What’s Ahead: This Week

Hearings/Markups –

  • Wednesday, December 5
    • House Energy & Commerce Committee, Subcommittee on Oversight & Investigations, “Examining the Availability of SAFE Kits at Hospitals in the United States.”
    • House Veterans Affairs Committee, “Is VA Ready for Full Implementation of Appeals Reform?”
    • House Veterans Affairs Committee, Subcommittee on Oversight & Investigations, “The Veterans First Program After Kingdomware.”
  • Thursday, December 6
    • Senate Veterans’ Affairs Committee and House Veterans’ Affairs Committee, “Joint Hearing: Tracking Transformation: VA MISSION Act Implementation.”

 Notable Policy Events –

  • Tuesday, December 4
    • Health Affairs, “Telehealth Forum.” Additional information: https://bit.ly/2BHtNHM
    • American Enterprise Institute (AEI), “Health Care that Matters: Real Choices for Real Competition.” Additional information: https://bit.ly/2SgEPJw
  • Wednesday, December 5
    • Washington Post Live, “Addiction in America: The New War on Drugs.” Additional information: https://wapo.st/2E6BU3k
  • Thursday, December 6
    • Bipartisan Policy Center (BPC), “Bipartisan Leadership in Health Care: CHRONIC Care Act of 2018.” Additional information: https://bit.ly/2P7U45G
  • Thursday, December 6 – Friday, December 7
    • Medicare Payment Advisory Committee (MedPAC), “December Public Meeting.” Additional information: http://bit.ly/2DXFV9p
  • Friday, December 7
    • Alliance for Health Policy (AHP), “Briefing: Aging in America.” Additional information: https://bit.ly/2rafZ2x


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

 116th Congress –

  • On November 29, House Democrats released the floor schedule for the 2019 calendar year. Schedule: https://bit.ly/2Rt9ymO

 Legislative Activity –

  • On November 27, Sen. Hirono (D-HI) led a group of 9 Democratic Senators in introducing the Health Equity and Accountability Act (HEAA) of 2018 (S. 3660), which lays out a comprehensive roadmap to address health disparities among racial and ethnic minorities, the LBGTQ community, rural populations, and socioeconomically disadvantaged communities. Rep. Lee (D-CA) previously introduced companion legislation in the House (H.R. 5942). Press release: https://bit.ly/2TUJjax
  • Also on November 27, Sens. Ernst (R-IA), King (I-ME), Gardner (R-CO), and Heinrich (D-NM) introduced the Department of Energy Veterans’ Health Initiative Act (S. 3656), which would authorize a program within the DoE to develop technologies to help solve complex data challenges for veterans health care. Press release: https://bit.ly/2TZB6ln Text: https://bit.ly/2Quyxc1
  • On November 28, the House passed by a voice vote the State of Modern Application, Research, and Trends of (SMART) IoT Act (H.R. 6032), which would direct the Department of Commerce to conduct a study on the state of the internet-connected devices industry. Press release: https://bit.ly/2BHqzEi Text: https://bit.ly/2Sl2AjH
  • Also on November 28, the House passed by a voice vote the Strengthening the Health Care Fraud Prevention Task Force Act of 2018 (H.R. 6753), which would direct the Secretary of HHS to establish a public-private partnership for purposes of identifying health care waste, fraud, and abuse. Press release: https://bit.ly/2BHqzEi Text: https://bit.ly/2BImpMh
  • On November 29, Rep. Gonzalez-Colon (R-PR) introduced H.R. 7193, which would amend the VA MISSION Act to expand the Veterans Healing Veterans medical access and scholarship program to include more students and schools. Press release: https://bit.ly/2ABTOq9
  • Also on November 29, Sen. Merkley (D-OR) introduced the Low Drug Prices Act (S. 3680), which would direct the Secretary of HHS to require drug companies to offer prescription drugs at the established reference price based on prices in 11 countries to all individuals in the U.S. market as a condition of participation in federal health programs, including Medicare, Medicaid, and all ACA Exchange plans. Press release: https://bit.ly/2Rk7Jsa Text: https://bit.ly/2Qqze6d
  • Also on November 29, Sen. Duckworth (D-IL) introduced the Breast Cancer Patient Equity Act (S. 3687), which would provide Medicare coverage for custom fabricated breast prostheses for breast cancer survivors who have experienced a mastectomy. Press release: https://bit.ly/2E54j9L
  • Also on November 29, the Senate HELP Committee favorably reported several healthcare bills: the Improving Access to Maternity Care Act (H.R. 315), which would amend the Public Health Service Act to require the Health Resources and Services Administration (HRSA) to identify maternity care health professional target areas; the BOLD Infrastructure for Alzheimer’s Act (S. 2076), which would create Centers of Excellence to advance public health knowledge on Alzheimer’s disease; the Traumatic Brain Injury Program Reauthorization Act of 2018 (S. 3657), which would reauthorize state grants and programs related to surveillance, prevention, care, and research of traumatic brain injuries; and the Emergency Medical Services for Children Program Reauthorization Act of 2018 (S. 3482), which would ensure that emergency health care providers are prepared to treat children. The measures now move to the full Senate for consideration. Press release: https://bit.ly/2KJBv7k Bill texts: https://bit.ly/2Q1QjnE and https://bit.ly/2BI636z and https://bit.ly/2PaT4xq and https://bit.ly/2KK8Q23

