Week in Brief

The House is in recess. The Senate has been working during the recess with an abbreviated schedule. CMS and FDA have released several key proposed rules.


Healthcare: White House Briefing Room Issues Fact Sheet on Administration’s Action on Health Care Issues.

Mental Health: President Trump Signs Legislation on National Suicide Hotline. Finance Committee Chairman Orrin Hatch (R-UT) Releases Statement.

Opioids: President Trump Urges Attorney General Jeff Sessions to Bring Federal Lawsuit Against Opioid Manufacturers.


Tuesday, August 7

Health Care Spending: Senate Finance Committee Chairman Orrin Hatch (R-UT) and House Energy and Commerce Committee Chairman Greg Walden (R-OR) Write Letter to Office of Management and Budget (OMB) Director Mick Mulvaney Regarding Proposed HHS/Office of Inspector General Rule on Drug Rebates.

ACA: House Oversight and Government Reform Committee Ranking Member Elijah E. Cummings (D-MD) Sends Letter to CMS Regarding Removal of ACA-Related Information from Medicare Website.

Short-Term Limited-Duration Plans: House Ways and Means Chairman Kevin Brady (R-TX) Releases Statement Regarding HHS Announcement on Short-Term Limited Duration Plans.

Wednesday, August 8

Veterans’ Health: Senate Veterans’ Affairs Ranking Member Jon Tester (D-MT) Sends Letter to VA Secretary Robert Wilkie Regarding Implementation of VA MISSION Act.

Labor, HHS: Senate Begins Floor Debate on FY 2019 Labor, HHS Spending Bill.

Monday, August 13

Medicare: Senate HELP Committee Ranking Member Patty Murray (D-WA) and House Education and Workforce Committee Ranking Member Bobby Scott (D-VA), Submit Public Comment to CMS Administrator Seema Verma Regarding Proposed Rule on Reassignment of Medicaid Provider Claims, Request Extension of Comment Period.

Tuesday, August 14

Skilled Nursing Facilities: Senate Finance Committee Ranking Member Ron Wyden (D-OR) Writes Letter to CMS Administrator Seema Verma Requesting Details on Efforts to Update the Skilled Nursing Facility (SNF) 5-Star Quality Rating System.

Substance Use Disorders: Congressional Budget Office Releases Cost Estimate for Substance Abuse Prevention Act of 2018.

Wednesday, August 15

Opioids: House Ways and Means Committee Chairman Kevin Brady (R-TX) and Health Subcommittee Chairman Peter Roskam (R-IL) Release Report on Regulations in Medicare Program.

Friday, August 17

Drug Pricing: Senators Elizabeth Warren (D-MA) and Tina Smith (D-MN) Write Letter to HHS Secretary Alex Azar Regarding Senate Testimony on Pharmacy Benefit Managers, Drug Pricing.


Monday, August 6

Opioids:  FDA Issues Draft Guidance on Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment Guidance for Industry.

Medicare: CMS Issues Final Rules on Payment Systems and Quality Reporting Requirements Within Medicare Program. For Related News, See:

  • Final Rule: FY 2019 Inpatient Psychiatric Facilities Prospective Payment System and Quality Reporting Updates for Fiscal Year Beginning October 1, 2018 (FY 2019)
  • Final Rule: Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2019
  • Final Rule: FY 2019 Hospice Wage Index and Payment Rate and Hospice Quality Reporting Requirements.

Tuesday, August 7

Medicare Advantage: CMS Provides Medicare Advantage Plans Option to Negotiate for Part B Drugs. For Related News, See:

Opioids: FDA Issues Draft Guidance on Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment of Opioid Use Disorder.

Medicare Hearings and Appeals: HHS Announces Reorganization and Revision of Office of Medicare Hearings and Appeals (OMHA) Case Processing Manual.

Wednesday, August 8

Drug Pricing: FDA Approves First Generic Drug to Receive Competitive Generic Therapy (CGT) Designation,  House Energy and Commerce Committee Republicans Release Announcement on Website.

Risk Adjustment Program: CMS Issues Proposed Additional Rule on 2018 Benefit Year Risk Adjustment Program.

Skilled Nursing Facilities: CMS Issues Final Rule on FY 2019 Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities (SNF), SNF Value-Based Purchasing Program, and SNF Quality Reporting Program.

Thursday, August 9

Accountable Care: CMS Issues Proposed Rule to Redesign Participation Options Available to Accountable Care Organizations (ACOs) Under Medicare Shared Savings Program, Facilitate Transition to Two-Sided Model. For Related News, See:

Opioids: CDC Analysis Finds Number of Women with Opioid Use Disorder at Labor and Delivery Quadrupled from 1999-2014.

Opioids: NIH-Funded Study Finds Notification of Patient Overdose Deaths Reduces Clinician Opioid Prescriptions.

Opioids: SAMHSA Publishes Spanish-Language Version of Opioid Overdose Prevention Toolkit.

