[Federal Register Volume 76, Number 131 (Friday, July 8, 2011)]
[Notices]
[Pages 40369-40370]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-17052]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10388, CMS-10252, CMS-R-235, CMS-304 and CMS-
304a, CMS-368 and CMS-R-144, CMS-10123 and CMS-10124]


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

AGENCY: Centers for Medicare & Medicaid Services, HHS.

    In compliance with the requirement of section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid 
Services (CMS), Department of Health and Human Services, is publishing 
the following summary of proposed collections for public comment. 
Interested persons are invited to send comments regarding this 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 function; (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.
    1. Type of Information Collection Request: New collection; Title of 
Information Collection: Section 1115 Demonstration HIV and AIDS 
Application Template; Use: Section 1115 of the Social Security Act (the 
Act) allows the Secretary of the Department of Health and Human 
Services (the Secretary) to waive selected provisions of section 1902 
of the Act for experimental, pilot, or demonstration projects 
(demonstrations), and to provide Federal Financial Participation (FFP) 
for demonstration costs which would not otherwise be considered as 
expenditures under the Medicaid State plan, when the Secretary finds 
that the demonstrations are likely to assist in promoting the 
objectives of Medicaid. While some States have applied for section 1115 
demonstrations, many have not because the process is long and often 
tenuous. The purpose of the application template is to streamline the 
process by collecting the minimally acceptable amount of information 
required to appropriately review a demonstration request. The template 
will minimize the amount of time the State spends preparing a 
demonstration request and it should shorten the review process because 
the required information should be present. Form Number: CMS-10388 
(OMB: 0938-NEW); Frequency: Once; Affected Public: State, 
Local, or Tribal Governments; Number of Respondents: 56; Total Annual 
Responses: 6; Total Annual Hours: 270; (For policy questions regarding 
this collection contact Robin Preston at 410-786-3420. For all other 
issues call 410-786-1326.)
    2. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Certificate of 
Destruction for Data Acquired from the Centers for Medicare and 
Medicaid Services; Use: The Certificate of Destruction is used by 
recipients of CMS data to certify that they have destroyed the data 
they have received through a CMS Data Use Agreement (DUA). The DUA 
requires the destruction of the data at the completion of the project/
expiration of the DUA. The DUA addresses the conditions under which CMS 
will disclose and the User will maintain CMS data that are protected by 
the Privacy Act of 1974, Sec.  552a and the Health Insurance 
Portability Accountability Act of 1996. CMS has developed policies and 
procedures for such disclosures that are based on the Privacy Act and 
the Health Insurance Portability Act (HIPAA). The Certificate of 
Destruction is required to close out the DUA and to ensure the data are 
destroyed and not used for another purpose. Form Number: CMS-10252 
(OMB: 0938-1046); Frequency: On occasion; Affected Public: 
Business or other for-profit; Number of Respondents: 500; Total Annual 
Responses: 500; Total Annual Hours: 84. (For policy questions regarding 
this collection, contact Sharon Kavanagh at (410) 786-5441. For all 
other issues call (410) 786-1326.)
    3. Type of Information Collection Request: Reinstatement of a 
previously approved collection; Title of Information Collection: Data 
Use Agreement (DUA) for Data Acquired from the Centers for Medicare & 
Medicaid Services (CMS); Use: The Privacy Act of 1976, Sec.  552a 
requires the Centers for Medicare & Medicaid Services (CMS) to track 
all disclosures of the agency's Personally Identifiable Information 
(PII) and the exceptions for these data releases. CMS is also required 
by the Health Insurance Portability and Accountability Act (HIPAA) of 
1996 and the Federal Information Security Management Act (FISMA) of 
2002 to properly protect all PII data maintained by the agency. When 
entities request CMS PII data, they enter into a Data Use Agreement 
(DUA) with CMS. The DUA stipulates that the recipient of CMS PII data 
must properly protect the data according to FISMA and also provide for 
its appropriate destruction at the completion of the project/study or 
the expiration date of the DUA. The DUA form enables the data recipient 
and CMS to document the request and approval for release of CMS PII 
data. The form requires the submitter to provide the Requestor's 
organization; project/study name; CMS contract number (if applicable); 
data descriptions and the years of the data; retention date; 
attachments to the agreement; name, title, contact information to 
include address, city, state, zip code, phone, e-mail, signature and 
date signed by the requester and custodian; disclosure provision; name 
of Federal Agency sponsor; Federal Representative name, title, contact 
information, signature, date; CMS representative name, title, contact 
information, signature and date;

