2011-17052. 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; N umber 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, § 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 [phone]. For all other issues call [phone].)

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, § 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; 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 [phone].)

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 [e-mail], or call the Reports Clearance Office on [phone].

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: [phone], E-mail: [e-mail].

Dated: July 1, 2011.

Michelle Shortt,

Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs.