What Happened, What You Missed: October 31-November 4 

CMS Finalizes Physician Fee Cuts for 2023 

Doctors face a nearly 4.5% payment cut from Medicare under the 2023 Physician Fee Schedule, which was finalized on Tuesday.  The final rule prompted strong criticism from provider organizations like the American Medical Association (AMA), who said the cuts “threaten patient access” to physicians who participate in Medicare.  The final rule will put pressure on Congress to enact legislation to counter the cuts in the coming months.  In addition to the payment cuts, the final rule will expand access to behavioral health care by allowing therapists to offer services under general supervision of a Medicare practitioner.  The rule will also allow Medicare to pay for opioid treatment programs that use telehealth to initiate medication-assisted treatment (MAT). 

Warner Lays Out Policy Options to Improve Health Care Cybersecurity 

Cyberattacks on the health sector affected 45 million Americans in 2021, according to a new report from Sen. Mark Warner (D-VA), who co-founded the Senate Cybersecurity Caucus.  To address the growing vulnerability of the health care sector, Warner offered several policy proposals, such as setting minimum security standards for health care providers, adding Medicare reimbursements for cybersecurity expenses, and creating a national stockpile with common equipment needed by hospitals facing cyberattacks.  The report is intended to solicit feedback from health care stakeholders on the proposed policy options.   

HHS Renews PHE for Monkeypox Outbreak 

Although new monkeypox case numbers continue to drop nationwide, Health and Human Services (HHS) Secretary Xavier Becerra renewed the monkeypox public health emergency (PHE) on Wednesday, which was initially declared on August 4th,  to ensure the continuation of vaccine effectiveness studies and to maintain data-sharing with states and jurisdictions.  Monkeypox case numbers peaked in early August and have since declined to about 30 new cases per day.  Over 28,000 monkeypox cases and six related deaths have been confirmed in the US since the outbreak began in the summer.  Public health experts say the drop in cases can be attributed to changes in behavior, particularly among men who have sex with men, a demographic that has been disproportionately affected by the outbreak. 

BPC Offers Ways to Make Employer-Sponsored Insurance More Affordable 

High unit prices for individual health care services and products are contributing to the rising cost of employer-sponsored health insurance, according to a report released this week from the Bipartisan Policy Center.  To ensure the viability of employer-sponsored insurance, which is the largest source of health care coverage in the US, the report calls on Congress to develop new legislation to spur use of biosimilars and to lower the threshold of what the Affordable Care Act (ACA) deems “affordable” for employer-sponsored plans.  The report also emphasized the need to create a mandatory federal all-payer health care claims database and full electronic access to health plan data for all employees to increase transparency.  

Pfizer’s RSV Vaccine Trial Shows Promise 

Pfizer announced this week that its vaccine candidate for respiratory syncytial virus (RSV) is 80% effective at preventing severe disease in infants.  The announcement comes as the US faces an unusual spike in RSV cases, likely due to delayed immunity to the virus since the start of the COVID-19 pandemic.  Unlike other RSV vaccine candidates, Pfizer’s is administered during pregnancy to allow antibodies to be transferred from mother to infant.  Pfizer said that it plans to submit data to the Food and Drug Administration (FDA) on the vaccine by the end of the year, with the hope of having it available by next winter.  If approved, Pfizer’s vaccine will be the first against RSV and the first new product related to the virus in over 20 years. 

ICYMI: Calls for Ouster of Architect of the Capitol Grow 

A growing chorus of lawmakers are calling on the Architect of the Capitol (AOC) J. Brett Blanton to step down after an AOC Office of the Inspector General (OIG) report found that Blanton had abused his power.  Released on Tuesday, the report found that Blanton had regularly used his official vehicles for personal purposes and even impersonated a police officer.  However, ousting Blanton could be difficult, as the AOC serves a 10-year term, and there is no explicitly described process for removing the AOC.  Then-President Donald Trump appointed Blanton to the post in December 2019. 

What Happened, What You Missed: October 24-28 

New White House Plan Aims to Increase Booster Numbers  

President Joe Biden got his updated bivalent COVID-19 booster shot on Tuesday to underscore the administration’s latest push to get more Americans boosted ahead of what’s expected to be a rise in the  case numbers over the coming weeks.  Since the bivalent boosters became available last month, only 8% of eligible Americans have received a shot so far.  Key components of the new plan include education and outreach to seniors and other high-risk Americans, which includes a media campaign and a #VaxUpAmerica Family Vaccine Tour.  The plan also calls for engagement with employers, pharmacies, and schools to urge members of their respective communities to get boosted.   The Biden administration is also urging Americans to get their annual flu shot alongside their COVID-19 vaccine booster. 

