Category: Public Health

AMA Downplays Importance of BMI 

Physicians should deemphasize the use of body mass index (BMI) when assessing a patient’s health and obesity, according to a new policy statement from the American Medical Association (AMA).  The policy was born from an AMA report that found BMI to be a flawed way to measure body fat in multiple groups because it does not account for differences across “racial/ethnic groups, sexes, genders, and age-span.”  BMI was initially determined by a Belgian mathematician in the 19^th century who only analyzed White non-Hispanic individuals.  While the AMA acknowledges that BMI is strongly tied to the amount of fat mass in the general population, the measure becomes less relevant when applied to individuals.   

USPSTF Recommends Anxiety Screening for All Adults 

Most adults should be screened for anxiety and depression even in the absence of symptoms, according to two final recommendations from the US Preventatives Services Task Force (USPSTF).  In one recommendation statement, USPSTF said that all adults should be screened for major depressive disorder, including those who are pregnant, postpartum, and age 65 and older.  In another recommendation statement, USPSTF said adults under age 65 should be screened for anxiety.  However, USPSTF declined to recommend screening adults 65 and older for anxiety due to insufficient evidence.  The new recommendations come amid a rise in adults reporting symptoms consistent with anxiety and depression since the start of the COVID-19 pandemic.   

Mandy Cohen Tapped to Lead CDC 

President Joe Biden announced his intent to appoint Mandy Cohen, MD, MPH as director of the Centers for Disease Control and Prevention (CDC).  Cohen will begin as soon as outgoing CDC Director Rochelle Walensky, MD officially steps down on June 30, since the position won’t require Senate confirmation until January 2025.  Currently CEO of Aledade Health Care Solutions, Cohen previously served as Secretary of Health in North Carolina and deputy director of the Center for Medicare and Medicaid Innovation.  Biden’s announcement has drawn praise from health care stakeholders across the nation. 

CDC Recommends RSV Vaccines for Older Adults  

A CDC advisory panel voted 9-5 to recommend two respiratory syncytial virus (RSV) vaccines for adults ages 65 and older, from drug manufacturers Pfizer and GSK.  Thirteen committee members, with a single abstention, also voted to recommend the vaccines for adults ages 60 to 64 based on individual risk factors and in consultation with a physician.  While RSV is generally mild for most healthy adults, up to 10,000 people ages 65 and older die from RSV each year.  CDC Director Rochelle Walensky is expected to endorse the vaccines soon, which is the last hurdle the vaccines must clear become they can become available to the public.  Drug manufacturers and pharmacies have pledged to make the vaccines available to older adults by late fall, just in time for the winter respiratory virus season.   

ICYMI: Smithsonian Folklife Festival Returns 

Visitors to the nation’s capital will have another fun outdoor entertainment option when the Smithsonian Folklife Festival returns next weekend.  The festival, which runs from June 29 to July 9, features participants and events from all 50 states and over 100 countries.  Key programs this year include events honoring living religions in the US, the programming on culture of the Ozarks, and activities celebrating the music and food of Ukraine.  Volunteers are encouraged to sign up and participate.  

New Guidelines Call for Women to Get Mammograms at Age 40 

Women should start getting mammograms to screen for breast cancer at the age of 40, according to new draft recommendations from the US Preventative Services Task Force (USPSTF).   While current guidelines recommend mammograms starting at age 50, a growing number of women at risk for breast cancer have started screening in their 40s.  The USPSTF issued the draft recommendations based on new evidence that shows a growing number of women in their 40s are getting breast cancer.  The draft recommendations also call for biennial screenings instead of annual screening, which runs counter to leading medical organizations like the American College of Radiology and the American Cancer Society.  According to the USPSTF, starting mammograms earlier will allow doctors to detect breast cancer sooner and save more lives.  Breast cancer is currently the most common cancer among women, and it is the second-leading cause of cancer-related death in women. 

