Politics

Health Care: Is It Top of Mind for Voters in the Midterms?

by Matt Gontarchick

Inflation.  Baby formula.  Gun control.  Countless important issues are at the top of voters’ minds as the midterm election approaches.  However, unlike previous election years, many voters aren’t saying health care is the most important issue to them.  How does health care stack up against a plethora of other important issues this year, and what could change in the coming months to bring health care to the forefront of the national conversation?

What the Polls Tell Us

According to a Kaiser Family Foundation (KFF) poll conducted in March 2022, health doesn’t appear to be a leading issue among voters.  When asked to name what they think will be the most important factor when voting for the 2022 midterm election, 37% of voters cited the economy, inflation, and rising prices.  Other issues mentioned by voters include climate change (4%), crime (3%), the Russian invasion into Ukraine (3%), and the COVID-19 pandemic (2%).

With inflation having reached a 30-year high of 8.5% in April 2022, it shouldn’t be surprising that voters are naming economic-related issues as their top concern.  However, what’s unusual about the 2022 polling is that compared to previous election years, health care isn’t even close to being a top issue for voters.

In October 2020, for example, 12% of voters told KFF that health care is their top issue, making it the fourth most-cited issue.  Meanwhile, the economy was a top issue for 29% of voters, while the COVID-19 pandemic and public safety each respectively garnered 18% and 13%.

Health care was even more important to voters in 2018, a midterm election year that saw Democrats regain control of the House after flipping 41 seats.   That year, 26% of respondents told KFF that health care was their top issue, placing it third on the list of topics important to voters.  Corruption in Washington came in first place with 32%, while the economy and jobs came in second with 27%. 

Even though voters might not cite health care as a top concern now, several factors could change in the coming months that could make health care top of mind for voters come November.

  • Expiration of enhanced ACA premium tax credits.  The American Rescue Plan Act of 2021 increased Premium Tax Credits (PTCs) for Marketplace insurance coverage and extended eligibility for PTCs to more individuals, making health insurance more affordable for millions in America. However, those ACA premium subsidies expire at the end of the year, and if Congress fails to renew them, 13 million Americans will start 2023 with higher insurance premiums that they may not be able to afford.  Importantly, those impacted would start receiving notices about their premium increases in October, just a month before they’re set to vote in the midterm election.  Furthermore, higher insurance premiums would make consumers less likely to receive care, potentially resulting in a combined $5.1 billion decline in spending on hospitals and physician practice services.   Democratic lawmakers that face difficult midterm races are already sounding the alarm, it remains unclear if the Senate can pass any type of legislation before the election that includes a renewal of the ACA premium subsidies.
  • Higher Medicare Part B premiums.  The Medicare Part B base premium increased by 14.5% from $148.50 a month to $170.0 a month in 2022.  On top of this, the annual deductible for all Part B beneficiaries increased from $203 in 2021 to $233 in 2022.  When the Biden administration finalized Part B premiums and deductibles in November 2021, inflation for the upcoming year wasn’t anticipated to be much different from the usual level of 2%.  However, with inflation currently hovering above 8%, higher Part B premiums are especially difficult for seniors to absorb, and continued higher-than-average inflation over the coming months could make health care costs a more important issue for seniors.
  • End of public health emergency (PHE).  The administration has repeatedly pledged to provide 60 days’ notice before letting the PHE expire.  The end date for the current PHE is July 16, 2022, and since the administration declined to say in mid-May that it will let the PHE expire, it is all but certain that come mid-summer, the PHE will be extended through October 2022 – less than a month before the midterm election on November 8.  The end of the PHE would immediately trigger a 151-day period for temporary Medicare telehealth waivers to unwind and a 365-period for states to initiate redetermination of Medicaid eligibility for all Medicaid enrollees.  While the end of telehealth waivers and loss of Medicaid coverage for certain individuals wouldn’t occur until long after Election Day, starting the countdown less than a month before voters cast their ballots could cause some voters to consider health care as an important issue.   However, due to the potential political implications of ending the PHE in October, it seems safe to assume that the administration will ensure the PHE remains in place until after the midterm election. 

Inflation, foreign conflicts, and public safety are likely to continue to dominate voters’ thinking as the 2022 campaign season continues.  However, a loss of ACA premiums subsidies, pressure from high Part B premiums, and the end of the PHE all have the potential to change the calculus for some voters as they decide who to cast their ballots for on November 8.

Congress

What Lawmakers Talked About during the HHS FY23 Budget Hearings

by Matt Gontarchick

Xavier Becerra made the rounds on Capitol Hill recently in his capacity as Secretary of Health and Human Services (HHS) to testify on the Biden administration’s Fiscal Year (FY) 2023 budget request for HHS.  Beyond the secretary’s submitted testimony – which was virtually the same for every hearing – here is a countdown of the top five health-related topics on lawmakers’ minds that were discussed across seven congressional hearings on the HHS budget request.

5. Ending the PHE

In a few hearings, lawmakers questioned Becerra on when the administration plans to unwind the COVID-19 public health emergency (PHE), which is currently set to expire on July 16, 2022.  Each and every time, Becerra reiterated the administration’s commitment to providing 60 days’ before ending the PHE in order to give states and health care providers time to prepare.  In recent weeks, the administration has given no indication that it will simply let the current PHE expire in two months.  Since May 16, 2022 marked exactly 60 days before the current PHE expiration date, the administration is all but certain to renew the PHE for another 90-day period come July.

