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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).

Accreditation↗

Primary care program improves reimbursement. The Federally Qualified Health Center program helps hospitals improve services to the medically indigent.

Under a program created by Congress in 1989, certain primary care treatment centers serving the medically and economically indigent can become Federally Qualified Health Centers (FQHCs). Recently enacted rules and regulations allow participants in the FQHC program to receive 100 percent reasonable cost reimbursement for Medicaid services and 80 percent for Medicare services. An all-inclusive annual cost report is the basis for determining reimbursement rates. The report factors in such expenses as physician and other healthcare and professional salaries and benefits, medical supplies, certain equipment depreciation, and overhead for facility and administrative costs. Both Medicaid and Medicare reimbursement is based on an encounter rate, and states employ various methodologies to determine the reimbursement level. In Illinois, for example, typical reimbursement for a qualified encounter ranges from $70 to $88. To obtain FQHC status, an organization must demonstrate community need, deliver the appropriate range of healthcare services, satisfy management and finance requirements, and function under a community-based governing board. In addition, an FQHC must provide primary healthcare by physicians and (where appropriate) midlevel practitioners; it must also offer its community diagnostic laboratory and x-ray services, preventive healthcare and dental care, case management, pharmacy services, and arrangements for emergency services. Because FQHCs must be freestanding facilities, establishing them can trigger a number of ancillary legal issues, such as those involved in forming a new corporation, complying with not-for-profit corporation regulations, applying for tax-exempt status, and applying for various property and sales tax exemptions. Hospitals that establish FQHCs must also be prepared to relinquish direct control over the delivery of primary care services.

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

Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); continued health care benefit program--DoD. Interim rule.

This rule establishes a Continued Health Care Benefit Program (CHCBP) for certain DoD health care beneficiaries who lose eligibility for health care in the Military Health Services System (MHSS). It provides for use of the CHAMPUS benefit structure and CHAMPUS rules and procedures for the CHCBP and seeks public comments on our plan to implement the Continued Health Care Benefit Program.

Eligibility Determination↗

Medicaid program; drug use review program and electronic claims management system for outpatient drug claims--HCFA. Final rule.

This final rule revises some of the regulatory requirements for the drug use review (DUR) program for covered outpatient drugs furnished to recipients under the Medicaid program. The regulatory requirements became effective on January 2, 1993, as a result of an interim final rule with comment period that we published on November 2, 1992. Specifically, these revisions-- Clarify the definitions of overutilization, underutilization, consensus process, peer-reviewed literature, adverse medical result, adverse drug-drug interaction, appropriate and medically necessary, and individual medical history; Change the requirements for licensure of DUR board members, and telephone counseling arrangements for mail order pharmacies; Include non-prescription drugs in the consideration of alteration of therapeutic effect; Require hospitals to give assurances that they have met the requirements of the statute before claiming the hospital exemption from DUR; Specify the issues that State agencies must address when formulating counseling standards; Clarify the bases for DUR board recommendations; Clarify the distinction between DUR and surveillance and utilization review (SUR); and Make certain technical and editorial corrections. The November 1992 interim final rule with comment period incorporated and interpreted certain provisions of section 4401 of the Omnibus Budget Reconciliation Act of 1990.

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

Medicare and Medicaid programs; recognition of the American Association for Accreditation of Ambulatory Surgery Facilities, Inc. for Ambulatory Surgical Centers Program--HCFA. Proposed notice.

In this notice we announce the receipt of an application from the American Association for Accreditation of Ambulatory Surgery Facilities, Inc. (AAAASF) for recognition as a national accreditation program for ambulatory surgical centers that wish to participate in the Medicare or Medicaid programs. The Social Security Act requires that the Secretary publish a notice identifying the national accreditation body making the request, describing the nature of the request, and providing a 30 day public comment period.

Accreditation↗

Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); TRICARE Program; reimbursement--DoD. Final rule.

This final rule revises certain requirements and procedures for reimbursement under the CHAMPUS program, the purpose of which is to implement a comprehensive managed health care delivery system composed of military medical treatment facilities and CHAMPUS. Issues addressed in this rule include: implementation of changes made to the Medicare Prospective Payment System (PPS) upon which the CHAMPUS DRG-based payment system is modeled and required by law to follow wherever practicable, along with changes to make our DRG-based payment system operate better; clarification of payment reduction for noncompliance with required utilization of publication of list of ambulatory surgery procedures; limitation on ambulatory surgery group payment rates; extension of the balance billing limitations currently in place for individual and professional providers to non-institutional, non-professional providers; adjustment of the CHAMPUS maximum allowable charge (CMAC) rate in the small number of cases where the CMAC rate is less than the Medicare rate; implementation of the government-wide debarment rule where any provider excluded or suspended from CHAMPUS shall be excluded from all other programs and activities involving Federal financial assistance, such as Medicare or Medicaid; elimination of the requirement for non-participating providers to file claims; and revision of the ambulatory surgery cost-share information to enable the cost-share to be assessed against the facility claim instead of the primary surgeon's claim.

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

Medicaid program; early and periodic screening, diagnosis, and treatment (EPSDT) program--HCFA. Proposed rule.

