What’s Ahead: This Week

Hearings and Markups –

  • Tuesday, March 3
    • House Veterans’ Affairs Committee, Health Subcommittee, “The Silver Tsunami: is VA Ready?”
    • House Energy & Commerce Committee, Health Subcommittee, “Combatting an Epidemic: Legislation to Help Patients with Substance Use Disorders.”
    • House Appropriations Labor, Health and Human Services, Education and Related Agencies Subcommittee, “Reducing Childhood Poverty.”
    • Senate HELP Committee, “An Emerging Disease Threat: How the U.S. is Responding to COVID-19, the Novel Coronavirus.”
  • Wednesday, March 4
    • House Appropriations Committee, Labor, Health and Human Services, Education and Related Agencies Subcommittee, “National Institutes of Health Budget Request for FY2021.”
    • House Appropriations Committee, Military Construction, Veterans Affairs, and Related Agencies Subcommittee, Department of Veterans Affairs Budget Request for FY2021.”
  • Thursday, March 5
    • Senate Homeland Security & Government Affairs Committee, “The Federal Interagency Response to the Coronavirus and Preparing for Future Global Pandemics.”
    • House Veterans Affairs Committee, Subcommittee on Technology Modernization, “Getting it Right: Challenges with Go-Live of Electronic Health Record Modernization.”

Notable Policy Events –

  • Tuesday, March 3
    • Better Medicare Alliance, “Medicare Advantage & Caring for Patients with Kidney Failure.” Additional information: http://bit.ly/39fTTjp
  • Wednesday, March 4 – Thursday, March 5
    • National Academy of Social Insurance, “Healthcare Coverage and Costs: Assessing Medicare-Based Approaches.” Additional information: http://bit.ly/2I8cEcQ
  • Thursday, March 5
    • The Partnership to Protect Coverage, “The Affordable Care Act at 10: Celebrating a Decade of Progress for Patients.” Additional information: http://bit.ly/32J3Y67
  • Thursday, March 5 – Friday, March 6
    • Medicare Payment Advisory Commission (MedPAC), “March Public Meeting.” Additional information: http://bit.ly/2TvJQjE

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

Legislative Activity –

Committee Actions and Votes –

  • On February 24, the Senate passed by a voice vote the Lifespan Respite Care Reauthorization Act of 2019 (S. 995), which would reauthorize the program under such title relating to lifespan respite care. The bill now moves to House for consideration. Press release: http://bit.ly/32HQSpX Bill text: http://bit.ly/2I1Dqn3
  • On February 25, the House passed by a voice vote the VA Reporting Transparency Act (H.R. 4613), which would direct the Secretary of Veterans Affairs to establish and maintain a website of the Department that allows the public to obtain electronic copies of certain legislatively requested reports of the Department of Veterans Affairs. Press release: Bill text: http://bit.ly/2uAMYCx
  • On February 28, the House passed by a vote of 213-195 the Protecting American Lungs and Reversing the Youth Tobacco Epidemic Act of 2020 (H.R. 2339), which would amend the Federal Food, Drug, and Cosmetic Act with respect to the sale and marketing of tobacco products. The House also passed the Gold Star Spouses and Spouses of Injured Servicemembers Leasing Relief Expansion Act of 2019 (H.R. 2227), the Legal Services for Homeless Veterans Act (H.R. 3749), the Protecting Business Opportunities for Veterans Act of 2019 (H.R. 561) and the G.I. and Veterans Education Empowerment (GIVE) Act (H.R. 4852). All five bills now move to the Senate for consideration. Press release: http://bit.ly/2TjSGB2 Bill text: http://bit.ly/3ci14d6

