Medicare program; physicians' referrals to health care entities with which they have financial relations (Phase II); continuation of effectiveness and extension of timeline for publication of final rule. Interim final rule; continuation of effectiveness and extension of timeline for publication of final rule

This notice announces the continuation of effectiveness of a Medicare interim final rule and the extension of the timeline for publication of the final rule. This notice is issued in accordance with section 1871(a)(3)(C) of the Social Security Act (the Act), which allows an interim final rule to remain in effect after the expiration of the timeline specified in section 1871(a)(3)(B) of the Act if the Secretary publishes a notice of continuation prior to the expiration of the timeline.     

Medicare program; Medicare+Choice program. Health Care Financing Administration (HCFA), HHS. Final rule with comment period

This final rule with comment period responds to comments on the June 26, 1998 interim final rule that implemented the Medicare+Choice (M+C) program and makes revisions to those regulations where warranted. We also are making revisions to the regulations that are necessary to reflect the changes to the M+C program resulting from the Balanced Budget Refinement Act of 1999 (BBRA). Revisions to the regulations reflecting changes in the law made by the BBRA are subject to public comment. Issues discussed in this rule include eligibility, election, and enrollment policies; marketing requirements; access requirements; service area and benefit policy; quality improvement standards; payment rates, risk adjustment methodology, and encounter data submission; provider participation rules; beneficiary appeals and grievances; contractual requirements; and preemption of State law by Federal law. This final rule also addresses comments on the interim final rule published on December 2, 1997, which implemented user fees for section 1876 risk contractors for 1998, and formed the basis for the M+C user fee provisions in the June 26, 1998 interim final rule, and the provider-sponsored organization (PSO) interim final rule published April 14, 1998.     

Medicare program; changes to the Medicare+Choice program. Health Care Financing Administration (HCFA), HHS. Final rule

The purpose of this final rule is to set forth limited changes to the Medicare+Choice regulations published in our June 26, 1998 interim final rule (63 FR 34968). Those regulations implemented section 4001 of the Balanced Budget Act of 1997 (BBA), which established the Medicare+Choice (M+C) program. This final rule addresses selected issues raised by commenters on the June 26, 1998 interim final rule where we have identified the need for changes or where we believe that clarifications are needed as soon as possible. Among these issues are provider participation procedures, beneficiary enrollment options, and several access-related issues, including initial care assessment requirements, notification requirements when specialists are terminated from an M+C plan, and several coordination of care requirements.     

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.     

Medicare program; payment for durable medical equipment and orthotic and prosthetic devices--HCFA. Final rule

This final rule addresses comments received on an interim final rule with comment period published on December 7, 1992. The interim final rule implemented section 4062(b) of the Omnibus Budget Reconciliation Act of 1987. It specified that payment under the Medicare program for durable medical equipment (DME), prosthetics, and orthotics furnished on or after January 1, 1989 is limited to the lower of the actual charge for the equipment or the fee schedule amount established by the carrier. This final rule describes amendments to the methods for computing fee schedules covering the six classes of DME and how they are updated in subsequent years in accordance with sections 13542 through 13546 of the Omnibus Budget Reconciliation Act of 1993.     

Medicare and Medicaid programs; programs of all-inclusive care for the elderly (PACE); program revisions. Final rule

This rule finalizes the interim final rule with comment period published in the Federal Register November 24, 1999 (64 FR 66234) and the interim final rule with comment period published in the Federal Register on October 1, 2002 (67 FR 61496). The November 1999 interim final rule implemented sections 4801 through 4803 of the Balanced Budget Act of 1997 (Pub. L. 105-33) and established requirements for Programs of All-inclusive Care for the Elderly (PACE) under the Medicare and Medicaid programs. The interim final rule with comment period published on October 1, 2002 (67 FR 61496) implemented section 903 of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA) (Pub. L. 106-554).     

