Health Care Policy Update – Weekly Wrap-Up and What’s Ahead


What’s Ahead: This Week

Hearings and Markups –

  • Tuesday, September 24
    • House Committee on Oversight & Reform, Subcommittee on Economic & Consumer Policy, “Don’t Vape: Examining the Outbreak of Lung Disease and CDC’s Urgent Warning Not to Use E-Cigarettes.”
  • Wednesday, September 25
    • House Energy & Commerce Committee, Subcommittee on Health, “Making Prescription Drugs More Affordable: Legislation to Negotiate a Better Deal for Americans.”
    • House Energy & Commerce Committee, Subcommittee on Oversight & Investigations, “Sounding the Alarm: The Public Health Threats of E-Cigarettes.”
    • House Veterans’ Affairs Committee, “MISSION Critical: Care in the Community Update.”
    • Senate Special Committee on Aging, “Promoting Healthy Aging: Living Your Best Life Long into Your Golden Years.”
    • Senate Veterans Affairs Committee, “Toxic Exposure: Examining the VA’s Presumptive Disability Decision-Making Process.”
  • Thursday, September 26
    • House Education & Labor Committee, Subcommittee on Health, Employment, Labor and Pensions, “Making Health Care More Affordable: Lowering Drug Prices and Increasing Transparency.”
    • House Veterans Affairs Committee, Subcommittee on Technology Modernization, “The Future of VA Scheduling: Implementing a Commercial Off the Shelf Scheduling Solution at the Department of Veterans Affairs.”
    • House Ways & Means Committee, Subcommittee on Oversight, “The Public Health Consequences and Costs of Gun Violence.”

Notable Policy Events –

  • Monday, September 23 – Thursday, September 26
    • America’s Health Insurance Plans (AHIP), “National Conferences on Medicare, Medicaid & Dual Eligibles.” Additional information: http://bit.ly/2m6LUlj
  • Tuesday, September 24
    • Partnership for Safe Medicines, “Drug Importation Proposals and Counterfeit Drug Developments.” Additional information: http://bit.ly/2m1kfSN
    • American Enterprise Institute (AEI) and Brookings Institution, “A New Vision for Health Reform.” Additional information: http://bit.ly/2kWFox1
    • Health Affairs, “Aging and Health: Improving Care for Older Adults.” Additional information: http://bit.ly/2kTXY92
  • Wednesday, September 25
    • Partnership to Empower Physician-Led Care, “Summit: The Role of Physicians in Value-Based Care.” Additional information: http://bit.ly/PEPCPolicySummit
    • National Academy of Sciences, “Webinar on Integrating Social Care into the Delivery of Health Care: Moving Upstream to improve the Nation’s Health.” Additional information: http://bit.ly/2mqVXSj
    • The American Academy of Actuaries, “Telehealth: A Digital Communication Approach to Improving Health.” Additional information: http://bit.ly/2kWGpoP
  • Thursday, September 26
    • Brookings Institution, “Data Disaggregation as a Means to Improved Health Research and Policy-Making.” Additional information: https://brook.gs/2kvxj2c
  • Thursday, September 26 – Friday, September 27
    • Medicaid and CHIP Payment and Access Commission (MACPAC), “September Public Meeting”. Additional information: http://bit.ly/2mqywbO
  • Friday, September 27
    • Alliance for Health Policy and Commonwealth Fund, “Unpacking Policy Options to Promote Prescription Drug Affordability.” Additional information: http://bit.ly/2mj5DOz

