80 FR 24255 - Agency Information Collection Activities: Submission for OMB Review; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 80, Issue 83 (April 30, 2015)
Centers for Medicare & Medicaid Services
Federal Register Volume 80, Issue 83 (April 30, 2015)
| Page Range | 24255-24256 | |
| FR Document | 2015-10197 |
[Federal Register Volume 80, Number 83 (Thursday, April 30, 2015)] [Notices] [Pages 24255-24256] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-10197] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-10336] Agency Information Collection Activities: Submission for OMB Review; Comment Request 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 any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) 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 June 1, 2015. 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: [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' Web site address at http://www.cms.hhs.gov/PaperworkReductionActof1995. 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: Reports Clearance Office 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: Extension of the currently approved collection; Reinstatement with change of a previously approved 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 [[Page 24256]] 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 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 Elisabeth Myers at 410-786-4751.) Dated: April 28, 2015. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2015-10197 Filed 4-29-15; 8:45 am] BILLING CODE 4120-01-P
![Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Notices 24255
V. Response to Comments DATES: Comments on the collection(s) of enacted on February 17, 2009. The
Because of the large number of public information must be received by the Recovery Act includes many measures
comments we normally receive on OMB desk officer by June 1, 2015. to modernize our nation’s infrastructure,
Federal Register documents, we are not ADDRESSES: When commenting on the and improve affordable health care.
able to acknowledge or respond to them proposed information collections, Expanded use of health information
please reference the document identifier technology (HIT) and certified
individually. We will consider all
or OMB control number. To be assured electronic health record (EHR)
comments we receive by the date and
consideration, comments and technology will improve the quality and
time specified in the ‘‘DATES’’ section
recommendations must be received by value of America’s health care. Title IV
of this preamble, and, when we proceed
the OMB desk officer via one of the of Division B of the Recovery Act
with a subsequent document, we will
following transmissions: OMB, Office of amends Titles XVIII and XIX of the
respond to the comments in the
Information and Regulatory Affairs, Social Security Act (the Act) by
preamble to that document. Upon
Attention: CMS Desk Officer, Fax establishing incentive payments to
completion of our evaluation, including
Number: (202) 395–5806 OR, Email: eligible professionals (EPs), eligible
evaluation of comments received as a
OIRA_submission@omb.eop.gov. hospitals and critical access hospitals
result of this notice, we will publish a (CAHs), and Medicare Advantage (MA)
notice in the Federal Register To obtain copies of a supporting
statement and any related forms for the organizations participating in the
announcing the result of our evaluation. Medicare and Medicaid programs that
proposed collection(s) summarized in
Dated: April 21, 2015. this notice, you may make your request adopt and successfully demonstrate
Andrew M. Slavitt, using one of following: meaningful use of certified EHR
Acting Administrator, Centers for Medicare 1. Access CMS’ Web site address at technology. These Recovery Act
& Medicaid Services. http://www.cms.hhs.gov/ provisions, together with Title XIII of
[FR Doc. 2015–10171 Filed 4–29–15; 8:45 am] PaperworkReductionActof1995. Division A of the Recovery Act, may be
BILLING CODE 4120–01–P 2. Email your request, including your cited as the ‘‘Health Information
address, phone number, OMB number, Technology for Economic and Clinical
and CMS document identifier, to Health Act’’ or the ‘‘HITECH Act.’’
DEPARTMENT OF HEALTH AND Paperwork@cms.hhs.gov. The HITECH Act creates incentive
HUMAN SERVICES 3. Call the Reports Clearance Office at programs for EPs and eligible hospitals,
(410) 786–1326. including CAHs, in the Medicare Fee-
Centers for Medicare & Medicaid FOR FURTHER INFORMATION CONTACT: for-Service (FFS), MA, and Medicaid
Services Reports Clearance Office at (410) 786– programs that successfully demonstrate
1326. meaningful use of certified EHR
[Document Identifier: CMS–10336] technology. In their first payment year,
SUPPLEMENTARY INFORMATION: Under the Medicaid EPs and eligible hospitals may
Agency Information Collection Paperwork Reduction Act of 1995 (PRA) adopt, implement or upgrade to certified
Activities: Submission for OMB (44 U.S.C. 3501–3520), federal agencies EHR technology. It also, provides for
Review; Comment Request must obtain approval from the Office of payment adjustments in the Medicare
Management and Budget (OMB) for each FFS and MA programs starting in FY
ACTION: Notice. collection of information they conduct 2015 for EPs and eligible hospitals
or sponsor. The term ‘‘collection of participating in Medicare that are not
SUMMARY: The Centers for Medicare & information’’ is defined in 44 U.S.C. meaningful users of certified EHR
Medicaid Services (CMS) is announcing 3502(3) and 5 CFR 1320.3(c) and technology. These payment adjustments
an opportunity for the public to includes agency requests or do not pertain to Medicaid providers.
