Office of the Secretary December 27, 2011 – Federal Register Recent Federal Regulation Documents

This rule is submitted as an interim final rule (IFR) in order to meet the Congressional requirement set forth in the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2011, Section 724, which required the Department of Defense to prescribe regulations by June 20, 2011, to establish the criteria, as had previously been studied in accordance with Section 717 of the NDAA 2008, that would allow licensed or certified mental health counselors to be able to independently provide care to TRICARE beneficiaries and receive payment for those services. Under current TRICARE requirements, mental health counselors (MHCs) are authorized to practice only with physician referral and supervision. This interim final rule establishes a transition period to phase out the requirement for physician referral and supervision for MHCs and to create a new category of allied health professionals, to be known as certified mental health counselors (CMHCs), who will be authorized to practice independently under TRICARE. During this transition period the MHCs who do not meet the requirements for independent practice as established in this rule, may continue to provide services to TRICARE beneficiaries under the requirements of physician referral and ongoing supervision. This transition period, ending December 31, 2014, will allow time for those MHCs who seek to continue providing services under the TRICARE program to meet the independent practice requirements as outlined in this notice. After December 31, 2014, the Department of Defense will no longer recognize those mental health counselors who do not meet the criteria for a CMHC and will no longer allow them to provide services even upon the referral and supervision of a physician.

Pursuant to the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), the Sunshine in the Government Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.150, the Department of Defense announces the following Federal advisory committee member solicitation of the Reserve Forces Policy Board (RFPB).

This notice is to advise interested parties of a Military Health System (MHS) demonstration project under the authority of Section 1092, Chapter 55, Title 10 of the United States Code (U.S.C.), entitled TRICARE Evaluation of Centers for Medicare & Medicaid Services Approved Laboratory Developed Tests Demonstration Project. The demonstration project is intended to determine whether it is feasible for the Department of Defense (DoD) to review Centers for Medicare and Medicaid Services (CMS) approved laboratory developed tests (LDTs), not yet examined by the United States Food and Drug Administration (FDA), to determine if they meet TRICARE requirements for safety and effectiveness according to the hierarchy of reliable evidence (32 CFR 199.2(b)) and allow those that do to be covered as a benefit under the TRICARE Program. The LDTs for this demonstration would be limited to only those that significantly inform clinical decision making for surveillance, surgical interventions, chemotherapy, or radiation therapy for cancer. The demonstration project will provide a valuation of the potential improvement of the quality of healthcare services for TRICARE beneficiaries who would not otherwise had access to these tests. In addition, the demonstration project will evaluate the need to modify 32 CFR 199.4(g)(15)(i)(A) to allow coverage for CMS approved LDTs. Interested LDT device manufacturers, or individual (single) laboratories developing their own proprietary tests that have a CMS National Coverage Determination (NCD) or Local Coverage Determination (LCD) who desire the DoD to consider their tests for coverage under the TRICARE Program, are encouraged to submit LDTs for consideration. Submissions must include the LDT description and complete documentation (including the CMS-assigned determination number) proving CMS National Coverage Determination (NCD) or Local Coverage Determination (LCD). Submissions will only be accepted for those LDTs which are CMS approved, but have not received FDA clearance or approval LDTs will be prioritized based on the combination of potential high utilization and potential high clinical impact on TRICARE beneficiaries. If no submission is received for a LDT and TMA is aware that a NCD or LCD exists, TMA may elect to include the LDT in the prioritization process. Relevant administrative data on number of diagnoses of specific oncological diseases, procedures, treatments, and other requested data and information will be used in the prioritization process. The prioritized list will be sent to the Director, TMA for approval. The approved list will then be reviewed in numerical order beginning with the test listed as having the highest priority. Those selected for review will be evaluated to determine whether they meet the TRICARE hierarchy of reliable evidence for safety and effectiveness as described in 32 CFR 199.4(g)(15). LDTs determined to meet TRICARE criteria for safety and efficacy will be recommended to the Director, TMA for approval for cost-sharing during the demonstration period.

This notice provides a 2-year extension of the Department of Defense Enhanced Access to Autism Services Demonstration Project under the Extended Care Health Option for beneficiaries diagnosed with an Autism Spectrum Disorder (ASD). Under the demonstration, the Department implemented a provider model that allows reimbursement for Intensive Behavioral Interventions (IBI) services, in particular, Applied Behavior Analysis, rendered by providers who are not otherwise eligible for reimbursement.