 ACA and Individual Insurance Markets –

  • On November 28, CMS released a Weekly Enrollment Snapshot for the fourth week of the 2019 Open Enrollment period, showing that 500,437 individuals selected plans using the HealthCare.gov platform, for a total of 2.42 million. Fact sheet: https://go.cms.gov/2E566eZ  
  • Also on November 28, CMS released a report on effectuated enrollment in the individual market for the first half of 2018, finding that an average of 10.3 million individuals had effectuated their coverage – approximately one percent higher compared to the same time period in 2017. Fact sheet: https://go.cms.gov/2zBAZ6O
  • Also on November 28, CMS announced that it has developed a new “enhanced” direct enrollment pathway for consumers to enroll in health insurance coverage through the Federally-facilitated Exchange. Fact sheet: https://go.cms.gov/2QtLbIn FAQ: https://go.cms.gov/2PawGo0
  • On November 29, CMS released a fact sheet and concept paper describing four new 1332 waiver concepts, known as State Relief and Empowerment Waivers, to help states in crafting new waiver proposals for their health insurance marketplaces. The same day, House Ways & Means Committee Ranking Member Neal (D-MA) and House Energy & Commerce Committee Ranking Member Pallone (D-NJ) sent a letter to HHS Secretary Azar, Treasury Secretary Mnuchin, IRS Commissioner Rettig, and CMS Administrator Verma requesting information about the Administration’s section 1332 guidance, and raising concerns that it is unlawful and will raise costs for Americans. CMS and HHS Press release: https://go.cms.gov/2BHqZdQ and https://bit.ly/2zyglo4 CMS Administrator Verma Remarks: https://go.cms.gov/2RkMIOc Fact sheet: https://go.cms.gov/2DPJtue Concept paper: https://go.cms.gov/2KNc2K6 W&M and E&C press release and letter: https://bit.ly/2DW90lu and https://bit.ly/2PfRKty

