What’s Ahead: This Week

Notable Policy Events –

  • Tuesday, April 3
    • The Economic Club of Washington, “The Future of Medicine.” Additional information: https://bit.ly/2IgVAzq
  • Wednesday, April 4
    • Bipartisan Policy Center, “Advancing Innovation, Competition, and Access for Biologics through Patent Policy.” Additional information: https://bit.ly/2GhLcL3
  • Thursday, April 5 – Friday, April 6
    • Medicare Payment Advisory Committee (MedPAC), “April Public Meeting.” Additional information: http://bit.ly/2GrIAGw


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

Nominations –

  • On March 28, President Trump announced his intention to nominate White House physician Rear Adm. Ronny Jackson to serve as Secretary of Veterans Affairs, replacing current Secretary Shulkin. Department of Defense Under Secretary of Defense for Personnel and Readiness will serve as Acting Secretary in the interim. Announcement: https://bit.ly/2pRhliw Press releases from Senate and House Veterans Affairs Committees: http://bit.ly/2uzDZR2 and http://bit.ly/2uIEatI and http://bit.ly/2Gq9m25
  • On March 29, HHS Secretary Azar announced the appointment of Daniel Best to serve as the Senior Advisor to the Secretary for Drug Pricing Reform and Brett Giroir as to serve as the Senior Advisor to the Secretary for Mental Health and Opioid Policy in addition to his current duties as the Assistant Secretary for Health. Press release: https://bit.ly/2IhmJC8

Legislative Activity –

  • On March 26, Senate HELP Committee Chair Alexander (R-TN) introduced two draft bills that would give FDA more tools to combat the opioid crisis: the first would require that certain opioids be dispensed in blister packages with set dosages; the second would improve coordination between the Food and Drug Administration (FDA) and Customs and Border Protection as they attempt to intercept drugs at the border. Press release: https://bit.ly/2IdROGR First draft measure: https://bit.ly/2G8Xd5H Second draft measure: https://bit.ly/2GFfHtS
  • On March 29, House Committee on Veterans Affairs Subcommittee on Oversight and Investigations Chairman Bergman (R-MI), along with Reps. Peters (D-CA), Banks (R-IN), and Dunn (R-FL) introduced the Veterans Affairs Medical-Surgical Purchasing Stabilization Act (H.R. 5418), which would direct the VA to inform the department’s medical surgical formulary using input from medical professionals rather than administrative staff. Press release: https://bit.ly/2GWqPAd

 ACA Implementation and Market Stabilization –

  • On March 29, CMS released the final Cost-Sharing Reduction Reconciliation guidance for benefit year 2017. Guidance: https://go.cms.gov/2pTf1qu

Medicare –

  • On March 28, House Committee on Ways & Means Chairman Brady (R-TX), Ranking Member Neal (D-MA), House Committee on Energy & Commerce Chairman Walden (R-OR), and Ranking Member Pallone (D-NJ) released a letter addressed to CMS Administrator Verma regarding proposed changes affecting Medicare Advantage and Part D payments and policies for 2019. Press release: https://bit.ly/2J9c25V Letter: https://bit.ly/2uz6ui2
  • On March 30, Senate Homeland Security & Governmental Affairs Committee minority staff released a report showing that the list prices for the top 20 most prescribed brand drugs in Medicare Part D have risen well above the pace of inflation in recent years. Press release: https://bit.ly/2pLxSEq Report: https://bit.ly/2pRI26F
  • On March 29, Senate and House Diabetes Caucus Co-Chairs Collins (R-ME) and Shaheen (D-NH) along with Reps. Reed (R-NY) and DeGette (D-CO) sent a letters to CMS Administrator Verma urging the agency to provide coverage for glucose monitoring smartphone apps. Press release: https://bit.ly/2J4vWPH Letter: https://bit.ly/2pRQBhV

Medicaid –

  • On March 28, Senate Committee on Finance Ranking Member Wyden (D-OR) and House Committee on Energy and Commerce Ranking Member Pallone (D-NJ) sent a letter to the U.S. Government Accountability Office (GAO) requesting that the Office study the costs of implementing and administering certain policies approved in recent Section 1115 Medicaid waivers, such as work requirements. Press release: https://bit.ly/2E851hV Letter: https://bit.ly/2H2WLDj
  • On March 30, HHS Office of Inspector General (OIG) released its Medicaid Fraud Control Units Fiscal Year 2017 Annual Report, finding that the units recovered over $1.8 billion in 2017. Summary with link to report: http://bit.ly/2pVhr7N