Introduced Legislation –

  • On February 25, Reps. LaHood (R-IL), Dingell (D-MI), Higgins (D-NY) and Bilirakis (R-FL) introduced the Hemophilia SNF Access Act (H.R. 5952), which would improve access to skilled nursing facility services for hemophilia patients. Press release Bill text: http://bit.ly/2I1DXp3
  • Also on February 25, Rep. Higgins (D-NY) and Steube (R-FL) introduced the Senior Health Planning Account Act (H.R. 5958), which would create senior health planning accounts funded by the proceeds of the sale or assignment of life insurance contracts. Press release: Bill text: http://bit.ly/2wT467k
  • Also on February 25, Rep. Krishnamoorthi (D-IL) and Maloney (D-NY) introduced the E-Cigarette Oversight and Accountability Act of 2020 (H.R. 5963), which would amend the Federal Food, Drug, and Cosmetic Act with respect to reporting of consumer complaints by electronic nicotine dispenser system manufacturers and importers. Press release: Bill text: http://bit.ly/2Vsj4vi
  • On February 26, Rep. Posey (R-FL) and Ryan (D-OH) introduced the Safe Medicine Act (H.R. 5982), which would direct the Secretary of Health and Human Services to study American dependence on Chinese pharmaceuticals and to empower the Food and Drug Administration to issue boxed warnings in the case of critical contamination. Press release: Bill text: http://bit.ly/3a92AfA
  • On February 27, Reps. Schakowsky (D-IL), DeLauro (D-CT), Porter (D-CA) and Pressley (D-MA) introduced the H.R. 5991, which would extend protections to part-time workers in the areas of family and medical leave and pension plans, and to ensure equitable treatment in the workplace. Sens. Warren (D-MA), Booker (D-NJ), Markey (D-MA) and Harris (D-CA) introduced companion legislation in the Senate (S. 3358). Press release: http://bit.ly/3ad3pUC Summary: http://bit.ly/3abbwkG Bill text: http://bit.ly/2TuSzT7
  • Also on February 27, Rep. Malinowski (D-NJ) and Bucshon (R-IN) introduced the Know the Price Act (H.R. 6005), which would increase transparency of group health plans and health insurance issuers offering group or individual health insurance coverage by removing gag clauses on price and quality information. Press release: http://bit.ly/2PymvNa
  • Also on February 27, Reps. Pascrell (D-NJ), Sewell (D-AL), and Beatty (D-OH) introduced the SAFE PLAY Act (H.R. 6007), which would promote youth athletic safety. Sen. Menendez (D-NJ) introduced companion legislation in the Senate (S. 3347). Press release: http://bit.ly/2VA6HNF  
  • Also on February 27, Sen. Hawley (R-MO) introduced S. 3343, which would provide enhanced security for the medical supply chain. Press release: http://bit.ly/2voeVh6 Bill text: http://bit.ly/2PyuY2J Additional information: http://bit.ly/2VveDQd
  • Also on February 27, Sen. Manchin (D-WV) introduced the SAFE Kids Act of 2020 (S. 3344), which would direct the Secretary of Education to develop and disseminate an evidence-based curriculum for kindergarten through grade 12 on substance use disorders. Press release: http://bit.ly/2I6arys One-pager: http://bit.ly/3aczYlv
  • Also on February 27, Sen. Crapo (R-ID) and Tester (D-MT) introduced the State Veterans Homes Inspection Simplification Act (S. 3350), which would deem certain State Veterans homes meeting certain health and safety standards as meeting conditions and requirements for skilled nursing facilities under the Medicare and Medicaid programs. The bill has companion legislation in the House (H.R. 4138). Press release: http://bit.ly/3ci2rbK Bill text: http://bit.ly/38aD8VI
  • Also on February 27, Sen. Cornyn (R-TX) and Rosen (D-NV) introduced the Advancing Research to Prevent Suicide Act (S. 3351), which would direct the Director of the National Science Foundation to support multidisciplinary research on the science of suicide, and to advance the knowledge and understanding of issues that may be associated with several aspects of suicide including intrinsic and extrinsic factors related to areas such as wellbeing, resilience, and vulnerability. Press release: http://bit.ly/2T6bMM1
  • Also on February 27, Sens. Cassidy (R-LA), Durbin (D-IL), Ernst (R-IA), Shaheen (D-NH), Whitehouse (D-RI) and Young (R-IN) introduced the Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act (S. 3353), which would provide for extended months of Medicare coverage of immunosuppressive drugs for kidney transplant patients. Press release: http://bit.ly/2wh64Ok Bill text: http://bit.ly/2I5Fs5S
  • Also on February 27, Sen. Brown (D-OH) introduced the Community Access to Resources and Education for Families Act (S. 3354), which would establish a community health partnership grant program. Press release: http://bit.ly/3cj17oW

Medicare – On February 28, U.S. Government Accountability Office (GAO) found that the number of Medicare-dependent hospitals decreased by about 28 percent between 2011 and 2017 because they became ineligible for the program, merged with other hospitals, or closed. Additionally, the typical Medicare-dependent hospital saw profits decrease by almost 2 percentage points during that period. Summary with link to report: http://bit.ly/39cnY3E

