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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.

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What Happened, What You Missed: April 11-15

Administration Extends PHE, Transportation Mask Mandate

On Tuesday, Secretary of Health and Human Services (HHS) Xavier Becerra issued a 90-day renewal of the public health emergency that was initially set to expire on April 16.  The renewal ensures that Medicaid coverage protections, telehealth services, and other waivers tied to the PHE will continue through at least July 15, 2022.  While the administration has declined to say how long the PHE will continue, Secretary Becerra has repeatedly stated that HHS would give 60 days’ notice before ending the PHE.  On Wednesday, the administration also announced a 15-day extension of the transportation mask mandate through May 3, 2022.  According to a press release, the administration is keeping the mandate in place as it assesses the impact for rising COVID-19 case numbers on severe disease and hospitalization.  In recent weeks, the airline industry has been lobbying the administration to wind down the transportation mask mandate, citing advanced air filtration systems on board aircrafts.

Pfizer to Seek FDA Authorization for Booster in Kids Ages 5-11

Pfizer announced on Thursday that it will soon ask the Food and Drug Administration (FDA) to issue an Emergency Use Authorization (EUA) for a third “booster” dose of its COVID-19 vaccine for kids  five through 11.  The announcement comes after data from the phase 2/3 clinical trial, which revealed that a third dose administered six months after the initial two-dose regimen yielded enough antibodies to neutralize both the original COVID-19 strain and the Omicron variant.  While the results are welcoming news, scientists are concerned that Pfizer’s booster dose may only provide a few months of protection against infection.  For instance, antibodies generated from a booster dose of the Pfizer vaccine in adults wane after about four months. However, Pfizer has yet to make the data available to outside scientists for review.

CMS Proposes Pay Cut for Nursing Homes

On Monday, the Centers for Medicare and Medicaid Services (CMS) announced  a proposed rule that plans to decrease Medicare Part A payments to skilled nursing facilities (SNFs) by around $320 million in Fiscal Year (FY) 2023.  The payment cut is partially in response to a new payment system implemented in FY 2020 that ended up paying SNFs 5% more than initially anticipated.  The proposed rule also asked for feedback on how to code for residents in isolation, the quality reporting program, and how CMS should create minimum staffing requirements.  The deadline for stakeholders to submit feedback is June 10, 2022.

House Appropriators to Begin Marking Up FY23 Spending Bills in June

The House Appropriations Committee is reportedly planning to begin marking up its FY 2023 spending bills in June, which means the bills could be up for consideration on the House floor by July.  Tentatively, subcommittees are planning to mark up their 12 spending bills from June 13-22, while the full committee would hold its markups June 22-30.  Appropriations committee leaders have voiced a desire to reach agreements on spending bills much quicker than they did for FY 2022, which wasn’t finalized until an omnibus was signed into law last month.  During a March 31 subcommittee hearing, Chairwoman Rosa DeLauro expressed a desire to pass all appropriations bills “on time” so they can be signed into law by September 30, 2022.

ICYMI: Rabid Fox Bites 9 around US Capitol Complex

Last week, a rabid fox bit nine people around the US Capitol Grounds, including Rep. Ami Bera (D-CA).  While foxes are common in the Washington, DC metropolitan area, last Wednesday’s incident marks the first time a fox has been spotted in the US Capitol Complex since 2014.  Out of an abundance of caution, Rep. Bera and the other individuals bitten went on to get rabies and tetanus shots.  The Humane Rescue Alliance eventually captured and euthanized the fox after it tested positive for the rabies virus.

