Solicitation of information and recommendations for developing OIG compliance program guidance for the durable medical equipment industry--HHS. Notice

This Federal Register notice seeks the input and recommendations of interested parties into the OIG's development of a compliance program guidance for the durable medical equipment (DME) industry, its providers and suppliers. Many providers and provider organizations have expressed an interest in better protecting their operations from fraud and abuse. Previously, the OIG has developed compliance program guidances for hospitals, clinical laboratories and home health agencies. In order to provide clear and meaningful guidance to those segments of the health care industry involved in the supply and distribution of DME, we are soliciting comments, recommendations and other suggestions from concerned parties and organizations on how best to develop compliance program guidance and reduce fraud and abuse within the DME industry.     

Medicare program; additional supplier standards--HCFA. Proposed rule

This proposed rule would establish additional standards for an entity to qualify as a Medicare supplier for purposes of submitting claims for durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS). This proposed rule would establish additional standards that must be satisfied before a DMEPOS supplier could receive payment from the Medicare program. The Social Security Act Amendments of 1994 require that a DMEPOS supplier meet standards related to compliance with State and Federal licensure requirements, maintaining a physical facility on an appropriate site, proof of appropriate liability insurance, and other standards the Secretary may specify.     

Medical facility construction and modernization--PHS. Final rule

Sections 603(b) and 1620(2) of the Public Health Service Act require the Secretary to prescribe by regulation general standards of construction, modernization, and equipment for projects assisted under Title VI and Title XVI, respectively, of the Act. Since the Title VI and Title XVI grant and loan authority have expired, there is no need to retain the standards in regulations. Projects for which applications were approved or grants awarded under Titles VI and XVI, but for which full project reimbursement has not yet been made, will be subject to continuing compliance with the "Minimum Requirements of Construction and Equipment for Hospital and Medical Facilities" as incorporated by reference in 42 CFR Parts 53 and 124 at the time of initial approval. This Rule amends Part 124 of Title 42, CFR, by removing provisions relating to minimum standards of construction, modernization, and equipment of hospitals and other medical facilities. Similar provisions in Part 53 were deleted earlier.     

Medical Area Body Network. Final rule

This document expands the Commission's Medical Device Radiocommunications Service (MedRadio) rules to permit the development of new Medical Body Area Network (MBAN) devices in the 2360-2400 MHz band. The MBAN technology will provide a flexible platform for the wireless networking of multiple body transmitters used for the purpose of measuring and recording physiological parameters and other patient information or for performing diagnostic or therapeutic functions, primarily in health care facilities. This platform will enhance patient safety, care and comfort by reducing the need to physically connect sensors to essential monitoring equipment by cables and wires. This decision is the latest in a series of actions to expand the spectrum available for wireless medical use. The Commission finds that the risk of increased interference is minimal and is greatly outweighed by the benefits of the MBAN rules.     

Occupational exposure to ethylene oxide--OSHA. Final standard

In this Final Standard, the Occupational Safety and Health Administration (OSHA) establishes a permissible exposure limit for occupational exposure to ethylene oxide (EtO) of 1 part EtO per million parts of air (1 ppm) determined as an 8-hour time-weighted average concentration. The basis for this action is a determination by the Assistant Secretary, based on animal and human data, that exposure to EtO presents a carcinogenic, mutagenic, genotoxic, reproductive, neurologic and sensitization hazard to workers. The standard provides for, among other requirements, methods of exposure control, personal protective equipment, measurement of employee exposures, training, medical surveillance, signs and labels, regulated areas, emergency procedures and recordkeeping. An "action level" of 0.5 ppm as an 8-hour time-weighted average is established as the level above which employers must initiate certain compliance activities such as periodic employee exposure monitoring and medical surveillance. In instances where the employer can demonstrate that employee exposures are below the action level, the employer is not obligated to comply with most of the requirements set forth in this final rule. The 1 ppm 8-hour limit reduces significant risk from exposure to EtO and is considered by OSHA to be the lowest levels feasible.     

