Department of Health and Human Services April 29, 2013 – Federal Register Recent Federal Regulation Documents

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, to provide the opportunity for public comment on proposed data collection projects, the Office of Extramural Research (OER) of the National Institutes of Health (NIH) is developing an electronic application form for the submission of requests to NIH for Certificates of Confidentiality (CoCs). Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Dr. Ann M. Hardy, NIH Extramural Human Research Protections Officer and Coordinator, Certificates of Confidentiality, Office of Extramural Programs, OER, NIH, 3701 Rockledge Drive, Room 3002, Bethesda, MD 20892; or call the non-toll-free number (301) 435-2690; or email your request, including your address, to hardyan@od.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: Certificate of Confidentiality Electronic Application System 0925-New, Office of Extramural Research (OER), National Institutes of Health (NIH). Need and Use of Information Collection: This application system will provide one electronic form to be used by all research organizations that wish to request a Certificate of Confidentiality (CoC) from NIH. As described in the authorizing legislation (Section 301(d) of the Public Health Service Act, 42 U.S.C. 241(d)), CoCs are issued by the agencies of the Department of Health and Human Services (HHS), including NIH, to authorize researchers conducting sensitive research to protect the privacy of human research subjects by enabling them to refuse to release names and identifying characteristics of subjects to anyone not connected with the research. At the NIH, the issuance of CoCs has been delegated to the individual NIH Institutes and Centers (ICs). The NIH ICs collectively issue approximately 1,000 new CoCs each year for eligible research projects. However, the process for submitting a CoC request is not consistent across the ICs, which creates confusion for applicants. To make the application process consistent across the entire agency, the OER is proposing to use an electronic application system that will be accessed by research organizations that wish to request a CoC from any NIH IC. Having one system for all CoC applications to NIH will be efficient for both applicants and NIH staff who process these requests. As is currently done, the NIH will use the information in the application to determine eligibility for a CoC and to issue the CoC to the requesting organization. Office of Management and Budget approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours is 1,500.

This proposed rule would revise the Incentive Reward Program provisions in Sec. 420.405 and certain provider enrollment requirements in part 424, subpart P. The most significant of these revisions include: changing the Incentive Reward Program potential reward amount for information on individuals and entities who are or have engaged in acts or omissions which resulted in the imposition of a sanction from 10 percent of the overpayments recovered in the case or $1,000, whichever is less, to 15 percent of the final amount collected applied to the first $66,000,000 for the sanctionable conduct; expanding the instances in which a felony conviction can serve as a basis for denial or revocation of a provider or supplier's enrollment; if certain criteria are met, enabling us to deny enrollment if the enrolling provider, supplier, or owner thereof had an ownership relationship with a previously enrolled provider or supplier that had a Medicare debt; enabling us to revoke Medicare billing privileges if we determine that the provider or supplier has a pattern or practice of submitting claims for services that fail to meet Medicare requirements; and limiting the ability of ambulance suppliers to ``backbill'' for services performed prior to enrollment. We believe this proposed rule wouldincrease the incentive for individuals to report information on individuals and entities that have or are engaged in sanctionable conduct; improve our ability to detect new fraud schemes; and help us ensure that fraudulent entities and individuals do not enroll in or maintain their enrollment in the Medicare program.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Improving Sickle Cell Transitions of Care through Health Information Technology Phase 1.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on February 7th, 2013 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.