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[Federal Register Volume 78, Number 142 (Wednesday, July 24, 2013)]
[Notices]
[Pages 44569-44571]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-17821]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10268, CMS-10287, CMS-R-70, CMS-R-72, CMS-R-
247, CMS-10151, CMS-10380, CMS-10286, and CMS-10339]

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 August 23, 2013.

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) 395-6974, or Email: OIRA_submission@omb.eop.gov.
    To obtain copies of a supporting statement and any related forms 
for the proposed collection(s) summarized in this notice, you may make 
your request using one of following:
    1. Access CMS' 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 Paperwork@cms.hhs.gov.
    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: Reinstatement of a 
currently approved collection; Title of Information Collection: 
Consolidated Renal Operations in a Web Enabled Network (CROWNWeb) 
Third-party Submission Authorization Form; Use: The Consolidated Renal 
Operations in a Web Enabled Network (CROWNWeb) Third-Party Submission 
Authorization form (CWTPSA) is to be completed by ``Facility 
Administrators'' (administrators of CMS-certified dialysis facilities) 
if they intend to authorize a third party (a business with which the 
facility is associated, or an independent vendor) to submit data to us 
to comply with the recently-revised Conditions for Coverage of dialysis 
facilities. The CROWNWeb system is the system used as the collection 
point of data necessary for entitlement of ESRD patients to Medicare 
benefits and for Federal Government monitoring and assessing of the 
quality and types of care provided to renal patients. The information 
collected through the CWTPSA form will allow us along with our 
contractors to receive data from authorized parties acting on behalf of 
CMS-certified dialysis facilities. Since February 2009, we have 
received 4,160 CWTPSA forms and anticipates that they will continue to 
receive no more than 400 new CWTPSA forms annually to address the 
creation of new facilities under the current participating ``third 
party submitters.'' Form Number: CMS-10268 (OCN: 0938-1052); Frequency: 
Occasionally; Affected Public: Private Sector--Business or other for-
profits and Not-for-profit institutions; Number of Respondents: 400; 
Total Annual Responses: 400; Total Annual Hours: 34. (For policy 
questions regarding this collection contact Michelle Tucker at 410-786-
0736.)
    2. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Medicare Quality 
of Care Complaint Form; Use: In

[[Page 44570]]

