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It’s time to reopen the US Capitol to visitors, say a growing number of lawmakers. Last month, 26 Republicans senators cosponsored a resolution to reopen the US Capitol and Senate Office buildings to the public, and Sen. Gary Peters (D-MI) said he’s supportive of restarting tours in the Capitol building. Even external stakeholder are joining the call – the National Institute for Lobbying and Ethics sent a letter to congressional leaders today urging leadership to start a dialogue with them on how to reopen the Capitol to the public without appointments .
But Congress can’t reopen to the American people without staff members to take meetings and give tours. Like a lot of Americans, congressional staff have spent most of the past two years working remotely while wearing casual, everyday attire. What does this mean for the dress code once staffers return to in-person work in Washington?
Before the pandemic, congressional staff wore professional, business attire on days Congress was in session, while casual attire was permitted when Congress was in recess.
Since May 2021, staff have been gradually returning to in-person work in Congress, although the actual number of people in offices have shifted based on the surges of the pandemic ( for instance, in early January 2022the Office of Attending Physician urged staff to return to “maximal telework” due to a surge of the Omicron variant ). Since then, DC-based staff have been dressing more casually in congressional offices, although some exceptions remain. For example, professional attire is still the norm when appearing on the House or Senate floor or in a committee hearing. Additionally, staff for congressional leadership like Speaker and the Senate Majority Leader also tends to lean professional.
It’s no surprise that most congressional staff reporting to work in-person can get away with more casual attire when they aren’t taking in-person meetings as congressional offices and the Capitol are still effectively closed to visitors. Therefore, what does this mean for when the US Capitol Complex reopens to the public?
While the pandemic has shaken up many aspects of office life, dress codes on Capitol Hill aren’t likely to change significantly, at least for when Congress is in session. Even though office workers throughout the US have been drifting towards casual clothing more and more in the years leading up to the pandemic, attire in the halls (and offices) of Congress have been slow to change. Even amid the brutally hot summers of DC, congressional staff still make their way to Capitol Hill in suits. Once visitors return to the Hill, staffers are likely to greet them in the kind of professional attire they would have seen pre-pandemic – albeit with some slightly casual tones.
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:
- Transition Plan for Medical Devices Issued EUAs During the COVID-19 Public Health Emergency. This provides a plan for manufacturers of drug products that received an EUA to seek formal market access (including a three-phase transition process with specific timelines for complying with regulations and submitting market application). It says HHS would issue an advanced notice of termination of the EUA declaration 180 days in advance.
- Transition Plan for Medical Devices that Fall Within Enforcement Policies Issued During the COVID-19 Public Health Emergency. This would also allow a three-phase transition process for manufacturers to seek formal market access decisions for modified use of their products, or to revert their products back to previous authorizations.
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.
White House Unveils New COVID-19 Strategy
On Wednesday, the White House unveiled a new pandemic road map that’s centered around four main goals: (1) protecting and treating against COVID-19; (2) preparing for new variants; (3) preventing business and school shutdowns; and (4) helping to vaccinate the rest of the world. A key feature of the new plan is a “test to treat” system to be deployed to hundreds of pharmacies that will allow high-risk individuals to be provided antiviral pills free-of-charge if they test positive for COVID-19. The plan is part of a broader initiative that centered around returning to a new normal while preparing for the possibility of new variants. However, implementing the road maps largely depends on funding from Congress, and it remains unclear if the White House can win the support of Republicans who have been demanding more transparency on existing COVID-19 aid.
Senate Strikes Down Vaccine Mandate in Symbolic Vote
The Senate voted 49-44 on Wednesday in favor of a joint resolution to strike the administration’s vaccine mandate for health care workers. Even though all Democratic senators, who were present for the vote, opposed the resolution there were too many Democratic absences that Republicans were able to pass the measure by a party-line vote. Many Republican lawmakers oppose the vaccine mandate because they say it is exacerbating the shortage of health care workers, especially in rural areas. However, the resolution is almost certain to fail in the Democrat-controlled House, and the White House has already threatened to veto the measure.
Administration Announces New Nursing Home Safety Initiatives
On Monday, the White House announced new initiatives to make nursing homes safer, which included minimum staffing levels, limits to the number of residents housed in a single room, and steps to improve inspections. Additionally, the administration said it will increase fines at poorly operated nursing homes from $21,000 to $1 million. Of note, the White House admonished private equity firms in its announcement for their alleged role in declining nursing home quality. The announcement follows a difficult two-year period that exposed the lack of safety measures in place for nursing homes and saw over 200,000 nursing home residents and staff die from COVID-19. The administration will issue rulemaking over the coming months to carry out the initiatives, and it will ask Congress to provide nearly $500 million in new Medicare funding to boost inspections.
