July 27

Federal Affairs Activity Report: July 27 – July 31, 2015

Below is an overview of federal activity in the U.S. House of Representatives, the U.S. Senate, and federal agencies this week related to health care and/or other areas of interest for our clients.

House of Representatives

The House will convene Monday, July 27 at 12:00 p.m.

Education and the Workforce Committee
The Education and Workforce full committee will hold a hearing entitled “Reviewing the Policies and Priorities of the U.S. Department of Health and Human Services (HHS).”
Witnesses: Sylvia Mathews Burwell, HHS Secretary
Date and time: Tuesday, July 28; 10:00 a.m. EDT
Location: 2175 Rayburn House Office Building, Washington, D.C. 20515
Additional information is available HERE.

Ways and Means Committee
The House Ways and Means Health Subcommittee will hold a hearing on rural health care disparities created by Medicare regulations.
Witnesses: TBA
Date and time: Tuesday, July 28; 10:00 a.m. EDT
Location: 1100 Longworth House Office Building, Washington, D.C. 20515
Additional information is available HERE.

Energy and Commerce Committee
The House Energy and Commerce full committee will hold a markup of the following legislation: H.R.985, the “Concrete Masonry Products Research, Education, and Promotion Act of 2015”; H.R.1344, the “Early Hearing Detection and Intervention Act of 2015”; H.R.1462, the “Protecting Our Infants Act of 2015”; H.R.1725, the “National All Schedules Prescription Electronic Reporting Authorization Act of 2015”; H.R.2820, the “Stem Cell Therapeutic and Research Reauthorization Act of 2015”; and H.R.3154, the “E-Warranty Act of 2015.”
Date and time: Tuesday, July 28; 5:00 p.m. EDT
Location: 2123 Rayburn House Office Building, Washington, D.C. 20515
Additional information is available HERE.


 

Senate

The Senate will convene Monday, July 27. No healthcare related votes are expected in the Senate this week.


 

Federal Agencies

Health and Human Services Department (HHS); Food and Drug Administration (FDA) (F.R. Page 10124) – Workshop
The Food and Drug Administration (FDA) will host a public, two day workshop on “Robotically-Assisted Surgical (RAS) Devices: Challenges and Opportunities,” to obtain information on the current challenges and opportunities related to robotically-assisted surgical Class II medical devices. Feedback and comments received throughout the workshop will be taken into consideration for future RAS regulatory controls.
Date and Time: Monday – Tuesday, July 27-28 at 8:00 AM
Location: FDA’s White Oak Campus, 10903 New Hampshire Avenue, Building 31 Conference Center, the Great Room, Room 1503A, Silver Spring, Md.
To register for the event and view the agenda, click HERE.

Health and Human Services Department (HHS); Food and Drug Administration (FDA) (F.R. Page 40070) – Meeting
The Food and Drug Administration (FDA) will hold a meeting of the Science Board to the Food and Drug Administration to accept a report from the Commissioner’s Fellowship Program Evaluation subcommittee and a progress report from the Science Looking Forward subcommittee. The meeting is meant to provide platform to address urgent and serious drug-resistant threats that affect society. During the meeting there will also be an overview of two scientific activities from the Center for Veterinary Medicine and strategies to implement targeted directives contained in the National Strategy for Combating Antibiotic-Resistant Bacteria.
Date and Time: Wednesday, July 29 at 8:30 am
Location: FDA White Oak Campus, 10903 New Hampshire Avenue, Building 31 Conference Center, the Great Room, Room 1503 B and C, Silver Spring, Md.
The agenda can be found HERE.

