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Medicare program; establishment of an expedited review process for Medicare beneficiaries enrolled in health maintenance organizations, competitive medical plans, and health care prepayment plans--HCFA. Final rule with comment period.

This final rule with comment period establishes a new administrative review requirement for Medicare beneficiaries enrolled in health maintenance organizations (HMOs), competitive medical plans (CMPs), and health care prepayment plans (HCPPs). This rule implements section 1876(c)(5) of the Social Security Act, which specifies the appeal and grievance rights for Medicare enrollees in HMOs and CMPs. This rule requires that an HMO, CMP, or HCPP establish and maintain, as part of the health plan's appeals procedures, an expedited process for making organization determinations and reconsidered determinations when an adverse determination could seriously jeopardize the life or health of the enrollee or the enrollee's ability to regain maximum function. This rule also revises the definition of appealable determinations to clarify that it includes a decision to discontinue services.

Centers for Medicare and Medicaid Services, U.S.↗

Medicaid program; allocation of enhanced federal matching funds for increased administrative costs resulting from welfare reform--HCFA. Notice with comment period.

This notice with comment period announces the methodology used to determine the allocation, among the States and certain Territories, of a $500 million fund to assist them with the additional expenses attributable to eligibility determinations incurred as a result of the provisions of the Personal Responsibility and Work Opportunity Reconciliation Act of 1996, which decouples Medicaid eligibility from receipt of cash assistance for families and children. Also, it announces the actual allocation amount for each State and Territory. The special fund is available for matching a State's or Territory's allowable administrative expenditures incurred only during Federal fiscal years 1997 through 2000, and only during the first 12 calendar quarters in which the State's Temporary Assistance to Needy Families program, which replaced the Aid to Families with Dependent Children program, is in effect after August 21, 1996.

Centers for Medicare and Medicaid Services, U.S.↗

Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (PRWORA); interpretation of "federal means-tested public benefit"--HHS. Notice with comment period.

This notice with comment period interprets the term "Federal means-tested public benefit[s]" as used in Title IV of the Personal Responsibility and work Opportunity Reconciliation Act of 1996 (PRWORA), Pub. L. 104-193, to include only mandatory spending programs of the Federal Government in which eligibility for the program's benefits, or the amount of such benefits or both, are determined on the basis of income or resources of the eligibility unit seeking the benefit. At HHS, the benefit programs that fall within this definition (and are not explicitly excerted from the definition by Section 403 (c)) are Medicaid and Temporary Assistance for Needy Families (TANF).

Eligibility Determination↗

Medicare program; changes to the hospital inpatient prospective payment systems and fiscal year 1998 rates--HCFA. Final rule with comment period.

We are revising the Medicare hospital inpatient prospective payment systems for operating costs and capital-related costs to implement necessary changes resulting from the Balanced Budget Act of 1997, Pub. L. 105-33, and changes arising from our continuing experience with the systems. In the addendum to this final rule with comment period, we describe changes in the amounts and factors necessary to determine prospective payment rates for Medicare hospital inpatient services for operating costs and capital-related costs. Generally, these changes are applicable to discharges occurring on or after October 1, 1997. We also set forth rate-of-increase limits and changes for hospitals and hospital units excluded from the prospective payment systems.

Capital Expenditures↗

Medicare program; carrier jurisdiction for claims for durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) and other issues involving suppliers, and criteria and standards for evaluating regional DMEPOS carriers--HCFA. Final rule with comment period.

This final rule Modifies regulations to provide that claims for durable medical equipment, prosthetics, orthotics and certain other items covered under part B of Medicare be processed by designated carriers. Specifies the jurisdictions each designated carrier will serve. Changes the method by which claims for these items are allocated among the carriers from "point of sale" to "beneficiary residence." Establishes certain minimum standards for suppliers for purposes of submitting the above claims. Incorporates in regulations certain supplier disclosure requirements imposed under section 4164 of the Omnibus Budget Reconciliation Act of 1990, as part of the process for issuing and renewing a supplier's billing number. Describes the criteria and standards to be used beginning October 1, 1993 for evaluating the performance of designated carriers processing claims for durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) in the administration of the Medicare program. Section 1842(b)(2) of the Social Security Act requires us to publish criteria and standards against which we evaluate Medicare carriers for public comment in the Federal Register. We expect the above changes to lead to more efficient and economical administration of the Medicare program.

Durable Medical Equipment↗

Medicare program; fee schedule for physicians' services for calendar year 1993--HCFA. Final notice with comment period.

This final notice with comment period announces the final relative value units (RVUs) for Medicare payment for existing procedure codes under the physician fee schedule and interim RVUs for new and revised codes. Section 6102(a) of the Omnibus Budget Reconciliation Act of 1989, as amended by section 4118 of the Omnibus Budget Reconciliation Act of 1990, requires establishment of the physician fee schedule and periodic review and adjustment of the RVUs.

