[Federal Register Volume 79, Number 172 (Friday, September 5, 2014)]
[Notices]
[Pages 53067-53069]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-21179]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10123 and -10124, CMS-10147, CMS-10252, CMS-
10340, CMS-R-235, CMS-R-268 and CMS-10519]


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

[[Page 53068]]

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 October 6, 2014.

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 a currently 
approved collection; Title of Information Collection: Fast Track 
Appeals Notices: NOMNC/DENC; Use: Providers shall deliver a Notice of 
Medicare (Provider) Non-Coverage (NOMNC) to beneficiaries, enrollees, 
or both beneficiaries and enrollees no later than two days prior to the 
end of Medicare-covered services in skilled nursing facilities, home 
health agencies, comprehensive outpatient rehabilitation facilities, 
and hospices. Beneficiaries, enrollees or both beneficiaries and 
enrollees will use this information to determine whether they want to 
appeal the service termination to their Quality Improvement 
Organization (QIO). If the beneficiaries, enrollees or both 
beneficiaries decide to appeal, the Medicare provider or health plan 
will send the QIO and appellant a Detailed Explanation of Non-Coverage 
(DENC) detailing the rationale for the termination decision. Form 
Number: CMS-10123 and -10124 (OMB control number: 0938-0953); 
Frequency: Occasionally; Affected Public: Private sector--Business or 
other for-profits and Not-for-profit institutions; Number of 
Respondents: 24,915; Total Annual Responses: 5,347,980; Total Annual 
Hours: 927,901. (For policy questions regarding this collection contact 
Janet Miller at 404-562-1799).
    2. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Medicare 
Prescription Drug Coverage and Your Rights; Use: Through the delivery 
of this standardized notice, Part D plan sponsors' network pharmacies 
are in the best position to inform enrollees (at the point of sale) 
about how to contact their Part D plan if their prescription cannot be 
filled and how to request an exception to the Part D plan's formulary. 
The notice restates certain rights and protections related to the 
enrollees Medicare prescription drug benefits, including the right to 
receive a written explanation from the drug plan about why a 
prescription drug is not covered. Form Number: CMS-10147 (OMB control 
number: 0938-0975); Frequency: Occasionally; Affected Public: Private 
sector--Business or other for-profits; Number of Respondents: 56,000; 
Total Annual Responses: 37,620,000; Total Annual Hours: 626,749. (For 
policy questions regarding this collection contact Kathryn M. Smith at 
410-786-7623).
    3. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Data Use 
Agreement (DUA) Certificate of Disposition (COD) for Data Acquired from 
the Centers for Medicare & Medicaid Services; Use: The Data Use 
Agreement (DUA) Certificate of Disposition (COD) is required to close 
out the release of the data under the DUA and to ensure the data are 
destroyed and not used for another purpose without written 
authorization from CMS. The Health Insurance Portability and 
Accountability Act (HIPAA) of 1996, Sec.  1173(d) (Security Standards 
for Health Information) requires CMS to protect Personally Identifiable 
Information (PII). Additionally, the Federal Information Security 
Management Act (FISMA) of 2002, Sec.  3544(b) (Federal Agency 
Responsibilities--Agency Program) also requires CMS to develop policies 
and procedures for the protection and destruction of sensitive data to 
include PII. Form Number: CMS-10252 (OMB control number: 0938-1046); 
Frequency: Biennial; Affected Public: Private Sector--Business or other 
for-profits, Not-for-profit institutions; Number of Respondents: 500; 
Total Annual Responses: 1000; Total Annual Hours: 84. (For policy 
questions regarding this collection contact Sharon Kavanagh at 410-786-
5441.)
    4. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Collection of 
Encounter Data from Medicare Advantage Organizations, Section 1876 Cost 
HMOS/CMPS, Section 1833 Health Care Prepayment Plans (HCPPS), and Pace 
Organizations; Use: We collect encounter data or data on each item or 
service delivered to enrollees of Medicare Advantage (MA) plans offered 
by MA organizations. MA organizations currently obtain this data from 
providers. We collect this information using standard transaction forms 
and code sets. We will use the data for determining risk adjustment 
factors for payment, updating the risk adjustment model, calculating 
Medicare DSH percentages, Medicare coverage purposes, and quality 
review and improvement activities. The data is also used to verify the 
accuracy and validity of the costs claimed on cost reports. For PACE 
organizations, encounter data would serve the same purpose it does 
related to the MA program and would be submitted in a similar manner. 
The information collection request has been