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

Legislative Activity –

Appropriations –

  • On September 18, Senate Appropriations Committee released the Fiscal Year 2020 (FY20) Labor, Health and Human Services, Education, and Related Agencies Appropriations bill, which provides $93.4 billion in discretionary funding for HHS, a $2.9 billion increase above the enacted FY19 level. The House Labor-HHS-Education bill, which was passed by the House in July, includes $99.4 billion for HHS. Press release: http://bit.ly/2QEbGfF Bill text: http://bit.ly/2QpMJ7n Report language: http://bit.ly/2Qo7eBs
  • On September 19, Senate Appropriations Committee unanimously approved the FY20 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill, which provides $3.15 billion in funding for FDA, an increase of $80 million from FY19. The bill now moves to the full Senate for consideration. Press release: http://bit.ly/2Qpwlnv
  • Also on September 19, the House passed by a vote of 301-123 a Continuing Resolution (CR) to extend funding at current FY19 levels through November 21 (H.R. 4378). The CR also includes several healthcare extenders, such as for Certified Community Behavioral Health Centers, and a delay of the scheduled Disproportionate Share Hospital (DSH) cuts. The bill now moves to the Senate for consideration. Press release: http://bit.ly/2Qkwokd Section-by-section: http://bit.ly/2QmLUMI CR: http://bit.ly/2QmLUwc

Committee Actions and Votes –

  • On September 18, the House Education & Labor Committee approved by a voice vote the Dignity in Aging Act of 2019 (H.R. 4334), which would make certain changes and authorize appropriations for fiscal years 2020 through 2024 for the Older Americans Act. The bill now moves to the full House for consideration. Press release: https://bit.ly/2m1ExLX Fact Sheet: https://bit.ly/2m6MX4r Section-by-Section: https://bit.ly/2lYfdGH Bill Text: https://bit.ly/2m1EIqB