Centers for Medicare and Medicaid Services, U.S.↗

Physician performance standard rates of increase for federal fiscal year 1993 and physician fee schedule update for calendar year 1993--HCFA. Final notice with comment period.

This notice announces the calendar year (CY) 1993 updates to the Medicare physician fee schedule and the Federal fiscal year (FY) 1993 performance standard rates of increase for expenditures and volume of physician services under the Medicare Supplementary Medical Insurance (Part B) program as required by sections 1848(d) and (f), respectively, of the Social Security Act. It also sets forth an "initial" procedure-specific list of surgical and nonsurgical services to be used in applying the CY 1993 updates. These surgical and nonsurgical designations are subject to public comment. The physician performance standard rates of increase for Federal FY 1993 are 10.0 percent for all physician services, 8.4 percent for surgical services, and 10.8 percent for nonsurgical services. The fee schedule update for CY 1993 is 3.1 percent for surgical services and 0.8 percent for nonsurgical services.

Abstracting and Indexing↗

Medicare, Medicaid and CLIA programs; regulations implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and Clinical Laboratory Improvement Act Program fee collection--HCFA. Final rule with comment period.

In the February 28, 1992, issue of the Federal Register (57 FR 7002), the Department of Health and Human Services established rules that set forth the test performance requirements for laboratories that are subject to the CLIA requirements. This rule corrects both typographical and technical errors made in that document as well as provides some additional clarification after a limited review of the comments we received after the publication of the rule.

Certification↗

Medical devices; illustrative and designated lists for device tracking--FDA. Final rule and request for comments.

The Food and Drug Administration (FDA) is amending the medical device tracking regulations to add the temporo-mandibular joint prostheses to the illustrative list of devices and the penile inflatable implant to the list of devices designated for tracking. These devices are being added to the illustrative and designated device lists based on the significance of the risk to health posed by their use. This action requires manufacturers to track these devices after distribution so that they can be located in the event of a recall or patient notification action. FDA requests comments on these changes. Elsewhere in this issue of the Federal Register, the agency is announcing notification of the change of status of the device tracking regulations and is suspending the effective date of the regulations until August 29, 1993.

Equipment Safety↗

Medicaid program: redeterminations of Medicaid eligibility due to welfare reform--HCFA. Final rule with comment period.

The Personal Responsibility and Work Opportunity Reconciliation Act of 1996 and the Contract with America Advancement Act of 1996 created changes in Federal law affecting the eligibility of large numbers of Medicaid recipients. These changes include revisions to the definition of disability for children and to the eligibility requirements of non-U.S. citizens and individuals receiving disability cash assistance based on a finding of alcoholism and drug addiction. This final rule with comment period protects Federal financial participation (FFP) in State Medicaid expenditures for states with unusual volumes of eligibility redeterminations caused by these recent changes in the law. We are making changes to the regulations to provide for additional time for States to process these redeterminations and provide services pending the redeterminations.

Alcoholism↗

Notice of specific list for categorization of laboratory test systems, assays, and examinations by complexity--CDC. Notice with comment period.

Regulations codified at 42 CFR 493.17, implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA), Public Law 100-578, require that the Secretary provide for the categorization of specific laboratory test systems, assays, and examinations by level of complexity. The criteria for such categorizations also are set forth in those regulations. This Notice announces the addition of approximately 1,300 test systems, assays, and examinations that have been categorized and notified between June 7, 1996 and December 31, 1996. These categorizations were effective on the issue date of the notification letter sent to the manufacturer and are subject to the 30 day comment period for this Notice.

Centers for Disease Control and Prevention, U.S.↗

Guidelines for the use of antiretroviral agents in pediatric HIV infection--HRSA. Request for comments.

The Health Resources and Services Administration (HRSA) is requesting comments from all interested parties on the following document: "Guidelines for Use of Antiretroviral Agents in Pediatric HIV Infection". The document was developed by specialists in the care of HIV-infected infants, children and adolescents, family members of HIV-infected children, and governmental agency representatives at a meeting on July 9 and 10, 1997, convened by the National Pediatric and Family HIV Resource Center (NPHRC) and HRSA. While the pathogenesis of HIV infection and the general virologic and immunologic principles underlying the use of antiretroviral therapy are similar for all HIV infected individuals, there are therapeutic and management considerations that are unique to HIV infected infants, children and adolescents. These include acquisition of infection through perinatal exposure for many infected children; in utero exposure to zidovudine (ZDV) and other antiretroviral medications in many perinatally-infected children; differences in diagnostic evaluation in perinatal infection; differences in immunologic markers (e.g. CD4+ lymphocyte count) in young children; changes in pharmacokinetic parameters with age due to the continuing development and maturation of organ systems involved in drug metabolism and clearance; differences in the clinical and virologic manifestations of perinatal HIV infection secondary to the occurrence of primary infection in a still-developing, immunologically naive individual; and special considerations related to treatment adherence in children and adolescents. This document addresses the pediatric-specific issues related to antiretroviral treatment and provides general guidelines to physicians caring for infected children and adolescents.

