What’s Ahead: This Week

Congressional Schedule

The House and Senate are in recess, returning Tuesday, January 3 for the start of the 115th Congress. 

Notable Policy Events

  • Monday, December 12
    • White House, “Helping Gamers Get Health Care Coverage (An Epic Win).” Additional information: http://bit.ly/2hcYkB1
    • American Enterprise Institute, “Obamacare’s Administrative Law Space: Navigating the Next Frontier.” Additional information: http://bit.ly/2hdOOjB
    • Alliance for Health Reform, “Investing in a Healthier America: the Role of Social Determinants.” Additional information: http://bit.ly/2hdN3mr
  • Monday, December 12 – Tuesday, December 13
    • National Academy of Sciences, “The Drug Development Paradigm in Oncology: A Workshop.” Additional information: http://bit.ly/2gp7Kec
    • American Bar Association, “14th Annual Washington Health Law Summit.” Additional information: http://bit.ly/2h83Pkk
  • Tuesday, December 13
    • POLITICO, “Beyond Medicine: Fixing the System for the Complex Patient.” Additional information: http://politi.co/2h82ZEy
  • Wednesday, December 14
    • HHS Office of the National Coordinator for Health IT (ONC), “ONC Health IT Certification Program: Enhanced Oversight and Accountability Final Rule.” Additional information: http://bit.ly/2h8A2rP
  • Wednesday, December 14 – Thursday, December 15
    • FDA/CMS Summit, “Driving Momentum Towards Approval of New Therapies.” Additional information: http://bit.ly/2he5PKw
  • Thursday, December 15
    • Brooking Institution, “Evaluating and Improving the Nursing Home Ratings System.” Additional information: http://brook.gs/2he60Wi
  • Thursday, December 15 – Friday, December 16
    • Medicaid and CHIP Payment and Access Commission (MACPAC), Public Meeting. Additional information: http://bit.ly/2hdQIR5
  • Friday, December 16
    • HHS Assistant Secretary for Planning and Evaluation (ASPE), “Physician-Focused Payment Model Technical Advisory Committee Meeting.” Additional information: http://bit.ly/2h7Wph0
    • American Enterprise Institute, “What’s Next for Healthcare?” Additional information: http://bit.ly/2he0xi8

Weekly Wrap Up: Notable Health Care Developments From Last Week

21st Century Cures

On December 7, the Senate passed the 21st Century Cures Act (H.R. 34) by a vote of 94-5. Previously passed by the House, the President is scheduled to sign the bill on December 13. House Energy & Commerce Committee Chairman Upton’s (R-MI) press release: http://bit.ly/2hcUK9X White House press release: http://bit.ly/2hcXap2

Legislative Activity

  • On December 6, Senate Finance Committee Chairman Hatch (R-UT), Ranking Member Wyden (D-OR), and Sens. Isakson (R-GA) and Warner (D-VA) introduced the Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act of 2016 (S. 3504). Press release: http://bit.ly/2gptQgZ Summary: http://bit.ly/2hedgS0 Bill text: http://bit.ly/2hebJv5
  • Also on December 6, the House passed by a voice vote the Expanding Capacity for Health Outcomes ECHO Act (S. 2873), which requires HHS to study technology-enabled collaborative learning models. Having previously passed the Senate, the bill now moves to the President for signature. Press release: http://bit.ly/2hdVeiv Bill text: http://bit.ly/2hejD7K
  • Also on December 6, the House passed by a voice vote the Childhood Cancer Survivorship, Treatment, Access, and Research (STAR) Act of 2015 (H.R. 3381), which would amend the Public Health Service Act (PHSA) to support additional research and development efforts for pediatric cancer treatment. The bill now moves to the Senate for consideration. Press release: http://bit.ly/2hdZxKG
  • Also on December 6, the House passed by a voice vote the Ethical Patient Care for Veterans Act of 2016 (H.R. 5399), which directs the Department of Veterans Affairs (VA) to require clinicians to report instances of unethical health care activities. The bill now moves to the Senate for consideration. Press release: http://bit.ly/2hdXmHc
  • On December 8, the Senate passed by a vote of 92-7 the National Defense Authorization Act (S. 2943), which authorizes fiscal year 2017 funding for the Department of Defense and adds telemedicine as a covered benefit in TRICARE. The House previously passed the measure on December 2 by a vote of 375-34. The bill now moves to the President for signature. Press release: http://bit.ly/2hcKXAT

ACA Implementation

On December 8, Maryland’s Department of Insurance announced that Evergreen Health Cooperative, one of the six remaining Consumer Operated and Oriented Plans, will not be issuing or renewing health benefit policies for the 2017 coverage year. Press release: http://bit.ly/2hcMMxO


  • On December 5, CMS released guidance for issuers for use in cost-sharing reduction reconciliation processes. Guidance: http://go.cms.gov/2gpcvVa and http://go.cms.gov/2gpcvVa
  • Also on December 5, HHS released new data indicating that approximately 12 million Americans may not be aware that they may be eligible for financial assistance for health insurance through the Marketplaces. Blog post: http://bit.ly/2hcVTyg


