What Happened, What You Missed: February 6-10, 2023

Judge Dismisses Lawsuit to Block States from Importing Drugs

On Tuesday, US District Court Judge Timothy Kelly dismissed a lawsuit from PhRMA that sought to block states from importing prescription drugs from Canada.  In his 26-page opinion, Kelly ruled that the plaintiffs were unable to prove that drug companies would face a “concrete risk of harm” from allowing drugs to be imported.  Additionally, Kelly explained that the drug industry lacked standing to file the lawsuit because there is no guarantee that the federal government will approve any state plans on drug importation.  The ruling comes amid growing concern about the rising cost of prescription drugs.  Over the years, many older Americans have traveled to Canada to purchase lower-cost drugs, while others have turned to online websites to purchase Canadian drugs.

PPE Manufacturers Launch New Lobbying Group

On Thursday, nine manufacturers of personal protective equipment (PPE) and health care supply chain stakeholders launched the American Medical Manufacturers Association (AMMA) to lobby for domestic production of PPE.  Most PPE used in US hospitals is currently manufactured in China, making it more vulnerable to supply chain disruptions and export restrictions, as was the case at the start of the COVID-19 pandemic.  To make American-made PPE more affordable, the AMMA will advocate for federal tax credits at a much higher reimbursement rate for hospital systems that purchase American-made equipment. 

Survey: Most Hospitals Not Complying with Price Transparency Rule

Only about 25% of hospitals are fully complying with a federal price transparency rule, according to a new survey of 2,000 large hospitals from the Patient Rights Advocate.  Implemented at the start of 2021, the Hospital Transparency Rule requires all hospitals to post their prices online in an accessible and searchable format.  While the survey found that most hospitals had posted their files online, the survey’s authors did not deem these hospitals to be fully compliant because the files were incomplete or not clearly associated with a plan or person.  However, the survey did show an increase of compliant hospitals from a previous survey in August 2022 where only 16% of hospitals were considered fully compliant.  Lawmakers from both parties have expressed an interest in exploring hospitals’ compliance with price transparency rule in the new Congress.

CDC Adds COVID-19 Shots to Immunization Schedules for Children, Adults

On Thursday, the Centers for Disease Control and Prevention (CDC) added COVID-19 vaccines to its immunization schedules for children, adolescents, and adults.  Changes to the schedules also include new recommendations on influenza and pneumococcal vaccines, as well as new vaccines for measles, mumps, and rubella (MMR), and for hepatitis B.  The inclusion of COVID-19 vaccines on the schedules normalizes the vaccines by being considered another routinely recommended vaccine.  However, the updated schedules do not mean schools will require COVID-19 vaccines, as school vaccination requirements are determined by state or local jurisdictions.

IMCYI: Labor Advocates Call for Senate Staff to Unionize

Amid an uncertain future for House staffer unions, the Congressional Workers Union (CWU) is urging Senate leaders to hold a vote later this month on whether to allow Senate staffers to unionize.  According to the CWU, if the Senate does not hold a vote by March, two Senate offices will voluntary take steps to seek voluntary recognition.  The House started allowing offices to unionize last year when the chamber was controlled by Democrats, but the new Republican majority in the House has since banned staff unions.  For unions to become a reality in the upper chamber, the Senate would have to approve an authorizing resolution.  However, given the 60-vote filibuster threshold, any successful resolution would require GOP support, and so far, no Senate Republicans have voiced their support for such a move.

What Happened, What You Missed: April 25-29

Moderna Requests Authorization for COVID-19 Vaccine in Children under 6

Moderna announced on Thursday that it has begun the application process for emergency use authorization (EUA) for its COVID-19 vaccine in children six months to six years of age.  Moderna also released revised clinical trial data on Thursday that showed its two-shot regimen is 51% effective at preventing symptoms in children ages 6 months to under 2 years.  However, Moderna’s application process is ongoing, and the company is not expected to submit all of its clinical trial data to the FDA until the first week of May.  According to a tentative schedule by the Food and Drug Administration (FDA), kids under age six maybe be able to receive their COVID-19 vaccine from Moderna as soon as this June. 

