Medicare program; payment for physician outpatient maintenance dialysis services and other physician services for ESRD patients--HCFA. Final rule

This final rule reinstates a modified version of the initial method of payment for physician dialysis services and clarifies and modifies some of the principles of the monthly capitation payment method. Under both the initial method and the monthly capitation payment method, we specify that, to be payable, physician services must meet certain requirements that distinguish services furnished to individual patients from services furnished to facilities that benefit the facilities' patients generally. The reinstatement of a modified version of the initial method is necessitated by a court order.     

Child support enforcement program; extension of services to Medicaid recipients and to former AFDC recipients--Office of Child Support Enforcement, HHS. Final rule

These final rules implement sections 9141 and 9142 of Public Law 100-203, the Omnibus Budget Reconciliation Act of 1987, which amended title IV-D of the Social Security Act (the Act). Section 9141, effective December 22, 1987, amended section 457(c) of the Act to require State child support enforcement (IV-D) agencies to provide appropriate notice and to continue to provide IV-D services to persons no longer eligible for Aid to Families with Dependent Children (AFDC) under title IV-A of the Act. The IV-D agency must continue to provide services and pay any amount of support collected to the family on the same basis and under the same conditions as pertain to other non-AFDC families, except that no application, other request to continue services or any application fee for services may be required. Section 9142, effective July 1, 1988, amended section 454 of the Act to require State IV-D agencies to provide IV-D services to families who receive Medicaid and have assigned to the State, under section 1912 of the Act, their rights to medical support and to payment of medical care from any third party, and to provide for distribution by the State of medical support collections under section 1912 of the Act.     

Medicare program; Medicare and laboratory certification program; enforcement procedures for laboratories--HCFA. Final rule

These regulations set forth the rules for sanctions that HCFA may impose on laboratories that are found not to meet Federal requirements. These include the principal sanctions of suspending, limiting, or revoking the laboratory's certificate issued under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), and cancelling the laboratory's approval to receive Medicare payment for its services, and the alternative sanctions that may be imposed instead of or before the principal sanctions. These amendments are necessary to conform HCFA regulations to changes made in the law by the Omnibus Budget Reconciliation Act of 1987 (OBRA '87) and the 1988 amendments to section 353 of the Public Health Service Act (PHS Act). The latter are commonly referred to as "CLIA 88". The purpose of the amendments is to ensure that functioning laboratories are capable of providing accurate and reliable test results and that the health of individuals served by the laboratory and that of the general public is not adversely affected by laboratory operations and by testing procedures that do not meet the standards set forth in other subparts of part 493 of the HCFA regulations.     

Administrative practices and procedures; promulgation of regulations for the efficient enforcement of law--FDA. Final rule

The Food and Drug Administration (FDA) is amending its regulation governing notice-and-comment (informal) rulemaking by removing from the regulation the requirement that the agency issue interpretative rules and rules of agency practice and procedure by informal rulemaking. As amended, the regulation provides that informal rulemaking procedures by followed to the extent required by the Administrative Procedure Act.     

Access charges; MTS and WATS market structure--Federal Communications Commission. Final rule

FCC, pursuant to the Fourth Supplemental Notice of Inquiry and Proposed Rulemaking published on June 21, 1982, at 47 FR 26668, adopts rules for the computation and assessment of end user and carrier's carrier access charges and the creation of an exchange carrier association to prepare access charge tariffs and distribute pooled access charge revenues. The Commission concluded that this action was necessary because existing methods of access compensation produced unlawful discrimination and preferences in interstate rates. These rules were designed to eliminate such unlawful discrimination and preferences.     

