What’s Ahead: This Week

Hearings & Markups –

  • Wednesday, October 3
    • Senate HELP Committee, Subcommittee on Children and Families, “Rare Diseases: Expediting Treatments for Patients.”
    • Senate Aging Committee, “Patient-Focused Care: A Prescription to Reduce Health Care Costs.”

 Notable Policy Events

  • Tuesday, October 2
    • Pew Charitable Trusts, “How to Better Match Patients with their Electronic Health Records.” Additional information: http://bit.ly/2QprLRp
    • The Atlantic, “The Equity of Health.” Additional information: https://bit.ly/2NQsVIA
    • Patient-Centered Outcomes Research Institute (PCORI), “Beyond Opioids: Evidence-Based Delivery of Alternative Treatments for Chronic Pain.” Additional information: http://bit.ly/2P1zDYV
  • Wednesday, October 3
    • The Economist Group, “Leading on Value: Solutions for an Evolving Health Care System.” Additional information: https://bit.ly/2ImpDqD
    • PhRMA, “Leading on Value: Solutions for and Evolving Health Care System.” Additional information: https://onphr.ma/2QlWGh5
    • Kaiser Family Foundation (KFF), “Media Web Briefing: Discussion of 2018 Employer Health Benefits Survey.”
  • Wednesday, October 3 – Friday, October 5
    • Interdisciplinary Association for Population Health Science (IAPHS), “Pushing the Boundaries of Population Health Science: Social Inequalities, Biological Processes and Policy Implications.” Additional information: https://bit.ly/2xKzO47
    • College of Healthcare Information Management Executives (CHIME), “Health Care IT Policy Conference.” Additional information: https://bit.ly/2RakTbI
    • National Association of ACOs (NAACOS), “Fall 2018 Conference.” Additional information: https://bit.ly/2NUdyxS
  • Thursday, October 4
    • Network for Regional Healthcare Improvement (NRHI), “2018 Annual National Affordability Summit.” Additional information: https://bit.ly/2Di80cB
  • Thursday, October 4 – Friday, October 5
    • Medicare Payment Advisory Commission, “October Public Meeting.” Additional information: http://bit.ly/2zDH6Ij
  • Friday, October 5
    • Alliance for Health Policy (AHP), “Briefing: Improving Care for Children with Complex Medical Needs.” Additional information: https://bit.ly/2OPHZT7


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

 Appropriations –

  • On September 28, the President signed into law the Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 (H.R. 6157). The bill includes over about $90.5 billion in funding for HHS for fiscal year 2019. It also includes a continuing resolution through December 7 for several agencies whose funding bills were not completed by the end of the fiscal year, including the Food and Drug Administration. The Senate previously passed the bill by a vote of 93-7 and the House passed the bill by a vote of 361-61. Press releases: http://bit.ly/2N9xs3N and http://bit.ly/2N8A69Y and http://bit.ly/2zGMASB Bill text: http://bit.ly/2zGI3zw

