Department of Health and Human Services February 17, 2017 – Federal Register Recent Federal Regulation Documents

In accordance with the memorandum of January 20, 2017, from the Assistant to the President and Chief of Staff, entitled ``Regulatory Freeze Pending Review'', this action delays for 60 days from the date of the memorandum the effective date of the rule entitled ``Advancing Care Coordination Through Episode Payment Models (EPMs); Cardiac Rehabilitation Incentive Payment Model; and Changes to the Comprehensive Care for Joint Replacement Model'' published in the January 3, 2017 Federal Register (82 FR 180). That rule implements three new Medicare Parts A and B episode payment models and a Cardiac Rehabilitation (CR) Incentive Payment model, and implements changes to the existing Comprehensive Care for Joint Replacement model under section 1115A of the Social Security Act (the Act). Under the three new episode payment models, acute care hospitals in certain selected geographic areas will participate in retrospective episode payment models targeting care for Medicare fee-for-service beneficiaries receiving services during acute myocardial infarction, coronary artery bypass graft, and surgical hip/femur fracture treatment episodes. All related care within 90 days of hospital discharge will be included in the episode of care. Under the CR Incentive Payment model, acute care hospitals in certain selected geographic areas will receive retrospective incentive payments for beneficiary utilization of cardiac rehabilitation/intensive cardiac rehabilitation services during the 90 days following discharge from a hospitalization treatment of an acute myocardial infarction or coronary artery bypass graft surgery. We believe these models will further our goals of improving the efficiency and quality of care for Medicare beneficiaries receiving care for these common clinical conditions and procedures.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting. This meeting will be open to the public. Preregistration is required for both public attendance and comment. Any individual who wishes to attend the meetings and/or participate in the public comment session should email OMH-ACMH@hhs.gov.

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.

The U.S. Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Dr. Raymond Sean Brown from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Dr. Brown was convicted of a felony under Federal law for conduct relating to the regulation of a drug product under the FD&C Act. Dr. Brown was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Brown failed to request a hearing. Dr. Brown's failure to request a hearing constitutes a waiver of his right to a hearing concerning this action.