What’s Ahead: This Week

 Hearings and Markups –

  • Wednesday, May 15
    • Senate Homeland Security and Governmental Affairs Committee, “Markup of the Repeal Insurance Plans of the Multi-State Program Act and Other Legislation.”
    • House Ways & Means Committee, “The Economic and Health Consequences of Climate Change.”
    • House Veterans’ Affairs Committee, Subcommittee on Health, “FY 2020 Department of Veterans Affairs Budget Request for the Veterans Health Administration.”
  • Thursday, May 16
    • House Ways & Means Committee, “Overcoming Racial Disparities and Social Determinants in the Maternal Mortality Crisis.”
    • House Oversight & Reform Committee, “HIV Prevention Drug: Billions in Corporate Profits after Millions in Taxpayer Investments.”

 Notable Policy Events –

  • Monday, May 13 – Wednesday, May 15
    • Institute for Defense and Government Advancement (IDGA), “2019 VA Healthcare Summit.” Additional information: https://bit.ly/2Wxuc7T
  • Monday, May 13
    • Health IT Advisory Committee (HITAC), “Health IT Advisory Committee Meeting.” Additional information: http://bit.ly/2WMrqfb
    • Bipartisan Policy Center (BPC), “The Role of Litigation in Response to the Opioid Epidemic.” Additional information: https://bit.ly/2IXqAZJ
  • Tuesday, May 14
    • Center for American Progress (CAP), “Antitrust and Health Care Providers: Policies to Promote Competition and Protect Patients.” Additional information: https://ampr.gs/2LykvVq
  • Wednesday, May 15
  • Thursday, May 16
    • Washington Post Live, “Mental Health and the Addiction Crisis.” Additional information: https://wapo.st/2Jf6tpU
    • Alliance for Health Policy (AHP), “Webinar: Prescription Drug Patents: Balancing Innovation, Access, and Affordability.” Additional information: https://bit.ly/309SWFe


Weekly Wrap-Up: Notable Health Care Developments From Last Week

Legislative Activity:


Committee Activity, Floor Votes, and Executive Action:

  • On May 8, the House unanimously passed the Orange Book Transparency Act of 2019 (H.R. 1503), which would clarify patent and exclusivity information that is included in FDA’s Orange Book, as well as the Purple Book Continuity Act of 2019 (H.R. 1520), which would provide for the publication of a list of licensed biological products. The measures now move to the Senate for consideration.. Press release: https://bit.ly/2E1YXdP Bill texts: https://bit.ly/2VQolNO and https://bit.ly/2WBCg7w
  • Also on May 8, the House Veterans’ Affairs Committee favorably reported by voice vote 18 veterans-related bills including the Vet Center Eligibility Expansion Act (H.R. 1812), which would furnish Vet Center readjustment counseling and related mental health services to certain individuals. The measures now move to the full House for consideration. Press release: https://bit.ly/2W05zU2 H.R. 1812 text: https://bit.ly/2V9Wio4
  • Also on May 8, the House Appropriations Committee approved, by a vote of 30-23 the Fiscal Year 2020 (FY2020) Labor-HHS-Education appropriations bill, which included several amendments from the version originally passed out of subcommittee. The bill now moves to the full House for consideration. Press release: http://bit.ly/2vVhMuA
  • On May 9, the House Appropriations Committee approved, by a vote a 31-21 the FY2020 http://bit.ly/2vVhMuA Military Construction-Veterans Affairs appropriations bill, which included several amendments from the version originally passed out of subcommittee. The bill now moves to the full House for consideration. Press release: http://bit.ly/2vUMuUO
  • Also on May 9, the House passed by a vote of 230-183 the Protecting Americans with Preexisting Conditions Act of 2019 (H.R. 986), which would provide that guidance related to short-term, limited duration health insurance shall have no force or effect. The measure now moves to the Senate for consideration. Bill text: https://bit.ly/2VeFYCx WH Statement of Administration Policy: https://bit.ly/2HbXlim

 Introduced Legislation:

