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 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; enhancement of transitional dental care for members of the Reserve Component on active duty for more than 30 days in support of a contingency operation. Final rule

The Department is publishing this final rule to implement section 703 of the National Defense Authorization Act for Fiscal Year 2010 (NDAA for FY10). Specifically, that legislation amends the transitional health care dental benefits for Reserve Component members on active duty for more than 30 days in support of a contingency operation. The legislation entitles these Reserve Component members to dental care in the same manner as a member of the uniformed services on active duty for more than 30 days, thus providing care to the Reserve member in both military dental treatment facilities and authorized private sector dental care. This final rule does not eliminate any medical or dental care that is currently covered as transitional health care for the member.     

Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); TRICARE Reserve Select for certain members of the selected reserve; Transitional Assistance Management Program; early eligibility for TRICARE for certain reserve component members. Interim final rule with comment period

This interim final rule establishes requirements and procedures for implementation of TRICARE Reserve Select. It also revises requirements and procedures for the Transitional Assistance Management Program. In addition, it establishes requirements and procedures for implementation of the earlier TRICARE eligibility for certain reserve component members. The rule is being published as an interim final rule with comment period in order to comply with statutory effective dates.     

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.     

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.     

Medicaid program; limitations on provider-related donations and health care-related taxes; limitations on payments to disproportionate share hospitals--HCFA. Final rule

This final rule clarifies HCFA's policies concerning provider related donations and health care related taxes. In addition, this final rule revises regulations with regard to disproportionate share hospital spending limitations. This final rule amends an interim final rule that was published in the Federal Register on November 24, 1992. The interim final rule established in Medicaid regulations limitations on Federal financial participation (FFP) in State medical assistance expenditures when States receive funds from provider-related donations and revenues generated by certain health care-related taxes. The interim final rule also added provisions that establish limits on the aggregate amount of payments a State may make to disproportionate share hospitals for which FFP is available. The provisions of the interim final rule were required by the Medicaid Voluntary Contribution and Provider Specific Tax Amendments of 1991.     

Registration of food facilities under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. Final rule

The Food and Drug Administration (FDA) is issuing a final regulation that confirms the interim final rule entitled "Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002" (68 FR 58894, October 10, 2003 (interim final rule) as corrected by a technical amendment (69 FR 29428, May 24, 2004), and responds to comments submitted in response to the request for comments in the interim final rule. This final rule affirms the interim final rule's requirement that domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States be registered with FDA by December 12, 2003. The interim final rule implemented the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which requires domestic and foreign facilities to be registered with FDA by December 12, 2003. This final rule does not make any changes to the regulatory requirements established by the interim final rule.     

Medicare and Medicaid programs; surety bond requirements for home health agencies--HCFA. Final rule

This final rule revises several provisions of an earlier final rule concerning surety bond requirements published in the Federal Register on January 5, 1998 (63 FR 292). This rule also establishes the surety bond submission compliance data, as described in a notice of intent and in a final rule concerning surety bond requirements published in the Federal Register on March 4, 1998 (63 FR 10730 and 10732). The March 4 documents advised the public that we intended to make technical revisions to the January 5, 1998 final rule and extend the February 27, 1998 compliance date for all home health agencies (HHAs) to furnish a surety bond to HCFA and/or the State Medicaid agency, or both, until 60 days after the date of publication of this final rule. In this rule, for Medicare-participating HHAs, we are establishing a new compliance date to submit a surety bond that is 60 days after the date of publication of this final rule. For Medicaid-participating HHAs, we are establishing a new compliance date to furnish a surety bond that is a date established by the State Medicaid agency up to 120 days after the date of publication of this final rule. We are also responding to comments we received in response to the January 5, 1998 final rule that pertain to the technical revisions we discussed in our March 4, 1998 notice. It is our intention to respond to all comments not addressed herein in a future Federal Register document. This final rule revision does not change the beginning date of the term the initial surety bond is to cover, that is, January 1, 1998.     

Medicare program; payment for customized wheelchairs--HCFA. Final rule

This final rule responds to comments we received on an interim final rule relating to payment for customized wheelchairs that was published on December 20, 1991 (56 FR 65995). The interim rule set forth the Secretary's criteria that a wheelchair must meet to be considered a customized item and allowed for a payment for the purchase of customized items based on the carrier's case-by-case determination. This rule establishes the interim rule as a final regulation with one change. The change is based on our review and consideration of the public comments. EFFECTIVE DATE: This final rule is effective on July 30, 1993.     

Office of Inspector General; Medicare and state health care programs: fraud and abuse; issuance of advisory opinions by the OIG. Final rule

OIG is adopting in final form, without change, an interim final rule published on March 26, 2008 (73 FR 15937). We received no comments to the interim final rule. The interim final rule revised the process for advisory opinion requestors to submit payments for advisory opinion costs.     