 Legislative Activity –

  • On September 24, Sens. Casey (D-PA), Hatch (R-UT), and Schatz (D-HI) introduced the Emergency Medical Services for Children (EMSC) Reauthorization Act of 2018 (S. 3482), which would reauthorize the EMSC program. Press release: https://bit.ly/2xIwIxr
  • Also on September 24, Sens. Cantwell (D-WA), Schumer (D-NY), Gillibrand (D-NY), and Stabenow (D-MI) introduced the Basic Health Program Expansion Act of 2018 (S. 3486), which would offer the states the option to expand eligibility for Basic Health Programs to the same income level as their CHIP eligibility line, which varies by state. Press release: https://bit.ly/2OfAGal
  • On September 25, the House passed by a voice vote the Pandemic and All-Hazards Preparedness and Advancing Information Act of 2018 (H.R. 6378), which would reauthorize certain programs under the Pandemic and All-Hazards Preparedness Reauthorization Act. The bill now moves to the Senate for consideration. Bill text: https://bit.ly/2ImuJ6m Press release: https://bit.ly/2xLKmzT
  • Also on September 25, the House passed by a voice vote the Department of Energy Veterans’ Health Initiative Act (H.R. 6398), which would authorize the Department of Energy to conduct collaborative research with the Department of Veterans Affairs in order to improve health care services for veterans. The bill now moves to the Senate for consideration. Bill text: https://bit.ly/2xVwqTh
  • Also on September 25, the House passed by a voice vote the Know the Lowest Price Act of 2018 (S. 2553), which would prohibit health plans and pharmacy benefit managers from restricting pharmacies from informing individuals regarding the prices for certain drugs and biologicals. Having previously passed the Senate, the bill now moves to the President for signature. Bill text: https://bit.ly/2zARMaH Press release: https://bit.ly/2RaJqNV
  • Also on September 25, the House passed by a voice vote the Patient Right to Know Drug Prices Act (S. 2554), which would ensure that health insurance issuers and group health plans do not prohibit pharmacy providers from providing certain information to enrollees. Having previously passed the Senate, the bill now moves to the President for approval. Bill text: https://bit.ly/2R2dNG5 Press release: https://bit.ly/2DuqVRq
  • Also on September 25, the House passed by a voice vote the Department of Veterans Affairs Expiring Authorities Act of 2018 (S. 3479), which would extend certain expiring provisions of law administered by the Department of Veterans Affairs. The bill now moves to the President for approval. Bill text: https://bit.ly/2xHLsww
  • Also on September 25, Sens. Warner (D-CA), Grassley (R-IA), and Nelson (D-FL) introduced the Addiction Treatment Quality Improvement Act (S. 3493), which would require CMS to develop a plan to eliminate treatment gaps in addiction treatment and establish standards of care for addiction treatment. Press release: https://bit.ly/2yN62gK Bill text: https://bit.ly/2Og6HiC
  • Also on September 25, Sens. Booker (D-NJ), Gillibrand (D-NY), Baldwin (D-WI), Cardin (D-MD), Blumenthal (D-CT), and Harris (D-CA) introduced the Maximizing Outcomes for Moms through Medicaid Improvement and Enhancement of Services (MOMMIES) Act (S. 3494), which would extend Medicaid coverage for pregnant women to a full year after childbirth. Press release: https://bit.ly/2Qcrely Bill text: https://bit.ly/2DM3wLN
  • Also on September 25, Sens. Daines (R-MT) and King (I-ME) introduced the Improving Seniors Access to Quality Benefits Act (S. 3496), which would direct the HHS Secretary to conduct a study and submit a report on the effects of the inclusion of quality increases in the determination of blended benchmark amounts under Medicare Advantage, as well as the Medicare Advantage Quality Payment Relief Act (S. 3497), which would eliminate a provision under the Medicare Advantage program that caps bonus payments to MA plans. Companion legislation to S. 3497 was previously introduced in the House (H.R. 908). Press release: https://bit.ly/2N7snsv
  • Also on September 25, Sen. Warren (D-MA) introduced the Surveillance and Testing of Opioids to Prevent (STOP) Fentanyl Deaths Act (S. 3500), which would authorize the HHS Secretary to conduct programs to address the usage of illicit drugs, particularly fentanyl. Press release: https://bit.ly/2xHevR7 Bill text: https://bit.ly/2OjYiKU
  • On September 26, Rep. Knight (R-CA) led ten Republican co-sponsors in introducing the Maintaining Protections for Patients with Pre-Existing Conditions Act of 2018 (H.R. 6898), which would duplicate statutes for pre-existing conditions protections in federal law and inserting them into HIPAA so they remain operative in the event that the ACA is struck down in court. Press release: https://bit.ly/2xU8y2m
  • Also on September 26, Sens. Ernst (R-IA), Grassley (R-IA), and Hatch (R-UT) introduced the Ensuring Quality Care for Our Veterans Act (S. 3501), which would ensure that a third party reviews each case where any veteran was treated by a VA provider who was later found to have a revoked license. Press release: https://bit.ly/2ImgVZt
  • On September 27, Rep. Moore (D-WI) led a group of bipartisan, bicameral legislators in introducing the Scarlett’s Sunshine on Sudden Unexpected Death Act (H.R. 6931), which would supply grants to help states, municipalities, and nonprofits to improve data collection and death scene investigations related to unexpected infant and child fatalities. Press release: https://bit.ly/2DDSqIA
  • On September 28, the House passed by a vote of 393-8 the conference report of the SUPPORT for Patients and Communities Act (H.R. 6). The final bill now moves to the Senate for consideration. Press releases: http://bit.ly/2N2TQM9  and http://bit.ly/2zH0q7x Section-by-section: http://bit.ly/2zGphrW Bill text: http://bit.ly/2zGPUx8
  • Also on September 28, Rep. Duffy (R-WI) introduced the Nursing Home Workforce Quality Act (H.R. 6986), which would amend Medicare and Medicaid with respect to nursing facility requirements. Press release: http://bit.ly/2zH2gFq Bill text: http://bit.ly/2zH2oVq
  • Also on September 28, Rep. O’Halleran (D-AZ) introduced the Capped Allowable Payments from Seniors (CAPS) Act (H.R. 7001), which would provide for a combined Medicare part B and D drug out-of-pocket costs limitation. Press release: http://bit.ly/2zHa7D8