Administration Announces New Penalties for Underperforming Nursing Homes 

Some of the nation’s worst nursing homes will soon see stiffer penalties, according to new enforcement measures laid out by the Biden administration last Friday.  The enforcement actions are part of a broader plan to boost nursing home quality that President Biden first announced in his State of the Union Address earlier this year.  Some of the new steps the administration is taking is increasing penalties for nursing homes that fail to address their violations and increasing safety standards. The administration also announced several actions to help nursing homes improve, such as $93 million in grant funding to support workforce development, education, and training.  Nursing homes have come under increased scrutiny over the past few years as the COVID-19 pandemic has exacerbated workforce shortages and resulted in subpar conditions for residents.   

KFF: Employers May Face Higher Insurance Premiums Next Year 

While premiums in employer-sponsored health plans remained stable in 2022, employers could face higher premiums in 2023, according to an annual employer benefits survey from the Kaiser Family Foundation (KFF).  That’s because insurance plans finalized premiums for 2022 before fall 2021, which precedes the surge in inflation observed this year.  While employers have largely absorbed higher premiums thus far amid a tight labor market, KFF notes that a spike in premiums next year could mean employers may have to reconcile between the difficultly of passing higher premiums on to employees while managing their own inflation-driven financial pressures.  The survey also found that nearly a third of large employers say their insurance networks don’t have sufficient access to behavioral health care providers, despite a growing demand among employees for mental health care services.   

NCI: Cancer Death Rate Continues to Decline 

The number of Americans who died from cancer between 2015 and 2019 declined by 2.1%, according to the latest annual report from the National Cancer Institute (NCI).  The biggest decline in cancer deaths was observed in two cancer types:  melanoma and lung cancer.  The report also found modest improvements in the survival rate for pancreatic cancer, which is notable given its association as one of the most lethal types of cancer.  However, the report found that the incidence of new cancers has remained largely unchanged, and that racial and ethnic minorities are more likely to die from certain types of cancer.  

Hill Staffer Unions Ponder Future in GOP-Controlled House 

Ever since Speaker Nancy Pelosi (D-CA) endorsed unions for congressional staff back in February, six Democratic congressional offices have voted to form unions, while another five offices have filed petitions to hold elections on forming their own unions.  As Republicans are likely to control the House in the next Congress, some are worried that staff unions in the House could be short-lived, given House Republican Leader Kevin McCarthy’s (R-CA) opposition to staff unions.  However, some union experts say Republicans may not bother to disband unions because such a move would require statutory changes (as opposed to a simple resolution), as well as the fact that no GOP offices have yet to unionize.  

ICYMI: Marine Corps Marathon Returns to DC 

After a two-year pandemic hiatus, the Marine Corps Marathon is back in action in Washington, DC this Sunday.  The marathon route starts in Arlington National Cemetery and continue across the Key Bridge into Georgetown and Rock Creek Park before heading over to the National Mall and crossing the river back into Virginia.  Up to 30,000 people are scheduled to attend, making it one of the most popular marathons in the world.   

What Happened, What You Missed: October 17-21

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.  

What Happened, What You Missed: October 10-14 

Administration Finalizes Rule to Fix “Family Glitch”  

On Tuesday, the Biden administration issued a final rule to close the “family glitch,” a loophole that blocked family members from receiving Affordable Care Act (ACA) tax credits if a member of their household had access to another source of minimum essential coverage, including employer-sponsored plans. According to the White House, 1 million Americans will gain coverage or see their insurance become more affordable as the result of the rule.  While stakeholders have been largely supportive over the rule, some questioned whether the administration had the authority to make the changes.  The final rule goes into effect in November.   

Walmart Steps into Health Care Research 

Retail giant Walmart launched the Walmart Healthcare Research Institute (WHRI) on Tuesday to add more medical services to its stores and address health disparities.  The new institute will be developing new interventions and medications that can impact underrepresented communities like seniors, rural residents, women, and minority populations.  To enhance clinical trial diversity, the WHRI will initially focus on including members of underserved communities in its studies on treatments for chronic conditions.  According to Walmart, about 4,000 of its stores are located in underserved communities.  The announcement comes amid a Food and Drug Administration (FDA) effort to increase racial and ethnic diversity in clinical trials. 