Medicare program; prospective payment system and consolidated billing for skilled nursing facilities. Department of Health and Human Services (HHS), Health Care Financing Administration (HCFA). Final rule

This final rule responds to comments submitted by the public on our May 12, 1998 interim final rule, that implemented provisions in section 4432 of the Balanced Budget Act of 1997 regarding Medicare payment for skilled nursing facility services. This legislation established a prospective payment system, a consolidated billing provision, and a number of related changes.     

Medicare program; physicians' referrals to health care entities with which they have financial relationships (Phase III). Final rule

This final rule is the third phase (Phase III) of a final rulemaking amending our regulations regarding the physician self-referral prohibition in section 1877 of the Social Security Act (the Act). Specifically, this rule finalizes, and responds to public comments regarding, the Phase II interim final rule with comment period published on March 26, 2004, which set forth the self-referral prohibition and applicable definitions, interpreted various statutory exceptions to the prohibition, and created additional regulatory exceptions for arrangements that do not pose a risk of program or patient abuse (69 FR 16054). In general, in response to public comments, in this Phase III final rule, we have reduced the regulatory burden on the health care industry through the interpretation of statutory exceptions and modification of the exceptions that were created using the Secretary's discretionary authority under section 1877(b)(4) of the Act to promulgate exceptions for financial relationships that pose no risk of program or patient abuse.     

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.     

Tribal child welfare. Interim final rule

The Administration for Children and Families (ACF) is issuing this interim final rule to implement statutory provisions related to the Tribal title IV-E program. Effective October 1, 2009, section 479B(b) of the Social Security Act (the Act) authorizes direct Federal funding of Indian Tribes, Tribal organizations, and Tribal consortia that choose to operate a foster care, adoption assistance and, at Tribal option, a kinship guardianship assistance program under title IV-E of the Act. The Fostering Connections to Success and Increasing Adoptions Act of 2008 requires that ACF issue interim final regulations which address procedures to ensure that a transfer of responsibility for the placement and care of a child under a State title IV-E plan to a Tribal title IV-E plan occurs in a manner that does not affect the child's eligibility for title IV-E benefits or medical assistance under title XIX of the Act (Medicaid) and such services or payments; in-kind expenditures from third-party sources for the Tribal share of administration and training expenditures under title IV-E; and other provisions to carry out the Tribal-related amendments to title IV-E. This interim final rule includes these provisions and technical amendments necessary to implement a Tribal title IV-E program.     

Grants to states for operation of qualified high risk pools. Final rule

This final rule implements a provision of the Trade Adjustment Assistance Reform Act of 2002 by providing $40 million in Federal fiscal year 2003 and $40 million in Federal fiscal year 2004 to States that have incurred losses in connection with the operation of qualified high risk pools that meet certain criteria. This final rule also addresses comments received in response to the interim final rule that was published on May 2, 2003. This grant program implements section 2745 of the Public Health Service Act, as added by the Trade Adjustment Assistance Reform Act of 2002.     

Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); enhancement of dental benefits under the TRICARE retiree dental program. Office of the Secretary, DoD. Interim final rule with request for comments

This interim final rule implements section 704 of the National Defense Authorization Act for Fiscal Year 2000, to allow additional benefits under the retiree dental insurance plan for Uniformed Services retirees and their family members that may be comparable to those under the Dependents Dental Program. The Department is publishing this rule as an interim final rule in order to comply timely with the desire of Congress to meet the needs of retirees for additional dental coverage. Public comments are invited and will be considered for possible revisions to this rule at the time of publication of the final rule.     

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.     

Countermeasures Injury Compensation Program (CICP): administrative implementation, interim final rule. Interim final rule with request for comments

The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (the Secretary) to establish the Countermeasures Injury Compensation Program (CICP or Program). The Department of Health and Human Services (HHS) is issuing this interim final rule with request for comments in order to establish administrative policies, procedures, and requirements for the CICP. This Program is designed to provide benefits to certain persons who sustain serious physical injuries or death as a direct result of administration or use of covered countermeasures identified by the Secretary in declarations issued under the PREP Act. In addition, the Secretary may provide death benefits to certain survivors of individuals who died as the direct result of such covered injuries or their health complications. The Secretary is seeking public comments on this interim final rule.     