comment on CMS’ intention to collect requirements that members of the public The first final rule for the Medicare
information from the public. Under the submit reports, keep records, or provide and Medicaid EHR Incentive Program,
Paperwork Reduction Act of 1995 information to a third party. Section which was published in the Federal
(PRA), federal agencies are required to 3506(c)(2)(A) of the PRA (44 U.S.C. Register on July 28, 2010 (CMS–0033–
publish notice in the Federal Register 3506(c)(2)(A)) requires federal agencies F), specified the initial criteria EPs,
concerning each proposed collection of to publish a 30-day notice in the eligible hospitals and CAHs, and MA
information, including each proposed Federal Register concerning each organizations must meet in order to
extension or reinstatement of an existing proposed collection of information, qualify for incentive payments;
collection of information, and to allow including each proposed extension or calculation of incentive payment
a second opportunity for public reinstatement of an existing collection amounts; payment adjustments under
comment on the notice. Interested of information, before submitting the Medicare for covered professional
persons are invited to send comments collection to OMB for approval. To services and inpatient hospital services
regarding the burden estimate or any comply with this requirement, CMS is provided by EPs, eligible hospitals and
other aspect of this collection of publishing this notice that summarizes CAHs failing to demonstrate meaningful
information, including any of the the following proposed collection(s) of use of certified EHR technology
following subjects: (1) The necessity and information for public comment: beginning in 2015; and other program
utility of the proposed information 1. Type of Information Collection participation requirements. On the same
collection for the proper performance of Request: Extension of the currently date, the Office of the National
mstockstill on DSK4VPTVN1PROD with NOTICES
the agency’s functions; (2) the accuracy approved collection; Reinstatement with Coordinator of Health Information
of the estimated burden; (3) ways to change of a previously approved Technology (ONC) issued a closely
enhance the quality, utility, and clarity collection; Title of Information related final rule (45 CFR part 170, RIN
of the information to be collected; and Collection: Medicare and Medicaid 0991–AB58) that specified the initial set
(4) the use of automated collection Programs: Electronic Health Record of standards, implementation
techniques or other forms of information Incentive Program; Use: The American specifications, and certification criteria
technology to minimize the information Recovery and Reinvestment Act of 2009 for certified EHR technology. ONC has
collection burden. (Recovery Act) (Pub. L. 111–5) was also issued a separate final rule on the
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![24256 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Notices
establishment of certification programs General Function of the Committee: AdvisoryCommittees/Calendar/
for health information technology (HIT) To provide advice and default.htm. Scroll down to the
(45 CFR part 170, RIN 0991–AB59). The recommendations to the Agency on appropriate advisory committee meeting
functionality of certified EHR FDA’s regulatory issues. link.
technology should facilitate the Date and Time: The meeting will be
held on June 9, 2015, from 8 a.m. to 5 Procedure: Interested persons may
implementation of meaningful use.
p.m. present data, information, or views,
Subsequently, final rules have been
issued by CMS (77 FR 53968) and ONC Location: Hilton Washington DC orally or in writing, on issues pending
(77 FR 72985) to create a Stage 2 of North/Gaithersburg, Grand Ballroom, before the committee. Written
meaningful use criteria and other 620 Perry Parkway, Gaithersburg, MD submissions may be made to the contact
changes to the CMS EHR Incentive 20877. The hotel telephone number is person on or before May 26, 2015. Oral
Programs and the 2014 Edition 301–977–8900. presentations from the public will be
Certification Criteria for EHR Contact Person: Philip Bautista, scheduled between approximately 1:15
technology. Center for Drug Evaluation and p.m. to 2:15 p.m. Those individuals
The information collection Research, Food and Drug interested in making formal oral
requirements contained in this Administration, 10903 New Hampshire presentations should notify the contact
information collection request are Ave., Bldg. 31, Rm. 2417, Silver Spring, person and submit a brief statement of
needed to implement the HITECH Act. MD 20993–0002, 301–796–9001, Fax: the general nature of the evidence or
In order to avoid duplicate payments, 301–847–8533, EMDAC@fda.hhs.gov, or arguments they wish to present, the
all EPs are enumerated through their FDA Advisory Committee Information names and addresses of proposed
National Provider Identifier (NPI), while Line, 1–800–741–8138 (301–443–0572 participants, and an indication of the
all eligible hospitals and CAHs are in the Washington, DC area). A notice in approximate time requested to make
enumerated through their CMS the Federal Register about last minute their presentation on or before May 15,
Certification Number (CCN). State modifications that impact a previously
2015. Time allotted for each
Medicaid agencies and CMS use the announced advisory committee meeting
presentation may be limited. If the
provider’s tax identification number and cannot always be published quickly
enough to provide timely notice. number of registrants requesting to
NPI or CCN combination in order to speak is greater than can be reasonably
make payment, validate payment Therefore, you should always check the
Agency’s Web site at http:// accommodated during the scheduled
eligibility and detect and prevent open public hearing session, FDA may
duplicate payments for EPs, eligible www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the conduct a lottery to determine the
hospitals and CAHs. Form Number:
appropriate advisory committee meeting speakers for the scheduled open public
CMS–10336 (OMB control number:
link, or call the advisory committee hearing session. The contact person will
0938–1158); Frequency: Occasionally;
information line to learn about possible notify interested persons regarding their
Affected Public: Private sector; Number
modifications before coming to the request to speak by May 18, 2015.
