Department of Health and Human Services February 2016 – Federal Register Recent Federal Regulation Documents

Results 301 - 347 of 347
National Institute of Nursing Research; Notice of Closed Meetings
Document Number: 2016-01912
Type: Notice
Date: 2016-02-03
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-01911
Type: Notice
Date: 2016-02-03
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive Kidney Diseases; Notice of Closed Meetings
Document Number: 2016-01910
Type: Notice
Date: 2016-02-03
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-01909
Type: Notice
Date: 2016-02-03
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2016-01908
Type: Notice
Date: 2016-02-03
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Closed Meeting
Document Number: 2016-01907
Type: Notice
Date: 2016-02-03
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2016-01906
Type: Notice
Date: 2016-02-03
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2016-01905
Type: Notice
Date: 2016-02-03
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2016-01904
Type: Notice
Date: 2016-02-03
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2016-01903
Type: Notice
Date: 2016-02-03
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2016-01902
Type: Notice
Date: 2016-02-03
Agency: Department of Health and Human Services, National Institutes of Health
Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability and Request for Comments
Document Number: 2016-01892
Type: Notice
Date: 2016-02-03
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance for industry and FDA staff entitled ``Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices.'' When finalized, this draft document will describe the Agency's intent not to enforce, before September 24, 2021, the prohibition against providing National Health Related Item Code (NHRIC) or National Drug Code (NDC) numbers on device labels and device packages, with respect to certain finished devices manufactured and labeled prior to September 24, 2018. In addition, when finalized, this draft guidance will describe the Agency's intent to continue considering requests for continued use of FDA labeler codes under a system for the issuance of unique device identifiers (UDIs) until September 24, 2018. This draft guidance is not the final version of the guidance nor is it in effect at this time.
List of Highest Priority Devices for Human Factors Review; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2016-01889
Type: Notice
Date: 2016-02-03
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``List of Highest Priority Devices for Human Factors Review.'' FDA is issuing this draft guidance document in order to inform medical device manufacturers which device types should have human factors data included in premarket submissions. FDA believes these device types have clear potential for serious harm resulting from use error and that review of human factors data in premarket submissions will help FDA evaluate the safety and effectiveness and substantial equivalence of these devices. This draft guidance is not final nor is it in effect at this time.
Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2016-01888
Type: Notice
Date: 2016-02-03
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and FDA staff entitled ``Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development.'' This document provides guidance to industry and FDA staff on the underlying principles of human factors (HF) studies during the development of combination products. Combination products are comprised of any combination of a drug and a device; a device and a biological product; a biological product and a drug; or a drug, a device, and a biological product.
Applying Human Factors and Usability Engineering to Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2016-01887
Type: Notice
Date: 2016-02-03
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Applying Human Factors and Usability Engineering to Medical Devices.'' FDA has developed this guidance document to assist industry in following appropriate human factors and usability engineering processes to maximize the likelihood that new medical devices will be safe and effective for the intended users, uses, and use environments. The recommendations in this guidance document are intended to support manufacturers in improving the design of medical devices to minimize potential use errors and resulting harm. FDA believes that these recommendations will enable manufacturers to assess and reduce risks associated with medical device use.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application
Document Number: 2016-01885
Type: Notice
Date: 2016-02-03
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Postmarketing Adverse Drug Experience Reporting
Document Number: 2016-01884
Type: Notice
Date: 2016-02-03
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Postmarketing Adverse Drug Experience Reporting'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Biosimilar User Fee Cover Sheet; Form FDA 3792
Document Number: 2016-01883
Type: Notice
Date: 2016-02-03
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Biosimilar User Fee Cover Sheet; Form FDA 3792'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Center for Food Safety and Applied Nutrition Library Address; Technical Amendments
Document Number: 2016-01787
Type: Rule
Date: 2016-02-03
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is amending certain regulations to update the location of references cited in our food regulations. We are taking this action to reflect the transfer of those references from our facility in College Park, MD, to our library at our main campus in Silver Spring, MD. We also are updating certain regulations to reflect the current names for specific FDA offices.
Medicare Program; Medicare Shared Savings Program; Accountable Care Organizations-Revised Benchmark Rebasing Methodology, Facilitating Transition to Performance-Based Risk, and Administrative Finality of Financial Calculations
Document Number: 2016-01748
Type: Proposed Rule
Date: 2016-02-03
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Under the Medicare Shared Savings Program (Shared Savings Program), providers of services and suppliers that participate in an Accountable Care Organization (ACO) continue to receive traditional Medicare fee-for-service (FFS) payments under Parts A and B, but the ACO may be eligible to receive a shared savings payment if it meets specified quality and savings requirements. This proposed rule addresses changes to the Shared Savings Program that would modify the program's benchmark rebasing methodology to encourage ACOs' continued investment in care coordination and quality improvement, and identifies publicly available data to support modeling and analysis of these proposed changes. In addition, it would streamline the methodology used to adjust an ACO's historical benchmark for changes in its ACO participant composition, offer an alternative participation option to encourage ACOs to enter performance-based risk arrangements earlier in their participation under the program, and establish policies for reopening of payment determinations to make corrections after financial calculations have been performed and ACO shared savings and shared losses for a performance year have been determined.
