What’s Ahead: This Week

Hearings/Markups –

  • Tuesday, December 11
    • House Energy & Commerce Committee, Subcommittee on Health, “Implementing the 21st Century Cures Act: An Update from the Office of the National Coordinator.”
  • Wednesday, December 12
    • 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?”
  • Thursday, December 13
    • House Oversight & Government Reform Committee, Subcommittee on Government Operations and Subcommittee on Health Care, Benefits, and Administrative Rules, “Exploring Alternatives to Fetal Tissue Research.”

 Notable Policy Events –

  • Monday, December 10
    • HHS, “December 2018 Public Meeting of the Physician-Focused Payment Model Technical Advisory Committee (PTAC).” Additional information: http://bit.ly/2rtdRmP
    • The Atlantic, “As Americans Live Longer, More Are Living Alone.” Additional information: https://bit.ly/2G47D6N
  • Monday, December 10 – Tuesday, December 11
    • American Bar Association (ABA), “16th Annual Washington Health Law Summit.” Additional information: https://bit.ly/2zJYg6M
  • Tuesday, December 11
    • Bipartisan Policy Center (BPC), “Financing Public Health Infrastructure.” Additional information:  https://bit.ly/2PtNUgw
  • Wednesday, December 12
    • Center for American Progress (CAP), “Eliminating Racial Disparities in Maternal and Infant Mortality.” Additional information: https://ampr.gs/2BY595X
    • Rural Health Information Hub (RHIhub), “Webinar: Insights on Rural Health Insurance Market Challenges from the National Advisory Committee on Rural Health and Human Services.” Additional information: https://bit.ly/2rnPWou
  • Thursday, December 13
    • Justice in Aging, “Webinar: The Impact of Medicaid Work Requirements on Family Caregivers and Older Adults.” Additional information: https://bit.ly/2E7lEOu
  • Thursday, December 13 – Friday, December 14
    • Medicaid and CHIP Payment and Access Commission (MACPAC), “December Public Meeting.” Additional information: https://bit.ly/2BYmI5Q


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

 Administration –

  • On December 6, HHS Secretary Azar announced that John O’Brien will serve as Senior Advisor to the Secretary on Drug Pricing Reform. Press release: http://bit.ly/2QHM8wS

 Appropriations –

  • On December 7, the President signed into law H.J. Res. 143, a stopgap appropriations bill that continues government funding for seven federal agencies and divisions, including the Food and Drug Administration through December 21, 2018. Fiscal year (FY) 2019 appropriations for HHS and VA have previously been approved. Bill text: http://bit.ly/2ruKIHM

 Legislative Activity –

  • On December 4, Senate Finance Committee Chair Hatch (R-UT) and Sen. Udall (D-NM) introduced the Smoke Free Schools Act of 2018 (S. 3701), which would ban e-cigarette use in educational and childcare facilities and clarify that state and local education agencies can use grant funding for e-cigarette prevention programs. Press release: https://bit.ly/2E7sYtw
  • Also on December 4, incoming Senate Finance Committee Chair Grassley (R-IA) and Ranking Member Wyden (D-OR) led a group of bipartisan members of the Senate Finance Committee in introducing the Right Rebate Act (S. 3702), which would give the Medicaid program more tools to pursue drug manufacturers when they are suspected of misclassifying a drug as a generic when it should be a brand name. Reps. Schrader (D-OR) and Welch (D-VT) introduced companion legislation in the House (H.R. 7223). Press releases and remarks: https://bit.ly/2EkaJC3 and https://bit.ly/2QISmfK and https://bit.ly/2L3OlgX Bill text: https://bit.ly/2PnY4Py
  • On December 5, Sen. Merkley (D-OR) introduced the Opioid Treatment Surge Act (S. 3711), which would fund an increase in opioid addiction treatment capacity by levying fees on opioid manufacturers. Press release: https://bit.ly/2RItn9M
  • On December 6, the Senate passed by a voice vote the Improving Access to Maternity Care Act (H.R. 315), which would require HRSA to identify maternity health care professional target areas for purposes of assigning maternity care health professionals to them. Press release: http://bit.ly/2G7bArn Bill text: https://bit.ly/2QKCgCE
  • Also on December 6, the Senate passed by a voice vote the Children’s Hospital GME Support Reauthorization Act of 2018 (S. 2597), which would reauthorize the program of payments to children’s hospitals that operate graduate medical education programs. Text: https://bit.ly/2Unl8Sc

