Week in Brief

340B: U.S. Court of Appeals for the District of Columbia Circuit Rules AHA Suit Against HHS Over Cuts to 340B Funding “Premature.” For Related News, See:


LEGISLATIVE UPDATE

Monday, July 16

Drug Pricing: Senate Finance Committee Ranking Member Ron Wyden (D-OR) Issues Statement on President’s Drug Pricing Plan as Trump Administration Drug Pricing Blueprint Comment Period Ends.

Tuesday, July 17

Health Care Costs: Senate HELP Committee Holds Hearing on Reducing Health Care Costs. For Related News, See:

Stark Law: House Ways and Means Subcommittee on Health Holds Hearing on Stark Law in the Medicare Program. For Related News, See:

  • Recap from House Ways and Means Majority Site
  • Opening Remarks from Representative Adrian Smith (R-NE) on behalf of House Ways and Means Health Subcommittee Chairman Peter Roskam (R-IL)
  • Opening Remarks from House Ways and Means Health Subcommittee Ranking Member Sander Levin (D-MI)

Medicare Fraud: House Ways and Means Oversight Subcommittee Holds Hearing on Combating Fraud in Medicare. For Related News, See:

  • Recap from House Ways and Means Majority Site
  • Opening Remarks From House Ways and Means Oversight Subcommittee Chairman Lynn Jenkins (R-KS)
  • Opening Remarks from House Ways and Means Subcommittee on Oversight Ranking Member John Lewis (D-GA)

Opioids: House Ways and Means Human Resources Subcommittee Chairman Adrian Smith (R-NE) Announces Subcommittee Hearing on HHS Implementation of Family First Prevention Services Act (FFPSA) to Combat Opioid Crisis.

Health Care Costs: House Energy and Commerce Subcommittee on Oversight and Investigations Holds Hearing to Examine State Efforts to Improve Transparency of Health Care Costs for Consumers. For Related News, See:

  • Recap and Statements from House Energy and Commerce Committee Chairman Greg Walden (R-OR) and Oversight and Investigations Subcommittee Chairman Gregg Harper (R-MS)
  • Remarks from House Energy and Commerce Committee Ranking Member Frank Pallone (D-NJ)

Wednesday, July 18

VA MISSION Act: House Budget Committee Chairman Steve Womack (R-AR) and Senate Budget Committee Chairman Mike Enzi (R-WY) Write Letter on Funding for VA MISSION Act. For Related News, See:

  • Response from House Appropriations Committee Ranking Member Nita Lowey (D-NY)
  • Response from House Committee on Veterans’ Affairs Ranking Member Tim Walz (D-MN) and House Military Construction, Veterans Affairs, and Related Agencies (MCVA) Appropriations Subcommittee Ranking Member Debbie Wasserman Schultz (D-FL)

Health Research: House Energy and Commerce Health Subcommittee Announces Second Hearing on 21st Century Cures to Focus on Work from FDA, NIH.

Thursday, July 19

Mental Health: House Energy and Commerce Subcommittee on Health Holds Hearing to Examine Implementation of 21st Century Cures Act, Impact on Mental Health and Substance Use. For Related News, See:

  • Recap and Statements from House Energy and Commerce Committee Chairman Greg Walden (R-OR) and Health Subcommittee Chairman Michael C. Burgess (R-TX)
  • Remarks from House Energy and Commerce Ranking Member Frank Pallone (D-NJ)

ACA: House Energy and Commerce Ranking Member Frank Pallone (D-NJ) and Vice Ranking Member Kathy Castor (D-FL) Send Letter HHS Secretary Alex Azar and CMS Administrator Seema Verma Regarding Administration’s Funding Cuts to ACA Navigators.

Pre-Existing Conditions: Senate Democrats Announce Plans To Defend Constitutionality of Pre-Existing Conditions Protections.

Veterans’ Health: Senate Veterans’ Affairs Committee Chairman Johnny Isakson (R-GA) Calls for Prompt Confirmation of Robert Wilkie for VA Secretary.

MACRA: House Energy and Commerce Health Subcommittee Announces Upcoming Hearing to Review MACRA and MIPS.


REGULATORY UPDATE

Tuesday, July 17

Over-the-Counter Drugs: FDA Draft Guidance Outlines Two Potential Strategies to Safely Increase Range of Drugs Approved as Nonprescription. For Related News, See:

Work Requirements: CMS Administrator Seema Verma Weighs in on Court’s Rejection of Kentucky Work Requirements.

Wednesday, July 18

Risk Adjustment Payments: CMS Sends Regulation to OMB, Reverses Suspension of $10.4 Billion in Payments to Health Insurers Through Risk Adjustment Program. For Related News, See:

  • Monday Letter from House Committee Democratic Leaders to CMS, HHS
  • Comments from House Ways and Means Committee Chairman Kevin Brady (R-TX)

Biosimilars: FDA Commissioner Scott Gottleib Announces Plan to Increase Access to Affordable Biosimilars. For Related News, See:

Drug Pricing: Dan Best, Senior Advisor to HHS Secretary Alex Azar for Drug-Pricing Reform, Addresses Topic of State Drug Pricing Negotiations in Blog Post.

Behavioral Health: SAMHSA Announces up to $3.75 Million in Funding to Enhance Training Efforts to Address Eating Disorders.

340B: GAO Releases Report on Characteristics of Hospitals Participating and Not Participating in the 340B Program.

Oncology: FDA Approves First Cancer Drug through New Oncology Review Pilot that Enables Greater Development Efficiency.

Thursday, July 19

Drug Shortages: HHS Secretary Alex Azar Directs FDA to Establish Working Group to Explore Possibility of Importing Drugs in Event of Dramatic Price Spikes. For Related News, See:

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

ESRD & DMEPOS Proposed Rule: CMS Releases Proposed Rule Regarding Services for Beneficiaries With End-Stage Renal Disease (ESRD); Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Competitive Bidding Program (CBP) and Fee Schedule Amounts.

Drug Pricing: HHS Secretary Azar Praises Merck’s Decision to Cut Drug Prices.


UPCOMING EVENTS
House Ways and Means Subcommittee on Human Resources
Hearing: “The Opioid Crisis: Implementation of the Family First Prevention Services Act (FFPSA).”
July 24, 10:00 AM
1100 Longworth House Office Building.

House Energy and Commerce Health Subcommittee
Hearing: “21st Century Cures Implementation: Updates from FDA and NIH”
July 25, 2018, 9:00 AM
2123 Raymond House Office Building

Senate HELP Committee
Executive Session: S. 2554, H.R. 1222, S. 2465, and S. 3016
July 25, 2018, 10:00 AM
430 Dirksen Senate Office Building

House Ways and Means Social Security Subcommittee
Hearing: “Examining Changes to Social Security’s Disability Appeals Process”
July 25, 2018, 10:00 AM
2020 Rayburn House Office Building

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

House Energy and Commerce Health Subcommittee
Hearing: “MACRA and MIPS: An Update on the Merit-based Incentive Payment System”
July 26, 2016, 10:00 AM
2123 Raymond House Office Building

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.