 ACA Implementation –

  • On September 27, Congressional Budget Office (CBO) Director Hall penned a letter to Rep. Mark Meadows (R-NC) responding to questions posed regarding CBO’s method for determining the budgetary treatment of cost-sharing reductions. Press release: https://bit.ly/2NNq2by Letter: https://bit.ly/2QgtisD

 Medicare –

  • On September 24, House Ways & Means Health Subcommittee Chair Roskam (R-IL) and Rep. Smith (R-NE) sent a letter to CMS Administrator Verma praising CMS’ efforts to reduce the time and cost of regulatory compliance, especially for rural providers. Letter: https://bit.ly/2xYWRrd
  • On September 25, HHS Office of Inspector General (OIG) released a study finding that Medicare Advantage Organizations (MAOs) overturned 75 percent of denials appealed during 2014 through 2016, and recommending greater oversight of the appeals process. Summary with link to report: https://bit.ly/2DF8qtM
  • On September 28, CMS announced that in 2019, Medicare Advantage premiums are set to decrease, plan choices are set to increase, and over 36 percent of Medicare beneficiaries are expected to be enrolled in Medicare Advantage. Press release: https://go.cms.gov/2xLjZKp Fact sheet: https://go.cms.gov/2QgzBMN
  • Also on September 28, CMS released a proposed rule that would revise the regulations setting forth the appeals process that Medicare beneficiaries, providers, and suppliers must follow in order to appeal adverse determinations regarding claims for benefits under Medicare Parts A, B, or D. Comments are due by December 2. Proposed rule: http://bit.ly/2OZwsRl

 Medicaid –

  • On September 24, HHS released a report comparing Health Care Utilization Project (HCUP) inpatient discharges with CHIP and Medicaid as expected payer with publicly available data. Report: https://bit.ly/2zDHtTc
  • On September 25, CMS deemed complete and released for public comment a waiver request submitted by the state of Michigan that would add work requirements as a condition of Medicaid eligibility. Virginia and Tennessee also released draft 1115 waiver requests, which would also impose work requirements, for state public comment. Michigan waiver: https://bit.ly/2NOPjSQ Virginia draft waiver: https://bit.ly/2zwT8U0 Tennessee Draft Waiver: http://bit.ly/2zGN3nM
  • On September 27, CMS Administrator Verma delivered remarks at the 2018 Medicaid Managed Care Summit, during which we remarked on on flexibility, accountability, and integrity in the Medicaid program. Transcript: https://go.cms.gov/2DByupP

 Payment and Delivery System Reforms –

  • On September 27, HHS announced the award of two $3 million grants to establish pilot projects that will test how a new Regional Disaster Health Response System could deliver trauma, burn, or other specialty care during a national emergency. Press release: https://bit.ly/2zADfMg
  • Also on September 27, CMS released a fact sheet providing background on the Medicare Diabetes Prevention Program (MDPP) Expanded Model. Fact sheet: https://bit.ly/2Ik966o