[[Page 53069]]

revised subsequent to the publication of the 60-day Federal Register 
notice (June 2, 2014; 79 FR 31336). Form Number: CMS-10340 (OMB control 
number: 0938-1152); Frequency: Weekly; Affected Public: Private 
sector--Business or other for-profits; Number of Respondents: 683; 
Total Annual Responses: 516,493,635; Total Annual Hours: 34,433 (For 
policy questions regarding this collection contact Michael Massimini at 
410-786-1566).
    5. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Data Use 
Agreement (DUA) Certificate of Disposition for Data Acquired from the 
Centers for Medicare & Medicaid Services (CMS); Use: The Privacy Act of 
1974 allows for discretionary releases of data maintained in Privacy 
Act protected systems of records under Sec.  552a(b) (Conditions of 
Disclosure). The mandate to account for disclosures of data under the 
Privacy Act is found at Sec.  552a(c) (Accounting of Certain 
Disclosures). This section states that certain information must be 
maintained regarding disclosures made by each agency. This information 
is: Date, Nature, Purpose, and Name and Address of Recipient. Section 
552a(e) sets the overall Agency Requirements that each agency must meet 
in order to maintain records under the Privacy Act. The Data Use 
Agreement (DUA) form is needed as part of the review of each CMS data 
request to ensure compliance with the requirements of the Privacy Act 
for disclosures that contain PII. The DUA form also provides data 
requestors and custodians with a formal means to agree to the data 
protection and destruction statutory and regulatory requirements of 
CMS' PII data. The Health Insurance Portability and Accountability Act 
(HIPAA) of 1996, Sec.  1173(d) (Security Standards for Health 
Information) requires CMS to protect Personally Identifiable 
Information (PII). Additionally, the Federal Information Security 
Management Act (FISMA) of 2002, Sec.  3544(b) (Federal Agency 
Responsibilities--Agency Program) also requires CMS to develop policies 
and procedures for the protection and destruction of sensitive data to 
include PII. The information collected by the DUA form is used by CMS 
to track disclosures, conditions for disclosure, accounting of 
disclosures and agency requirements dictated by the Privacy Act, HIPAA 
and FISMA. Form Number: CMS-R-235 (OMB control number: 0938-0734); 
Frequency: Annually; Affected Public: Private Sector--Business or other 
for-profits and Not-for-profit institutions; Number of Respondents: 
9220; Total Annual Responses: 9220; Total Annual Hours: 2740. (For 
policy questions regarding this collection contact Sharon Kavanagh at 
410-786-5441.)
    6. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Survey Tool for 
www.medicare.gov and www.cms.hhs.gov; Use: The Balanced Budget Act of 
1997 states that the Secretary of Health and Human Services shall 
maintain a Web site to provide information about CMS activities, 
programs and topics related to its services. The submission is for OMB 
authorization to collect data on the reactions of users of the Web 
sites through the survey tool. We will use the data to improve the Web 
sites so that they can best serve the needs of their users. Information 
collected from the survey will be used to make improvements to the 
sites to make them more user-friendly. Form Number: CMS-R-268 (OMB 
control number: 0938-0756); Frequency: Annual; Affected Public: 
Individuals or households; Number of Respondents: 7,000; Total Annual 
Responses: 4,900; Total Annual Hours: 817. (For policy questions 
regarding this collection contact Kymeiria Ingram at 410-786-8431.)
    7. Type of Information Collection Request: New collection (Request 
for a new OMB control number); Title of Information Collection: 
Physician Quality Reporting System (PQRS) and the Electronic 
Prescribing Incentive (eRx) Program Data Assessment, Accuracy and 
Improper Payments Identification Support; Use: The incentive and 
reporting programs have data integrity issues, such as rejected and 
improper payments. This four year project will evaluate incentive 
payment information for accuracy and identify improper payments, with 
the goal of recovering these payments. Additionally, based on the 
project's results, recommendations will be made so that we can avoid 
future data integrity issues.
    Data submission, processing, and reporting will be analyzed for 
potential errors, inconsistencies, and gaps that are related to data 
handling, program requirements, and clinical quality measure 
specifications of PQRS and eRx program. Surveys of Group Practices, 
Registries, and Data Submission Vendors (DSVs) will be conducted in 
order to evaluate the PQRS and eRx Incentive Program. Follow-up 
interviews will occur with a small number of respondents. Form Number: 
CMS-10519 (OMB control number: 0938-NEW); Frequency: Annually; Affected 
Public: Business or other for-profits; Number of Respondents: 115; 
Total Annual Responses: 115; Total Annual Hours: 201. (For policy 
questions regarding this collection contact Sungsoo Oh at 410-786-
7611.)

    Dated: September 2, 2014.
Martique Jones,
Director, Regulations Development Group, Office of Strategic Operations 
and Regulatory Affairs.
[FR Doc. 2014-21179 Filed 9-4-14; 8:45 am]
BILLING CODE 4120-01-P