What’s Ahead: This Week

Notable Policy Events

  • Tuesday, November 6
  • Wednesday, November 7
    • Bipartisan Policy Center (BPC), “Webinar: My Healthy Weight: A Solution for Employers to Address Obesity.” Additional information: https://bit.ly/2F2Ag3N
  • Thursday, November 8
    • Patient-Centered Primary Care Collaborative (PCPCC), “Key Policies to Elevate Primary Care.” Additional information: https://bit.ly/2yKPk0s
    • BPC, “Public Forum: Promising Practices for the Federal Government’s Data Strategy.” Additional information: http://bit.ly/2PG4iP3
    • BPC, “Webinar: My Healthy Weight: A Solution for Medicaid to Address Obesity.” Additional information: https://bit.ly/2Dkc37g


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

 ACA and Individual Insurance Markets –

  • On October 30, Rep. Beyer (D-VA) led 45 House Democrats in letters to President Trump and the 18 state attorneys general and two governors leading a lawsuit to overturn the ACA’s pre-existing condition protections. Press release: https://bit.ly/2SEISQZ Letter to President Trump: https://bit.ly/2F1hJoG Letters to AGs and Governors: https://bit.ly/2RzbHgt

 Medicare –

  • On October 29, CMS released updates to the Market Saturation and Utilization Data Tool that includes interactive maps and a dataset with national-, state-, and county-level provider services and utilization data for selected health service areas. Fact sheet: https://go.cms.gov/2DiB0jA Tool: https://bit.ly/2lSpC4I
  • On October 31, CMS and AARP released a joint statement encouraging Medicare enrollees to review their coverage to see if they can find something that’s a better fit for their budget or health needs via the eMedicare tool. Press release: https://go.cms.gov/2SFsKib
  • Also on October 31, CMS finalized the Calendar Year (CY) 2019 Home Health Prospective Payment System (PPS) rule, which will allow remote patient monitoring in home health, update payments with a new case-mix system, begin a new home infusion therapy benefit, and reduce provider burden. Press release: https://go.cms.gov/2CVfhxf Fact sheet: https://go.cms.gov/2OjUs0s Final rule: https://bit.ly/2yMTBk1
  • On November 1, CMS released the final CY 2019 Physician Fee Schedule (PFS) and Quality Payment Program (QPP) rule, which will streamline payment for evaluation and management, reimburse physicians for certain types of virtual care, and reduce payment amounts for certain new drugs under Part B. The final rule also includes an interim final rule with comment implementing a provision from the SUPPORT for Patients and Communities Act that expands the use of telehealth services for the treatment of substance use disorder. Comments are due by January 23. Press release: https://go.cms.gov/2OkkqAT Fact sheet: https://go.cms.gov/2OgVdat Final rule: https://bit.ly/2Jzjvfa
  • Also on November 1, CMS finalized changes to the CY 2019 payment rules for Durable Medical Equipment Prosthetics, Orthotics, and Supplies (DMEPOS) and End-Stage Renal Disease (ESRD) programs. The rule implements lead item bidding for DMEPOS and expands the Transitional Drug Add-on Payment Adjustment (TDAPA) for new ESRD drugs and biologicals, which will be effective in 2020. Press release: https://go.cms.gov/2QfDC4N Fact sheet: https://go.cms.gov/2OmHdfv Final rule: https://bit.ly/2AKmQ8v
  • On November 2, CMS released the final CY 2019 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System rule, which will implement site-neutral payments for certain clinical visits, to be phased in over two years. Press release: https://go.cms.gov/2P8XYzZ Fact sheet: https://go.cms.gov/2CW9jw6 Final rule: https://bit.ly/2Pyb6hC
  • Also on November 2, CMS Administrator Verma penned a blog post warning of the potential negative outcomes of transitioning to a Medicare for All system. Blog Post: https://go.cms.gov/2PJBqoY

 Medicaid –

  • On October 31, CMS approved Wisconsin’s section 1115 demonstration waiver, which would impose work requirements for non-pregnant, non-elderly, non-disabled adults with incomes up to 100 percent of the federal poverty level. The demonstration also expands access to substance abuse treatment and recovery services. CMS Blog post: https://go.cms.gov/2RrN9po Waiver approval: http://bit.ly/2PzPp0o

 Substance Use and Mental Health –

  • On November 2, Food and Drug Administration (FDA) announced the approval of Dsuvia, a new opioid formulation that is restricted to use in certain medically-supervised settings. In announcing the approval, FDA also described the factors it will consider while reviewing future opioid products, including the public health implications of each new approval. Press release: http://bit.ly/2RwOyLj

 Drug Prices and Regulation

  • On October 29, Sen. Cassidy (R-LA) penned a letter in the Journal of the American Medical Association (JAMA) describing a model in which coalition of payers could pay a flat subscription fee for an unlimited amount of hepatitis C medications over a predetermined period of time, also known as “the Netflix model.” Paper: https://bit.ly/2SGEpNO
  • On October 30, HHS posted a blog with frequently asked questions about its proposed International Pricing Index drug-pricing model. Blog post: http://bit.ly/2RvcazU
  • On October 31, HHS issued a proposed rule moving the effective date of the 340B ceiling price and civil monetary penalties up to January 1, 2019 from the previous effective date of July 1, 2019. Comments are due by November 22. Proposed rule: https://bit.ly/2On5cuU
  • On November 1, Congressional Diabetes Caucus Co-Chairs Reed (R-NY) and DeGette (D-CO) released a report on the increasing price of insulin, which included eleven recommendations to help lower prices. Press release: https://bit.ly/2JyP9JH Report: https://bit.ly/2QcViOu

 Military & Veterans’ Health –

  • On November 1, Department of Veterans Affairs announced that the number of homeless veterans has dropped 5.4 percent since last year, and by nearly half since 2010. Press release: http://bit.ly/2RuaS8s
  • On November 2, FDA and the Department of Defense announced a Memorandum of Understanding regarding medical product development and assessment which will foster and prioritize the efficient development of safe and effective medical products intended to serve service members. Press release: http://bit.ly/2Rx3k4S

Health IT –

  • On October 29, HHS Office of Inspector General released a report finding that the FDA’s policies and procedures should better address postmarket cybersecurity risk to medical devices. Summary with link to report: http://bit.ly/2Rzwbpl
  • On October 30, HHS announced the official opening of the Health Sector Cybersecurity Coordination Center (HC3) which will work with the health sector to understand the threats that it faces and how it can address them. Press release: https://bit.ly/2Rv4jlU
  • On November 1, FDA issued a blog post on the FDA’s role in ensuring that medical devices are safeguarded from cyber intrusions. Blog post: http://bit.ly/2Rzw2lL