What Happened, What You Missed: July 19-23

CDC Panel Recommends Continued Use of J&J Vaccine, Despite Risks

On July 22, the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) agreed the federal government should continue to recommend Johnson & Johnson’s COVID-19 vaccine amid concerns of side effects.  According to the panel, the benefits of the single-dose vaccine outweigh the risk of Guillain-Barre, a rare neurological disease.  However, two members of the panel felt the risk of Guillain-Barre should be conveyed to potential recipients of the J&J vaccine, noting that two highly effective mRNA vaccines are available as alternatives.  ACIP convened just days after New York University researchers released a study that found the J&J vaccine is only 33% effective against the Delta variant, a significant decrease from the 66% efficacy observed against the original COVID-19 strain in clinical trials.

NEJM: Pfizer, AstraZeneca Vaccines Still Highly Effective against Delta Variant

A study published in the New England Journal of Medicine (NEJM) on July 21 found two doses of Pfizer’s COVID-19 vaccine is 88% effective against the Delta variant, compared to 94% against the Alpha variant.  The same study found two doses of the AstraZeneca vaccine is 67% effective against Delta, a small decrease from a 75% efficacy rate with Alpha.  The release of the NEJM study findings come after a pair of studies released earlier this month found the Pfizer vaccine has varying degrees of efficacy against the Delta variant. Those studies include a research published by the Israeli Health Ministry on July 5, which found a double dose of the Pfizer vaccine to be only 64% effective against Delta, while an analysis posed on June 14 by Public Health England found two Pfizer doses to be at least 90% effective.

Major Hospital Groups Back Vaccination Mandates

On July 21, the American Hospital Association and America’s Essential Hospital separately issued statements urging its member hospitals to require vaccination for all employees.  According to both organizations, vaccines help protect not only health care workers but also patients and their communities.  The announcement comes as hospitals nationwide see a rise in COVID-19 patients who are unvaccinated and growing number of hospitals and health systems mandate their employees be vaccinated.

Details of Bipartisan Infrastructure Bill Could Come as Soon as Monday

A bipartisan group of 22 Senators are hashing out the final details of a $579 billion infrastructure bill that could be released as soon as Monday, July 26.  Senators previously attempted to begin debating the bipartisan infrastructure bill on Wednesday as a way to push negotiations forward, but Senate Republicans mounted a filibuster, saying more time is needed to finalize details and resolve differences.  Since Wednesday’s failed vote, Senators have tentatively agreed to delay a Medicare rule that eliminates Part D drug rebates that drug makers offer to pharmacy benefit managers in exchange for participation on their formularies as a way to partially pay for the infrastructure bill.  Remaining sticking points include how much spending should be directed to public transit and assurances that the Drinking Water and Wastewater Infrastructure Act will be fully funded.

ICYMI: No Smithsonian Tickets? No Problem!

Starting on July 19, visitors to all open Smithsonian museums will no longer need timed-entry passes for general admission.  The two exceptions to the new policy are the National Zoo and the National Museum of African American History and Culture, which already required timed-entry tickets before the pandemic.  Other currently shuttered museums, like the Air and Space Museum and Smithsonian Castle, are also set to reopen later this month.

Meet Michael (Mikey J) Smith, Storyteller and Activist

What drew you to studying journalism?

For as long as I can remember, my goal in life was to be a local TV news anchor.  When watching the evening news, the anchor seemed like the pinnacle of what a put-together person was supposed to be, and from a very young age, I just knew that was what I wanted to do.  I started college at St. John’s University in New York City, but I ended up hating that school, so I transferred to University of Maryland, which has one of the best journalism programs in the country.  As I got more into my major, what kept me going was the ability to meet people and learn their stories.  Journalism is really dependent on your ability to tell stories, and the opportunity to meet people from all walks of life, live through their emotions, and give them a platform, is such a beautiful thing. 

How does your journalism degree help you in your current role?

It definitely taught me how to speak with everyone.  I’ve always been a relatively social person, but to speak to someone in a way that makes some one immediately comfortable with you is a skill you have to learn, and journalism definitely taught me how to connect with people in a way that they can trust you with your story.  It teaches you how to speak with people from all different walks of life, even people you have nothing in common with.  Without my training, I don’t know if I would be as effective from a relationship management standpoint that I am.

