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: 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. 

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.

How Is the Federal Government Doing on Health Equity?

Equity has been a cornerstone of the Biden administration since day one.  On his first day in office, President Joe Biden signed an executive order (EO) to advance racial equity across the federal government in many areas – including health. 

Policies to promote health equity are crucial to addressing health disparities, which affect populations with a lower socioeconomic status, rural communities, people with cognitive and physical disabilities, and communities of color.  For example, African Americans and Hispanic Americans are less likely to have health insurance coverage and more likely to have chronic health conditions than non-Hispanic whites. 

As the nation wraps up celebrating its second Juneteenth – a holiday paramount to the cause of racial equity – what steps has Congress and the administration taken since the president’s inauguration to advance health equity?

Health Equity and COVID-19

The EO called for the creation of the administration’s COVID-19 Health Equity Task Force, whose mission was to ensure that elements of the COVID-19 response, including the mass vaccination campaign, prioritized equity.  The task force ultimately played a pivotal role in the administration’s response to COVID-19 by addressing barriers to vaccinations like the need to take time off work and lack of transportation to vaccination centers. This ultimately led to the administration to advocate for paid leave to allow people to get vaccinated and reimburse their transportation costs to vaccination sites. 

Released in November 2022, the task force’s final report  coalesced around several key actions: investing in local community-based efforts, putting more resources into collecting data on health-related concerns by race and ethnicity, and increasing representation of people of color in the health care system.   The task force also recommended that the White House create a “permanent health equity structure” to coordinate health equity efforts across the executive branch, although the administration has yet to address this.

American Rescue Plan Act of 2021

Enacted in March 2021, the American Rescue Plan Act did much more than providing COVID-19 aid – it also made key investments in health equity by closing gaps in access to medical care, investing in community health, and addressing social determinants of health.  Funding provided by the law has since gone on to bolster initiatives like a $90 million investment to support data driven approaches to reducing health disparities. 

Health Equity Strategy at CMS

The Centers for Medicare and Medicaid Services (CMS) adopted an action plan on health equity in April 2022, which the agency outlined as a continuation of the administration’s drive to improve health equity.  Some of the goals laid out in the plan include increased outreach to individuals about the Affordable Care Act (ACA) marketplaces, promoting culturally and linguistically appropriate services, and gathering more data factors like ethnicity, language, income, and sexual orientation.

One of the ways the action plan has manifested is through the CMS Innovation Center (CMMI), which added “advancing health equity” as one of its five strategic objectives in 2022 .   

Legislation on Deck

Since the American Rescue Plan became law, lawmakers have been working on several bills aimed at improving health equity.  Examples include:

  • The Advancing Maternal Health Equity under Medicaid Act (H.R. 6612) – Provides a 90% federal matching rate for Medicaid maternal health care expenditures that exceed 2021 levels.
  • The Rural Health Equity Act (S. 3149) Establishes the Office of Rural Health within the Centers for Disease Control and Prevention (CDC) to serve as the primary point of contact within the CDC on rural health matters and coordinate public health research on issues affecting rural populations.
  • The Pursuing Equity in Mental Health Act (S. 1795/H.R. 1475) – Directs the federal government to award grants to establish inter-professional behavioral health care teams in areas with a high proportion of racial and ethnic minority groups.

What could happen next?  Although the window of opportunity for Congress to advance any sort of health equity legislation before the midterm elections is rapidly closing, the administration has yet to carry out many of the recommendations listed in the COVID-19 Health Equity Task Force’s report. This means there are still plenty of opportunities for the Biden administration to make strides on health equity over the next two years.

What’s Next for the Public Health Emergency?

July 15, 2022.  That’s the new end-date for the COVID-19 public health emergency (PHE) after Secretary of Health and Human Services (HHS) Xavier Becerra renewed the PHE for 90 days last week.  HHS has continually renewed the PHE over the last two years, and as the pandemic extends into its third year, many are wondering when the federal government will finally let the PHE expire.

A Brief History of the PHE

The Trump administration first declared a PHE for the COVID-19 pandemic in late January 2020.  Since then, HHS has continually renewed the PHE for 90-day periods.  Shortly after President Joe Biden took office, HHS promised to provide 60 days’ notice before ending the PHE to give health care providers and states time to prepare.  In his recent appearances before several congressional committees on his department’s budget request, HHS Secretary Becerra has reaffirmed the administration’s commitment to providing 60 days’ notice.    

