[Federal Register Volume 81, Number 43 (Friday, March 4, 2016)]
[Notices]
[Pages 11569-11571]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04841]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10110, CMS-10387, CMS-10400 and CMS-10593]


Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

ACTION: Notice.

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SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is 
announcing an opportunity for the public to comment on CMS' intention 
to collect information from the public. Under the Paperwork Reduction 
Act of 1995 (PRA), federal agencies are required to publish notice in 
the Federal Register concerning each proposed collection of 
information, including each proposed extension or reinstatement of an 
existing collection of information, and to allow a second opportunity 
for public comment on the notice. Interested persons are invited to 
send comments regarding the burden estimate or any other aspect of this 
collection of information, including 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 April 4, 2016.

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.

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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 of a 
previously approved collection; Title of Information Collection: 
Skilled Nursing Facility (SNF) Prospective Payment System and 
Consolidated Billing; Use: We are requesting approval of a 
reinstatement of a Change of Therapy OMRA for Skilled Nursing 
Facilities (SNFs). As described in CMS-1351-F, we finalized the 
assessment effective October 1, 2011. The SNFs are required to submit 
this assessment. The COT OMRA is comprised of a subset of resident 
assessment information developed for use by SNFs to satisfy a Medicare 
payment requirement. The burden associated with this is the SNF staff 
time required to complete the COT OMRA, SNF staff time to encode the 
data, and SNF staff time spent in transmitting the data. The SNFs are 
required to complete a COT OMRA when a SNF resident was receiving a 
sufficient level of rehabilitation therapy to qualify for an Ultra 
High, Very High, High, Medium, or Low Rehabilitation category and when 
the intensity of therapy (as indicated by the total reimbursable 
therapy minutes (RTM) delivered, and other therapy qualifiers such as 
number of therapy days and disciplines providing therapy) changes to 
such a degree that it would no longer reflect the RUG-IV classification 
and payment assigned for a given SNF resident based on the most recent 
assessment used for Medicare payment. The COT OMRA is a type of 
required PPS assessment which uses the same item set as the End of 
Therapy (EOT) OMRA. Form Number: CMS-10387 (OMB Control Number: 0938-
1140); Frequency: Yearly; Affected Public: Private sector (Business or 
other For-profits and Not-for-profit institutions); Number of 
Respondents: 15,421; Total Annual Responses: 678,524; Total Annual 
Hours: 701,119. (For policy questions regarding this collection contact 
Penny Gershman at 410-786-6643).
    2. Type of Information Collection Request: Reinstatement of a 
previously approved collection; Title of Information Collection: 
Manufacturer Submission of Average Sales Price (ASP) Data for Medicare 
Part B Drugs and Biologicals; Use: In accordance with Section 1847A of 
the Social Security Act (the Act), Medicare Part B covered drugs and 
biologicals not paid on a cost or prospective payment basis are paid 
based on the average sales price (ASP) of the drug or biological, 
beginning in Calendar Year (CY) 2005. The ASP data reporting 
requirements are specified in Section 1927 of the Act. The reported ASP 
data are used to establish the Medicare payment amounts. The reporting 
template was revised in CY 2011 in order to facilitate accurate 
collection of ASP data. An accompanying user guide with instructions on 
the template's use was also created and included an explanation of the 
data elements in the template. Form Number: CMS-10110 (OMB Control 
Number: 0938-0921); Frequency: Quarterly; Affected Public: Private 
sector (Business or other For-profits); Number of Respondents: 180; 
Total Annual Responses: 720; Total Annual Hours: 34,560. (For policy 
questions regarding this collection contact Amy Gruber at 410-786-
1542).
    3. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Establishment of 
Exchanges and Qualified Health Plans; Use: The Patient Protection and 
Affordable Care Act, Public Law 111-148, enacted on March 23, 2010, and 
the Health Care and Education Reconciliation Act, Public Law 111-152, 
enacted on March 30, 2010 (collectively, ``Affordable Care Act''), 
expand access to health insurance for individuals and employees of 
small businesses through the establishment of new Affordable Insurance 
Exchanges (Exchanges), including the Small Business Health Options 
Program (SHOP).
    As directed by the rule Establishment of Exchanges and Qualified 
Health Plans; Exchange Standards for Employers (77 FR 18310) (Exchange 
rule), each Exchange will assume responsibilities related to the 
certification and offering of Qualified Health Plans (QHPs). To offer 
insurance through an Exchange, a health insurance issuer must have its 
health plans certified as QHPs by the Exchange. A QHP must meet certain 
minimum certification standards, such as network adequacy, inclusion of 
Essential Community Providers (ECPs), and non-discrimination. The 
Exchange is responsible for ensuring that QHPs meet these minimum 
certification standards as described in the Exchange rule under 45 CFR 
parts 155 and 156, based on the Affordable Care Act, as well as other 
standards determined by the Exchange. The reporting requirements and 
data collection in the Exchange rule address Federal requirements that 
various entities must meet with respect to the establishment and 
operation of an Exchange; minimum requirements that health insurance 
issuers must meet with respect to participation in a State based or 
Federally-facilitated Exchange; and requirements that employers must 
meet with respect to participation in the SHOP and compliance with 
other provisions of the Affordable Care Act. This proposed information 
collection was published in the Federal Register on November 23, 2015 
(80 FR 72968). No comments were received. Form Number: CMS-10400; 
Frequency: Monthly, Annual; Affected Public: Private Sector; Number of 
Respondents: 11,004; Number of Responses: 11,485; Total Annual Hours: 
55,775. (For policy questions regarding this collection, contact Leigha 
Basini at 301-492-4380.)
    4. Type of Information Collection Request: New collection (Request 
for a new OMB control number); Title of Information Collection: 
Establishment of an Exchange by a State and Qualified Health Plans; 
Use: The Patient Protection and Affordable Care Act, Public Law 111-
148, enacted on March 23, 2010, and the Health Care and Education 
Reconciliation Act, Public Law 111-152, enacted on March 30, 2010 
(collectively, ``Affordable Care Act''), expand access to health 
insurance for individuals and employees of small businesses through the 
establishment of new Affordable Insurance Exchanges (Exchanges), 
including the Small Business Health Options Program (SHOP). As directed 
by the rule Establishment of Exchanges and Qualified Health Plans; 
Exchange Standards for Employers (77 FR 18310) (Exchange rule), each 
Exchange will assume responsibilities related to the certification and 
offering of Qualified Health Plans (QHPs). To offer insurance through 
an Exchange, a health insurance issuer must have its health plans

