E6-20678. 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: New collection; Title of Information Collection: Collection of Physician Administered Drug National Drug Code (NDC) Numbers on State Medicaid Claims and Supporting Regulations at 42 CFR 447.520. Use: Section 6002 of the Deficit Reduction Act of 2005 (DRA) added provisions under Section 1927 of the Social Security Act to require physicians in their offices and hospital outpatient settings or other entities (e.g., non-profit facilities) to collect and submit the drug NDC numbers on Medicaid claims to their State within specified timeframes. We estimate that there are 20,000 physician offices, hospital outpatient settings or other entities concentrating in the specialties of oncology, rheumatology and urology that will be required by their State Medicaid Programs to collect and submit “J” drug code data match with NDC numbers. Form Number: CMS-10215 (OMB#: 0938-NEW); Frequency: Reporting—weekly; Affected Public: Business or other for-profit and not-for-profit institutions; Number of Respondents: 20,000; Total Annual Responses: 3,910,000; Total Annual Hours: 15,836.

2. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: HIPAA Administrative Simplification Enforcement Non-Privacy Enforcement; Use: The Health Insurance Portability and Accountability Act (HIPAA) became law in 1996 (Pub. L. 104-191). Subtitle F of Title II of HIPAA, entitled “Administrative Simplification,” requires the Secretary of HHS to adopt national standards for certain information-related activities of the health care industry. The HIPAA provisions, by statute, apply only to “covered entities” referred to in section 1320d-2(a)(1) of this title. Responsibility for administering and enforcing the HIPAA Administrative Simplification Transactions, Code Sets, Identifiers and Security rules has been delegated to CMS. The initial information collected to enforce these rules will be used to initiate enforcement actions. This information collection change clarifies the “Identify the HIPAA Non-Privacy complaint category” section of the complaint form. In this section, complainants are given an opportunity to check the “Unique Identifiers” option to categorize the type of HIPAA complaint being filed. The revised form now includes a “For a Unique Identifier Complaint” section, that allows a complaint to further categorize their identifier complaint as either a “National Provider Identifier (NPI)” or an “Employer Identification Number (EIN)” complaint. Form Number: CMS-10148 (OMB#: 0938-948); Frequency: Reporting—On occasion; Affected Public: Individuals or Households, Business or other for-profit, Not-for-profit institutions, and State, Local, or Tribal governments; Number of Respondents: 500; Total Annual Responses: 500; Total Annual Hours: 500.

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 at the address below, no later than 5 p.m. on February 6, 2007.

CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development—A, Attention: Melissa Musotto, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.

Dated: November 30, 2006.

Michelle Shortt,

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