Introduced Legislation –

  • On September 17, Sens. Gardner (R-CO), Jones (D-AL) and six bipartisan cosponsors introduced the Suicide Training and Awareness Nationally Delivered for Universal Prevention (STANDUP) Act (S. 2492) which would provide best practices on student suicide awareness and prevention training and condition state, local and tribal educational agencies to establish and implement a school-based student suicide awareness and prevention training policy. Press release: https://bit.ly/2lWnZVt
  • Also on September 17, Rep. DeSaulnier (D-CA) introduced the Suicide Prevention Assistance Act (H.R. 4352), which would establish a grant program to expand suicide prevention efforts for adults in doctor’s offices and other primary care settings. Press release: https://bit.ly/2m6bPt3
  • On September 18, Reps. Biggs (R-AZ), Gosar (R-AZ), Armstrong (R-ND), and Hunter (R-CA) introduced the TBI and PTSD Treatment Act (H.R. 4370), which would direct the Secretary of Veterans Affairs to furnish hyperbaric oxygen therapy to veterans with traumatic brain injury and post-traumatic stress disorder. Press release: https://bit.ly/2kV8xZC
  • Also on September 18, Rep. Axne (D-IA) and seven cosponsors introduced the UPDATE Act (H.R. 4379), which would require qualified health plants to have a process to remove from publicly accessible provider directories of such plans providers that are no longer within the network of such plans. Press release: https://bit.ly/2ks9h8i
  • Also on September 18, House Ways & Means Committee, Subcommittee on Health Chair Doggett (D-TX) and 33 cosponsors introduced Stop the Wait Act (H.R. 4386), which would eliminate the Medicare and disability insurance benefits waiting periods for disabled individuals. Sens. Casey (D-PA), Brown (D-OH), Leahy (D-VT), Sanders (I-VT), and Gillibrand (D-NY) introduced companion legislation in the Senate (S. 2496). Press release: https://bit.ly/2m6gH1m
  • Also on September 18, Rep. Swalwell (D-CA) and 4 cosponsors introduced the Advancing Access to Precision Medicine Act (H.R. 4393), which would provide for a State option under the State Medicaid plan to provide DNA sequencing clinical services for certain children and provide for a study by the National Academy of Medicine on the use of genetic and genomic testing to improve health care. Press release: https://bit.ly/2kN4wGL
  • Also on September 18, Sens. Burr (R-NC) and Bennet (D-CO) introduced the Compassionate Retirement Act (S. 2495), which would establish an exception to the penalty on early distributions from qualified plans for individuals diagnosed with certain terminal illnesses. Press release: https://bit.ly/2lYrc6Z Section-by-section: https://bit.ly/2kMcqQG
  • Also on September 18, Sen. Merkley (D-OR) and eight cosponsors introduced the End Price Gouging for Medications Act (S. 2499), which would establish reference prices for prescription drugs for purposes of federal health programs. Press release: https://bit.ly/2KIt2Eb Bill text: https://bit.ly/2kJwH9v
  • Also on September 18, Sens. Harris (D-CA) and Gardner (R-CO) introduced the Mental Health Professionals Workforce Shortage Loan Repayment Act (S. 2500), which would authorize a loan repayment program for mental health professionals to relieve workforce shortages. Press release: https://bit.ly/2m1O99v
  • On September 19, House Energy & Commerce Committee Chair Pallone (D-NJ), Ways & Means Committee Chair Neal (D-MA), and Education & Labor Committee Chair Scott (D-VA) introduced H.R. 3 which would establish a fair price negotiation program, protect the Medicare program from excessive price increases, and establish out-of-pocket maximums for Medicare part D enrollees. Press releases: http://bit.ly/2QmYEmt and http://bit.ly/2QmMoT2 Bill text: http://bit.ly/2QpQycJ
  • Also on September 19, House Education & Labor Committee Chair Scott D-VA) and Rep. Lee (D-NV) introduced the Direct Creation, Advancement, and Retention of Employment (CARE) Opportunity Act (H.R. 4397), which would award grants for the recruitment, retention and advancement of direct care workers. Sens. Kaine (D-VA) and Hassan (D-NH) introduced companion legislation in the Senate (S. 2521). Press releases: https://bit.ly/2m6knjG and https://bit.ly/2kVJ1mU Fact sheet: https://bit.ly/2msC7WS Bill text: https://bit.ly/2mlr69A
  • Also on September 19, Rep. Cicilline (D-RI) introduced the Affordable Prescriptions for Patients through Promoting Competition Act (H.R. 4398), which would prohibit anticompetitive behaviors by drug product manufacturers. Press release: https://bit.ly/2msCLDJ
  • Also on September 19, Reps. Bucshon (R-IN) and Engel (D-NY) introduced the Advancing Education on Biosimilars Act (H.R. 4400), which would provide for an internet website to provide educational materials for health care providers, patients and caregivers, regarding the meaning of the terms and the standards for review and licensing of biological products. Press release: https://bit.ly/2mpnJP5
  • Also on September 19, Rep. Rush (D-IL) introduced the Depression Effect Labeling Awareness Act of 2019 (H.R. 4404), which would require that the label of drugs with an increased risk of suicide or depression present such increased risk prominently. Press release: https://bit.ly/2m2Y0Mh
  • Also on September 19, Reps. Wild (D-PA), Trone (D-MD), and Moulton (D-MA) introduced the Greater Mental Health Access Act (H.R. 4428), which would establish a special enrollment period for family members of an individual who has died by suicide, and to establish a competitive grant program to provide services and support to friends and family members impacted by an individual’s suicide. Press release: https://bit.ly/2kya6wu
  • On September 20, Rep. Butterfield (D-NC) and nine bipartisan cosponsors introduced the Creating Hope Reauthorization Act (H.R. 4439), which would make permanent the authority of the Secretary of HHS to issue priority review vouchers to encourage treatments for rare pediatric diseases. Press release: https://bit.ly/2m1iaWQ Bill text: https://bit.ly/2m7deQ5
  • Also on September 20, Reps. Schrader (D-OR) and Gianforte (R-MT) introduced the Bolstering Innovative Options to Save Immediately on Medicines (BIOSIM) Act (H.R. 4455), which would provide a temporary payment increase under the Medicare program for certain biosimilar biological products to encourage the development and use of such products. Press release: https://bit.ly/2kLY4zP

Medicare  –

  • On September 17, Sens. Brown (D-OH), Stabenow (D-MI), Klobuchar (D-MN), Sanders (I-VT), Blumenthal (D-CT), and Murphy (D-CT) sent a letter to CMS Administrator Verma urging the Administration to increase their oversight of MA plans and their billing practices. Press release with link to letter:http://bit.ly/2NqgKSf
  • On September 18, U.S. Government Accountability Office (GAO) released a report noting that federal requirements for oversight in nursing homes and assisted living facilities differ. Summary with link to report: http://bit.ly/32W5f8Y
  • On September 19, HHS Office of Inspector General (OIG) released a report finding that Medicare Part D insurance companies sometimes inappropriately rejected or denied pharmacy and drug coverage requests, delaying or preventing access to prescribed drugs for beneficiaries. Summary with link to report: https://bit.ly/2kGwgwF
  • Also on September 19, GAO released a report stating that CMS could more effectively ensure its quality measurement activities promote its objectives. Summary with link to report: https://bit.ly/2lZz0pa

