What’s Ahead: This Week

Hearings & Markups –

  • Wednesday, August 29
    • Senate HELP Committee, “FDA Oversight: Leveraging Cutting-Edge Science and Protecting Public Health.”

Notable Policy Events

  • Wednesday, August 29 – Thursday, August 30
    • Department of Veterans Affairs, “VHA Innovation: Experience (I:E).” Additional information: http://bit.ly/2od5EBv


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

 Appropriations –

  • On August 23, the Senate passed by a vote of 85-7 the Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 (H.R. 6157), which includes $90.1 billion in fiscal year (FY) appropriations for the Department of Health and Human Services (HHS), an increase of $2.3 billion from FY 2018. The bill now moves to conference negotiations between the House and Senate. Press release: https://bit.ly/2MvlNR7 Bill text: http://bit.ly/2BOJhMg

 Legislative Activity –

  • On August 21, Sens. Hassan (D-NH), Cassidy (R-LA), and Jones (D-AL) introduced the Synthetic Drug Awareness Act of 2018 (S. 3356), which would require the Surgeon General to submit to Congress a report on the health effects of new psychoactive substances, including synthetic drugs, on young adults. Press release: https://bit.ly/2PyAeBM Bill text: https://bit.ly/2Pvv1uF
  • On August 22, Sen. Brown (D-OH) introduced the Full-Service Community Schools in Distressed Communities Act (S. 3362), which would provide grants to communities affected by substance use disorder to enable those communities to plan for and implement full-service community schools. Press release: https://bit.ly/2o4Czbu
  • Also on August 22, Sen. Harris (D-CA) introduced the Maternal Care Access and Reducing Emergencies (CARE) Act (S. 3363), which would create two new grant programs focused on reducing racial disparities in maternal health and would direct the National Academy of Medicine to study and make recommendations for incorporating bias recognition in clinical skills testing for U.S. medical schools. Press release: https://bit.ly/2wjw7kp Bill text: https://bit.ly/2oa9qf3
  • Also on August 22, Sens. Shaheen (D-NH) and Collins (R-ME) introduced the Expanding Access to Diabetes Self-Management Training Act of 2018 (S. 3366), which would expand Medicare coverage for diabetes self-management training sessions. Press release: https://bit.ly/2NcGHAQ Bill text: https://bit.ly/2BCKZ3q
  • On August 23, Sens. Baldwin (D-WI) and Ernst (R-IA) introduced the Ensuring Lasting Smiles Act (S. 3369), which would require that group and individual health insurance coverage and group health plans provide coverage for treatment of a congenital anomaly or birth defect. Press release: https://bit.ly/2P4mmOZ
  • Also on August 23, Sen. Donnelly (D-IN) introduced S. 3380, which would direct the Office of National Drug Control Policy to track and review federally funded drug demand reduction activities. Press release: https://bit.ly/2w5qGpM
  • Also on August 23, Sen. Cardin (D-MD) introduced the Rural Development of Opioid Capacity Services (DOCS) Act (S. 3383), which would provide for a demonstration project to increase substance use provider capacity under the Medicaid program.
  • Also on August 23, Sen. Cardin (D-MD) introduced the Medicaid Health Homes for Opioid-Use Disorder Medicaid Enrollees Encouraged (Medicaid Health HOME) Act (S. 3384), which would provide for an extension of the enhanced FMAP for certain Medicaid health homes for individuals with substance use disorders.
  • On August 24, Senate HELP Committee Chair Alexander (R-TN) led a group of 10 Republican Senators in introducing the Ensuring Coverage for Patients with Pre-Existing Conditions Act (S. 3388), which would amend HIPAA to guarantee the availability of coverage in the individual or group market. Press release: https://bit.ly/2BJMFrR Bill text: https://bit.ly/2PwehU2