4. Telehealth Waivers

One reason why lawmakers are so interested in how long the PHE will last is because several emergency health care flexibilities are tied to the end of the PHE.  These flexibilities include several Medicare telehealth waivers that waive geographic site originating requirements and allow coverage of audio-only services, among other items.  During the hearings, Becerra repeatedly thanked lawmakers extending temporary telehealth waivers for 151 days – 5 months –  beyond the end of the PHE in the Fiscal Year (FY) 2022 omnibus. 

Members were also strongly supportive of extending at least some of the telehealth waivers permanently. Some of the telehealth benefits lawmakers cited include increased access to health care in rural areas and relief for the health care workforce shortage.  Becerra voiced agreements on telehealth’s many benefits during the hearings, and he urged lawmakers to work with the administration on developing legislation to make the temporary telehealth authorities permanent.  Fortunately, members are already hard at work and a bipartisan group of House members have already introduced legislation to permanently expand coverage of audio-only telehealth and remove geographic restrictions on originating sites.

3. No Surprises Act

Members from both parties across multiple committees criticized the secretary for not following congressional intent in implementing the No Surprises Act because the rulemaking process establishes the Qualifying Payment Amount (QPA) as the presumptive out-of-network rate in the independent dispute resolution (IDR) process.  They argued that doing so tips the scale in favor of insurers during the IDR process. During the hearing, authors of the No Surprises Act like House Ways and Means Committee Chairman Richard Neal (D-MA) said members went to great lengths to ensure that the legislation established a level playing for all factors to be considered in the IDR process.   

In February 2022, a district court ruling struck down provisions of the No Surprises Act that gave weight to the QPA.  Becerra assured members during the hearings that the administration’s final rule on the No Surprises Act will heed the court’s ruling, although he declined to provide a timeline  on when  the rule will be released.  The secretary also said that HHS is working with the Department of Justice (DOJ) on whether to appeal or accept the ruling.  Additionally, Becerra was confident that the new rule will protect patients from surprise medical bills. 

2. 988 Suicide Hotline

988 will officially become the new suicide hotline on July 16, 2022, and members were curious to see how the administration is ensuring the hotline will work from day one.  States and territories will be responsible for operating the actual hotline, and Becerra explained that the administration is providing states with funding to make sure they can onboard enough counselors and behavioral health professionals to take incoming calls.  In the event that existing state call centers are overwhelmed, Becerra told lawmakers that HHS is working to set-up back-up call centers.  As the launch date approaches, Becerra assured the congressional committees that HHS is “keeping tabs” with states on call center preparation, although he noted that some states will be in a better position than others to take calls right away once the new hotline goes live this summer.

1. ARPA-H

The FY 2022 omnibus established the Advanced Research Projects Agency for Health (ARPA-H) as the newest biomedical research agency within HHS.  While members were unanimous in their support of the new agency, some including Reps. Rosa DeLauro (D-CT) and Anna Eshoo (D-CA) were critical of the administration’s decision to house ARPA-H within the organizational structure of the National Institutes of Health (NIH).  DeLauro, Eshoo, and others had been advocating for ARPA-H to be an independent agency within HHS because they felt this arrangement would help cultivate an independent culture within the new agency that would best facilitate the development of new cures.  Additionally, some members including Sen. Jerry Moran (R-KS) and Rep. Tom Cole (R-OK) were concerned that the administration’s was proposing additional FY 2023 funding for ARPA-H at the expense of additional funding for existing research projects at NIH.

Becerra assured lawmakers that the placement of ARPA-H was purely administrative, and he explained that having NIH assume functions like accounting and human resources would allow ARPA-H to focus on developing breakthroughs from the get-go.  To further point to the new agency’s independence, he said the ARPA-H director would report to the secretary – not the NIH director – and he added that ARPA-H would not be “physically housed” within the NIH campus. 

Becerra additionally told the congressional panels that ARPA-H will be operational once a director is appointed.  While the secretary said the search for a director is currently underway, he was unable to provide a timeline. 

Administration

People Injured by the COVID-19 Vaccine Need More Help from the Federal Government

by Matt Gontarchick

No vaccine is perfect, and unfortunately, COVID-19 vaccines have caused serious adverse side effects in a tiny percentage of people.   For those whose side effects are severe enough to put them out of work or generate high medical bills, the federal government can provide benefits via the Countermeasures Injury Compensation Program (CICP).  This program is not to be confused with the National Vaccine Injury Compensation Program (VICP), which does not address caused by COVID-19 vaccines.  Examples of serious side effects from COVID-19 vaccines can include blood clots, long-lasting shoulder pain, and swelling of the tongue. 

However, the CICP is not up to snuff, and the majority of claims are not being addressed.  As public health officials continue to encourage Americans to get vaccinated against COVID-19, how can the government better serve those who face rare yet serious consequences from doing the right thing and getting their shots?

The CIPC, explained.  Created in 2010, the CICP was created to provide compensation for injuries resulting from any vaccination, medication, or other device that’s recommended to treat against a declared pandemic, epidemic, or security threat such as Ebola, Zika, and anthrax. 

In March 2020, then-HHS Secretary Alex Azar issued a declaration to provide liability immunity for countermeasures like vaccines and treatments related to COVID-19.  He also directed the CICP to provide benefits to individuals who “sustain a serious physical injury or die” from a COVID-19 countermeasure. 

In terms of coverage, the CICP provides $50,000 a year to replace lost wages and reimburse out-of-pocket medical expenses.  If a person dies, a next-of-kin can receive up to $370,376.  Those who are injured by a countermeasure can request compensation by filing a request and submitting medical records within one year from the date the countermeasure was administered.  CICP medical staff then process to review compensation claims, and those who feel their claims are unfairly rejected can review an appeal before an independent panel.   

