Clinical Laboratories Improvement Act program; granting and withdrawal of deeming authority to private nonprofit accreditation organizations and of CLIA exemption under state laboratory programs--HCFA. Final rule

This rule permits HCFA to approve or disapprove accreditation organizations and State laboratory programs and thereby determine that laboratories accredited by a HCFA-approved private, nonprofit accreditation organization are deemed to meet the requirements set forth in 42 CFR part 493 of the regulations, which implement section 353 of the Public Health Service Act (PHSA) or, in the case of State laboratory programs, are exempt from the requirements. Section 353 of the PHSA was enacted by the Clinical Laboratories Improvement Act of 1967 (CLIA '67) and was amended by the Clinical Laboratory Improvement Amendments of 1988 (CLIA).     

Medicare program; Medicare and Laboratory Certification Program; enforcement procedures for laboratories--HCFA. Correction notice

In the February 28, 1992 issue of the Federal Register (FR Doc. 92-4050) (57 FR 7218), we established rules for sanctions that HCFA may impose on laboratories that are found not to meet Federal requirements. This notice corrects both typographical and technical errors made in that document.     

Medicare program; required laboratory procedures for rural health clinics--HCFA. Final rule with comment period

This rule revises the range of laboratory tests rural health clinics (RHCs) are required to provide in order to meet the Medicare conditions of participation. We are eliminating tests not classified as waived under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). RHCs that elect to furnish tests not waived under CLIA must comply with CLIA requirements as specified in regulations on Laboratory Requirements and will receive appropriate payment for covered laboratory services. We are making these changes because the CLIA program introduced participation requirements that may cause some RHCs to withdraw from the program, creating a shortage of available medical care in some areas.     

CLIA program; fee schedule revision--HCFA. General notice with comment period

This notice updates the certificate fees for laboratories established under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) consistent with the methodology set forth in 42 CFR part 493. Section 353 (m) of the Public health Service Act requires that fees be collected to recoup costs of general administration of the CLIA Program. By economizing at every opportunity, the CLIA program has managed to maintain the fees established in 1992 and has absorbed all increases in costs. Revisions to the fees are necessary because the current fees are no longer sufficient to support the administration of the CLIA program. This restructuring of fees will move equitably distribute fees across all sizes and complexity of laboratories. For purposes of simplification, this notice announces a flat fee of $100 for a certificate of registration.     

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.     

CLIA program; approval of the College of American Pathologists--HCFA. Notice

This notice announces the approval of the College of American Pathologists (CAP) as an accrediting organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program. We have found that the accreditation process of this organization provides reasonable assurance that the laboratories accredited by it meet the conditions required by Federal law and regulations. Consequently, laboratories that voluntarily become accredited by CAP in lieu of receiving direct Federal oversight and continue to meet CAP requirements would meet the CLIA condition level requirements for laboratories and therefore are not subject to routine inspection by State survey agencies to determine their compliance with Federal requirements. They are, however, subject to validation and complaint investigation surveys.     

Medicare program; Medicare secondary payer for individuals entitled to Medicare and also covered under group health plans--HCFA. Final rule with comment period

These regulations establish limits on Medicare payment for services furnished to individuals who are entitled to Medicare on the basis of disability and who are covered under large group health plans (LGHPs) by virtue of their own or a family member's current employment status with an employer; and prohibit LGHPs from taking into account that those individuals are entitled to Medicare on the basis of disability. They also implement certain other provisions of section 1862(b) of the Social Security Act, as amended by the Omnibus Budget Reconciliation Acts of 1986, 1989, 1990, and 1993 and the Social Security Act Amendments of 1994. Those amendments affect the Medicare secondary payer rules for individuals who are entitled to Medicare on the basis of age or who are eligible or entitled on the basis of end stage renal disease and who are also covered under group health plans (GHPs). The provisions that apply to all three groups include-- The rules under which HCFA determines that a GHP or LGHP is not in conformance with the requirements and prohibitions of the statute; The appeals procedures respecting GHPs and LGHPs that HCFA finds to be nonconforming. The referral of nonconforming plans to the Internal Revenue Service; and The rules for recovery of conditional or mistaken Medicare payments made by HCFA. The intent of the MSP provisions is to ensure that Medicare does not pay primary benefits for services for which a GHP or LGHP is the proper primary payer and that beneficiaries covered under these plans are not disadvantaged vis-a-vis other individuals who are covered under the plan but are not entitled to Medicare.     