Senate Panel Advances Bipartisan PBM Bill 

The Senate Health, Education, Labor, and Pensions (HELP) Committee passed by a 18-3 vote legislation to reform pharmacy benefit manager (PBM) practices.  The legislation was among a group of bipartisan bills and amendments approved by the committee that are aimed at addressing high drug costs.  The bill’s most notable component would ban PBMs from using spread pricing, which is the practice of charging health plans for prescription drugs more than what they pay the pharmacy and pocketing the difference.  Other measures approved by the committee would direct the Department of Labor to conduct a study into the fiduciary duties of PBMs and require PBMs to pass on all rebates they get from drug manufacturers to health plans. 

mRNA Vaccine for Pancreatic Cancer Shows Promise 

A group of pancreatic cancer survivors who were found to have an immune response from an experimental mRNA vaccine showed no signs of relapse, according to a study published in Nature.   Conducted by researchers at Memorial Sloan Kettering Cancer Center in New York City, the study involved 16 patients who had their tumors surgically removed.  All 8 patients whose immune systems responded to the vaccine made T-cells against their tumors that have persisted for at least 2 years.  Researchers believe the spleen could be key to understanding who could benefit from the vaccine, as 5 of the 8 patients who didn’t generate an immune response had their spleens removed.  Scientists have been working to develop cancer vaccines for decades, and only in recent years have mRNA vaccines shown promise in treating the disease.  In April, early-stage clinical trial results for a personalized vaccine using mRNA technology was found to be effective in preventing melanoma from reoccurring. 

FDA Updates Blood Donation Policy for Gay, Bisexual Men 

Gay and bisexual men in monogamous relationships are now allowed to donate blood at any time, according to an updated blood donation policy from the Food and Drug Administration (FDA).  The update is part of an effort to ease blood shortages by loosening restrictions on who can donate.   Previously, men who have sex with men were only permitted to donate blood after three months from their last sexual encounter with other men.  The new policy nixes time-based restrictions in favor of individual risk-based questions that will be the same for every donor, regardless of sexual orientation, sex, or gender.   The FDA originally proposed the new policy in January 2023. 

End of COVID-19 PHE Means End to Emergency Rules, Waivers 

With the end of COVID-19 public health emergency (PHE) yesterday, numerous rules and waivers that have been in place for over more than years are now out of the picture.  The Centers for Disease Control and Prevention (CDC) will no longer be able to access some surveillance data based on new case numbers; instead, the CDC will use hospital admissions to determine the level of community risk.  Additionally, Medicare and private insurers will no longer be required to fully cover 8 rapid antigen tests per month, although the administration is urging insurers to continue covering the test.   Furthermore, certified registered nurse anesthetists will once again require physician supervision, and patients will again have to spend 3 consecutive days in a hospital before being eligible to move to a skilled nursing facility. 

ICYMI: Jazz in the Garden Returns Next Week 

Jazz in the Garden, a popular free summer concert series held in the National Gallery of Art’s outdoor Sculpture Garden, will return on May 19 and run through August 4.  To cope with high demand, the National Gallery is instituting for the first time a free lottery system that will open the Monday before a concert and close Friday at noon.  However, admission will remain free.  This year’s concerts will feature jazz, zydeco, Latin fusion, bluegrass, and other musical performances. 

Multiple Problems Plague Primary Care in America 

Primary care across the nation is in a dire state, according to a new report from the Milbank Memorial Fund and the Physicians Foundation.  Among the most concerning findings is an increase in the percentage of adults who don’t have a usual source of care, and the fact that too few primary care physicians are being trained in community settings.  According to the report, a major contributing factor to these problems is inadequate investment in primary care.  For example, average spending on primary care for all insurance types declined from 6.2% in 2013 to 4.6% in 2020, which is far below average spending in other wealthy nations. 

FDA Begins Review of Babies’ RSV Vaccine 

The Food and Drug Administration (FDA) granted priority review for a vaccine to protect infants up to six months of age from respiratory syncytial virus (RSV), according to an announcement from Pfizer.  The priority review status means the agency will try to review the application within six months instead of the standard 10.  There are currently no RSV vaccines available for infants, and the FDA offers priority review for drugs that promise “significant improvements” over existing drugs.  If deemed effective, the Pfizer’s RSV vaccine could be available for infants ahead of a likely RSV season next winter. 

FDA Issues First Fines to E-Cigarette Manufacturers 

The FDA fined four electronic cigarette manufacturers over their alleged sales of unauthorized products on Wednesday, marking the first time the agency has issued civil money penalty complaints against tobacco product manufacturers for allowing products to go to market without federal approval.  According to a press release, the FDA has sent more than 550 warning letters since the start of 2021 to companies that manufacture, sell, or distribute new tobacco products without being allowed. Most of the companies that received warning letter have taken their products off the market and are now complying with FDA regulations. 