What’s the most challenging part of starting a new job in a pandemic?

The inability to walk into a room and meet my coworkers.  This was my first step into my career post-graduation, and I was super-excited to have this opportunity to take on work that’s interesting and engaging.  Starting a new job all from home was sort of a let-down because I was looking forward to meeting with my coworkers and learning.  I’ve been able to do this to an extent remotely but being secluded in my home and having to keep my spirits up has been difficult.  I’m a social person – I like to be around people, speak to people, laugh, joke – and that’s hard to do remotely.  

What’s some of the best advice you’ve received?

Be blunt.  Part of my nature is to be very tactful.  What that means is I’m not always going to get to the heart of an issue because I want to make sure I’m not offending anyone or stepping on anyone’s toes.  That’s not always helpful, and sometimes you just need to state what’s going on to get past something, especially in business.  Someone once told me I sugarcoat things way too much, and you need to just tell them what’s going on to make a decision.  That’s helped me a great deal, both in journalism and business, because people know what I’m actually trying to say to them.  And I’m learning more and more every day that it’s not bad to not be tactful. 

What else should we know about you?

During my entire college career, I was active in social issues, and one of the organizations I worked for was Preventing Sexual Assault (PSA).  I was part of the team that was able to bring in Victoria Valentino, a noted survivor and Bill Cosby accuser, to campus to speak about her experiences and offer an ear to people going through such a hard time in their lives. That’s one of my passions – to make sure that issue is never forgotten.  It’s a hugely important issue, especially on college campuses, and there’s so much more work to be done.  It’s definitely one of those projects I’m going to continue working on, because I want to see true change happen before I leave this planet.

What’s in the Surprise Billing Rule, and What Happens Next?

It’s the beginning of the end for surprise medical bills.  On July 1, the Biden-Harris Administration through the Department of Health and Human Services (HHS), the Department of Labor, and the Department of the Treasury (collectively known as the Departments), along with the Office of Personnel Management (OPM), released an interim final rule as a first step in implementing the No Surprises Act that was signed into law as part of the omnibus appropriations package in late 2020.  However, the regulations won’t go into effect until January 1, 2022, and stakeholders can provide comments by September 7.   

What’s In the Rule?

Below are the provisions in the interim final rule that establishes new protections from surprise billing and excessive cost-sharing for consumers receiving health care items and services.  

  • Surprise billing will be banned.  The interim final rule bans out-of-network charges for emergency services, regardless of location.  Providers are required to bill emergency services on an in-network basis without prior authorization. The rule also prohibits surprise billing for ancillary services at in-network facilities in all cases, including anesthesiology services. 
  • Patients must consent to waive balance-billing protections. The rule directs federal agencies to establish a process to allow patients to waive their balance-billing protections and consent to out-of-network charges.  Notably, providers are not allowed to request patient consent in three scenarios: (1) The provider provides an ancillary service not selected by the patients, such as a radiologist or anesthesiologist; (2) there are no in-network providers available at the facility; or (3) the service is urgent or arises from unforeseen circumstances.
  • Insurers have 30 days to issue an interim payment or notice of denial from insurers. The interim final rule requires health plans to make an initial payment or issue a notice of denial to providers in 30 days after it receives a clean claim. 
  • CMS must determine the qualifying payment amount. The rule calls on the Centers for Medicare and Medicaid Services (CMS) to define the qualifying payment amount (QPA), which will calculate patient cost-sharing and be used by an arbitrator in the independent dispute resolution process. The rule addresses several factors that will determine how the rates are set, including the type of contract, insurance market, geographic region, and rates for same or similar services. 
  • Insurers must provide more transparency.  The interim final rule requires health plans to take several steps to promote price transparency and by requiring them to provide an advanced explanation of benefits, transitional continuity of coverage when a provider leaves the network, and access to accurate provider network directories. 

What’s Next?

The interim final rule issued on July 1 is only the first step in a multipart regulatory process, as the Departments will need to issue two additional rules to fully enact the No Surprises Act. 

By October 1, the Departments are required to put forth a rule on an audit process to ensure that plans and insurers are complying with the QPA calculation and requirement.  The audit may be performed by federal or state officials, depending on who is enforcing the surprise bill.  Enforcement follows the same rules as the Affordable Care Act, with the federal government tasked with enforcing self-insured group health plans, while states may enforce rules over non-group health plans and fully insured employer-sponsored plans.  The rule expected by October 1 will contain details on how the auditing process will work as well as how federal agencies will address enforcement. 