Defense Department (DOD); Office of the Secretary of Defense (F.R. Page 7844) – Meeting
The Food and Drug Administration (FDA) will host a public meeting on the reauthorization of the Medical Device User Fee Amendments (MDUFA) for FY2018 through FY2022. The meeting objectives include reviewing actuarial assumptions and methods needed for calculation of various user fees. In September 2017, the current legislative authority for the medical device user fee program will terminate and new legislation will be necessary for the FDA to continue gathering user fees for the medical device program.
Date and Time: Friday, July 31 at 10:00 AM
Location: 4800 Mark Center Drive, Conference Room 18, Level B1, Alexandria, Va.
The agenda is available HERE.

July 20

Federal Affairs Activity Report: July 20 – July 24, 2015

Below is an overview of federal activity in the U.S. House of Representatives, the U.S. Senate, and federal agencies this week related to health care and/or other areas of interest for our clients.

House of Representatives

The House will reconvene Tuesday, July 21 at 12:00 p.m. No healthcare related votes are expected in the House this week.

Ways and Means Committee
The House Ways and Means Health Subcommittee will hold a hearing with the Medicare Payment Advisory Commission (MedPAC) on hospital payment issues, rural health issues, and beneficiary access to care.
Witnesses: TBA
Date and time: Wednesday, July 22; 10:00 a.m. EDT
Location: B-318 Rayburn House Office Building, Washington, D.C. 20515
Additional information is available HERE.

Veteran Affairs Committee
The House Veterans’ Affairs full committee will hold a hearing entitled “Pending VA Health Care Budget Shortfall and System Shutdown.”
Witnesses: Robert McDonald, VA Secretary
Date and time: Wednesday, July 22; 10:00 a.m. EDT
Location: 334 Cannon House Office Building, Washington, D.C. 20515
Additional information is available HERE.

Energy and Commerce Committee
The House Energy and Commerce Oversight and Investigations Subcommittee will hold a hearing entitled “An Overdue Checkup: Examining the Affordable Care Act’s State Insurance Marketplaces.”
Witnesses: TBA
Date and time: Friday, July 24; 9:15 a.m. EDT
Location: 2123 Rayburn House Office Building, Washington, D.C. 20515
Additional information is available HERE.


 

Senate

The Senate will convene Monday, July 20. No healthcare related votes are expected in the Senate this week.

Finance Committee
The Senate Finance full committee will hold a hearing on a bill to extend certain expired tax provisions (aka “tax extenders”).
Witnesses: TBA
Date and time: Tuesday, July 21; 11:00 a.m. EDT
Location: 215 Dirksen Senate Office Building, Washington, D.C. 20510
Additional information is available HERE.

Health, Education, Labor, and Pensions Committee
The Senate Health, Education, Labor, and Pensions full committee will hold a hearing entitled “Achieving the Promise of Health Information Technology: Information Blocking and Potential Solutions.”
Witnesses: David Kendrick, chair of the Department of Medical Informatics at the University of Oklahoma and CEO of MyHealth Access Network in Tulsa, Okla.; David Kibbe, president and CEO of DirectTrust and senior advisor to the American Academy of Family Physicians; Michael Mirro, past chair of the Medical Informatics Committee in the American College of Cardiology and chief academic/research officer with Parkview Mirro Center for Research and Innovation in Fort Wayne, Ind.; and Paul Black, president and CEO and director of Allscripts in Chicago, Ill
Date and time: Thursday, July 23; 10:00 a.m. EDT
Location: 430 Dirksen Senate Office Building, Washington, D.C. 20510
Additional information is available HERE.


 

Special

Aging Committee
The Senate Aging full committee will hold a hearing entitled “The Doctor’s Not In: Combating Medicare Provider Enrollment Fraud.”
Witnesses: TBA
Date and time: Wednesday, July 22; 2:15 a.m. EDT
Location: 562 Dirksen Senate Office Building, Washington, D.C. 20510
Additional information is available HERE.