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

This final rule revises regulations applicable to laboratories and implements provisions of the Clinical Laboratory Improvement Amendments of 1988 (CLIA), Public Law 100-578. The regulation applies to laboratories that examine human specimens for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings. They specify the performance requirements, based on 19 test complexity and risk factors related to erroneous test results, that apply to laboratories that are subject to CLIA. They also list requirements for laboratories performing certain limited testing to be eligible for a certificate of waiver. These laboratories will not be inspected routinely, nor will they be required to meet certain other CLIA requirements.     

Medicare, Medicaid and CLIA programs; revision of the laboratory regulations for the Medicare, Medicaid, and Clinical Laboratories Improvement Act of 1967 programs--HCFA. Final rule with comment period

This rule revises regulations for laboratories regulated under the Medicare, Medicaid and Clinical Laboratories Improvement Act of 1967 (CLIA '67) programs. The revisions recodify the regulations for these programs into a new part 493 in order to simplify administration and unify the health and safety requirements for all programs as much as possible. We will now have a single set of regulations for the three programs, with an additional subpart for the licensure procedures unique to the CLIA program. We are revising the regulations to remove outdated, obsolete and redundant requirements, make provision for new technologies and place increased reliance on outcome measures of performance. We provide for new uniform proficiency testing standards. We have also added requirements for additional specialties, such as clinical cytogenetics. We also implement the now and self-implementing provisions of the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88).     

Medicare and Medicaid programs; OBRA '87 conforming amendments--HCFA. Final rule with comment period

These regulations amend certain sections of Medicare and Medicaid rules to reflect 15 self-executing provisions of the Omnibus Budget Reconciliation Act of 1987 (OBRA '87) and changes made by sections 102, 103, and 211(b) of the Medicare Catastrophic Coverage Act of 1988 (MCCA), section 608(d)(3)(G) of the Family Support Act of 1988 (Pub. L. 100-485), and sections 6113 and 6301 of the Omnibus Budget Reconciliation Act of 1989 (OBRA '89). They also clarify related rules. The amendments are needed to make HCFA rules consistent with current provisions of law and to ensure that users of the regulations are not confused by outdated provisions or unclear language. This document also makes technical amendments, primarily to correct internal cross-references, make nomenclature changes, and revise an outdated definition.     

Approval of the Commission on Office Laboratory Accreditation for Immunohematology--HCFA. Notice

This notice announces the approval of the Commission on Office Laboratory Accreditation (COLA), which is an accrediting organization for clinical laboratories under the Clinical Laboratory Improvement Amendments (CLIA) program, for the addition of the full specialty of immunohematology. This approval adds immunohematology to the specialties and subspecialties approved by HCFA in a notice published in the Federal Register on December 23, 1993 (58 FR 68148). We have found that the accreditation process of this organization provides reasonable assurance that the laboratories accredited by it for immunohematology meet the conditions required by Federal law and regulations. Consequently, laboratories that voluntarily become accredited by COLA for the specialty of immunohematology in lieu of receiving direct Federal oversight and continue to meet COLA requirements would meet the CLIA immunohematology condition level requirements for laboratories. These laboratories performing immunohematology testing are not subject to routine inspection by State survey agencies to determine their compliance with applicable Federal requirements. They are, however, subject to validation and complaint investigation surveys.     

Medicare and Medicaid; eligibility for premium hospital insurance; state buy-in agreements--HCFA. Final rule with comment period