accordance with Section 1154(a)(14) of the Social Security Act, Quality 
Improvement Organizations (QIOs) are required to conduct appropriate 
reviews of all written complaints submitted by beneficiaries concerning 
the quality of care received. The Medicare Quality of Care Complaint 
Form will be used by Medicare beneficiaries to submit quality of care 
complaints. This form will establish a standard form for all 
beneficiaries to utilize and ensure pertinent information is obtained 
by QIOs to effectively process these complaints. Form Number: CMS-10287 
(OCN: 0938-1102); Frequency: Reporting--Occasionally; Affected Public: 
Individuals or Households; Number of Respondents: 3,500; Total Annual 
Responses: 3,500; Total Annual Hours: 583. (For policy questions 
regarding this collection contact Coles Mercier at 410-786-2112.)
    3. Type of Information Collection Request: Reinstatement with a 
change of a previously approved collection; Title of Information 
Collection: Information Collection Requirements in HSQ-110, 
Acquisition, Protection and Disclosure of Peer review Organization 
Information and Supporting Regulations in 42 CFR, Sections 480.104, 
480.105, 480.116, and 480.134; Use: The Peer Review Improvement Act of 
1982 authorizes quality improvement organizations (QIOs), formally 
known as peer review organizations (PROs), to acquire information 
necessary to fulfill their duties and functions and places limits on 
disclosure of the information. The QIOs are required to provide notices 
to the affected parties when disclosing information about them. These 
requirements serve to protect the rights of the affected parties. The 
information provided in these notices is used by the patients, 
practitioners and providers to: obtain access to the data maintained 
and collected on them by the QIOs; add additional data or make changes 
to existing QIO data; and reflect in the QIO's record the reasons for 
the QIO's disagreeing with an individual's or provider's request for 
amendment.: Form Number: CMS-R-70 (OCN: 0938-0426); Frequency: 
Reporting--On occasion; Affected Public: Business or other for-profits; 
Number of Respondents: 400; Total Annual Responses: 21,200; Total 
Annual Hours: 42,400. (For policy questions regarding this collection 
contact Coles Mercier at 410-786-2112.)
    4. Type of Information Collection Request: Reinstatement without 
change of a previously approved collection; Title of Information 
Collection: Information Collection Requirements in 42 CFR 478.18, 
478.34, 478.36, 478.42, QIO Reconsiderations and Appeals; Use: In the 
event that a beneficiary, provider, physician, or other practitioner 
does not agree with the initial determination of a Quality Improvement 
Organization (QIO) or a QIO subcontractor, it is within that party's 
rights to request reconsideration. The information collection 
requirements 42 CFR 478.18, 478.34, 478.36, and 478.42, contain 
procedures for QIOs to use in reconsideration of initial 
determinations. The information requirements contained in these 
regulations are on QIOs to provide information to parties requesting 
the reconsideration. These parties will use the information as 
guidelines for appeal rights in instances where issues are actively 
being disputed. Form Number: CMS-R-72 (OCN: 0938-0443); Frequency: 
Reporting--On occasion; Affected Public: Individuals or Households and 
Business or other for-profit institutions; Number of Respondents: 
2,590; Total Annual Responses: 5,228; Total Annual Hours: 2,822. (For 
policy questions regarding this collection contact Coles Mercier at 
410-786-2112.)
    5. Type of Information Collection Request: Reinstatement with a 
change of a previously approved collection; Title of Information 
Collection: Expanded Coverage for Diabetes Outpatient Self-Management 