 Medicare –

  • On November 26, CMS released a proposed rule which would allow Part D plans greater flexibility in negotiating discounts for drugs in protected classes, implement a statutory requirement that prohibits pharmacy gag clauses in Part D, and codify a policy to allow step therapy in MA for Part B drugs. Comments are due on January 25. Press release: https://go.cms.gov/2ArFaBP Fact sheet: https://go.cms.gov/2ApgMkh CMS Administrator Verma blog: https://go.cms.gov/2PY8tGY Proposed rule: https://bit.ly/2ArmrGH
  • On November 27, CMS launched a new online tool, the Procedure Price Lookup, that allows consumers to compare Medicare payments and copayments for certain procedures that are performed in both hospital outpatient departments and ambulatory surgical centers. Press release: https://go.cms.gov/2PZR9RM CMS Administrator Verma blog: https://go.cms.gov/2RkbGgu Tool: https://bit.ly/2Q68QiK
  • Also on November 27, HHS Office of Inspector General (OIG) released a report finding that significant vulnerabilities exist in the Hospital Wage Index system for Medicare payments. Summary with link to report: https://bit.ly/2Q67158
  • On November 30, U.S. Government Accountability Office (GAO) released a report noting that the implementation of new rates for Medicare laboratory tests may lead to billions in excess payments. GAO recommended that the CMS Administrator should phase in payment-rate reductions and use bundled rates for panel tests. Summary with link to report: https://bit.ly/2U1DPdT
  • Also on November 30, HHS OIG released a report finding the CMS’s enhanced controls did not always prevent terminated drug utilization in Medicare Part D. Summary with link to report: https://bit.ly/2P8qptb
  • Also on November 30, CMS announced the release of payroll-based staffing data for nursing homes, which is intended to bolster oversight and to improve transparency. Press release: https://go.cms.gov/2rf61ga

 Medicaid –

  • On November 28, CMS released the Medicaid Modified Adjusted Gross Income (MAGI) and CHIP Application Processing Time Report for February through April 2018, finding that nearly 50 percent of all MAGI applications were determined in less than seven days and over 30 percent of all MAGI applications were determined in less than 24 hours. Press release: https://bit.ly/2U0RF03 Report: https://bit.ly/2BK7tgN

 Payment and Delivery System Reform –

  • On November 29, CMS posted evaluation reports of the Financial Alignment Initiative for Medicare-Medicaid Enrollees for California, Illinois, Ohio, Minnesota, and Washington. Reports: https://bit.ly/2PazWj7
  • On November 30, CMS posted Payment Year 2019 health IT requirements and electronic quality measure reporting overview documents for the Comprehensive Primary Care Plus (CPC+) model. Documents: https://bit.ly/23xXKQo
  • Also on November 30, CMS posted an updated fact sheet and FAQ document for the Medicare Advantage Qualifying Payment Arrangement Incentive (MAQI) Demonstration. Fact sheet: https://bit.ly/2QC24Rn FAQ: https://bit.ly/2rhgQyw
  • Also on November 30, CMS posted first year results fact sheet for the Part D Enhanced Medication Therapy Management Model. Fact sheet: https://bit.ly/2DWe7BW
  • Also on November 30, CMS posted target prices and reconciliation payments materials for the Comprehensive Care for Joint Replacement Model. Target prices document: https://bit.ly/2AG9qch Reconciliation payments document: https://bit.ly/2rgqmlC

 Substance Use and Mental Health –

  • On November 27, HHS released an issue brief describing four key challenges related to the use of medication-assisted treatment (MAT) in child welfare contexts for parents with opioid use disorder, which include: limited availability of appropriate treatment; misunderstanding of MAT by some stakeholders; limited interaction between child welfare agencies and MAT providers; and aligning systems and stakeholders with different perspectives and objectives. Summary with link to report: https://bit.ly/2E7Ix5k

 Drug and Medical Device Prices and Regulation

  • On November 26, Food and Drug Administration (FDA) Commissioner Gottlieb and Director of the Center for Devices and Radiological Health Shurn released a joint statement on FDA”s new steps to modernize the 510(k) program to advance the review of the safety and effectiveness of medical devices. Statement: https://bit.ly/2zneqmk
  • On November 27, FDA Commissioner Gottlieb released a statement on how modern predicates can promote innovation and advance safety and effectiveness of medical devices that use the 510(k) pathway. Statement: https://bit.ly/2QmMWan
  • On November 29, FDA Deputy Commissioner for Policy, Planning, Legislation, and Analysis Abram and Acting Deputy Commissioner for Global Regulatory Operations and Policy Abdoo posted a blog on FDA’s global efforts to protect patients and consumers from unsafe products. Blog: https://bit.ly/2KJVYc8
  • Also on November 29, HHS finalized a rule establishing January 1, 2019 as the effective date for the 340B drug pricing program ceiling price and manufacturer civil monetary penalties regulation. Rule: https://bit.ly/2Q51bkB
  • Also on November 29, Senate Judiciary Committee Chair and Incoming Senate Finance Committee Chair Grassley (R-IA) delivered a Senate floor speech on transparency in drug pricing, and the prices of generic drugs. Transcript: https://bit.ly/2BJubW8
  • On November 30, FDA Center for Devices and Radiological Health Director Shuren and Office of Device Evaluation Chief Medical Officer Jarow posted a blog on FDA’s role in inspiring the medical device industry’s innovation to combat the opioid crisis. Blog: https://bit.ly/2AAphct
  • Also on November 30, GAO released a report recommending that FDA could improve designation review consistency in the rare disease drug development process. Summary with link to report: https://bit.ly/2KJTwlX

