80 FR 23011 - 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 79 (April 24, 2015)
Centers for Medicare & Medicaid Services
Federal Register Volume 80, Issue 79 (April 24, 2015)
| Page Range | 23011-23013 | |
| FR Document | 2015-09591 |
[Federal Register Volume 80, Number 79 (Friday, April 24, 2015)] [Notices] [Pages 23011-23013] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-09591] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-10392 and CMS-10418] 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 May 26, 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: Revision of a currently approved information collection; Title of Information Collection: Consumer Operated and Oriented (CO-OP) Program; Use: The Consumer Operated and Oriented Plan (CO-OP) program was established by Section 1322 of the Affordable Care Act. This program provides for loans to establish at least one consumer-operated, qualified nonprofit health insurance issuer in each State. Issuers supported by the [[Page 23012]] CO-OP program will offer at least one qualified health plan at the silver level of benefits and one at the gold level of benefits in the individual market State Health Benefit Exchanges (Exchanges). At least two-thirds of policies or contracts offered by a CO-OP will be open to individuals and small employers. Profits generated by the nonprofit CO- OPs will be used to lower premiums, improve benefits, improve the quality of health care delivered to their members, expand enrollment, or otherwise contribute to the stability of coverage offered by the CO- OP. By increasing competition in the health insurance market and operating with a strong consumer focus, the CO-OP program will provide consumers more choices, greater plan accountability, increased competition to lower prices, and better models of care, benefiting all consumers, not just CO-OP members. The CO-OP program will provide nonprofits with loans to fund start- up costs and State reserve requirements, in the form of Start-up Loans and Solvency Loans. An applicant may apply for (1) joint Start-up and Solvency Loans; or (3) only a Solvency Loan. Planning Loans are intended to help loan recipients determine the feasibility of operating a CO-OP in a target market. Start-up Loans are intended to assist loan recipients with the many start-up costs associated with establishing a new health insurance issuer. Solvency Loans are intended to assist loan recipients with meeting the solvency requirements of States in which the applicant seeks to be licensed to issue qualified health plans. Form Number: CMS-10392 (OMB control number 0938-1139); Frequency: Occasionally; Affected Public: Private Sector (Not-for-profit institutions); Number of Respondents: 23; Total Annual Responses: 675; Total Annual Hours: 93,220. (For policy questions regarding this collection contact Deepti Loharikar at 301-492-4126.) 2. Type of Information Collection Request: Revision of currently approved collection; Title of Information Collection: Annual MLR and Rebate Calculation Report and MLR Rebate Notices; Use: Under Section 2718 of the Affordable Care Act and implementing regulation at 45 CFR part 158, a health insurance issuer (issuer) offering group or individual health insurance coverage must submit a report to the Secretary concerning the amount the issuer spends each year on claims, quality improvement expenses, non-claims costs, Federal and State taxes and licensing and regulatory fees, the amount of earned premium, and beginning with the 2014 reporting year, the amounts related to the reinsurance, risk corridors, and risk adjustment programs established under sections 1341, 1342, and 1343, respectively, of the Affordable Care Act. An issuer must provide an annual rebate if the amount it spends on certain costs compared to its premium revenue (excluding Federal and States taxes and licensing and regulatory fees) does not meet a certain ratio, referred to as the medical loss ratio (MLR). An interim final rule (IFR) implementing the MLR was published on December 1, 2010 (75 FR 74865) and modified by technical corrections on December 30, 2010 (75 FR 82277), which added Part 158 to Title 45 of the Code of Federal Regulations. The IFR is effective January 1, 2011. A final rule regarding selected provisions of the IFR was published on December 7, 2011 (76 FR 76574, CMS-9998-FC) and an interim final rule regarding an issue not included in issuers' reporting obligations (disbursement of rebates by non-federal governmental plans) was also published December 7, 2011 (76 FR 76596, CMS-9998-IFC2). Both rules published on December 7, 2011 are effective January 1, 2012. Each issuer is required to submit annually MLR data, including information about any rebates it must provide, on a form prescribed by CMS, for each State in which the issuer conducts business. Each issuer is also required to provide a rebate notice to each policyholder that is owed a rebate and each subscriber of policyholders that are owed a rebate for any given MLR reporting year. Additionally, each issuer is required to maintain for a period of seven years all documents, records and other evidence that support the data included in each issuer's annual report to the Secretary. Under Section 1342 of the Patient Protection and Affordable Care Act and implementing regulation at 45 CFR part 153, issuers of qualified health plans (QHPs) must participate in a risk corridors program. A QHP issuer will pay risk corridors charges or be eligible to receive risk corridors payments based on the ratio of the issuer's allowable