Inhofe to Retire Early Next Year
On February 28, Sen. James Inhofe (R-OK) announced he will retire from the US Senate on January 3, 2023, four years earlier than the end of his current term in 2027. While the 87-year-old senator declined to provide a reason for his retirement, reports suggest his wife’s health may have been a factor. Inhofe served as an Oklahoma state lawmaker and as Mayor of Tulsa before being elected to the US House of Representatives in 1986 and later the US Senate in 1994, where he went on to chair the committees on Armed Services and Environment and Public Works. Inhofe is also an avid aviator and is the only member of Congress to have flown an airplane around the world. Oklahomans will choose Inhofe’s successor in a special election this November. Already, three Republicans have announced their intent to run in the deep-red state, including Rep. Markwayne Mullin (R-OK), former Inhofe chief of staff Luke Holland, whom Inhofe has endorsed; and Republican state Sen. Nathan Dahm.
ICYMI: Landmarks Across DC Show Support for Ukraine
Since Russia began its unlawful invasion of Ukraine over a week ago, countless buildings and landmarks across the Washington, DC area have been shining blue and gold lights in support of Ukraine. Some of the buildings and structures to feature the colors of the Ukrainian flag include the Basilica of the National Shrine, the National Cathedral, the Frederick Douglass Memorial Bridge, the George Washington Masonic Temple, and the Kennedy Center. Additionally, Ukrainian flags currently fly along Pennsylvania Avenue NW between the White House and the US Capitol.
An abrupt end to the public health emergency (PHE) on April 16 could shock the health care system – absent any new laws or regulations to extend the PHE’s popular emergency provisions. Last week’s blog post discussed some of the important Medicare telehealth waivers currently in place due to the PHE, and how ending the PHE would affect access to these health care services. This week’s blog post focuses on what ending the PHE would mean for Medicaid and the millions of people who’ve gained coverage since the pandemic started.
Background: Medicaid is a federal and state health insurance program that provides health coverage for eligible low-income adults, children, pregnant women, elderly adults, and people with disabilities. Currently, 76 million Americans – nearly a quarter of the US population – is covered by Medicaid or the Children’s Health Insurance Program (CHIP), a program that focuses on children.
Then came the pandemic. To ensure continuous health care coverage, Congress enacted the Families First Coronavirus Response Act in March 2020, which gave states a 6.2% Federal Medical Assistance Percentage (FMAP) increase if they agreed to maintain eligibility levels in place at the time.
Before the PHE went into effect, states regularly reviewed whether people still qualified for coverage based on income, age, disability status, and other factors. Since the PHE began, however, state Medicaid agencies have been prohibited from disenrolling anyone during the pandemic.
The end of the PHE could eventually trigger a tsunami of coverage losses, which experts project would affect 15 million Americans – including 6.7 million children Once the PHE ends, state Medicaid officials will be tasked with evaluating the eligibility requirements of all their enrollees, which they did not need to do over the past year and half. Beneficiaries who earn too much money or failed to provide necessary information about income or residency could be dropped from their coverage, leaving them uninsured for a period of time with Medicaid programs facing the resurface of the “churn.”
However, the PHE’s end wouldn’t immediately cause millions to lose coverage. The administration has said that the additional Medicaid funds provided through the FMAP increase would last until the end of the quarter when the PHE expires, meaning that if the PHE truly ends on April 16, the additional Medicaid funds would last until June 30 – giving state Medicaid officials some breathing room.
The administration has also said it would give state Medicaid agencies a year to redetermine eligibility for current enrollees, but many states could be pressed to reevaluate immediately and ultimately drop coverage for some beneficiaries due to financial pressures.
What happens next? The Biden administration has not specifically said whether it will extend the PHE or let it expire on April 16 . However, as an indication of what the administration may do, the Centers for Medicare and Medicaid Services (CMS) put out a request for information (RFI) on February 17 seeking feedback to develop a more comprehensive strategy on Medicaid and CHIP. According to the RFI, CMS is looking for specific feedback on access to health care, including maintaining coverage and looking to improve provider participation by ensuring adequate provider payment rates to encourage provider availability and quality.
Absent specific actions from the federal government, states should consider these steps to blunt the impact of coverage losses:
- Use available funding sources like COVID-19 relief funds to invest in community-based navigators to educate beneficiaries about their coverage options, like ACA marketplace coverage.
- Improve the redetermination process by establishing an automated review process that uses different data sources to verify eligibility.
- Use multiple outreach strategies like telephone, email, and text to contact beneficiaries who are harder to reach and for whom state Medicaid offices has received returned mail.