  • On May 6, Sens. Portman (R-OH) and Casey (D-PA) introduced the Utilizing National Data Effectively Reforming Standards and Tools to Address Negative Determinants of Health (UNDERSTAND) Act (S. 1323), which would collect information under Medicare, Medicaid, and CHIP related to social determinants of health. Press release: https://bit.ly/2VXBgNV
  • Also on May 6, Sens. Hoeven (R-ND) and Baldwin (D-WI) introduced the Chronic Wasting Disease Research Act (S. 1326), which would establish a chronic wasting disease research grant program. Press release: https://bit.ly/2J6yT5v
  • Also on May 7, Reps. Kilmer (D-WA) and Stefanik (R-NY) introduced the Protecting Local Access to Care for Everyone (PLACE) Act (H.R. 2552), which would direct the Secretary of Health and Human Services (HHS) to prevent certain payment reductions for clinic visit services furnished at excepted off-campus outpatient departments of a provider under the Medicare program. Press release: http://bit.ly/2vSceRJ
  • Also on May 7, Rep. S. Maloney (D-NY) introduced the Get Veterans a Doctor Now Act (H.R. 2556), which would provide for an extension of the authority of the Secretary of Veterans Affairs (VA) to provide for the conduct of medical disability examinations by contract physicians. Press release: https://bit.ly/2JrkShU
  • Also on May 7, Sens. Booker (D-NJ), Gillibrand (D-NY), Baldwin (D-WI), Blumenthal (D-CT), Harris (D-CA), Warren (D-MA), and Hirono (D-HI) introduced the Maximizing Outcomes for Moms through Medicaid Improvement and Enhancement of Services (MOMMIES) Act (S. 1343), which would extend coverage for new mothers from two months to a full year after childbirth. Reps. Pressley (D-MA), Underwood (D-IL), and Adams (D-NC) introduced companion legislation in the House (H.R. 2602). Press release: https://bit.ly/2VslFGw Bill text: https://bit.ly/309UIGo
  • Also on May 7, Sen. Cassidy (R-LA) and 7 bipartisan cosponsors introduced the Good Samaritan Health Professionals Act (S. 1350), which would limit the liability of health care professionals who volunteer to provide health care services in response to a disaster. Press release: https://bit.ly/2V7WK6d Bill text: https://bit.ly/2Wy2APP
  • On May 8, House Oversight & Reform Committee Chair Cummings (D-MD) and 88 cosponsors introduced the Comprehensive Addiction Resources Emergency (CARE) Act (H.R. 2569), which would invest $100 billion in federal funding over 10 years to fight the opioid and substance use epidemic, including a total of more than $800 million per year provided directly to tribal governments and organizations. Sen. Warren (D-MA) and 8 cosponsors introduced companion legislation in the Senate (S. 1365). Press release: https://bit.ly/2VR6qGP Bill text: https://bit.ly/2HhoHU6
  • Also on May 8, Rep. Sewell (D-AL) and 10 bipartisan cosponsors introduced the Home Health Payment Innovation Act of 2019 (H.R. 2573), which would prevent home health payment rate cuts by basing any behavioral adjustment on evidence and provide a phase-in for any necessary rate increases or decreases. Sens. Collins (R-ME) and Jones (D-AL) previously introduced companion legislation in the Senate (S. 433). Press release: https://bit.ly/2VhfyAa Bill text: https://bit.ly/2JbP1md
  • Also on May 8, House Veterans’ Affairs Committee Ranking Member Roe (R-TN) and Rep. Suozzi (D-NY) introduced the Modernizing Drug Enforcement Act (H.R. 2580), which would automatically classify drugs and other substances that act as opioid receptor agonists as Schedule I narcotics. Press release: https://bit.ly/2YhxM6k Bill text: https://bit.ly/2JCtBxM
  • Also on May 8, Rep. Schakowsky (D-IL) and 26 cosponsors introduced the Nurse Staffing Standards for Hospital Patient Safety and Quality Care Act (H.R. 2581), which would set minimum nurse-to-patient staffing ratios, study best practices for nurse staffing, and provide whistleblower protections for nurses. Sen. Brown (D-OH) introduced companion legislation in the Senate (S. 1357). Press release: https://bit.ly/2Ym5NCK