Request for Information: Certification Frequency and Requirements for the Reporting of Quality Measures Under CMS Programs; Extension of Comment Period
Document Number: 2016-01937
Type: Notice
Date: 2016-02-02
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document extends the comment period for the December 31, 2015 request for information entitled ``Request for Information: Certification Frequency and Requirements for the Reporting of Quality Measures Under CMS Programs'' (80 FR 81824) (referred to in this document as December 31 RFI). The comment period for the December 31 RFI, which would have ended on February 1, 2016, is extended for 15 days.
Medicaid Program; Final FY 2013 and Preliminary FY 2015 Disproportionate Share Hospital Allotments, and Final FY 2013 and Preliminary FY 2015 Institutions for Mental Diseases Disproportionate Share Hospital Limits
Document Number: 2016-01836
Type: Notice
Date: 2016-02-02
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the final federal share disproportionate share hospital (DSH) allotments for federal fiscal year (FY) 2013 and the preliminary federal share DSH allotments for FY 2015. This notice also announces the final FY 2013 and the preliminary FY 2015 limitations on aggregate DSH payments that states may make to institutions for mental disease and other mental health facilities. In addition, this notice includes background information describing the methodology for determining the amounts of states' FY DSH allotments.
Medicare, Medicaid, and Children's Health Insurance Programs: Announcement of the Extended Temporary Moratoria on Enrollment of Ground Ambulance Suppliers and Home Health Agencies in Designated Geographic Locations
Document Number: 2016-01835
Type: Notice
Date: 2016-02-02
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document announces the extension of temporary moratoria on the enrollment of new Medicare Part B ground ambulance suppliers and Medicare home health agencies, subunits, and branch locations in specific locations within designated metropolitan areas in Florida, Illinois, Michigan, Texas, Pennsylvania, and New Jersey to prevent and combat fraud, waste, and abuse. These moratoria also apply to the enrollment of home health agencies and ground ambulance suppliers in Medicaid and the Children's Health Insurance Program.
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2016-01833
Type: Notice
Date: 2016-02-02
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Medicare Program; Request for an Exception to the Prohibition on Expansion of Facility Capacity Under the Hospital Ownership and Rural Provider Exceptions to the Physician Self-Referral Prohibition
Document Number: 2016-01830
Type: Notice
Date: 2016-02-02
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Social Security Act (the Act) prohibits a physician-owned hospital from expanding its facility capacity, unless the Secretary of the Department of Health and Human Services (the Secretary) grants the hospital's request for an exception to that prohibition after considering input on the hospital's request from individuals and entities in the community where the hospital is located. The Centers for Medicare & Medicaid Services (CMS) has received a request from a physician-owned hospital for an exception to the prohibition against expansion of facility capacity. This notice solicits comments on the request from individuals and entities in the community in which the physician-owned hospital is located. Community input may inform our determination regarding whether the requesting hospital qualifies for an exception to the prohibition against expansion of facility capacity.
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
Document Number: 2016-01819
Type: Notice
Date: 2016-02-02
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809). A notice listing all currently HHS-certified laboratories and IITFs is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at http:// www.samhsa.gov/workplace.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-01818
Type: Notice
Date: 2016-02-02
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2016-01817
Type: Notice
Date: 2016-02-02
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2016-01816
Type: Notice
Date: 2016-02-02
Agency: Department of Health and Human Services, National Institutes of Health
Medicare Program: Expanding Uses of Medicare Data by Qualified Entities
Document Number: 2016-01790
Type: Proposed Rule
Date: 2016-02-02
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would implement new statutory requirements that would expand how qualified entities may use and disclose data under the qualified entity program to the extent consistent with applicable program requirements and other applicable laws, including information, privacy, security and disclosure laws. In doing so, this proposed rule would explain how qualified entities may create non- public analyses and provide or sell such analyses to authorized users, as well as how qualified entities may provide or sell combined data, or provide Medicare claims data alone at no cost, to certain authorized users. This proposed rule would also implement certain privacy and security requirements, and impose assessments on qualified entities if the qualified entity or the authorized user violates the terms of a data use agreement (DUA) required by the qualified entity program.