 

Federal Agencies

Health and Human Services Department (HHS); Agency for Healthcare Research and Quality (F.R. Page 42497) – Meeting
Health and Human Services Department (HHS); Agency for Healthcare Research and Quality (F.R. Page 42497) will hold a meeting of the Special Emphasis Panel (SEP) on “Patient Safety Learning Laboratories: Innovative Design and Development to Improve Healthcare Delivery Systems.”
Date and Time: Tuesday, July 21 at 9:00 AM
Location: Gaithersburg Marriott Washingtonian Center, 9751 Washingtonian Boulevard, Gaithersburg, Md.
More information is available HERE.

Health and Human Services Department (HHS); Office of the Assistant Secretary for Health (F.R. Page 35655) – Meeting
Health and Human Services Department (HHS); Office of the Assistant Secretary for Health (F.R. Page 35655) to hold a meeting of the Secretary’s Advisory Committee on Human Research Protections. SACHRP was established to provide expert advice and recommendations to the Secretary of Health and Human Services through the Assistant Secretary for Health on issues and topics pertaining to or associated with the protection of human research subjects.
Date and Time: Tuesday, July 21 – Wednesday, July 22 at 8:30 am
Location: Fishers Lane Conference Center, 5635 Fishers Lane, Terrace Level, Rockville, Md.
More information is available HERE.

Health and Human Services Department (HHS); Centers for Medicare & Medicaid Services (CMS) (F.R. Page 23007) – Meeting
Health and Human Services Department (HHS); Centers for Medicare & Medicaid Services (CMS) (F.R. Page 23007) will hold a meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) focusing on lower extremity peripheral artery disease.
Date and Time: Wednesday, July 22 at 7:30 am
Location: Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Main Auditorium, Baltimore, Md.
More information is available HERE.

Health and Human Services Department (HHS); Centers for Medicare & Medicaid Services (CMS) (F.R. Page 35650) – Meeting
Health and Human Services Department (HHS); Centers for Medicare & Medicaid Services (CMS) (F.R. Page 35650) holds a meeting of the Advisory Panel on Outreach and Education on enhancing the effectiveness of consumer education strategies concerning the Health Insurance Marketplace, Medicare, Medicaid, and the Children’s Health Insurance Program (CHIP).
Date and Time: Wednesday, July 22 at 8:30 am
Location: HHS, 200 Independence Avenue SW, Room 738 G, Conference Room, Washington, D.C.
More information is available HERE.

Health and Human Services Department (HHS); Agency for Healthcare Research and Quality (F.R. Page 38207) – Meeting
Health and Human Services Department (HHS); Agency for Healthcare Research and Quality (F.R. Page 38207) holds a meeting of the National Advisory Council for Healthcare Research and Quality. Topics to be discussed include an update on current research, programs, and initiatives, an update on the National Healthcare Quality and Disparities Report and a discussion on cost and quality transparency
Date and Time: Friday, July 24 at 8:30 am
Location: Agency for Healthcare Research and Quality, 540 Gaither Road, Eisenberg Conference Center, Rockville, Md.
The agenda and supplemental information is available HERE.

July 13

Federal Affairs Activity Report: July 13 – July 17, 2015

Below is an overview of federal activity in the U.S. House of Representatives, the U.S. Senate, and federal agencies this week related to health care and/or other areas of interest for our clients.

House of Representatives

The House will convene today, July 13 at 12:00 p.m. No healthcare related votes are expected in the House this week.

Energy and Commerce Committee
The House Energy and Commerce Oversight and Investigations Subcommittee will hold hearing entitled “Medicare Part D: Measures Needed to Strengthen Program Integrity.”
Witnesses: Ann Maxwell, assistant Health and Human Services inspector general evaluation and inspections; and Shantanu Agrawal, deputy administrator and director of the Centers for Medicare and Medicaid Services’ Center for Program Integrity
Date and time: Tuesday, July 14; 10:00 a.m. EDT
Location: 2322 Rayburn House Office Building, Washington, D.C. 20515
Additional information is available HERE.

