Health Care Checkup
June 17, 2022
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The Senate is continuing to negotiate on a gun legislation package and hopes to pass it before the July 4 recess, however negotiations hit a snag this week. On Thursday evening, Senators Chris Murphy (D-CT), John Cornyn (R-TX), Kyrsten Sinema (D-AZ), and Thom Tillis, (R-NC) met to try to finalize an agreement but could not come to a consensus on how to close the “boyfriend loophole.” While federal law prohibits firearm purchases for those convicted of domestic violence against someone they have lived with, been married to, or had a child with, it leaves out other partners. Senate Republicans are looking to ensure that relationships that are long over are not impacted by closing the loophole, but Democrats want the language to be more comprehensive. After Thursday’s session, Senator John Cornyn told reporters he was “through talking.” However, it is expected that negotiations will continue.
Earlier in the week, a bipartisan group of Senators announced that they had come to an agreement on a slew of proposals, including support for State Crisis Intervention Orders, investments in mental health and telehealth services, funding for school safety resources, and more stringent requirements for who can qualify as a Federally Licensed Firearms Dealer. The package would also include funding for enhanced background checks and red flag laws. Senator Debbie Stabenow (D-MI), a lead negotiator of the legislation, said that it will also include approximately $8 billion to make the Certified Community Behavioral Health Clinics model a nationwide program. Senator Chris Murphy (D-CT) warned that tying mental health to gun violence legislation “risk[s] creating the impression that people with mental illness are prone to violence, when the opposite is true,” however he said that “we shouldn’t forsake the opportunity to put billions of dollars into new mental health services.”
On Tuesday, the Senate Health, Education, Labor and Pensions Committee (HELP) marked up five health bills, including the bipartisan FDASLA Act ( S. 4348), which Chairwoman Patty Murray (D-WA) called the most important, comprehensive Food and Drug Administration (FDA) legislation to come out of the Committee in many years. The amended FDA package includes measures on diagnostic test modernization, reform in the areas of cosmetics and dietary supplements, appropriate avenues for drug importation, and steps to combat the nation’s current infant formula shortage. The Committee voted 13-9 to approve the legislation. Our full summary of the Senate HELP markup can be found here.
On Wednesday, the Supreme Court of the United States (SCOTUS) unanimously ruled that HHS's 2018 and 2019 reduced drug reimbursement rates for 340B hospitals were unlawful. The justices ruled the reduced reimbursement rates unlawful because HHS did not survey hospital costs before adjusting payments for 340B, which cut payments to hospitals in the program by approximately 30%. The opinion, which was authored by Justice Brett Kavanaugh stated, “Absent a survey of hospitals' acquisition costs, HHS may not vary the reimbursement rates only for 340B hospitals; HHS's 2018 and 2019 reimbursement rates for 340B hospitals were therefore unlawful.” The ruling may open the door for 340B hospitals to recoup billions of dollars in drug subsidies.
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What to Expect Next Week: The House Appropriations Labor HHS Subcommittee will mark up the FY 2023 Labor, Health and Human Services, Education, and Related Agencies bill. Additionally, the House Select Subcommittee on the Coronavirus Crisis will hold a hearing with the former Trump White House Coronavirus Response Coordinator, Dr. Deborah Birx. Also next week, the House is expected to consider H.R. 7666, the Restoring Hope for Mental Health and Well-Being Act, which is legislation that would expand and modify various programs, grants, and related activities that focus on mental and behavioral health. The House will also consider H.R. 5585, the ARPA-H Act. This legislation would establish the Advanced Research Projects Agency for Health (ARPA-H), an agency within HHS, to accelerate innovation in health and medicine.
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Senate HELP Committee Approves Amended FDA Package, Among Other Health Bills
On Tuesday, the Senate Health, Education, Labor and Pensions Committee (HELP) marked up five health bills, including the bipartisan FDASLA Act ( S. 4348), which Chairwoman Patty Murray (D-WA) called the most important, comprehensive Food and Drug Administration (FDA) legislation to come out of the Committee in many years. The amended FDA package includes measures on diagnostic test modernization, reform in the areas of cosmetics and dietary supplements, appropriate avenues for drug importation, and steps to combat the nation’s current infant formula shortage. The Committee voted 13-9 to approve the legislation. The Committee also advanced the MOBILE Health Care Act ( S. 958), the RISE & SHINE Act ( S. 4353), the Cardiovascular Advances in Research and Opportunities Legacy Act ( H.R. 1193), and the Early Hearing Detection and Intervention Act of 2022 ( S. 4052). The legislation will now head to the full Senate for consideration. As a reminder, the House passed its FDA user fee legislation ( H.R. 7667) on June 8. Mehlman Castagnetti’s full summary of the Senate HELP markup can be found here.
