Jkt 244001
51; Total Annual Responses: 663; Total
Annual Hours: 41,004. (For policy
questions regarding this collection
contact Emeka Egwim at 410–786–
1092.)
4. Type of Information Collection
Request: Extension of a currently
approved information collection; Title
of Information Collection: Essential
Community Provider Data Collection to
Support QHP Certification for PYs
2021–2023; Use: For plan years
beginning on or after January 1, 2021,
Health and Human Services (HHS)
intends to continue collecting more
complete provider data for inclusion on
the HHS Essential Community Provider
(ECP) list to ensure a more accurate
reflection of the universe of qualified
available ECPs in a given service area
that can be counted toward an issuer’s
satisfaction of the ECP standard. HHS
intends to continue collecting these data
on qualified and available ECPs directly
from providers through the online ECP
petition. Providers will submit an ECP
petition to be added to the HHS ECP list
or update required data fields to remain
on the list. Form Number: CMS–10561
(OMB Control Number: 0938–1295);
Frequency: Annually; Affected Public:
Private sector (Business or other forprofits and Not-for-profit Institutions);
Number of Respondents: 14,260; Total
Annual Responses: 14,260; Total
Annual Hours: 7,468. (For policy
questions regarding this collection
contact Deborah Hunter at (202) 309–
1098).
5. Type of Information Collection
Request: Extension of a currently
approved information collection; Title
of Information Collection: Medicare and
Medicaid Programs; Electronic Health
Record Incentive Program; Use: The
American Recovery and Reinvestment
Act of 2009 (Recovery Act) (Pub. L. 111–
5) was enacted on February 17, 2009.
The Recovery Act includes many
measures to modernize our nation’s
infrastructure, and improve affordable
health care. Expanded use of health
information technology (HIT) and
certified electronic health record (EHR)
technology will improve the quality and
value of America’s health care. Title IV
of Division B of the Recovery Act
amends Titles XVIII and XIX of the
Social Security Act (the Act) by
establishing incentive payments to
eligible professionals (EPs), eligible
hospitals and critical access hospitals
(CAHs), and Medicare Advantage (MA)
organizations participating in the
Medicare and Medicaid programs that
adopt and successfully demonstrate
meaningful use of certified EHR
technology. These Recovery Act
provisions, together with Title XIII of
PO 00000
Frm 00013
Fmt 4703
Sfmt 4703
13131
Division A of the Recovery Act, may be
cited as the ‘‘Health Information
Technology for Economic and Clinical
Health Act’’ or the ‘‘HITECH Act.’’
The HITECH Act creates incentive
programs for EPs and eligible hospitals,
including CAHs, in the Medicare Feefor-Service (FFS), MA, and Medicaid
programs that successfully demonstrate
meaningful use of certified EHR
technology. In their first payment year,
Medicaid EPs and eligible hospitals may
adopt, implement or upgrade to certified
EHR technology. It also, provides for
payment adjustments in the Medicare
FFS and MA programs starting in FY
2015 for EPs and eligible hospitals
participating in Medicare that are not
meaningful users of certified EHR
technology. These payment adjustments
do not pertain to Medicaid providers.
The first final rule for the Medicare
and Medicaid EHR Incentive Program,
which was published in the Federal
Register on July 28, 2010 (CMS–0033–
F), specified the initial criteria EPs,
eligible hospitals and CAHs, and MA
organizations must meet in order to
qualify for incentive payments;
calculation of incentive payment
amounts; payment adjustments under
Medicare for covered professional
services and inpatient hospital services
provided by EPs, eligible hospitals and
CAHs failing to demonstrate meaningful
use of certified EHR technology
beginning in 2015; and other program
participation requirements. On the same
date, the Office of the National
Coordinator of Health Information
Technology (ONC) issued a closely
related final rule (45 CFR part 170, RIN
0991–AB58) that specified the initial set
of standards, implementation
specifications, and certification criteria
for certified EHR technology. ONC has
also issued a separate final rule on the
establishment of certification programs
for health information technology (HIT)
(45 CFR part 170, RIN 0991–AB59). The
functionality of certified EHR
technology should facilitate the
implementation of meaningful use.
