Week in Brief

ACA Court Case: Senate Majority Leader Mitch McConnell Affirms Senate Support for Consumer Protections for People with Pre-Existing Conditions Following Last Week’s DOJ Announcement. For Related News, See:

  • Comments from HHS Secretary Alex Azar
  • Floor Statement from Senate HELP Committee Ranking Member Patty Murray (D-WA)
  • Statement from Senate HELP Committee Chairman Lamar Alexander (R-TN)
  • Statement from Senate HELP Committee Ranking Member Patty Murray (D-WA)
  • Statement from House Judiciary Committee Democrats
  • Statement from House Oversight and Government Reform Committee Democrats
  • Statement from House Ways and Means Committee Democrats
  • News Release: “Senior DOJ official resigns in wake of ObamaCare decision”

Opioids: New Legislation Passed, Introduced in House.

House Passes 25 Bills to Combat the Opioid Crisis. For Related News, See:

  • Op-ed from House Speaker Paul Ryan
  • Statement from House Ways and Means Chairman Kevin Brady (R-TX)
  • Recap from House Energy and Commerce Committee (“E&C’s Opioid Week in Review: House Floor Edition”)

House Energy and Commerce Committee Chairman Greg Walden (R-OR), Ways and Means Committee Chairman Kevin Brady (R-TX), Energy and Commerce Committee Ranking Member Frank Pallone, Jr. (D-NJ), and Ways and Means Committee Ranking Member Richard Neal (D-MA) Introduce New Legislation to Combat Opioid Crisis.


LEGISLATIVE UPDATE

Monday, June 11

Drug Pricing: Democrats Continue to Inquire into Federal Drug Pricing Plan.

DNC Publishes Memo on Trump Administration’s Drug Pricing Plan.

Senators Elizabeth Warren (D-MA) and Tina Smith (D-MN) Seek Additional Information on Federal Drug Pricing Plan in 12-Page Letter to Health and Human Services (HHS) Secretary Alex Azar.

Tuesday, June 12

Opioids: New Legislation Passes Through Committee, Members of Congress Raise Concerns about Oversight.

Senate Finance Committee Approves HEAL Substance Use Disorders Act of 2018. For Related News, See:

Mark DeSaulnier (D-CA) and Ranking Member of the Oversight and Government Reform Committee Elijah E. Cummings (D-MD) Ask Attorney General Jeff Sessions to Produce DOJ Report Regarding OxyContin Abuses.

Energy and Commerce Committee Writes Letter to FDA Commissioner Scott Gottleib, Raises Questions About Agency’s Efforts to Block Drugs at Ports of Entry.

Drug Pricing: Senate HELP Committee Holds Hearing on President’s ‘American Patients First’ Drug Pricing Plan. For Related News, See:

  • Remarks from Senate HELP Committee Chairman Lamar Alexander (R-TN)
  • Remarks from Senate HELP Committee Ranking Member Patty Murray (D-WA)
  • Testimony from HHS Secretary Alex Azar

340B Program: House Energy and Commerce Committee Member Doris Matsui (D-CA) Introduces Legislation in Support of 340B Program.

Wednesday, June 13

Opioids: Opioid Legislation Passed and Introduced, Legislators Share Stories of Those Personally Affected.

House Judiciary Committee Celebrates House Approval of REGROUP Act of 2018. For Related News, See:

  • Floor Statement from House Judiciary Committee Chairman Bob Goodlatte (R-VA).

House Energy and Commerce Committee Chairman Greg Walden (R-OR) Shares Patient Story at House Republicans Weekly Press Conference.

House Judiciary Committee Shares Video of Personal Testimony from Opioid Crisis.

House Ways and Means Committee Chairman Kevin Brady (R-TX) Assesses Ways and Means Efforts to Combat Opioids Crisis.