The method for expert assessment as a tool for the improvement of the methodological basis of the activities of a bureau of forensic medical expertise

An important aspect of the problem of iatrogenic poisoning is the lack of comprehensive relevant information. Many experts employed at the bureaus of forensic medical expertise believe that this problem can be resolved only based on a multifaceted approach. The results of questionnaire studies and cause-and-effect analysis allowed the following recommendations to be proposed for addressing the problem under consideration: making a minimal list of equipments necessary to maintain activities of forensic medical departments, updating the list of toxic substances to be studied in the laboratories of bureaus of forensic medical expertise, modification of the reporting form No 42 to be filled by such bureaus. The optimal approach is thought to be the equipment of all bureaus in compliance with the universal requirements, introduction of standard methods and technologies for the analysis of the materials included in the list of toxic substances to be determined.     

Wireless medical telemetry service. Federal Communications Commission. Final rule

This document allocates new spectrum and establishes rules for a Wireless Medical Telemetry Service (WMTS) that allows potentially life-critical equipment to operate on an interference-protected basis. Medical telemetry equipment is used in hospitals and health care facilities to transmit patient measurement data, such as pulse and respiration rates to a nearby receiver, permitting greater patient mobility and increased comfort. This action will increase the reliability of medical telemetry equipment.     

Income and employment taxes; self-insured medical reimbursement plans--Internal Revenue Service. Final regulations

This document contains final regulations relating to self-insured medical reimbursement plans and the withholding of income tax under these plans. Changes to the applicable law were made by the Revenue Act of 1978 and the Technical Corrections Act of 1979. These regulations provide necessary guidance to the public for compliance with the law and affect both employers who maintain self-insured medical reimbursement plans and certain employees who receive medical benefits under these plans.     

Quality mammography standards--FDA. Final rule

The Food and Drug Administration (FDA) is amending its regulations governing mammography. Amendments are being made to the requirements for accreditation bodies; procedures for facility certification; and quality standards for mammography personnel, equipment and practices, including quality assurance. This action is being taken to provide increased assurance of adequate and consistent evaluation of mammography facilities on a nationwide level and compliance of the facilities with quality standards. It also carries out the intent of Congress that FDA replace the existing interim rules with more comprehensive final regulations.     

Child Support Enforcement program; medical support. Final regulation

This regulation revises Federal requirements for establishing and enforcing medical support obligations in Child Support Enforcement (CSE) program cases receiving services under title IV-D of the Social Security Act (the Act). The changes: require that all support orders in the IV-D program address medical support; redefine reasonable-cost health insurance; require health insurance to be accessible, as defined by the State; and make conforming changes to the Federal interstate, substantial compliance audit, and State self-assessment requirements.     

Responding to disruptive patients. Final rule

This final rule amends the Department of Veterans Affairs (VA) regulation that authorizes appropriate action when a patient engages in disruptive behavior at a VA medical facility. This amendment updates VA's current regulation to reflect modern medical care and ethical practices. The final rule authorizes VA to modify the time, place, and/or manner in which VA provides treatment to a patient, in order to ensure the safety of others at VA medical facilities, and to prevent any interference with the provision of medical care.     

Requirements for accrediting bodies of mammography facilities--FDA. Interim rule with request for comments

The Food and Drug Administration (FDA) is issuing regulations to implement the Mammography Quality Standards Act of 1992 (MQSA), which requires the establishment of a Federal certification and inspection program for mammography facilities; regulations and standards for accrediting bodies for mammography facilities; and standards for mammography equipment, personnel, and practices, including quality assurance. This rule establishes procedures for application to FDA for approval as an accrediting body and requirements and responsibilities of such bodies. This action is being taken to assure adequate and consistent evaluation of mammography facilities on a nationwide level and to help assure their compliance with quality standards. The agency requests comments on the contents of this document.     

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

The rules below revise 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 for such services. The revisions below amend the rules to permit facilities that provide substantial free or below cost medical services but nonetheless cannot receive credit for such services under current requirements with an alternative method of compliance that will enable them to fulfill their uncompensated services obligations.     

