Department of Health and Human Services May 17, 2013 – Federal Register Recent Federal Regulation Documents

Medicare Program; Bundled Payments for Care Improvement Model 1 Open Period
Document Number: 2013-11819
Type: Notice
Date: 2013-05-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces an open period for additional organizations to be considered for participation in Model 1 of the Bundled Payments for Care Improvement initiative.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-11812
Type: Notice
Date: 2013-05-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2013-11811
Type: Notice
Date: 2013-05-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Advisory Commission on Childhood Vaccines; Notice of Meeting
Document Number: 2013-11777
Type: Notice
Date: 2013-05-17
Agency: Department of Health and Human Services, Health Resources and Services Administration
Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting
Document Number: 2013-11765
Type: Notice
Date: 2013-05-17
Agency: Food and Drug Administration, Department of Health and Human Services
Proposed Information Collection Activity; Comment Request
Document Number: 2013-11762
Type: Notice
Date: 2013-05-17
Agency: Department of Health and Human Services, Administration for Children and Families
HIT Standards Committee Advisory Meeting
Document Number: 2013-11742
Type: Notice
Date: 2013-05-17
Agency: Department of Health and Human Services
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meeting
Document Number: 2013-11741
Type: Notice
Date: 2013-05-17
Agency: Department of Health and Human Services, National Institutes of Health
HIT Standards Committee; Schedule for the Assessment of HIT Policy Committee Recommendations
Document Number: 2013-11740
Type: Notice
Date: 2013-05-17
Agency: Department of Health and Human Services
Section 3003(b)(3) of the American Recovery and Reinvestment Act of 2009 mandates that the HIT Standards Committee develop a schedule for the assessment of policy recommendations developed by the HIT Policy Committee and publish it in the Federal Register. This notice fulfills the requirements of Section 3003(b)(3) and updates the schedule posted in the Federal Register on April 11, 2012. In anticipation of receiving recommendations originally developed by the HIT Policy Committee, the HIT Standards Committee has created six (6) workgroups to analyze the areas of clinical quality, clinical operations, implementation, consumer technology, nationwide health information networks and privacy and security. Other groups will be convened to address specific issues as needed. HIT Standards Committee's Schedule for the Assessment of HIT Policy Committee Recommendations is as follows: The National Coordinator will establish priority areas based in part on recommendations received from the HIT Policy Committee regarding health information technology standards, implementation specifications, and/or certification criteria. Once the HIT Standards Committee is informed of those priority areas, it will: (A) Direct the appropriate workgroup or other special group to develop a report for the HIT Standards Committee, to the extent possible, within 90 days, which will include, among other items, the following: (1) An assessment of what standards, implementation specifications, and certification criteria are currently available to meet the priority area; (2) an assessment of where gaps exist (i.e., no standard is available or harmonization is required because more than one standard exists) and identify potential organizations that have the capability to address those gaps; and (3) a timeline, which may also account for NIST testing, where appropriate, and include dates when the HIT Standards Committee is expected to issue recommendation(s) to the National Coordinator. (B) Upon receipt of a report from a workgroup or other special group, the HIT Standards Committee will: (1) accept the timeline provided by the subcommittee, and, if necessary, revise it; and (2) assign subcommittee(s) to conduct research and solicit testimony, where appropriate, and issue recommendations to the full committee in a timely manner. (C) Advise the National Coordinator, consistent with the accepted timeline in (B)(1) and after NIST testing, where appropriate, on standards, implementation specifications, and/or certification criteria, for the National Coordinator's review and determination whether or not to endorse the recommendations, and possible adoption of the proposed recommendations by the Secretary of the Department of Health and Human Services. The standards and related topics which the HIT Standards Committee is expected to address over the coming year include, but may not be limited to standards to support: Transport of data to and from patients, image exchange, current content gaps, securing data at rest, digital signature, longitudinal record sharing, advanced care preferences, application programming interfaces, measuring and reporting quality, clinical decision support, defect reporting and registry support. For a listing of upcoming HIT Standards Committee meetings, please visit the ONC Web site at https://healthit.gov. Notice of this schedule is given under the American Recovery and Reinvestment Act of 2009 (Pub. L. 111-5), section 3003.
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2013-11738
Type: Notice
Date: 2013-05-17
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-11737
Type: Notice
Date: 2013-05-17
Agency: Department of Health and Human Services, National Institutes of Health
State Medicaid Fraud Control Units; Data Mining
Document Number: 2013-11735
Type: Rule
Date: 2013-05-17
Agency: Department of Health and Human Services, Office of Inspector General
This final rule amends a provision in HHS regulations prohibiting State Medicaid Fraud Control Units (MFCU) from using Federal matching funds to identify fraud through screening and analyzing State Medicaid data, known as data mining. To support and modernize MFCU efforts to effectively pursue Medicaid provider fraud, we finalize proposals to permit Federal financial participation (FFP) in costs of defined data mining activities under specified circumstances. In addition, we finalize requirements that MFCUs annually report costs and results of approved data mining activities to OIG.
Center for Devices and Radiological Health Appeals Processes: Questions and Answers About 517A; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2013-11708
Type: Notice
Date: 2013-05-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Center for Devices and Radiological Health (CDRH) Appeals Processes: Questions and Answers About 517A.'' This draft document provides CDRH's proposed interpretation of key provisions of the Federal Food Drug and Cosmetic Act (FD&C Act), which were added by the FDA Safety and Innovation Act (FDASIA), as those provisions pertain to requests for documentation of rationales for significant decisions and requests for supervisory review of regulatory decisions and actions taken by CDRH. This draft guidance is not final nor is it in effect at this time.
Center for Devices and Radiological Health Appeals Processes; Guidance for Industry and FDA Staff; Availability
Document Number: 2013-11706
Type: Notice
Date: 2013-05-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Center for Devices and Radiological Health (CDRH) Appeals Processes.'' This document describes the processes available to outside stakeholders to request additional review of decisions or actions by CDRH employees which include requests for supervisory review of an action, petitions, and hearings. Of these, the most commonly used process is the request for supervisory review (a ``10.75 appeal''). This document provides general information about each process as well as guidance on how to submit related requests to CDRH and FDA.