Poll: High Costs Is America’s Number 1 Public Health Worry 

Reducing high drug and health costs was the top public health priority for 50% of Americans, according to a new poll from Axios-Ipsos.  In comparison, 14% said reducing gun deaths and another 14% listed research into cures and treatment for major diseases as a top priority for government intervention.  When asked to name the number one threat to public health, over a quarter of respondents said opioids and fentanyl, 21% cited obesity, 17% listed gun violence, and 12% said cancer.  Additionally, a large majority of respondents said the country is not prepared to handle another pandemic.  The poll was conducted in February and included over 1,200 adults. 

ICYMI: Cicilline to Resign from Congress in June 

Rep. David Cicilline (D-RI) announced earlier this week that he will officially leave Congress on June 1, 2023.  A member of the Foreign Affairs and Judiciary committee, the 61-year-old Cicilline has been elected to seven terms in Congress.  Prior to entering Congress, he served in the Rhode Island state legislative and as mayor of Providence.  Cicilline is leaving to Congress to lead the Rhode Island Foundation, which supports community programs in the Ocean State through grants and investments.  His retirement will trigger a special election in the heavily Democratic 1^st Congressional District. 

CDC: Drug Overdose Deaths May Have Peaked 

Drug overdose deaths in the US have declined for the past three consecutive months, according to new data from the Centers for Disease Control and Prevention (CDC).  The CDC found that there were about 107,600 overdose deaths for the 12-month period between July 2021 and June 2022, which is 40 fewer overdose deaths than in calendar year 2021.  Public health officials in several states attribute the decline to social media and health education campaigns on the dangers of drug use, greater access to substance abuse treatment, and expanded distribution of opioid overdose-reducing treatment naloxone.  While trends indicating a peak in overdose deaths is hopeful, some public health experts are skeptical due to the fact that previous periods of decline have not lasted long.   

Cassidy Poised to Become Top Republican on HELP Committee 

Sen. Rand Paul (R-KY) announced Thursday that he plans to serve as the top Republican on the Senate Homeland Security and Government Affairs (HSGA) Committee in the next Congress, thereby allowing Sen. Bill Cassidy (R-LA) to become the ranking member of the Senate Health, Education, Labor, and Pensions (HELP) Committee.  Paul likely chose to become ranking member of the HSGA Committee because he would have subpoena power – something he would lack had he chosen to become the top GOP member on the HELP Committee.  Since Paul’s announcement, Cassidy has publicly expressed his desire to serve as the ranking member of the HELP Committee, where he will be the Republican counterpart to expected incoming Chairman Bernie Sanders (I-VT).  Health care stakeholders have already voiced a preference for Cassidy to become the ranking member due to his history of deal-making and bipartisanship.  

Pediatric Organizations Press for New PHE 

The Children’s Hospital Association (CHA) and the American Academy of Pediatrics (AAP) said in a letter to the Department of Health and Human Services (HHS) on Monday that due to alarming spike in hospitalizations from respiratory syncytial virus (RSV) and influenza the administration should declare a new public health emergency (PHE). With pediatric hospitals facing a dwindling number of available beds, the CHA and AAP say a PHE would help address capacity issues by allowing the waiver of certain Medicare, Medicaid, or Children’s Health Insurance Program (CHIP) requirements to enable providers to share resources. The pediatric organizations also asked the federal government to encourage state Medicaid agencies to support telehealth and out-of-state care flexibilities to help manage hospital capacity.   

Moderna: Bivalent Booster Less Effective against New Subvariants 

Moderna announced on Monday that its new bivalent COVID-19 booster yields higher levels of antibody protection against the Omicron BA.4 and BA.5 subvariants compared to the booster shot using the company’s original formula.   According to a press release, Moderna’s bivalent shot triggered antibody responses against BA.4/BA.5 that were average 15.1-fold higher compared with the company’s first vaccine.  Moderna also said that while its bivalent booster also generated an immune response to the growing Omicron BQ.1.1 subvariant, the booster was not as effective as it was against BA.5.  While BA.5 is currently the dominant COVID-19 strain the US accounting for nearly 30% of new cases, BQ.1 and BQ.1.1 make up for about 44% of new infections.   