Subsequently, final rules have been
issued by CMS (77 FR 53968) and ONC
(77 FR 72985) to create a Stage 2 of
meaningful use criteria and other
changes to the CMS EHR Incentive
Programs and the 2014 Edition
Certification Criteria for EHR
technology.
The information collection
requirements contained in this
information collection request are
needed to implement the HITECH Act.
In order to avoid duplicate payments,
all EPs are enumerated through their
National Provider Identifier (NPI), while
all eligible hospitals and CAHs are
E:\FR\FM\27MRN1.SGM
27MRN1
13132
Federal Register / Vol. 83, No. 59 / Tuesday, March 27, 2018 / Notices
enumerated through their CMS
Certification Number (CCN). State
Medicaid agencies and CMS use the
provider’s tax identification number and
NPI or CCN combination in order to
make payment, validate payment
eligibility and detect and prevent
duplicate payments for EPs, eligible
hospitals and CAHs. Form Number:
CMS–10336 (OMB Control Number:
0938–1158); Frequency: Occasionally;
Affected Public: Private sector; Number
of Respondents: 214,694; Total Annual
Responses: 214,694; Total Annual
Hours: 2,034,740. (For policy questions
regarding this collection contact Steven
Johnson at (410) 786–3332).
Dated: March 22, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2018–06081 Filed 3–26–18; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–D–0073]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance on
Consultation Procedures: Foods
Derived From New Plant Varieties
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995
(PRA).
SUMMARY:
Fax written comments on the
collection of information by April 26,
2018.
DATES:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0704. Also
include the FDA docket number found
in brackets in the heading of this
document.
amozie on DSK30RV082PROD with NOTICES
ADDRESSES:
VerDate Sep<11>2014
18:07 Mar 26, 2018
Jkt 244001
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Guidance on Consultation Procedures:
Foods Derived From New Plant
Varieties
OMB Control Number 0910–0704—
Extension
This information collection supports
the above captioned Agency guidance
document. FDA recommends that
producers who use biotechnology in the
manufacture or development of foods
and food ingredients work cooperatively
with FDA to ensure that products
derived through biotechnology are safe
and comply with all applicable legal
requirements and has instituted a
voluntary consultation process with
industry. To facilitate this process the
Agency has issued a guidance entitled,
‘‘Guidance on Consultation Procedures:
Foods Derived From New Plant
Varieties,’’ which is available on our
website at https://www.fda.gov/
FoodGuidances. The guidance describes
FDA’s consultation process for the
evaluation of information on new plant
varieties provided by developers. The
Agency believes this consultation
process will help ensure that human
food and animal feed safety issues or
other regulatory issues (e.g., labeling)
are resolved prior to commercial
distribution. Additionally, such
communication will help to ensure that
any potential food safety issues
regarding a new plant variety are
resolved during development, and will
help to ensure that all market entry
decisions by the industry are made
consistently and in full compliance with
the standards of the Federal Food, Drug,
and Cosmetic Act (FD&C Act).
In the Federal Register of December
13, 2017 (82 FR 58619), we published a
60-day notice requesting public
comment on the proposed extension of
this collection of information. Two
comments were received in response to
the notice. Overall, the comments
supported FDA’s need for the
information collection and neither
comment suggested revising our
estimate of the associated burden.
However, both comments reminded us
that significant resources were invested
into developing data upon which
PO 00000
Frm 00014
Fmt 4703
Sfmt 4703
respondents rely to bring information to
FDA regarding the development of foods
derived from new plant varieties. All
the more reason, the comments said,
FDA should identify mechanisms by
which it can better incorporate its
experience over time and, where
possible, implement more efficient,
streamlined review processes for those
products similar to those the Agency
has reviewed in the past. The comments
recommended FDA compare efficiencies
with a process at the U.S. Department of
Agriculture regarding the review of
agricultural biotechnology products. We
appreciate this suggestion. FDA strives
to allocate its limited resources in ways
that maximize protection to the public
health and facilitate compliance with
existing regulatory requirements
implemented to do so. We also look for
ways in which we might coordinate our
efforts with those by other agencies who
share these objectives.