The Arthritis Foundation-Food and Drug Administration Accelerating Osteoarthritis Clinical Trials Workshop
Document Number: 2016-01789
Type: Notice
Date: 2016-02-02
Agency: Food and Drug Administration, Department of Health and Human Services
Osteoarthritis is the most common form of arthritis, and occurs when the cartilage that cushions the bones of the joint break down and the bones begin to rub together. This can cause pain, swelling, and loss of motion of the joint. The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research, in co- sponsorship with the Arthritis Foundation is announcing a workshop entitled, ``Accelerating OA Clinical Trials Workshop''. The purpose of the workshop is to discuss recommendations from the international Arthritis Foundation Accelerating Osteoarthritis Clinical Trial workgroup and identify next steps in forging new approaches to osteoarthritis clinical trials that may improve the likelihood of successful conduct and outcomes of these trials and lead to the development of safe and effective treatments for osteoarthritis.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Studies on Consumer Perceptions of Modified Risk Tobacco Products
Document Number: 2016-01788
Type: Notice
Date: 2016-02-02
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.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived From Genetically Engineered Plants
Document Number: 2016-01786
Type: Notice
Date: 2016-02-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived From Genetically Engineered Plants'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Improving Food Safety and Defense Capacity of the State and Local Level: Review of State and Local Capacities
Document Number: 2016-01785
Type: Notice
Date: 2016-02-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Improving Food Safety and Defense Capacity of the State and Local Level: Review of State and Local Capacities'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification
Document Number: 2016-01784
Type: Notice
Date: 2016-02-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry on Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; General Licensing Provisions; Section 351(k) Biosimilar Applications
Document Number: 2016-01783
Type: Notice
Date: 2016-02-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``General Licensing Provisions; Section 351(k) Biosimilar Applications'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities: Proposed Collection; Comment Request; Applications for Food and Drug Administration Approval to Market a New Drug: Patent Submission and Listing Requirements and Application of 30-Month Stays on Approval of Abbreviated New Drug Applications Certifying That a Patent Claiming a Drug Is Valid or Will Not Be Infringed
Document Number: 2016-01782
Type: Notice
Date: 2016-02-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the reporting requirements for submission and listing of patent information associated with a new drug application (NDA), an amendment, or a supplement.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees
Document Number: 2016-01781
Type: Notice
Date: 2016-02-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Regulatory Site Visit Training Program
Document Number: 2016-01780
Type: Notice
Date: 2016-02-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA's) Center for Biologics Evaluation and Research (CBER) is announcing an invitation for participation in its Regulatory Site Visit Training Program (RSVP). This training program is intended to give CBER regulatory review, compliance, and other relevant staff an opportunity to visit biologics facilities. These visits are intended to allow CBER staff to directly observe routine manufacturing practices and to give CBER staff a better understanding of the biologics industry, including its challenges and operations. The purpose of this document is to invite biologics facilities to contact CBER for more information if they are interested in participating in this program.
Medicaid Program; Face-to-Face Requirements for Home Health Services; Policy Changes and Clarifications Related to Home Health
Document Number: 2016-01585
Type: Rule
Date: 2016-02-02
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule revises the Medicaid home health service definition consistent with section 6407 of the Patient Protection and Affordable Care Act of 2010 (the Affordable Care Act) and section 504 of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) to add requirements that, for home health services, physicians document, and, for certain medical equipment, physicians or certain authorized non-physician practitioners (NPP) document the occurrence of a face-to- face encounter (including through the use of telehealth) with the Medicaid eligible beneficiary within reasonable timeframes. This rule also aligns the timeframes for the face-to-face encounter with similar regulatory requirements for Medicare home health services. In addition, this rule amends the definitions of medical supplies, equipment, and appliances. We expect minimal impact with the implementation of section 6407 of the Affordable Care Act and section 504 of MACRA. We recognize that states may have budgetary implications as a result of the amended definitions of medical supplies, equipment and appliances. Specifically, this rule may expand coverage of medical supplies, equipment and appliances under the home health benefit. There will be items that had previously only been offered under certain sections of the Act that will now be covered under the home health benefit.
Psychopharmacologic Drugs Advisory Committee; Notice of Meeting
Document Number: 2016-01752
Type: Notice
Date: 2016-02-01
Agency: Food and Drug Administration, Department of Health and Human Services
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2016-01750
Type: Notice
Date: 2016-02-01
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit a new Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2016-01723
Type: Notice
Date: 2016-02-01
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed revision of the National Program of Cancer Registries Cancer Surveillance System information collection, which provides useful data on cancer incidence and trends.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2016-01722
Type: Notice
Date: 2016-02-01
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on proposed revisions of the information collection entitled Application for Training (OMB Control No. 0920-0017). CDC seeks to request Office of Management and Budget approval to (1) continue to collect information through the use of the Training and Continuing Education Online New Participant Registration form for new learners to establish an account that provides CDC necessary information to process learner requests for continuing education, and (2) implement a new electronic information collection through the use of the Training and Continuing Education Online Proposal form that allows training developers to provide CDC necessary information to process and accredit trainings for continuing education.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2016-01721
Type: Notice
Date: 2016-02-01
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collect project entitled ``Evaluation of Enhancing HIV Prevention Communication and Mobilization Efforts through Strategic Partnerships''.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-01720
Type: Notice
Date: 2016-02-01
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Medicaid Program; Covered Outpatient Drugs
Document Number: 2016-01274
Type: Rule
Date: 2016-02-01
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule implements provisions of the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively referred to as the Affordable Care Act) pertaining to Medicaid reimbursement for covered outpatient drugs (CODs). This final rule also revises other requirements related to CODs, including key aspects of their Medicaid coverage and payment and the Medicaid drug rebate program.