 ACA and Individual Insurance Markets –

  • On December 3, House Democratic leadership announced that they had signed on to an amicus brief in opposition to the Department of Labor’s association health plan regulation. Press release: https://bit.ly/2Usn1wT Amicus brief: https://bit.ly/2rr1K9B
  • On December 4, CMS announced the approval of HealthSherpa as the first partner to use enhanced direct enrollment to help consumers enroll in health insurance through the federally-facilitated Exchange. Press release: https://go.cms.gov/2SyEB0x
  • On December 6, CMS released a Weekly Enrollment Snapshot for the fifth week of the 2019 Open Enrollment period, showing that 773,250 individuals selected plans using the HealthCare.gov platform, for a total of 3.2 million. Fact sheet: https://go.cms.gov/2E8CbSs  
  • On December 7, CMS finalized a rule which reissues, with additional explanation, the HHS-operated ACA risk adjustment methodology previously established for the 2018 benefit year. The rule allows CMS to continue normal operations of the risk adjustment program for the 2018 benefit year. Press release: https://go.cms.gov/2UqwEfN Final rule: https://bit.ly/2Psk9wB
  • Also on December 7, House Democratic Ranking Members Neal (D-MA), Pallone (D-NJ), Nadler (D-NY), and Scott (D-VA) penned a follow-up letter to HHS Secretary Azar and CMS Administrator Verma reiterating their request for answers on the Administration’s decision to decline to defend protections for individuals with pre-existing conditions in the Texas v. United States lawsuit. Press release: https://bit.ly/2RJtxxM Letter: https://bit.ly/2BWjy2n
  • On December 8, Sens. Klobuchar (D-MN) and Smith (D-MN), and Reps. Emmer (D-MN), Peterson, (D-MN), Nolan (D-MN), and McCollum (D-MN) sent a letter to CMS Administrator Verma and Treasury Secretary Mnuchin expressing concern about CMS’ recent decision to reduce funding for Minnesota’s reinsurance program for the 2019 plan year. Press release with text of letter: http://bit.ly/2QKZt7B

 Medicare –

  • On November 30, CMS released a Medicare Advantage Online Provider Directory Review Report which found that almost 49 percent of the provider directory locations listed had at least one inaccuracy. Report: https://go.cms.gov/2StPAIu
  • On December 3, CMS released FY19 results for the Hospital Value-Based Purchasing (VBP) Program. CMS estimates that the total amount available for value-based incentive payments in FY19 will be approximately $1.9 billion. Fact sheet: https://go.cms.gov/2ElWVqw
  • On December 4, HHS Office of Inspector General (OIG) released a report finding that 21 percent of Medicare patients in LTCHs experienced adverse events, which are particularly serious instances of patient harm resulting from medical care. Summary with link to report: https://bit.ly/2rszX8E
  • Also on December 4, HHS OIG released a report finding that Medicare improperly paid suppliers $34 million for durable medical equipment, prosthetics, orthotics, and supplies provided to beneficiaries during inpatient stays. Summary with link to report: https://bit.ly/2G2Vb7r

 Medicaid –

  • On December 3, MACPAC released its latest MACStats data book, which includes updated data on national and state Medicaid and CHIP enrollment, spending, benefits, and beneficiaries’ health, service use, and access to care, and finds that total enrollment in Medicaid and CHIP decreased 2.2 percent from July 2017 to July 2018. MACStats: https://bit.ly/1RRDa7X
  • On December 6, CMS posted an informational bulletin informing states of changes in nursing facility case-mix payments. Bulletin: https://bit.ly/2RJGWpq
  • On December 7, U.S. Government Accountability Office (GAO) released a report on improper payments made by the federal government in FY 2017, finding that almost $37 billion in improper payments were made in the Medicaid program. Summary with link to report: https://bit.ly/2QHAkdV
  • Also on December 7, CMS deemed complete and released for public comment Virginia’s 1115 waiver demonstration, which imposes a work requirement as a condition of Medicaid eligibility for certain beneficiaries. Comments are due by January 6. Waiver: https://bit.ly/2EksJfM

 Payment and Delivery System Reform –

  • On December 3, CMS posted the 2019 Quality Set and Weights document for use in the Comprehensive End-Stage Renal Disease Care Model. Document: https://bit.ly/2UqLy5J

