What’s Ahead: This Week

Hearings/Markups –

  • Tuesday, January 30
    • Senate HELP Committee, Subcommittee on Primary Health and Retirement Security, “Roundtable on Small Business Health Plans.”
    • House Energy & Commerce Committee, Subcommittee on Health, “Exampling Implementation of the Compounding Quality Act.”
    • House Committee on Veterans Affairs, “Appeals Reform: Will VA’s Implementation Effectively Serve Veterans?”

 Notable Policy Events –

  • Tuesday, January 30
    • Food and Drug Administration (FDA), “Opioid Policy Steering Committee: Prescribing Intervention – Exploring a Strategy for Implementation.” Additional information: http://bit.ly/2n2IJc1
    • FDA, “Fostering Digital Health Innovation: Developing the Software Precertification Program.” Additional information: http://bit.ly/2BvJAGm
  • Wednesday, January 31
    • Bipartisan Policy Center, “A Policy Roadmap for Individuals with Complex Care Needs.” Additional information: http://bit.ly/2BjzgRO
    • Substance Abuse and Mental Health Services Administration (SAMHSA), “SAMHSA Public Listening Sessions: 42 CFR Part 2 – Confidentiality of Substance Use Disorder Patient Records Final Rule.” Additional information: http://bit.ly/2n07Qfc
  • Thursday, February 1


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

 Nominations –

  • On January 24, the Senate confirmed by a vote of 55-43 the nomination of Alex Azar to be Secretary of Health and Human Services.


  • On January 22, President Trump signed into law a continuing resolution that would fund the federal government through February 8. The bill also provides 6 years of funding for CHIP, and delays the ACA’s Cadillac tax, medical device tax, and health insurer tax. Earlier in the day, the Senate passed by bill by a vote of 81-18 and the House passed the bill by a vote of 266-150. Press releases: http://bit.ly/2n4rK9c and http://bit.ly/2n818nF and http://bit.ly/2n60JC0 CR: http://bit.ly/2nhDLIq
  • On January 23, Joint Committee on Taxation released an estimate of the revenue effects of the recent continuing resolution, finding that the delay of the medical device, Cadillac, and health insurance taxes would cost $31 billion over ten years. Estimate: http://bit.ly/2n9pcGE

 Legislative Activity –

  • On January 23, Reps. David Schweikert (R-AZ), Johnson (R-OH), Lujan (D-NM), and Thompson (D-CA) introduced the Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018 (H.R. 4841), which would create an electronic prior authorization system under Medicare Part D for covered Part D drugs. Press release: http://bit.ly/2BtuSzA Bill text: http://bit.ly/2FgDUSO
  • On January 24, Senate Veterans Affairs Committee Ranking Member Tester (D-MT) introduced S. 2336, which would require the Secretary of Veterans Affairs to carry out a pilot program on providing intensive community care coordination and supportive services to veteran families who lack adequate access to services. Press release: http://bit.ly/2n9ajUS
  • On January 25, Senate Veterans Affairs Committee Ranking Member Tester (D-MT), and Sens. Brown (D-OH) and Blumenthal (D-CT) introduced the Veterans’ Debt Fairness Act (S. 2341), which would improve the processing of veterans benefits by the Department of Veterans Affairs, to limit the authority of the Secretary of Veterans Affairs to recover overpayments made by the department and other amounts owed by veterans to the U.S. Press release: http://bit.ly/2nlcjcL

ACA Market Stabilization & Implementation –

  • On January 21, Wisconsin Governor Walker announced his intention to pursue a state-based reinsurance program through a section 1332 innovation waiver. Press release: http://bit.ly/2n76U9a
  • On January 23, U.S. Government Accountability Office (GAO) released a report finding that approximately one percent of plan year 2015 enrollments were potentially fraudulent due to unresolved inconsistencies related to citizenship or lawful presence, social security number, or death. Summary with link to report: http://bit.ly/2n4m7Yy
  • On January 26, the Attorneys General from New York and Minnesota filed suit against the Trump Administration for allegedly withholding funding owed to the states to operate their Basic Health Programs. Press release: http://on.ny.gov/2njgXb1 Lawsuit: http://on.ny.gov/2nj9CbK