 Military & Veterans’ Health –

  • On November 26, GAO released a letter addressed to Sen. Warren (D-MA) noting that the office will investigate whether members of the Mar-a-Lago country club inappropriately influenced decision making at VA. Sen. Warren press release: https://bit.ly/2AE1YhW Letter: https://bit.ly/2KKOHc9
  • On November 27, GAO released a report recommending that additional assessments are needed to better ensure an efficient total workforce in the Department of Defense’s health system. Summary with link to report: https://bit.ly/2BIkoQt
  • Also on November 27, Sens. Duckworth (D-IL) and Hassan (D-NH) released a joint statement calling for the VA Inspector General to investigate potential legal and ethical violations at the Department. Press release: https://bit.ly/2AE3ssw
  • On November 28, VA announced that it will accept public comments for 15 days on how to implement certain changes to the Program of Comprehensive Assistance for Family Caregivers (PCAFC) required by the VA MISSION Act of 2018. Press release: https://bit.ly/2BK9wS1
  • On November 30, VA Vocational Rehabilitation and Employment Program (VR&E) announced the ability for veterans nationwide to meet with more than 1,000 Vocational Rehabilitation Counselors (VRC) via telecounseling or virtual communication. Press release: https://bit.ly/2FTceZt

 Health IT –

  • On November 28, HHS issued a draft strategy designed to help reduce administrative and regulatory burden on clinicians caused by the use of health information technology such as EHRs. Comments are due by January 28. Press release: https://bit.ly/2FILiLN ONC blog: https://bit.ly/2BELsA2 Draft strategy: https://bit.ly/2Qv0Kja
  • Also on November 28, HHS announced the winners of the Easy EHR Issue Reporting Challenge. Winners of the challenge created software tools that could help clinicians report EHR usability and safety issues faster, more efficiently, and in alignment with their regular clinical workflow. Press release: https://bit.ly/2KKsA5s

Misc. –

  • On November 26, HHS released a study published in Pediatrics finding that an estimated 1 in 40 U.S. children has diagnosed autism. Press release: https://bit.ly/2BJGK40 Study: https://bit.ly/2TZUpLh
  • On November 29, Centers for Disease Control and Prevention (CDC) released three reports related to mortality in the U.S., finding that life expectancy decreased from 2016-2017. The decrease has been attributed to a substantial increase in substance use disorder-related deaths and suicides. The age-adjusted rate of drug overdose deaths involving synthetic opioids other than methadone (drugs such as fentanyl, fentanyl analogs, and tramadol) increased by 45 percent between 2016 and 2017, from 6.2 to 9.0 per 100,000. Press release: https://bit.ly/2FTdlZ9 Suicide mortality report: https://bit.ly/2zzeGP7 Drug overdose deaths report: https://bit.ly/2Sg9Tcu Overall mortality report: https://bit.ly/2BG7thD
  • Also on November 29, Senate HELP Committee Ranking Member Murray (D-WA) penned a letter to CDC Director Redfield seeking an update on the Ebola outbreak response in the Democratic Republic of the Congo. Press release: https://bit.ly/2Ec0xLQ Letter: https://bit.ly/2BMdM3r