Department of Health and Human Services January 18, 2012 – Federal Register Recent Federal Regulation Documents

The Office of the National Coordinator for Health Information Technology (ONC), part of the Department of Health and Human Services (HHS), is announcing the launch of the Healthy New Year Challenge. This challenge is an open call for people nationwide to create and submit short videos that capture New Year's resolutions geared towards improving their health or the health of a loved one through the use of technology. The Healthy New Year Challenge is the first in a series of video contests for the public to share their personal stories about how they use health information technology (health IT) or consumer e-health tools to impact their health or the health of a loved one. The goal of this video contest series is to generate winning videos that will be used to motivate and inspire others and their loved ones to use health information technology to be more engaged partners in improving health and health care. Each challenge will be a call to action for members of the public to create a short video clip [2 minutes or less] on a particular theme, and will award cash prizes to winners in several categories.

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage'' dated December 2011. The guidance document provides sponsors of an investigational device exemption application (IDE) or an investigational new drug application (IND) recommendations about certain information that should be included in a submission describing a product intended to repair or replace knee cartilage. The guidance does not apply to prostheses such as unicondylar or total knee implants, or meniscus replacement products. The guidance supplements recommendations regarding IDE and IND submissions contained in other FDA publications. The guidance announced in this notice finalizes the draft guidance of the same title dated July 2007.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of the Notification Procedure for Substances Generally Recognized as Safe (GRAS) and new Form FDA 3667, which may be submitted electronically via the Electronic Submission Gateway (ESG).

This proposed rule addresses the hospital-specific limitation on Medicaid disproportionate share hospital (DSH) payments under the Social Security Act. Under this limitation, DSH payments to a hospital cannot exceed the uncompensated costs of furnishing hospital services by the hospital to individuals who are Medicaid-eligible or ``have no health insurance (or other source of third party coverage) for the services furnished during the year.'' This rule would provide that the quoted phrase would refer in context to a lack of coverage on a service-specific basis, so that the calculation of uncompensated care for purposes of the hospital-specific DSH limit would include the cost of each service furnished to an individual who had no health insurance or other source of third party coverage for that service.