Dental devices; reclassification of root-form endosseous dental implants and endosseous dental implant abutments. Final rule

The Food and Drug Administration (FDA) is reclassifying root-form endosseous dental implants and endosseous dental implant abutments from class III to class II (special controls). Root-form endosseous dental implants are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Endosseous dental implant abutments are separate components that are attached to the dental implant and intended to aid in prosthetic rehabilitation. FDA is reclassifying these devices on its own initiative on the basis of new information. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for these devices. FDA is taking this action under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990, the Food and Drug Administration Modernization Act of 1997, and the Medical Device User Fee and Modernization Act of 2002.     

Assistant Secretary of Defense for Health Affairs--DoD. Final rule

This document revises the responsibilities, functions, relationships, and authorities of the Assistant Secretary of Defense for Health Affairs ASD(HA). The principal revision, the assignment of the Health Affairs functions under the Under Secretary of Defense for Personnel and Readiness is consistent with Section 903 of the FY 1994 Defense Authorization Act.     

TRICARE: Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); nonavailability statement requirement for maternity care. Office of the Secretary, DoD. Final Rule

This final rule implements Section 712(c) of the National Defense Authorization Act for Fiscal Year 2000 (Pub. L. No. 106-65), which requires that a nonavailability-of-health-care statement shall be required for a beneficiary not enrolled in TRICARE Prime for TRICARE cost-share of maternity care services related to outpatient prenatal, outpatient or inpatient delivery, and outpatient post-partum care subsequent to the visit which confirms the pregnancy. The Act reestablishes a requirement which was previously eliminated under the broad direction of the National Defense Authorization Act for FY 1997, section 734, which removed authority for nonavailability statements (NASs) for outpatient services. Therefore, the Act changes the provisions which require an NAS for inpatient delivery, but do not require an NAS for outpatient prenatal and post-partum care. The change will significantly contribute to continuity of care for maternity patients. In furtherance of that principle, and consistent with the previous policy, an NAS for maternity care shall not be required when a beneficiary has other health insurance for primary coverage.     

Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); Amendment on reimbursement methodology: Office of the Secretary. DOD. Amendment of final rule

This amends the Civilian Health and Medical Program of the Uniformed Services (CHAMPUS) Regulation to implement The Department of Defense Authorization Act, 1982 and the Department of Defense Appropriation Act, 1982 (Pub. L. 96-86 and 97-114, respectively). These public laws require CHAMPUS to calculable prevailing charges at the 80th percentile of billed charges made for similar services in the same locality during the base period. It also allows prevailing charges (profiles) to be updated more frequently than once a year. The intent of these changes is to simplify profile development procedures, and make appropriate benefit payments, and make profiles more reflective of all providers' current charges.     

Tricare; Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); nonavailability statement requirement for maternity care. Office of the Secretary, DoD. Interim final rule

This interim final rule implements Section 712(c) of the National Defense Authorization Act for Fiscal Year 2000 (Pub. L. No. 106-65), which requires that a nonavailability-of-health-care statement shall be required for a non-enrolled beneficiary for TRICARE cost-share of maternity care services related to outpatient prenatal, outpatient or inpatient delivery, and outpatient post-partum care subsequent to the visit which confirms the pregnancy. The Act reestablishes a requirement which was previously eliminated under the broad direction of The National Defense Authorization Act of FY 1997, section 734, which removed authority for nonavailability statements (NASs) for outpatient services. Therefore, the Act changes the existing provisions require an NAS for inpatient delivery but do not require an NAS for outpatient prenatal and post-partum care. The change will significantly contribute to continuity of care for maternity patients. In furtherance of that principle, and consistent with the previous policy, an NAS for maternity care shall not be required when a beneficiary has other health insurance for primary coverage. This is being issued as an interim final rule in order to comply with the statutory mandate. Public comments, however, are invited and will be considered in connection with possible revisions to this rule.     

Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); reimbursement of providers, claims filing, and participating provider program--Office of the Secretary, DoD. Final rule

This final rule implements provisions of the Department of Defense Appropriations Act, 1993, section 9011, which limits increases in maximum allowable payments to physicians and other individual professional providers (including clinical laboratories), authorizes reductions in such amounts for overpriced procedures, provides special procedures to assure beneficiary access to care, and establishes limits on balance billing by providers. Also, the final rule implements a provision of the National Defense Authorization Act for Fiscal Year 1992 that requires providers to file claims on behalf of CHAMPUS beneficiaries, builds into the CHAMPUS Regulation provisions that have been in effect for several years regarding the Participating Provider Program, and implements a new approach for CHAMPUS reimbursement for ambulatory surgery.     