These rules-- 1. Set forth the requirements and procedures for certain individuals under age 65 to enroll and become entitled to Medicare Part A benefits through payment of monthly premiums; 2. Revise the rules on State buy-in for Medicare benefits to provide that-- After 1988, a State may, at any time, request a buy-in agreement or a modification of an existing agreement, including a modification under which the State may enroll a pay Part B premiums on behalf of a new buy-in coverage group--Qualified Medicare Beneficiaries (QMBs); and After 1989, a State may request and obtain a modification of an existing agreement, under which the State may also enroll QMB's in Part A and pay Part A premiums on their behalf. These amendments are necessary to conform HCFA rules to changes made by section 9010 of the Omnibus Budget Reconciliation Act of 1987 (OBRA '87), section 301 of the Medicare Catastrophic Coverage Act of 1988 (MCCA), and sections 6012 and 6013 of the Omnibus Budget Reconciliation Act of 1989 (OBRA '89). The purposes of the amendments are-- 1. To make it possible for certain disabled individuals to become entitled to Medicare Part A benefits that require payment of a monthly premium. The provisions apply to an individual under age 65 who loses entitlement to Medicare Part A without premiums because his or her earnings exceed the limit imposed for entitlement to social security disability benefits, on which Medicare Part A entitlement was based; and 2. To make available to States, for payment of premiums for QMBs, the administrative and cost efficiencies of the State buy-in procedures.     

Medicare program; Essential Access Community Hospitals (EACHs) and Rural Primary Care Hospitals (RPCHs)--HCFA. Final rule

These final rules set forth the requirements for designating certain hospitals as EACHs or RPCHs; the conditions that an RPCH must meet to participate in Medicare; and the rules for Medicare payment for services furnished by EACHs and RPCHs. These rules are necessary to implement sections 6003(g) and 6116 of the Omnibus Budget Reconciliation Act of 1989 (OBRA 89) and section 4008(d) of the Omnibus Budget Reconciliation Act of 1990 (OBRA 90). The amendments are intended to promote regionalization of rural health services in grant States, improve access to hospital and other health services for rural residents, and enhance the provision of emergency and other transportation services related to health care.     

Medicare, Medicaid and CLIA programs; extension of certain effective dates for clinical laboratory requirements and personnel requirements for cytologists--HCFA. Final rule with comment period

This final rule extends certain effective dates for clinical laboratory requirements in regulations published on February 28, 1992, which implemented provisions of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and announces our approval of a certifying organization for qualifying cytotechnologists. This rule extends the date by which an individual must enroll in an HCFA-approved cytology proficiency testing (PT) program and the date by which an individual with a doctoral degree must possess board certification to qualify as a director of a laboratory that performs high complexity testing. In addition, we are extending the phase-in of the quality control requirements applicable to unmodified, moderate complexity tests cleared for commercial distribution by the Food and Drug Administration (FDA). We are extending the date to meet applicable CLIA QC requirements for laboratories using commercial, nonmodified tests to fulfill certain quality control (QC) requirements. These effective date extensions do not reduce the current requirements for quality test performance. The date extensions are necessary due to the limited number and scope of currently operating cytology PT programs, resource constraints that have prevented commencement of the substantial number of quality control reviews, and inability of many laboratory directors to complete certification requirements within the time period originally specified.     

Medicare program; granting and withdrawal of deeming authority to national accreditation organizations--HCFA. Final rule

This rule implements section 1865(a) of the Social Security Act, as amended by sections 2345 and 2346 of the Deficit Reduction Act of 1984 and section 6019 of the Omnibus Budget Reconciliation Act of 1989. The amendments expand the types of providers and suppliers of services that we may consider to meet conditions of participation or certification, nursing home requirements, or conditions for coverage by virtue of their accreditation by a national accreditation program; these providers and suppliers are also subject to validation surveys. The rule also extends confidentiality to accreditation surveys, other than home health agency surveys, done by accreditation programs in addition to the Joint Commission on Accreditation of Healthcare Organizations, except that we may disclose survey and related information to the extent that such information relates to an enforcement action we take on the basis of accreditation survey findings. The rule also provides for: the release to, and use by, HCFA of all accreditation surveys and other relevant information even if a provider or supplier is not subject to a validation survey; the removing of deemed status of a facility based on a validation survey, an accreditation survey, or other information related to either; and appeal procedures for denied or withdrawn approval.     

Medicare program; payment to health maintenance organizations and competitive medical plans--HCFA. Final rules with comment period

These regulations implement section 114 of the Tax Equity and Fiscal Responsibility Act of 1982 by authorizing Medicare reimbursement for health care services to eligible health maintenance organizations (HMOs) and competitive medical plans (CMPs) on a prospective basis for those entities that have a risk contract or on a reasonable cost basis for those that have a cost contract. The regulations set forth the requirements that an entity must meet in order to be: Eligible to enter into a Medicare contract (either risk or reasonable cost) as an eligible organization; and Reimbursed by Medicare on a capitation basis (either prospectively or retrospectively) for items and services furnished to Medicare enrollees. In addition, these regulations implement sections 2322 and 2350 (b) and (c) of Pub. L. 98-369 (Deficit Reduction Act of 1984), which further amended the Social Security Act concerning payments to HMOs and CMPs.     