Medicare program; beneficiary counseling and assistance grants program--HCFA. Interim final rule with comment period

This interim final rule establishes a minimum level of funding for grants made to States for the purpose of providing information, counseling, and assistance relating to the procurement of adequate and appropriate health insurance coverage to individuals who are eligible to receive benefits under the Medicare program. This rule implements, in part, section 4360(a) of the Omnibus Budget Reconciliation Act of 1990.     

Establishment of the permanent certification program for health information technology. Final rule

This final rule establishes a permanent certification program for the purpose of certifying health information technology (HIT). This final rule is issued pursuant to the authority granted to the National Coordinator for Health Information Technology (the National Coordinator) by section 3001(c)(5) of the Public Health Service Act (PHSA), as added by the Health Information Technology for Economic and Clinical Health (HITECH) Act. The permanent certification program will eventually replace the temporary certification program that was previously established by a final rule. The National Coordinator will use the permanent certification program to authorize organizations to certify electronic health record (EHR) technology, such as Complete EHRs and/or EHR Modules. The permanent certification program could also be expanded to include the certification of other types of HIT.     

Medicaid program; home and community-based services waivers for individuals age 65 or older--HCFA. Interim final rule with comment period

This interim final rule amends current Medicaid regulations to permit States to offer, under a Secretarial waiver, a wide array of home and community-based services to individuals age 65 or older who are determined, but for the provision of these services, to be likely to require the level of care furnished in a skilled nursing facility (SNF) or intermediate care facility (ICF) (nursing facility (NF) effective October 1, 1990). The rule allows Federal payment for these and other long term care services, up to an amount specified in section 1915(d)(5)(B) of the Social Security Act, subject to HCFA's approval of the States' requests for waivers and certain assurances made by the States. Once granted, waivers are in effect for 3 years, unless terminated by the State with notice to the Secretary, and are renewable for periods of 5 years. Periodic evaluation, assessment, and review of the care furnished under the waivers is required. This rule implements section 4102 of the Omnibus Budget Reconciliation Act of 1987, as modified by section 411(k) of the Medicare Catastrophic Coverage Act of 1988, section 8432 of the Technical and Miscellaneous Revenue Act of 1988, and section 4741(b) of the Omnibus Budget Reconciliation Act of 1990. This rule is being issued in final and, for the most part, without a delay in the effective date for the reasons explained in section IV, "Waiver of Proposed Rulemaking and Delay in the Effective Date."     

Medicare program; revisions to payment policies under the physician fee schedule for calendar year 2001. Health Care Financing Administration (HCFA), HHS. Final rule with comment period

This final rule with comment period makes several changes affecting Medicare Part B payment. The changes include: refinement of resource-based practice expense relative value units (RVUs); the geographic practice cost indices; resource-based malpractice RVUs; critical care RVUs; care plan oversight and physician certification and recertification for home health services; observation care codes; ocular photodynamic therapy and other ophthalmological treatments; electrical bioimpedance; antigen supply; and the implantation of ventricular assist devices. This rule also addresses the comments received on the May 3, 2000 interim final rule on the supplemental survey criteria and makes modifications to the criteria for data submitted in 2001. Based on public comments we are withdrawing our proposals related to the global period for insertion, removal, and replacement of pacemakers and cardioverter defibrillators and low intensity ultrasound. This final rule also discusses or clarifies the payment policy for incomplete medical direction, pulse oximetry services, outpatient therapy supervision, outpatient therapy caps, HCPCS "G" Codes, and the second 5-year refinement of work RVUs for services furnished beginning January 1, 2002. In addition, we are finalizing the calendar year (CY) 2000 interim physician work RVUs and are issuing interim RVUs for new and revised codes for CY 2001. We are making these changes to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services. This final rule also announces the CY 2001 Medicare physician fee schedule conversion factor under the Medicare Supplementary Medical Insurance (Part B) program as required by section 1848(d) of the Social Security Act. The 2001 Medicare physician fee schedule conversion factor is $38.2581.