Training Services and Supporting Regulations Contained in 42 CFR 
410.141, 410.142, 410.143, 410.144, 410.145, 410.146, 414.63; Use: 
According to the National Health and Nutrition Examination Survey 
(NHANES), as many as 18.7 percent of Americans over age 65 are at risk 
for developing diabetes. The goals in the management of diabetes are to 
achieve normal metabolic control and reduce the risk of micro- and 
macro-vascular complications. Numerous epidemiologic and interventional 
studies point to the necessity of maintaining good glycemic control to 
reduce the risk of the complications of diabetes. Despite this 
knowledge, diabetes remains the leading cause of blindness, lower 
extremity amputations and kidney disease requiring dialysis. Diabetes 
and its complications are primary or secondary factors in an estimated 
9 percent of hospitalizations (Aubert, RE, et al., Diabetes-related 
hospitalizations and hospital utilization. In: Diabetes in America. 2nd 
ed. National Institutes of Health, National Institute of Diabetes and 
Digestive and Kidney Disease, NIH, Pub. No 95-1468-1995: 553-570). 
Overall, beneficiaries with diabetes are hospitalized 1.5 times more 
often than beneficiaries without diabetes. HCFA-3002-F provided for 
uniform coverage of diabetes outpatient self-management training 
services. These services include educational and training services 
furnished to a beneficiary with diabetes by an entity approved to 
furnish the services. The physician or qualified non-physician 
practitioner treating the beneficiary's diabetes would certify that 
these services are needed as part of a comprehensive plan of care. This 
rule established the quality standards that an entity would be required 
to meet in order to participate in furnishing diabetes outpatient self-
management training services. It set forth payment amounts that have 
been established in consultation with appropriate diabetes 
organizations. It implements section 4105 of the Balanced Budget Act of 
1997. Form Number: CMS-R-247 (OCN: 0938-0818); Frequency: Recordkeeping 
and Reporting--Occasionally; Affected Public: Business or other for-
profit institutions; Number of Respondents: 5327; Total Annual 
Responses: 63,924; Total Annual Hours: 197,542. (For policy questions 
regarding this collection contact Kristin Shifflett at 410-786-4133.)
    6. Type of Information Collection Request: Reinstatement with 
change of a previously approved collection; Title of Information 
Collection: Data Collection for Medicare Beneficiaries Receiving 
Implantable Cardioverter-Defibrillators for Primary Prevention of 
Sudden Cardiac Death; Use: We provide coverage for implantable 
cardioverter-defibrillators (ICDs) for secondary prevention of sudden 
cardiac death based on extensive evidence showing that use of ICDs 
among patients with a certain set of physiologic conditions are 
effective. Accordingly, we consider coverage for ICDs reasonable and 
necessary under Section 1862 (a) (1) (A) of the Social Security Act. 
However, evidence for use of ICDs for primary prevention of sudden 
cardiac death is less compelling for certain patients.
    To encourage responsible and appropriate use of ICDs, we issued a 
``Decision Memo for Implantable Defibrillators'' on January 27, 2005, 
indicating that ICDs will be covered for primary prevention of sudden 
cardiac death if the beneficiary is enrolled in either an FDA-approved 
category B IDE clinical trial (42 CFR 405.201), a trial under the CMS 
Clinical Trial Policy (NCD Manual Sec.  310.1) or a qualifying 
prospective data collection system (either a practical clinical trial 
or prospective systematic data collection, which is sometimes referred 
to as a registry). Form Number: CMS-10151 (OMB: 0938-0967); 
Frequency: Occasionally; Affected Public: Private