Medicare program; physician financial relationships with, and referrals to, health care entities that furnish clinical laboratory services and financial relationship reporting requirements--HCFA. Final rule with comment period

This final rule with comment period provides that, if a physician or a member of a physician's immediate family has a financial relationship with an entity, the physician may not make referrals to the entity for the furnishing of clinical laboratory services under the Medicare program, except under specified circumstances. It contains revisions to our proposal of March 11, 1992, based on comments submitted by the public. Further, it incorporates the new expansions and exceptions created by the Omnibus Budget Reconciliation Act of 1993 and the amendments in the Social Security Act Amendments of 1994 (SSA '94), that are related to referrals for clinical laboratory services and have a retroactive effective date of January 1, 1992. In addition, we are responding to comments received on the interim final rule with comment period (published on December 3, 1991) that set forth Medicare reporting requirements for the submission by certain health care entities of information about their relationships with physicians. That document implemented the reporting requirements of section 1877(f) of the Social Security Act. This rule revises those requirements to incorporate the amendments to section 1877(f) made by SSA '94, to apply to any further reporting we may require.     

Medicare program; qualified health maintenance organizations: technical amendments--HCFA. Final rule with comment period

This rule clarifies and updates portions of the HCFA regulations that pertain to Federal qualification and continued regulation of health maintenance organizations (HMOs), inclusion of qualified HMOs in employee health benefits plans, and the administration of outstanding loans and loan guarantees that were awarded before October 1, 1986, under the Public Health Service Act (PHS Act). This rule is part of a special project to clarify and update all of 42 CFR part 417, which contains the regulations applicable to all entities that provide prepaid health care, that is, HMOs, CMPs (competitive medical plans) and HCPPs (health care prepayment plans). These are technical and editorial changes that do not affect the substance of the regulations. They are intended to make it easier to find particular provisions, to provide overviews of the different program aspects, and to better ensure uniform understanding of the rules.     

Medicare program; reporting requirements for financial relationships between physicians and health care entities that furnish selected items and services--HCFA. Interim final rule with comment period

This interim final rule sets forth reporting requirements under the Medicare program for the submission by certain health care entities of information about their financial relationships with physicians. It implements section 1877(f) of the Social Security Act, which includes the requirements that entities furnishing Medicare covered clinical laboratory services must provide HCFA with information concerning their ownership arrangements. It also provides notice of HCFA's decision to waive the requirements of section 1877(f) with respect to certain entities that do not furnish clinical laboratory services.     

Medicare program; Medicare integrity program, intermediary and carrier functions, and conflict of interest requirements--HCFA. Proposed rule

This proposed rule would implement section 1893 of the Social Security Act (the Act) by establishing the Medicare integrity program (MIP) to carry out Medicare program integrity activities that are funded from the Medicare Trust Funds. Section 1893 expands our contracting authority to allow us to contract with "eligible entities" to perform Medicare program integrity activities. These activities include review of provider and supplier activities, including medical, fraud, and utilization review: cost report audits; Medicare secondary payer determinations; education of providers, suppliers, beneficiaries, and other persons regarding payment integrity and benefit quality assurance issues; and developing and updating a list of durable medical equipment items that are subject to prior authorization. This proposed rule would set forth the definition of eligible entities, services to be procured, competitive requirements based on Federal acquisition regulations and exceptions (guidelines for automatic renewal), procedures for identification, evaluation, and resolution of conflicts of interest, and limitations on contractor liability. In addition, this proposed rule would bring certain sections of the Medicare regulations concerning fiscal intermediaries and carriers into conformity with the Act. The rule would distinguish between those functions that the statute requires be included in agreements with intermediaries and those that may be included in the agreements. It would also provide that some or all of the listed functions may be included in carrier contracts. Currently all these functions are mandatory for carrier contracts. These changes would give us the flexibility to transfer functions from one intermediary or carrier to another or to otherwise limit the functions an intermediary or carrier performs if we determine that to do so would result in more effective and efficient program administration.