Department of Health and Human Services February 27, 2015 – Federal Register Recent Federal Regulation Documents

Medicare Program; Public Meetings in Calendar Year 2015 for All New Public Requests for Revisions to the Healthcare Common Procedure Coding System (HCPCS) Coding and Payment Determinations
Document Number: 2015-04178
Type: Notice
Date: 2015-02-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the dates, time, and location of the Healthcare Common Procedure Coding System (HCPCS) public meetings to be held in calendar year 2015 to discuss our preliminary coding and payment determinations for all new public requests for revisions to the HCPCS. These meetings provide a forum for interested parties to make oral presentations or to submit written comments in response to preliminary coding and payment determinations. The discussion will be focused on responses to our specific preliminary recommendations and will include all items on the public meeting agenda. (Please note that two of CMS' 2015 HCPCS public meetings have a late starting time.)
Medicare Program: Notice of Four Membership Appointments to the Advisory Panel on Hospital Outpatient Payment
Document Number: 2015-04175
Type: Notice
Date: 2015-02-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces four new membership appointments to the Advisory Panel on Hospital Outpatient Payment (the Panel). The four new appointments to the Panel will each serve a four-year period. The new members have terms that began on January 14, 2015 and continue through January 31, 2019. 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 relative payment weights. The Panel also addresses and makes recommendations regarding supervision of hospital outpatient services. The advice provided by the Panel will be considered as we prepare the annual updates for the hospital outpatient prospective payment system.
Health Insurance Marketplace, Medicare, Medicaid, and Children's Health Insurance Programs; Renewal of the Advisory Panel on Outreach and Education (APOE) and Request for Nominations
Document Number: 2015-04174
Type: Notice
Date: 2015-02-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the renewal of the Advisory Panel (the Panel) on Outreach and Education (APOE) charter. It also requests nominations for individuals to serve on the APOE.
Health Insurance Marketplace, Medicare, Medicaid, and Children's Health Insurance Programs; Meeting of the Advisory Panel on Outreach and Education (APOE), March 19, 2015
Document Number: 2015-04173
Type: Notice
Date: 2015-02-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces a meeting of the Advisory Panel on Outreach and Education (APOE) (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on opportunities to enhance the effectiveness of consumer education strategies concerning the Health Insurance Marketplace, Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). This meeting is open to the public.
Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review
Document Number: 2015-04169
Type: Proposed Rule
Date: 2015-02-27
Agency: Department of Health and Human Services
In accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, Subtitle A (Department of Health and Human Services) of Title II (Enhancing Controls on Dangerous Biological Agents and Toxins) of Public Law 107-188 (June 12, 2002) (the Bioterrorism Response Act), the Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) has initiated the review of the HHS list of biological agents and toxins that have the potential to pose a severe threat to public health and safety. We are considering whether to propose amending the HHS list by removing six biological agents.
Medicare Program; Right of Appeal for Medicare Secondary Payer Determinations Relating to Liability Insurance (Including Self-Insurance), No-Fault Insurance, and Workers' Compensation Laws and Plans
Document Number: 2015-04143
Type: Rule
Date: 2015-02-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule implements provisions of the Strengthening Medicare and Repaying Taxpayers Act of 2012 (SMART Act) which require us to provide a right of appeal and an appeal process for liability insurance (including self-insurance), no-fault insurance, and workers' compensation laws or plans when Medicare pursues a Medicare Secondary Payer (MSP) recovery claim directly from the liability insurance (including self-insurance), no-fault insurance, or workers' compensation law or plan.
Proposed Information Collection Activity; Comment Request
Document Number: 2015-04141
Type: Notice
Date: 2015-02-27
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Document Number: 2015-04138
Type: Notice
Date: 2015-02-27
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Marketing Act of 1987; Administrative Procedures, Policies, and Requirements
Document Number: 2015-04131
Type: Notice
Date: 2015-02-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
Document Number: 2015-04128
Type: Notice
Date: 2015-02-27
Agency: Food and Drug Administration, Department of Health and Human Services
The 2015 Office of Regulatory Science and Innovation Science Symposium
Document Number: 2015-04123
Type: Notice
Date: 2015-02-27
Agency: Food and Drug Administration, Department of Health and Human Services
Determination and Declaration Regarding Emergency Use of New In Vitro Diagnostics for Detection of Enterovirus D68
Document Number: 2015-04121
Type: Notice
Date: 2015-02-27
Agency: Department of Health and Human Services
The Secretary of Health and Human Services (HHS) is issuing this notice pursuant to section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act, 21 U.S.C. 360bbb-3. On February 6, 2015, the Secretary determined that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad and that involves enterovirus D68 (EV-D68). On the basis of this determination, she also declared that circumstances exist justifying the authorization of emergency use of new in vitro diagnostics for detection of EV-D68 pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section.
Meeting of the Secretary's Advisory Committee on Human Research Protections
Document Number: 2015-04120
Type: Notice
Date: 2015-02-27
Agency: Department of Health and Human Services
Pursuant to Section 10(a) of the Federal Advisory Committee Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold a meeting that will be open to the public. Information about SACHRP and the full meeting agenda will be posted on the SACHRP Web site at: https://www.dhhs.gov/ohrp/sachrp/mtgings/.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2015-04115
Type: Notice
Date: 2015-02-27
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 any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2015-04113
Type: Notice
Date: 2015-02-27
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 any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Proposed Information Collection Activity; Comment Request
Document Number: 2015-04101
Type: Notice
Date: 2015-02-27
Agency: Department of Health and Human Services, Administration for Children and Families
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2015-04057
Type: Notice
Date: 2015-02-27
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2015-04056
Type: Notice
Date: 2015-02-27
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2015-04055
Type: Notice
Date: 2015-02-27
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2015-04054
Type: Notice
Date: 2015-02-27
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2015-04053
Type: Notice
Date: 2015-02-27
Agency: Department of Health and Human Services, National Institutes of Health
Medical Device Reporting: Electronic Submission Requirements; Correcting Amendments
Document Number: 2015-03943
Type: Rule
Date: 2015-02-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending its regulation regarding postmarket electronic Medical Device Reporting (eMDR) to address the unintentional removal of certain provisions of the Unique Device Identification (UDI) System regulations and to update the contact information listed in the regulations.
Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2016
Document Number: 2015-03751
Type: Rule
Date: 2015-02-27
Agency: Department of Health and Human Services
This final rule sets forth payment parameters and provisions related to the risk adjustment, reinsurance, and risk corridors programs; cost sharing parameters and cost-sharing reductions; and user fees for Federally-facilitated Exchanges. It also finalizes additional standards for the individual market annual open enrollment period for the 2016 benefit year, essential health benefits, qualified health plans, network adequacy, quality improvement strategies, the Small Business Health Options Program, guaranteed availability, guaranteed renewability, minimum essential coverage, the rate review program, the medical loss ratio program, and other related topics.
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