[[Page 40370]]

and concurrence/non-concurrence signatures and dates from 3 CMS System 
Manager or Business Owners. While the data elements collected are not 
subject to change, the individualized clauses that are incorporated 
into any specific DUA are subject to change based on a specific case or 
situation such as disclosures to states, oversight agencies or DUAs for 
disproportionate share hospital (DSH) data requests as well as updates 
to DUAs with additional data descriptions, changes to the requestor or 
adding custodians to current DUAs. Form Number: CMS-R-235 (OCN: 0938-
0734) Frequency: Once; Affected Public: Private Sector--Business or 
other For-profits and Not-for-profit Institutions; Number of 
Respondents: 2,200; Number of Responses: 2,200; Total Annual Hours: 
916. (For policy questions regarding this collection, contact Sharon 
Kavanagh at 410-786-5441. For all other issues call (410) 786-1326.)
    4. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Medicaid Drug 
Rebate Program--Labelers Reconciliation of State Invoice (CMS-304) and 
Prior Quarter Adjustment Statement (CMS-304a); Use: Section 1927(b)(2) 
of the Social Security Act establishes manufacturer requirements for 
paying quarterly rebates to States as part of the Medicaid Drug Rebate 
Program. Specifically, in order to receive a rebate on drugs dispensed 
to Medicaid recipients, States are required to submit quarterly 
utilization data to drug manufacturers that have national rebate 
agreements with the Federal Government. Form CMS-304 is used by 
manufacturers for both unit adjustments and disputes in response to the 
State's invoice for current quarter utilization. The form CMS-304a is 
required only in those instances where a manufacturer discovers unit 
adjustments and/or disputes from a previous quarter's State invoice. 
Both forms are used to reconcile drug rebate payments made by 
manufacturer with the State invoices of rebates due; Form Numbers: CMS-
304 and CMS-304a (OMB: 0938-0676); Frequency: Quarterly; 
Affected Public: Private Sector: Business or other for-profits; Number 
of Respondents: 1,011; Total Annual Responses: 4,044; Total Annual 
Hours: 183,120. (For policy questions regarding this collection contact 
Andrea Wellington at 410-786-3490. For all other issues call 410-786-
1326.)
    5. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: State Medicaid 
Drug Rebate Forms: CMS-368 (Administrative Data) and CMS-R-144 
(Quarterly Report Data); Use: Section 1927(b)(2) of the Social Security 
Act establishes State requirements for reporting drug utilization data 
to CMS and to drug manufacturers participating in the Medicaid Drug 
Rebate Program. Specifically, in order to receive a rebate on drugs 
dispensed to Medicaid recipients, States are required to submit 
quarterly utilization data reports to drug manufacturers that have 
national rebate agreements with the Federal Government. In addition, a 
copy of these reports must also be submitted to CMS. Form CMS-R-144 is 
used by the States to submit this utilization information to both 
manufacturers and CMS. Form CMS-368 is a report of contact for the 
State to name the individuals involved in the drug rebate program and 
is required only in those instances where a change to the original data 
submittal is necessary. The ability to require the reporting of any 
changes to these data is necessary to the efficient operation of the 
rebate program; Form Numbers: CMS-R-144 and CMS-368 (OMB: 
0938-0852); Frequency: Quarterly; Affected Public: State, Local or 
Tribal Governments; Number of Respondents: 56; Total Annual Responses: 
224; Total Annual Hours: 12,101. (For policy questions regarding this 
collection contact Andrea Wellington at 410-786-3490. For all other 
issues call 410-786-1326.)
    6. Type of Information Collection Request: Extension of a currently 
approved collection;
    7. Title of Information Collection: Notice of Provider Non-Coverage 
(CMS-10123) and Detailed Explanation of Non-Coverage (CMS-10124); Use: 
The Notice of Medicare Provider Non-Coverage (CMS-10123) is used to 
inform fee-for-service Medicare beneficiaries of the determination that 
their provider services will end, and of their right to an expedited 
review of that determination. The Detailed Explanation of Non-Coverage 
(CMS-10124) is used to provide beneficiaries who request an expedited 
determination with detailed information of why the services should end. 
The revised Notice of Provider Non-Coverage and Detailed Explanation of 
Provider Non-Coverage will no longer require use of the beneficiary's 
Medicare number as a patient identifier. Instead, when applicable, 
providers may use a number that helps to link the notice with a related 
claim. Form Number: CMS-10123 and 10124 (OMB: 0938-0953); 
Frequency: Occasionally; Affected Public: Business or other for-profit, 
Not-for-profit institutions, and Individuals or households; Number of 
Respondents: 5,314,164; Total Annual Responses: 5,314,194; Total Annual 
Hours: 885,699. (For policy questions regarding this collection contact 
Janet Miller at 404-562-1799. For all other issues call 410-786-1326.)
    To obtain copies of the supporting statement and any related forms 
for the proposed paperwork collections referenced above, access CMS Web 
Site address at http://www.cms.hhs.gov/PaperworkReductionActof1995, or 
E-mail your request, including your address, phone number, OMB number, 
and CMS document identifier, to [email protected], or call the 
Reports Clearance Office on (410) 786-1326.
    To be assured consideration, comments and recommendations for the 
proposed information collections must be received by the OMB desk 
officer at the address below, no later than 5 p.m. on August 8, 2011.

    OMB, Office of Information and Regulatory Affairs, Attention: CMS 
Desk Officer, Fax Number: (202) 395-6974, E-mail: [email protected].

    Dated: July 1, 2011.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations 
and Regulatory Affairs.
[FR Doc. 2011-17052 Filed 7-7-11; 8:45 am]
BILLING CODE 4120-01-P