Unfortunately, many claims are not being address.  As of October 2021, over 1,300 countermeasure claims linked to COVID-19 vaccines remain pending before the CICP independent panel.  Since its creation over a decade ago, the CICP has only compensated 29 claims – none of which stem from the COVID-19 pandemic.

One of these unaddressed claims belongs to Cody Flint, an agricultural pilot from Mississippi who has been experiencing serious health issues after getting vaccinated for COVID-19 in February 2021.  Sen. Cindy Hyde-Smith (R-MS) shared Flint’s story to Health and Human Services (HHS) Secretary Xavier Becerra in a May 4th congressional hearing, where she remarked that CICP has shown a lack of urgency and transparency in addressing claims. 

In response, Becerra didn’t provide any information on how CICP is addressing the backlog of claims.   Instead, he voiced agreement on the importance of providing transparency, and he explained he wants to make sure no one is “gaming the system” so that “those who really have medical issues to report are the ones who are receiving assistance.” 

However, Becerra did seemingly acknowledge that many claims aren’t being addressed, saying “we’ve heard this story before,” and he promised to put a member of his staff in touch with the senator to provide further details. 

Some lawmakers aren’t waiting around for the administration to take action on CICP claims, though.  Hyde-Smith is a cosponsor of the Countermeasure Injury Compensation Fund Amendment Act, which would update CICP’s adjudication framework and create a new commission to look at countermeasures specifically caused by COVID-19 vaccines.  Unfortunately, the backlog of CICP claims hasn’t captured the attention of many lawmakers so far.  The Senate bill has only garnered thee cosponsors as of this writing, and only one House bill has been introduced that would address CICP in some fashion.  Thus, it doesn’t seem like either measure has a shot at advancing in Congress anytime soon. 

While the number of countermeasures arising from COVID-19 vaccines remains incredibly small, people who’ve legitimately suffered from countermeasures deserve compensation.  Although the federal government seems aware of the fact that the CICP claims backlog is nothing short of outstanding, without any additional commentary from top HHS officials like Becerra, it remains unclear if and when the administration will take action to address the backlog.   In the meantime, the best course of action for people impacted by countermeasures is to continue to advocate for changes at CICP, with the hope that more lawmakers will take notice and put pressure on the administration to get the program in order.

FDA

Is Public Pressure Impacting the FDA’s Vaccine Review Strategy?

by Matt Gontarchick

Parents of young children are frustrated and mad.  While adults have been able to get third and even fourth COVID-19 vaccines doses for some time now, children under six years are still unable to get their shots while the rest of society reverts to a pre-pandemic normal.

Anger among parents hit a boiling point last week when White House Chief Medical Advisor Dr. Anthony Fauci confirmed reports that the Food and Drug Administration (FDA) will not approve vaccines for kids under 6 until it can simultaneously review and approve vaccines from both Pfizer and Moderna.

However, less than a week later, FDA officials seemingly changed course when they announced that they may move forward on reviewing Moderna’s vaccine without waiting for Pfizer’s application – meaning that young children could get vaccinated as soon as June.  What caused the FDA to take an about face on its vaccine review strategy?

At the time of Fauci’s comment on April 21, Moderna was poised to begin applying for an emergency use authorization (EUA) within the next week or two, as initial data showed its vaccine generated strong protection in kids.  News that the FDA could soon begin reviewing Moderna’s EUA application set off a sign of relief among parents, who have had to contend with constant delays in the race to get young kids vaccinated.

However, Pfizer’s vaccine for children under 5 is still undergoing clinical trials for a three-dose regimen after results from a two-dose regimen did not yet provide strong protection against the virus, and it’s not clear when Pfizer will be ready to submit its data.  By waiting to review vaccines from both companies, the timeline for getting shots into kids’ arms faced a decent chance of getting extended once again.

What was the FDA thinking?  According to reports,  FDA officials wanted to review vaccines from Moderna and Pfizer simultaneously because approving both at the same time would be less confusing for parents than approving each at different times.  Additionally, FDA officials were worried about a possible backlash from parents if the agency approved Moderna’s vaccine first and Pfizer’s several week later when Pfizer’s vaccine demonstrated stronger efficacy. 

Despite the FDA’s rationale, reports that federal officials were delaying the review process once again elicited a strong backlash from concerned parents and lawmakers.  In the days following Fauci’s comments, lawmakers wrote to the FDA requesting an explanation as to why vaccines for young children were being delayed again, and parents and pediatricians launched an advocacy campaign to urge the FDA to review each vaccine application “at the earliest opportunity.”

Did Public Pressure Make a Difference?

The FDA finally changed its tune on April 29, when a top official announced the agency will consider vaccine applications as soon as they are ready.  While it is not clear if the FDA shifted its strategy purely in response to political and public pressures, it wouldn’t be first time public pressure might have made a difference. 

In mid-2021, the FDA appeared to be on track to approve the vaccine for children aged 5-11 by early fall, just in time for the start of school.  However, in July, the FDA asked Pfizer and Moderna to expand the size of their clinical trials for children to make sure they could detect potentially rare side effects, namely myocarditis, or heart inflammation – effectively pushing the timeline for vaccine approval out to winter 2021 or early 2022.  This drew sharp criticism from parents and pediatricians, who argued that complications from COVID-19 posed a greater threat to kids than myocarditis.

The strongest sign of pressure on the FDA came in the form of an August 2021 letter from the American Academy of Pediatrics (AAP) that called on agency to stick to its original timeline for collecting data and authorize vaccines for children under 12 as soon as possible.  A month after the pediatricians weighed in, the FDA issued an unprecedented statement saying that it would no longer wait for additional follow-up data from expanded clinical trials to made a decision on an EUA and stick to its original timeline. 