FDA, CDC Approve Bivalent Booster for Kids 5-11 

Both the FDA and the Centers for Disease Control and Prevention (CDC) signed off on the bivalent COVID-19 vaccine booster doses from Pfizer and Moderna for children ages five to 11 earlier this week.  The bivalent boosters, which target both the original iteration of COVID-19 and the Omicron BA.4/BA.5 subvariants, were made available to all US adults last month.  Only 40% of US children ages five to 11, who have already gotten their two primary doses, are eligible for the booster.  While children are far less likely than adults to face severe consequences from COVID-19, hospitalization rates in children have increased during previous surges, and federal health officials are urging patents to get their kids vaccinated or boosted ahead of a potential new COVID-19 surge in the late fall or winter. 

March of Dimes: Maternity Care “Deserts” Are Increasing 

The March of Dimes painted a sobering picture of the state of maternal health care in the US in a new report that found nearly seven million women of childbearing age and half-a-million babies live in maternity care “deserts,” meaning they lack obstetric hospitals or birth centers.  More so, the report found the number of maternity care deserts has grown 2% since the release of the last report in 2020.  The report also found that racial and ethnic minorities are more likely to live in maternity care deserts.  For example, about a quarter of Native American babies and 17% of Black babes are born in areas with limited or no maternity care services.  As policy solutions, the March of Dimes recommends that Congress passes legislation that will extend Medicaid postpartum coverage from 60 days to a year and expand telehealth services to bridge gaps in health care. 

ICYMI: Library of Congress Kicks Off Fall Concert Series 

If you’re in DC and you’re bummed about missing Jazz in the Garden this summer, don’t worry there are still plenty of opportunities to catch free live music at the Library of Congress Fall Concert Series, which officially starts tonight at the Thomas Jefferson Building.  The inaugural concert will feature Greek, English, Italian, Portuguese, French, and Japanese folk songs.  Piano and opera performances will also be on deck throughout the fall.   

What Happened, What You Missed: October 3-7 

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. 

What Happened, What You Missed: September 26-30

Medicare Part B Premiums to Decrease Next Year 

Medicare beneficiaries will see lower Part B premiums in 2023, according to an announcement from the Centers for Medicare and Medicaid Services (CMS) on September 27. The upcoming premium drop follows a spike in 2022 premiums that was largely driven by the high projected cost of the new Alzheimer’s drug Aduhelm.  However, CMS was able to lower its estimates for 2023 after the cost of Aduhelm fell, paving the way for the agency to lower its Part B premiums for next year.  Lower-than-expecting spending on Part B services also factored into the agency’s decision to lower 2023 premiums.  CMS also announced earlier this week that Part A premiums will rise to $7 in 2023.  On Thursday, CMS also announced lower premiums for Medicare Advantage and Part D prescription drug plans in 2023.  

Pfizer Applies for EUA for Omicron Booster for Children Ages 5-11 

On Monday, Pfizer applied for an emergency use authorization (EUA) to the Food and Drug Administration (FDA) for its Omicron-targeted bivalent COVID-19 booster for children ages five to eleven years old.  The submission comes a week after Moderna filed an EUA application with the FDA for its own bivalent booster for children ages six to seventeen.  In a document released on September 20, the Centers for Disease Control and Prevention (CDC) said it expects to make a recommendation in early- to mid-October on the use of the new bivalent vaccines in children and adolescents, pending authorization by the FDA.  While human data on the efficacy of the new COVID-19 boosters won’t be available for another month or two, FDA and CDC officials are confident that the updated boosters offer better protection against infections and disease in the coming months. 

Experimental Alzheimer’s Drug Shows Promise 

Pharmaceutical companies Biogen and Esai announced on Tuesday that their experimental Alzheimer’s disease treatment slowed the rate of cognitive decline by 27% in a clinical trial.  The announcement increases the likelihood that the FDA could approve the drug as early as January 2023.  The clinical trial data also renews hope in the potential for anti-amyloid drugs, which work by clearing the buildup of amyloid proteins which are linked to development of Alzheimer’s disease.   The FDA greenlit Biogen’s first anti-amyloid drug known as Aduhelm last year, despite the little evidence demonstrating the drug’s efficacy.  According to both companies, the new drug began to show a benefit to patients about six months after they began taking it in clinical trial consisted of 1,800 participants with mild cognitive impairment or mild Alzheimer’s disease. 