New Payment and Delivery System Models –

  • On February 25, CMS posted HHS Secretary Azar’s response to the Physician-Focused Payment Technical Advisory Committee (PTAC) on three proposed Physician-Focused Payment Models (PFPM), including Upstream Rehabilitation, Seha Medical and Wound Care and the Johns Hopkins University School of Nursing and the Stanford Medicine Clinical Excellence Research Center. HHS Secretary Azar response: http://bit.ly/32yKO2J
  • On February 27, CMS announced the selection of 205 applicants to participate in the Emergency Triage, Treat and Transport (ET3) Model, a payment model that will provide greater flexibility to ambulance care teams to address emergency health care needs of Medicare fee-for-service beneficiaries. Press release: https://go.cms.gov/2I5HGBS Information: http://bit.ly/38bZyGc
  • On February 28, CMS posted the second annual report and associated materials for the Medicare Care Choices Model. Report: http://bit.ly/2T9y9QK Two-pager: http://bit.ly/398yqc9 

Prescription Drug and Medical Device Policy –

  • On February 24, FDA announced its plans to update the Purple Book, a database of LDA-licensed biological products, to permit full search functionality for all approved biosimilar products and their reference products and to support transparency in biosimilars. Brief: http://bit.ly/399psf0
  • On February 25, Senate Finance Committee Chair Grassley (R-IA) and Ranking Member Wyden (D-OR) sent a letter to Express Scripts requesting documents as part of the committee’s investigation into insulin prices. Press release: http://bit.ly/3cgFLIN Letter: http://bit.ly/2I7BQQs
  • On February 26, Senate Finance Committee Chair Grassley (R-IA) and Ranking Member Wyden (D-OR) sent a letter to Optum to provide information on how Optum’s practices impact the operation of Medicare and Medicaid, the cost to taxpayers and the out-of-pocket costs that patients face, particularly for insulin. Press release: http://bit.ly/2I4ZblW Letter: http://bit.ly/3cm8P1J
  • Also on February 26, HHS Office of Inspector General (OIG) found that ownerships, not physical movement of selected drugs, can be traced through the supply chain. HHS OIG recommended that FDA seek legislative authority to require information about a drug product’s complete physical path through the supply chain on tracing information. Summary with link to report: http://bit.ly/3c9h0yd

Health Data and IT –

  • On February 24, HHS released national health IT priorities for research including leveraging high-quality electronic health data for research and advancing a health IT infrastructure to support research. Blog: http://bit.ly/2HU49lp Agenda: http://bit.ly/399ooYy
  • On February 27, HHS released a blog highlighting the Office of the National Coordinator (ONC) work as part of the Precision Medicine Initiative (PMI) including supporting pilot projects and standards to improve health IT interoperability for research, adopting policies and standards to support privacy and security of participant data and advancing standards that support participants’ decisions to share their data with researchers. Blog: http://bit.ly/32ztmv4

Mental Health and Substance Use Policy – On February 26, CDC announced a request for information (RFI) on developing a workforce supported recovery program to assist workers facing the nation’s crisis related to the misuse of opioids and related substance use disorders. RFI: http://bit.ly/2PQ8quP

Veterans and Military Health –

  • On February 24, VA and the Department of Defense (DOD) Offices of Inspectors General announced plans to begin to a joint audit of efforts to achieve electronic health record interoperability between the agencies’ two health systems. Press release: http://bit.ly/39kC9na
  • On February 27, GAO found that DOD surveys indicate beneficiary experience remained generally unchanged in the first year of TRICARE Select. Additionally, there was no change in the percent of beneficiaries reporting positive ratings of their TRICARE health care and health plans, however, there was a six percent increase in the percent of beneficiaries reporting problems accessing specialty providers. Summary with link to report: http://bit.ly/3cgKVEI

Public Health –

  • On February 25, CDC announced the updated number of confirmed and probable injury cases and deaths associated with e-cigarette product use to 2,807 injury cases and 68 deaths. Press release: http://bit.ly/2I40dyw
  • Also on February 25, House Energy & Commerce Committee Chair Pallone (D-NJ) sent a letter to FDA Commissioner Hahn urging FDA to proceed with setting a maximum nicotine level in cigarettes. Press release: http://bit.ly/2wh8vjW Letter: http://bit.ly/38aepAT
  • On February 26, HHS awarded approximately $117 million to expand access to HIV care, treatment, medication and prevention services to effectively end the HIV epidemic in the United States. Press release: http://bit.ly/2weXpfC
  • On February 27, CMS announced that UnitedHealthcare and Atrium Health are the winners of the 2020 CMS Health Equity Award for their demonstrated commitment to health equity. Press release: https://go.cms.gov/2whSiLE