This proposal would modify present regulations to conform to recent legislative changes enacted by section 2181 of Pub. L. 97-35, the Omnibus Budget Reconciliation Act of 1981. That section eliminates the penalty which reduces by one percent Federal funds for a States's Title IV-A program, Aid to Families with Dependent Children (AFDC), for any quarter during which a State fails to: (1) inform all AFDC families of the availability of early and periodic screening, diagnosis, and treatment EPSDT services; (2) provide or arrange for requested screening services; and (3) arrange for corrective treatment of health problems found. In addition, section 2181 mandates that States incorporate these three requirements into their State Medicaid plan with respect to all EPSDT eligibles. Further, this proposed rule would modify current Medicaid EPSDT regulations to reflect Congressional intent that States should continue to develop fully effective EPSDT programs; however, current requirements which entail a large volume of paperwork should be significantly streamlined.

Aid to Families with Dependent Children↗

Using a systems approach to evaluate the effectiveness of health service programs: the Health Care Facility Accreditation Program as an example.

This paper examines the value of developing a "systems" perspective of organisational/suborganisational characteristics as an aid to evaluating the effectiveness of programs within the health services context. An example of applying the theory to a specific health service program is given. The commonly used approach to evaluation--the goal attainment model--is examined in detail. It is contrasted with other approaches including systems theory. The conclusion is reached that the systems approach is more suitable as a means of structuring evaluation within the health care field.

Accreditation↗

Medicare program; end-stage renal disease program; prospective reimbursement for dialysis services and approval of special purpose renal dialysis facilities--HCFA. Final rule.

These regulations change the reimbursement system by which Medicare pays for outpatient maintenance dialysis and related physician and laboratory services. These changes establish a prospective method of payment for maintenance dialysis, whether furnished at home or in a hospital-based or independent dialysis facility, and revise other aspects of the reimbursement system to encourage home dialysis and provide incentives for economy and efficiency in furnishing these services. These amendments implement section 2145 of the Omnibus Budget Reconciliation Act of 1981. We expect that these changes will improve our administration of the end-stage renal disease program and enable us to control the rapidly growing costs of furnishing dialysis. The controls on quality of care that have been in effect since the beginning of the program will continue to apply. These regulations will also ensure access to care by providing for adequate reimbursement to isolated, essential facilities, where patients have no alternative sources of dialysis care. These regulations also provide for time-limited approval for Medicare participation of special purpose renal dialysis facilities. As a general rule we have not approved facilities such as transient or mobile units set up for emergency purposes or to serve vacationing dialysis patients in State parks and children's camps. This change in regulations will remove this limitation.

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

Medicare program; End Stage Renal Disease Program; redesignation of networks and reorganization of network organizations--HCFA. Final rule.

This final rule revises the requirements in current regulations pertaining to the End-Stage Renal Disease (ESRD) networks and organizations and establishes provisions for new, more efficient network organizations. This rule removes the criteria that define existing networks, removes the requirement that HCFA change designations of ESRD networks through rulemaking, and removes the list of currently-designated networks that now appears in regulations. It is intended that these amendments will increase the efficiency and effectiveness of the ESRD program by instituting a faster process for changing network designations and organizations as program needs arise. These amendments also permit the reduction of the number of existing networks to as few as 14, which is consistent with section 9214 of Pub. L. 99-272, the Consolidated Omnibus Budget Reconciliation Act of 1985 (COBRA).

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

Medicare program; recognition of the Community Health Accreditation Program, Inc. (CHAP) for hospices. Health Care Financing Administration (HCFA), HHS. Final notice.

This notice recognizes the Community Health Accreditation Program, Inc. (CHAP) as a national accreditation organization for hospices that request participation in the Medicare program. We believe that accreditation of hospices by CHAP demonstrates that all Medicare hospice conditions of participation are met or exceeded. Thus, we grant deemed status to those hospices accredited by CHAP. The proposed notice included the application from the Joint Commission for Accreditation of Healthcare Organizations (JCAHO). We have separated the final notices to appropriately process each application and will issue a separate final notice containing the decision for JCAHO under HCFA-2039-FN.

Accreditation↗

The Clinical Laboratory Improvement Program: not your ordinary regulatory program.

The Clinical Laboratory Improvement Amendments of 1988 (CLIA'88) established national standards of laboratory practice and test performance in the areas of registration and certification, inspection, proficiency testing, personnel qualifications, quality control, patient test management, and quality assurance. A memorandum of agreement between the Department of Health and Human Services and the Department of Defense (DOD) established the DOD Clinical Laboratory Improvement Program (CLIP) and authorized the Assistant Secretary of Defense for Health Affairs to develop CLIA'88-comparable regulations governing DOD laboratories. In implementing the DOD program, the CLIA'88 regulations were adopted to the maximum extent possible and modified only as required to meet those unique DOD missions that precluded compliance. This article provides an abbreviated historical background on CLIA'88/CLIP, defines the testing categories identified under the CLIP regulations, and briefly describes the process for application and requirements for compliance.

Accreditation↗

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.

Budgets↗

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".

Eligibility Determination↗

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.

Government Agencies↗

[A pathogenic manpower program: the program for foreign domestics].

Every year, a special federal program arranges for the arrival of about 12,000 educated women to Canada to work several years in private homes as housekeepers. However, in order to meet the needs of the employer and the Canadian economy, these women are denied their fundamental freedoms and are deliberately kept in a precarious situation material and psychologically and with respect to their status. Because it exposes these female workers to such factors of instability and to the negative effects of key experiences, this program carries the seed of mental illness.

Canada↗