E9-20839. Agency Information Collection Activities: Submission for OMB Review; Comment Request

AGENCY:

Centers for Medicare & Medicaid Services.

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: Revision of a currently approved collection; Title of Information Collection: Publication Usage Survey; Use: The Publication Usage survey was developed to gather information from people who request or access Medicare publications, to ensure comprehension, usability, and use of the publications. CMS is seeking understanding about whether publications have been effective in informing members of the Medicare audience regarding policy and benefits. Included in the survey are questions regarding the satisfaction of publication users with specific publications and whether the information they received informed them about the Medicare program. Information gathered in this survey will be used only for purposes of targeting and improving communications with Medicare beneficiaries, caregivers, partners, and community organizations. Form Number: CMS-10080 (OMB#: 0938-0892); Frequency: Reporting—On occasion; Affected Public: Individuals or Households; Number of Respondents: 3,800; Total Annual Responses: 3,800; Total Annual Hours: 950. (For policy questions regarding this collection contact Renee Clarke at 410-786-0006. For all other issues call 410-786-1326.)

2. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Information Collection Requirements in HSQ-110, Acquisition, Protection and Disclosure of Peer review Organization Information and Supporting Regulations in 42 CFR, Sections 480.104, 480.105, 480.116, and 480.134; Use: The Peer Review Improvement Act of 1982 authorizes quality improvement organizations (QIOs), formally known as peer review organizations (PROs), to acquire information necessary to fulfill their duties and functions and places limits on disclosure of the information. The QIOs are required to provide notices to the affected parties when disclosing information about them. These requirements serve to protect the rights of the affected parties. The information provided in these notices is used by the patients, practitioners and providers to: obtain access to the data maintained and collected on them by the QIOs; add additional data or make changes to existing QIO data; and reflect in the QIO's record the reasons for the QIO's disagreeing with an individual's or provider's request for amendment.: Form Number: CMS-R-70 (OMB#: 0938-0426); Frequency: Reporting—On occasion; Affected Public: Business or other for-profits; Number of Respondents: 362; Total Annual Responses: 3729; Total Annual Hours: 60,919. (For policy questions regarding this collection contact Tom Kessler at 410-786-1991. For all other issues call 410-786-1326.)

3. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Conditions of Certification for Rural Health Clinics and Supporting Regulations in 42 CFR 491.9, 491.10, 491.11; Use: The Rural Health Clinic (RHC) conditions of certification are based on criteria prescribed in law and are designed to ensure that each facility has a properly trained staff to provide appropriate care and to assure a safe physical environment for patients. The Centers for Medicare and Medicaid Services (CMS) uses these conditions of participation to certify RHCs wishing to participate in the Medicare program. These requirements are similar in intent to standards developed by industry organizations such as the Joint Commission on Accreditation of Hospitals, and the National League of Nursing/American Public Association and merely reflect accepted standards of management and care to which rural health clinics must adhere. Form Number: CMS-R-38 (OMB#: 0938-0334); Frequency: Recordkeeping and Reporting—Annually and upon initial application for Medicare approval; Affected Public: Business or other for-profits; Number of Respondents: 3,937; Total Annual Responses: 3,937; Total Annual Hours: 18,932. (For policy questions regarding this collection contact Mary Collins at 410-786-3189. For all other issues call 410-786-1326.)

4. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Durable Medical Equipment Medicare Administrative Contractors (MAC), Certificates of Medical Necessity; Use: The certificate of medical necessity (CMN) collects information required to help determine the medical necessity of certain items. CMS requires CMNs where there may be a vulnerability to the Medicare program. Each initial claim for these items must have an associated CMN for the beneficiary. Suppliers (those who bill for the items) complete the administrative information (e.g., patient's name and address, items ordered, etc.) on each CMN. The 1994 Amendments to the Social Security Act require that the supplier also provide a narrative description of the items ordered and all related accessories, their charge for each of these items, and the Medicare fee schedule allowance (where applicable). The supplier then sends the CMN to the treating physician or other clinicians (e.g., physician assistant, LPN, etc.) who completes questions pertaining to the beneficiary's medical condition and signs the CMN. The physician or other clinician returns the CMN to the supplier who has the option to maintain a copy and then submits the CMN (paper or electronic) to CMS, along with a claim for reimbursement.

Due to a technical oversight on the part of CMS, an important question on CMN Form 10269 was omitted from the last OMB submission that would allow claims with an apnea-hypopnea index (AHI) or respiratory disturbance index (RDI) greater than or equal to 5 without symptoms for Criterion 2 be paid for by the Medicare program. The omission of the following question “Does the patient have documented evidence of at least one of the following: Excessive daytime sleepiness, impaired cognition, mood disorders, insomnia, hypertension, ischemic heart disease or history of stroke” could cause improper payment of claims without regards as to whether the patient has signs or symptoms in support of meeting the applicable coverage criteria for PAP devices. We are resubmitting this information collection request to have the revised CMN Form 10269 approved. None of the other CMN forms have changed. Form Number: CMS-846-849, 854, 10125, 10126, 10269 (OMB# 0938-0679); Frequency: Occasionally; Affected Public: Business or other for-profit and Not-for-profit institutions; Number of Respondents: 59,200; Total Annual Responses: 6,480,000; Total Annual Hours: 1,296,000. (For policy questions regarding this collection contact Doris Jackson at 410-786-4459. 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 September 28, 2009.

OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: [phone], e-mail: [e-mail].

Dated: August 21, 2009.

Michelle Shortt,

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