Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); clarification of the CHAMPUS exclusion of unproven drugs, devices and medical treatments and procedures--DoD. Final rule

This final rule clarifies the CHAMPUS exclusion of unproven drugs, devices and medical treatments and procedures and describes the process that the Office of CHAMPUS follows in determining when such drugs, devices, treatments and procedures have moved from the status of unproven to the position of proven medical effectiveness. This clarification is necessary to ensure the CHAMPUS beneficiary and provider population understand the process the Office of CHAMPUS (OCHAMPUS) follows prior to endorsement by CHAMPUS of a new emerging medical technology, drug, or device for which the safety and efficacy have been proven.     

Natural rubber-containing medical devices; user labeling; cold seal adhesives partial stay--FDA. Final rule

The final rule for user labeling requirements for natural rubber-containing medical devices, 21 CFR 801-437, was published on September 30, 1997, and becomes effective on September 30, 1998. The Food and Drug Administration (FDA) is adding a note to that rule to stay, for 270 days from the effective date, paragraphs (f) and (g) as those final rule requirements relate to device packaging that uses "cold seal" adhesives. Labeling changes required by other paragraphs of this final rule must be incorporated in the labeling of devices distributed after September 30, 1998, even if the devices are packaged in "cold seal" packages. Device packaging that uses natural rubber only on adhesives contained in the flaps of device packaging is not considered subject to the rule. Manufacturers of devices packaged with "cold seal" adhesives may, if necessary, submit a petition for an extension of the 270-day stay.     

TRICARE Program; surgery for morbid obesity. Final rule

This final rule adds a definition of Bariatric Surgery, amends the definition of Morbid Obesity, and revises the language relating to the treatment of morbid obesity to allow benefit consideration for newer bariatric surgical procedures that are considered appropriate medical care. The final rule removes language that specifically limits the types of surgical procedures to treat co-morbid conditions associated with morbid obesity and retains the TRICARE Program exclusion of non-surgical interventions related to morbid obesity, obesity and/or weight reduction. This final rule is necessary to allow coverage for other surgical procedures that reduce or resolve co-morbid conditions associated with morbid obesity and the use of the Body Mass Index (BMI), which is the more accurate measure for excess weight to estimate relative risk of disease. As new technologies or procedures evolve from investigational into generally accepted norms for medical practice, the statutes and regulations governing the TRICARE Program allow the Department to offer beneficiaries these new benefits. These changes are required in order to allow the Department to provide these newer technologies and procedures for the treatment of morbid obesity as they evolve.     

Natural rubber-containing medical devices; user labeling--FDA. Final rule

The Food and Drug Administration (FDA) is issuing a final rule requiring labeling statements on medical devices, including device packaging containing natural rubber that contacts humans. The rule requires labeling of medical devices containing natural rubber latex that contacts humans to state: "Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions."; labeling of medical devices containing dry natural rubber that contacts humans to state: "This Product Contains Dry Natural Rubber."; labeling of medical devices containing natural rubber latex in their packaging that contacts humans to state: "Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions."; labeling of medical devices containing dry natural rubber in their packaging that contacts humans to state: "The Packaging of This Product Contains Dry Natural Rubber."; and that the claim of hypoallergenicity be removed from the labeling of medical devices that contain natural rubber. These requirements are being established in response to numerous reports of severe allergic reactions and deaths related to a wide range of medical devices containing natural rubber.     

TRICARE; expansion of geographic scope of the TRICARE Retiree Dental Program. Final rule

This final rule expands the geographic scope of the TRICARE Retiree Dental Program (TRDP) to overseas locations not currently covered by the program. At this time, TRDP is applicable only in the 50 United States (U.S.) and the District of Columbia, Canada, Puerto Rico, Guam, American Samoa, the Commonwealth of the Northern Mariana Islands, and the U.S. Virgin Islands. Expanding the geographic scope of the program will ensure that all TRICARE-eligible retirees are eligible for the same dental benefits, regardless of their location. There are no additional Government costs associated with this final expansion of TRDP overseas as TRDP costs are borne entirely by enrollees through premium payments.     