Medical: advance healthcare planning--VA. Proposed rule

This document proposes to amend the VA medical regulations to codify VA policy regarding advance healthcare planning. The proposed rule sets forth a mechanism for the use of written advance directives, i.e., a VA Living Will, a VA durable power of attorney for health care, and a state-authorized advance directive. The proposed rule also sets forth a mechanism for honoring verbal or nonverbal instructions from a patient when the patient is admitted to care when critically ill and loss of capacity may be imminent and the patient is not physically able to sign an advance directive form, or the appropriate form is not readily available. This is intended to help ensure that VA acts in compliance with patients' wishes concerning future healthcare.     

Occupational exposure to hexavalent chromium. Final rule

The Occupational Safety and Health Administration (OSHA) is amending the existing standard which limits occupational exposure to hexavalent chromium (Cr(VI)). OSHA has determined based upon the best evidence currently available that at the current permissible exposure limit (PEL) for Cr(VI), workers face a significant risk to material impairment of their health. The evidence in the record for this rulemaking indicates that workers exposed to Cr(VI) are at an increased risk of developing lung cancer. The record also indicates that occupational exposure to Cr(VI) may result in asthma, and damage to the nasal epithelia and skin. The final rule establishes an 8-hour time-weighted average (TWA) exposure limit of 5 micrograms of Cr(VI) per cubic meter of air (5 [mu]g/cu m). This is a considerable reduction from the previous PEL of 1 milligram per 10 cubic meters of air (1 mg/10 cu m, or 100 [mu]g/cu m) reported as CrO3, which is equivalent to a limit of 52 [mu]g/cu m as Cr(VI). The final rule also contains ancillary provisions for worker protection such as requirements for exposure determination, preferred exposure control methods, including a compliance alternative for a small sector for which the new PEL is infeasible, respiratory protection, protective clothing and equipment, hygiene areas and practices, medical surveillance, recordkeeping, and start-up dates that include four years for the implementation of engineering controls to meet the PEL. The final standard separately regulates general industry, construction, and shipyards in order to tailor requirements to the unique circumstances found in each of these sectors. The PEL established by this rule reduces the significant risk posed to workers by occupational exposure to Cr(VI) to the maximum extent that is technologically and economically feasible.     

Medical: advance health care planning. Final rule

This document amends VA medical regulations to codify VA policy regarding advance health care planning. The final rule sets forth a mechanism for the use of written advance directives, i.e., a VA living will, a VA durable power of attorney for health care, and a State-authorized advance directive. The final rule also sets forth a mechanism for honoring verbal or non-verbal instructions from a patient when the patient is admitted to care when critically ill and loss of capacity may be imminent and the patient is not physically able to sign an advance directive form, or the appropriate form is not readily available. This is intended to help ensure that VA acts in compliance with patients' wishes concerning future health care.     

Medicare program; payment for durable medical equipment and orthotic, and prosthetic devices--HCFA. Interim final rule with comment period

This interim final rule implements section 4062(b) of the Omnibus Budget Reconciliation Act of 1987 which specifies that payment under the Medicare program for durable medical equipment, orthotics, and prosthetics furnished on or after January 1, 1989 is limited to the lower of the actual charge for the equipment or the fee schedule established by the carrier. We are setting forth the methods for computing fee schedules for six classes of these items. We are also describing how the fee schedules are updated in subsequent years.     

Medicare program; additional supplier standards. Health Care Financing Administration (HCFA), HHS. Final rule with comment period

This final rule establishes additional standards for an entity to qualify as a Medicare supplier for purposes of submitting claims and receiving payment for durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS). These regulations will ensure that suppliers of DMEPOS are qualified to provide the appropriate health care services and will help safeguard the Medicare program and its beneficiaries from any instances of fraudulent or abusive billing practices.     

Medical devices; classification for medical washer and medical washer-disinfector. Final rule

The Food and Drug Administration (FDA) is classifying the medical washer and medical washer-disinfector intended for general medical purposes to clean and dry surgical instruments, decontaminate or disinfect anesthesia equipment, hollowware, and other medical devices into class II (special controls). FDA is also identifying the guidance document entitled "Class II Special Controls Guidance Document: Medical Washers and Medical Washer-Disinfectors" (the guidance) as the special control that, in addition to general controls, the agency believes will reasonably ensure the safety and effectiveness of the device. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997 (the FDAMA).     

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.