New Payment and Delivery System Models –

  • On March 26, CMS posted episode creation specifications documents for model years 1 and 2 in the Bundled Payments for Care Improvement (BPCI) Advanced program. On March 30, CMS also released a Frequently Asked Questions (FAQ) document. Specifications documents: https://bit.ly/2Gn1uhZ
  • On March 28, CMS posted its Model Test Awards Round One fourth annual report for the State Innovation Models (SIM) Initiative. Report: https://bit.ly/2GjEfsS
  • On March 30, CMS released the third annual report for the Maryland All-Payer Model. Report: http://bit.ly/2pSSn1j

Mental Health and Substance Abuse –

  • On March 26, the Drug Enforcement Administration (DEA) announced that it will be adding 250 task force officers and dozens of additional analysts to areas across the country where the opioid crisis is at its worst. Press release: https://bit.ly/2pT4zz2
  • On March 27, Reps. Shea-Porter (D-NH) and Kuster (D-NH) joined Sens. Shaheen (D-NH) and Hassan (D-NH) sent a letter to HHS Secretary Azar and Assistant Secretary for Mental Health and Substance Use McCance-Katz calling for a minimum of $10 million in opioid funding per state for a short and targeted list of states that have been impacted the most by the opioid epidemic. Press release: https://bit.ly/2GXiyft Letter: https://bit.ly/2pRfvNR
  • On March 29, Centers for Disease Control and Prevention (CDC) released a report showing that U.S. drug overdose deaths continue to rise, largely due to the rise of synthetic opioids. Press release: https://bit.ly/2E4CVo1

 Drugs and Medical Devices

  • On March 26, HHS OIG released a report on the security of the drug supply chain, finding that all 40 dispensers selected for review received at least some drug product tracing information from their trading partners, and 26 of these received all required elements of this information. Summary with link to report: http://bit.ly/2pU2rHs
  • On March 27, Food and Drug Administration (FDA) authorized the first fully interoperable continuous glucose monitoring device and streamlined the review pathway for similar devices. Press release: https://bit.ly/DV2OHJ
  • On March 30, FDA Commissioner Gottlieb released a statement on FDA’s efforts to enhance the patient perspective and experience in drug development review by enhancing the agency’s benefit-risk assessments. Statement: https://bit.ly/2GDU6C9
  • Also on March 30, GAO released a report on the Patient-Centered Outcomes Research Institute’s (PCORI) financial statements for fiscal year 2017. Summary with link to report: http://bit.ly/2pTJDYZ

Veterans’ Health –

  • On March 26, House Veterans Affairs Committee Ranking Member Walz (D-MN) and Rep. Correa (D-CA) called for funding to research the safety and effectiveness of medical cannabis in treating veterans diagnosed with PTSD and chronic pain. Press release: https://bit.ly/2E5Z455
  • On March 29, GAO released a report finding that non-enrolled beneficiaries’ access to providers who accept TRICARE has generally improved. Summary: https://bit.ly/2GjDT5v Report: https://bit.ly/2EaV7wk

Misc. –

  • On March 26, Senate HELP Committee Democrats released a letter addressed to Chairman Alexander (R-TN) and Ranking Member Murray (D-WA) in support of holding a committee hearing on how public health research and interventions could support efforts to end mass shootings. Press release: https://bit.ly/2pMOevQ Letter: https://bit.ly/2GnsPR5
  • Also on March 26, CDC released a report on estimated HIV incidence and prevalence in the United States from 2010 through 2015. Report: https://bit.ly/2GUIGaI
  • On March 27, HHS released data finding disproportionately higher diabetes mortality rates in rural areas compared to other regions of the country. Press release: https://bit.ly/2J1JFqt
  • Also on March 27, a group of 18 Democratic Senators led by Senate HELP Committee Ranking Member Murray (D-WA) penned a letter to Health and Human Services (HHS) Secretary Azar voicing their strong objections to the proposed rule “Protecting Statutory Conscience Rights in Health Care; Delegations of Authority.” Press release: https://bit.ly/2J84VdW Letter: https://bit.ly/2IgUWlu
  • On March 29, GAO released a report on the country’s physician workforce, finding that HHS needs better information to comprehensively evaluate graduate medical education funding. Summary with link to report: http://bit.ly/2E8gE8x
  • Also on March 29, FDA Commissioner Gottlieb announced the FDA Nutrition Innovation Strategy, which will review what can be done to reduce preventable death and disease related to poor nutrition. Announcement: http://bit.ly/2Gr9YV8