Administration Finalizes the 2023 Notice of Benefit and Payment Parameters

On Thursday, the Department of Health and Human Services (HHS) and Centers for Medicare and Medicaid Services (CMS) issued a final rule on the 2023 Notice of Benefit and Payment Parameters, which includes updates to the nondiscrimination policy for Affordable Care Act essential health benefits, standardized health plan options, and other changes.  The rule also refined prospective network adequacy reviews to focus on time and distance as well as appointment waiting times starting in plan year 2024. 

New CDC Data Shows Most Americans Have Had COVID-19

New data from the Centers for Disease Control and Prevention (CDC) revealed that at least 60% of adults and 75% percent of children have been infected with COVID-19.  The latest figures show a considerable jump from December 2021 data which estimated that 35% of adults at the time had contracted the virus at some point.  According to a CDC report, the higher percentage of Americans having COVID-19 over the past several months can be contributed to the more transmissible Omicron variant.  The CDC gathered the data by analyzing blood specimens.

Former Sen. Orrin Hatch (R-UT) dies at 88

On April 23, former Sen. Orrin Hatch (R-UT), the longest-serving Republican senator, died in his home in Salt Lake City at age 88.  First elected to the Senate in 1977, Hatch was an ardent conservative who helped advance the Tax Cuts and Jobs Act of 2017 while serving as chairman of the Senate Finance Committee.  Hatch also made a bid for the Republican presidential nomination in 2000 but lost to George W. Bush.  In contrast to other members of Congress who recently passed away – including Sen. Harry Reid (D-NV) and Rep. Don Young (R-AK) – Hatch will not lie in state at the US Capitol.  Instead, Hatch will lie in state at the Utah State Capitol due to the late senator’s strong connections to the state.

ICYMI: Wild Turkey Attacks People in DC Parks

If you’re visiting Washington, DC anytime soon, you may want to take extra caution when visiting Anacostia Park and Kenilworth Aquatic Gardens.  That’s where a wild male turkey has been aggressively attacking cyclists, runners, pedestrians, and nature enthusiasts for at least the past five months.  The National Park Service says they’re aware of the turkey and have been attempting to catch it for weeks.  Until the turkey is captured, park rangers are advising people to “appear bigger and louder” if they come across the animal.

Uncertainty over Medicaid Coverage Looms for Millions

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.

Everything You Need to Know About the 2022 Primary Elections

The 2022 primary season kicks off in Texas on March 1, and with the start of primary season comes some big questions about which direction either party will go.  Democrats will be duking out over what direction the party will take after its agenda has largely stalled in Congress, while Republican candidates face tough questions about former President Donald Trump’s role in the party and whether they acknowledge the results of the 2020 presidential election. 

On top of this, the 2022 primary season includes numerous races for offices like governor and attorney general, who will play an important role in certifying election results for 2024 and beyond, adding extra weight to the questions some candidates will face over democracy and the legitimacy of the 2020 election.

Wait, what is a primary?  Political parties hold primary elections to select their nominees for candidates who will run on behalf of the party in the general election.  In a primary, Republicans run against Republicans, while Democrats run against other Democrats.  In contrast, the general election determines which candidates will occupy offices that are up for election.

Additionally, different states have different rules on how they conduct their primaries.  These are the four types of basic primary elections:

  • Open primaries, where anyone of any political party affiliation may vote.
  • Closed primaries, where only those voters who registered with that particular political party may vote.
  • Hybrid primaries, also called semi-open and semi-closed primaries, where anyone of any political party affiliation can vote, but can only vote in one primary. 
  • Runoff primaries, where a few states hold a second primary between two candidates with the most votes.  Of note, both Louisiana and Georgia will have runoff races for their general elections scheduled after Election Day on November 8 for the top-two candidates if one candidate fails to win at least 50% of the vote in their most recent primary.

Below is a list of all key primary dates for congressional races with their respective state and runoff status.