Administration Extends PHE, Transportation Mask Mandate On Tuesday, Secretary of Health and Human Services (HHS) Xavier Becerra issued a 90-day renewal of the public health emergency that was initially set to expire on April 16. The renewal ensures that Medicaid coverage protections, telehealth services, and other waivers tied to the PHE will continue through at least July 15, 2022. While the administration has declined to say how long the PHE will continue, Secretary Becerra has repeatedly stated that HHS would give 60 days’ notice before ending the PHE. On Wednesday, the administration also announced a 15-day extension of the transportation mask mandate through May 3, 2022. According to a press release, the administration is keeping the mandate in place as it assesses the impact for rising COVID-19 case numbers on severe disease and hospitalization. In recent weeks, the airline industry has been lobbying the administration to wind down the transportation mask mandate, citing advanced air filtration systems on board aircrafts. Pfizer to Seek FDA Authorization for Booster in Kids Ages 5-11 Pfizer announced on Thursday that it will soon ask the Food and Drug Administration (FDA) to issue an Emergency Use Authorization (EUA) for a third “booster” dose of its COVID-19 vaccine for kids five through 11. The announcement comes after data from the phase 2/3 clinical trial, which revealed that a third dose administered six months after the initial two-dose regimen yielded enough antibodies to neutralize both the original COVID-19 strain and the Omicron variant. While the results are welcoming news, scientists are concerned that Pfizer’s booster dose may only provide a few months of protection against infection. For instance, antibodies generated from a booster dose of the Pfizer vaccine in adults wane after about four months. However, Pfizer has yet to make the data available to outside scientists for review. CMS Proposes Pay Cut for Nursing Homes On Monday, the Centers for Medicare and Medicaid Services (CMS) announced a proposed rule that plans to decrease Medicare Part A payments to skilled nursing facilities (SNFs) by around $320 million in Fiscal Year (FY) 2023. The payment cut is partially in response to a new payment system implemented in FY 2020 that ended up paying SNFs 5% more than initially anticipated. The proposed rule also asked for feedback on how to code for residents in isolation, the quality reporting program, and how CMS should create minimum staffing requirements. The deadline for stakeholders to submit feedback is June 10, 2022. House Appropriators to Begin Marking Up FY23 Spending Bills in June The House Appropriations Committee is reportedly planning to begin marking up its FY 2023 spending bills in June, which means the bills could be up for consideration on the House floor by July. Tentatively, subcommittees are planning to mark up their 12 spending bills from June 13-22, while the full committee would hold its markups June 22-30. Appropriations committee leaders have voiced a desire to reach agreements on spending bills much quicker than they did for FY 2022, which wasn’t finalized until an omnibus was signed into law last month. During a March 31 subcommittee hearing, Chairwoman Rosa DeLauro expressed a desire to pass all appropriations bills “on time” so they can be signed into law by September 30, 2022. ICYMI: Rabid Fox Bites 9 around US Capitol Complex Last week, a rabid fox bit nine people around the US Capitol Grounds, including Rep. Ami Bera (D-CA). While foxes are common in the Washington, DC metropolitan area, last Wednesday’s incident marks the first time a fox has been spotted in the US Capitol Complex since 2014. Out of an abundance of caution, Rep. Bera and the other individuals bitten went on to get rabies and tetanus shots. The Humane Rescue Alliance eventually captured and euthanized the fox after it tested positive for the rabies virus.

Members of Congress Related to Celebrities

Most members of Congress aren’t household names, but quite a few have people in their family who are, particularly in the world of film and television.  Here are some notable celebrity-lawmaker connections.

Rep. Fred Upton (R-MI)

The Michigan congressman’s niece is model and actress Kate Upton.  Kate was born in her uncle’s hometown of St. Joseph, MI but later moved with her family to Florida when she was seven years old.  She rose to fame after appearing in the Sports Illustrated Swimsuit Issue in 2011, and since then, she’s appeared in prominent publications like Vogue and Vanity Fair.  Kate is also a successful actress who has appeared in several hit comedy films including Tower Heist and The Layover.  In 2016, Rep. Upton hosted his niece and gave her  a tour of the US Capitol – along with her husband, Houston Astros pitcher Justin Verlander.

Senate Majority Leader Chuck Schumer (D-NY)

Comedienne and actress Amy Schumer and the Senate Majority Leader are first cousins, once removed.  Both Schumers have appeared publicly together to advocate on issues like gun violence, and in 2016, Amy attended a White House press conference with her uncle when then-President Barack Obama announced new actions on gun control.  However, both cousins were largely estranged from one another during Amy’s childhood, and the senator and the comedienne didn’t start to develop a relationship until Amy’s fame started to grow in 2009.

Sen. John Hickenlooper (D-CO)

The freshman Colorado senator’s cousin is filmmaker George Hickenlooper.  His feature-length documentary, 1991’s Heart of Darkness: A Filmmaker’s Apocalypse, explored the chaotic production of the 1979 Vietnam War film Apocalypse Now.  George’s final film was the 2010 comedy-drama movie Casino Jack, which focused on the corruption scandal surrounding lobbyist Jack Abramoff.  The film notably featured actor Kevin Spacey in the titular role, and George’s cousin John even had a brief cameo in the film.  Sadly, George Hickenlooper died in his sleep at the age of 47 on October 29, 2010, just a month after the film’s release.