Like many things with the pandemic, nothing is certain as the FDA determines how it will review vaccines for younger children.  Moderna only began to submit data for its EUA on April 28, and the FDA has laid out a tentative schedule that leaves open the possibility that kids under 6 could get their shots sometimes this June.  However, things could still change. An FDA official say the agency could still review EUA applications from Moderna and Pfizer simultaneously if both are filed less than a week apart, and many parents and pediatricians say June is still too long of a wait for young kids to get vaccinated, especially considering that the review process for other age groups took less time. 

However, actions undertaken by the FDA last fall and last week suggest that the agency isn’t immune to public pressure.  This sets up a precedent where advocacy could sway the FDA review process in the future – for better or for worse.

Public Health

What’s Next for the Public Health Emergency?

by Matt Gontarchick

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.

FDA

Will We Need More Booster Shots?

by Matt Gontarchick

People will only need annual COVID-19 booster shots after getting their third vaccine dose, according to a top Food and Drug Administration (FDA) official at the 2022 Innovation in Regulatory Science Summit in January 2022.  Since then, however, mounting evidence over waning immunity plus the potential of a new wave of COVID-19 are feeding calls for people to get their fourth vaccine doses sooner rather than later.  Does that mean Americans can expect to get a second booster shot in the coming months?

First, some Americans are already able to get a second booster shot.  According to guidance from the Centers for Disease Control and Prevention (CDC), people ages 12 years and older who are moderately or severely immunocompromised should receive a total of four mRNA vaccine doses.  This includes transplant patients and those undergoing chemotherapy for cancer.

Drug manufacturers are already asking for approval on second boosters for additional populations.  In mid-March, Pfizer and Moderna submitted applications to the FDA for an emergency use authorization (EUA) for a second booster dose of their respective COVID-19 vaccines.  While Pfizer is specifically seeking an EUA for adults over age 65, Moderna is requesting an EUA for anyone over 18 years of age. 

The submission of both applications came just days after Pfizer CEO Albert Bourla said a fourth vaccine dose will probably be needed for everyone.

  • One reason for this is mounting data that shows protection acquired from a third COVID-19 vaccine dose wanes over time.  According to CDC data, a booster shot’s effectiveness in protecting against hospitalization dropped from 91% to 78% between August 2021 and January 2022 – a timeframe that includes both the Delta and Omicron variants. 
  • Another reason for a fourth shot is a need to protect Americans ahead of a new wave of COVID-19 cases.  In recent weeks, a new Omicron subvariant known as BA.2 has driven an increase in cases across Europe, which many experts say could foreshadow an increase in cases in the US within the coming weeks.  Although BA.2 is roughly 30% more transmissible than the original Omicron strain, it does not appear to be more severe or lead to more hospitalizations.  While overall COVID-19 case numbers are still trending downward in the US, 10 states have reported an increase in case numbers over the last 14 days. 

Due to these concerns over waning immunity and growing case numbers, nearly a dozen countries including Australia, Belgium, Denmark, Israel, Poland, Sweden, and the United Kingdom have already begun offering fourth doses, albeit eligibility is limited to seniors and medically vulnerable people in most cases.  Additionally, reports suggest the FDA could authorize second boosters for all adults over age 50 as soon as March 29.  However, that doesn’t necessarily mean the government will follow suit in recommending a fourth mRNA vaccine dose to every individual age 12 and up who’s already cleared to get a third dose anytime soon, as a couple issues stand in the way.  These include:   

  • Regulatory approval.  The FDA’s vaccine advisory committee will meet on April 6 to discuss the need for additional COVID-19 booster shots.  However, the advisory panel will NOT be reviewing any EUA applications from Pfizer or Moderna or taking a vote on recommendations – instead, the committee will discuss the timing and populations for additional doses in the coming months.  The April 6 agenda is a sign of the federal government’s cautious approach to boosters, which means it might take some time for federal regulators to sign off on additional doses, especially for the broader population.  In September 2021, for instance, a CDC advisory panel declined to recommend third doses for people who work in “high-risk” settings like health care practitioners and teachers – a decision which was ultimately overruled by CDC Director Rochelle Walensky.
  • Data.  Even though a number of countries have already cleared fourth shots for certain populations, the jury’s still out on whether a second booster will make a difference for non-elderly adults who are not considered medically vulnerable.  Preliminary results from a study involving 154 health care workers in Israel found that a fourth mRNA dose is only “partially effective” in protecting against the Omicron variant.  Without any strong evidence of the effectiveness of a fourth shot, US regulators are likely to continue to take a cautious approach on recommending additional boosters for the broader population.
  • Funding.  Lawmakers dropped $15 billion in additional COVID-19 funding from the Fiscal Year (FY) 2022 omnibus appropriations bill, and so far, congressional leaders are locked in a stalemate on passing separate legislation on additional COVID-19 support.  Without additional funding, Biden administration officials have warned that they won’t have enough money to purchase a potential fourth vaccine dose for even 70% of all Americans.  And barring additional funding, the federal government will no longer be able to cover the cost of vaccinations for uninsured people starting on April 5, which means uninsured immunocompromised Americans may not be able to afford a booster if they need one.

Ultimately, the trajectory of the COVID-19 pandemic may ultimately inform whether additional boosters are necessary for Americans, and in turn, whether Congress decides to allocate enough money to pay for additional vaccine doses.  While White House Chief Medical Advisor Anthony Fauci has acknowledged that the BA.2 subvariant is likely to cause cases to rise in the US, he doesn’t anticipate new cases will culminate in a major surge that results in high levels of hospitalizations. 