  • Also on May 8, Rep. Cicilline (D-RI) introduced the Opioid Quota Act (H.R. 2582), which would require the Attorney General to make procurement quotas for opioid analgesics publicly available. Sen. Markey (D-MA) introduced companion legislation in the Senate (S. 1366). Press release: https://bit.ly/2HaNgDn Bill text: https://bit.ly/2E1ikDT
  • Also on May 8, Reps. DeGette (D-CO) and Burgess (R-TX) introduced the Preventive Health Savings Act of 2019 (H.R. 2584), which would allow the House Budget, Ways & Means, or Energy & Commerce Committees to request a CBO analysis of the potential long-term cost savings that would be created by certain preventive measure beyond the existing 10-year window. Sen. Cardin (D-MD) introduced companion legislation in the Senate (S. 1361). Press release: https://bit.ly/2E2efPA Bill text: https://bit.ly/2HcwG6c
  • Also on May 8, Reps. Kind (D-WI) and Walorski (R-IN) introduced the Rural Access to Hospice Act (H.R. 2594), which would allow rural health clinics (RHCs) and federally-qualified health centers (FQHCs) to bill for hospice care. Press release: https://bit.ly/2vQSwG8 Bill text: https://bit.ly/2Wyp4QB
  • Also on May 8, Sens. McSally (R-AZ) and Murphy (D-CT) introduced the Metastatic Breast Cancer Access to Care Act (S. 1374), which would eliminate the waiting periods for disability insurance benefits and Medicare coverage for individuals with metastatic breast cancer. Companion legislation was introduced in the House by Reps. King (R-NY) and Castor (D-FL) (H.R. 2178). Press release: https://bit.ly/2JcQxEx Bill text: https://bit.ly/2VhUI3q
  • On May 9, Reps. Brindisi (D-NY), Reschenthaler (R-PA), Katko (R-NY), and Meadows (R-NC) introduced the Care and Readiness Enhancement (CARE) for Reservists Act (H.R. 2629), which would expand eligibility for VA mental health services to include members of the reserve components of the Armed Forces. Press release: http://bit.ly/2E4hUg6
  • Also on May 9, Sens. Romney (R-UT) and Braun (R-IN) introduced the Prescription Drug Rebate Reform Act of 2019 (S. 1384), which would require that all patients’ coinsurance obligations be set as a percentage of net price rather than list price. Press release: https://bit.ly/2Yqie0l Bill text: https://bit.ly/2ViB4oh
  • Also on May 9, Sens. Baldwin (D-WI) and Braun (R-IN) introduced the FAIR Drug Pricing Act (S. 1391), which would require transparency from pharmaceutical companies that plan to increase drug prices. Reps. Schakowsky (D-IL) and Rooney (R-FL) introduced companion legislation in the House earlier this year (H.R. 2296). Press release: https://bit.ly/2PWpuxW Bill text: https://bit.ly/2HcRLxu
  • Also on May 9, Sens. Merkley (D-OR) and Burr (R-NC) introduced the Nursing Workforce Reauthorization Act of 2019 (S. 1399), which would reauthorize through FY 2024 a broad range of programs outlined under Title VIII of the Public Health Services Act. Press release: https://bit.ly/2HeU1V7 Bill text: https://bit.ly/2LAStca
  • Also on May 9, Sens. Casey (D-PA), Menendez (D-NJ), and Booker (D-NJ) introduced the State Allowance for a Variety of Exchanges (SAVE) Act (S. 1400), which would provide $200 million in competitive federal grant funding to support states in establishing their own state-based health exchanges. Press release: https://bit.ly/2WFJxU0 Bill text: https://bit.ly/2HgBxDH
  • Also on May 9, Sens. Cornyn (R-TX) and Blumenthal (D-CT) introduced the Affordable Prescriptions for Patients Act (S. 1416), which would codify definitions of product hopping and patent thicketing within the Federal Trade Commission (FTC) Act. Press release: https://bit.ly/2HcDHnq
  • On May 10, Congressional Diabetes Caucus Co-Chairs Degette (D-CO) and Reed (R-NY) introduced H.R. 2668, which would reauthorize special programs for Type 1 diabetes. Press release: http://bit.ly/2E7o0w1

