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

Medicare Program; Advancing Care Coordination Through Episode Payment Models (EPMs); Cardiac Rehabilitation Incentive Payment Model; and Changes to the Comprehensive Care for Joint Replacement Model; Delay of Effective Date
Document Number: 2017-03347
Type: Rule
Date: 2017-02-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Meeting of the Advisory Committee on Minority Health
Document Number: 2017-03247
Type: Notice
Date: 2017-02-17
Agency: Department of Health and Human Services
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.
Meeting of the Presidential Advisory Council on HIV/AIDS
Document Number: 2017-03245
Type: Notice
Date: 2017-02-17
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA or the Council) will be holding a meeting to continue discussions and possibly develop recommendations regarding People Living with HIV/AIDS. The meeting will be open to the public.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2017-03235
Type: Notice
Date: 2017-02-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2017-03234
Type: Notice
Date: 2017-02-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates 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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2017-03190
Type: Notice
Date: 2017-02-17
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Food and Drug Administration/Xavier University PharmaLink Conference-Leadership in a Global Supply Chain
Document Number: 2017-03176
Type: Notice
Date: 2017-02-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) Cincinnati District, in co-sponsorship with Xavier University, is announcing a public conference entitled ``FDA/Xavier University PharmaLink Conference: Leadership in a Global Supply Chain.'' The PharmaLink conference seeks solutions to important and complicated issues by aligning with the strategic priorities of FDA, and includes presentations from key FDA officials and industry experts.
Raymond Sean Brown: Debarment Order
Document Number: 2017-03173
Type: Notice
Date: 2017-02-17
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Karis Copper Delong: Debarment Order
Document Number: 2017-03172
Type: Notice
Date: 2017-02-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Karis Copper Delong for a period of 12 years 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 Ms. Delong was convicted of four misdemeanor counts under the FD&C Act for introducing, delivering for introduction, and causing the introduction and delivery for introduction of a misbranded drug into interstate commerce, which relates to the regulation of drug products under the FD&C Act. In addition, FDA determined that the type of conduct that served as the basis for the conviction undermines the process for the regulation of drugs. Ms. Delong was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Ms. Delong failed to request a hearing. Ms. Delong's failure to request a hearing constitutes a waiver of her right to a hearing concerning this action.
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2017-03169
Type: Notice
Date: 2017-02-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meeting
Document Number: 2017-03168
Type: Notice
Date: 2017-02-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2017-03167
Type: Notice
Date: 2017-02-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Meetings
Document Number: 2017-03166
Type: Notice
Date: 2017-02-17
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2017-03165
Type: Notice
Date: 2017-02-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2017-03164
Type: Notice
Date: 2017-02-17
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-03163
Type: Notice
Date: 2017-02-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meeting
Document Number: 2017-03162
Type: Notice
Date: 2017-02-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2017-03161
Type: Notice
Date: 2017-02-17
Agency: Department of Health and Human Services, National Institutes of Health
Patient Protection and Affordable Care Act; Market Stabilization
Document Number: 2017-03027
Type: Proposed Rule
Date: 2017-02-17
Agency: Department of Health and Human Services
This rule proposes changes that would help stabilize the individual and small group markets. This proposed rule would amend standards relating to special enrollment periods, guaranteed availability, and the timing of the annual open enrollment period in the individual market for the 2018 plan year; standards related to network adequacy and essential community providers for qualified health plans; and the rules around actuarial value requirements.