Thursday, June 14

Drug Pricing: Senate Judiciary Committee Approves CREATES Act. For Related News, See:

  • Statement from Committee Chairman Chuck Grassley (R-IA)

Opioids: House Passes STOP Act in Effort to Stop the Flow of Synthetic Opioids Through the International Mail System. For Related News, See:

  • Statement from House Ways and Means Chairman Kevin Brady (R-TX), Rep. Mike Bishop (R-MI), Trade Subcommittee Chairman Dave Reichert (R-WA), Trade Subcommittee Ranking Member Rep. Bill Pascrell, Jr. (D-NJ), and Rep. John Faso (R-NY).
  • Op Ed from House Ways and Means Committee Member Mike Bishop (R-MI) and Senate Finance Committee Member Rob Portman (R-OH)

Friday, June 15

Appropriations: House Appropriations Committee Holds Subcommittee Markup of Labor, Health and Human Services, and Education Appropriations Bill. For Related News, See:

  • Summary of Bill, Released Prior to Markup
  • Statements from House Appropriations Chairman Rodney Frelinghuysen and Labor, Health and Human Services, and Education Subcommittee Chairman Tom Cole (R-OK), Prior to Markup
  • Statement from Ranking Member of House Appropriations Labor, Health, Human Services, and Education Subcommittee Rosa DeLauro (D-CT), Prior to Markup
  • Statement from House Appropriations Committee Ranking Member Nita Lowey (D-NY), During Markup
  • Statement from Ranking Member of House Appropriations Labor, Health, Human Services, and Education Subcommittee Rosa DeLauro (D-CT), During Markup

Opioids: Energy and Commerce Committee Chairman Greg Walden (R-OR) and Health Subcommittee Chairman Michael C. Burgess (R-TX) Release Statement After House Passes Legislation to Stop Illegal Importation and Distribution of Synthetic Drugs.

Health Insurance: Senate HELP Committee Leaders Discuss Ways to Lower Costs, Expand Access.

Senate HELP Committee Chairman Lamar Alexander (R-TN) Leads Group of 30 Senate Republicans in Urging Department of Labor Expand Association Health Plans (AHPs).

Senate HELP Committee Chairman Lamar Alexander (R-TN) Sends Letter to CMS Regarding Section 1332 State Innovation Waivers. For Related News, See:

  • Statement from Senate HELP Committee Ranking Member Patty Murray (D-WA)

REGULATORY UPDATE

Monday, June 11

Opioids: Regulatory Agencies Provide Tools to Manage Crisis.

CMS Releases Guidance to Help States Use Medicaid to Combat Opioid Crisis. For Related News, See:

  • CMS Information Bulletin on Addressing Neonatal Abstinence Syndrome with Medicaid Resources
  • CMS Letter Advising State Medicaid Directors of Related Funding Opportunities
  • Statement from Energy and Commerce Committee Chairman Greg Walden (R-OR) and Health Subcommittee Chairman Michael C. Burgess (R-TX)
  • Statement from HHS First Lady Melania Trump

SAMHSA Publishes Updated Toolkit to Help Prevent Opioid Overdoses.

Tuesday, June 12

Drug Pricing: FDA Issues Two Final Guidance Documents for Drug and Device Manufacturers. For Related News, See:

  • Statement from Senate HELP Committee Chairman Lamar Alexander (R-TN)
  • Statement from House Energy and Commerce Committee Leaders.

Opioids: NIH Outlines $500M Research Plan for HEAL Initiative, Aimed at Opioid Epidemic. For Related News, See:

  • Statement from Energy and Commerce Committee Chairman Greg Walden (R-OR) and Health Subcommittee Chairman Michael C. Burgess (R-TX)

Drug Development: FDA Issues Draft Guidance on Patient-Focused Drug Development.

Hospital Ratings: CMS Delays Update of Hospital Star Ratings Data on QualityNet Portal, Originally Scheduled for July 2018.

Wednesday, June 13

Pediatrics: NIH Forms New Trans-NIH Consortium to Advance Global Pediatric Research.