White House Proposes Medicare-Covered Meals to End Hunger  

On Tuesday, President Joe Biden proposed Medicare coverage for medically tailored meals as a part of an overarching plan to end hunger that includes updates to nutrition labels and an expansion of food security programs.  The president also called for expanded access to nutrition and obesity counseling for people on Medicare and Medicaid as well as making the Medicare Diabetes Prevention Program a Medicare preventive services benefit.  However, many of the president’s proposals have an uncertain future, as most ideas would require the support of a polarized Congress.  

House to Vote on Stopgap Spending Bill Today 

The Senate voted 72-25 yesterday afternoon to approve a continuing resolution (CR) to keep the federal government open through December 16, setting the stage for the House to vote on the CR sometime today.  The CR notably includes a five-year extension of FDA user fee programs that lacks policy riders that were initially a part of previous user fee extension proposals.  Additionally, the CR includes disaster relief funding for Alaska, Florida, and Puerto Rico, as well as billions of dollars in aid to Ukraine.  Following today’s vote, lawmakers will return to the campaign trail for the 2022 midterm election.  While the House isn’t scheduled to return until after the election in November, the Senate will be reconvening in mid-October. 

ICYMI: Pop Star Performs with James Madison’s Flute 

At a concert in Washington, DC earlier this week, pop artist Lizzo performed with a crystal flute that once belonged to President James Madison. This was the first time the instrument had been played in over 200 years.  The flute was a part of a collection at the Library of Congress, which is allegedly the largest flute collection in the world.  A French flute designer originally gifted the fourth president the instrument in 1813 to commemorate Madison’s second inauguration.  Lizzo began training as a classical flutist at the age of 10 and had studied the instrument in college. 

What Happened, What You Missed: September 19-23

CDC: 80% of Pregnancy Deaths Are Preventable 

More than four out of five pregnancy-related deaths could have been avoided, according to a new report from the Centers for Disease Control and Prevention (CDC).  Highlighting the role of health disparities, the report found non-Hispanic Black mothers were three times more likely to die than white mothers, and that 93% of deaths among American Indian and Alaska Native mothers were preventable.  The CDC also found that nearly 25% of deaths were due to mental health conditions, 14% due to hemorrhage and 13% due to heart problems. The remaining deaths were caused by cardiomyopathy, embolism, infection, and hypertension. 

FDA Clears Millions of Moderna Booster Doses 

The Food and Drug Administration (FDA) gave the green light for a vaccine packaging plant in Indiana to release millions of Moderna’s bivalent booster doses after initially withholding the doses from being released over concerns that the packaging plant was not sufficiently sterile.  Since the new bivalent booster doses were made available after Labor Day, state and local officials nationwide have reported shortages of Moderna doses, prompting many booster-seekers to turn to Pfizer instead.  Health officials now expect supply issues related to Moderna’s booster to resolve in about two weeks.  According to reports, administration officials have so far avoided publicly commenting on the decision to withhold millions of Moderna boosters over concerns that their comments could undermine vaccine confidence. 

USPSTF Recommend All Adults Get Screened for Anxiety 

On Tuesday, the US Preventive Services Task Force (USPSTF) issued a draft recommendation calling for all adults under the age of 65 to be screened for anxiety.  The panel’s recommendation comes amid a spike in new cases of anxiety and depression during the COVID-19 pandemic.  According to data from the CDC, the share of adults ages 18 to 44 who received mental health treatment jumped from 18% in 2019 to 23% in 2021.  The panel additionally noted that Black and Hispanic/Latino Americans are more likely to face barriers to receiving mental health care due to high treatment costs and lack of insurance coverage.   The USPSTF also looked at the benefits of screening for suicide risk in all adults but did not find enough evidence to justify a recommendation. 

Senate Leaders Reach Deal on PDUFA Reauthorization 

On Thursday afternoon, Senate leaders struck a deal to reauthorize the Prescription Drug User Fee Act (PDUFA) and ensure the Food and Drug Administration (FDA) can pay staff in charge of reviewing prescription drugs, biologics, and medical devices.  According to the Ranking Member of the Senate Health, Education, Labor and Pensions (HELP) Committee Richard Burr (R-NC), his policy rider addressing the baby formula shortage was cut from the bill, making the reauthorization measure “practically clean.”  However, it remains unclear if House lawmakers have agreed to the deal.  The reauthorization bill is expected to be tied to a continuing resolution that Congress is now expected to take up next week. 

