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.
WHITE HOUSE UPDATE
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.
LEGISLATIVE UPDATE
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.
REGULATORY UPDATE
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:
- Statement from HHS Secretary Alex Azar
- Statement from House Ways and Means Chairman Kevin Brady (R-TX)
- Fact Sheet from CMS
- Responses from Patient Groups and Drugmakers
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:
- CMS Press Release
- Health Affairs Post by CMS Administrator Seema Verma
- Reactions from Industry Observers
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.
UPCOMING EVENTS
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
Meeting
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
Meeting
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
Meeting
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
Meeting
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
NIH
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
FDA
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
Meeting
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
Meeting
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
Meeting
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.