 ACA Implementation –

  • On August 20, CMS awarded $8.6 million to 30 states and the District of Columbia for individual health insurance market economic analyses and market scans, as well as examining plan policies, procedures, and claims related data related to access to mental health and substance use disorder treatment services. Press release: https://go.cms.gov/2Msr3VE Fact sheet: https://go.cms.gov/2Mn3NZg
  • On August 22, CMS approved Maryland’s section 1332 waiver request to establish a statewide reinsurance program. The approval is effective from January 1, 2019 through December 31, 2023. Approval letter: https://go.cms.gov/2BEoaME
  • On August 23, U.S. Government Accountability Office (GAO) released a report on HHS’ management of the 2018 Open Enrollment period, noting that lower enrollment from 2017 may have been due to higher premiums as well as reduced federal consumer outreach. Summary with link to report: https://bit.ly/2wsDw14
  • Also on August 23, CMS Deputy Administrator Pate published an informational blog on the potential value that high-deductible health plans (HDHPs) and health savings accounts (HSAs) may provide to exchange enrollees. Blog: https://go.cms.gov/2MQuxAE

 Medicare –

  • On August 20, HHS Office of Inspector General (OIG) released a report finding that Medicare improperly paid hospitals as much as $21.5 million for intensity-modulated radiation therapy (IMRT) planning services, and recommending that CMS implement an edit to prevent improper payments for IMRT planning services. Summary: https://bit.ly/2BIVemx Report: https://bit.ly/2LmTIq1
  • Also on August 20, HHS OIG released a report showing that Medicare made improper payments totaling $1.9 million for emergency ambulance transports to destinations other than hospitals or skilled nursing facilities, and recommending that CMS direct Medicare contractors to recover the improper payments. Summary: https://bit.ly/2BJlDAL Report: https://bit.ly/2LmNs1m
  • On August 24, GAO released a report finding that during the first year of nationwide reduced payment rates for durable medical equipment (DME), the number of suppliers who sold DME decreased – continuing a long-term trend – but that beneficiaries continued to be able to get needed items. Summary: https://bit.ly/2P42KKG Report: https://bit.ly/2Lqv9Zb
  • Also on August 24, CMS issued a request for information (RFI) regarding how the Anti-Kickback Statute and the beneficiary inducements civil monetary penalty may act as barriers to coordinated care or value-based care. Comments are due by October 26. RFI: https://bit.ly/2Lo3JTV

 Medicaid –

  • On August 20, Sens. Booker (D-NJ), Menendez (D-NJ), and Hirono (D-HI) led a group of 40 Democratic members of Congress in a letter to CMS Administrator Verma, expressing concern over the agency’s proposed rule to limit home care workers’ ability to authorize direct deductions from their paychecks for benefits such as health care, workers’ compensation, union dues, and professional development. Press release: https://bit.ly/2wc0Xwe Letter: https://bit.ly/2LnYTWG
  • Also on August 20, CMS released a Disaster Preparedness Toolkit for State Medicaid Agencies, which serves as a guide for states in times of crisis. Toolkit: https://bit.ly/2NfVwCU
  • Also on August 20, Ohio released a report finding that the state’s uninsured rate fell significantly over the period from 2014 through 2018 largely due to the state’s Medicaid expansion. Louisiana also released a report on the state’s insurance coverage, finding that the state’s Medicaid expansion also played a significant role in reducing uninsurance. Reports: http://bit.ly/2oacNCx and http://bit.ly/2whyuVF
  • On August 21, GAO released a report finding that CMS has taken steps to address program risks, but further actions are needed to strengthen program integrity and recommending that CMS bolster its collaborations with state auditors. Summary with link to report: https://bit.ly/2w8SJow
  • On August 22, Senate Finance Committee Ranking Member Wyden (D-OR) and House Energy & Commerce Committee Ranking Member Pallone (D-NJ) penned a letter to HHS Secretary Azar urging the Administration against moving forward on Kentucky’s Medicaid waiver, which includes work requirements. Press release: https://bit.ly/2whKsyP Letter: https://bit.ly/2Lqp0MC
  • Also on August 22, CMS released guidance to State Medicaid Directors outlining CMS’s new approach to ensure that Medicaid section 1115 demonstrations remain budget neutral. Press release: https://go.cms.gov/2MtXV0m Guidance: https://bit.ly/2wjpTky
  • On August 23, the Supreme Judicial Court of Maine ordered Gov. LePage (R-ME) to submit a plan to the federal government for the state’s Medicaid expansion, following the Governor’s refusal to expand the program despite a voter-approved ballot initiative. Court decision: https://bit.ly/2Mz1ZfN
  • Also on August 23, House Committee on Oversight & Government Reform Ranking Member Cummings (D-MD) and Subcommittee on Health Care, Benefits, and Administrative Rules Kirshnamoorthi (D-IL) sent a letter to HHS Secretary Azar and CMS Administrator Verma expressed concern regarding the Administration’s actions to promote work requirements for Medicaid. Press release: http://bit.ly/2ocX3Pa Letter: http://bit.ly/2wkcYQ2
  • On August 24, Nebraska Secretary of State Gale announced that enough signatures had been certified to place Medicaid expansion on the state’s November ballot. Press release: http://bit.ly/2wg2bX1

