What’s Ahead: This Week


  • Tuesday, September 12
    • Senate HELP Committee, “Stabilizing Premiums and Helping Individuals in the Individual Insurance Market for 2018: Health Care Stakeholders.”
    • Senate Finance Committee, “Health Care: Issues Impacting Cost and Coverage.”
  • Wednesday, September 13
    • House Energy & Commerce Committee, Subcommittee on Health, “Modernizing FDA’s Regulation of Over-the-Counter Drugs.”
  • Thursday, September 14
    • Senate HELP Committee, “Stabilizing Premiums and Helping Individuals in the Individual Market for 2018: State Flexibility.”
    • House Energy & Commerce Committee, Subcommittee on Health, “Supporting Tomorrow’s Health Providers: Examining Workforce Programs Under the Public Health Service Act.”

Notable Policy Events –

  • Tuesday, September 12
    • The Hill, “Turning Genes into Medicine: Reimagining our Health Care System.” Additional information: http://bit.ly/2wGR1LL
  • Wednesday, September 13
    • Food and Drug Administration (FDA), “Developing a Framework for Regulatory Use of Real-World Evidence.” Additional information: http://bit.ly/2wDriUF
    • The Hill, “American’s Opioid Epidemic: Search for Solutions.” Additional information: http://bit.ly/2wGB73S
    • Health Affairs, “Understanding the Value of Innovations in Medicine.” Additional information: http://bit.ly/2w8en9p
  • Thursday, September 14 – Friday, September 15
    • Medicaid and CHIP Payment Access Commission, “September 2017 MACPAC Public Meeting.” Additional information: http://bit.ly/2wem2TZ
  • Friday, September 15
    • Duke Margolis Center for Health Policy, “Mobilizing mHealth Innovation for Real-World Evidence Generation.” Additional information: http://bit.ly/2weBUpg

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

 Appropriations –

  • On September 7, Senate Appropriations Committee approved the fiscal year 2018 Labor-HHS-Education appropriations bill (S. 1771) by a vote of 29-2. The bill provides $79.4 billion in discretionary funding for HHS, a $1.7 billion increase from fiscal year 2017. The bill now moves to the full Senate for consideration. The House has prepared its own version of the Labor-HHS-Education appropriations bill, H.R. 3358, which has not yet been voted on. Press release: http://bit.ly/2wfXKZG
  • On September 8, President Trump signed into law a H.R. 601, which provides $15.25 billion in supplemental appropriations for disaster relief, increases the debt limit, and funds the government through a continuing resolution through December 8. Earlier in the week, the House passed the bill by a vote of 316-90 and the Senate passed the bill by a vote of 80-17. Press release: http://bit.ly/2wTAXX1

 Legislative Activity –

  • On September 6, the Senate passed by unanimous consent the National Clinical Care Commission Act (S. 920), which would establish a National Clinical Care Commission within HHS to evaluate and recommend solutions regarding better coordination and leveraging of federal programs related to complex metabolic or autoimmune diseases that result from issues related to insulin and represent a significant disease burden. The bill now moves to the House for consideration. Press release: http://bit.ly/2wf9uvt
  • On September 7, the Senate passed by unanimous consent the Early Hearing Detection and Intervention Act of 2017 (S. 652), which would reauthorize a program for early detection, diagnosis, and treatment regarding deaf and hard-of-hearing newborns, infants, and young children. The bill now moves to the House for consideration. Press release: http://bit.ly/2wThu8R
  • Also on September 7, Sens. Collins (R-ME) and Donnelly (D-IN) introduced the 40 Full Time Hours is Full Time Act (S. 1782), which would modify the definition of full-time employee for purposes of the employer mandate in the Patient Protection and Affordable Care Act. Press release: http://bit.ly/2wTFRU9
  • Also on September 7, Reps. Tonko (D-NY) and Lujan (D-NM) introduced the Addiction Treatment Access Improvement Act (H.R. 3692), which would provide for additional flexibility with respect to medication-assisted treatment for opioid use disorders. Press release: http://bit.ly/2wfl3CF
  • Also on September 7, House Committee on Energy & Commerce Ranking Member Pallone (D-NJ) and Ruiz (D-CA) introduced the Native Health Access Improvement Act (H.R. 3704), which would improve behavioral health outcomes for American Indians and Alaskan Natives, and the Native Health and Wellness Act (H.R. 3706), which would improve the public health system in tribal communities and increase the number of American Indians and Alaska Natives pursuing health careers. Press release: http://bit.ly/2wf6wXX