By December 27, the Departments must outline through rulemaking the details of an independent dispute resolution (IDR) process that providers and health plans can opt for if they fail to reach an agreement on an out-of-network rate.  The IDR process is characterized as binding, baseball-style arbitration, meaning the arbitrator must select one party’s offer.  Federal regulators face the challenge of setting up an IDR process that’s considered fair but doesn’t cause providers and insurers to overuse the process and incur higher administrative costs.  The details of the IDR process have been debated repeatedly among stakeholders and are considered to be the most consequential part of the No Surprises Act.

What Are the Reactions?

Initial reactions to the interim final rule suggest the rule favors employers and insurers over hospitals.  The American Benefits Council, an organization who advocates for employer-sponsored plans, applauded the publication of the  interim final rule as it included many of the organization’s recommendations. However, the council noted that many key issues won’t be addressed until the release of the rule on the IDR process.  One fundamental issue the council cited is confirmation that either party participating in IDR can defer the QPA except in extenuating circumstances.  Similarly, the ERISA Industry Committee applauded the rule for “taking a firm stand” to protect Americans from surprise billing and address high health care costs.  In contrast, the California Medical Association said it has “serious concerns” about the new regulations, specifically as they pertain to the QPA, although the organization declined to specify its concerns.   

What Happened, What You Missed: July 12-16

CMS Proposes to Extend Some Telehealth Services through 2023

In its physician fee schedule for 2022, the Center for Medicare and Medicaid Services (CMS) proposed extending coverage for some Medicare telehealth services through the end of 2023.  Under the rule, CMS is proposing to remove certain statutory restrictions to allow patients in any geographic location and in their homes access to telehealth services for diagnosis, evaluation, and treatment of mental health disorders and allow for coverage of audio-only telehealth services to apply to counseling and therapy for opioid treatment.  The release of the proposed rule comes just one day after a group of bipartisan House Energy and Commerce Committee members sent a letter to Health and Human Services (HHS) Secretary Xavier Becerra urging the Department to make Medicare coverage for some telehealth services added under the public health emergency permanent.  Comments on the proposed rule are due on September 13. 

Senate Democrats Reach Agreement on $3.5 Trillion Infrastructure Package

On July 13, Senate Majority Leader Chuck Schumer (D-NY) announced an agreement on a $3.5 trillion “human infrastructure” package after a meeting with Democrats on the Senate Budget Committee.  Major proposals include subsidized child care, national paid family leave, free community college, a host of climate change initiatives, and expanding Medicare coverage for vision, dental, and hearing services.  Democrats are hoping to pass the legislation through budget reconciliation, which would allow the bill to advance in the evenly split Senate with a simple majority.  However, it remains to be seen if the White House and Democratic leadership can count on all Senate Democrats to support the package, including moderate Democrats like Sen. Joe Manchin (D-VW), who is concerned about how the legislation will be paid for.

Drug Overdose Deaths Hit New Record in 2020

According to data from the Centers for Disease Control and Prevention, drug overdose deaths increased nearly 30% from 2019 to hit a record high of over 93,000 in 2020.  A contributing factor is the widespread use of fentanyl, which can halt breathing even if a small amount is ingested. Additionally, the pandemic played a significant role in the increase of deaths, strained health care resources, and made addiction treatment more difficult to obtain.   

CMS Studying How Much Medicare Should Pay for New Alzheimer’s Drug

On July 12, CMS launched a National Coverage Determination analysis to determine whether and under what circumstances Medicare should cover Biogen’s recently approved Alzheimer’s drug Aduhelm. Aduhelm has attracted controversy for its high price tag of $56,000 and inconsistent efficacy in clinical trials. Furthermore, on July 15, a group assembled by the Institute for Clinical and Economic Review unanimously agreed that Aduhelm does not work better than existing Alzheimer’s treatments. However, CMS will propose a decision within six months and then allow stakeholders to comment within a 30-day period with CMS making a final decision three months later. Until then, Medicare Administrative contractors will be left to make coverage determinations for the Alzheimer’s drug. 