TRICARE; Continued Health Care Benefit Program expansion. Final rule

This final rule executes the expansion of section 1078a of title 10, United States Code (U.S.C). With the recent expansions of Military Health System (MHS) coverage, particularly with the Reserve Component (RC) members, some MHS beneficiaries would not be eligible to purchase Continued Health Care Benefit Program (CHCBP) coverage under certain circumstances that terminate their MHS coverage. This provision allows the Secretary to establish CHCBP eligibility for any category of MHS beneficiaries who otherwise would lose MHS coverage with no continued care eligibility. Although the proposed rule listed each authorized category of MHS beneficiary eligible to receive care, on further examination this format for the rule appeared cumbersome and perhaps confusing. Thus this final rule contains some organizational changes to simplify the rule to enhance understanding and make clear that any category including future categories of beneficiaries are entitled to purchase this CHCBP coverage. This final rule also includes administrative changes providing clarification on eligibility notifications and the CHCBP premium rate publication process. It updates the previous final rule published in the Federal Register on September 30, 1994.     

Natural rubber-containing medical devices; user labelling--FDA. Final rule; interpretation

The Food and Drug Administration (FDA) is providing notice that it does not intend to apply to combination products currently regulated under human drug or biologic labeling provisions its September 30, 1997, final rule requiring certain labeling statements for all medical devices that contain or have packaging that contains natural rubber that contacts humans. FDA is taking this action, in part, in response to a citizen petition and other communications from industry that the agency has received since the publication of the final rule. FDA intends to initiate a proceeding to propose natural rubber labeling requirements for drugs and biologics, including combination products that are currently regulated under drug and biologic labeling provisions. Such a proceeding may include a combination of rulemaking and guidance and will offer opportunity for public comment.     

Medical devices; classification for medical washer and medical washer-disinfector. Final rule

The Food and Drug Administration (FDA) is classifying the medical washer and medical washer-disinfector intended for general medical purposes to clean and dry surgical instruments, decontaminate or disinfect anesthesia equipment, hollowware, and other medical devices into class II (special controls). FDA is also identifying the guidance document entitled "Class II Special Controls Guidance Document: Medical Washers and Medical Washer-Disinfectors" (the guidance) as the special control that, in addition to general controls, the agency believes will reasonably ensure the safety and effectiveness of the device. This action is being taken 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 SMDA), and the Food and Drug Administration Modernization Act of 1997 (the FDAMA).     

TRICARE; Reserve and Guard family member benefits. Final rule

This final rule implements sections 704 and 705 of the Ronald W. Reagan National Defense Authorization Act for Fiscal Year 2005. These provisions apply to eligible family members who become eligible for TRICARE as a result of their Reserve Component (RC) sponsor (including those with delayed effective date orders up to 90 days) being called or ordered to active duty for more than 30 days in support of a federal/contingency operation and choose to participate in TRICARE Standard or Extra, rather than enroll in TRICARE Prime. The first provision gives the Secretary the authority to waive the annual TRICARE Standard (or Extra) deductible, which is set by law (10 U.S.C. 1079(b)) at $150 per individual and $300 per family ($50/$100 for families of members in pay grades E-4 and below). The second provision gives the Secretary the authority to increase TRICARE payments up to 115 percent of the TRICARE maximum allowable charge, less the applicable patient cost share if not previously waived under the first provision, for covered inpatient and outpatient health services received from a provider that does not participate (accept assignment) with TRICARE. These provisions help ensure timely access to health care and maintain clinically appropriate continuity of health care to family members of Reservists and Guardsmen activated in support of a federal/contingency operation; limit the out-of-pocket health care expenses for those family members; and remove potential barriers to health care access by Guard and Reserve families.     

Supplemental applications proposing labeling changes for approved drugs, biologics, and medical devices. Final rule

The Food and Drug Administration (FDA) is amending its regulations regarding changes to an approved new drug application (NDA), biologics license application (BLA), or medical device premarket approval application (PMA). This final rule provides that a supplemental application submitted under certain FDA regulations is appropriate to amend the labeling for an approved product to reflect newly acquired information and to add or strengthen a contraindication, warning, precaution, or adverse reaction if there is sufficient evidence of a causal association with the drug, biologic, or device, as defined in other FDA regulations and guidance documents.     