Office of the Secretary; Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); transitional assistance management program; early eligibility for TRICARE for certain reserve component members. Final rule

This final rule revises requirements and procedures for the Transitional Assistance Management Program, which was temporarily revised by section 704 of the National Defense Authorization Act for Fiscal Year 2004 (NDAA-04) (Pub. L. 108-136) and section 1117 of the Emergency Supplemental Appropriations Act for the Reconstruction of Iraq and Afghanistan, 2004 (Emergency Supplemental) (Pub. L. 108-106), which revisions were made permanent by section 706(a) of the Ronald W. Reagan National Defense Authorization Act for Fiscal Year 2005 (NDAA-05) (Pub. L. 108-375). In addition, it establishes requirements and procedures for implementation of the earlier TRICARE eligibility for certain reserve component members authorized by section 703 of NDAA-04 and section 1116 of the Emergency Supplemental, which provisions were made permanent by section 703 of NDAA-05. The rule adopts the interim rule published in the Federal Register on March 16, 2005 (70 FR 12798).     

Human drugs and biologics; determination that informed consent is NOT feasible or is contrary to the best interests of recipients; revocation of 1990 interim final rule; establishment of new interim final rule. Food and Drug Administration, HHS. Interim final rule; opportunity for public comment

The Food and Drug Administration (FDA) is revoking its 1990 interim final regulations that permitted the Commissioner of Food and Drugs (the Commissioner) to determine that obtaining informed consent from military personnel for the use of an investigational drug or biologic is not feasible in certain situations related to military combat. FDA also is issuing a new interim final rule addressing waiver of informed consent in military operations. FDA is taking these actions based on its analysis and consideration of all relevant facts, including its evaluation of the Department of Defense's (DOD) experience during the Persian Gulf War, its evaluation of the comments received by the agency in response to the agency's July 31, 1997, request for comments on whether the agency should revise or revoke the interim regulations, and the enactment of the Strom Thurmond National Defense Authorization Act for Fiscal Year 1999 (the Defense Authorization Act). Under the Defense Authorization Act, the President is authorized to waive the Federal Food, Drug, and Cosmetic Act's (the act) informed consent requirements in military operations if the President finds that obtaining consent is infeasible or contrary to the best interests of recipients and on an additional ground that obtaining consent is contrary to national security interests. In light of the enactment of the Defense Authorization Act, with an immediate effective date, and because the President could be called upon to make a waiver determination for military personnel engaged in a specific military operation at any time, the agency believes that it is critical to have in place adequate criteria and standards for the President to apply in making an informed consent waiver determination. Therefore, FDA is issuing a new interim final regulation with an immediate effective date to establish criteria and standards for the President to apply in making a determination that informed consent is not feasible or is contrary to the best interests of the individual recipients.     

TRICARE: elimination of co-payments for authorized preventive services for certain TRICARE Standard beneficiaries. Final rule

The Department of Defense is publishing this final rule to implement section 711 of the National Defense Authorization Act (NDAA) for Fiscal Year 2009 (FY 2009), Public Law 110-417. Section 711 eliminates copayments for authorized preventive services for TRICARE Standard beneficiaries other than Medicare-eligible beneficiaries. This rule also realigns the covered preventive services listed in the Exclusions section of the regulation to the Special Benefits section in the regulation.     

Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); reimbursement of individual health providers--Department of Defense. Final rule

This final rule implements the provisions of the Defense Appropriations Act for Fiscal Year 1991, Public Law 101-511, section 8012, which limits increases in maximum allowable payments to physicians and other individual health care providers and authorizes reductions in such amounts for overpriced procedures.     

Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); reimbursement of individual health providers--Department of Defense. Final rule

The Department of Defense is publishing this document to correct errors in the final rule on reimbursement of individual health providers contained in section 199.14(g). In addition to typographical and proofreading errors, the final rule failed to specify that changes to 1991 payment levels apply to the lesser of prevailing charges or the fiscal year 1988 prevailing charge levels adjusted by the Medicare Economic Index. The Fiscal Year 1991 Defense Appropriations Act prohibited payments "in excess of amounts allowed in fiscal year 1990 for similar services." Such amounts are, by definition, the lesser of prevailing charges, MEI-limited 1988 prevailing charge levels, or actual charges.     

Payment method for health care services under the Supplemental Health Care Program for Active Duty Members of the Uniformed Services; adoption of CHAMPUS procedures--DoD. Final rule

This final rule partially implements 10 U.S.C. 1074(c), as amended by section 729 of the National Defense Authorization Act for Fiscal Years 1990 and 1991, Public Law 101-189. The recent amendment authorizes the Department of Defense to establish for the active duty supplemental care program payment rules similar to those used under the Civilian Health and Medical Program of the Uniformed Services (CHAMPUS). The supplemental care program is the program which provides for the payment to civilian (non federal-governmental) health care providers for care provided to active duty members of the uniformed services. This final rule would adopt CHAMPUS payment amounts for the supplemental care program.     

