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This Week (May 24 - 28)

House Energy and Commerce Committee Hearing on “A Shot at Normalcy: Building COVID-19 Vaccine Confidence.”

• Detail: Wednesday, May 26, 2021, 11:00am ET
• More information available here.

Senate HELP Committee Executive Session: S. 1675, Maternal Health Quality Improvement Act; S. 1491; S.1662; S. 1301; S. 610; and S. 1658

• Detail: Tuesday, May 25, 2021. 10:00am ET
• More information available here.

Last Week (May 17 - 21)

Health Care Highlights

Biden’s budget expected to omit health care priorities. President Biden’s fiscal 2022 Budget, which is expected to be released on May 28, will not include key health care campaign pledges such as enacting a public option or action to reduce the cost of prescription drugs, according to White House officials. Rob Friedlander, spokesman for the White House budget office, said that "the President's budget will focus on advancing the historic legislative agenda he's already put forward for this year… the budget won't propose other new initiatives but will put together the full picture of how these proposals would advance economic growth and shared prosperity while also putting our country on a sound fiscal course." President Biden has called for Congress to address rising drug costs in part through enabling Medicare to negotiate the price of prescription drugs and to strengthen Medicare, Medicaid, and the Affordable Care Act (ACA), however the budget is not expected to include specific policies to advance these measures.

Drug pricing news:

• House passes orphan drug bill. On Wednesday (May 19), the House passed, by a vote of 402 to 23, a bipartisan bill, The Fairness in Orphan Drug Exclusivity Act (H.R. 1629), aimed at closing a loophole in the Orphan Drug Act, which advocates say let drugmakers inappropriately create monopolies. The bill would amend the cost recovery prong pathway under the Orphan Drug Act to require drug makers seeking orphan drug designations to demonstrate they don’t expect to recoup development costs.
• House Chairmen ask for FTC AbbVie inquiry. In other drug pricing news, House Oversight & Reform Chair Carolyn Maloney (D-NY) and Judiciary Chair Jerrold Nadler (D-NY) asked the Federal Trade Commission Tuesday (May 18) to investigate whether AbbVie broke antitrust laws by fending off biosimilar competition with its patent strategy. During a House Oversight and Reform Committee hearing this week, the committee unveiled a new report finding that AbbVie targeted the U.S. for higher drug prices as it was forced to cut costs in the rest of the world and engaged in anticompetitive practices such as patent settlements to delay biosimilar competition for its blockbuster drug Humira.
• HHS sends 340B enforcement letters to drugmakers. On Monday (May 17), the Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) sent letters to six drugmakers, warning them that they could face fines of up to $5,000 per overcharge if they don't start abiding by 340B statutory obligations, which includes discounting drug prices for pharmacies that contract with 340B providers, and refund all covered entities for past overcharges.

SAMHSA to distribute $3 billion for mental health and SUD. On Tuesday (May 19), the Biden administration announced the Substance Abuse and Mental Health Services Administration (SAMHSA) will distribute $3 billion from the American Rescue Plan to support mental health and substance abuse services, with $1.5 billion each going to states and territories for the Community Mental Health Services Block Grant (MHBG) and Substance Abuse Treatment Block Grant (SATBG) Programs.  HHS notes the funding is on top of the $2.5 billion announced in March, and says the disbursement is being expedited to quickly assist communities grappling with mental health and substance abuse needs during the pandemic. Health and Human Services (HHS) Secretary Xavier Becerra also announced the creation of a new Behavioral Health Coordinating Council (BHCC) comprised of top department officials to integrate and prioritize behavioral health priorities across departments.

Texas files lawsuit over Medicaid waiver rescinding. Texas has filed a lawsuit over the Biden administration's decision to rescind a Medicaid 1115 waiver extension approved by the Trump Administration a few days before President Joe Biden was inaugurated, with the state calling it an unconstitutional effort to compel Texas to expand Medicaid under the Affordable Care Act (ACA). Federal health officials have told Texas the waiver approval process was flawed due to an insufficient public comment period, and that an extension could still be renegotiated given the current waiver expires in September 2022.

Supreme court agrees to hear abortion case. The U.S.Supreme Court agreed this week to hear Mississippi’s appeal of their law that would ban abortion after 15 weeks of pregnancy in almost all cases. If Mississippi wins, the ruling would allow states to put more restrictions on the procedure than any time since the 1973 decision in Roe v. Wade, which legalized abortion nationwide. The high court will consider the case in its next term, which begins in October.

COVID-19 news:

• Global vaccine effort. The Biden administration announced this week that the U.S. would ship 20 million doses of U.S. authorized COVID-19 vaccines overseas in June as part of what he called an “entirely new effort” to shore up global vaccine supply. The Administration has already pledged to share 60 million doses of AstraZeneca’s vaccine, which has not yet been approved in the U.S. The global vaccine alliance Gavi also said this week it will purchase 200 million doses of Johnson & Johnson's COVID-19 vaccine, with the goal of making the shots available this year to both poor countries struggling to vaccinate their populations and wealthier nations that joined COVAX, the global COVID-19 vaccine initiative.
• Pushback on IP waiver. More than a dozen Republican senators are pushing the Biden administration to rescind its “disastrous decision” to support an effort to get the World Trade Organization to waive intellectual property protections for COVID-19 vaccines, saying in a letter that the proposal “would undermine the extraordinary global response that has achieved historically remarkable results in record time and our nation’s global leadership in the technologies, medicines, and treatments of the future.” The Republican senators wrote to Gina Raimondo, the Department of Commerce Secretary, and Katherine Tai, the U.S. Trade Representative.
• Requests for Biden mask guidance clarification. Rep. Bobby Scott (D-VA), chairman of the House Education and Labor Committee, said in a statement on Tuesday (May 18), that the Biden administration should clarify how the new guidance on masks apply in the workplace. Scott said the government’s embrace of an “honor system” for mask wearing and inaction on an emergency temporary standard from the Occupational Safety and Health Administration have failed workers. The nation’s largest nurse’s union, National Nurses United, also came out this week against the mask easing, warning of new variants and the danger to the unvaccinated.
• House approves DPA bills. The House passed two bills this week (H.R. 3146 and H.R. 3125) to clarify the president’s authority to use the Defense Production Act (DPA) to bolster the supply chain for critical medical supplies and designate COVID-19 tests, personal protective equipment, and drugs could be designated as scarce and critical materials.