costs to the target amount. A final rule (Premium Stabilization Rule) implementing the risk corridors program was published on March 23, 2012 (77 FR 17220), which added part 153 to title 45 of the Code of Federal Regulations. The Premium Stabilization Rule is effective May 22, 2012. Final rules (2014 Payment Notice, 2015 Payment Notice, and 2016 Payment Notice) outlining the risk corridors benefit and payment parameters for the 2014, 2015, and 2016 benefit years were published on March 11, 2013 (78 FR 15410), March 11, 2014 (79 FR 13744), and February 27, 2015 (80 FR 10750), respectively. Additionally, on October 30, 2013, HHS published the Second Final Program Integrity rule (78 FR 65076) to align the risk corridors program with the requirements of the single risk pool provision at 45 CFR 156.80. The risk corridors data collection applies to QHP issuers the individual and small group markets. Each QHP issuer is required to submit an annual report to CMS concerning the issuer's allowable costs, allowable administrative costs, premium, and proportion of market premium in QHPs. Risk corridors premium information that is specific to an issuer's QHPs is collected through a separate data reporting form. CMS is publishing the risk corridors plan-level reporting form, and instructions for completing the form for public comment as part of the proposed revision to this information collection requirement. On January 30, 2015, CMS published a 60-day notice in the Federal Register (80 FR 5118) for the public to submit written comments on this information collection; the public comment period closed on March 31, 2015. As part of the 60-day notice, CMS updated its annual burden hour estimates, including to reflect the additional burden (published in the 2015 Payment Notice) related to the risk corridors data submission requirements. The proposed revisions in the 60-day notice also made changes regarding the new MLR reporting and rebate distribution deadlines and the accounting for the reinsurance, risk adjustment, and risk corridors. We received a total of 3 public comments on a number of specific issues regarding the notice of the revised MLR PRA package. We have taken into consideration all of the comments and has modified the 2014 MLR Annual Reporting Form, the Risk Corridors Plan Level Data Form, and the accompanying Instructions in order to correct minor errors and to provide additional clarifications. These modifications do not affect the previously estimated burden hours or costs. Form Number: CMS-10418 (OMB control number: 0938-1164); Frequency: Annually; Affected Public: Private sector (Business or other for-profits and Not- for-profit institutions); Number of Respondents: 517; Number of Responses: 3,307; Total Annual Hours: 271,600. (For policy questions regarding this collection, contact Julie McCune at (301) 492-4196.) [[Page 23013]] Dated: April 21, 2015. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2015-09591 Filed 4-23-15; 8:45 am] BILLING CODE 4120-01-P
![Federal Register / Vol. 80, No. 79 / Friday, April 24, 2015 / Notices 23011
of Diabetes Educators’ (AADE) request able to acknowledge or respond to them ADDRESSES: When commenting on the
for the Secretary’s approval of its individually. We will consider all proposed information collections,
accreditation program for outpatient comments we receive by the date and please reference the document identifier
DSMT services. The AADE submitted time specified in the DATES section of or OMB control number. To be assured
all the necessary materials to enable us this preamble, and, when we proceed consideration, comments and
to make a determination concerning its with a subsequent document, we will recommendations must be received by
request for re-approval as a deeming respond to the comments in the the OMB desk officer via one of the
organization for DSMTs. AADE was preamble to that document. Upon following transmissions: OMB, Office of
initially accredited on August 27, 2012, completion of our evaluation, including Information and Regulatory Affairs,
for a period of 3 years. This application evaluation of comments received as a Attention: CMS Desk Officer, Fax
was determined to be complete on result of this notice, we will publish a Number: (202) 395–5806 OR, Email:
February 27, 2015. This notice also notice in the Federal Register OIRA_submission@omb.eop.gov.
solicits public comments on the ability announcing the result of our evaluation. To obtain copies of a supporting
of the AADE to continue to develop Dated: April 7, 2015. statement and any related forms for the
standards that meet or exceed the proposed collection(s) summarized in
Andrew M. Slavitt,
Medicare conditions for coverage and this notice, you may make your request
apply them to entities furnishing Acting Administrator, Centers for Medicare
using one of following:
& Medicaid Services.
outpatient. 1. Access CMS’ Web site address at
The regulations specifying the [FR Doc. 2015–09610 Filed 4–23–15; 8:45 am]
http://www.cms.hhs.gov/
Medicare conditions for coverage for BILLING CODE 4120–01–P PaperworkReductionActof1995.
outpatient diabetes self-management 2. Email your request, including your
training services are located in parts address, phone number, OMB number,
410, subpart H. These conditions DEPARTMENT OF HEALTH AND and CMS document identifier, to
implement section 1861(qq) of the Act, HUMAN SERVICES Paperwork@cms.hhs.gov.
which provides for Medicare Part B 3. Call the Reports Clearance Office at
Centers for Medicare & Medicaid
coverage of outpatient DSMT services (410) 786–1326.
