What’s Ahead: This Week

Hearings and Markups –

  • Tuesday, February 26
  • Senate Finance Committee, “Drug Pricing in America: A Prescription for Change, Part II.”
  • Wednesday, February 27
  • House Energy & Commerce Committee, Subcommittee on Oversight and Investigations, “Confronting a Growing Public Health Threat: Measles Outbreaks in the U.S.”
  • House Appropriations Committee, Subcommittee on Agriculture, Rural Development, and FDA, “Food and Drug Administration – Status of Operations.”
  • House Education & Labor Committee, Subcommittee on Higher Education and Workforce Investment, “Caring for Our Caregivers: Protecting Health Care and Social Service Workers from Workplace Violence.”
  • Thursday, February 28
  • Senate Appropriations Committee, Subcommittee on Labor, HHS, and Education, “Addressing the Opioid Epidemic in America.”
  • House Appropriations Committee, Subcommittee on MilCon and VA, “Female Veterans’ Access to VA.”

 Notable Policy Events –

  • Wednesday, February 27
  • CQ Roll Call, “Empowering Patients as Partners in Health Care.” Additional information: https://bit.ly/2GFdAqn
  • The Atlantic, “What is the Future of the American Health Care System?” Additional information: https://bit.ly/2GXCDEm
  • American Enterprise Institute (AEI), “Navigating the Evolving Opioid Crisis.” Additional information: https://bit.ly/2Ix81Mp
  • CMS, “Emergency Triage, Treat, and Transport (ET3) Model Overview Webinar.” Additional information: https://bit.ly/2U1nOnT
  • National Academy of Medicine (NAM), “Systemic and Health Consequences on the Payment Gap Between Medicare and Private Insurance.” Additional information: http://bit.ly/2BRY7ix
  • Thursday, February 28


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

Legislative Activity –

  • On February 19, Rep. Courtney (D-CT) and 26 cosponsors introduced the Workplace Violence Prevention for Health Care and Social Service Workers Act (H.R. 1309), which would direct the Occupational Safety and Health Administration (OSHA) to issue a standard requiring health care and social service employers to write and implement a workplace violence prevention plan. Press release: https://bit.ly/2Xjd1aT
  • On February 20, Rep. Welch (D-VT) announced his intention to introduce a bill to allow patients, pharmacists, and wholesalers to import insulin from Canada and other leading countries. Press release: https://bit.ly/2U4gnwa                                                                                          

Health Spending –

  • On February 18, HHS released a report finding that in 2016, the top one percent of persons ranked by their healthcare expenditures accounted for about 22 percent of total healthcare expenditures. Summary with link to report: https://bit.ly/2IrXXnJ
  • On February 20, CMS Office of the Actuary released projections of national health expenditures from 2018 through 2027. National health expenditure growth is expected to average 5.5 percent annually throughout that time period, reaching nearly $6 trillion in 2027. Press release: https://go.cms.gov/2U1mQIh Report: https://go.cms.gov/1FKpTuz

 ACA and Individual Market –

  • On February 19, CMS released a Frequently Asked Questions (FAQ) document on Medicare Periodic Data Matching (PDM), a process which is used by Health Insurance Exchanges to identify consumers enrolled in Exchange plans with financial help at the same time they are determined eligible for or enrolled in Medicare Parts A or C. FAQ: https://go.cms.gov/2TakmKp
  • Also on February 19, Senate HELP Committee Ranking Member Murray (D-WA), Senate Finance Committee Ranking Member Wyden (D-OR), House Energy & Commerce Committee Chair Pallone (D-NJ), and House Education & Labor Committee Chair Scott (D-VA) penned a letter to CMS Administrator Verma expressing concerns regarding certain policies proposed in the Notice of Benefit and Payment Parameters for 2020 proposed rule. Press release: https://bit.ly/2E7AyTp Letter: https://bit.ly/2GEm9ld
  • On February 21, CMS issued a guidance on third-party auditor operational readiness reviews for the Enhanced Direct Enrollment (EDE) pathway and related oversight requirements. Guidance: https://go.cms.gov/2GG16Ps
  • On February 22, Departments of Labor, Treasury, and HHS issued a request for information (RFI) to better understand the challenges that group health plans and insurance issuers face in avoiding a loss of grandfathered status. RFI: https://bit.ly/2E9XWiW

 Medicare and Medicaid –

  • On February 19, CMS announced the launch of the “Beyond the Policy” podcast, which will offer regular episodes that discuss agency updates and policies. The podcast will be available on Apple Podcasts and Google Play. Press release: https://go.cms.gov/2twe7Cx
  • Also on February 19, House Energy & Commerce Committee Chair Pallone (D-NJ) and Senate Finance Committee Ranking Member Wyden (D-OR) sent a letter to HHS Secretary Azar expressing their concern regarding the Administration’s approval of Medicaid 1115 waiver demonstrations that adopt conditions on eligibility, such as work requirements. Press release: https://bit.ly/2tG7WvP Letter: https://bit.ly/2SW3zf5
  • Also on February 20, HHS Office of Inspector General (OIG) released a report finding that CMS improperly paid $84 million for skilled nursing facilities (SNF) that did not meet the 3-day rule during 2013 through 2015. Summary with link to report: https://bit.ly/2tAlitk

