Department of Health and Human Services August 10, 2020 – Federal Register Recent Federal Regulation Documents
Results 1 - 5 of 5
Agency Information Collection Activities: Submission for OMB Review; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Drug-Drug Interaction Assessment for Therapeutic Proteins; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Drug-Drug Interaction Assessment for Therapeutic Proteins.'' The purpose of this guidance is to provide a systematic, risk-based approach to help sponsors of investigational new drug applications (INDs) and applicants of biologic license applications (BLAs) determine the need for drug- drug interaction (DDI) studies for a therapeutic protein (TP).
Medicare Program; Announcement of the Advisory Panel on Hospital Outpatient Payment Meeting
This notice announces a virtual meeting of the Advisory Panel on Hospital Outpatient Payment (the Panel) for 2020. In addition, this notice announces four new membership appointments to the Panel. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services concerning the clinical integrity of the Ambulatory Payment Classification groups and their associated weights, and supervision of hospital outpatient therapeutic services. The advice provided by the Panel will be considered as we prepare the annual updates for the hospital outpatient prospective payment system.
Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2021
This final rule updates the prospective payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2021. As required by statute, this final rule includes the classification and weighting factors for the IRF prospective payment system's case-mix groups and a description of the methodologies and data used in computing the prospective payment rates for FY 2021. This final rule adopts more recent Office of Management and Budget statistical area delineations and applies a 5 percent cap on any wage index decreases compared to FY 2020 in a budget neutral manner. This final rule also amends the IRF coverage requirements to remove the post-admission physician evaluation requirement and codifies existing documentation instructions and guidance. In addition, this final rule amends the IRF coverage requirements to allow, beginning with the second week of admission to the IRF, a non-physician practitioner who is determined by the IRF to have specialized training and experience in inpatient rehabilitation to conduct 1 of the 3 required face-to-face visits with the patient per week, provided that such duties are within the non-physician practitioner's scope of practice under applicable state law.
Request for Information and Comments on Consumption of Certain Uncommon Produce Commodities in the United States; Establishment of a Public Docket
The Food and Drug Administration (FDA, the Agency, or we) is opening a docket to receive information and comments related to certain produce commodities with no or low reported consumption in the database relied on to create the list of rarely consumed raw commodities that are exempt from the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption regulation. FDA intends to use the information to consider whether any of these commodities should be added to the rarely consumed raw list.
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