Federal register
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The Food and Drug Administration (FDA) is issuing final regulations under which the agency will accelerate approval of certain new drugs and biological products for serious or life-threatening illnesses, with provisions for any necessary continued study of the drugs' clinical benefits after approval or with restrictions on use, if necessary. These new procedures are intended to provide expedited marketing of drugs for patients suffering from such illnesses when the drugs provide meaningful therapeutic benefit compared to existing treatment. Accelerated approval will be considered in two situations: (1) When approval can be reliably based on evidence from adequate and well-controlled studies of the drug's effect on a surrogate endpoint that reasonably suggests clinical benefit or on evidence of the drug's effect on a clinical endpoint other than survival or irreversible morbidity, pending completion of studies to establish and define the degree of clinical benefits to patients; and (2) when FDA determines that a drug, effective for the treatment of a disease, can be used safely only if distribution or use is modified or restricted. Drugs or biological products approved under these procedures will have met the requisite standards for safety and effectiveness under the Federal Food, Drug and Cosmetic Act (the act) or the Public Health Service Act (the PHS Act) and, thus, will have full approval for marketing.
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Before January 1, 1992, Medicare payments for physicians' services under Part B were limited by the Medicare Economic Index (MEI), which capped prevailing charges. Beginning January 1, 1992, Medicare payments for physicians' services under Part B are made based on a fee schedule. Annual updates to the conversion factor used in establishing the physician fee schedule are based in part on the MEI. This final rule revises the method used to calculate the MEI to more accurately reflect year-to-year price changes affecting the cost of providing physicians' services, thus ensuring appropriate adjustment of Medicare payments.
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This action modifies 90.38 of the Commission's Rules by expanding the eligibility of end users to which special emergency paging licensees can provide service. Hospital paging systems could not be used to inform participants in an organ donor program of the availability of a suitable organ. The Commission has decided that patients actively awaiting an organ transplant should be eligible under the Special Emergency Radio Service to receive paging service.
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In the July 1, 1992 issue of the Federal Register (FR Doc. 92-15496) (57 FR 29410), we published a notice with comment period that set forth a revised schedule of limits on home health agency costs that may be paid under the Medicare program. The July 1, 1992 notice applies to cost reporting periods beginning on or after July 1, 1992. This notice corrects errors made in the July 1, 1992 document.
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In the November 25, 1991 final rule (56 FR 59624) on the Medicare fee schedule for physician services, we inadvertently set forth regulations on the fee schedule at 42 CFR, part 415. However, our plan for the recodification of HCFA regulations calls for general regulations on payment for Part B medical and other health services to be codified in part 414, with part 415 reserved for regulations on payment to teaching physicians, teaching hospitals, and provider-based physicians. Therefore, in this correction notice, we are redesignating in their entirety the physician fee schedule regulations contained in part 415, subpart A to part 414, subpart A, and reserving part 415 for future use. Also, this document corrects technical errors that appeared in the final rule published in the Federal Register on November 25, 1991 (56 FR 59502) entitled "Medicare Program; Fee Schedule for Physicians' Services".