March 1TexasRunoff
May 3IndianaOpen
May 3OhioOpen
May 10NebraskaHybrid
May 10West VirginiaHybrid
May 17IdahoHybrid
May 17KentuckyClosed
May 17OregonClosed
May 17PennsylvaniaClosed
May 17North CarolinaRunoff
May 24AlabamaRunoff
May 24ArkansasRunoff
May 24GeorgiaRunoff
May 24*Texas*Runoff
June 7CaliforniaOpen
June 7IowaOpen
June 7MississippiRunoff
June 7MontanaOpen
June 7New JerseyHybrid
June 7New MexicoClosed
June 7South DakotaHybrid
June 14MaineClosed
June 14NevadaClosed
June 14North DakotaOpen
June 14South CarolinaRunoff
June 21VirginiaOpen
June 21Alabama*Runoff
June 21Arkansas*Runoff
June 21*Georgia*Runoff
June 28ColoradoHybrid
June 28IllinoisOpen
June 28MarylandClosed
June 28New YorkClosed
June 28OklahomaRunoff
June 28UtahHybrid
June 28*Mississippi*Runoff
June 28*South Carolina*Runoff
July 26*North Carolina*Runoff
August 2ArizonaHybrid
August 2KansasHybrid
August 2MichiganOpen
August 2MissouriOpen
August 2WashingtonOpen
August 4TennesseeOpen
August 9ConnecticutClosed
August 9MinnesotaOpen
August 9VermontOpen
August 9WisconsinOpen
August 13HawaiiOpen
August 16AlaskaOpen
August 16WyomingOpen
August 16South DakotaHybrid
August 23FloridaClosed
August 23*Oklahoma*Runoff
September 6MassachusettsHybrid
September 13DelawareClosed
September 13New HampshireHybrid
September 13Rhode IslandHybrid
November 8LouisianaRunoff
December 6*Georgia*Runoff
December 10*Louisiana*Runoff

*Indicates runoff election date.

What Happened, What You Missed: February 14-18

Administration Working on New Masking Guidelines

On Wednesday, White House Coronavirus Response Coordinator Jeff Zients told reporters that the administration is working with public health experts and business leaders to updates its pandemic guidance. The guidance will focus on hospitalizations rather than case numbers as metrics for determining when Americans should wear masks indoors.  The announcement comes as many blue states and cities have announced plans to roll back indoor mask requirements without input from the federal government.  In recent weeks, both case numbers and hospitalizations have declined across the nation.  Reports suggest new mask guidance from the Center for Disease Control and Prevention (CDC) could come as early as next week.

Senate Narrowly Confirms Robert Califf to Lead FDA

On Tuesday, the Senate voted 50-46 to confirm Robert Califf as the new Food and Drug Administration (FDA) Commissioner, clearing the way for the FDA to have a permanent leader in over a year.  The narrow vote comes after senators from both parties raised concerns about Califf’s handling of the opioid epidemic when he led the FDA from 2016 to 2017 as well as his ties to the pharmaceutical industry.  Califf will replace Janet Woodcock, who has served as the FDA’s temporary chief since January 2021 and will remain at FDA as principal deputy commissioner. It is not clear when Califf will officially begin his new role. 

Senate Approves Bill to Fund Government through March 11

The Senate voted 65-27 to approve a continuing resolution (CR) on Thursday night to move the government funding deadline to March 11, giving lawmakers three more weeks to hammer out an agreement on a Fiscal Year (FY) 2022 appropriations omnibus.  Earlier in the week, the status of the three-week CR was in doubt after several GOP senators called for votes on controversial amendments to be added to the CR.  Some of the amendments, which only required a simple majority vote, would have prevented the Biden administration from enforcing vaccine mandates and make it harder to raise the debt ceiling.  Any changes to the CR would have forced the measure to go back to the House, which is in the middle of a two-week recess and where Democrats are unlikely to support a bill with any controversial amendments attached.  However, with several Republican senators absent from Washington to attend a security conference in Munich, the amendments failed to garner a majority vote.  President Biden is expected to sign the CR in law later today.