Medical devices; medical device distributor reporting--FDA. Final rule; notification of status under the Safe Medical Devices Act; confirmation of effective date

The Food and Drug Administration (FDA) is announcing that the tentative final rule on medical device distributor reporting that appeared in the Federal Register of November 26, 1991 (56 FR 60024), is now a final rule by operation of law. This final rule requires distributors to submit reports to FDA and to manufacturers, of deaths, serious illnesses, and serious injuries related to medical devices and to submit reports to manufacturers of certain malfunctions that may cause a death, serious illness, or serious injury, if the malfunction were to recur. The final rule also changes the reporting standard for certain distributors that are importers, and changes the definition of the term "serious injury" to conform to a recent statutory amendment. In issuing this final rule, FDA is announcing that the tentative final rule relating to adverse event reporting requirements for distributors, including importers, has the status of a final rule, as of May 28, 1992, by operation of law under the Safe Medical Devices Act of 1990 (the SMDA), as amended by the Medical Device Amendments of 1992 (the 1992 amendments), and is setting forth the regulations reflecting those requirements. FDA is also amending the regulations, based on consideration of comments on the November 26, 1991, tentative final rule, to require distributors to register their facilities and to list their devices with FDA.     

Medicare program; end-stage renal disease prospective payment system and quality incentive program; ambulance fee schedule; durable medical equipment; and competitive acquisition of certain durable medical equipment prosthetics, orthotics and supplies. Final rule

This final rule updates and makes certain revisions to the End-Stage Renal Disease (ESRD) prospective payment system (PPS) for calendar year (CY) 2012. We are also finalizing the interim final rule with comment period published on April 6, 2011, regarding the transition budget-neutrality adjustment under the ESRD PPS,. This final rule also sets forth requirements for the ESRD quality incentive program (QIP) for payment years (PYs) 2013 and 2014. In addition, this final rule revises the ambulance fee schedule regulations to conform to statutory changes. This final rule also revises the definition of durable medical equipment (DME) by adding a 3-year minimum lifetime requirement (MLR) that must be met by an item or device in order to be considered durable for the purpose of classifying the item under the Medicare benefit category for DME. Finally, this final rule implements certain provisions of section 154 of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) related to the durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) Competitive Acquisition Program and responds to comments received on an interim final rule published January 16, 2009, that implemented these provisions of MIPPA effective April 18, 2009. (See the Table of Contents for a listing of the specific issues addressed in this final rule.)     

Medicaid program; time limitation on recordkeeping requirements under the drug rebate program. Final rule

This final rule finalizes 10-year recordkeeping requirements for drug manufacturers under the Medicaid drug rebate program. Manufacturers must retain records for 10 years from the date the manufacturer reports data to us for a rebate period. This final rule also finalizes the requirement that manufacturers must retain records beyond the 10-year period if the records are known by the manufacturer to be the subject of an audit or a government investigation. Furthermore, this final rule responds to public comments on the January 6, 2004 interim final rule with comment period and the proposed rule pertaining to the 10-year recordkeeping requirements, respectively.     

Conforming regulations regarding removal of section 507 of the Federal Food, Drug, and Cosmetic Act; confirmation of effective date. Food and Drug Administration, HHS. Direct final rule; confirmation of effective date

The Food and Drug Administration (FDA) published in the Federal Register of January 5, 1999 (64 FR 396), a direct final rule. The direct final rule amended FDA's regulations by removing references to the repealed statutory provision of the Federal Food, Drug, and Cosmetic Act (the act) under which the agency certified antibiotic drugs. The direct final rule also removed references to the repealed antibiotic monograph regulations and to those regulations dealing with antibiotic applications. This document confirms the effective date of the direct final rule.     

Medicare and Medicaid programs; fire safety requirements for certain health care facilities; amendment. Final rule

This final rule adopts the substance of the April 15, 2004 tentative interim amendment (TIA) 00-1 (101), Alcohol Based Hand Rub Solutions, an amendment to the 2000 edition of the Life Safety Code, published by the National Fire Protection Association (NFPA). This amendment allows certain health care facilities to place alcohol-based hand rub dispensers in egress corridors under specified conditions. This final rule also requires that nursing facilities at least install battery-operated single station smoke alarms in resident rooms and common areas if they are not fully sprinklered or they do not have system-based smoke detectors in those areas. Finally, this final rule confirms as final the provisions of the March 25, 2005 interim final rule with changes and responds to public comments on that rule.     

Medicare program; physician fee schedule update for calendar year 2003. Final rule

This final rule revises the estimates used to establish the sustainable growth rates (SGRs) for fiscal years 1998 and 1999 for the purposes of determining future updates to the physician fee schedule and announces a 1.6 percent increase in the calendar year (CY) 2003 physician fee schedule conversion factor (CF) for March 1 to December 31, 2003. The physician fee schedule CF from March 1 to December 31, 2003, will be $36.7856. The anesthesia CF for this period will be $17.05. Any information contained in this final rule related to the CY 2003 physician or anesthesia CFs takes the place of the information contained in the December 31, 2002, final rule. All other provisions of the December 31, 2002, final rule are unchanged by this final rule.     

Medicare and Medicaid programs: reporting outcome and assessment information set data as part of the conditions of participation for home health agencies. Final rule

This final rule makes revisions in response to public comments received on the January 25, 1999 interim final rule with comment period (64 FR 3748). The interim final rule requires electronic reporting of data from the Outcome and Assessment Information Set as a Condition of Participation for home health agencies.