FDA: Some E-Cigarettes Resemble Toys, Target Children 

The Food and Drug Administration (FDA) issued warning letters to five electronic-cigarette manufacturers for packaging their products to resemble toys, which appeals to children.  According to the letters, some of the e-cigarettes were designed to look like glow sticks, video game consoles, and walkie-talkies, or food products like popsicles.  Additionally, some of the companies’ e-cigarette products features the likenesses of characters from “The Simpsons,” “Family Guy,” and “Rick and Morty.”  The FDA noted that failure to correct the violations can result in additional injunctions, seizure of products, or civil money penalties. 

ICYMI: Naomi Biden to Wed at White House on Saturday 

On Saturday, Naomi Biden, the granddaughter of President Joe Biden, and her fiancé Peter Neal will marry on the South Lawn, marking the 19^th wedding to take place at the White House.  Naomi Biden, 28, and Neal, 25, are both attorneys who met through mutual friends about four years ago in New York City, and the pair currently resides in Washington, DC.  This Saturday’s nuptials will mark the first wedding with a president’s granddaughter as the bride.  The most recent weddings to take place at the White House are Richard Nixon’s daughter, Tricia, in 1971, and Lyndon B. Johnson’s daughter, Lynda, in 1967. 

Voters Approve Medicaid Expansion, Medical Debt Reform, Flavored Tobacco Ban 

Voters in Tuesday’s midterm elections weighed in on several key health care questions in handful of states.  In South Dakota, 56% of voters approved expanding Medicaid, which will allow 42,000 state residents to become eligible for Medicaid coverage.  The vote makes South Dakota the seventh Republican-controlled state to expand Medicaid.  In Arizona, voters passed a proposition to reduce medical debt by dropping interest from 10% to 3%.  The proposition will also increase the value of the debtor’s home protection from and decrease the portion of weekly disposable income subject to debt collection.  In California, voters approved a ban on most flavored tobacco products and rejected a measure that would have required a doctor, nurse practitioner or physicians’ assistant to be present during treatment at outpatient dialysis facilities. 

SFC Offers New Policy Recommendations on Mental Health 

The Senate Finance Committee put forth several legislative proposals to address mental health in a discussion draft released on Thursday morning.  The discussion draft includes proposals to create a bundled payment in Medicare for crisis stabilization, create a standardized payment in Medicare for mobile crisis response team services, and increase payment rates to help providers integrate behavioral health and primary care.  While there is interest among members of both parties to advance mental health reform, next steps on the discussion draft are unclear as control of the next Congress has yet to be determined. 

Stakeholders Call for Additional PHE Extension 

The current public health emergency (PHE) related to COVID-19 is set to expire on January 11, 2023, and with the new year fast approaching, stakeholders are already calling on the administration to extend the PHE at least one more time.  This week, Families USA said an extension is necessarily to give states more time to prepare for one-year Medicaid redetermination process that will begin as soon as the PHE ends.  Families USA said the extra preparations are needed to ensure states can connect the millions of beneficiaries who are expected to lose coverage with other sources of coverage.  Earlier this month, the American Health Care Association (AHCA) similarly called for another PHE extension to help prepare for coverage disruptions.  With COVID-19 case numbers projected to rise during the winter, many expect the administration will indeed extend the PHE at least one more time next year.   

Study: Antivirals Could Reduce Risk of Long COVID 

Antivirals like Paxlovid could lessen a person’s chances of getting long COVID, according to a new study from the Department of Veterans Affairs.  The study found that patients who took Paxlovid were 26% less likely to develop one of more symptoms of long COVID such as heart issues, fatigue, and trouble breathing within one to three months from infection.  Researchers conducted the study analyzing electronic health records (EHRs) from more than 56,000 patients in the VA health system who tested positive for COVID-19 between March and June 2022 and compared health outcomes with 9,000 patients that had taken Paxlovid with 47,000 who did not.   Currently, Paxlovid is only authorized for use in patients who have risk factors for complications with COVID-19, like being older or having underlying health conditions. 

ICYMI: Debate Continues on Reopening of the Capitol 

Senior House Republicans are pledging to fully reopen US Capitol Complex to visitors once they regain a majority in the House of Representatives, as current trends indicate.  All visitors to the House and Senate office buildings are currently required to have a staff escort, and while virtual meetings are likely to persist to some extent, many advocacy professionals agree that in-person meetings are the most effective way to get a message across.  However, in the wake of the attack on husband of Speaker Nancy Pelosi (D-CA), many Democratic lawmakers remain concerned about security, and questions remain on how the US Capitol Police will handle a fully-reopen Capitol amid ongoing staffing issues. 

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.