FTC Rejects Probe into Pharmacy Benefit Managers

On Thursday, the Federal Trade Commission (FTC) voted 2-2 to defeat a proposed investigation into whether pharmacy benefit managers (PBMs) are violating federal anti-competitive regulations.  Three PBMs currently control 80% of the market, and pharmacists and patient advocates have voiced concern for years that PBMs engage in anticompetitive practices that lead to higher drug prices and disadvantage independent or specialty pharmacies.  While the two commissioners who voted against the probe say they aren’t opposed to looking into the role of PBMs, they ultimately voted against the proposed investigation because it wasn’t comprehensive enough and they weren’t provided with sufficient notice of the vote. 

ICYMI: The Obamas’ Portraits Go On Tour

In May 2021, the National Portrait Gallery’s portraits of former President Barack Obama and former First Lady Michelle Obama embarked on a five-city tour that includes an audio-visual element, educational workshops, presentations, and an illustrated book. The portraits were initially supposed to return to Washington this summer, but the Smithsonian has since announced new stops in San Francisco and Boston that will keep the portraits away from Washington until the fall.  Anyone who wants to see the portraits now can view them at Atlanta’s High Art Museum until March 20.

Is There a Place for Earmarks in the FY22 Omnibus Package?

Earmarks returned to the appropriations process last year for the first time since Congress banned the practice over a decade ago.  However, as lawmakers keep kicking the can down the road on Fiscal Year (FY) 2022 appropriations with continuing resolution after continuing resolution (also known as a CR), the likelihood that these earmarks will make it into an appropriations omnibus for FY 2022 is looking less likely.   

The Demise and Rise of Earmarks

Earmarks, or provisions inserted in appropriations bills directed for a specific project or recipient, exploded in practice throughout the 1990s and 2000s.  Earmarks gradually gained a bad reputation over time for their perceived role in adding to corruption or fueling “pork barrel spending,” which caused lawmakers to place a moratorium on the practice in 2011. 

In the years since the ban on earmarks took hold, the appropriations process only got worse, with government shutdowns becoming more common.  To incentivize lawmakers to work together on spending bills – and ultimately reduce dysfunction in the appropriations process – the Select Committee on the Modernization of Congress issued a recommendation that earmarks should return, albeit with some changes to make the process more transparent. 

In February 2021, House Democrats brought earmarks back to the appropriations process as Community Project Funding.  Unlike the earmarks of the past, House members are limited to 10 earmark requests and must declare that they have no financial connections to the projects they request.   Additionally, earmark requests are limited to schools, hospital, municipal authorities, and other non-profit organizations

And in the Senate, earmarks returned in April 2021 under the moniker of Congressionally Directed Spending.  Senators must follow the same earmarks rules as their counterparts in the House, with the exception that they can make an unlimited number of requests.

Earmarks and FY 2022 Appropriations

Members of both parties have made earmark requests since the start of the FY 2022 appropriations process, although activity is much higher among Democrats than Republicans.  In the House, over 220 Democrats requested funding for more than 2,000 projects, while 108 Republicans issued requests for over 700 projects.  In the Senate, a total of 60 Senators, 44 Democrats and 16 Republicans, have submitted earmarks to be included in an omnibus package.   

However, none of these earmarks will fund their intended projects until Congress finalizes appropriations for FY 2022.  The current CR to fund the government expires in less than two weeks, and there are still major disagreements between both parties that include policy riders over controversial issues like the Hyde Amendment, disagreements over parity between defense and non-defense spending increases, and finalizing topline spending levels.   In anticipation of continued gridlock, congressional leaders introduced on February 7 a new CR that would extend the government funding deadline from February 18 to March 11. 

However, the longer it takes lawmakers to agree on an appropriations omnibus for FY 2022, the less likely earmarks will be included.  Many Republicans are still concerned about the optics of earmarks, and many top Republicans in the House and Senate opted not to make earmark requests last summer when the FY 2022 appropriations process began in earnest.  As discussions on major sticking points continue, congressional leaders may simply decide to strike community funding or congressionally directed projects from an omnibus, especially if they make it harder to reach a final compromise. 

A Year-Long Continuing Resolution?

Additionally, concerns are growing that Congress could ultimately settle for a year-long CR – which means earmark might not have another shot at getting funded until the FY 2023 appropriations process is underway.