Services
specified by the Secretary. FOR FURTHER INFORMATION CONTACT:
Under section 1865(a)(2) of the Act Reports Clearance Office at (410) 786–
and our regulations at § 410.142 (CMS [Document Identifier: CMS–10392 and CMS–
1326.
process for approving accreditation 10418]
organizations) and § 410.143 SUPPLEMENTARY INFORMATION: Under the
Agency Information Collection Paperwork Reduction Act of 1995 (PRA)
(Requirements for approved
Activities: Submission for OMB (44 U.S.C. 3501–3520), federal agencies
accreditation organizations), we review
Review; Comment Request must obtain approval from the Office of
and evaluate a national accreditation
organization based on (but not Management and Budget (OMB) for each
ACTION: Notice. collection of information they conduct
necessarily limited to) the criteria set
forth in § 410.142(b). or sponsor. The term ‘‘collection of
SUMMARY: The Centers for Medicare & information’’ is defined in 44 U.S.C.
We may conduct on-site inspections Medicaid Services (CMS) is announcing
of a national accreditation 3502(3) and 5 CFR 1320.3(c) and
an opportunity for the public to includes agency requests or
organization’s operations and office to comment on CMS’ intention to collect
verify information in the organization’s requirements that members of the public
information from the public. Under the submit reports, keep records, or provide
application and assess the Paperwork Reduction Act of 1995
organization’s compliance with its own information to a third party. Section
(PRA), federal agencies are required to 3506(c)(2)(A) of the PRA (44 U.S.C.
policies and procedures. The on-site publish notice in the Federal Register
inspection may include, but is not 3506(c)(2)(A)) requires federal agencies
concerning each proposed collection of to publish a 30-day notice in the
limited to, reviewing documents, information, including each proposed
auditing documentation of meetings Federal Register concerning each
extension or reinstatement of an existing proposed collection of information,
concerning the accreditation process, collection of information, and to allow
evaluating accreditation results or the including each proposed extension or
a second opportunity for public reinstatement of an existing collection
accreditation status decision making comment on the notice. Interested
process, and interviewing the of information, before submitting the
persons are invited to send comments collection to OMB for approval. To
organization’s staff. regarding the burden estimate or any comply with this requirement, CMS is
IV. Collection of Information other aspect of this collection of publishing this notice that summarizes
Requirements information, including any of the the following proposed collection(s) of
following subjects: (1) The necessity and information for public comment:
This document does not impose
utility of the proposed information 1. Type of Information Collection
information collection requirements,
collection for the proper performance of Request: Revision of a currently
that is, reporting, recordkeeping or
the agency’s functions; (2) the accuracy approved information collection; Title
third-party disclosure requirements.
of the estimated burden; (3) ways to of Information Collection: Consumer
Consequently, there is no need for
enhance the quality, utility, and clarity Operated and Oriented (CO–OP)
review by the Office of Management and
of the information to be collected; and Program; Use: The Consumer Operated
Budget under the authority of the
(4) the use of automated collection
tkelley on DSK3SPTVN1PROD with NOTICES
Paperwork Reduction Act of 1995 (44 and Oriented Plan (CO–OP) program
techniques or other forms of information was established by Section 1322 of the
U.S.C. 3501 et seq.).
technology to minimize the information Affordable Care Act. This program
V. Response to Comments collection burden. provides for loans to establish at least
Because of the large number of public DATES: Comments on the collection(s) of one consumer-operated, qualified
comments we normally receive on information must be received by the nonprofit health insurance issuer in
Federal Register documents, we are not OMB desk officer by May 26, 2015. each State. Issuers supported by the
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![Federal Register / Vol. 80, No. 79 / Friday, April 24, 2015 / Notices 23013
Dated: April 21, 2015. DEPARTMENT OF HEALTH AND and interpretive regulations, and other
William N. Parham, III, HUMAN SERVICES Federal Register notices that were
Director, Paperwork Reduction Staff, Office published from January through March
of Strategic Operations and Regulatory Centers for Medicare & Medicaid 2015, relating to the Medicare and
Affairs. Services Medicaid programs and other programs
[FR Doc. 2015–09591 Filed 4–23–15; 8:45 am] [CMS–9091–N] administered by CMS.