Calls to end the PHE grow: Pandemic fatigue is growing and in recent months, Republican lawmakers have been pushing for the administration to let the PHE end as a signal that the country is going back to normal.  Back in February 2022, 71 House Republicans proclaimed in a letter to the administration that as long as the PHE remains in effect, it “sends the message that the country is still in a crisis that requires emergency powers.”

But health care stakeholders are saying “not so fast” on ending the PHE.  A number of emergency measures are tied to the PHE that have become a vital part of the health care system, and a 60-day notice would provide some time to allow providers and patients to prepare accordingly.  These emergency measures include:

The federal government has taken steps to ensure some of these measures don’t come to an immediate end once the PHE expires.  For instance, the omnibus signed into law last month extends certain telehealth services for Medicare beneficiaries for 151 days (5 months) after the PHE, and additional Medicaid funds provided to states to allow them to maintain current enrollment levels would last under the end of the quarter when the PHE expires.

However, Congress has yet to enact any permanent fixes, specifically regarding telehealth flexibilities that are popular with both providers and patients.  On top of this, many providers are still reeling with staffing shortages and the high cost of contract labor necessary to fill in critical gaps. However well-intentioned, the cushioning provided by Congress combined with the administration’s 60-day notice still leaves health care stakeholders without enough time to prepare for a post-pandemic world.

What happens next?  As long as the administration is committed to providing 60 days’ notice, HHS is likely to make a decision on whether or not to extend the PHE, that’s currently set to end on July 16, no later than Monday, May 16 – less than one month away.  While it’s hard to predict exactly what will happen by mid-May, a lack of permanent fixes from Congress to address popular PHE-tied measures and pressure from health care providers likely means HHS is likely to extend the PHE this summer

A 90-day extension beginning in mid-July would mean a new expiration date of October 13, 2022 – less than a month away from the 2022 midterm elections.  If Congress fails to enact legislation to address temporary pandemic measures this summer, the administration would be wise to renew the PHE once again this fall – otherwise, it would be forced to reckon with the political fallout of starting the expiration countdown for popular emergency health measures.    Additionally, letting the PHE expire will trigger health care coverage cliffs and without new laws in place to allow the states and providers a smoother transition to a post-pandemic world will be far worse for patients.  Thus, the PHE is likely to remain in effect for the rest of 2022.

What Happened, What You Missed: March 28-April 1

BA.2 Omicron Subvariant Now Dominant in US

The BA.2 Omicron subvariant now accounts for more than 54% of new COVID-19 cases in the US, according to data released on Tuesday by the Centers for Disease Control and Prevention (CDC).   While the BA.2 subvariant is considered to be at least 30% more transmissible than the original Omicron strain, there is no data to indicate that it’s more severe.  The rise of the BA.2 strain comes as the Biden administration continues to press Congress for at least $22.5 billion in additional COVID-19 funding to prepare the health care system for a potential surge in new case numbers.  While COVID-19 hospitalizations are at their lowest level since the start of the pandemic, infections are ticking upwards in 13 states.

Adults Over Age 50 Now Eligible for Second Booster Shots

On Tuesday, the Food and Drug Administration (FDA) and CDC authorized second booster shots of mRNA vaccines for people over the age of 50 at least four months after their first booster.  The federal agencies also authorized third booster doses for people aged 12 and older who are immunocompromised.  Federal officials opted to authorize the additional boosters to shore up protection for vulnerable Americans ahead of a potential late spring-early summer wave as increasing evidence points to waning immunity from previous vaccine doses.  However, data on whether an additional booster provides stronger protection remains scant.  On Wednesday, President Joe Biden publicly received his second booster dose and urged Congress to provide billions of dollars in additional COVID-19 funds to ensure the administration has enough money to purchase second booster doses for all Americans.

Biden’s Budget Request Stresses Pandemic Preparedness

Preparing for the next pandemic and shoring up the nation’s biodefense strategy are key components of President Biden’s Fiscal Year (FY) 2023 budget request for the Department of Health and Human Services (HHS), which was released on Monday.  Within the $127 billion request for HHS, the administration is asking for $28 billion to boost pandemic preparedness, $12.1 billion to develops tests and treatments for biological threats, and $500 million to bolster safety inspections at nursing homes.  The budget request also asks Congress to provide hundreds of millions of dollars to address other public health crises like the opioid epidemic, health disparities, and domestic violence.