Indeed, a good portion of the US population has acquired some degree of immunity through infection, vaccination, or both over the last two years of the pandemic, which could protect Americas from the worst consequences if case numbers continue to rise over the next few weeks.  However, if hospitalizations suddenly spike across multiple populations, it may be too late for the federal government to act swiftly on additional boosters.

FDA

What Would the End of the Public Health Emergency Mean for EUAs?

by Matt Gontarchick

The current public health emergency (PHE) is set to expire on April 16.  While the Biden administration is likely to extend the PHE, administration officials have yet to comment on their specific plans.  Uncertainty over the end of the PHE has fueled conversations over what the implications would look like for temporary health care policies that expire once the PHE officially concludes. 

Blog posts from the last two weeks have looked at how the end of the PHE would affect Medicare’s temporary telehealth waivers and Medicaid coverage.  This week’s blog post focuses on how ending the PHE would impact the Food and Drug Administration’s (FDA) emergency use authorizations (EUAs).

Background:  An EUA allows the FDA to authorize unapproved medical products or unapproved uses of approved medical products – like vaccines and treatments – to be used to diagnose, treat, or prevent serious or life-threatening diseases in cases where there are no adequate, approved, and available alternatives.  Since the start of the COVID-19 PHE on January 31, 2020, the FDA issued hundreds of EUAs for pharmaceutical and medical devices related to COVID-19.

How? Section 564 of the Federal Food, Drug and Cosmetic (FD&C) Act allows the FDA to issue four different types of EUAs during a PHE for diagnostics, respiratory equipment, medical devices, and drugs/biologics.  However, the FDA still has the authority to issue an EUA outside of a PHE thanks to the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) of 2013, which grants Department of Health and Human Services flexibility to declare that “circumstances exist” outside of a PHE to allow EUAs to be issued.

What does the end of the PHE mean for the EUAs?  Unlike the other temporary authorities related to telehealth and Medicaid, all EUAs that are issued by the FDA remain in effect until the FDA withdraws the EUA declaration.  For instance, the EUA declarations issued for the Zika and Ebola pandemics were never withdrawn and are currently in effect, even though their respective PHEs have long since expired. 

However, one FDA policy, separate from EUAs, will expire at the conclusion of the PHE – enforcement discretion.  This policy allows the FDA to waive enforcement of its usual requirements for pre-market approval to allow drug products to be modified for additional uses without full approval from the agency.  In contrast, drug products approved via an EUA must still meet specific criteria on safety and effectiveness.  Once the PHE ends, the FDA will revert to its regular enforcement policies, and all products where enforcement discretion once applied must then meet all standard FDA legal requirements in order to continue to be sold in the US.  

Planning for a Post-EUA Future

Unlike the EUAs for Zika and Ebola treatments, the FDA has communicated that it doesn’t want the COVID-19 EUAs to stick around forever and manufacturers should expect an “eventual resumption of normal operations.”  To this end, the FDA issued two draft guidance documents in late December to help facilitate a return to normal:

Uncertain Future for Stakeholders

On February 22, the FDA held a webinar for industry stakeholders about its draft guidance documents on its post-pandemic transition plans, and like their counterparts in telehealth and Medicaid, the stakeholders from the pharmaceutical and medical device industries had a lot of questions. 

  • Of the four EUA declarations, three are specific to devices, and it’s not clear if the agency will withdraw those EUAs all at once or at different times.
  • The webinar did not offer stakeholders a clear answer on whether HHS issues the advance notice on withdrawing the EUA declarations first, or FDA will finalize its two guidance documents on its transition plans.   Instead, FDA staff told attendees that whatever happens first depends on the course of the pandemic.  If hospitalizations continue to decline and stay low, HHS may pull the EUA declarations first; otherwise, finalization of the guidance documents could come sooner.
  • The FDA says more guidance is on the way, but it’s unknown when it will be released.  According to FDA staff, this would pertain to the types of data FDA will consider when transitioning a drug product from an EUA to formal market access, such as how real-world evidence will be considered. 

While pharmaceutical industry stakeholders can feel relieved that EUAs won’t expire with the end of the PHE and that the FDA is making plans for a post-pandemic world, question about what that world will look like simply add to the narrative that the federal government’s take on health care policies once the PHE ends need significant refinement.

Administration

Why Aren’t Rapid COVID-19 Tests More Readily Available in the US?

by Matt Gontarchick

“Should we just send one to every American?”  That’s what White House Press Secretary said on December 7 when asked during a press briefing why more Americans don’t have access to rapid antigen tests. Psaki’s response – which many deemed sarcastic – sparked a wave of backlash from members of the medical community who think that’s exactly what the Biden administration should do and make tests available to everyone at no cost.  So why isn’t the administration doing it?

Rapid tests are seen as an important public health tool for reducing the spread of COVID-19 because they can be used at home by an individual and provide results in as little as 15 minutes.  While not as accurate as PCR tests, rapid tests are available over- the-counter, which makes it easier and more convenient for people to get access tests.  And more people taking rapid tests would mean identifying more COVID-19 cases than would otherwise be possible with only PCR testing. Having an increase in access to rapid tests could also make forthcoming COVID-19 antiviral pills more useful, since their effectiveness depends on being taken within the first five days of illness.  Due to the convenience of rapid tests and their potential to stop the spread of COVID-19, some public health experts have pointed to over-the-counter tests as a way to potentially control the pandemic and return to “normal life.”

Currently, the availability of rapid tests in the US pales in comparison to other wealthy nations, where people can readily access tests at little or no cost.  In Germany, rapid tests are available in grocery stores for less than $1, while people in the United Kingdom can request mail-order rapid tests free-of-charge.

Here are some of the reasons why Americans can’t get rapid tests as easily as Germans or the British.

