2013-19379. 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 September 9, 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: [phone] or, Email: [e-mail] .

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 [e-mail].

3. Call the Reports Clearance Office at [phone].

FOR FURTHER INFORMATION CONTACT:

Reports Clearance Office at [phone].

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 without change of a currently approved collection; Title of Information Collection: Medicaid Drug Program Monthly and Quarterly Drug Reporting Format; Use: Labelers transmit drug data to us within 30 days after the end of each calendar month and quarter. We calculate the unit rebate amount (URA) for each National Drug Code and distributes to all state Medicaid agencies. States use the URA to invoice the labeler for rebates. The monthly data is used to calculate Federal Upper Limit prices for applicable drugs and for states that opt to use this data to establish their pharmacy reimbursement methodology. Form Number: CMS-367 (OCN: 0938-0578); Frequency: Monthly and quarterly; Affected Public: Private sector—Business or other for-profits; Number of Respondents: 590; Total Annual Responses: 9,440; Total Annual Hours: 139,712. (For policy questions regarding this collection contact Cindy Bergin at 410-786-1176.)

2. Type of Information Collection Request: Reinstatement with a change of a previously approved collection; Title of Information Collection: Mandatory Insurer Reporting Requirements of Section 111 of the Medicare, Medicaid and SCHIP Act of 2007; Use: The purpose of this submission is to renew the information collection request (ICR) and the information collected in accordance with to Section 111 of the Medicare, Medicaid and SCHIP Act of 2007 (MMSEA). The information is collected from applicable reporting entities for the purpose of coordination of benefits. Section 111 mandates the reporting of information in the form and manner specified by the Secretary, DHHS. Data the Secretary collects is necessary for both pre-payment and post-payment coordination of benefit purposes, including necessary recovery actions.

Section 111 establishes separate mandatory reporting requirements for GHP arrangements as well as for liability insurance (including self-insurance), no-fault insurance, and workers' compensation; for purposes of this ICR these may be collectively be referred to as “non-GHP.” Both GHP and non-GHP entities have had and continue to have the responsibility for determining when they are primary to Medicare and to pay appropriately, even without the mandatory Section 111 process. In order to make this determination, they should already and always be collecting most of the information CMS will require in connection with Section 111 of the MMSEA. Form Number: CMS-10265 (OCN: 0938-1074); Frequency: Yearly; Affected Public: Private sector—Business or other for-profits, Not-for-profit institutions and State, Local or Tribal Governments; Number of Respondents: 22,647; Total Annual Responses: 22,647; Total Annual Hours: 333,130. (For policy questions regarding this collection contact Cynthia Ginsburg at 410-786-2579.)

3. Type of Information Collection Request: Reinstatement with change of a previously approved collection; Title of Information Collection: Ambulatory Surgical Center Conditions for Coverage; Use: The Ambulatory Surgical Center (ASC) Conditions for Coverage (CfCs) focus on a patient-centered, outcome-oriented, and transparent processes that promote quality patient care. The CfCs are designed to ensure that each facility has properly trained staff to provide the appropriate type and level of care for that facility and provide a safe physical environment for patients. The CfCs are used by Federal or state surveyors as a basis for determining whether an ASC qualifies for approval or re-approval under Medicare. We, along with the healthcare industry, believe that the availability to the facility of the type of records and general content of records, which this regulation specifies, is standard medical practice and is necessary in order to ensure the well-being and safety of patients and professional treatment accountability. Form Number: CMS-10279 (OCN: 0938-1071); Frequency: Annual; Affected Public: Private sector—Business or other for-profit and not-for-profit institutions; Number of Respondents: 5,300; Total Annual Responses: 5,300; Total Annual Hours: 206,700. (For policy questions regarding this collection contact Jacqueline Leach at 410-786-4282.)

4. Type of Information Collection Request: New Collection (Request for a new control number); Title of Information Collection: Evaluation of the Multi-Payer Advanced Primary Care Practice (MAPCP) Demonstration: Conduct Beneficiary Experience with Care Surveys; Use: On September 16, 2009, the Department of Health and Human Services announced the establishment of the Multi-payer Advanced Primary Care Practice (MAPCP) Demonstration, under which Medicare joined Medicaid and private insurers as a payer participant in state-sponsored patient-centered medical home (PCMH) initiatives. We selected eight states to participate in this demonstration: Maine, Vermont, Rhode Island, New York, Pennsylvania, North Carolina, Michigan, and Minnesota. We are conducting a survey to assess the care experiences of beneficiaries involved in the MAPCP Demonstration. We have chosen to measure patient experience using a validated, standardized survey questionnaire, the PCMH version of the Consumer Assessment of Healthcare Providers and Systems (PCMH-CAHPS). The PCMH-CAHPS is a validated, federally developed instrument that measures patient experience in 6 domains (access to care, provider communication, office staff interactions, attention to medical, emotional, or both medical and emotional health, health care support, and medication decisions). Form Number: CMS-10483 (OCN: 0938-NEW); Frequency: Annually; Affected Public: Individuals and households; Number of Respondents: 10,038; Total Annual Responses: 10,038; Total Annual Hours: 3,313. (For policy questions regarding this collection contact Suzanne Wensky at 410-786-0226.)

Dated: August 6, 2013.

Martique Jones,

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