Insights^

White House Announces New Biodefense Plan

On Tuesday, President Joe Biden unveiled a new National Defense Strategy that incorporates lessons learned from the COVID-19 pandemic to help prepare for future public health emergencies.  The strategy takes a whole-of-government approach to preventing pandemics, enhancing the response to pandemics, and improving laboratory safety. It also outlines several goals, including developing vaccines within 100 days and manufacturing enough doses for the US population within 130 days.  The administration’s ability to achieve its goals will require Congress to provide billions of dollars in funding, which may prove unlikely in the near term given Congress’s unwillingness to provide additional COVID-19 and monkeypox funding despite the administration’s call for more resources.

FDA, CDC Approve Novavax COVID-19 Booster

Earlier this week, both the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) signed-off on Novavax’s COVID-19 booster for US adults aged 18 years or older who are at least six months past a primary COVID-19 vaccine series.  According to the FDA, individuals who received their initial two-dose regimen from Pfizer, Moderna, and Novavax are all eligible for the Novavax booster. Novavax’s vaccine is the only COVID-19 vaccine option available in the US that relies on traditional protein-based vaccine technology, which may help people get booster who cannot or prefer not to receive mRNA boosters (Pfizer and Moderna). Novavax is also developing its own bivalent booster that targets both the original interaction of COVID-19 and key Omicron subvariants (Pfizer and Moderna also market bivalent boosters).

CDC Panel OKs COVID-19 Vaccine for Childhood Vaccine Schedule

The CDC Advisory Committee on Immunization Practices (ACIP) voted unanimously on Wednesday to add the COVID-19 vaccine to the recommended vaccine schedule for children.  The ACIP’s decision does not mandate the vaccine; instead, the decision serves as a guideline for states to incorporate into their own vaccination requirements. The decision notably adds the COVID-19 vaccine to the Vaccines for Children Program, which provides free vaccines to kids under age 19 whose families cannot afford them. A CDC official announced the agency will start awarding contracts to health care providers to give the free vaccine doses to eligible children.

FDA, DOJ Seek Court Injunctions on E-Cigarette Makers

On Tuesday, the Department of Justice (DOJ) and the FDA filed permanent injunctions in federal courts against six electronic cigarette manufacturers, marking the first time the FDA used injunction proceedings to enforce premarket requirements for new tobacco products. The FDA said in a press release that it filed the court injunctions because the six companies ignored several warning letters from the FDA for failing to submit the necessary premarket applications for their tobacco product. Since January 2021, the FDA has sent out nearly 300 warning letters to companies that failed to submit premarket applications, and most companies that received letters complied and removed their products from the market.

Deadline for Decision on New Smithsonian Museums Nears

The Smithsonian Board of Regents will meet on October 24 to consider the locations for the future Smithsonian American Women’s History Museum and the National Museum of the American Latino. Outgoing Rep. Carolyn Maloney (D-NY), who sits on the advisory board for the women’s museum is advocating for a location on the South Monument site directly across from the National Museum of African American History and Culture. Meanwhile, Rep. Tony Cárdenas (D-CA), who sits on the Board of Trustees for the Latino history museum, is pushing for a location across the street from the Holocaust Memorial Museum that is currently home to a rugby field. The Board of Regents is required to make a final decision by the end of December.

ICYMI: RIP Rusty the Red Panda

Rusty, a red panda who made national news in 2013 when he escaped from the National Zoo, died Tuesday at the Pueblo Museum in Colorado.  Rusty’s escaped from the zoo nine years ago due to heavy rains causing his tree branches to lower enough to enable his getaway. He was found in DC’s Adams Morgan neighborhood, and shortly after his return to the National Zoo, was sent to the Smithsonian Conservation Biology Institute in Virginia where he fathered three cubs. While red pandas have similar markings to giant pandas, the species is more closely related to racoons.