TRICARE program; TRICARE Prime Remote for active duty family members and TRICARE Prime enrollment period. Final rule

This final rule implements 10 U.S.C. 1079(p), as added by section 722(b) of the Floyd D. Spence National Defense Authorization Act for Fiscal Year 2001. The rule provides coverage for medical care for active duty family members who reside with an active duty member of the Uniformed Services assigned to remote areas and eligible for the program known as TRICARE Prime Remote. Active duty family members who enroll in TRICARE Prime Remote for Active Duty Family Members (TPRADFM) will enjoy benefits generally comparable to TRICARE Prime enrollees including access standards, benefit coverage, and cost-shares. This final rule also implements Section 702 of the NDAA for FY 2003, which establishes circumstances under which dependents of Reserve Components and National Guard members called to active duty in support of contingency operations may enroll in TRICARE Prime Remote for Active Duty Family Members, and dependents of TRICARE Prime Remote service members may remain enrolled when the service member receives orders for an unaccompanied follow-on assignment. Finally, this final rule establishes circumstances under which eligible beneficiaries may enroll in TRICARE Prime for a period of less than 1 year.     

Medical devices; procedures for investigational device exemptions--Food and Drug Administration. Final rule

This rule sets forth the procedures and conditions under which investigations of medical devices involving human subjects may be exempt from certain requirements of the Federal Food, Drug, and Cosmetic Act, in accordance with the Medical Device Amendments of 1976. The rule sets out the procedures to obtain an investigational device exemption (IDE); it delineates the responsibilities of sponsors, institutional review boards, and clinical investigators with respect to clinical investigations of medical devices; and the rule also prescribes informed consent requirements and specifies recordkeeping and reporting requirements.     

Radiology devices; classifications for five medical image management devices--FDA. Final rule

The Food and Drug Administration (FDA) is classifying five radiology devices that provide functions related to medical image communication, storage, processing, and display into class I (general controls) or class II (special controls). The medical image storage device and medical image communications device are classified into class I, and they are exempted from the requirement of premarket notification when they do not use irreversible compression. The medical image digitizer, the medical image hardcopy device, and the picture archiving and communications system are classified into class II. These actions are being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 and the Safe Medical Devices Act of 1990.     

Medical devices; device tracking. Final rule

The Food and Drug Administration (FDA) is amending the medical device tracking regulation. FDA is making substantive changes to revise the scope of the regulation and add certain patient confidentiality requirements, and nonsubstantive changes to remove outdated references and simplify terminology. These revisions are made to conform the regulation to changes made in section 519(e) of the Federal Food, Drug, and Cosmetic Act (the act) by the FDA Modernization Act of 1997 (FDAMA), and to simplify certain requirements.     

TRICARE; certain survivors of deceased active duty members; and adoption intermediaries. Final rule

This rule confirms as final a January 2007 interim final rule which implements two provisions of the National Defense Authorization Act for Fiscal Year 2006 (NDAA FY06). First, Section 715 of the NDAA FY06 extends the time frame certain dependents of active duty service members (ADSM) who die while on active duty for more than 30 days shall receive TRICARE medical benefits at active duty dependent payment rates. Second, Section 592 of the NDAA FY06 modifies the requirement for those intermediaries who provide adoption placements. Additionally, this final rule makes an administrative clarification to the following two eligibility provisions: those placed in the legal custody of a member or former member; and those placed in the home of a member or former member in anticipation of adoption. This clarification makes a distinction between the two groups and specifies that for placement into legal custody by court order, the court order must be for a period of 12 consecutive months.     

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.     

Medical devices; radiology devices; reclassification of bone sonometers. Final rule

The Food and Drug Administration (FDA) is issuing a final rule to reclassify bone sonometer devices from class III into class II, subject to special controls. FDA is taking this action on its own initiative after reviewing recent scientific and technological studies regarding bone sonometer devices. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled "Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Bone Sonometers" that will serve as the special control for these devices.