[[Page 11571]]

certified as QHPs by the Exchange. A QHP must meet certain minimum 
certification standards, such as network adequacy, inclusion of 
Essential Community Providers (ECPs), and non-discrimination. The 
Exchange is responsible for ensuring that QHPs meet these minimum 
certification standards as described in the Exchange rule under 45 CFR 
parts 155 and 156, based on the Affordable Care Act, as well as other 
standards determined by the Exchange. The reporting requirements and 
data collection in the Exchange rule address Federal requirements that 
various entities must meet with respect to the establishment and 
operation of an Exchange; minimum requirements that health insurance 
issuers must meet with respect to participation in a State based or 
Federally-facilitated Exchange; and requirements that employers must 
meet with respect to participation in the SHOP and compliance with 
other provisions of the Affordable Care Act. Comments have been 
received, however; there were no comments that impacted the burden, and 
therefore no additional changes were made. Form Number: CMS-10593 (OMB 
Control Number: 0938-NEW); Frequency: Annually, Monthly; Affected 
Public: Private Sector; Business or other for-profit; Number of 
Respondents: 20; Total Annual Responses: 400; Total Annual Hours: 
36,900. (For policy questions regarding this collection contact Christy 
Woods at 301-492-5140.)

    Dated: March 1, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2016-04841 Filed 3-3-16; 8:45 am]
BILLING CODE 4120-01-P