ICYMI: Capitol Police Once Again Prevail over Lawmakers on the Gridiron  

The Capitol Police defeated members of Congress at the Congressional Football Game on Wednesday night by a score of 19-8.  Except for a 2019 matchup, the Capitol Police have consistently defeated the lawmakers since the first game took place in 2004.   The matchup will notably be the last for the lawmakers’ co-captain Rep. Rodney Davis (R-IL), who lost a primary race earlier in the summer after his district was combined with another.  The game generated over $400,000 for the Capitol Police Memorial Fund, which supports the families of officers who are severely injured or killed in the line of duty.

What Happened, What You Missed: September 12-16

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 60th 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.   

What Happened, What You Missed: September 5-9


Becerra Authorizes FDA to Issue EUAs for Monkeypox Tests 

Health and Human Services (HHS) Secretary Xavier Becerra issued an emergency declaration on Wednesday to allow the Food and Drug Administration (FDA) to issue emergency use authorizations (EUAs) for monkeypox tests.  The announcement comes one month after HHS declared monkeypox to be a public health emergency.  According to Becerra, the declaration will help propel the government’s response to monkeypox by expanding access to testing.  In a separate announcement, the FDA issued its first EUA for a monkeypox test to Quest Diagnostics.  While the US is currently conducting more than 80,000 tests per week, some experts warn confusion over where patients get tests could be limiting access to monkeypox tests.    

White House Pushes for COVID-19 Funding in CR 

The Biden administration is pushing Congress to include $22.4 billion in a continuing resolution (CR) to help the domestic fight against COVID-19.  Due to dwindling funds, the administration has already announced it will no longer send free COVID-19 tests to people’s homes, and federal funding for COVID-19 vaccines is likely to end soon.  Additionally, the White House has communicated that it has no objection to attaching the reauthorization of FDA user fees to a CR, although the administration declined to offer its outright support for the proposal.   However, the likelihood that either proposal makes it into a CR is uncertain, as congressional appropriations leaders are currently hashing out whether to include Democratic energy policies in a stopgap spending measure.  Even if Congress is able to quickly pass a CR later this month, lawmakers could become embroiled in another appropriations fight later this year when the CR is expected to end.   

Study: Private Equity-Owned Practices Leave Patients with Higher Bills 

Physician practices acquired by private equity firms were associated with higher spending and more patient visits, according to a study published by the Journal of the American Medical Association.  The study found an average increase of 20%, or $71, in charges per claim, and 11%, or $24, in amount allowed per claim.  Private equity-owned practices were also reported to have about 26% more unique patients.  According to a press release by the study’s authors, the higher billing could be due to either more efficient documentation of services or up-coding/up-charging to insurance companies.   The study only examined dermatology, gastroenterology and ophthalmology medical practices purchased by private equity. 

Federal Judge Rules HIV Drug Coverage Requirement Violates Religious Freedom 

On Wednesday, US District Judge Reed O’Connor ruled that requiring employers to provide the HIV prevention drug PrEP violates their religious freedom, potentially jeopardizing the mandatory coverage of preventative health care services under the Affordable Care Act (ACA).   According to the Texas employers behind the suit, the provision violates the Religious Freedom Restoration Act by forcing people to pay for coverage that conflicts with their faith and values.  The ruling is not the first time O’Connor has challenged the ACA – in 2018 he ruled the entire health care law to be unconstitutional, which the Supreme Court overturned in 2021.  It was not immediately clear what kind of impact the ruling will have beyond the employers challenging the ACA provision.   

ICYMI: Portraits of Barack and Michelle Obama Unveiled at White House  

Former President Barack Obama and former First Lady Michelle Obama returned to the White House this week for the unveiling of their official portraits.  President Obama’s photo-realistic portrait was painted by Robert McCurdy and Michelle Obama’s portrait was painted by Sharon Sprung.  The portrait unveiling is a long tradition that goes back to 1978 when President Jimmy Carter invited his immediate predecessor, Gerald Ford, back to the White House. Wednesday’s unveiling event would have traditionally been held during the Trump presidency, although both parties mutually declined to participate according to sources