Both comments also included the
suggestion that FDA develop a less
redundant review process (such as
reciprocity if no material differences are
identified) that better coordinates
expertise across the Center for Food
Safety and Nutrition (CFSAN) and the
Center for Veterinary Medicine (CVM)
into a single, efficient review. We
appreciate this suggestion as well and,
as discussed in the guidance, note the
following:
[FDA’s] Office of Premarket Approval
of the CFSAN and the Office of
Surveillance and Compliance of the
CVM have established a Biotechnology
Evaluation Team (BET) to facilitate, and
to ensure consistency in the process by
which firms consult under the 1992
policy and inform FDA regarding the
marketing of bioengineered foods and
food ingredients derived from new plant
varieties including those developed
using rDNA techniques. The BET
oversees the consultation process,
identifies regulatory and scientific
issues that need to be addressed, and
once all relevant issues have been
adequately addressed, brings the
consultation to closure.
At the same time, we have shared the
comments received in response to this
notice under the PRA with the BET.
Consistent with our Good Guidance
Practice regulations (21 CFR 10.115),
FDA welcomes comments on our
guidance documents at any time.
In consideration of these comments,
we have retained the currently approved
burden estimated associated with the
information collection, which is as
follows:
E:\FR\FM\27MRN1.SGM
27MRN1
]]>Agencies
[Federal Register Volume 83, Number 59 (Tuesday, March 27, 2018)]
[Notices]
[Pages 13130-13132]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06081]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10341, CMS-10538, CMS-R-153, CMS-10561 and
CMS-10336]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare & Medicaid Services.
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 (the 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 60 days for public
comment on the proposed action. Interested persons are invited to send
comments regarding our burden estimates 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 must be received by May 29, 2018.
ADDRESSES: When commenting, please reference the document identifier or
OMB control number. To be assured consideration, comments and
recommendations must be submitted in any one of the following ways:
1. Electronically. You may send your comments electronically to
https://www.regulations.gov. Follow the instructions for ``Comment or
Submission'' or ``More Search Options'' to find the information
collection document(s) that are accepting comments.
2. By regular mail. You may mail written comments to the following
address: CMS, Office of Strategic Operations and Regulatory Affairs,
Division of Regulations Development, Attention: Document Identifier/OMB
Control Number __, Room C4-26-05, 7500 Security Boulevard, Baltimore,
Maryland 21244-1850.
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 https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.
2. Email your request, including your address, phone number, OMB
number, and CMS document identifier, to [email protected].
3. Call the Reports Clearance Office at (410) 786-1326.
FOR FURTHER INFORMATION CONTACT: William Parham at (410) 786-4669.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the use and burden associated
with the following information collections. More detailed information
can be found in each collection's supporting statement and associated
materials (see ADDRESSES).
CMS-10341 Affordable Care Act Information and Collection Requirements
for Section 1115 Demonstration Projects
CMS-10538 Hospice Information for Medicare Part D Plans
CMS-R-153 Medicaid Drug Use Review (DUR) Program
CMS-10561 Essential Community Provider Data Collection to Support QHP
Certification for PYs 2021-2023
CMS-10336 Medicare and Medicaid Programs; Electronic Health Record
Incentive Program
Under the 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 requires federal agencies
to publish a 60-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.
Information Collection
1. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Section 1115
Demonstration Projects Regulations at 42 CFR 431.408, 431.412, 431.420,
431.424, and 431.428; Use: This collection is necessary to ensure that
states comply with regulatory and statutory requirements related to the
development, implementation and evaluation of demonstration projects.
States seeking waiver authority under Section 1115 are required to meet
certain requirements for public notice, the evaluation of demonstration
projects, and reports to the Secretary on the implementation of
approved demonstrations. Form Number: CMS-10341 (OMB control number
0938-1162); Frequency: Yearly and quarterly; Affected Public: State,
Local, or Tribal Governments; Number of Respondents: 37; Total Annual
Responses: 300; Total Annual Hours: 24,092. (For policy questions
regarding this collection contact Tonya Moore at 410-786-0019.)
2. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Hospice
Information for Medicare Part D Plans; Use: The form would be completed
by the prescriber or the beneficiary's hospice, or if the prescriber or
hospice provides the information verbally to the Part D sponsor, the
form would be completed by the sponsor. Information provided on the
form would be used by the Part D sponsor to establish coverage of the
drug under Medicare Part D. Per statute, drugs that are necessary for
the palliation and management of the terminal illness and related
conditions are not eligible for payment under Part D. The standard form
provides a vehicle for the hospice provider, prescriber or sponsor to
document that the drug prescribed is ``unrelated'' to the
[[Page 13131]]
terminal illness and related conditions. It also gives a hospice
organization the option to communicate a beneficiary's change in
hospice status and care plan to Part D sponsors. Form Number: CMS-10538
(OMB control number 0938-1269); Frequency: Occasionally; Affected
Public: Private sector (business or other for-profits); Number of
Respondents: 424; Total Annual Responses: 376,487; Total Annual Hours:
31,374. (For policy questions regarding this collection contact Shelly
Winston at 410-786-3694.)
3. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Medicaid Drug Use
Review (DUR) Program; Use: States must provide for a review of drug
therapy before each prescription is filled or delivered to a Medicaid
patient. This review includes screening for potential drug therapy
problems due to therapeutic duplication, drug-disease
contraindications, drug-drug interactions, incorrect drug dosage or
duration of drug treatment, drug-allergy interactions, and clinical
abuse/misuse. Pharmacists must make a reasonable effort to obtain,
record, and maintain Medicaid patient profiles. These profiles must
reflect at least the patient's name, address, telephone number, date of
birth/age, gender, history, e.g., allergies, drug reactions, list of
medications, and pharmacist's comments relevant to the individual's
drug therapy.
The State must conduct RetroDUR which provides for the ongoing
periodic examination of claims data and other records in order to
identify patterns of fraud, abuse, inappropriate or medically
unnecessary care. Patterns or trends of drug therapy problems are
identified and reviewed to determine the need for intervention activity
with pharmacists and/or physicians. States may conduct interventions
via telephone, correspondence, or face-to-face contact.
Annual reports are submitted to CMS for the purposes of monitoring
compliance and evaluating the progress of States' DUR programs. The
information submitted by States is reviewed and results are compiled by
CMS in a format intended to provide information, comparisons and trends
related to States' experiences with DUR. The States benefit from the
information and may enhance their programs each year based on State
reported innovative practices that are compiled by CMS from the DUR
annual reports. Form Number: CMS-R-153 (OMB control number: 0938-0659);
Frequency: Yearly, quarterly, and occasionally; Affected Public: State,
Local, or Tribal Governments; Number of Respondents: 51; Total Annual
Responses: 663; Total Annual Hours: 41,004. (For policy questions
regarding this collection contact Emeka Egwim at 410-786-1092.)
4. Type of Information Collection Request: Extension of a currently
approved information collection; Title of Information Collection:
Essential Community Provider Data Collection to Support QHP
Certification for PYs 2021-2023; Use: For plan years beginning on or
after January 1, 2021, Health and Human Services (HHS) intends to
continue collecting more complete provider data for inclusion on the
HHS Essential Community Provider (ECP) list to ensure a more accurate
reflection of the universe of qualified available ECPs in a given
service area that can be counted toward an issuer's satisfaction of the
ECP standard. HHS intends to continue collecting these data on
qualified and available ECPs directly from providers through the online
ECP petition. Providers will submit an ECP petition to be added to the
HHS ECP list or update required data fields to remain on the list. Form
Number: CMS-10561 (OMB Control Number: 0938-1295); Frequency: Annually;
Affected Public: Private sector (Business or other for-profits and Not-
for-profit Institutions); Number of Respondents: 14,260; Total Annual
Responses: 14,260; Total Annual Hours: 7,468. (For policy questions
regarding this collection contact Deborah Hunter at (202) 309-1098).