 New Payment and Delivery System Reforms –

  • On August 23, CMS announced the Integrated Care for Kids (InCK) Model, which is a child-centered local service delivery and state payment model aimed at reducing expenditures and improving quality of care for children covered by Medicaid and CHIP who are impacted by the opioid crisis. Press release: https://go.cms.gov/2P21ojG

 Mental Health and Substance Use –

  • On August 22, Food and Drug Administration (FDA) Commissioner Gottlieb released a statement outlining new steps to advance the development of evidence-based, indication-specific guidelines to help guide appropriate prescribing of opioid analgesics. Statement: https://bit.ly/2PsAulT

Drug Prices and Regulation

  • On August 21, HHS released a report describing the actions taken by the Administration and other stakeholders since the release of President Trump’s Drug Pricing Blueprint. The report finds that there were 60 percent fewer brand name product price increases in 2018 compared to the same period in 2017. Press release: https://bit.ly/2OU2fCW Fact sheet: http://bit.ly/2LpJpRU Report Summary: http://bit.ly/2LtpD8k Report: https://bit.ly/2LpCM1V
  • Also on August 21, Patient-Centered Outcomes Research Institute (PCORI) approved $85 million to fund 16 new studies comparing new approaches to conditions that impose high burdens on patients, caregivers, and the health care system, such as unsafe opioid use, cancer, depression, and stroke. Press release: https://bit.ly/2LeV2uT

 Military & Veterans’ Health –

  • On August 21, Department of Veterans Affairs (VA) Office of Inspector General (OIG) released a report on processing inaccuracies involving veterans’ intent to file submissions for benefits. The inaccuracies resulted in $72.5 million in improper payments between March 2015 and September 2017. Summary: https://bit.ly/2Nfj8HT Report: https://bit.ly/2wnhNrg
  • Also on August 21, VA OIG released a report finding that about 1,300 of the 2,700 military sexual trauma-related claims denied between April 2017 and September 2017 were incorrectly processed, and may have resulted in the denial of benefits to veterans who could have been entitled to receive them. Summary: https://bit.ly/2w9qm9R Report: https://bit.ly/2P41gQC
  • On August 23, VA noted its progress in implementing the Veterans Appeals Improvement and Modernization Act of 2017, which was signed into law on August 23, 2017. Full implementation of the law goes into effect in February 2019. Press release: https://bit.ly/2LnDKfa

 Health IT –

  • On August 24, Office of the National Coordinator for Health IT (ONC) issued a request for information seeking input regarding the EHR Reporting Program established in the 21st Century Cures Act. The RFI serves as a first step toward implementing the statute. Comments are due by October 17. RFI: https://bit.ly/2PCGYir


  • On August 20, Senate HELP Committee Ranking Member Murray (D-WA) penned a letter to Senate Judiciary Committee Chair Grassley (R-IA) raising concerns about Supreme Court nominee Kavanaugh’s past positions on women’s health. Press release: https://bit.ly/2MxdpAD Letter: https://bit.ly/2MvR9as