  • Regulatory issues.  Some manufacturers say the regulatory framework on rapid tests is too stringent because it requires test performance benchmarks to be at the same level of PCR tests, which test developers say is too high.  Additionally, US standards for approval are higher compared to some other peer nations, including the UK.
  • Supply chain problems.  There has been a consistent shortage of raw materials used to manufacture the diagnostic components of at-home tests.  Additionally, low COVID-19 case numbers during the summer caused some manufacturers like Abbott to pull-back on test production, leaving the company unable to keep up with increased demand for tests once case numbers began to jump in July 2021.
  • Lack of federal investment.  While the US government has invested billions of dollars into the development of vaccines, much less has been put towards the development and purchase of rapid tests.  In contrast, countries like the UK and Germany invested billions in both vaccines and at-home tests.   

Fortunately, rapid tests are a part of the Biden administration’s plans to combat COVID-19.  On December 2, President Joe Biden announced that insurance companies will soon reimburse individuals who buy over-the-counter rapid tests.  Other recent actions the administration has taken include investing $650 million to strengthen manufacturing capacity for rapid tests and a $70 million investment to develop an accelerated pathway within the Food and Drug Administration (FDA) to evaluate rapid tests.

But…rapid tests might not make a huge difference, anyway.  While rapid tests were frequently lauded by public health officials as a way to curb the pandemic, real-world evidence in countries where rapid tests are readily available suggests otherwise. In Germany, infections, hospitalizations, and deaths have increased dramatically since October, while the UK has seen COVID-19 case numbers grow since restrictions were fully lifted in July (although hospitalizations and deaths remain low). 

And even though Biden recently committed to new investments in testing, which could result in 300 million new rapid tests per month, it would still amount to less than one test per month per person in the US. 

While convenience of rapid tests is undeniable, a boost in the availability of tests might accomplish little in the US, where most of the country is already grappling with a surge of new cases.

Administration

Will the Definition of “Fully Vaccinated” Change?

by Matt Gontarchick

Right now, “fully vaccinated” means two shots of an mRNA vaccine or one shot of the Johnson & Johnson vaccine.  But that could change.  In a recent interview, NIAID Director Dr. Anthony Fauci said the definition of fully vaccinated could change from two to three mRNA doses as mounting evidence shows waning efficacy of a two-dose regimen over time.  With the administration now recommending all US adults to get their COVID-19 booster shots, is it just a matter of time until the definition of fully vaccinated changes from two to three doses?

The Evidence for One More Shot

Evidence shows that the immunity against infection from COVD-19 does wane over time, including cases that are asymptomatic or mildly symptomatic.  A study from the Centers for Disease Control and Prevention (CDC) published in September found effectiveness against infection among adults in New York fell from 92% to 75% between May and July 2021.  Additionally, a study based on data from the Veterans Health Administration (VHA) found effectiveness against infection among veterans fell from 88% to 48% between February and October 2021.

However, evidence suggests that vaccine effectiveness against severe disease and hospitalization remains strong, despite declining protection against infection  The New York study found vaccine effectiveness in preventing hospitalization only declined from 95% to 90% over the three-month period, while a study in the Netherlands found vaccine effectiveness against hospitalization remained unchanged at 94% between July and October 2021. 

New Variant, New Urgency

Concerns that the new Omicron variant is both more transmissible and may be somewhat resistant to immunity from vaccines or prior infection is underscoring an emphasis from the Biden administration on booster shots.  On November 29, the CDC updated its COVID-19 booster recommendations to say everyone ages 18 and older “should” get a booster shot as added protection against the new variant.  A few days later, President Joe Biden announced a new plan to ensure that the nearly 100 million eligible Americans who have not yet received their booster shots do so as soon as possible.  The plan includes:

  • Sending texts, calls, and emails to eligible Americans.
  • Launching a new public education campaign.
  • Expanding pharmacy availability through December 2021.

While it’s too early to tell how much protection current vaccines will offer against the Omicron variant, experts say the higher antibody response generated by a booster shot could provide broad protection against new variants.  Experts are also keen to stress that Delta remains the dominant variant in the US, and it remains unknown if Omicron will eventually become the new dominant strain.  With the Delta variant already contributing to a rise in cases nationwide, booster shots remain as important as ever. 

If booster shots are so important regardless of which variant is circulating, then why doesn’t the administration just change the definition of fully vaccinated from two shots to three?  First of all, some public health experts fear changing the definition suddenly could spark confusion.  The FDA and CDC only authorized booster shots for all American adults just before Thanksgiving, and new changes could be problematic given the current administration’s challenges in communicating public health information and guidelines. 

More importantly, changing the definition of fully vaccinated to three shots could undermine efforts to reach Americans who have yet to receive their first two shots.  Only about 60% of American adults have been fully vaccinated, and some public health experts believe efforts to reach the unvaccinated would be more effective in preventing a spike in hospitalizations than convincing young, health Americans to get a third dose.  Still as evidence on waning immunity mounts and concerns over the Omicron variant rise, it remains a possibility that the federal government could revise its definition of fully vaccinated some time next year. 

FDA

Will COVID-19 Antiviral Pills Make a Difference?

by Matt Gontarchick

A new era in treating COVID-19 could be upon us. On November 30, the Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) will discuss Merck’s request for an emergency use authorization (EUA) for Molnupiravir, an  oral antiviral drug to treat COVID-19.  But Molnupiravir isn’t the only oral COVID-19 antiviral in the mix – in October 2021, Pfizer requested an EUA for Paxlovid, its antiviral pill.  If FDA advisors recommend an EUA for Molnupiravir, and eventually Paxlovid, could it change the course of the pandemic as we know it?