Of course, lawmakers could still reach a deal, and earmarks could ultimately make their grand return in a 2022 appropriations omnibus.  Members of Congress who submitted earmark requests know their projects will remain unfunded until a deal is reached regarding FY 22 funding, and therefore they could be incentivized to break the gridlock in the near-term. 

Additionally, with the Democrats hitting pause on passing some version of the Build Back Better Act  could mean Republicans aren’t  as sensitive to a compromise appropriations bill that calls for big spending increases.  But as Republicans don’t have as much skin in the game on earmarks as Democrats, there is no reason to believe Congress will hang its hat on earmarks being the saving grace on passing an omnibus package, which means the possibility of a year-long CR looms larger by the day. 

However, even if FY 2021 spending levels are sustained through September 30, 2022, the practice of including earmarks in future appropriation cycles aren’t out for the count.  There’s no reason to suspect the House and Senate won’t include Community Project Funding or Congressionally Directed Spending in the FY 2023 appropriations process, meaning advocates have plenty of time to prepare to lobby for projects in the next appropriations cycle.

What Happened, What You Missed: January 24-28

Bipartisan Senators Release Draft of Pandemic Preparedness Bill

On Tuesday, Senate Health, Education, Labor, and Pensions (HELP) Committee Chairwoman Patty Murray (D-WA) and Ranking Member Richard Burr (R-NC) released the discussion draft of legislation aimed at improving the nation’s response to pandemics.  Some of the draft’s key components include creating a 9/11 Commission-style task force to examine the response the pandemic, making the Director of the Centers for Disease Control and Prevention (CDC) a Senate-confirmed position, and authorizing new grants for genomic sequencing to detect new pathogens or variants.  The Senators requested feedback by February 4 to hopefully markup the legislation in the next few weeks. 

NIH: It’s OK to Mix-and-Match COVID-19 Vaccine Doses

According to research published by the National Institutes of Health (NIH) on Wednesday, any combination of primary and booster vaccines against COVID-19 yields strong antibody levels.  The findings support a “mix-and-match” approach to COVID-19 booster that means people who received an initial vaccination regiment from one of the three COVID-19 vaccines granted Emergency Use Authorization (EUA) or approval from the Food and Drug Administration (FDA) can expect enhanced protection from an additional booster dose from any of the vaccines.  However, the study did not look into which mix-and-match approach might be the most effective. According to the CDC, only about 40% of Americans fully vaccinated against COVID-19 have received booster shots.

FDA Limits Use of 2 COVID-19 Antibody Treatments

On Monday, the FDA announced that it will curb the use of COVID-19 antibody treatments from Regeneron and Eli Lilly because they aren’t effective against the Omicron variant, which accounts for nearly 99% of COVID-19 cases in the US.  Now, only patients infected with other variants such as Delta will be able to use the antibody treatments from either company.  A third antibody treatment from GlaxoSmithKline and Vir Biotechnology remains effective against Omicron and continues to have full authorization from the FDA.  While the Department of Health and Human Services (HHS) has said that it will no longer distribute antibody treatments from Regeneron and Eli Lilly, the drugs could be fully authorized once again if proven effective against any future variants.

Supreme Court Justice Breyer Announces Retirement

On Thursday, US Supreme Court Justice Stephen Breyer announced that he would step down from the high court following the end of the 2021-2022 term in late June-early July.  For the past year, some Democratic members of Congress and liberal activists have been calling on the 83-year-old justice to retire so that President Joe Biden could nominate a younger, liberal justice to replace him.  Nominated to the Supreme Court by former President Bill Clinton in 1994, Breyer served as a clerk to Supreme Court Associate Justice Arthur Goldberg and taught at Harvard Law School before being nominated to the US Court of Appeals in 1980 under former President Jimmy Carter.  President Biden has since announced that he will nominate a Black woman to fill Breyer’s seat.