Lawmakers Pay Tribute to Late Rep. Don Young in Capitol

Members of Congress from both parties gathered on Tuesday to pay their respects to the late Rep. Don Young (R-AK), who died on March 18 at age 88.  Young’s eulogy featured remarks from Speaker Nancy Pelosi (D-CA), Republican Leader Kevin McCarthy (R-CA), and a performance of “Amazing Grace” by the US Army Chorus.  First elected to Congress in 1973, Young was known for his colorful personality and played a key role in advancing infrastructure projects and protecting Alaska’s natural resources.  Young was the Republican Party’s longest-serving member of Congress in history, and he was the last serving member who was first elected during the Nixon administration.  The late congressman is survived by his wife, Anne, and two daughters, Joni and Dawn.

ICYMI: DC Welcomes Reese Witherspoon

Earlier this week, Academy-Award winning actor and producer Reese Witherspoon appeared at a Women’s History Month reception honoring women artists at Vice President Kamala Harris’s residence.  While in town, Witherspoon visited a few shops on M Street NW in Georgetown and the National Portrait Gallery, which notably includes a portrait of John Witherspoon – a signer of the Declaration of Independence who is also a direct ancestor of the actress.

Are High Housing Costs Bad for Your Health?

Housing prices have reached new heights, and after a brief pause, rent is once again climbing.  Not only are record-high housing costs bad for your wallet – they can be bad for your health, too.

Snapshot of America’s housing market: The median sale price for a new home in September 2021 was $408,800, compared to $217,000 in September 2011.  In Washington, DC the median price for all housing types in the city reached a new record-high of $705,000 in October 2021, while the median for all types of housing in the entire DC-metro area was $535,000, a 7% increase from last year.

  • It’s not just expensive coastal cities: Housing prices across the Sun Belt have been shooting up, too.  The median sale price of home in the Austin, TX-metro area hit $480,000 in July 2021, up 37% from the previous year, while the median sale price for a home in Nashville, TN reached $368,567 in September 2021, an 18.8% increase from September 2020.

Why? Supply and Demand

The biggest reason Americans are facing skyrocket housing prices is due to a lack of homes on the marketHalf as many homes were built in 2010-2020 as there were in the previous decade, and the US entered 2020 with a shortage of 2.5 million housing units.  Exacerbating the low supply of housing is an uptick in demand that’s being driven by record low-interest rates, remote work opportunities, and interest from millennials.

Housing as a Social Determinant of Health

 Social determinants of health, or the economic and social conditions that influence health outcomes, are receiving more attention from the health policy world than ever before.  In addition to employment, education, and access to food, housing is a top social determinant of health, and numerous studies show a strong relationship between housing and health.

What’s to be done?  While not a panacea, boosting the housing supply would mark a major step in addressing the nation’s affordable housing supply – and improving health outcomes for people who lack housing stability.  A major barrier to building more housing are zoning codes, which overwhelmingly limit new construction to single-family homes that take up more space than other types of housing and limit the overall number of new housing units that can be constructed. 

Fortunately, reforming zoning codes to allow for higher-density construction to include more diverse housing types like apartments, townhomes, and accessory dwelling units has gained steam in recent years as a popular policy option.  Federal policymakers and lawmakers have noticed, and the Build Back Better Act currently includes more than $4.26 billion for a program to incentivize “streamlining regulatory requirements and shorten[ing] processes, [and] reform[ing] zoning codes.” 

While building more residential units would be a major step in cooling rising housing prices, zoning reform won’t solve America’s housing affordability crisis overnight.  New construction is almost always more expensive than existing units, and labor shortages in the construction industry combined with a shortage of raw materials like lumber are increasing the prices for new construction homes more than normal. However, in the meantime there are some more immediate policy options that can provide housing stability including:

  • Housing vouchers, which public housing agencies provide to low-income families, the elderly, and the disabled to allow them to afford housing.  The Build Back Better Act notably includes $25 billion in new funding for housing vouchers.
  • Inclusionary zoning, which requires developer to set aside a certain number of housing units that are affordable to low- or moderate-income renters.  Jurisdictions can also offer a density bonus, or an allowance to build more units than would otherwise be allowed, to offset the cost of providing affordable housing.

America’s housing affordability crisis is deeply complex and has no simple solutions.  But without any major policy changes, the circumstances surrounding a major social determinant of health aren’t likely to change soon, and housing will continue to remain unaffordable for a large swath of Americans.