Agency Information Collection Activities: Proposed Collection; 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) 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 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.

1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Medicare Part D Reporting Requirements and Supporting Regulations; Use: Title I of 42 CFR, part 423, § 423.514, requires each Part D Sponsor to have an effective procedure to provide statistics indicating: the cost of its operations, the patterns of utilization of its services, the availability, accessibility, and acceptability of its services, information demonstrating it has a fiscally sound operation and other matters as required by CMS. In addition, subsection 423.505 of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA), establishes as a contract provision that Part D Sponsors must comply with the reporting requirements for submitting drug claims and related information to CMS. Data collected via Medicare Part D Reporting Requirements is an integral resource for oversight, monitoring, compliance and auditing activities necessary to ensure quality provision of the Medicare Prescription Drug Benefit to beneficiaries. The data collected will be validated, analyzed, and utilized for trend reporting.

The revisions for the CY2013 include the removal, addition or both of data elements for the Prompt Payment by Part D Sponsors, Grievances, Fraud, Waste, and Abuse Compliance Programs, and Plan Oversight of Agents reporting sections; however, these changes resulted in no changes to the burden for these sections. In addition, we added data elements and revised data elements for the Medication Therapy Management Programs and the Coverage Determinations and Exceptions reporting sections, which resulted in an increase in burden hours for both sections. Lastly, we removed the following reporting sections and decreased burden estimates associated with these sections because these data are no longer necessary for monitoring through these reporting requirements: Access to Extended Day Supplies at Retail Pharmacies; and Pharmacy Support of E-prescribing. Form Number: CMS-10185 (OCN: 0938-0992); Frequency: Yearly, Quarterly, Semi-Annually; Affected Public: Private Sector, business or other for-profit; Number of Respondents: 3,180; Total Annual Responses: 48,152; Total Annual Hours: 76,240. (For policy questions regarding this collection contact LaToyia Grant at 410-786-5434. For all other issues call 410-786-1326.)

2. Type of Information Collection Request: New collection (Request for a new OMB Control Number). Title of Information Collection: Surveys of Physicians and Home Health Agencies to Assess Access Issues for Specific Medicare Beneficiaries as Defined in Section 3131(d) of the ACA. Use: This collection is part of a study called for under section 3131(d) of the Patient Protection and Affordable Care Act (ACA). The study is focused on two major issues: (1) Supporting CMS' efforts to improve payment accuracy and (2) understanding issues of access for the ACA populations under the existing home health prospective payment system. The study team's analytic plan focuses on understanding payment accuracy for the specific study populations through claims and cost data analyses, which will reflect payments and costs for patients who have gained access to home health care. In order to understand access issues for the ACA defined populations, the study team proposes using survey instruments to better understand the characteristics of Medicare beneficiaries who are not able to gain access to or have experienced delays in gaining access to home health services.

As a new collection, the information collected is expected to support CMS' efforts to improve the home health prospective payment system payment accuracy for vulnerable populations and thereby ensure the payment system does not inadvertently cause avoidable access problems. The questions are designed to provide insights into access issues for vulnerable populations that cannot be learned through analyses of administrative data. Form Number: CMS-10429 (OCN: 0938-New); Frequency: Once. Affected Public: Private Sector (business or other for-profit and not-for-profit institutions). Number of Respondents: 875. Total Annual Responses: 292. Total Annual Hours: 73. (For policy questions regarding this collection contact Kristy Chu at 410-786-8953. 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 Email your request, including your address, phone number, OMB number, and CMS document identifier, to Paperwork@cms.hhs.gov, or call the Reports Clearance Office on (410) 786-1326.

In commenting on the proposed information collections please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in one of the following ways by June 18, 2012:

1. Electronically. You may submit your comments electronically to http://www.regulations.gov. Follow the instructions for “Comment or Submission” or “More Search Options” to find the information collection document(s) accepting comments.

2. By regular mail. You may mail written comments to the following address:

CMS, Office of Strategic Operations and Regulatory Affairs,

Division of Regulations Development,

Attention: Document Identifier/OMB Control Number___,

Room C4-26-05,

7500 Security Boulevard,

Baltimore, Maryland 21244-1850.