ACA Implementation and Market Stabilization –

  • On September 6, the U.S. Government Accountability Office (GAO) published a report on the tax on high-cost health plans, recommending that, in implementing the age and gender adjustment, the IRS consider taking steps to mitigate the limitations of the benchmark premium cost data. Report: http://bit.ly/2wOsLYf
  • On September 7, GAO published a report that reviewed three selected state-based marketplaces’ key processes to verify applicant eligibility for subsidized coverage, finding that despite varied data sources used, the states had few indications of potentially improper enrollments. Report: http://bit.ly/2wOAdCo
  • On September 8, Senate Finance Committee Chair Hatch (R-UT) published an op-ed in the Washington Post arguing that potential legislative efforts to stabilize the marketplace by appropriating funding for cost-sharing reduction payments to issuers should be paired with “reforms such as relief for American families and job creators from the onerous mandates and taxes.” Press release with text of op-ed: http://bit.ly/2wSWNKe
  • Also on September 8, House Ways & Means Committee Subcommittee on Health Ranking Member Levin (D-MI) sent a letter to CMS Administrator Verma highlighting concerns that the reduced 2018 budget for the ACA Navigator programs “is creating confusion and hindering their ability to plan for the next Open Enrollment Period.” Press release: http://bit.ly/2wUNzxi Letter: http://bit.ly/2wUsT8o

 Medicare –

  • On September 5, HHS Office of the Inspector General (HHS OIG) published a report on the impact of price substitutions based on 2014 average sales prices on Medicare Part B drug payments, recommending that any future expansion of the payment-substitution policy could contain a provision that would prevent a price substitution when there are indications that the substitution amount is below the provide acquisition cost. Summary with link to report: http://bit.ly/2wT1MKT
  • Also on September 5, HHS OIG released a report finding that although Medicare does not currently have a rebate program for Part B drugs, a potential program could have resulted in at least $2.7 billion in rebates in 2011. Summary with link to report: http://bit.ly/2wTJqd3


  • On September 7, CMS provided guidance to states on the treatment of funds in, contributions to, and distributions from Achieving a Better Life Experience (ABLE) Act accounts in Medicaid financial eligibility determinations; the ABLE Act allows people with disabilities to save money for disability-related expenses in tax-advantaged accounts. Guidance: http://bit.ly/2wPq3Sh
  • On September 8, HHS OIG published a report on states’ use of Medicaid payment suspensions, recommending that CMS provide additional technical assistance to address challenges and help Medicaid agencies fully utilize Medicaid payment suspensions as a program integrity tool. Report: http://bit.ly/2wOD3HM
  • Also on September 8, GAO published a report on state funding for services for adults in institutions of mental disease (IMD), finding that over time CMS changed policies to allow some states to finance care for adult Medicaid beneficiaries in an IMD, including through Medicaid demonstrations and Medicaid managed care. Summary with link to report: http://bit.ly/2wPzOjn

 New Payment and Delivery System Models –

  • On September 7, CMS posted the third annual report for the State Innovation Model Initiative. Report: http://bit.ly/2wOLL97
  • Also on September 7, CMS posted the second annual report for the Maryland All-Payer Model. Report: http://bit.ly/2wOzlxD
  • On September 8, CMS published HHS Secretary Price’s response to proposals submitted for physician-focused payment models as part of the Physician Focused Payment Model Technical Advisory Committee review process. Responses: http://bit.ly/2wOr6Sp

 Mental Health and Substance Abuse –

  • On September 5, Centers for Disease Control and Prevention (CDC) announced an award of more than $28.6 million in additional funding to 44 states and the District of Columbia to support their responses to the opioid overdose epidemic. Press release: http://bit.ly/2w8m67K
  • On September 7, Substance Abuse and Mental Health Services Administration (SAMHSA) published its latest National Survey on Drug Use and Health (NSDUH) report, which finds that in 2016 there were 11.8 million people aged 12 or older who misused opioids in the past year and the majority of that use is pain reliever misuse rather than heroin use. Press release: http://bit.ly/2wOxadv
  • Also on September 7, National Institutes of Health (NIH) announced an award of nine research grants totaling nearly $100 million over the next five years for the Autism Centers of Excellence, a program that supports large research projects aimed at understanding and developing interventions for autism spectrum disorder. Press release: http://bit.ly/2wOzlOg
  • On September 8, Sens. Capito (R-WV) and Warren (D-MA) sent a letter to FDA Commissioner Gottlieb, governors across the country, and 11 national medical member organizations, urging them to implement provisions of the Reducing Unused Medications Act in their efforts to combat the opioid epidemic. Press release with links to letters: http://bit.ly/2wf5sTH
  • Also on September 8, Senate Judiciary Chair Grassley (R-IA) and Sen. Ernst (R-IA) sent a letter to the Office of National Drug Control Policy urging it to include an evaluation of drug take back programs in the final report of the President’s Commission on Combatting Opioid Abuse. Press release: http://bit.ly/2wV1Ji1 Letter: http://bit.ly/2wUI3KR