ICYMI: Bidens Welcome New Cat to White House

This week, the First Family welcomed a new White House resident: a two-year-old gray tabby cat named Willow.  First Lady Dr. Jill Biden first met Willow in 2020 during a campaign stop in her hometown of Willow Grove, PA, where the young kitten jumped on stage as Dr. Biden was speaking.  Willow will become the first cat to live in the White House since India, President George W. Bush’s cat, in 2009.  The new cat won’t be the only White House pet – last month, the Bidens adopted Commander, a German shepherd puppy.

What Happened, What You Missed: November 8-12

Pfizer Asks FDA to Authorize Its COVID-19 Booster Shot for All Adults

On November 9, Pfizer announced it’s asking the Food and Drug Administration (FDA) to amend its emergency use authorization (EUA) to allow all individuals ages 18 and older to get a third “booster” dose of its COVID-19 vaccine.  Currently, only individuals over age 65, people with chronic medical conditions, and at-risk workers are eligible to receive booster doses.  Pfizer also submitted data to the FDA from a Phase 3 clinical trial that found its booster shot is 95% effective against symptomatic COVID-19.  The request comes as more and more data suggests efficacy of currently approved vaccines wanes over time.

Federal Court Blocks Administration’s Vaccination Mandate for Employers

On November 6, a federal court in Louisiana block an emergency temporary standard (ETS) from the Occupational Safety and Health Administration (OSHA) that requires employers with 100 or more employees to develop a mandatory COVID-19 vaccination policy, with an exception for testing.  The 26 states are behind the lawsuit are making the argument that the Department of Labor lacks the authority to issue the rule and did not follow the correct procedure to issue the ETS.  The Department of Justice has vowed to fight the ruling in court.

CBO Says Congress Will Have to Wait for a Full Score on BBB Act

On Tuesday, the Congressional Budget Office (CBO) announced that lawmakers will have to wait some time for a final score on the Build Back Better (BBB) Act, Democrats’ social and climate spending bill.  In a blog post, CBO say it will provide a cost estimate for the full bill “as soon as practicable” and will provide advance notice once a release date can be determined.  CBO has taken a piecemeal approach to issuing cost estimates, and so far, only the titles for Science, Space, and Technology, Homeland Security, Small Business, and Veterans Affairs have been scored.  Several centrist Democrats in both chambers including Sen. Joe Manchin (D-WV) and Rep. Josh Gottheimer (D-NJ) have said they will hold off on supporting the BBB Act until the CBO fully scores the bill.

Former New Hampshire Governor Nixes Senate Run

On November 9, former New Hampshire Governor Chris Sununu, a Republican, declared that he will not be running to represent the Granite State in the US Senate.  Many Republicans considered Sununu to be a top recruit against Sen. Maggie Hassan (D-NH).  Hassan, who won her seat in 2016 by a margin of only 1,017 votes, is considered to be one of the most vulnerable Senators.  Sununu’s decision is a setback for the Republicans’ plans to retake the Senate majority, as the party was already facing a difficult Senate map heading into 2022.

ICYMI: For the First Time, Tomb of the Unknown Soldier Opens to Public

This week, the Tomb of the Unknown Solider in Arlington National Cemetery allowed the public to walk on to the plaza and lay flowers for the first time ever to commemorate 100 years since an unknown soldier, who died in World War I, was interred at the tomb.  Visitors waited in line for hours this week for this opportunity to pay their respects, which has been under the watch of the US Army’s Old Guard for a century. This was a once-in-a-lifetime opportunity as the Arlington National Cemetery does not “anticipate holding another event in our lifetimes in which the public will be able to approach the Tomb in this manner.”

What Happened, What You Missed: September 27-October 1

Pfizer Submits Initial Data on COVID-19 Vaccine in Kids

On September 28, Pfizer submitted initial data to the Food and Drug Administration (FDA) that shows its COVID-19 vaccine generates “robust” protection in children aged 5-11.  The announcement came just a week after Pfizer announced positive topline results in its clinical trials for children.  Pfizer says it will formally apply for Emergency Use Authorization for children in that age range “in the coming weeks,” teeing up FDA authorization potentially by the end of October.  Pfizer also announced that it is expected to have topline results for children under 5 in the fourth quarter of this year. 