 Payment and Delivery System Reform –

  • On February 19, Senate Finance Committee Ranking Member Wyden (D-OR) and Sen. Markey (D-MA) released a statement lauding the Independence at Home program, in response to data released on February 8 which found that the model saved over $16.3 million in its third performance year, averaging $1,431 per participating beneficiary. Data: https://bit.ly/2Brr6JT  Statement: https://bit.ly/2SR23L8

 Drug and Medical Device Prices and Regulation –

  • On February 19, Food and Drug Administration (FDA) Commissioner Gottlieb and Center for Biologics Evaluation and Research Director Marks issued a statement cautioning consumers against receiving young donor plasma infusions that are promoted as unproven treatment for varying conditions. Press release: https://bit.ly/2twkl52
  • Also on February 19, FTC announced that it had reached a global settlement resolving pending claims in three separate federal court antitrust lawsuits involving Teva Pharmaceuticals’ so-called “pay-for-delay” practices. If approved by the various court, the stipulated order would prohibit Teva from engaging in such practices. Press release: https://bit.ly/2IvYbun Stipulated order: https://bit.ly/2T5VR1d
  • On February 20, HHS OIG released a report comparing average sales prices (ASP) and average manufacturers prices (AMP) for prescription drugs in the third quarter of 2018, showing that nine drug codes met CMS’s price substitution criteria by exceeding the 5 percent threshold for 2 consecutive quarters or 3 of the previous 4 quarters. Summary with link to report: https://bit.ly/2twmrSC
  • On February 21, FDA issued a draft guidance entitled “Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products,” which helps lay out a framework for new potential clinically relevant outcomes for smoking cessation products. Press release: https://bit.ly/2NnobH8
  • On February 22, FDA Commissioner Gottlieb and Center for Drug Evaluation and Research Director Woodcock issued a statement on FDA’s efforts to maintain strong oversight of generic drug quality issues in the U.S. and abroad. Press release: https://bit.ly/2SkzvVg
  • Also on February 22, Senate Finance Committee Chair Grassley (R-IA) and Ranking Member Wyden (D-OR) launched an investigation into insulin prices, sending letters to several insulin manufacturers requesting information on price increases. Press release with links to letters: http://bit.ly/2BUBpGO

 Substance Use and Mental Health –

  • On February 19, National Institutes of Health (NIH) released a study suggesting that long-acting buprenorphine formulation BUP-XR, a monthly extended-release injection, is more effective than placebo in helping patients struggling with addiction to opioids. Press release: https://bit.ly/2EoiANM
  • On February 21, HHS released a report on trends in the number of neonatal abstinence syndrome (NAS) births in the U.S., showing an increase from 19,569 NAS births in 2013 to 25,213 NAS births in 2016. Report: https://bit.ly/2E33yeZ
  • On February 22, CMS issued a guidance on Medicaid strategies for non-opioid pharmacologic and non-pharmacologic chronic pain management. Guidance: https://bit.ly/2XdwSIx
  • Also on February 22, CMS released an expanded version of its Opioid Prescribing Mapping Tool, which now includes Medicaid and rural data. Press release: https://go.cms.gov/2U7tTQ0
  • Also on February 22, Sen. Klobuchar (D-MN) sent a letter to FDA Commissioner Gottlieb requesting information on what steps that FDA is taking to address the use of deceptive sales tactics and fraudulent marketing by opioid manufacturers. Press release with text of letter: http://bit.ly/2BUB9rk

 Health Data and IT –

  • On February 19, House Energy & Commerce Committee Chair Pallone (D-NJ) and Subcommittee on Consumer Protection & Commerce Chair Schakowsky (D-IL) penned a letter to Facebook CEO Mark Zuckerberg requesting a briefing following a consumer complaint filed with the Federal Trade Commission (FTC) that personal health information of Facebook users who were participating in “closed” groups may have been exposed. Press release: https://bit.ly/2H3RM7p Letter: https://bit.ly/2GFXxZA
  • On February 21, Sen. Warner (D-VA) wrote to various health care stakeholders seeking input on ways to best improve cybersecurity in the health care industry. Press release with letter text: https://bit.ly/2Nky0FA

Veterans and Military Health –

  • On February 19, VA launched a campaign to help veterans quit smokeless tobacco. Press release: https://bit.ly/2tvI4lV
  • Also on February 19, VA announced that the Veterans Appeals Improvement and Modernization Act of 2017 went into effect, which brings changes to the benefit appeals review process. Press release: https://bit.ly/2Se0At4
  • On February 21, U.S. Government Accountability Office (GAO) released a report with recommendations on actions that are needed to determine the required size and readiness of operational medical and dental forces in the Department of Defense (DoD). Summary with link to report: https://bit.ly/2T5TADd
  • On February 22, VA published the proposed rules for veteran community care access standards in the Federal Register, which would allow veterans to seek care from non-VA providers if they meet certain geographic criteria. Comments are due by March 25. Press release: https://bit.ly/2GFBrGe Proposed rule:

 Misc. –

  • On February 21, GAO released a report highlighting selected states’ efforts to educate and address access challenges related to advance care planning. Summary with link to report: https://bit.ly/2T90Q0X
  • On February 22, HHS Secretary Azar delivered the 2019 State of the Department address, in which he highlighted his accomplishments as head of the Department for the previous year and outlined HHS’ agenda in the upcoming year. Transcript: https://bit.ly/2VgcCEh