The FDA has already authorized a few treatments for COVID-19, but they have serious drawbacks.

  • Remdesivir the only treatment to have received full FDA approval, has limitations.  For example, it has to be administered intravenously (meaning it’s difficult to provide in an outpatient setting), it’s expensive (about $2,600 for a three-day regimen), and recent research says it’s not very effective.
  • Monoclonal antibodies, which have received an EUA from the FDA, offers another treatment option. While studies show monoclonal antibodies are effective at reducing hospitalization and death, they suffer from many of the same drawbacks as remdesivir – they still have to be provided intravenously, and they’re still expensive (about $2,000 per treatment).

Enter Molnupiravir and Paxlovid. Both antiviral drugs stop SARS-CoV-2, the virus that causes COVID-19, from replicating in the body, but do so in different ways.  Molnupiravir, which was first developed as a flu treatment, works by fooling the virus’s RNA into creating mutations that render the virus unable to survive.  Paxlovid takes a different approach by disrupting the virus’s replication by destroying enzymes vital to its reproduction.

Both treatments offer clear advantages compared to their predecessors. A prominent advantage is early intervention, which is key to administering antiviral treatments.

  • Severe COVID-19 has two stages – one where the virus initially infects a person, and another when the immune system overreacts and spirals out of control. Remdesivir is typically administered in the second phase, when a patient is already hospitalized – and the damage may already be done.
  • Molnupiravir and Paxlovid, on the other hand, attack the virus before it can wreak havoc and put people in the hospital, avoiding further stress on the health care system.  

Additionally, both antiviral pills can be administered orally, meaning patients can take them in any setting. And unlike intravenous treatments, Merck and Pfizer’s antiviral drugs are much easier to ship and store.

  • Oh, and about that name. Molnupiravir comes from Mjölnir, the mythical hammer of the Norse god Thor.

Plans for distribution of the antiviral pills are shaping up.  The Biden administration purchased 1.7 million courses of Molnupiravir for $1.2 billion back in June and is now considering options to buy 1.4 million more.  Based on this agreement, Molnupiravir will cost roughly  $700 per patient, a more than 50% reduction from currently approved treatments.

Additionally, the administration is planning to buy enough courses of Paxlovid for 10 million people.  To allow their drugs to be manufactured around the globe and sold at lower prices in poorer countries, both Merck and Pfizer have entered into license-sharing agreements.

However, Molnupirabir and Paxlovid aren’t magic bullets, and while they are far better than currently approved treatment options, they still have limitations of their own.

  • First, both have a strict dosing regimen.  Each must be taken over a five-day period, with Molnupiravir taken four times a day and Paxlovid taken three times a day. 
  • Second, both antivirals must be taken within the first five days of illness.  Unfortunately, a lack of access to both rapid at-home antigen tests and testing labs that can quickly process PCR results means the onset of symptoms, a positive test result, and a prescription for an oral antiviral may exceed the five-day window.
  • Third, there are questions about the efficacy of the oral antivirals.  Merck originally reported in October 2020 that Molnupiravir reduces risk of hospitalization or death by 50%.  However, in November, updated data from Merck revealed that its antiviral only cut the risk of hospitalization and death by 30%.  Pfizer says that Paxlovid reduces the risk of hospitalization and death by 89%, but these results have yet to be peer-reviewed.

Despite these limitations, both Molnupiravir and Paxlovid could be the most important pharmaceutical development since the introduction of vaccines. However, just like vaccines won’t make a difference until people get their shots, new antiviral pills won’t help unless people take them. If the administration wants to ensure oral antivirals are utilized effectively , it needs to drastically improve the testing infrastructure and ensure adequate distribution to suppliers. Doing so will ensure as many people as necessary have access to antivirals and allow the new drugs to be an effective additional tool to fight the pandemic.  

CMS

Where Are We at with Medicare’s Temporary Telehealth Waivers?

by Matt Gontarchick

Telehealth usage has exploded during the COVID-19 pandemic, thanks to legislation like the CARES Act that expanded Medicare coverage of telehealth services to make it easier for beneficiaries to access health care services while minimizing their exposure to COVID-19.  Now that the final stage of the pandemic is (hopefully) winding down, what are the implications for telehealth? 

It’s all about the PHE.  Expanded telehealth coverage is set to expire at the end of the COVID-19 public health emergency (PHE), which is currently January 16, 2021.  The Secretary of the Health and Human Services (HHS) has the authority to renew the PHE for 90-day increments, meaning the PHE could potentially extend through April 2022 – or longer.  Below are key Medicare telehealth coverage restrictions and rules that have been waived for the duration of the PHE.

  • Qualifying Technology: Medicare may now cover telehealth services conducted through devices like smartphones that offer audio-visual capabilities and can be used to facilitate two-way, real-time communication between a beneficiary and a practitioner.  Previously, this was limited to beneficiaries in rural areas.  Additionally, the requirement for visual capabilities is now waived for certain services, meaning some beneficiaries can now use audio-only telehealth services.
  • Geographic Location: Medicare will reimburse for telehealth services anywhere in the US, with no pre-existing patient relationship required.
  • Qualifying Service: Medicare can reimburse 238 telehealth services, compared to 101 prior to the PHE. 
  • Qualifying Originating Site Type: Telehealth services can be provided to all patients in all settings, including at a beneficiary’s home.
  • Qualifying Site Practitioner: Any health care practitioner who can bill Medicare may now furnish Medicare telehealth service.

All of these temporary changes expire once the PHE ends, but Congress could take action and can change that. Lawmakers from both parties have been pushing to take some of these temporary telehealth coverage extensions and make them permanent, beyond the PHE. 