of Respondents: 214,694; Total Annual
Responses: 214,694; Total Annual meeting. Persons attending FDA’s advisory
Hours: 2,034,740. (For policy questions Agenda: The committee will discuss committee meetings are advised that the
regarding this collection contact the safety and efficacy of biologics Agency is not responsible for providing
Elisabeth Myers at 410–786–4751.) license application 125559, proposed access to electrical outlets.
trade name PRALUENT (established
Dated: April 28, 2015. name: Alirocumab) for injection, FDA welcomes the attendance of the
William N. Parham, III, submitted by Sanofi Aventis, U.S., as an public at its advisory committee
Director, Paperwork Reduction Staff, Office adjunct to diet, for long-term treatment meetings and will make every effort to
of Strategic Operations and Regulatory of adult patients with primary accommodate persons with physical
Affairs. hypercholesterolemia (non-familial and disabilities or special needs. If you
[FR Doc. 2015–10197 Filed 4–29–15; 8:45 am] heterozygous familial) or mixed require special accommodations due to
BILLING CODE 4120–01–P dyslipidemia including patients with a disability, please contact Philip
type 2 diabetes mellitus, to reduce low- Bautista at least 7 days in advance of the
density lipoprotein cholesterol, total meeting.
DEPARTMENT OF HEALTH AND cholesterol, non-high-density
HUMAN SERVICES FDA is committed to the orderly
lipoprotein cholesterol, apolipoprotein conduct of its advisory committee
B, tryglyceride, and lipoprotein A, and meetings. Please visit our Web site at
Food and Drug Administration
to increase high-density lipoprotein http://www.fda.gov/
[Docket No. FDA–2015–N–0001] cholesterol and apolipoprotein A–1
AdvisoryCommittees/
either in combination with a statin or as
Endocrinologic and Metabolic Drugs AboutAdvisoryCommittees/
monotherapy including in patients who
Advisory Committee; Notice of Meeting ucm111462.htm for procedures on
cannot tolerate statins.
FDA intends to make background public conduct during advisory
AGENCY: Food and Drug Administration, committee meetings.
HHS. material available to the public no later
than 2 business days before the meeting. Notice of this meeting is given under
ACTION: Notice.
If FDA is unable to post the background the Federal Advisory Committee Act (5
mstockstill on DSK4VPTVN1PROD with NOTICES
This notice announces a forthcoming material on its Web site prior to the U.S.C. app. 2).
meeting of a public advisory committee meeting, the background material will Dated: April 24, 2015.
of the Food and Drug Administration be made publicly available at the
location of the advisory committee Peter Lurie,
(FDA). The meeting will be open to the
public. meeting, and the background material Associate Commissioner for Public Health
Name of Committee: Endocrinologic will be posted on FDA’s Web site after Strategy and Analysis.
and Metabolic Drugs Advisory the meeting. Background material is [FR Doc. 2015–10023 Filed 4–29–15; 8:45 am]
Committee. available at http://www.fda.gov/ BILLING CODE 4164–01–P
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Document Created: 2018-02-21 10:15:06
Document Modified: 2018-02-21 10:15:06
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments on the collection(s) of information must be received by the OMB desk officer by June 1, 2015. | |
| Contact | Reports Clearance Office at (410) 786- 1326. | |
| FR Citation | 80 FR 24255 |
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