June 21, 2021
This Week in Health Policy for June 18
This Week (June 21 - 25)
The Senate Health, Education, Labor and Pensions Committee holds a hearing on "Vaccines: America's Shot at Ending the COVID-19 Pandemic."
The Senate Finance Committee holds a hearing on the nomination of Melanie Anne Egorin to be assistant HHS secretary for legislation.
The House Energy and Commerce Health Subcommittee holds a hearing on "Empowered by Data: Legislation to Advance Equity and Public Health."
Last Week (June 14 - 18)
Health Care Highlights
ACA survives Supreme Court challenge. On Thursday (June 17), the Supreme Court ruled 7-2 to reject a challenge to the Affordable Care Act (ACA), holding that the plaintiffs had not suffered the sort of direct injury that gave them standing to sue. Justice Thomas filed a concurring opinion and Justices Samuel Alito and Neil Gorsuch dissented. The case, California v. Texas, was brought by Republican attorneys general who said the mandate requiring health insurance coverage became unconstitutional after Congress eliminated the penalty for failing to obtain coverage in the 2017 Tax Cuts and Jobs Act, arguing that the mandate could no longer be justified as a tax. The argument was based on the court's 2012 ruling finding that the mandate was constitutional due to Congress's power to assess taxes. The challenge was largely successful in the lower courts, with a federal judge in Texas ruling in late 2018 that the entire law was invalid, and the United States Court of Appeals for the Fifth Circuit agreeing in 2019 that the mandate was unconstitutional but declining to rule on its severability from the rest of the law. Centers for Medicare & Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure said in response to the ruling that "millions of Americans can breathe a sigh of relief … this victory assures access to affordable and comprehensive health insurance for patients and families across the country."
HHS announces impact of enhanced premium credits. On Monday (June 14), the Department of Health and Human Services (HHS) announced that more than 1 million new and returning consumers have health coverage through the Health Insurance Marketplace that costs $10 or less per month after advance payments of premium tax credits (APTC) following the April 1 implementation of the American Rescue Plan's (ARP) expanded APTC. Of the 1,034,624 consumers who selected a Marketplace plan with premiums of $10 or less per month, after APTC, 687,275 were returning consumers and 347,349 were new consumers. Over 1.2 million Americans signed up for health insurance since February 15 through HealthCare.gov as a result of the Biden-Harris Administration's Special Enrollment Period (SEP) for the COVID-19 Public Health Emergency. HHS Secretary Xavier Becerra said in response to the announcement: "Thanks to the Biden-Harris administration's Special Enrollment Period and expanded premium tax credits from the American Rescue Plan, each week we continue to see more Americans experience the relief and security that comes with affordable, quality health coverage."
Becerra says more time is needed on FDA pick. HHS Secretary Xavier Becerra said this week that President Biden needs more time to consider who is best to lead the FDA. "This is one of those positions where obviously the president is very interested because FDA is just not another agency, it's a critical agency. They've done some tremendous things during COVID. So I think what you're going to do is find that as soon as the president has a chance to think a little bit closer, we'll be able to work with him to see if we can get a nominee," Becerra said in an interview with Bloomberg Law. He added that "FDA is an important position and it should not be taken lightly, and it won't go to just anybody. And I think you're gonna find that whoever gets to step in as the full-time is gonna be credentialed and ready to lead."
U.S. pledges global vaccine help, purchases more vaccines. Following the completion of the Group of Seven (G-7) summit, President Joe Biden said the U.S. might be able to provide 1 billion more doses of coronavirus vaccine to the world by 2023, following a promise during the meeting to send 500 million doses to poorer countries by the end of next year. German Chancellor Angela Merkel said the G-7 would collectively distribute 2.3 billion vaccine doses to developing countries by next year, but that figure includes a much wider array of contributions already offered, as well future exports. Also this week, the U.S. government agreed to pay $3.3 billion for 200 million additional doses of Moderna's COVID-19 vaccine, exercising its remaining options to purchase the shots in a deal that includes the potential to buy other vaccines in testing. The federal government has now ordered a total of 500 million Moderna vaccines, 217 million of which had already been delivered as of June 14. The FDA also released 10 million doses of vaccine produced by Emergent BioSolutions this week, following a months-long delay due to problems at a manufacturing facility in Baltimore, but millions more may end up being thrown away.