CDC: Side Effects from Booster Shots Are Mild

A third “booster” shot from Pfizer’s mRNA COVID-19 vaccine produces side effects consistent with the side effects individuals experienced after their second shot, according to a report posted Tuesday by the Centers for Disease Control and Prevention (CDC).  The report found side effects usually appeared the day after the injection, with the most common side effects being mild-to-moderate arm pain, fatigue, and headache.  According to the White House, over 400,000 Americans have received a third Pfizer shot over the past week, including President Joe Biden, who was administered his booster shot during a live event on Monday.  Both the FDA and the CDC approved booster shots for senior citizens, high-risk workers, and people with chronic medical conditions last week.

Gallup: Delta Variant Likely Prompted More Americans to Get Vaccinated

According to a Gallup poll released on September 29, the percentage of US adults who reported being vaccinated for COVID-19 grew to 75%, largely due to growing concerns of being infected with the virus as the Delta variant continues to take its toll.  The poll also found that a rise in vaccine mandates from employers and the FDA fully approving the Pfizer vaccine may have also contributed to higher vaccination rates.  Additionally, for the first time, Gallup found that a majority of adults who identify as Republican say they have been administered at least one vaccine dose. 

Congress Averts Shutdown, but Leaves Debt Limit Unresolved

President Biden signed a continuing resolution (CR) late Thursday to fund the government through December 3, averting a government shutdown that otherwise would have begun on October 1.  The standalone CR was fast-tracked through Congress after Senate Republicans initially blocked a measure that paired government funding with a debt ceiling increase on Tuesday.  Earlier this week, Treasury Secretary Janet Yellen sent a letter to congressional leadership saying that without any action to raise or suspend the debt ceiling, the government could default on its debt obligations as soon as October 18.  Senate Republicans want Democrats to address the debt ceiling through the budget reconciliation process, but Senate Majority Leader Chuck Schumer (D-NY) has so far refused to do so, setting up a standoff between the two parties for the next few weeks. 

ICYMI: DC’s “Cat Census” Estimates 200,000 Felines in the District

There are about 200,000 cats residing in Washington, DC according to the DC Cat Count, the first-ever project to conduct a census on felines in a major US city.  The project estimates that the overwhelming majority of the District’s cats are owned or cared for while about 3,000 are feral.  Of the cats who receive at least some care from humans, half are indoor-only, while the other half have some access to the outdoors.  To conduct the cat census, the Human Research Alliance collaborated with the Smithsonian to place over 1,500 motion-sensor cameras in locations across the District, resulting in about 1.2 million cat photos.

What’s Going on with the Provider Relief Fund?

The Provider Relief Fund (PRF) was essential for keeping countless health care providers afloat as the health care sector struggled with the COVID-19 pandemic throughout 2020. This is why Congress appropriated $178 billion in the CARES Act for the fund.  Nearly a year and a half after its creation, let’s take a deep dive look at the PRF to see what providers are saying about the program and where the program is today.

The Unsmooth Transition of the PRF

$178 billion in appropriations to the PRF has not equated to $178 billion in relief for hospitals and the distribution process for PRF money has been “uneven” and the plans of distributing the funds have been “opaque.” This unsmooth transition has not only caught the eyes of providers, but also Congress, who has urged HHS to respond to these challenges over the last couple of months.

HHS Responds

Fortunately, recent actions by HHS indicate the department is listening to health care providers.  On September 10, HHS announced it will make available $25.5 billion to affected providers, who can begin applying for the funds in September 29.  Payments will be distributed based on pandemic-related revenue losses between July 1, 2020, and March 31, 2021. 

About $8.5 billion will be set aside for rural Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) providers operating in regions disproportionately affected by the pandemic, with the remaining $17 billion going to smaller providers who can demonstrate lost revenue and increased expenses due to the pandemic.  HHS has also announced it will offer bonus payments to Medicare, Medicaid, and CHIP providers.

To recognize the challenge providers are facing due to the Delta variant and recent natural disasters, HHS also announced it will offer providers a 60-day grace period on reporting requirements for relief fund recipients.  During this 60-day period, HHS will not carry out any enforcement or collection activities.  However, deadlines on PRF grants and the reporting period that HHS extended on June 11, 2021remain unchanged. 

