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

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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

What Happened, What You Missed: August 29-September 2

FDA Authorizes Boosters Tailored to BA.5 

On Wednesday, the Food and Drug Administration (FDA) authorized bivalent COVID-19 booster shots from Pfizer and Moderna that target both the original COVID-19 strain and the Omicron BA.4/5 subvariants.   The Centers for Disease Control and Prevention (CDC) is widely expect to sign-off on the boosters today, which means pharmacies could start administering doses after Labor Day weekend.  According to the FDA, it may take up to two months before data is available on how effective the updated boosters are at preventing infection.  So far, the federal government has secured 171 million doses from Pfizer and Moderna.   

House Democrats Consider CR through December 16 

According to news reports, House Democratic leaders are working on a continuing resolution (CR) that would extend current government funding levels through December 16.  The current fiscal year ends on September 30, and House Democrats are hoping to bring their CR to the House floor for consideration during the week of September 12.  While negotiations over stopgap spending bills have typically been contentious, lawmakers may be more willing to cut a deal sooner rather than later this month due to an eagerness to return to the campaign trail ahead of November’s midterm elections.   Of note, a CR could include a reauthorization of FDA user fee programs, which are also set to expire at the end of September.     

CDC: Life Expectancy in US Dropped to 76 Years in 2021 

Life expectancy in the US fell from 79 years in 2019 to 76.1 years in 2021, according to data from the CDC.  The decline marks the first time life expectancy dropped two consecutive years in nearly a century.  According to the CDC, the decline in life expectancy can be attributed to the COVID-19 pandemic and increases in unintentional injuries, namely drug overdoses.  While a drop in life expectancy was observed in all 50 states, the CDC found that Southern states saw the biggest declines, as well as Indiana, Missouri, New Mexico, Ohio, and Oklahoma.   

HHS Issues $20M in Grants on Maternal and Infant Health 

On Monday, the Biden administration took a major step in carrying out its Blueprint for Addressing the Maternal Health Crisis by announcing investments of over $20 million to improve maternal and infant health.  According to a press release from the Department of Health and Human Services (HHS), the awards include $9 million to the State Maternal Health Innovation Program, $4 million to the Rural Maternity and Obstetrics Management Strategies Program, $3 million to 19 Healthy Start programs to reduce maternal health disparities, and $4.5 million to the Catalyst for Infant Health Equity Program.   

ICYMI: Fencing Around Supreme Court Removed 

Metal fencing that had surrounded the Supreme Court building for the past few months finally came down earlier this week.  The fences were initially erected in May after a draft decision to overturn Roe v. Wade leaked, which prompted protests in front of the court building.  However, the building itself remains closed, and the court has yet to comment on when the building will reopen to the public. 

What Happened, What You Missed: August 22-26

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 31st 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. 

Why the Hearing Aid Rule is a Big Deal

On August 16, the Food and Drug Administration (FDA) finalized rulemaking to allow hearing aids to be purchased over-the-counter (OTC), which is widely expected to increase access for millions of Americans with mild to moderate hearing loss.  This rule was 5 years in the making – why now? 

Background 

While FDA has regulated hearing aids for decades, the agency had previously only focused on assuring safety and effectiveness of prescription hearing aids.  In 2017, Congress stepped in and passed a law to require the agency to issue rules for over-the-counter devices. Lawmakers were hoping establishing a new category of hearing aids would address: 

  • Cost:  Lack of competition in the market means hearing aids can cost between $2,000 and $7,000 per pair.   
  • Coverage:  Most commercial insurance plans and Medicare don’t cover the cost of hearing aids for people with mild to moderate hearing loss because they’re not considered an essential medical device – or in other words, they’re considered “elective.”  
  • Access:  Additionally, getting hearing aids requires a prescription from an audiologist or other specialist.  Buying devices in a retail setting or online would provide more options for consumers. 

A Rule that Was Years in the Making 

It’s taken a long time for the idea of over-the-counter hearing aid sales to go from initial concept to final rule.  Sens. Chuck Grassley (R-IA) and Elizabeth Warren (D-MA) got so fed up with the agency dragging its feet that they introduced legislation to require FDA to issue rulemaking on OTC hearing aids.  Even though the bill was signed into law as part of the FDA Reauthorization Act of 2017, it still took the agency 5 years to finalize the rule.  Why?   