Friday, August 10

Physician Certification: SAMHSA Publishes List of Department of Health and Human Services (HHS) Approved Medical Review Officers Certification Entities. Risk Adjustment: CMS Issues Proposal to Adopt Previously Established Risk Adjustment Methodology.

Disorders of Consciousness: National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR) Announces Release of New Guideline for Managing Disorders of Consciousness.

Monday, August 13

Medicare: CMS Releases Quarterly Listing of Medicare and Medicaid Programs Issuances from April Through June 2018.

Tuesday, August 14

Medicaid Work Requirements: Medicaid Recipients in Arkansas File Lawsuit Against HHS Over Approval of Work Requirements.

ACA: Oral arguments in Texas Suit Over Constitutionality of ACA Set for September 10.

Wednesday, August 15

Health Centers: HHS Awards $125 Million to Support Community Health Center Quality Improvement.

Substance Use Disorders: CDC Data Reflects Number of Drug Overdoses in 2017.

Pediatrics: FDA Announces Issuance of Priority Review Voucher to Sponsor of Rare Pediatric Disease Product Application.

Indian Health Service: GAO Publishes Report on Provider Vacancies in Indian Health Service.

Thursday, August 16

Drug Pricing: HHS Secretary Azar Meets with Specialty and Patient Groups Regarding Drug Pricing.

Disability: CDC Report Finds 1 in 4 US Adults Live With a Disability.

Medicaid: CMS Announces Changes to Medicaid Review Process.

Friday, August 17

Medicare: CMS Issues Final Rule Revising Medicare Hospital Inpatient Prospective Payment Systems (IPPS), Long-Term Care Hospital Prospective Payment System, Other Program Requirements. House Ways and Means Committee Chairman Kevin Brady (R-TX) and Subcommittee on Health Chairman Peter Roskam (R-IL) Release Statements.

Behavioral Health: FDA Permits Marketing of Transcranial Magnetic Stimulation for Treatment of Obsessive Compulsive Disorder.

Medical Devices: FDA Requests Comments on Medical Device Classification.


CMS Advisory Panel on Hospital Outpatient Payment
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
August 22, 2018, 7:30 AM to 4:30 PM
CMS Single Site Campus: Main Auditorium
7500 Security Boulevard
Baltimore, MD 21244

Senate HELP Committee
Hearing: “Prioritizing Cures: Science and Stewardship at the National Institutes of Health”
August 23, 2018, 10:00 AM
428 Dirksen Senate Office Building

NIH National Institute of Nursing Research
September 4, 2018, 1:00 PM to 5:00 PM
National Institutes of Health
Building 31, 6th Floor, C Wing, Room 6,
31 Center Drive
Bethesda, MD 20892

NIH National Heart, Lung, and Blood Institute
September 5, 2018, 8:00 AM to 3:00 PM
National Institutes of Health
Building 35A, Porter Building, Room 640
35A Convent Drive
Bethesda, MD 20892

NIH National Institute on Drug Abuse
September 5, 2018, 10:30 AM to 4:30 PM
National Institutes of Health
Neuroscience Center
6001 Executive Boulevard
Rockville, MD 20852

NIH National Diabetes and Digestive and Kidney Diseases Advisory Council
Meetings (Various)
September 7, 2018; Various times
National Institutes of Health
Building 31, C Wing, 6th Floor
31 Center Drive
Bethesda, MD 20892

Symposium on Chronic Pain: The Science of Complementary and Integrative Health Approaches
September 11, 2018
Boston Convention and Exhibition Center
415 Summer Street
Boston, MA 02210

Public Workshop: Advancing the Development of Pediatric Therapeutics 5: Advancing Pediatric Pharmacovigilance
September 14, 2018 8:00 AM to 5:00 PM
FDA White Oak Campus
10903 New Hampshire Ave. Bldg 31, Room 1503
Silver Spring, MD 20903

FDA Pediatric Advisory Committee
September 20, 2018, 8:30 AM to 4 PM
FDA White Oak Campus
Building 31, Conference Center, the Great Room (Rm. 1503)
10903 New Hampshire Ave
Silver Spring, MD 20993-002

FDA Neurological Devices Panel Advisory Committee
September 27, 2018, 8 AM to 5 PM
Hilton Washington
DC/North, Salons A, B, C, and D
620 Perry Pkwy
Gaithersburg, MD 20877

NIH National Institute of Aging
Meeting of the Board of Scientific Counselors
October 9, 2018, 8:00 AM to 6:10 PM
National Institutes on Aging, Biomedical Research Center
3rd Floor Conference Room 03C227
251 Bayview Boulevard
Baltimore, MD 21224

NIH National Institute of Mental Health
October 17, 2018, 9:00 AM to 5:00 PM
National Institutes of Health, Neuroscience Center
6001 Executive Boulevard, Conference Room C and D
Rockville, MD 20852

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.

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