Health IT –

  • On September 6, GAO published a report finding that HHS has made little progress toward implementing an electronic nationwide public health situational awareness network, recommending that HHS complete a plan that includes all actions for establishing the network, develop a project management plan that identifies measurable steps for completing the actions, and conduct IT management processes according to CIO guidance. Summary with link to report: http://bit.ly/2wOLaEl
  • Also on September 6, Food and Drug Administration (FDA) issued guidance to assist industry and FDA staff in identifying specific considerations related to the ability of electronic medical devices to safely and effectively exchange and use exchanged information. Guidance: http://bit.ly/2w7XZpF
  • On September 7, Office of the National Coordinator for Health IT (ONC) released a report on skilled nursing facilities’ adoption and use of electronic health records (EHRs), finding that while approximately two-thirds of facilities have adopted EHRs, few share data easily. Blog post: http://bit.ly/2weOTYg Report: http://bit.ly/2wOOzD0

Veterans Health –

  • On September 5, GAO published a report on existing opportunities for improving implementation and oversight of enrollment processes for veterans, recommending that the VA define the roles of medical centers in resolving pending applications, define oversight responsibilities to help ensure timely application processing, develop procedures for collecting reliable data system-wide, and clarify its 5-day timeliness standard. Report: http://bit.ly/2w8nozv
  • On September 7, Department of Veterans Affairs (VA) unveiled the Decision Ready Claims (DRC) initiative, a disability claims submission option with accredited Veterans Service Organizations (VSO) that promises to deliver faster claims decisions to veterans and their families. Press release: http://bit.ly/2wOdyGo


  • On September 6, HHS Secretary Price declared a public health emergency in Puerto Rico and the U.S. Virgin Islands due to Hurricane Irma. Press release: http://bit.ly/2wOwu7X
  • On September 7, HHS Secretary Price declared a public health emergency in Florida due to Hurricane Irma. Press release: http://bit.ly/2wOHUc2
  • On September 7, CMS finalized new guidance for Fee-for-Service (FFS) Medicare beneficiaries who have lost or realized damage to their durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) as a result of Hurricane Harvey. HHS Secretary Price established a waiver under section 1135 of the Social Security Act that allows CMS to temporarily suspend the face-to-face requirement, a new physician’s order, and new medical necessity documentation for replacement due to loss or damage from the hurricane. Press release: http://go.cms.gov/2wOutZu Fact sheet: http://go.cms.gov/2wfgDfq
  • Also on September 7, CMS approved suspending certain Medicare enrollment screening requirements for healthcare providers and suppliers that are assisting with Hurricane Harvey recovery efforts in areas impacted in Texas and Louisiana. Press release: http://go.cms.gov/2wfhTPH
  • On September 8, Sen. Rubio (R-FL) sent a letter to HHS Secretary Price requesting that the Department prepare for an increase in the mosquito population following the storm, which could contribute to the spread of viruses, such as Zika, and ensuring coordination is taking place to help hospitals with vulnerable patients. Press release: http://bit.ly/2wTHtNK Letter: http://bit.ly/2wTky4R

 Misc. –

  • On September 5, CDC published a report on infant mortality rates in rural and urban areas in the United States in 2014, finding that rates decreased as urbanization level increased, from 6.55 deaths per 1,000 births in rural counties to 6.20 in small and medium urban counties and 5.44 in large urban counties. Report: http://bit.ly/2w7XyM3
  • On September 6, Sens. Brown (D-OH) and Cassidy (R-LA) sent a letter to HHS Secretary Price to express their interest in helping to convene a diverse commission of national healthcare experts to develop a strategy for improving and advancing the health care delivery system so that it can effectively meet the needs of all Americans. Press release with text of letter: http://bit.ly/2wcvDdS
  • On September 7, the Food and Drug Administration (FDA) issued a notice requesting comment on regulations that could be withdrawn in accordance with President Trump’s January executive order on reducing bureaucracy and controlling regulatory costs. Comments are due by December 7. Notice: http://bit.ly/2wOOteE FDA Blog Post: http://bit.ly/2wOOvTO