  • Several bills (S. 368, S. 1988, H.R. 341, H.R. 1332, and H.R. 5425) would strike Medicare’s geographic site originating requirement and allow Medicare beneficiaries to access telehealth services in all settings. 
  • Another (H.R. 2168) would permanently allow audiologists, physical therapists, occupational therapists, speech-language pathologists, and other providers to provide telehealth services under Medicare.
  • Additional bills (H.R. 5425 and S. 1988) would ensure permanent Medicare coverage of certain telehealth services using audio-only technology.

However, none of these have bills have advanced in either chamber since their introduction, and the Build Back Better Act, Democrats’ social spending and climate package, does not contain any provisions that address Medicare coverage of telehealth services.

It would be amiss not to highlight a major barrier to continued telehealth coverage is reimbursement.  Under the PHE, telehealth services are reimbursed under Medicare at the same rate as in-person services, and lawmakers and stakeholders disagree over whether permanently expanded telehealth services should be reimbursed at or below the level of in-person services. 

So, what does the future hold for telehealth?  In summer and fall 2020, more than a quarter of Medicare beneficiaries used telehealth services, representing a massive increase in telehealth utilization since before the pandemic.  Given that the waiver of Medicare’s telehealth restrictions will expire once the PHE ends, the question of what telehealth coverage will look like post-pandemic looms large.  The numerous proposals on Capitol Hill to expand certain telehealth flexibilities suggest lawmakers want to ensure beneficiaries have continued access to telehealth services.  However, absent any serious progress on these proposals, Medicare beneficiaries are still staring down the very real possibility of losing popular, safe, and convenient ways to access medical treatment that they gained in the early days of the pandemic.   

Administration

What’s Going on with Booster Shots?

by Matt Gontarchick

There’s been a lot of discussion about COVID-19 booster shots lately – so much so, that it’s hard to keep track of who can get booster shots and what kind of booster shots are available.  Here, we provide a lay of the land on booster shots.

Why are booster shots necessary?  Booster shots provide an extra “boost” to immunity through an additional dose that cues the immune system to produce a stronger antibody response.  While all three currently approved vaccines from Pfizer, Moderna, and Johnson & Johnson are highly effective in protecting against hospitalization and death, a growing number of studies show that vaccine efficacy gradually wanes over time. 

Who can get booster shots now?  Pfizer’s COVID-19 vaccine is the only vaccine that is currently authorized by the Food and Drug Administration (FDA) to be used as a booster dose.  The FDA formally amended the emergency authorization use (EUA) for the Pfizer vaccine on September 22.  According to the amended EUA, the following people are eligible for booster shots at least six months after their initial series of shots:

  • People over age 65.
  • People ages 18 to 64 at high risk of severe COVID-19 due to chronic medical conditions or compromised immune systems.
  • People with greater risk of workplace exposure, such as frontline medical workers, teachers, and emergency responders.

More booster shots are on the way.  The FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted during an October 14-15 public meeting to recommend booster doses from Moderna and Johnson & Johnson. The panel recommended the Moderna booster be administered under the same criteria as Pfizer’s – six months after the second dose for people over 65, individuals at risk for serious complication from COVID-19, and essential workers.  However, the panel recommended broader criteria for the Johnson & Johnson booster – it said anyone who received the single dose Johnson & Johnson vaccine should be eligible to receive a second booster dose at least two months later. 

  • Why? Several studies have shown the Johnson & Johnson vaccine is less effective that other currently approved shots, particularly against new variants like Delta.

What happens next: The CDC Advisory Committee on Immunization Practices (ACIP) will meet on October 20-21 to offer its recommendations on who should get the Moderna and Johnson & Johnson booster shots.  Its recommendations are subject to a final decision from the CDC director.  Afterwards, the FDA could officially authorize booster shots from both companies in the following days. 

The conversation on booster shots hasn’t been without controversy.  Over the past few months, scientists, researchers, and public health officials within the federal government haven’t seen eye-to-eye on when booster shots should become available, and who should get them. 

  • For example, CDC Director Rochelle Walensky partially overruled ACIP last month when the panel initially declined to offer booster shots for essential workers under 65 who do not have chronic medical conditions.  Some ACIP members said that without additional data, they weren’t comfortable automatically allowing younger people to get boosters just because of their jobs.  While Walensky acknowledged the panel’s uncertainty, she said in a statement that CDC must use “imperfect data” to “take actions that we anticipate will do the greatest good.”
  • There are also ethical considerations as billions worldwide remain unvaccinated.  While many public health experts believe people with chronic health conditions should get additional shots, they feel extra doses should be allocated to countries with low vaccination rates first in order to prevent more dangerous variants from developing. 

The administration’s internal disputes have been quite apparent to the public.  Back in August, President Biden announced a plan to start distributing booster shots to all eligible Americans as soon as September 20.  However, the health care agencies tasked with rolling out boosters have taken a more conservative approach, and one month later after Biden’s original deadline, only certain segments of the population have access to one vaccine booster.   

With limited information and uncertainty about the future of the virus, administration officials are between a rock and a hard place.  On one hand, federal officials don’t have enough data to make definitive decisions on who needs a booster and how much a booster would improve efficacy.  On the other hand, the administration knows it can’t wait for definitive findings to become available, especially if case number surge once again in the next few months as colder temperatures drive more Americans indoors.

At the end of the day, COVID-19 is still a novel virus, and there are many unanswered questions on how long protection from vaccines last and how much that protection varies between different groups of people.  While new data on vaccines will continue to gradually become available, federal health officials will have to continue discussing and weighing the risks and benefits of authorizing vaccines in the US.