Brain Injury: NIH Study Finds No Significant Link Between Brain Injury and IV Fluid Treatment of Pediatric Diabetic Ketoacidosis.

Thursday, June 14

Opioids: FDA Approves First Generic Versions of Opioid Dependence Treatment, Suboxone Sublingual Film. For Related News, See:

Suicide Prevention: Co-Chairs of the Bipartisan House Suicide Prevention Task Force Don Beyer (D-VA) and John Katko (R-NY) Write Letter to House Appropriators, Ask for Increase in Suicide Prevention Funding.

Brain Trauma: FDA Classifies Brain Trauma Assessment Test into Class II.

Friday, June 15

Opioids: HRSA Releases FY2018 Expanding Access to Quality Substance Use Disorder and Mental Health Services Grants. For Related News, See:

  • Statement from Energy and Commerce Committee Chairman Greg Walden (R-OR) and Health Subcommittee Chairman Michael C. Burgess (R-TX)

Risk Corridors: Citing Legislative Mandate that Program Remain “Budget Neutral,” Federal Appellate Court Sides with Administration, Denies Insurers Compensation from ACA Risk Corridor Program.

Limb Loss: Administration for Community Living (ACL) Announces Intent to Award Single-Source Supplement to Amputee Coalition of America, Inc. for National Limb Loss Resource Center Cooperative Agreement.


UPCOMING EVENTS

Senate HELP Committee
Hearing: “Effective Administration of the 340B Drug Pricing Program”
June 19, 2018, 10:00 AM
430 Dirksen Senate Office Building

Senate Special Committee on Aging
Hearing: “Changing the Trajectory of Alzheimer’s: Reducing Risk, Detecting Early Symptoms, and Improving Data”
June 19, 2018, 2:30 PM
106 Dirksen Senate Office Building

House Appropriations Committee
Full Committee Markup: FY 2019 State and Foreign Operations Appropriations Bill; Labor, Health and Human Services, and Education Appropriations Bill; and Revised Report on the Suballocation of Budget Allocations for FY 2019
June 20, 2018, 10:00 AM
2154 Rayburn House Office Building

Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee
Public Meeting and Opportunity for Comment
June 20, 2018, 8 AM to 4:30 PM
FDA White Oak Campus
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503)
Silver Spring, MD 20993

Senate HELP Committee
Hearing: “How to Reduce Health Care Costs: Understanding the Cost of Health Care in America”
June 17, 2018, 10:00 AM
430 Dirksen Senate Office Building

FDA
Meeting: “Patient-Focused Drug Development for Chronic Pain.”
July 9, 2018, 10 AM to 4 PM
FDA White Oak Campus
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503)
Silver Spring, MD 20993

CMS
Meeting of the Medicare Evidence Development and Coverage Advisory Committee
July 25, 2018 7:30 AM to 4:30 PM
CMS Single Site Campus: Main Auditorium
7500 Security Boulevard
Baltimore, MD 21244

SAMHSA
Center for Substance Abuse Treatment: Public Meeting
August 1, 2018, 9:00 AM to 5:00 PM
SAMHSA
5600 Fishers Lane, 5E49
Rockville, MD 20857

CMS
Advisory Panel on Hospital Outpatient Payment (the Panel): Annual Meeting
August 20, 2018 9:30 AM to 5 PM
August 21, 2018, 9:30 AM to 1 PM
CMS Single Site Campus: Main Auditorium
7500 Security Boulevard
Baltimore, MD 21244

CMS
Medicare Evidence Development and Coverage Advisory Committee: Public Meeting
August 22, 2018, 7:30 AM to 4:30 PM
CMS Single Site Campus: Main Auditorium
7500 Security Boulevard
Baltimore, MD 21244


For more information about this issue of Power Play: Washington Week in Review or more legislative and regulatory updates, contact the Powers Pyles Sutter & Verville Government Relations and Public Policy group at (202) 466-6550.