Speaker Nancy Pelosi (D-CA)

The speaker’s daughter is filmmaker Alexandra Pelosi, who has filmed, produced, and directed 14 films to date.  Pelosi’s first film was the Emmy-nominated 2002 documentary Journeys with George, which chronicled George W. Bush’s first presidential campaign.  Since then, Pelosi has gone on to receive critical acclaim for a host of other documentaries, including Citizen USA: A 50 State Road Trip, which explored the citizenship process for immigrants, and Meet the Donors, which looks at the influence money has  in politics.

Former Rep. Mike Capuano (D-MA)

A US Representative from Massachusetts who served from 1999 to 2019, Capuano’s famous nephew is actor Chris Evans.  After playing supporting role in films like 2001’s Not Another Teen Movie and 2005’s Fantastic Four, Evans rose to worldwide fame for his portrayal of the titular role in 2011’s Captain America: The First Avenger.  Since then, Evans has appeared as Captain America in several Marvel Cinematic Universe films, and he’s acted in critically acclaimed films like 2013’s Snowpiercer and 2019’s Knives Out.  Notably, Evans told Esquire in 2016 that he’s considered getting into politics someday, and in 2019, he met with several Democratic senators on Capitol Hill for A Starting Pointnew political venture aimed at addressing partisanship and distrust.

Sen. Bernie Sanders (I-VT)

Actor, comedian, writer, and filmmaker Larry David and the former presidential candidate are third or fourth cousins.  Neither man was aware of their relation until historian and literary critic Henry Louis Gates Jr. revealed the family connection in a 2017 episode of Finding Your Roots.  David has played Sanders in multiple episodes of Saturday Night Live since 2016.  Both men were born in Brooklyn, New York City and trace their ancestry back to Ashkenazi Jewish immigrants from Poland.

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What Will ARPA-H Look Like?

There’s a new federal agency in town.  The Fiscal Year (FY) 2022 omnibus appropriations bill officially created the Advanced Research Projects Agency for Health (ARPA-H), which the Biden administration first proposed last year to drive “transformational innovation” in health research.  However, the omnibus bill is scant on details, and lawmakers have much to decide about the structure of the new agency.

What’s in the spending bill? Beyond appropriating $1 billion in funds to the new agency through September 30, 2024, the FY 2022 omnibus bill allows the ARPA-H director to use those funds to make awards in the form of “grants, contracts, cooperative agreements, and cash prizes.”  Notably, the bill gave the Department of Health and Human Services (HHS) 30 days to decide whether the new agency would be independent or part of an existing institution, like the National Institutes of Health (NIH).

The issue of whether to make ARPA-H an independent agency within HHS or house the new agency within the NIH has been the subject of debate for months.  Public health experts who testified before a congressional panel on February 8 unanimously agreed that ARPA-H would need to foster an independent culture to be successful in delivering biomedical breakthroughs, and most witnesses and lawmakers felt that housing the ARPA-H within NIH would make it impossible to cultivate its own identity and operating structure.

Since then, more details about ARPA-H have come into focus.  In a March 31 congressional hearing, HHS Secretary Xavier Becerra announced that ARPA-H would be placed within NIH.  However, Becerra did offer key details that suggests the administration wants to help foster an independent culture within the new agency.  For example, he said the ARPA-H director will be under the supervision of the HHS secretary, not the NIH director.  Additionally, Becerra clarified that ARPA-H would not be “physically housed” within NIH.  According to Becerra, the reason for the new agency’s placement within NIH is to allow ARPA-H to focus on research from the get-go while NIH handles all the administrative work like human resources and legal functions.

However, the makeup and structure of ARPA-H won’t be up to the Biden administration.  That’s the job of Congress where a trio of authorizing bills are under consideration that flesh out the details of ARPA-H. The bills – the Cures 2.0 Act plus the House and Senate versions of the ARPA-H Act – propose similar requirements on the new agency, such as:

  • Presidential appointment of the APRA-H director for one five-year term, with the option to extend for one additional term.
  • Establish goals for delivering biomedical breakthroughs by prioritizing high-risk, high-reward innovations and identifying potential areas of health research advancement that industry stakeholders aren’t currently addressing due to technical or financial reasons.
  • Collaboration with other HHS entities like the Food and Drug Administration (FDA).