Adolescent↗

Medicare program; schedules of limits and prospectively determined payment rates for skilled nursing facility inpatient routine service costs--HCFA. Final notice with comment period.

This final notice with comment period sets forth an updated schedule of limits on skilled nursing facility (SNF) routine service costs for which payment may be made under the Medicare program and sets forth an updated schedule of payment rates for low Medicare volume SNFs that elect to receive prospectively determined payment rates for routine service costs. Section 1888(a) of the Social Security Act (the Act) requires that the Secretary update the per diem cost limits for SNF routine service costs for cost reporting periods beginning on or after October 1, 1995, and every 2 years thereafter. In addition, section 1888(d)(4) of the Act requires the Secretary to establish and publish prospectively determined payment rates at least 90 days prior to the beginning of the Federal fiscal year (FY) to which such rates are to be applied.

Centers for Medicare and Medicaid Services, U.S.↗

Medicare program; home health agency physician certification regulations--HCFA. Decision to reexamine interpretations, with comment.

This document with comment period announces our decision to reexamine our recent interpretations of the Medicare regulations pertaining to indirect compensation arrangements between home health agencies (HHAs) and physicians who certify or recertify the need for home health services or establish or review the home health plan of care. We are withdrawing recent interpretations regarding indirect compensation arrangements where the physicians are salaried employees of, or have a contractual arrangement to provide services for, an entity that also owns the HHA. This will enable us to evaluate our recent interpretations of these regulations and related provisions of section 1877 of the Social Security Act to ensure consistent application of Medicare policy among providers of services.

Centers for Medicare and Medicaid Services, U.S.↗

Medicare+Choice program; collection of user fees from Medicare+Choice plans and risk-sharing contractors--HCFA. Interim final rule with request for comments.

This interim final rule with a request for comments establishes the methodology that will be employed to assess fees applicable to Medicare risk-sharing contractors for fiscal year (FY) 1998. Under section 4002 of the Balanced Budget Act of 1997, these contractors must contribute their pro rata share of costs relating to beneficiary enrollment, dissemination of information, and certain counseling and assistance programs. The Medicare+Choice regulation to be published in June of 1998 will implement this requirement for Medicare+Choice plans.

Aged↗

Diagnostic x-ray equipment performance standard; request for comments and information--FDA. Advance notice of proposed rulemaking.

The Food and Drug Administration (FDA) is announcing its intention to propose amendments to the performance standard for diagnostic x-ray systems and their major components. The agency is taking this action to address changes in the technology and use of radiographic and fluoroscopic systems. The agency is issuing this advance notice of proposed rulemaking (ANPRM) in accordance with its policy of early public disclosure of rulemaking activities. The FDA is soliciting comments and information from interested persons concerning the subject matter of the proposed amendments.

Device Approval↗

Medicare program; limit on the valuation of a depreciable asset recognized as an allowance for depreciation and interest on capital indebtedness after a change of ownership--HCFA. Final rule with comment period.

This final rule with comment period revises the Medicare provider reimbursement regulations relative to allowable costs and sets a limit on the valuation of a depreciable asset that may be recognized in establishing an appropriate allowance for depreciation and for interest on capital indebtedness after a change of ownership that occurs on or after December 1, 1997. These provisions apply to providers that are reimbursed on the basis of reasonable costs. This change implements the mandate in section 4404 of the Balanced Budget Act of 1997 (Pub. L. 105-33).

Capital Financing↗

Medicare program; physicians' referrals; issuance of advisory opinions--HCFA. Final rule with comment period.

This final rule with comment period incorporates into HCFA's regulations the provisions of section 1877(g)(6) of the Social Security Act (the Act), as added by section 4314 of the Balanced Budget Act of 1997. Section 1877(g)(6) requires that the Secretary issue written advisory opinions to outside parties concerning whether the referral of a Medicare patient by a physician for certain designated health services (other than clinical laboratory services) is prohibited under the physician referral provisions in section 1877 of the Act. Section 1877 not only prohibits certain referrals under the Medicare program, but also affects Federal financial participation payments to States under the Medicaid program for medical assistance consisting of designated health services furnished as the result of certain physician referrals. This final rule sets forth the specific procedures HCFA will use to issue advisory opinions.

Centers for Medicare and Medicaid Services, U.S.↗