Medicare –

  • On January 24, Sens. Tester (D-MT, Capito (R-WV) and 19 bipartisan senators sent a letter to CMS Administrator Verma expressing support for a proposal from CMS that would help increase the transparency and accuracy of prescription drug costs in Medicare Part D. Press release: http://bit.ly/2BvneVC Letter: http://bit.ly/2Bvni7O
  • On January 25, Sens. Tester (D-MT) and Daines (R-MT) sent a letter to CMS Administrator Verma urging her to increase transparency and accuracy of prescription drug costs for seniors by adopting a proposal that would restrict pharmacy benefit managers from imposing retroactive fees. Press release: http://bit.ly/2Bv2cXf Letter: http://bit.ly/2BwaZYO
  • On January 26, CMS released a final report on the evaluation of the diffusion and impact of the Chronic Care Management (CCM) services, which finds that over 684,000 beneficiaries received CCM services during the first two years of the new payment policy. Report: http://bit.ly/2Bw2soy
  • On January 26, CMS released information about the 2016 Medicare Electronic Health Record (EHR) incentive program payment adjustment for critical access hospitals. Fact sheet: http://go.cms.gov/2BxIbiG

Medicaid –

  • On January 23, CMS deemed complete applications for section 1115 demonstration projects from Mississippi and Wisconsin that would implement work requirements as a condition of eligibility. Comments for both are due by February 22. Waiver applications: http://bit.ly/2niNkHc and http://bit.ly/2ninNxB
  • Also on January 23, Texas Gov. Abbott sent a letter to President Trump urging the approval of the state’s section 1115 family planning waiver. Letter:  http://bit.ly/2n52MGH

 New Payment & Delivery System Models –

  • On January 23, CMS announced that 165 new primary care practices are participating in the Comprehensive Primary Care Plus model for 2018. List of practices: http://bit.ly/2n4VYsw

 Mental Health and Substance Abuse –

  • On January 23, Drug Enforcement Administration released a final rule expanding the categories of practitioners who may, under certain conditions on a temporary basis, dispense a narcotic drug in Schedule III, IV, or V for the purposes of opioid use disorder treatment. Final rule: http://bit.ly/2nb1VUT
  • On January 24, SAMHSA announced it is accepting applications for up to $52 million in grants under its Treatment for Individuals Experiencing Homelessness program. Applications are due by March 5. Press release: http://bit.ly/2n78is6
  • Also on January 24, SAMHSA announced it is accepting applications for up to $17.4 million in grants under its Minority AIDS Initiative. Press release: http://bit.ly/2n89Imt
  • Also on January 24, Senate Committee on Homeland Security and Governmental Affairs Permanent Subcommittee on Investigations Chair Portman (R-OH) and Ranking Member Carper (D-DE) released a report finding that drug traffickers can easily ship drugs like illicit fentanyl through the mail. Press release: http://bit.ly/2BvFQof Report: http://bit.ly/2BwndRl
  • On January 25, SAMHSA announced it is accepting applications for up to $13.4 million in grants over the next five years for the Law Enforcement and Behavioral Health Partnerships for Early Diversion program. Applications are due by March 5. Press release: http://bit.ly/2BvQj2U

Veterans Health –

  • On January 23, CMS and the Department of Veterans Affairs (VA) announced a partnership to share data, data analytics tools and best practices for identifying and preventing fraud, waste, and abuse. Press release: http://go.cms.gov/2n4vmYO

Drug and Device Regulation –

  • On January 23, FDA announced the extension of a public comment period for its draft guidance on least burdensome principals. Comments are now due by March 15. Notice: http://bit.ly/2BvEQjZ
  • On January 24, FDA and the Federal Trade Commission posted joint warning letters to the marketers and distributors of 12 opioid cessation products, for illegally marketing unapproved products with claims about their ability to help in the treatment of opioid addiction and withdrawal. Press release: http://bit.ly/2BvQBH2
  • On January 26, FDA released a final rule amending its general biologics regulations relating to time of inspection requirements. Comments are due by April 11. Rule: http://bit.ly/2BxL4Qy

 Misc. –

  • On January 23, National Academy of Medicine released a report finding that while millions of Americans use e-cigarettes, rates of smoking combustible tobacco cigarettes continues to decline among youth and adults. Summary with link to report: http://bit.ly/2BxlHOE
  • On January 26, HHS released a report highlighting its accomplishments from 2017. Press release: http://bit.ly/2BvcVkh Report: http://bit.ly/2Bw5qcF
  • Also on January 26, HHS released data on trends in hospital inpatients stays, finding that between 2000 and 2015, the population of nonneonatal, nonmaternal inpatient stays dropped for all age groups. Summary with link to report: http://bit.ly/2BvCwcL
  • Also on January 26, Centers for Disease Control and Prevention (CDC) released a report finding that there was a significant increase in birth defects related to the Zika virus during the second half of 2016 in jurisdictions with local Zika virus transmissions. Report: http://bit.ly/2Bwa1f8