Supplements and other changes to an approved application. Final rule

The Food and Drug Administration (FDA) is amending its regulations on supplements and other changes to an approved application to implement the manufacturing changes provision of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). The final rule requires manufacturers to assess the effects of manufacturing changes on the identity, strength, quality, purity, and potency of a drug or biological product as those factors relate to the safety or effectiveness of the product. The final rule sets forth requirements for changes requiring supplement submission and approval before the distribution of the product made using the change, changes requiring supplement submission at least 30 days prior to the distribution of the product, changes requiring supplement submission at the time of distribution, and changes to be described in an annual report.     

Medicare program; application of inherent reasonableness payment policy to Medicare Part B services (other than physician services). Final rule

This final rule finalizes the process that was set forth in an interim final rule published on December 13, 2002, for establishing a realistic and equitable payment amount for Medicare Part B services (other than physicians' services) when the existing payment amounts are inherently unreasonable because they are either grossly excessive or grossly deficient. This process does not apply to services paid under a prospective payment system, such as outpatient hospital services or home health services. The December 2002 interim final rule also described the factors we (or our carriers) will consider and the procedures we will follow in establishing realistic and equitable payment amounts for Medicare Part B services. In addition, this final rule responds to public comments we received on two provisions in the December 13, 2002 interim final rule relating to how we define grossly excessive or deficient payment amounts and to the criteria for using valid and reliable data in applying the inherent reasonableness authority.     

Medicare program; prior determination for certain items and services. Final rule

This final rule establishes a process for Medicare contractors to provide eligible participating physicians and beneficiaries with a determination of coverage relating to medical necessity for certain physicians' services before the services are furnished. This rule is intended to afford the physician and beneficiary the opportunity to know the financial liability for a service before expenses are incurred. This final rule establishes reasonable limits on physicians' services for which a prior determination of coverage may be requested and discusses generally our plans for establishing the procedures by which those determinations may be obtained. This rule also responds to public comments on the August 30, 2005 proposed rule.     

Debarment, suspension, and ineligibility of contractors--DHHS. Final rule

The Office of the Secretary, Department of Health and Human Services, is amending the HHS Acquisition Regulation, Title 48 CFR Chapter 3, by adding a new subpart concerning debarment, suspension, and ineligibility of contractors. This new subpart will implement the provisions of Subpart 9.4, Debarment, Suspension and Ineligibility, of the Federal Acquisition Regulations.     

State Children's Health Insurance Program; eligibility for prenatal care and other health services for unborn children. Final rule

In order to provide prenatal care and other health services, this final rule revises the definition of "child" under the State Children's Health Insurance Program (SCHIP) to clarify that an unborn child may be considered a "targeted low-income child" by the State and therefore eligible for SCHIP if other applicable State eligibility requirements are met. Under this definition, the State may elect to extend eligibility to unborn children for health benefits coverage, including prenatal care and delivery, consistent with SCHIP requirements.     

Implementation of the Equal Access to Justice Act in agency proceedings--HHS. Final rule

These regulations implement the Equal Access to Justice Act, 5 U.S.C. 504 and 504 note, for the Department of Health and Human Services. They describe the circumstances under which the Department may award attorney fees and certain other expenses to eligible individuals and entities who prevail over the Department in specified administrative proceedings where the Department's position in the proceeding was not substantially justified.     

Medicare program; uniform relative value guide for anesthesia services furnished by physicians--HCFA. Final rule

We are establishing a relative value guide for use in all carrier localities in making payment for anesthesia services furnished by physicians under Medicare Part B. This final rule implements section 4048(b) of the Omnibus Budget Reconciliation Act of 1987. The relative value guide is designed to ensure that payments using the guide do not exceed the amount that would have been paid absent the guide. This final rule also implements section 6106 of the Omnibus Budget Reconciliation Act of 1989. Section 6106 revises the method under which time units are determined for anesthesia services furnished by anesthesiologists or certified nurse anesthetists on or after April 1, 1990.     