COVID.  Yes, the needed change in focus of the agency to address COVID was a no-brainer, but President Trump signed the bill 2+ years before the virus struck….   

Change in administration.  Yes there was a change in administration but it took President Biden until July 2021 to issue an executive order directing his own agency to issue rule making. 

So why the delay?  It turns out that balancing stakeholder concerns was complicated.  When FDA issued the proposed rule in October 2021, the agency received more than 1,000 comments from the public.  Here is where the rule ended up: 

  • Output levels:  Lowers the maximum sound output to reduce the risk from over-amplification of sound 
  • Volume control:  Requires all OTC aids have a user-adjustable volume control 
  • Label and packaging language:  Simplifies phrasing so safety concerns can be easily understood 
  • State authority:  Retains authority by States to require an audiological evaluation for minors and other previously granted State exemptions applicable to non-OTC hearing aids 

What’s Next?  

The final rule goes into effect in 60 days, which is the date that over-the-counter hearing aids can officially be marketed.  Already, Best Buy has announced that it plans to have hearing aids available in 300 of its 1,000 stores by the fall.   

Even though Congressional Democrats weren’t able to get Medicare coverage for hearing aids signed into law, the rule signals real financial relief and a step toward health equity for millions.  Good news for consumers makes for good politics…right ahead of the November 8th elections. 

What Happened, What You Missed: August 8-12

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.

What Happened, What You Missed: August 1-5

Administration Declares Monkeypox a Public Health Emergency            

On Thursday, Health and Human Services (HHS) Secretary Xavier Becerra declared a public health emergency over the monkeypox outbreak, giving federal agencies access to emergency funding and other resources for efforts to fight the virus’ spread.  Becerra is also considering a second declaration that would enable the Food and Drug Administration to issue emergency use authorizations for medical countermeasures like treatments and vaccines.  So far, over 616 cases detected in the US, although that total is likely an undercount. Most cases in the US are concentrated in the gay and queer community, primarily among men who have sex with men.

Administration Releases National Research Plan on Long-COVID

The Biden administration released on Wednesday a national research plan outlining a government-wide agenda focused on improving prevention, diagnosis, treatment, and provision of services for people experiencing long-COVID.  To meet the administration’s objectives, the research plan directs HHS to issue two reports within 120 days laying out an “actionable path forward” to address long-COVID and associated conditions.  The administration also issued a report outlining services and supports for long-COVID patients and as well as resources for individuals confronting challenges related to mental health, substance use, and bereavement.  According to a press release, the administration estimates that nearly one million Americans may be out of the workforce at any given time due to long-COVID, which equates to roughly $50 billion in lost earnings annually.

CMS Finalizes 4.3% Payment Increase for Inpatient Services in FY23

Medicare payments for hospital inpatient services will get a 4.3% boost in Fiscal Year 2023, according to a final inpatient prospective payment system (IPPS) rule released on Monday.  The final rule also carries out the administration’s focus on health equity by adding health equity-focused measures to hospital reporting programs like the Hospital Inpatient Quality Reporting (IQR) Program.  Among other provisions, the rule finalizes proposals to create a “birthing friendly” hospital designation, continue COVID-19 reporting requirements for hospitals, apply a budget-neutral 5% cap on any decrease to a hospital’s wage index from the prior fiscal year, and make prescription drug monitoring program queries mandatory under the Medicare Promoting Interoperability Program.

ICYMI: National Air and Space Museum to Partially Reopen in October

Since March, visitors to the Smithsonian museums in Washington, DC haven’t had the opportunity to view the Apollo 11 command module or the Spirit of St. Louis.  That will change on October 14 when the National Air and Space Museum partially reopens to the public following a lengthy renovation period.  In anticipation of strong interest, the museum will be requiring free timed entry passes that will be available on September 14.  Come October 14, visitors to the museum will have the opportunity to see eight new exhibits, including ones on the Wright brothers and the planets of the Solar System.