Department of Defense--Implementation of the Civilian Health and Medical Program of the Uniformed Services; Amendment No. 4. Final rule

This amendment extends benefits under the Civilian Health and Medical Program of the Uniformed Services (CHAMPUS) for abortion services, and adds an exclusion in the provisions for cosmetic, reconstructive, and/or plastic surgery procedures. This amendment also implements language contained in Public Law 96-154, Department of Defense Appropriations Act of 1980, and Public Law 96-173, effective October 1, 1979, which deletes the CHAMPUS exclusion of benefits for Military Service-connected disabilities.     

Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); TRICARE Dental Program. Office of the Secretary, DoD. Final rule

On October 23, 2000 (65 FR 63202), the Department of Defense published a final rule on TRICARE Family Member Dental Plan. The rule had an effective date that began during the Presidential Moratium on Rules, therefore, this rule is republished to change the effective date to April 1, 2001. This rule is published exactly as previously published. No changes have been made. It revises the comprehensive CHAMPUS regulation pertaining to the Expanded Active Duty Dependents Benefit Plan, or more commonly referred to as the TRICARE Family Member Dental Plan (TFMDP). The TFMDP limited eligibility to eligible dependents of active duty members (under a call or order that does not specify a period of thirty (30) day or less). Concurrent with the timeframe of the publication of the proposed rule, the Defense Authorization Act for Fiscal Year 2000 (Pub. L. 106-65, sec. 711) was signed into law and its provisions have been incorporated into this final rule. The Act authorized a new plan, titled the TRICARE dental program (TDP), which allows the Secretary of Defense to offer a comprehensive premium based indemnity dental insurance coverage plan to eligible dependents of active duty members (under a call or order that does not specify a period of thirty (30) days or less), eligible dependents of members of the Selected Reserve and Individual Ready Reserve, and eligible members of the Selected Reserve and Individual Ready Reserve. The Act also struck section 1076b (Selected Reserve dental insurance), or Chapter 55 of title 10, United States Code, since the affected population and the authority for that particular dental insurance plan has been incorporated in 10 U.S.C. 1076a. Consistent with the proposed rule and the provisions of the Defense Authorization Act for Fiscal Year 2000, the final rule places the responsibility for TDP enrollment and a large portion of the appeals program on the dental plan contractor; allows the dental plan contractor to bill beneficiaries for plan premiums in certain circumstances; reduces the former TFMDP enrollment period from twenty-four (24) to twelve (12) months; excludes Reserve component members ordered to active duty in support of a contingency operation from the mandatory twelve (12) month enrollment; clarifies dental plan requirements for different beneficiary populations; simplifies enrollment types and exceptions; reduces cost-shares for certain enlisted grades; adds anesthesia as a covered benefit; provides clarification on the Department-s use of the Congressional waiver for surviving dependents; incorporates legislative authority for calculating the method by which premiums may be raised and allowing premium reductions for certain enlisted grades; and reduces administrative burden by reducing redundant language, referencing language appearing in other CFR sections and removing language more appropriate to the actual contract. These improvements will provide Uniformed Service members and families with numerous quality of life benefits that will improve participation in the plan, significantly reduce enrollment errors and positively effect utilization of this important dental plan. The proposed rule was titled the --TRICARE Family Member Dental Plan.     

TRICARE; changes included in the National Defense Authorization Act for Fiscal Year 2010; expansion of survivor eligibility under the TRICARE Dental Program. Final rule

The Department is publishing this final rule to implement the National Defense Authorization Act for Fiscal Year 2010 (NDAA for FY10), as amended by the National Defense Authorization Act for Fiscal Year 2011 (NDAA for FY11). Specifically, that legislation expands the survivor eligibility under the TRICARE Dental Program (TDP). The 2011 amendment to the legislation entitles the surviving spouse and child(ren) continuation of eligibility for the TDP regardless of whether they were previously enrolled in the TDP. Prior enrollment in the TDP had been a requirement of the 2010 legislation for both the spouse and children. The period of continued eligibility for a spouse will be 3 years beginning on the date of the member's death. The legislation entitles a child to continuation of eligibility for the TDP for the longer of three years or until age 21 (or 23 for most full-time students). Survivors, who meet the new eligibility requirements, will obtain TDP eligibility as of the publishing of the final rule in the Federal Register. Retroactive payment of premiums or claims paid for dental treatment during the time of loss of TDP eligibility will not be reimbursed to surviving dependents.     