Veteran Affairs Committee
The House Veterans’ Affairs Health Subcommittee will hold a hearing on H.R.272, the “Medal of Honor Priority Care Act”; H.R.353, the “Veterans’ Access to Hearing Health Act of 2015”; H.R.359, the “Veterans Dog Training Therapy Act”; H.R.421, the “Classified Veterans Access to Care Act”; H.R.423, the “Newborn Care Improvement Act”; H.R.1356, the “Women Veterans Access to Quality Care Act of 2015”; H.R.1688, to amend the Veterans Access, Choice and Accountability Act of 2014 to designate 20 graduate medical education residency positions specifically for the study of optometry; H.R.1862, the “Veterans’ Credit Protection Act”; H.R.2464, the “Demanding Accountability for Veterans Act of 2015”; H.R.2914, the “Build a Better VA Act”; H.R.2915, the “Female Veteran Suicide Prevention Act”; H.R.3016, to clarify the role of podiatrists in VA; and draft legislation to authorize VA major medical facility construction projects for FY2015 and to make certain improvements in the administration of VA medical facility construction projects.
Witnesses: Ian de Planque, Legislative Director American Legion; Adrian Atizado, Assistant National Legislative Director, Disabled American Veterans; Christopher Neiweem, Legislative Associate Iraq and Afghanistan, Veterans of America; Carlos Fuentes, Senior Legislative Associate, National Legislative Service Veterans of Foreign Wars of the United States; Madhulika Agarwal MD, MPH, Deputy Under Secretary for Health for Policy and Services, Veterans Health Administration U.S. Department of Veterans Affairs; and Janet P. Murphy MBA, Acting Deputy Under Secretary for Health for Operations and Management, Veterans Health Administration U.S. Department of Veterans Affairs
Date and time: Tuesday, July 14; 10:00 a.m. EDT
Location: 334 Cannon House Office Building, Washington, D.C. 20515
Additional information is available HERE.


Senate

The Senate will convene today, July 13 at 3:00 p.m. No healthcare related votes are expected in the Senate this week.

Commerce, Science and Transportation Committee
The Senate Commerce, Science and Transportation full committee will hold a hearing entitled “Unlocking the Cures for America’s Most Deadly Diseases.”
Witnesses: Former Sen. Tom Coburn (R-OK); Christopher Frangione, vice president for prize development at XPRIZE; Peter Huber, senior fellow at the Manhattan Institute; and Keith Yamamoto, vice chancellor for research at the University of California, San Francisco
Date and time: Tuesday, July 14; 10:00 a.m. EDT
Location: 253 Russell Senate Office Building, Washington, D.C. 20510
Additional information is available HERE.

Finance Committee
The Senate Finance full committee will hold a hearing on “Reviewing HealthCare.gov Controls.”
Witnesses: TBA
Date and time: Thursday, July 16; 10:00 a.m. EDT
Location: 215 Dirksen Senate Office Building, Washington, D.C. 20510
Additional information is available HERE.


Special

Aging Committee
The Senate Aging Committee will hold a hearing on “Diabetes Research: Improving Lives on the Path to a Cure.”
Witnesses: TBA
Date and time: Wednesday, July 15; 2:15 a.m. EDT
Location: G-50 Dirksen Senate Office Building, Washington, D.C. 20510
Additional information is available HERE.


Federal Agencies

Health and Human Services Department (HHS); Food and Drug Administration (FDA) (F.R. Page 34679) – Meeting
Health and Human Services Department (HHS); Food and Drug Administration (FDA) held a meeting on the reauthorization of the Medical Device User Fee Amendments (MDUFA) for FY2018 through FY2022. The current legislative authority for the medical device user fee program expires in September 2017 and new legislation will be required for FDA to continue collecting user fees for the medical device program.
Date and Time: Monday, July 13, 9:00 AM
Location: FDA’s White Oak Campus, 10903 New Hampshire Avenue, Building 31 Conference Center, the Great Room, Room 1503, Silver Spring, Md.
The agenda is available HERE.