Medicaid –

  • On September 16, GAO issued a report recommending CMS provide additional data and oversight of the early and periodic screening, diagnostic and treatment (EPSDT) benefit needed to ensure children receive recommended screenings. Summary with link to report: https://bit.ly/2mgSaH1
  • On September 17, Tennessee released for state public comment an amendment to its current section 1115 demonstration, TennCare, which requests that CMS provide federal funding in the form of block grants. Comments are due by October 18. Notice:http://bit.ly/2Axee3W Waiver: http://bit.ly/2Aprxnh
  • On September 20, HHS OIG released a report on CMS’s oversight of the Medicaid Drug Rebate Program, recommending CMS take steps to ensure accuracy of reasonable assumptions made by manufacturers with respect to Average Manufacturer Price and Best Prices. Summary with link to report: https://bit.ly/2kVNqq6

Payment and Delivery System Reform –

  • On September 16, CMS extended the deadline for Request for Applications for the Emergency Triage, Treat, and Transport (ET3) model until October 5. Information: https://bit.ly/2trlafq
  • On September 20, CMS released a solicitation for payer participation and a memorandum of understanding (MOU) for the Maryland Total Cost of Care Model. Solicitation: http://bit.ly/32P7QRQ MOU: http://bit.ly/32RQfJ5

Drug and Medical Device Prices and Regulation –

  • On September 16, Reps. Engel (D-NY), Guthrie (R-KY) and 92 bipartisan representatives sent a letter to FDA Acting Commissioner Sharpless requesting information about the agency’s actions to address medical drug shortages. Press release: http://bit.ly/2Ntm5rN
  • On September 17, Sens. Baldwin (D-WI) and Klobuchar (D-MN) sent a letter to Federal Trade Commission Chair Simons raising concern about the potential impact of pharmaceutical company mergers on drug prices and patient access to essential medications. Press release with text of letter: http://bit.ly/2ABHrLb
  • Also on September 17, Sens. Smith (D-MN) and Cramer (R-ND) sent a letter to Senate Finance Committee Chair Grassley (R-IA) and Ranking Member Wyden (D-OR) requesting that the Committee hold a hearing on their bipartisan bill to address the rising price of insulin. Press release: http://bit.ly/2AvQVYq Letter: http://bit.ly/2AxCcME
  • On September 23, House Ways & Means Committee released a report finding that U.S. drug prices are nearly four times higher than the combined average of 11 other similar countries and Americans pay as much as 67 times more than consumers in other nations for prescription drugs, even when accounting for rebates. Press release: http://bit.ly/2m5BpP2 Report: http://bit.ly/2maCN2M

Substance Use and Mental Health –

  • On September 16, HHS OIG released a report with insights for states and recommendations to CMS to better identify and provide behavioral health services to Medicaid enrollees. Summary with link to report: https://bit.ly/2m2iMeE
  • Also on September 16, HHS released a final report assessing substance use disorder treatment capacity highlighting best practices and identifying gaps and opportunities for improvement. Report: https://bit.ly/2m2AEXa Appendix C: https://bit.ly/2m4i8NL
  • On September 18, CMS announced the awardees for planning grants authorized under the SUPPORT for Patients and Communities Act that aims to increase the capacity of Medicaid providers to deliver substance use disorder treatment or recovery services. Information: http://bit.ly/2Aykqc7
  • On September 19, House Energy & Commerce Committee Chair Pallone (D-NJ) and Ranking Member Walden (R-OR), Subcommittee on Health Chair Eshoo (D-CA) and Ranking Member Burgess (R-TX), and Subcommittee on Oversight & Investigations Chair DeGette (D-CO) and Ranking Member Guthrie (R-KY) sent letters to 16 states asking how states are using federal funds to assist treatment and recovery efforts in response to the opioid crisis. Press release with links to letters: https://bit.ly/2kqyYWN
  • On September 20, CMS released a set of frequently asked questions (FAQ) clarifying existing CMS policy regarding Institutions for Mental Diseases (IMD) and its potential impact on Qualified Residential Treatment Programs. FAQ: https://bit.ly/2m1ImAN
  • On September 20, FDA Acting Commissioner Sharpless released a statement on efforts to increase availability of all forms of naloxone to help reduce opioid overdose deaths. Press release: https://bit.ly/2kV449i