Gallup: Most Americans Have a Negative View of US Health Care

About 44% of Americans give the US health care system a “D” or “F” grade, according to a new Gallup poll.  The poll also found that over 75% assign a failing grade to health care costs in the US.  Public opinion on health care quality in the US trended positive, with nearly half giving an “A” or “B” grade.  Responses differed by gender and race/ethnicity, with women more likely to assign failing grades to health care quality, access, and equity.  Additionally, people of color were more likely to have negative views on health care equity.  Gallup conducted the survey in June with over 5,500 US adults participating, to conduct research for its annual report that explores the impact of high health care costs.

CDC: Most with Long COVID Face Problems Daily

About 80% of US adults with long COVID are having trouble carrying out “day-to-day activities,” according to new data from the Centers of Disease Control and Prevention (CDC).  The data also found that 25% of adults with long COVID reported “significant limitations” in day-to-day activity, which increased to 40% among Black, Latino or disabled respondents.  Additionally, while young Americans are among the least likely to experience hospitalization or death from COVID-19, the survey found people between ages 18 and 29 with long COVID were most likely to have trouble performing daily tasks. The CDC has been sending out surveys regularly on COVID-19 since April 2020, but a September 2022 survey, which was sent to over 50,000 households, was the first to ask how long-COVID has impacted people’s daily lives.

CMS Seeks Feedback on Establishing a National Provider Directory

The Centers for Medicare and Medicaid Services (CMS) is seeking public input on establishing the first national directory of health care providers and services, according to a Request for Information (RFI) published on Wednesday.  According to the RFI, the directory would be enabled by an application programming interface (API) and serve as a central data hub for digital contact information on providers and services nationwide.  While provider directories already exist, these directories are generally maintained by health care providers and don’t always provide accurate information for patients.  CMS noted in its announcement that creating a national directory could reduce administrative burden and produce savings throughout the health care system. The RFI’s public comment period closes on December 6.

FDA Warns Evusheld Not Effective against New Omicron Subvariant

On Monday, the Food and Drug Administration (FDA) announced that AstraZeneca’s COVID-19 pre-exposure drug Evusheld is ineffective against Omicron subvariant BA.4.6, one of the latest Omicron subvariants to emerge.  While BA.4.6 only makes up about 13% of new COVID-19 cases in the US, an AstraZeneca spokesperson noted that the subvariant is “growing slowly,” although it is not expected to become a dominant strain.   News that Evusheld may not offer protection against COVID-19 first emerged in early September when researchers at Columbia University found that the drug failed to generate any antibodies against the virus.  Evusheld is currently the only approved drug for prophylactic use against COVID-19 infection in people who are immunocompromised.

ICYMI: Push for Diversity among Congressional Staff Falls Short

Despite efforts to recruit congressional staffers from more diverse backgrounds over the past few years, a new report from the Joint Center for Political and Economic Studies found that people of color are still underrepresented in the congressional workforce.  According to the report, while people of color account for 40% of the US population, they only account for about 18% of top House staffers. The report also found that of the 308 personal offices of white members, only 23 (7.4%) are led by chiefs of staff of color. Thirteen work for Democratic members, and ten for Republican members. Among the reasons for a lack of representation among top congressional staffers cited in the report include low pay on the Hill and hiring culture that relies on personal networks of other top staffers who are generally white.

Biden to Nominate Renee Wegrzyn as First ARPA-H Director

The White House announced on Monday that President Joe Biden intends to nominate Dr. Renee Wegrzyn to be the inaugural director of the Advanced Research Projects Agency for Health (ARPA-H).  Currently the vice president of business development at biotechnology company Ginkgo Bioworks, Wegrzyn was previously employed with the Defense Advanced Research Projects Agency’s (DARPA) Biological Technologies Office, where she studied synthetic biology and gene editing to support the agency’s efforts to enhance biosecurity and promote public health. However, many other details about the new biomedical research agency remain uncertain, including the location of the agency and how ARPA-H will fit into the organizational structure of the Department of Health and Human Services.

Biden Announces Ambitious Goals to Lower Cancer Deaths

While commemorating the 60^th anniversary of President John F. Kennedy’s moonshot speech, President Biden announced a new moonshot of his own – to erase cancer “as we know it.”  To achieve this goal, Biden signed an executive order (EO) to launch a National Biotechnology and Biomanufacturing Initiative, in order to help ensure that the technology that will help end cancer is manufactured domestically.  According to the president, the EO will spur the creation of new technologies for cancer treatments and make the US less reliant on other countries for the advancement of cancer treatment.  Biden also noted that the EO would help achieve a goal of halving cancer deaths in the next 25 years.