 ACA and Individual Market –

  • On May 7, Sens. Collins (R-ME) and Manchin (D-WV) penned a letter to U.S. Attorney General Barr urging him to reverse the Department of Justice’s decision not to defend the consumer protections of the ACA. Press release: https://bit.ly/2LznFII Letter: https://bit.ly/2Vh5Hds
  • On May 8, CMS released a set of frequently asked questions for issuers in in submitting data for the user fee adjustment submission process. FAQs: https://go.cms.gov/2VXWcEr

 Medicare and Medicaid –

  • On May 7, CMS issued guidance for states on the availability of an extension of the enhanced Federal Medical Assistance Percentage (FMAP) period for certain Medicaid health homes for individuals with substance use disorders (SUD). Guidance: https://bit.ly/2E1p5FL
  • Also on May 7, CMS Administrator Verma published a blog on the agency’s efforts to streamline the Medicaid State Plan Amendment (SPA) review process and reduce approval times so that states can more effectively manage their programs. Blog: https://go.cms.gov/2YfCSA6
  • Also on May 7, CMS issued a final rule which will make changes to the Medicare claims and prescription drug coverage determination appeals procedures beginning on July 8, 2019. Final rule: https://bit.ly/2VZEW1y
  • Also on May 7, Sen. Murphy (D-CT) and 23 Democratic Senators penned a letter to Senate Appropriations Subcommittee on Labor-HHS-Education Chair Blunt (R-MO) and Ranking Member Murray (D-WA) requesting at least $70 million in appropriations for the Medicare State Health Insurance Assistance Program (SHIP). Press release: https://bit.ly/2VZYDGs Letter: https://bit.ly/2Hd8Q9j
  • On May 8, CMS Administrator Verma delivered remarks at the National Rural Health Association Annual Conference, highlighting the agency’s efforts in reducing administrative burden, addressing drug pricing, and deploying value-based delivery models. The Administrator also published a blog post on the topic. Transcript: https://go.cms.gov/2Hb1cxe Blog: https://go.cms.gov/2LBdjYH
  • Also on May 8, CMS issued guidance for states on the additional extension of the spousal impoverishment rules for married Medicaid applicants and recipients of home and community-based services (HCBS). Guidance: https://bit.ly/2YgskAA
  • On May 10, HHS released a report on the costs and benefits of extending coverage of immunosuppressive drugs under Medicare. Summary with link to report: http://bit.ly/2vTnL37

 Payment and Delivery System Reform –

  • On May 7, CMS posted slides from the April 9 hospice intervention webinar as part of the Medicare Advantage Value-Based Insurance Design (VBID) model. Slides: https://bit.ly/2TYxDCj
  • On May 10, CMS posted the Letter of Intent (LOI) for the Professional and Global PBP options of the Direct Contracting model. LOI: https://bit.ly/2PYc4Bi
  • Also on May 10, CMS released a request for applications for performance year 2020 of the Maryland Total Cost of Care model. Request for applications: http://bit.ly/2W1p5zy