Senate Finance Committee Leaders Unveil Discussion Draft of Youth Mental Health Bill
On Wednesday, Senate Finance Committee leaders, Chair Ron Wyden (D-OR) and Ranking Member Mike Crapo (R-ID), released a youth mental health discussion draft, which includes policies to allow all providers to receive Medicaid reimbursement for behavioral and physical health services delivered on the same day, support mental health care in schools by updating Medicaid guidance, improve oversight of Medicaid’s Early and Periodic Screening, Diagnostic and Treatment (EPSDT) benefit, streamline enrollment for out-of-state providers in another state’s Medicaid program, and direct Medicaid to guide states on how mental health care can be covered by Medicaid for foster youth with “intensive” mental health needs. Wyden said that he is “proud” of the bipartisan policies, and he looks forward to continuing work on the legislation in the coming weeks and months. The press release can be found here.
SCOTUS Rules in Favor of Hospitals in Medicare Drug Reimbursement Dispute
On Wednesday, the Supreme Court of the United States (SCOTUS) unanimously ruled that HHS's 2018 and 2019 reduced drug reimbursement rates for 340B hospitals were unlawful. The justices ruled the reduced reimbursement rates unlawful because HHS did not survey hospital costs before adjusting payments for 340B, which cut payments to hospitals in the program by approximately 30%. The opinion, which was authored by Justice Brett Kavanaugh stated, “Absent a survey of hospitals' acquisition costs, HHS may not vary the reimbursement rates only for 340B hospitals; HHS's 2018 and 2019 reimbursement rates for 340B hospitals were therefore unlawful.” The ruling may open the door for 340B hospitals to recoup billions of dollars in drug subsidies.
HHS Issues Guidance on HIPAA and Audio-Only Telehealth
The Department of Health and Human Services (HHS) issued new guidance for how audio-only telehealth care can be provided in compliance with the Health Insurance Portability and Accountability Act (HIPAA). HHS said that the guidance “will help individuals to continue to benefit from audio-only telehealth by clarifying how covered entities can provide these services in compliance with the HIPAA Rules and by improving public confidence that covered entities are protecting the privacy and security of their health information.” The guidance can be found here.
Senate Gun Legislation Package is Expected to Include Behavioral Health Provisions, as Negotiations are Ongoing
The Senate is continuing to negotiate on a gun legislation package and hopes to pass it before the July 4 recess, however negotiations hit a snag this week. On Thursday evening, Senators Chris Murphy (D-CT), John Cornyn (R-TX), Kyrsten Sinema (D-AZ), and Thom Tillis, (R-NC) met to try to finalize an agreement but could not come to a consensus on how to close the “boyfriend loophole.” While federal law prohibits firearm purchases for those convicted of domestic violence against someone they have been married to, lived with, or had a child with, it leaves out other partners. Senate Republicans are looking to ensure that relationships that are long over are not impacted by closing the loophole, but Democrats want the language to be more comprehensive. After Thursday’s session, Senator John Cornyn told reporters he was “through talking.” However, it is expected that negotiations will continue.
Earlier in the week, a bipartisan group of Senators announced that they had come to an agreement on a slew of proposals, including support for State Crisis Intervention Orders, investments in mental health and telehealth services, funding for school safety resources, and more stringent requirements for who can qualify as a Federally Licensed Firearms Dealer. The package would also include funding for enhanced background checks and red flag laws. Senator Debbie Stabenow (D-MI), a lead negotiator of the legislation, said that it will also include approximately $8 billion to make the Certified Community Behavioral Health Clinics model a nationwide program. Senator Chris Murphy (D-CT) warned that tying mental health to gun violence legislation “risk[s] creating the impression that people with mental illness are prone to violence, when the opposite is true,” however he said that “we shouldn’t forsake the opportunity to put billions of dollars into new mental health services.”
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SENATE HEARINGS AND EXECUTIVE SESSIONS
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HOUSE HEARINGS AND EXECUTIVE SESSIONS
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House Committee on Veterans' Affairs - Hearing
Subcommittee on Health Hearing: H.R. 291, the COST SAVINGS Enhancement Act; H.R. 345, the Reproductive Health Information for Veterans Act; H.R. 1216, the Modernizing Veterans' Health Care Eligibility Act; H.R. 1957, the Veterans Infertility Treatment Act of 2021; H.R. 6273, the VA Zero Suicide Demonstration Project Act of 2021; H.R. 7589, the REMOVE Copays Act
Wednesday, June 22 at 10:00 AM ET
House Select Subcommittee on the Coronavirus Crisis - Hearing
Select Subcommittee on the Coronavirus Crisis Hearing: "A Hearing with Trump White House Coronavirus Response Coordinator Dr. Deborah Birx"
Thursday, June 23 at 10:00 AM ET
House Committee on Appropriations - Markup
Subcommittee on Labor, Health and Human Services, Education, and Related Agencies Markup: FY 2023 Labor, Health and Human Services, Education, and Related Agencies Bill
Thursday, June 23 at 5:30 PM ET
House Select Committee on the Climate Crisis - Hearing
House Select Committee on the Climate Crisis Hearing: Cutting Methane Pollution: Safeguarding Health, Creating Jobs, and Protecting our Climate
Friday, June 24 at 9:00 AM ET
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ADMINISTRATION ANNOUNCEMENTS
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Centers for Medicare & Medicaid Services
Food and Drug Administration
Guidance Documents from the Centers for Disease Control and Prevention
National Institutes of Health
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