E9-26831. 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: Extension without change of a currently approved collection; Title of Information Collection: Creditable Coverage Disclosure to CMS On-Line Form and Instructions; Use: Most entities that currently provide prescription drug benefits to any Medicare Part D eligible individual must disclose to the CMS whether the prescription drug benefit that they offer is creditable. The disclosure is required to be provided annually and upon any change that affects whether the coverage is creditable prescription drug coverage. CMS released a Disclosure to CMS Guidance Paper and a disclosure to CMS notification on-line form in January 2006.

Section 1860D-1 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) and implementing regulations at 42 CFR 423.56 require that entities that offer prescription drug benefits under any of the types of coverage described in 42 CFR 423.56 (b) provide a disclosure of creditable coverage to CMS informing us whether such coverage meets the actuarial requirements specified in guidelines provided by CMS. Form Number: CMS-10198 (OMB#: 0938-1013); Frequency: Reporting—Yearly and Semi-annually; Affected Public: Federal Government, Business or other for-profits and not-for-profit institutions, and State, Local, or Tribal Governments; Number of Respondents: 87,500; Total Annual Responses: 87,500; Total Annual Hours: 7,291.7. (For policy questions regarding this collection contact Louis Blank at 410-786-5511. For all other issues call 410-786-1326.)

2. Type of Information Collection Request: New collection; Title of Information Collection: Electronic Health Records (EHR) Testing; Use: The Centers for Medicare and Medicaid Services (CMS) has indicated through statements in proposed and final rulemaking for the Reporting Hospital Quality Data for Annual Payment Update (RHQDAPU) program that it is actively seeking to pursue quality measurement based on alternative sources of data that do not require manual chart abstraction or that utilize data already being reported by many hospitals for other programs, as doing so would potentially reduce the burden associated with the collection and reporting of measures for the program. Over the years, we have encouraged hospitals to take steps toward the adoption of electronic health records (EHRs) that would allow for reporting of clinical quality data from the EHRs directly to a CMS data repository beginning with the FY 2006 Inpatient Prospective Payment System (IPPS) Rule (70 FR 47420 through 47421). We have also encouraged hospitals that are implementing, upgrading, or developing EHR systems to ensure that the technology obtained, upgraded, or developed conforms to standards adopted by the Department of Health and Human Services (HHS).

In the IPPS 2010 proposed rule (74 FR 24182), we described our intent to begin a voluntary testing program for the submission to CMS of standardized data elements needed to calculate inpatient hospital quality measures on the topics of Stroke, Venous Thromboembolism, and Emergency department throughput. These measures have not been adopted for Reporting Hospital Quality for Annual Payment Update (RHQDAPU) program, and participation in this voluntary EHR-testing program will not substitute for submission of data elements required under the RHQDAPU program in a time, form and manner specified by the Secretary. Similarly, non-participation in this voluntary program will not incur any penalties. The results of this voluntary testing process will enable CMS to assess the feasibility of collecting data elements via electronic health records as a future alternative to submission of manually chart abstracted data elements by hospitals, thereby potentially reducing the administrative burden associated with submission of quality measures for the RHQDAPU program. Form Number: CMS-10296 (OMB#: 0938-New); Frequency: Reporting—Once; Affected Public: Private Sector—Business or other for-profits and Not-for-profit institutions; Number of Respondents: 55; Total Annual Responses: 55; Total Annual Hours: 28,655. (For policy questions regarding this collection contact Shaheen Halim 410-786-0641. 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 December 7, 2009.

OMB, Office of Information and Regulatory Affairs,

Attention: CMS Desk Officer.

Fax Number: [phone].

E-mail: [e-mail].

Dated: October 30, 2009.

Michelle Shortt,

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