The disbursement of remaining PRF dollars and new flexibility on reporting aren’t the only changes HHS has made recently.  On August 31, HHS announced via the Federal Register the reorganization of the Health Resources and Services Administration Office of Provider Support into the Provider Relief Bureau.  These changes suggest HHS understands the importance of ensuring funds from the PRF are getting to health care providers.

However, even after these recent responses, HHS has yet to lay out a timetable for the disbursement of the remaining PRF dollars, as many hospitals are still grappling with a nationwide surge in COVID-19 cases.  The PRF has been clearly valuable for hospitals by allowing them to survive since the beginning of the pandemic and so, HHS needs to continue to follow through with specific actions that provides meaningful relief.

What Happened, What You Missed: August 23-27

FDA Fully Approves Pfizer/BioNTech COVID-19 Vaccine

On August 23, the Food and Drug Administration (FDA) fully approved the Pfizer/BioNTech COVID-19 vaccine for people age 16 and older, but did not fully approve the vaccine for individuals ages 12 to 15, which is still only authorized for emergency use.  Full approval of the vaccine, which will be marketed as Comirnaty, is likely to spur additional companies and organizations to mandate employees to be vaccinated.  Just a few days later, Pfizer/BioNTech announced that it intends to submit a biologics license application (BLA) for a third dose of its vaccine to act as a booster shot.  Additionally, Moderna submitted a BLA for its COVID-19 vaccine this week, setting the stage for full FDA approval within the next few months.

New Data Shows J&J Booster Shot Increases Immune Response

Johnson & Johnson says data from a phase 2 clinical trial shows a second dose “booster shot” of its single-dose COVID-19 vaccine administered six to eight months after the first dose resulted in a nine-fold increase in antibodies compared to 28 days after the first dose.  The announcement comes amid concerns that the viral vector Johnson & Johnson vaccine may not be as effective as the mRNA vaccines offered by Pfizer/BioNTech and Moderna.  Last week, the Biden administration announced plans to make third-dose booster shots of the Pfizer/BioNTech vaccine to all eligible Americans by late September, but declined to make a final decision on whether recipients of the Johnson & Johnson vaccine should also receive booster shot.  Johnson & Johnson also announced that that it is working with FDA and other regulators regarding the need for booster shots.

Intelligence Report Inconclusive on Origins of COVID-19

According to news reports, an intelligence report delivered to President Joe Biden this week was inconclusive over whether COVID-19 originated naturally via human contact with an infected animal or originated in a laboratory.  In late May, Biden ordered the US intelligence community to produce a report within 90 days on the origins of COVID-19 after a hypothesis that the virus escaped from a laboratory gained traction.  While some scientists have called for all possibilities for COVID-19’s origin to be explored, many believe the most likely scenario is that the virus jumped from animals to humans.  Intelligence officials plan on publicly releasing a summary of the report in the coming days.

House Passes FY22 Budget Resolution after Democrats Reach Agreement

On August 24, the House narrowly approved a $3.5 trillion budget resolution for Fiscal Year (FY) 2022 along a party-line vote, following a period of deadlock between a group of moderate Democrats and party leadership that threatened to derail the budget resolution.  Earlier this month, nearly a dozen centrist-leaning Democrats including Reps. Josh Gottheimer (D-NJ) and Stephanie Murphy (D-FL) communicated that they would not support the budget resolution unless the House first voted on the Senate-passed bipartisan infrastructure bill.  Per their public agreement with the group of centrists, House leadership have committed to consider the bipartisan infrastructure bill by September 27.  House approval of the FY22 budget resolution sets the stage for Congress to advance a social spending bill in both chambers without any Republican support.

ICYMI: Washington Monument Could Reopen Soon

The Washington Monument has been closed since August 15, following a lightning strike that damaged the monument’s electronic access system that operates the door and the elevators.  Since then, the National Park Service has been awaiting replacement parts to get the electronic access system back in working order.  The parts finally arrived on August 25, and the National Park Service says it will begin installing and testing on Thursday in the hopes of reopening “as soon as possible.”