Veterans and Military Health –

  • On September 16, VA announced the launch of a training program to support its electronic health record modernization effort, called the VA Innovative Technology Advancement Lab. Press release: http://bit.ly/2ABgGqk
  • Also on September 16, GAO issued a report on the expansion of the VA’s Family Caregiver Program, recommending that VA collect reliable staffing and monitoring data, establish a process to ensure the data are accurate, and establish an interim method for collecting system-wide data on required contacts and visits. Summary with link to report: https://bit.ly/2lX8eh0
  • On September 17, VA announced the actions it will take to restore trust, after ongoing issues at Atlanta VA Medical Center’s Eagles’ Nest Community Living Center and other VA facilities in the region. Press release: https://bit.ly/2m64N7D
  • On September 19, GAO released a report finding that opportunities remain for the VA to improve its oversight of contracted disability claims examiners. Summary with link to report: http://bit.ly/32W5jWg
  • On September 20, VA released its 2019 National Veteran Suicide Prevention Report, which includes findings from its most recent analysis of veteran suicide data form 2005 to 2017. Press release with link to report: http://bit.ly/2AC7WAb

Public Health –

  • On September 16, Centers for Disease Control and Prevention (CDC) activated its Emergency Operations Center (EOC) to provide increased operational support for the investigation into cases of lung injury associated with e-cigarette product use. Press release: https://bit.ly/2kQYMeO
  • On September 18, House Committee on Oversight and Reform Subcommittee on Economic & Consumer Policy Chair Krishnamoorthi (D-IL) sent a letter to JUUL Labs warning them to comply with the Subcommittee’s documentation requests. Press release:https://bit.ly/2kVPrTc Letter: https://bit.ly/2m4oYTO
  • Also on September 18, National Institutes of Health (NIH) released data finding that teenager use of e-cigarettes has doubled since 2017. Press release:http://bit.ly/2AA8rLm
  • Also on September 18, HHS announced the award of over $85 million to help health centers expand access to oral health care. Press release:http://bit.ly/32TIKBl
  • On September 19, CDC Director Redfield released a statement on lung injury and deaths associated with e-cigarette or vaping products. Statement:https://bit.ly/2kVflX0
  • Also on September 19, President Trump signed an Executive Order to modernize influenza vaccine manufacturing. Press release: http://bit.ly/32YpdQr Executive Order: http://bit.ly/2NqeJWi
  • Also on September 19, HHS released its first National Youth Sports Strategy, the first federal roadmap that outlines the steps to increase youth sports participation. Press release:http://bit.ly/32TlAeh
  • On September 20, FDA issued a proposed rule for premarket tobacco product applications as part of the agency’s commitment to oversight of e-cigarettes and other tobacco products. Comments are due by November 20. Proposed rule: https://bit.ly/2m5c2g8

Misc. –

  • On September 16, House Energy & Commerce Committee Chair Pallone (D-NJ) and Ranking Member Walden (R-OR) announced the launch of a bipartisan investigation into private equity firms’ role in surprise billing practices. Press releases: https://bit.ly/2kCKOgR and https://bit.ly/2kV7zws Letters to companies: http://bit.ly/2QkNvCD
  • Also on September 16, Senate Finance Committee Health Tax Policy Taskforce released a report on the temporary tax policies in the health area that expire between December 31, 2017 and December 31, 2019. Report: http://bit.ly/2NqRueJ
  • On September 20, HHS released the annual Medical Expenditure Panel Survey (MEPS) Insurance Component chartbook, which found that average deductibles for single and family enrollees in employer-sponsored health insurance plans did not increase significantly in 2018. Summary with link to report: http://bit.ly/2ADnDHt