5. Type of Information Collection Request: Extension of a currently
approved information collection; Title of Information Collection:
Medicare and Medicaid Programs; Electronic Health Record Incentive
Program; Use: The American Recovery and Reinvestment Act of 2009
(Recovery Act) (Pub. L. 111-5) was enacted on February 17, 2009. The
Recovery Act includes many measures to modernize our nation's
infrastructure, and improve affordable health care. Expanded use of
health information technology (HIT) and certified electronic health
record (EHR) technology will improve the quality and value of America's
health care. Title IV of Division B of the Recovery Act amends Titles
XVIII and XIX of the Social Security Act (the Act) by establishing
incentive payments to eligible professionals (EPs), eligible hospitals
and critical access hospitals (CAHs), and Medicare Advantage (MA)
organizations participating in the Medicare and Medicaid programs that
adopt and successfully demonstrate meaningful use of certified EHR
technology. These Recovery Act provisions, together with Title XIII of
Division A of the Recovery Act, may be cited as the ``Health
Information Technology for Economic and Clinical Health Act'' or the
``HITECH Act.''
The HITECH Act creates incentive programs for EPs and eligible
hospitals, including CAHs, in the Medicare Fee-for-Service (FFS), MA,
and Medicaid programs that successfully demonstrate meaningful use of
certified EHR technology. In their first payment year, Medicaid EPs and
eligible hospitals may adopt, implement or upgrade to certified EHR
technology. It also, provides for payment adjustments in the Medicare
FFS and MA programs starting in FY 2015 for EPs and eligible hospitals
participating in Medicare that are not meaningful users of certified
EHR technology. These payment adjustments do not pertain to Medicaid
providers.
The first final rule for the Medicare and Medicaid EHR Incentive
Program, which was published in the Federal Register on July 28, 2010
(CMS-0033-F), specified the initial criteria EPs, eligible hospitals
and CAHs, and MA organizations must meet in order to qualify for
incentive payments; calculation of incentive payment amounts; payment
adjustments under Medicare for covered professional services and
inpatient hospital services provided by EPs, eligible hospitals and
CAHs failing to demonstrate meaningful use of certified EHR technology
beginning in 2015; and other program participation requirements. On the
same date, the Office of the National Coordinator of Health Information
Technology (ONC) issued a closely related final rule (45 CFR part 170,
RIN 0991-AB58) that specified the initial set of standards,
implementation specifications, and certification criteria for certified
EHR technology. ONC has also issued a separate final rule on the
establishment of certification programs for health information
technology (HIT) (45 CFR part 170, RIN 0991-AB59). The functionality of
certified EHR technology should facilitate the implementation of
meaningful use. Subsequently, final rules have been issued by CMS (77
FR 53968) and ONC (77 FR 72985) to create a Stage 2 of meaningful use
criteria and other changes to the CMS EHR Incentive Programs and the
2014 Edition Certification Criteria for EHR technology.
The information collection requirements contained in this
information collection request are needed to implement the HITECH Act.
In order to avoid duplicate payments, all EPs are enumerated through
their National Provider Identifier (NPI), while all eligible hospitals
and CAHs are
[[Page 13132]]
enumerated through their CMS Certification Number (CCN). State Medicaid
agencies and CMS use the provider's tax identification number and NPI
or CCN combination in order to make payment, validate payment
eligibility and detect and prevent duplicate payments for EPs, eligible
hospitals and CAHs. Form Number: CMS-10336 (OMB Control Number: 0938-
1158); Frequency: Occasionally; Affected Public: Private sector; Number
of Respondents: 214,694; Total Annual Responses: 214,694; Total Annual
Hours: 2,034,740. (For policy questions regarding this collection
contact Steven Johnson at (410) 786-3332).
Dated: March 22, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2018-06081 Filed 3-26-18; 8:45 am]
BILLING CODE 4120-01-P