[[Page 44571]]

Sector; Business or other for-profits, Not-for-profit institutions; 
Number of Respondents: 1,702; Total Annual Responses: 82; Total Annual 
Hours: 139,356. (For policy questions regarding this collection contact 
JoAnna Baldwin at 410-786-7205.)
    7. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Reporting 
Requirements for Grants to Support States in Health Insurance Rate 
Review and Pricing Transparency--Cycles I, II, and III; Use: Under the 
Section 1003 of the Affordable Care Act (ACA) (Section 2794 of the 
Public Health Service Act), the Secretary, in conjunction with the 
states and territories, is required to establish a process for the 
annual review, beginning with the 2010 plan year, of unreasonable 
increases in premiums for health insurance coverage. Section 2794(c) 
requires the Secretary to establish the Rate Review Grant Program to 
States to assist states to implement this provision. In addition, 
Section 2794(c) requires the Rate Review Grant Program to assist states 
in the establishment and enhancement of ``Data Centers'' that collect, 
analyze, and disseminate health care pricing data to the public.
    The U.S. Department of Health and Human Services (HHS) released the 
Rate Review Grants Cycle I funding opportunity twice--first to states 
(and the District of Columbia) in June 2010 and then to the territories 
and the five states that did not apply during the first release, 
(http://www.hhs.gov/ociio/initiative/final_premium_review_grant_solicitation.pdf). The second release was due to the decision that the 
territories were subject to provisions of the ACA and hence eligible 
for the Rate Review Grants. Forty-five (45) states, 5 U.S. territories, 
and the District of Columbia were awarded grants. On February 24, 2011, 
HHS released the Funding Opportunity Award (FOA) for Cycle II Rate 
Review Grants. On December 21, 2012, Cycle II of the Rate Review Grant 
Program was amended in order to include an additional application date. 
Thirty (30) states, the District of Columbia, and three territories 
were awarded grants in Cycle II.
    On May 8, 2013, CMS published the Cycle III Funding Opportunity 
Announcement, ``Grants to Support States in Health Insurance Rate 
Review and Pricing Transparency''. On July 12, 2013, the Funding 
Opportunity Announcement for Cycle III of the Rate Review Grants 
Program was amended in order to extend the deadline for submission of 
Letters of Intent. Concurrent with the publication of the Funding 
Opportunity Announcement for Cycle III, CMS published associated 
grantee reporting requirements consisting of: (4) quarterly reports, 
(5) rate review transaction data reports (quarterly and annual), (1) 
annual report, and (1) final report from all grantees. This information 
collection is required for effective monitoring of grantees and to 
fulfill statutory requirements under section 2794(b)(1)(A) of the ACA 
that requires grantees, as a condition of receiving a grant authorized 
under section 2794(c) of the ACA, to report to the Secretary 
information about premium increases. Form Number: CMS-10380 (OCN: 0938-
1121); Frequency: Annually; On Occasion; Affected Public: Public 
Sector--State and Territory Governments; Number of Respondents: 56; 
Total Annual Responses: 1,001; Total Annual Hours: 31,378; (For policy 
questions regarding this collection contact Sarah Norman at 301-492-
4185.)
    8. Type of Information Collection Request: Reinstatement with 
change of a previously approved information collection; Title of 
Information Collection: Notice of Research Exception under the Genetic 
Information Nondiscrimination Act; Use: Under the Genetic Information 
Nondiscrimination Act of 2008 (GINA), a plan or issuer may request (but 
not require) a genetic test in connection with certain research 
activities so long as such activities comply with specific 
requirements, including: (i) The research complies with 45 CFR part 46 
or equivalent Federal regulations and applicable State or local law or 
regulations for the protection of human subjects in research; (ii) the 
request for the participant or beneficiary (or in the case of a minor 
child, the legal guardian of such beneficiary) is made in writing and 
clearly indicates that compliance with the request is voluntary and 
that non-compliance will have no effect on eligibility for benefits or 
premium or contribution amounts; and (iii) no genetic information 
collected or acquired will be used for underwriting purposes. The 
Secretary of Labor or the Secretary of Health and Human Services is 
required to be notified if a group health plan or health insurance 
issuer intends to claim the research exception permitted under Title I 
of GINA. Nonfederal governmental group health plans and issuers solely 
in the individual health insurance market or Medigap market will be 
required to file with the Centers for Medicare & Medicaid Services 
(CMS). The Notice of Research Exception under the Genetic Information 
Nondiscrimination Act is a model notice that can be completed by group 
health plans and health insurance issuers and filed with either the 
Department of Labor or CMS to comply with the notification requirement. 
Form Number: CMS-10286 (OCN: 0938-1077); Frequency: On Occasion; 
Affected Public: State, Local, or Tribal Governments, Private Sector; 
Number of Respondents: 2; Total Annual Responses: 2; Total Annual 
Hours: 1; (For policy questions regarding this collection contact Usree 
Bandyopadhyay at 410-786-6650.)
    9. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Pre-Existing 
Health Insurance Plan and Supporting Regulations; Use: On March 23, 
2010, the President signed into law H.R. 3590, the Patient Protection 
and Affordable Care Act (Affordable Care Act), Public Law 111-148. 
Section 1101 of the law establishes a ``temporary high risk health 
insurance pool program'' (which has been named the Pre-Existing 
Condition Insurance Plan, or PCIP) to provide health insurance coverage 
to currently uninsured individuals with pre-existing conditions. The 
law authorizes HHS to carry out the program directly or through 
contracts with states or private, non-profit entities.
    We are requesting an extension of this package because this 
information is needed to assure that PCIP programs are established 
timely and effectively. This request is being made based on regulations 
and guidance that have been issued and contracts which have been 
executed by HHS with states or an entity on their behalf participating 
in the PCIP program. PCIP is also referred to as the temporary 
qualified high risk insurance pool program, as it is called in the 
Affordable Care Act, but we have adopted the term PCIP to better 
describe the program and avoid confusion with the existing state high 
risk pool programs. Form Number: CMS-10339 (OMB: 0938-1100); 
Frequency: Reporting--On occasion; Affected Public: state governments; 
Number of Respondents: 51; Total Annual Responses: 2,652; Total Annual 
Hours: 36,924. (For policy questions regarding this collection contact 
William Brice at 410-786-1777.)

    Dated: July 19, 2013.
Martique Jones,
Deputy Director, Regulations Development Group, Office of Strategic 
Operations and Regulatory Affairs.
[FR Doc. 2013-17821 Filed 7-23-13; 8:45 am]
BILLING CODE 4120-01-P
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