House Passes Bill to Streamline Prior Authorization in MA

On Wednesday, the House unanimously approved H.R.3173, the Improving Seniors’ Timely Access to Care Act of 2021, which streamlines the prior authorization process in Medicare Advantage by establishing an electronic prior authorization process and a process for real-time approvals for routinely approved services. The popular bill attracted 320 cosponsors and won the endorsement of over 500 organizations prior to the vote.  Forty senators have expressed support for the bill, and some have speculated that the bill could be included in a year-end spending package.

Policy Riders Stall Progress on FDA User Fee Reauthorization 

Extra policy riders are dragging out negotiations on legislation to reauthorize the Food and Drug Administration’s (FDA) user fee programs ahead of a September 30 deadline.  Some of the riders still in play pertain to reforms to the FDA’s accelerated approval pathway and efforts to increase diversity in clinical trials.  If lawmakers don’t reach a deal by the end of the month, the FDA would be forced to send furlough notices to thousands of employees, which industry experts warn could damage morale at the agency.

ICYMI: Lawmakers Win Congressional Softball Game

Members of Congress defeated members of the press at Wednesday’s Congressional Softball Game for the first time in five years.  This year’s game also raised a record total of $540,000 for the Young Survival Coalition, which supports breast cancer patients under the age of 40. Retiring Rep. Ed Perlmutter (D-CO), the coach of the lawmakers’ team, said minimizing mistakes and getting hits were the keys to victory.

Updated Boosters Could Be Available in September

The Biden administration is hoping to authorize updated COVID-19 boosters from Pfizer and Moderna shortly after Labor Day, according to news reports.   Earlier this week, both Pfizer and Moderna submitted applications for emergency use authorization (EUA) to the Food and Drug Administration (FDA) for their bivalent vaccines, which target the BA.4 and BA.5 Omicron subvariants as well as the initial COVID-19 strain.  According to social media from FDA Commissioner Robert Califf, the agency’s independent advisory panel will not convene to review the new bivalent vaccines.   If the FDA approves the EUA from either manufacturer by September 1, Center for Disease Control and Prevention (CDC) Directory Rochelle Walensky has said she would be able to sign-off on the updated vaccines after her agency’s advisory committee meets on September 1-2.  According to CDC data, 90% of new COVID-19 cases are from the BA.5 variant.

Fauci Announces December Retirement

Dr. Anthony Fauci, who has served as director of the National Institute of Allergy and Infectious Diseases (NIAID) since 1984, announced that he will retire from government service in December.  Fauci’s retirement will mark the end of a half-century of government service that began in 1968 when he first joined the National Institutes of Health (NIH) at age 27.  Fauci’s tenure at the helm of NIAID saw his involvement in several key outbreaks, epidemics, and pandemics, including AIDS, the 2001 anthrax attacks, H1N1, Ebola, Zika, and the COVID-19 pandemic.  Since January 2021, Fauci has also served as the Biden administration’s Chief Medical Advisor.  It remains unknown who with replace Fauci in either role.

KFF: MA Enrollees Make Up Nearly Half of Medicare Population

More than 28 million people or 48% of the eligible Medicare population are enrolled in a Medicare Advantage (MA) plan, according to a new report from the Kaiser Family Foundation (KFF).  As enrollment in MA plans continues to grow, the report projects that most Medicare beneficiaries will be getting their coverage through MA as soon as 2023.  In 25 states and Puerto Rico, at least 50% of Medicare beneficiaries are already enrolled in MA plans.  Due to the growing presence of these plans, the report emphasizes the importance of analyzing how well MA is working to improve quality and lower costs for enrollees.