Coronavirus –

  • On February 24, FDA provided an update on the status of FDA inspections in China and the agency’s oversight of imported products from China that have been impacted by the COVID-19 outbreak. FDA stated that while they are unable to conduct inspections of medical products and food safety in China, they are utilizing other tools to monitor the safety of products. Press release: http://bit.ly/3a9DeOx
  • Also on February 24, Sen. Hawley (R-MO) sent a letter to FDA Commissioner Hahn requesting information on how the FDA will mitigate the potential drug and medical device shortages during the coronavirus outbreak. Press release with letter: http://bit.ly/39avWKB
  • On February 26, CDC confirmed the first possible instance of community spread of COVID-19 in the United States, bringing the total number of cases to 15. Press release: http://bit.ly/2wRBUBD
  • On February 27, CDC stated that it has identified the first known drug shortage caused by the coronavirus outbreak in China. FDA did not identify the medicine. Press release: http://bit.ly/2PwLQXC
  • Also on February 27, Senate Finance Committee Ranking Member Wyden (D-OR) sent a letter to HHS Secretary Azar regarding a recent whistleblower report that HHS deployed federal non-health care staff from HHS to two coronavirus quarantine sites in California without adequate procedures, safety protocols, training or protective equipment. Press release: http://bit.ly/39bEuk6 Letter: http://bit.ly/2PvbVq8
  • Also on February 27, Senate HELP Committee Ranking Member Murray (D-WA) sent a letter to President Trump urging him to reconsider appointing Vice President Pence to lead the nation’s 2019 Novel Coronavirus response and replace him with a public health expert. Press release: http://bit.ly/2Pwmqtu Letter: http://bit.ly/2PAG7QR
  • Also on February 27, Senate HELP Committee Ranking Member Murray (D-WA) and Senate Homeland Security and Government Affairs Committee Ranking Member Peters (D-MI) sent a letter to HHS Secretary Azar regarding the decision to transport people infected with novel coronavirus on a flight with uninfected people. Press release: http://bit.ly/2VxNBrE Letter: http://bit.ly/385cbTn
  • Also on February 27, Senate Homeland Security and Government Affairs Committee Ranking Member Peters (D-MI) and Sen. Johnson (R-WI) sent a letter to HHS Secretary Azar and Department of Homeland Security Acting Secretary Wolf requesting information about the security and stability of our medical supply chains in the event of a coronavirus outbreak in the United States. Press release: http://bit.ly/2uIruUk Letter: http://bit.ly/32HlSWT
  • Also on February 27, Department of Education Secretary DeVos announced creation of a task force to prepare for the possible impacts of the coronavirus, including a webpage that includes guidance from CDC for administrators of childcare programs and K-12 schools. Information: http://bit.ly/3cmJMv9
  • Also on February 27, Senate Minority Leader Schumer (D-NY) and House Speaker Pelosi (D-CA) issued a joint statement saying that the government should do more to address the spread of the virus, and that vaccines should be affordable and available to all that need it. Statement: http://bit.ly/2wn7yqi
  • On February 29, FDA issued new guidance to expedite the availability of diagnostic tests for coronavirus to facilitate more rapid testing capacity in the U.S. Press release: http://bit.ly/2TuCZHr Guidance: http://bit.ly/3chQsuA
  • Also on February 29, CDC announced the first death due to COVID-19, in Washington State. Press release: http://bit.ly/2whWFGz

Misc. –

  • On February 24, CMS Administrator Verma spoke at the National Association of Healthcare Underwriters (NAHU) 2020 Capitol Conference saying that government’s role in the healthcare system should be limited and voiced concerns that a public option would result in one unaffordable and inferior option offered by the government. Press release: https://go.cms.gov/2w8oLUD
  • On February 25, CMS Administrator Verma spoke at the 2020 CMS Quality Conference unveiling a new, reimagined quality strategy that will establish clear and reasonable expectations for quality, strengthen oversight and enforcement of those standards, promote transparency, competition and consumer choice and modernize quality improvement efforts. Press release: https://go.cms.gov/2Vvja5s
  • On February 27, HHS appointed former Kansas Governor Jeff Colyer to serve as Chair of the National Advisory Committee on Rural Health and Human Services, which advices the Secretary on access to, delivery of, and financing for health care and human services in rural areas. Press release: http://bit.ly/2T93a7z
  • Also on February 27, HHS released a statistical data brief which found that in 2017, the top one percent of persons ranked by their healthcare expenditures accounted for about 22 percent of total healthcare expenditures, while the bottom 50 percent accounted for only about three percent. Inpatient hospital care accounted for 40 percent of spending for persons in the top five percent of the spending distribution. Press release: http://bit.ly/2T8u6nT Data brief: http://bit.ly/2Vw5s1T