Health and Human Services Department (HHS); Food and Drug Administration (FDA) (F.R. Page 27323) – Meeting
Health and Human Services Department (HHS); Food and Drug Administration (FDA) (F.R. Page 27323) has scheduled a meeting on the reauthorization of the Prescription Drug User Fee Act (PDUFA) for FY2018 through FY2022.
Date and Time: Wednesday, July 15 at 9:00 am
Location: FDA White Oak Campus, 10903 New Hampshire Avenue, Building 31 Conference Center, Sections B and C of the Great Room, Room 1503, Silver Spring, Md.
More information and registration information is available HERE.

Health and Human Services Department (HHS); Centers for Medicare & Medicaid Services (CMS) (F.R. Page 26264) – Meeting
Health and Human Services Department (HHS); Centers for Medicare & Medicaid Services (CMS) holds a meeting on establishing payment amounts for new or substantially revised Healthcare Common Procedure Coding System codes being considered for Medicare payment under the clinical laboratory fee schedule for CY 2016.
Date and Time: Thursday, July 16 at 9:00 am
Location: Centers for Medicare & Medicaid Services, Central Building, 7500 Security Boulevard, Main Auditorium, Baltimore, Md.
More meeting information is available HERE.

July 6

Federal Affairs Activity Report: July 6 – July 10, 2015

Below is an overview of federal activity in the U.S. House of Representatives, the U.S. Senate, and federal agencies this week related to health care and/or other areas of interest for our clients.

House of Representatives

The House will reconvene on Tuesday, July 7 at 2:00 p.m. No healthcare related votes are expected in the House this week.

Energy and Commerce Committee
The House Energy and Commerce Health Subcommittee will hold a hearing on “Medicaid at 50: Strengthening and Sustaining the Program.”
Witnesses: TBA
Date and time: Wednesday, July 8; 10:15 a.m. EDT
Location: 2322 Rayburn House Office Building, Washington, D.C. 20515
Additional information is available HERE.

Appropriations Committee
The House Appropriations full committee will hold a markup of the FY2016 Agriculture Appropriations bill and the revised report on the suballocation of budget allocation for FY2016.
Date and time: Wednesday, July 8; 10:15 a.m. EDT
Location: 2359 Rayburn House Office Building, Washington, D.C. 20515
Additional information is available HERE.

Senate

The Senate will reconvene on Tuesday, July 7 at 2:30 p.m. No healthcare related votes are expected in the Senate this week.

Health, Education, Labor and Pensions Committee
The Senate Health, Education, Labor, and Pensions Primary Health and Retirement Security Subcommittee will hold a hearing entitled “Small Business Health Care Challenges and Opportunities.”
Witnesses: Thomas Harte, owner of Landmark Benefits in Hampstead, N.H.; James Scott, owner of Applied Policy in Alexandria, Va.; Sabrina Corlette, senior research fellow And project director at Georgetown University; and Kelly Conklin, owner of Foley-Waite in Kenilworth, N.J.
Date and time: Tuesday, July 7; 2:00 p.m. EDT
Location: 430 Dirksen Senate Office Building, Washington, D.C. 20510
Additional information is available HERE.

Federal Agencies

Health and Human Services Department (HHS); Food and Drug Administration (FDA) (F.R. Page 29721) – Meeting
Health and Human Services Department (HHS); Food and Drug Administration (FDA) (F.R. Page 29721) holds a meeting of the Oncologic Drugs Advisory Committee to discuss biologics license application 125547, necitumumab injection, application submitted by Eli Lilly and Company. The proposed indication (use) for this product is in combination with gemcitabine and cisplatin for first-line treatment of patients with locally advanced or metastatic squamous non-small cell lung cancer.
Date and Time: Thursday July 9th at 9:00 am
Location: FDA White Oak Campus, 10903 New Hampshire Avenue, Building 31 Conference Center, the Great Room (Room 1503), Silver Spring, Md.
The agenda is available HERE.

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