WTO members agree to weekly meetings to negotiate IP waiver. During an informal meeting of the Council for Trade-Related Aspects of Intellectual Property (TRIPS) on Thursday, World Trade Organization (WTO) members agreed to weekly negotiating sessions on an approach to waiving some intellectual property (IP) obligations in response to the COVID-19 pandemic, beginning on June 24. A revised waiver proposal covers COVID-19 vaccines, diagnostics and therapeutics, but the U.S. has indicated it wants the waiver to focus solely on vaccines. The debate over the waiver has largely been split between developing countries in support and developed countries opposed, however the dynamic changed last month when U.S Trade Representative Katherine Tai announced U.S. support for a waiver. The June 24 meeting will be a discussion of an alternative proposal from the European Union (EU), which aims to make it simpler for countries to use existing compulsory licensing provisions. The TRIPS chair, Norwegian Ambassador Dagfinn Sørli, plans to present a progress report to the WTO General Council during its July 27-28 meeting.
HHS, OSHA picks teed up for Senate votes. This week, the Senate Health, Education, Labor and Pensions (HELP) Committee advanced two of President Joe Biden's high-level health nominees, as well as the lead for the Occupational Safety and Health Administration (OSHA) this week, teeing them up for full Senate consideration. The committee voted 20-2 in favor of Dawn O'Connell, who would be assistant secretary for preparedness and response, 20-2 for Miriam Delphin-Rittmon, who would lead the Substance Abuse and Mental Health Services Administration, and 13-9 for Doug Parker to lead the Occupational Safety and Health Administration. It wasn't immediately clear when Senate Majority Leader Chuck Schumer (D-NY) may schedule votes to limit floor debate on the nominees, the next procedural step before a confirmation vote.
Hearings and Mark-ups
Senate Finance Committee Hearing on Mental Health. On Tuesday (June 15) the Senate Finance Committee held a hearing entitled, "Mental Health Care in America: Addressing Root Causes and Identifying Policy Solutions." Throughout the hearing, there was bipartisan agreement on the need for committee action to address the mental health care crisis in this country, with members and panelists highlighting a slew of issues including inadequate access, coverage, and payment; workforce shortages and inadequate training; lack of appropriate care integration and case management functions; siloed care delivery and funding streams, and more. Chairman Ron Wyden (D-OR) said at the close of the hearing that he and Ranking Member Mike Crapo (R-ID) "think this is an issue that the committee can come together on" and that they would be doing more in coming days. Among other items, there was bipartisan support for increasing funding for states to create Certified Community Behavioral Health Clinics (CCBHCs), extending telehealth flexibilities beyond the pandemic period and removing additional barriers such as in-person requirements for tele-mental health, and incentivizing states to improve care coordination and case management, particularly for dual-eligible individuals and children.
House Energy and Commerce Hearing on Vaccines. On Tuesday (June 15) the House Energy and Commerce Committee held a hearing entitled, "Booster Shot: Enhancing Public Health through Vaccine Legislation," focusing on expanding vaccine access for seniors and low-income children. Three of the bills discussed during the hearing would expand vaccine access generally for seniors (H.R. 1978), low-income adults (H.R. 2170), and children (H.R. 2347) by reducing cost-sharing and expanding who is eligible for vaccine coverage through federal or state funded health programs. Although many of the bills discussed were bipartisan, Health Subcommittee ranking member Brett Guthrie (R-KY) expressed concerns that "a number of these bills are duplicative of current efforts already underway to address the Covid-19 pandemic," including bills requiring HHS to offer weekly reports on vaccine allocation and funding transportation to vaccine sites. Witnesses discussed the critical importance of vaccinations, the need to close racial and ethnicity disparities in vaccine administration, and the need to boost public health infrastructure, among other things.
Reports, Studies, and Journals
Kaiser Family Foundation: Disparities in Reaching COVID-19 Vaccination Benchmarks: Projected Vaccination Rates by Race/Ethnicity as of July 4. At the current pace of vaccination, 65% of those ages 12 and older would be at least partially vaccinated by July 4, but rates would be lower for Hispanic, and especially Black, people.
JAMA: Early Hospital Compliance With Federal Requirements for Price Transparency. Researchers analyzed a random sample of 100 hospitals and the 100 hospitals with highest gross revenue in 2017. Of the 100 randomly sampled hospitals, 83% were noncompliant with at least 1 major requirement and of the 100 hospitals with highest gross revenue, 75% were noncompliant with at least one requirement.
JAMA: Association of California's Prescription Drug Coupon Ban With Generic Drug Use. A 2017 California law banning use of co-payment coupons for brand-name drugs with direct generic competitors was associated with no significant increase in generic substitution in its first year.
CDC: Emergency Department Visits for Suspected Suicide Attempts Among Persons Aged 12-25 Years Before and During the COVID-19 Pandemic — United States, January 2019-May 2021. Emergency-room visits for suspected suicide attempts by teenagers, particularly girls, rose sharply during coronavirus lockdowns, according to new data. The study found that suspected suicide attempts in the 12-17 age group in winter of 2020—2021 by teenaged girls surged to 51% higher than the same period of 2019.