TRICARE; elimination of non-availability statement and referral authorization requirements and elimination of specialized treatment services program. Final rule

This rule implements Section 735 of the National Defense Authorization Act for Fiscal Year 2002 (NDAA-02) (Pub. L. 107-107). It also implements Section 728 of the Floyd D. Spence National Defense Authorization Act for Fiscal Year 2001 (NDAA-01) (Pub. L. 106-398). Section 735 of NDAA-02 eliminates the requirement for TRICARE Standard beneficiaries who live within a 40-mile radius of a military medical treatment facility (MTF) to obtain a nonavailability statement (NAS) or preauthorization from an MTF before receiving inpatient care (other than mental health services) or maternity care from a civilian provider in order that TRICARE will cost-share for such services. Section 735 of NDAA-02, however, authorizes the Department of Defense to make exceptions to the elimination of the requirement for a NAS through the exercise of a waiver process under certain specified conditions. This section also eliminates the NAS requirement for specialized treatment services (STSs) for TRICARE Standard beneficiaries who live outside the 200-mile radius of a designated STS facility. This rule portrays the Department's decision to eliminate the STS program entirely. Finally, Section 728 of NDAA-01 requires that prior authorization before referral to a specialty care provider that is part of the contractor network be eliminated under any new TRICARE contract.     

Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); TRICARE Dental Program. Office of the Secretary, DoD. Final rule

This final rule revises the comprehensive CHAMPUS regulation pertaining to the Expanded Active Duty Dependents Benefit Plan, or more commonly referred to as the TRICARE Family Member Dental Plan (TFMDP). The TFMDP limited eligibility to eligible dependents of active duty members (under a call or order that does not specify a period of thirty (30) day or less). Concurrent with the timeframe of the publication of the proposed rule, the Defense Authorization Act for Fiscal Year 2000 (Public Law 106-65, sec. 711) was signed into law and its provisions have been incorporated into this final rule. The Act authorized a new plan, titled the TRICARE dental program (TDP), which allows the Secretary of Defense to offer a comprehensive premium based indemnity dental insurance coverage plan to eligible dependents of active duty members (under a call or order that does not specify a period of thirty (30) days or less), eligible dependents of members of the Selected Reserve and Individual Ready Reserve, and eligible members of the Selected Reserve and Individual Ready Reserve. The Act also struck section 1076b (Selected Reserve dental insurance), or Chapter 55 of title 10, United States Code, since the affected population and the authority for that particular dental insurance plan has been incorporated in 10 U.S.C. 1076a. Consistent with the proposed rule and the provisions of the Defense Authorization Act for Fiscal Year 2000, the final rule places the responsibility for TDP enrollment and a large portion of the appeals program on the dental plan contractor; allows the dental plan contractor to bill beneficiaries for plan premiums in certain circumstances; reduces the former TFMDP enrollment period from twenty-four (24) to twelve (12) months; excludes Reserve component members ordered to active duty in support of a contingency operation from the mandatory twelve (12) month enrollment; clarifies dental plan requirements for different beneficiary populations; simplifies enrollment types and exceptions; reduces cost-shares for certain enlisted grades; adds anesthesia as a covered benefit; provides clarification on the Department's use of the Congressional waiver for surviving dependents; incorporates legislative authority for calculating the method by which premiums may be raised and allowing premium reductions for certain enlisted grades; and reduces administrative burden by reducing redundant language, referencing language appearing in other CFR sections and removing language more appropriate to the actual contract. These improvements will provide Uniformed Service members and families with numerous quality of life benefits that will improve participation in the plan, significantly reduce enrollment errors and positively effect utilization of this important dental plan. The proposed rule was titled the "TRICARE Family Member Dental Plan".     

Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); TRICARE Young Adult. Interim final rule with comment period

This interim final rule implements Section 702 of the Ike Skelton National Defense Authorization Act for Fiscal Year 2011 (NDAA for FY11). It establishes the TRICARE Young Adult (TYA) program to provide an extended medical coverage opportunity to most unmarried children under the age of 26 of uniformed services sponsors. The TRICARE Young Adult program is a premium-based program.     

Absence and leave; sick leave. Final rule

The U.S. Office of Personnel Management is issuing final regulations on the use of sick leave and advanced sick leave for serious communicable diseases, including pandemic influenza when appropriate. We are also permitting employees to substitute up to 26 weeks of accrued or accumulated sick leave for unpaid Family and Medical Leave Act (FMLA) leave to care for a seriously injured or ill covered servicemember, as authorized under the National Defense Authorization Act for Fiscal Year 2008, including up to 30 days of advanced sick leave for this purpose. Finally, we are reorganizing the existing sick leave regulations to enhance reader understanding and administration of the program.     

Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); certified clinical social workers--Office of the Secretary, DoD. Amendment of final rule

This final rule amends DoD Regulation 6010.8-R (32 CFR 199) which implements the Civilian Health and Medical Program of the Uniformed Services (CHAMPUS). This amendment implements language contained in the Department of Defense Appropriation Act, 1983, Pub. L. 97-377, which authorizes CHAMPUS payments to certified clinical social workers who practice independent of physician referral and supervision.