Department of Defense June 27, 2012 – Federal Register Recent Federal Regulation Documents

The Department of the Navy hereby gives notice of its intent to grant Emerging Growth Enterprise LLC a revocable, nonassignable, exclusive license to practice in the field of fire fighting foam discharge and suppression testing systems in the United States and its territories, and North America for the Government-owned invention represented by U.S. Patents numbers 6,588,286 (Issued July 8, 2003), 6,615,675 (Issued September 9, 2003), 6,715,373 (Issued April 6, 2004), 6,739,174 (Issued May 25, 2004), and 7,290,457 (Issued November 6, 2007) and entitled, ``Nofoam system for testing a foam delivery system on a vehicle'', No. 7,293,478 (Issued November 13, 2007) and entitled ``Method for testing a foam delivery system on a vehicle'', and patent application numbers 13/372,755 and 13/372,712 and entitled ``Foam Free Testing Systems and Methods.''

The Department of Defense is publishing this final rule to revise the definition of ``unlabeled or off-label drug'' to ``off-label use of a drug or device.'' This provision codifies the coverage of those medically necessary indications for which there are demonstrations from medical literature, national organizations, or technology assessment bodies that the off-label use is safe and effective and in accordance with nationally accepted standards of practice in the medical community. Additionally, this rule removes the partial list of examples of unproven drugs, devices, and medical treatments or procedures proscribed in TRICARE regulations. We are removing the partial list from the regulation but will maintain the partial list in the TRICARE Policy Manual at www.tricare.mil.

The Department is publishing this final rule to implement section 706 of the National Defense Authorization Act (NDAA) for Fiscal Year 2010, Public Law 111-84. Specifically, section 706 exempts TRICARE beneficiaries under the age of 65 who become disabled from the requirement to enroll in Medicare Part B for the retroactive months of entitlement to Medicare Part A in order to maintain TRICARE coverage. This statutory amendment and final rule only impact eligibility for the period in which the beneficiary's disability determination is pending before the Social Security Administration. Eligible beneficiaries are still required to enroll in Medicare Part B in order to maintain their TRICARE coverage for future months, but are considered to have coverage under the TRICARE program for the retroactive months of their entitlement to Medicare Part A. This final rule also amends the eligibility section of the TRICARE regulation to more clearly address reinstatement of TRICARE eligibility following a gap in coverage due to lack of enrollment in Medicare Part B.