  • On December 6, Senate Finance Committee Chairman Hatch (R-UT) and Ranking Member Wyden (D-OR) released a bipartisan report finding shortfalls in federal monitoring activities that are intended to ensure compliance with Medicare billing restrictions on concurrent and overlapping surgeries. Press release: http://bit.ly/2gpqM4m Report: http://bit.ly/2gpswuj
  • Also on December 6, U.S. Government Accountability Office (GAO) released a report finding that consumers could benefit from certain improvements to CMS’ Nursing Home Care Website and its Five-Star Quality Rating System. Summary with link to report: http://bit.ly/2gpl7Lu
  • On December 7, HHS OIG released a final rule amending the anti-kickback statute by adding new safe harbors and amending the civil monetary penalty rules. Rule: http://bit.ly/2gtvfmq
  • Also on December 7, CMS released new 2015 Medicare drug spending and utilization data for Parts B and D. Link to data: http://go.cms.gov/2h8xkmg
  • On December 8, CMS released the final Medicare Outpatient Observation Notice (MOON), which is required to be furnished by hospitals and critical access hospitals to Medicare beneficiaries receiving outpatient observation services. Press release: http://go.cms.gov/2gtAKBH MOON: http://go.cms.gov/2gtKjjZ
  • On December 9, GAO released a report on barriers to small and rural practice participation in Medicare’s value-based payment models. Summary with link to report: http://bit.ly/2gtwWAC


  • On December 5, CMS released guidance describing 2017 updates to core sets of health care quality measures for Medicaid and CHIP. Guidance: http://bit.ly/2gpccJW
  • On December 6, HHS Office of the Inspector General (OIG) wrote a letter to Senate Judiciary Committee Chairman Grassley (R-IA) announcing its intention to review the Medicaid Drug Rebate Program. Letter: http://bit.ly/2hcTm7y
  • On December 8, CMS sent a letter to the Director of the Arkansas Department of Human Services approving of an extension of Arkansas’ Medicaid section 1115 demonstration project, “Arkansas Works,” now effective through December 31, 2021. Approval letter: http://bit.ly/2hcLkvr
  • Also on December 8, MACPAC released an updated edition of MACStats, a compendium of data and information on Medicaid and CHIP. Data book: http://bit.ly/2hcTm7j
  • On December 9, Centers for Disease Control and Prevention (CDC) released a report on State Medicaid expansion and tobacco cessation coverage, finding that 32 states have extended cessation coverage to 2.3 million adult smokers not previously eligible for Medicaid. Report: http://bit.ly/2hcWOyQ

New Payment and Delivery System Models

On December 8, CMS announced two new demonstration models aimed at increasing patient engagement in care decision making. The Shared Decision Making (SDM) Model will test the integration of a shared decision making process into clinical practice workflows, while the Direct Decision Support (DDS) Model will test the provision of health management and decision support services by participating organizations. Letters of intent are due by March 5. Blog post: http://bit.ly/2gpiZDA SDM fact sheet and model: http://go.cms.gov/2gtvQ7O and http://bit.ly/2gpg9i2 DDS fact sheet and model: http://go.cms.gov/2gtxV3y and http://bit.ly/2gplaqU

Health IT

  • On December 7, HHS released a guide warning of potential cyber attacks from connected medical devices and highlighting best prevention practices. Guide: http://bit.ly/2h8u6Pu
  • On December 8, HHS released a blog post and fact sheet highlighting how the Health Insurance Portability and Accountability Act (HIPAA) supports the electronic exchange of protected health information for treatment and certain health care operations. Blog post: http://bit.ly/2hcTdAW Fact sheet: http://bit.ly/2hcSIqu

Zika Virus

  • On December 7, CDC released updated Zika data, indicating that there are now 4,575 and 33,838 cases of the virus in the states and territories, respectively. Data: http://bit.ly/2cddcRi
  • On December 8, CMS released a notice providing information on a funding opportunity for up to $66.1 million to support Zika prevention and treatment activities. Notice: http://bit.ly/2gpdIvE
  • Also on December 8, HHS announced the award of nearly $39 million in funding to 23 health centers in Puerto Rico, American Samoa, and the U.S. Virgin Islands and $1 million to two Primary Care Associations to help combat the Zika virus. Press release: http://bit.ly/2gpc7WN 


  • On December 7, Food and Drug Administration (FDA) issued guidance explaining that it does not intend to enforce a regulatory requirement that would require adults to receive a medical evaluation or sign a waiver prior to purchasing most hearing aids. FDA also announced that it is committed to creating a category of over-the-counter hearing aids. Press release: http://bit.ly/2gpoRg1 Guidance: http://bit.ly/2gpnj5D
  • Also on December 7, Senate Finance Committee Ranking Member Wyden (D-OR) and Sen. Warren (D-MA), and 19 Democratic Senators wrote to President-Elect Trump, asking him to clarify whether he opposes cuts to Medicare and Medicaid. Press release: http://bit.ly/2h8uTjL Letter: http://bit.ly/2h8G4sG
  • Also on December 7, House Ways & Means Committee Chairman Brady (R-TX) released the 2016 Green Book, which provides information on programs within the committee’s jurisdiction. Press release: http://bit.ly/2hdVjDa Book: http://bit.ly/2hdZ6jU
  • On December 8, U.S. Surgeon General released a report on adult and youth e-cigarette use. Press release: http://bit.ly/2gpbXi2 Report: http://bit.ly/2gtx56M
  • Also on December 8, CDC released updated mortality data, finding that life expectancy in the U.S. fell from 78.9 years to 78.8 years between 2014 and 2015. Report: http://bit.ly/2h8uqhb
  • On December 9, FDA released draft guidance outlining procedures for identifying and notifying the FDA of “suspect products” in the drug supply chain. The guidance is the latest step in the implementation of the Drug Supply Chain Security Act (also known as the “track and trace” legislation), signed into law by President Obama in 2013. Comments are due by February 7. Guidance: http://bit.ly/2gtGXNV
  • On December 9, GAO released a report finding that action is needed to increase awareness of best practices for accessible labels on prescription drug containers for individuals who are blind or visually impaired. Summary with link to report: http://bit.ly/2hcMRS0