 Mental Health and Substance Use –

  • On September 24, HHS announced $6.2 million in new grants to Fairbanks Native Association and Tanana Chiefs Conference, Inc., which will focus on opioid and mental health services. Press release: https://bit.ly/2Q8sNku
  • On September 25, HHS awarded over $12 million through the Pediatric Mental Health Care Access Program and the Screening and Treatment for Maternal Depression and Behavioral Disorders Program. Press release:  https://bit.ly/2QgNElN
  • Also on September 25, Substance Abuse and Mental Health Services Administration (SAMHSA) published a Tobacco Cessation Toolkit for substance use disorder treatment programs. Press release: https://bit.ly/2DsZyr0
  • On September 26, HHS announced $50 million to assist American Indian and Alaska Native tribal efforts in combating the opioid overdose epidemic. Press release: https://bit.ly/2DCguLJ
  • On September 27, House Energy & Commerce Chair Walden (R-OR), Ranking Member Pallone (D-NJ), Subcommittee on Oversight Chair Harper (R-MS) and Ranking Member DeGette (D-CO), and Subcommittee on Health Chair Burgess (R-TX) and Ranking Member Green (D-TX) penned letters to three federal agencies regarding the trafficking of fentanyl into the United States. Letter to Department of Homeland Security: https://bit.ly/2Om6xq6 Letter to Drug Enforcement Agency: https://bit.ly/2xOiEmd Letter to Department of State: https://bit.ly/2QeRP1e

Drug Prices and Regulation

  • On September 24, Food and Drug Administration (FDA) awarded 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases. Press release: https://bit.ly/2IeGvzk
  • Also on September 24, FDA released guidance to reduce the time that it takes for new generic drugs to reach the market. Press release: https://bit.ly/2N8ycpz Guidance: https://bit.ly/2IlV9ox

Military & Veterans’ Health –

  • On September 24, Department of Veterans Affairs (VA) researchers in Michigan announced that they are working to create a 3D-printed artificial lung that could potentially revolutionize treatment of veterans affected by lung disease. Press release: https://bit.ly/2zA49Ul
  • On September 26, VA released data on veteran suicides from 2005 to 2016, finding that overall suicides decreased by 365 from 7,663 in 2015 to 7,298 in 2016, however, the rate of suicide among 18-34 veterans continues to increase. Press release: https://bit.ly/2xH6Zph
  • On September 27, U.S. Government Accountability Office (GAO) released a report recommending that VA designate a focal point to oversee system-wide pharmacy inventory management. Summary with link to report: https://bit.ly/2ImXhfX
  • On September 28, GAO released a report finding that further improvements are needed within the Veterans Choice Program to help ensure that timely payments are made to community providers. Summary with link to report: https://bit.ly/2DEhMWK

Health IT –

  • On September 24, HHS Office of the National Coordinator for Health IT (ONC) announced two awards totaling nearly $2 million over two years to two awardees under the Leading Edge Acceleration Projects (LEAP) in Health IT funding opportunity. Press release: https://bit.ly/2xXJk31
  • On September 26, FDA Commissioner Gottlieb posted a blog highlighting the agency’s flexible, risk-based approach to regulation in an effort to reduce time and cost of market entry, assure patient safeguards are in place, and encourage more developers. Blog: https://bit.ly/2Ij2dCl


  • On September 25, HHS and Patient-Centered Outcomes Research Institute (PCORI) announced $40 million in awards over five years to 11 institutions to support the training of researchers to conduct patient-centered outcomes research within learning health systems. Press release: https://bit.ly/2OR3dAm
  • On September 27, HHS awarded $361 million to support families through the Maternal, Infant and Early Childhood Home Visiting Program. Press release: https://bit.ly/2R1PZ58
  • On September 28, GAO released a report on the number and characteristics of rural hospital closures, finding that they disproportionately occurred in the South due to financial distress. Summary with link to report: https://bit.ly/2xN0xgm
  • Also on September 28, HHS announced $2.6 million in prizes to redesign dialysis as a part of its KidneyX competition. Press release: https://bit.ly/2xXcHmm