Medical facility construction and modernization; requirements for provision of services to persons unable to pay--PHS. Final rule

This document revises the rules currently governing how certain health care facilities, assisted under Titles VI and XVI of the Public Health Service Act, fulfill the assurance, given in their applications for assistance, that they would provide a reasonable volume of services to persons unable to pay. Public comment on the current rules and operational experience with them indicated the need to revise the current requirements with respect to nursing homes, many of which are unable under current requirements to meet their obligation to provide such services. The rules below should permit qualified facilities to satisfy their uncompensated services assurance.     

Medicare and Medicaid programs; hospital conditions of participation: laboratory services. Final rule

This final rule finalizes the hospital conditions of participation requirements for hospitals that transfuse blood and blood components. It requires hospitals to: Prepare and follow written procedures for appropriate action when it is determined that blood and blood components the hospitals received and transfused are at increased risk for transmitting hepatitis C virus (HCV); quarantine prior collections from a donor who is at increased risk for transmitting HCV infection; notify transfusion recipients, as appropriate, of the need for HCV testing and counseling; and extend the records retention period for transfusion-related data to 10 years. The intent is to aid in the prevention of HCV infection and to create opportunities for disease prevention that, in most cases, can occur many years after recipient exposure to a donor.     

Protecting the public and our employees in our hearing process. Final rule

We are clarifying our regulations to ensure the safety of the public and our employees in our hearing process. Due to increasing reports of threats to our hearing office employees, we are taking steps to explicitly increase the level of protection we provide to our staff and to the public during the hearing process. We expect these changes to result in a safer work environment for our employees, while at the same time ensuring that our claimants continue to receive a full and fair hearing on their claims for benefits.     

Medicare program; periodic interim payments for hospitals and other providers--HCFA. Final rule

This final rule responds to public comments on the January 21, 1988 final rule with comment period that implemented section 9311 of the Omnibus Budget Reconciliation Act of 1986. The January 21, 1988 rule described the circumstances under which the periodic interim payment (PIP) method is available for services furnished by hospitals and other providers.     

Regulation for the enforcement of federal health care provider conscience protection laws. Final rule

The Department of Health and Human Services issues this final rule which provides that enforcement of the federal statutory health care provider conscience protections will be handled by the Department's Office for Civil Rights, in conjunction with the Department's funding components. This Final Rule rescinds, in part, and revises, the December 19, 2008 Final Rule entitled "Ensuring That Department of Health and Human Services Funds Do Not Support Coercive or Discriminatory Policies or Practices in Violation of Federal Law" (the "2008 Final Rule"). Neither the 2008 final rule, nor this final rule, alters the statutory protections for individuals and health care entities under the federal health care provider conscience protection statutes, including the Church Amendments, Section 245 of the Public Health Service Act, and the Weldon Amendment. These federal statutory health care provider conscience protections remain in effect.     

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 program; fee schedules for the services of certified registered nurse anesthetists--HCFA. Final rule

We are revising the Medicare regulations to allow certified registered nurse anesthetists (CRNAs) to receive Medicare payment for the anesthesia services and related care they furnish. In addition, this final rule sets forth the fee schedules under which payment is made for the services of CRNAs, except for the services of CRNAs in certain rural hospitals who are paid on a reasonable cost basis. This rule, which is effective for services furnished on or after January 1, 1989, implements section 9320 of the Omnibus Budget Reconciliation Act of 1986, as amended by section 4084 of the Omnibus Budget Reconciliation Act of 1987, section 411(i)(3) of the Medicare Catastrophic Coverage Act of 1988, section 608(c) of the Family Support Act of 1988, and sections 6106, 6107 and 6132 of the Omnibus Budget Reconciliation Act of 1989. This final rule does not reflect the changes concerning the calculation of payment rates contained in section 1833(1)(4) of the Social Security Act, as enacted by section 4160 of the Omnibus Budget Reconciliation Act of 1990. Those changes apply to services furnished on or after January 1, 1991. Thus, the changes to the payment calculation provisions described and published below are applicable only to services furnished in calendar years 1989 and 1990.