 Substance Use and Mental Health –

  • On December 4, HHS issued a request for data and supplemental evidence on interventions for substance use disorders in adolescents. Submissions are due by January 3. Request: https://bit.ly/2rp88hP
  • On December 5, Senate HELP Committee Ranking Member Murray (D-WA), and Sens. Durbin (D-IL) and Markey (D-MA) led a group of 18 Democratic Senators in a letter to FDA Commissioner Gottlieb urging FDA to take additional, stronger steps to prevent and reduce e-cigarette use among youth. Press release: https://bit.ly/2L381Br Letter: https://bit.ly/2zNZjCB

 Drug and Medical Device Prices and Regulation

  • On November 30, Medicare Payment Advisory Commission (MedPAC) issued a comment suggesting that CMS take a more aggressive approach to enforcing its proposal to make brand drug companies disclose list prices in television advertisements and urged CMS to expand the requirement to other internet platforms, such as social media, podcasts, radio and print. Letter: https://bit.ly/2BWYWHv
  • On December 4, Food and Drug Administration (FDA) announced that it is now recognizing genetic variant information in the ClinGen Expert Curated Human Genetic Data system as a source of valid scientific evidence. FDA took this action to advance the development of reliable and beneficial genetic tests that can improve patient care. Press release: https://bit.ly/2PmG5ZW
  • Also on December 4, FDA Commissioner Gottlieb, Center for Devices and Radiological Health Director Shuren, and Patient Science and Engagement Director Tarver posted a blog on how the Center for Devices and Radiological Health (CDRH) is fostering collaborative communities to improve patient health care. Blog: https://bit.ly/2PkWbmD
  • Also on December 6, FDA released a new strategic framework to advance the use of real-world evidence to support the development of drugs and biologics. FDA Commissioner Gottlieb statement: https://bit.ly/2Qi34dV Strategic framework: https://bit.ly/2E5ZM68
  • Also on December 6, Senior Advisor to the Secretary for Drug Pricing Reform O’Brien posted a blog on how the international pricing index (IPI) model would introduce new market competition to Medicare drug spending. Blog: https://bit.ly/2RDO6eV

 Military & Veterans’ Health –

  • On December 6, Department of Veterans Affairs (VA) hosted a national telehealth summit to promote cross-sector collaboration in an effort to increase health care access for veterans. Press release: https://bit.ly/2E59iqd
  • On December 7, VA announced the launch of its first Health Application Programming Interface (API) that will power the next generation of Blue Button features by enabling veterans to interact with their own personal health data. Press release: https://bit.ly/2ElyVEj

 Health IT –

  • On December 4, Federal Communications Commission (FCC) announced that it is seeking additional comment on discrete issues raised in a proposed rule related to determining the rural and urban rates used to calculate support in the Telecom Program within the Rural Health Care Program. RFC:  https://bit.ly/2RHRNQP
  • On December 6, HHS Office of the National Coordinator for Health IT (ONC) announced the winners of the Certified Health IT Product List (CHPL) Data Challenge, which seeks to promote the use and application of CHPL data across the health care industry. Press release: https://bit.ly/2QHu99H
  • On December 7, House Energy & Commerce Committee Subcommittee on Oversight and Investigations released a cumulative report identifying core strategies to address and prevent cybersecurity incidents. Press release: https://bit.ly/2AZq6f5 Report: https://bit.ly/2BXEqX6

Alaska Earthquake and Emergency Response –

  • On December 3, HHS Secretary Azar declared a public health emergency in Alaska due to earthquake damage. Press release: https://bit.ly/2E4mGeh
  • On December 4, HHS released a plain language checklist to help first responders provide services to individuals with limited English proficiency and individuals with disabilities during emergency response and recovery efforts. Press release: https://bit.ly/2PmnlK5 Checklist: https://bit.ly/2UmgLH4
  • On December 6, CMS Administrator Verma announced that the agency will issue a blanket SNF waiver and special enrollment opportunities for individuals impacted by the Alaska earthquake. Press release: https://go.cms.gov/2E60twk

 Misc. –

  • On December 3, Departments of HHS, Treasury, and Labor released a report on health care competition in the United States, focusing on four main issues: health care workforce and labor markets, health care provider markets, health care insurance markets, and consumer-driven health care. HHS press release: https://bit.ly/2KSJ2ke Report: https://bit.ly/2QAOzRy
  • Also on December 6, CMS Office of the Actuary released a report on 2017 national health expenditures, finding that overall national health spending grew at a rate of 3.9 percent in 2017, almost 1 percentage point slower than growth in 2016. Press release: https://go.cms.gov/2Um81AV Report: https://go.cms.gov/1Jy5kin