 Drug and Medical Device Prices and Regulation –

  • On May 6, HHS Office of Inspector General (OIG) issued a report finding that one percent of drugs with Medicaid reimbursement were not FDA-approved. OIG recommends that CMS work with states to recoup potentially inappropriate payments and work with states to ensure that they prevent inappropriate reimbursement for non-FDA-approved drugs. Summary with link to report: https://bit.ly/2vPxmrN
  • Also on May 6, Senate Finance Committee Chair Grassley (R-IA) issued a statement urging the National Institutes of Health (NIH) to take red flags in clinical trials seriously, following an incident reported by the Wall Street Journal. Press release: https://bit.ly/2vQE54M
  • On May 7, Sen. Fischer (R-NE) penned a letter to Senate Commerce Subcommittee on Manufacturing, Trade, and Consumer Protection Chair Moran (R-KS) and Ranking Member Blumenthal (D-CT) calling for a subcommittee hearing on the rising cost of prescription drugs. Press release: https://bit.ly/2PXT0U7 Letter: https://bit.ly/2YjEKaX
  • On May 8, HHS finalized a rule which will require drug manufacturers to disclose drug prices in direct-to-consumer television ads. Press release: https://bit.ly/2LuOaPo Fact sheet: https://bit.ly/2YlDg08 Final rule: https://bit.ly/2E0G4bk Senate Finance Committee Chair Grassley statement: https://bit.ly/2HhxcP6
  • Also on May 8, Food & Drug Administration (FDA) Principal Deputy Commissioner Abernethy and Center for Drug Evaluation and Research Director Woodcock issued a statement on the agency’s policies designed to capture more data to better understand the effects of prescription drugs in pregnant and nursing women. Press release: https://bit.ly/2LOp5PR
  • Also on May 8, CDC released a report showing that in 2015-2016, 45.8% of the U.S. population used prescription drugs in the past 30 days. Report: https://bit.ly/2Vtxqgd
  • On May 10, FDA issued a final guidance on the pathway for “interchangeable” biologics, which may be substituted without the involvement of the prescriber. Final guidance: https://bit.ly/2VyxVWp FDA Acting Commissioner Sharpless statement: https://bit.ly/2VqTY0Z

 Substance Use and Mental Health –

  • On May 7, HHS released guidance on the availability of an extension of the enhanced federal match for certain Medicaid health homes for individuals and substance use disorders. Guidance: http://bit.ly/2VXVKWL
  • On May 8, the White House released a report entitled “An Update on the President’s Commission on Combating Drug Addiction and the Opioid Crisis: One Year Later.” The report finds a decrease in opioid prescriptions and an increase in naloxone prescriptions. Press release: https://bit.ly/2W0kDRA Report: https://bit.ly/2LB9hjj
  • On May 9 and 10, the Pain Management Best Practice Interagency Task Force voted on final recommendations for pain management best practices. The final report is expected to be posted by May 30. Press release: https://bit.ly/2YjxQmb HHS blog post: http://bit.ly/2DZ9Qx1 Draft final report: https://bit.ly/2PWM5u3
  • Also on May 9, U.S. Government Accountability Office (GAO) released a report assessing treatment expansion efforts and drug control strategies and programs. GAO has previously recommended that HHS establish performance measures with targets to better gauge progress toward achieving agency goals for expanding access to medication-assisted treatment (MAT). Summary with link to report: https://bit.ly/2vTcMql

Veterans and Military Health –

  • On May 6, Sen. Duckworth (D-IL) penned a letter to U.S. National Archives and Records Administration (NARA) OIG requesting an investigation into the potential manipulation of the public comment submission process for the Veterans Community Care Program access standards. Press release with text of letter: https://bit.ly/2Yi8jtF

 Misc. –

  • On May 7, CDC published a report finding that pregnancy-related deaths can occur up to a year after a woman gives birth, and most of these deaths are preventable. Press release: https://bit.ly/2Vm7iDP
  • On May 9, HHS Secretary Azar issued a statement regarding the Administration’s surprise billing principles following President Trump’s announcement to take aim at surprise billing practices. Press release: https://bit.ly/2Yj1jfZ House Energy & Commerce Chair Pallone (D-NJ) and Ranking Member Walden (R-OR) joint statement: https://bit.ly/2JCxFhT House Ways & Means Chair Neal (D-MA) and Ranking Member Brady (R-TX) joint statement: https://bit.ly/2HbmGZT
  • Also on May 9, HHS announced a partnership with Gilead Sciences, which has agreed to donate billions of dollars in HIV prevention drugs. Press release: https://bit.ly/2JvosHR
  • Also on May 9, 378 bipartisan House members penned a letter to House leadership calling for funding for special diabetes research programs. Press release: https://bit.ly/2WBF4RU Letter: https://bit.ly/2Vrobgg
  • Also on May 9, Centers for Disease Control and Prevention (CDC) released early health insurance coverage estimates from the 2018 National Health Interview Survey, showing that 30.4 million individuals (9.4%) were uninsured at the time of interview. Report: https://bit.ly/2LKcFbk
  • On May 10, HHS released information about a new data visualization challenge for community-level social determinants of health. Applications are due by June 7. Information: http://bit.ly/2VZw8ce