Hearings

Senate Finance Committee Hearing on COVID-19 Health Care Flexibilities. On Wednesday (May 19), the Senate Finance Committee held a hearing entitled, “COVID-19 Health Care Flexibilities: Perspectives, Experiences, and Lessons Learned.” Among the telehealth issues discussed, the committee focused on the “digital divide” and the need to build up infrastructure for rural areas that lack access to broadband, while also questioning the panel on the need for audio-only telehealth for underserved populations and the concern over creating a “two-tiered system.” Several panelists noted their support for audio-only services not only for underserved communities but also as a stop-gap when technologies fail, as a choice for consumers, and as an additional “tool in the toolbox” as part of the care continuum. The panel also noted the importance of permanently waiving geographic restrictions to ensure access in rural communities, expand the ability to remotely prescribe buprenorphine and manage substance use disorder via telehealth, and the need to explore alternative payment models after the initial steps taken by the committee on the issue. The committee and panelists also expressed support for expansions of Hospital at Home waivers, revisiting the Skilled Nursing Facility 3-Day Rule, easier access to audiologists in the Medicare programs without a referral, and first dollar coverage of virtual care for beneficiaries with high-deductible health plans (HDHPs).

• Hearing information

Senate HELP Subcommittee Hearing on the Health Care Workforce Shortage. On Thursday (May 20), the Senate Committee Health, Education, Labor and Pensions (HELP) Subcommittee on Primary Health and Retirement Security held a hearing entitled, “A Dire Shortage and Getting Worse: Solving the Crisis in the Health Care Workforce.” Throughout the hearing, the panel expressed their support for legislation that would increase GME slots and funding for training programs, such as through the Health Resources and Services Administration (HRSA), for loan repayment, faculty support, diversity and equity initiatives, and programs focused on vulnerable and underserved communities. There was consensus that more investment is needed in areas such as primary care and mental health and addiction medicine in particular, and that there are fundamental flaws in payment that incentivize things like high-cost procedures and less on people-focused specialties like primary care, which can improve health and reduce costs in the long-term. Subcommittee Chairman Bernie Sanders (I-VT) also announced he is introducing legislation, the Addressing the Shortage of Doctors Act, which would authorize 14,000 new Medicare-supported medical residency positions over seven years, 50% of which would have to go towards primary care. Other subcommittee members also took the chance to discuss their legislation to address the workforce shortage, including Ranking Member Susan Collins (R-ME), whose Opioid Workforce Act would create 1,000 new medical residency positions focus on addiction medicine.

Senate Committee on Homeland Security & Governmental Affairs hearing on COVID-19. On Wednesday (May 19), the Senate Committee on Homeland Security & Governmental Affairs held a hearing entitled, “COVID-19 Part II: Evaluating the Medical Supply Chain and Pandemic Response Gaps.” Bipartisan committee members including Committee Chairman Gary Peters (D-MI) discussed how overreliance on foreign sources for critical drugs and supplies, such as masks, gowns, gloves and other personal protective equipment, created a national security risk and cost lives, pressing for details on additional steps lawmakers can take to strengthen supply chain security and bolster domestic manufacturing of critical medical supplies to create jobs and ensure our nation is prepared for future crises. Ranking Member Rob Portman (R-OH) and others also highlighted the importance of diversifying supply chains away from China, and reshoring manufacturing to the United States. Witnesses said that the past year has exposed how the nation didn’t have enough reserves to meet demand for necessary supplies and that rebuilding the stockpile and major reform in how its run is necessary.

Reports, Studies, and Journals

National Bureau of Economic Research: Statewide Reopening During Mass Vaccination: Evidence on Mobility, Public Health and Economic Activity from Texas. In the midst of this mass vaccination effort, Texas became the first state to abolish its statewide mask mandate and fully lift capacity constraints for all businesses. Researchers found no evidence that the Texas reopening led to substantial changes in social mobility, including foot traffic at a wide set of business establishments in Texas, or affected the rate of new COVID-19 cases during the five weeks following the reopening.

Centers for Disease Control and Prevention. Disparities in COVID-19 Vaccination Coverage Between Urban and Rural Counties - United States, December 14, 2020-April 10, 2021. COVID-19 vaccination coverage was lower in rural counties (38.9%) than in urban counties (45.7%); disparities persisted among age groups and by sex.

The Commonwealth Fund. The Economic and Employment Effects of Medicaid Expansion Under the American Rescue Plan. Expanding Medicaid would increase federal revenue to the 14 states by $49 billion in 2022; state matching costs would be $5 billion. Collectively, the 14 states would expand their economies by $350 billion from 2022 to 2025.

Government Accountability Office: COVID-19 in Nursing Homes: Most Homes Had Multiple Outbreaks and Weeks of Sustained Transmission from May 2020 through January 2021. From May 2020 to January 2021, nursing homes in the review had an average of about three outbreaks, with 84 percent having an outbreak that lasted five weeks or longer.

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