Administration Releases Final Surprise Billing Rules

The Departments of Health and Human Services (HHS), the Treasury (TREAS) and Labor (DOL) released a final rule on August 19 implementing the No Surprises Act, which aims to protect patients from out-of-network medical bills when they seek care at in-network facilities.  The rule notably provides new details on independent dispute resolution (IDR) process that provider and insurers can use to settle out-of-network billing disputes after several court rulings forced the administration to modify its initial IDR framework.  According to the rule, arbitrators will no longer be required to give more weight to the qualified payment amount (QPA) over other factors when determining the payment rate.  While stakeholders are continuing to review the rule, many consider the changes to the IDR process to be slightly more favorable to providers.

ICYMI: Celebrate Ukraine’s Independence Day Tomorrow in DC

If you weren’t able to make the trip to Kyiv to celebrate Ukraine’s Independence Day yesterday, fear not!  Tomorrow afternoon, a 31^st Independence Day celebration will convene in front of the White House in Lafayette Square.  The Ukrainian Embassy-organized event will feature a rally, a musical program, parade, and a commemoration of victims of the ongoing Russo-Ukrainian War.

CDC Updates COVID-19 Guidelines

People no longer need to stay at least six feet away from other people to reduce the risk of exposure to COVID-19, according to new guidelines from the Centers for Disease Control and Prevention (CDC). The revised guidelines represent a shift away from limiting the spread of the virus through more restrictive means like social distancing and quarantines and instead focuses on reducing severe disease from COVID-19. Additional changes in the guidelines include a lifting of the requirement to quarantine if exposed to the virus and elimination of the test-to-stay recommendation for schools after a potential exposure. However, some measures in the updated guidelines remain unchanged, including a recommendation for people to wear masks indoors in counties with high levels of transmission.

FDA Issues EUA to Increase Supply of Monkeypox Vaccine

The Food and Drug Administration (FDA) issued an emergency use authorization (EUA) on Tuesday to expand the supply of the Jynneos monkeypox vaccine amid high demand. According to the EUA, the vaccine can now be administered to high-risk adults intradermally, or between the layers of the skin, as opposed to subcutaneously, or under the skin. This new strategy will allow health care providers to use an existing one-dose vial of the vaccine to administer a total of up to five separate doses, which the administration estimates will increases the number of doses available in the National Strategic Stockpile from 441,000 to over 2.2 million. However, the administration has warned that expanded access to vaccines will not be a panacea for the monkeypox outbreak, as demand for vaccines is likely to continue to exceed supply.

House Poised to Vote on Inflation Reduction Act Today

The House Rules Committees approved the Inflation Reduction Act on Wednesday, clearing the way for a floor vote on the Democrats’ long-awaited reconciliation package on Friday. The House is expected to take up the measure at 9:00 AM EDT on Friday, with three hours of debate equally divided among the leaders of the Energy and Commerce, Ways and Means, and Budget Committees. Major health care provisions of the bill would allow Medicare to negotiate with pharmaceutical manufacturers on prescription drug prices and extend enhanced Affordable Care Act (ACA) premium subsidies through 2025. .

Lawsuit Threatens ACA’s Preventative Care Coverage Requirements

The ACA’s preventive care requirements that cover everything from birth control to cancer screening could be in jeopardy thanks to a lawsuit in Texas. According to the plaintiffs in Kelley v. Becerra, the ACA’s requirements for health plans to cover preventative care like birth control and HIV medications violate the Religious Freedom Restoration Act, which states the federal government should not “substantially burden” the practice of religion without sufficient justification. Judge Reed O’Connor of the US District Court, Northern District Texas heard the case in July and is expected to make a decision within the next few weeks. Notably, O’Connor is the same judge who ruled the ACA to be unconstitutional in 2018.

ICYMI: Batman-Superfan Sen. Leahy Returns to the Hill

Sen. Patrick Leahy (D-VT) returned to the Hill last Sunday for the first time since fracturing his hip in a fall in late June. Leahy, who is recovering from two surgeries, arrived at the Capitol for the Senate’s “vote-a-rama” session on the Inflation Reduction Act in a black wheelchair featuring a Batman logo. Leahy is a longtime Batman fan as he has appeared in five Batman films and wrote a foreword to a Batman comic book in 1992. The 82-year-old senator is set to retire at the end of his term in January 2023.