BILLING CODE 4120–01–P
Medicare and Medicaid Programs; FOR FURTHER INFORMATION CONTACT: It is
Quarterly Listing of Program possible that an interested party may
Issuances—January through March need specific information and not be
2015 able to determine from the listed
information whether the issuance or
AGENCY: Centers for Medicare & regulation would fulfill that need.
Medicaid Services (CMS), HHS. Consequently, we are providing contact
ACTION: Notice. persons to answer general questions
This quarterly notice lists
SUMMARY: concerning each of the addenda
CMS manual instructions, substantive published in this notice.
Addenda Contact Phone number
I CMS Manual Instructions .................................................................................................................. Ismael Torres .............. (410) 786–1864
II Regulation Documents Published in the Federal Register ............................................................. Terri Plumb ................. (410) 786–4481
III CMS Rulings .................................................................................................................................... Tiffany Lafferty ............ (410)786–7548
IV Medicare National Coverage Determinations ................................................................................. Wanda Belle ................ (410) 786–7491
V FDA-Approved Category B IDEs ..................................................................................................... John Manlove .............. (410) 786–6877
VI Collections of Information ................................................................................................................ Mitch Bryman .............. (410) 786–5258
VII Medicare –Approved Carotid Stent Facilities ................................................................................. Lori Ashby ................... (410) 786–6322
VIII American College of Cardiology-National Cardiovascular Data Registry Sites ........................... Marie Casey, BSN, (410) 786–7861
MPH.
IX Medicare’s Active Coverage-Related Guidance Documents .......................................................... JoAnna Baldwin .......... (410) 786–7205
X One-time Notices Regarding National Coverage Provisions ........................................................... JoAnna Baldwin .......... (410) 786–7205
XI National Oncologic Positron Emission Tomography Registry Sites ............................................... Stuart Caplan, RN, (410) 786–8564
MAS.
XII Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities ............................ Marie Casey, BSN, (410) 786–7861
MPH.
XIII Medicare-Approved Lung Volume Reduction Surgery Facilities .................................................. Marie Casey, BSN, (410) 786–7861
MPH.
XIV Medicare-Approved Bariatric Surgery Facilities ........................................................................... Jamie Hermansen ....... (410) 786–2064
XV Fluorodeoxyglucose Positron Emission Tomography for Dementia Trials ................................... Stuart Caplan, RN, (410) 786–8564
MAS.
All Other Information ............................................................................................................................ Annette Brewer ........... (410) 786–6580
SUPPLEMENTARY INFORMATION: authority granted to the Secretary of the as our resources. This is the most
Department of Health and Human current up-to-date information and will
I. Background
Services under sections 1102, 1871, be available earlier than we publish our
The Centers for Medicare & Medicaid 1902, and related provisions of the quarterly notice. We believe the Web
Services (CMS) is responsible for Social Security Act (the Act) and Public site list provides more timely access for
administering the Medicare and Health Service Act. We also issue beneficiaries, providers, and suppliers.
Medicaid programs and coordination various manuals, memoranda, and We also believe the Web site offers a
and oversight of private health statements necessary to administer and more convenient tool for the public to
insurance. Administration and oversight oversee the programs efficiently. find the full list of qualified providers
of these programs involves the Section 1871(c) of the Act requires for these specific services and offers
following: (1) Furnishing information to that we publish a list of all Medicare more flexibility and ‘‘real time’’
Medicare and Medicaid beneficiaries, manual instructions, interpretive rules, accessibility. In addition, many of the
health care providers, and the public; statements of policy, and guidelines of
and (2) maintaining effective Web sites have listservs; that is, the
general applicability not issued as
communications with CMS regional public can subscribe and receive
regulations at least every 3 months in
offices, state governments, state the Federal Register. immediate notification of any updates to
Medicaid agencies, state survey the Web site. These listservs avoid the
agencies, various providers of health II. Format for the Quarterly Issuance need to check the Web site, as
care, all Medicare contractors that Notices notification of updates is automatic and
process claims and pay bills, National This quarterly notice provides only sent to the subscriber as they occur. If
tkelley on DSK3SPTVN1PROD with NOTICES
Association of Insurance Commissioners the specific updates that have occurred assessing a Web site proves to be
(NAIC), health insurers, and other in the 3-month period along with a difficult, the contact person listed can
stakeholders. To implement the various hyperlink to the full listing that is provide information.
statutes on which the programs are available on the CMS Web site or the
based, we issue regulations under the appropriate data registries that are used
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Document Created: 2015-12-16 08:42:56
Document Modified: 2015-12-16 08:42:56
| 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 May 26, 2015. | |
| Contact | Reports Clearance Office at (410) 786- 1326. | |
| FR Citation | 80 FR 23011 |
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