There’s one key area where the bills differ – the Cures 2.0 Act calls for APRA-H to be a part of NIH, while both versions of the ARPA-H Act say the new agency should be independent within HHS.  The House Energy and Commerce Subcommittee on Health held a legislative hearing on March 17 to review both the Cures 2.0 Act and the ARPA-H Act, and currently, House leadership supports the ARPA-H Act, which increases the odds the new agency will ultimately be independent from the NIH.

As lawmakers continue their work, stakeholders outside of Washington are focusing on a different question: the specific location of ARPA-H.  While Becerra told lawmakers back in March that the new agency wouldn’t physically be a part of the NIH campus in Bethesda, Maryland – neither the FY 2023 omnibus bill nor the three authorizing bills say anything about where ARPA-H should be headquartered.  Currently, cities in California, Massachusetts, North Carolina, and Texas are lobbying to become the location of the new biomedical research agency.

Congress is in recess until the week of April 25, and neither chamber has indicated when it will markup and vote on their respective authorizing bills on APRA-H.  Until the finish line is in sight, conversations over the makeup of ARPA-H – and whether it should be a part of the NIH – are likely to continue.

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What Happened, What You Missed: April 4-8

Administration Proposes Fix to ACA “Family Glitch”

On Tuesday, the Treasury Department (USDT) and the Internal Revenue Service (IRS) issued a proposed rule to create a minimum value for family member of employees who are eligible for premium tax credits under the Affordable Care Act (ACA).  The rule aims to fix the “family glitch,” an ACA loophole that provides premium tax credits to individuals but not their family members.  According to the Kaiser Family Foundation, the family glitch has impacted about 5.1 million Americans.

CMS Limits Aduhelm Coverage to Clinical Trial Enrollees

On Thursday, the Centers for Medicare and Medicaid Services (CMS) issued a final coverage determination for Alzheimer’s drug Aduhelm that limits Medicare coverage of the drug to patients currently enrolled in clinical trials.  Aduhelm has been the subject of controversy since it was granted accelerated approval last summer due to its high out-of-pocket cost of $28,000 and mixed data on its efficacy.  In the coverage determination memo, CMS also outlined conditions of coverage for future drugs like Aduhelm that also target amyloid proteins.  For example, if the drugs were to go through the traditional approval process as opposed to accelerated approval, patients would not need to be enrolled in clinical trials to receive Medicare coverage.

CMS Proposes to Indefinitely Delay RO Model

On Wednesday, CMS issued a proposed rule that would indefinitely delay the implementation of the Radiation Oncology (RO) model, with no specific date for relaunching the model.  The proposed rule carries out legislation passed in December 2021 that required the RO model to be delayed until January 1, 2023.   The RO model was initially set to begin on January 1, 2021 but has been delayed multiple times.  The model, which would provide bundled payments for a 90-day episode of care to certain radiotherapy providers and suppliers, attracted controversy from radiology stakeholders over its mandatory status and reimbursement cuts.  In the proposed rule, CMS raised concerns over the costs of continually delaying the model’s implementation.

Republican Congressman Fred Upton to Retire

Rep. Fred Upton (R-MI) announced in a speech on the House floor Tuesday that he will not seek reelection in 2022.  Upton, who is among the 10 House Republicans who voted to impeach then-President Donald Trump in January 2021, cited Michigan’s new congressional map as a main reason for his decision to retire.  First elected to Congress in 1986, Upton forged a bipartisan reputation as chairman of the House Energy and Commerce Committee, where he was instrumental in advancing the 21st Century Cures Act.

ICYMI: Lawmakers Defeat Lobbyists in Congressional Hockey Game

On Thursday night, the first Congressional Hockey Challenge in two years ended with the Lawmakers defeating the Lobbyists by a score of 4-2.  The Congressional Hockey Challenge began nearly a decade ago from a weekly pickup match consisting of congressional staff and lobbyists, and like all congressional sporting events, the game raises funds for a variety of charities.  Three members of Congress played for the Lawmakers this year: Reps. Tom Emmer (R-MN), Mike Quigley (D-IL), and Larry Bucshon (R-IN).  A prominent former member of Congress, who once laced up for the Lawmakers, is Sen. John Kerry (D-MA), who played on Yale’s varsity hockey team.

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