ICMYI: Library of Congress Reopens to the Public

On July 15, the Library of Congress reopened to the public, marking a major step in reopening the US Capitol complex.  Visitors are required to get tickets online for a timed entry on Thursday, Friday, or Saturday, and face masks are required for all visitors regardless of vaccination status.  The library’s Thomas Jefferson building is considered an architectural gem and was modeled after the Pantheon in Rome.  However, it’s unclear when the Capitol itself will reopen to the public. 

The “Committees of Jurisdiction” That Shape Health Care Policy in Congress

Congressional committees help Congress with the important work of reviewing, debating, and passing legislation.  As Congress considers legislative action on drug pricing, paid leave, and other key health care policies, it’s important to understand a committee’s “jurisdiction,” or its area of responsibility.  The jurisdiction of each Senate committee is specified in Senate Rule XXV, while each House committee draws from House Rule X.  The following list contains each congressional committee that has  jurisdiction over health policy, along with a brief description of each committee’s role, issues that each committee covers, and the recent activities of each committee.  

Senate Finance Committee

This committee, in addition to various issues related to taxation and trade, oversees health programs under the Social Security Act, such as Medicare, Medicaid, the Children’s Health Insurance Program (CHIP), Temporary Assistance to Needy Families (TANF), and other programs financed by a certain tax or trust fund.  The committee also shares or has sole jurisdiction over numerous departments and agencies, including the Department of Health and Human Services (HHS), which includes the Centers for Medicare and Medicaid Services (CMS) and the Administration for Children and Families, and the Social Security Administration.  The committee is additionally tasked with reviewing nominations for the HHS Secretary, the CMS Administrator, and other high-ranking appointed positions with HHS and other departments under its jurisdiction.  Furthermore, the committee oversees employer-sponsored insurance per the Employee Retirement Income Security Act of 1974. 

Recent Activity: Separately, leaders of the Senate Finance Committee are working on legislation to address drug prices.  In June, Chairman Ron Wyden (D-OR) released a set of principles on legislation to lower drug prices that includes allowing for government negotiation of drug prices and changes to the Medicare drug benefit design.  Additionally, Ranking Member Mike Crapo (R-ID) and Sen. Richard Burr (R-NC) recently reintroduced the Lower Costs, More Cures Act, which does not provide for government negotiation of  drug prices but also include benefit design.

Senate Health, Education, Labor, and Pensions Committee

Commonly abbreviated as “HELP,” this committee has wide jurisdiction over health care, education, labor and retirement policies, and public welfare.  Broadly speaking, the issues it deals with entail biomedical research and development, public health, and occupational health.  The HELP Committee also has jurisdiction over matters within the Food, Drug, and Cosmetics Act, and the Commissioner of Food and Drugs is subject to the committee’s nomination process.

Recent Activity: The HELP Committee has spent much of this year focusing on the response to the COVID-19 pandemic with regards to vaccinations, behavioral health, and preparing for the next public health crisis.   Its next hearing on the COVID-19 response is currently scheduled for July 20

Senate and House Judiciary Committees

Broadly, these committees consider legislation related to the judicial system and play a critical role in providing oversight of the Department of Justice (DOJ) and the agencies under the Department’s jurisdiction, including the Federal Bureau of Investigation (FBI), and the Department of Homeland Security (DHS).  In particular, the Senate Judiciary Committee considers executive nominations for positions in the DOJ, FBI, and DHS.  The Senate committee also reviews all judiciary nominations, including Supreme Court, appellate court, and district court nominees.  Specific to health care, both committees review matters relating to antitrust law, such as the merger and acquisition of health providers.  The committees also review patent law issues as they apply to drug and medical device manufacturers. 

Recent Activity: The Senate Judiciary Committee has focused much of its work in July on reviewing and voting on the Administration’s judicial nominees.  Other issues of note have focused on anti-competitive behavior among health care providers, particularly as it relates to drug pricing and hospital consolidation.  Meanwhile, the House Judiciary Committee recently advanced several antitrust bills and has held similar hearings on anti-competitive behavior in health care as well as voting rights and immigration.

Senate and House Appropriations Committees

These committees are responsible for the appropriation of revenue for the support of the government.  Appropriations is divided into 12 accounts, with two having the most influence on health care: Labor, Health and Human Service, Education, and Related Agencies (LHHS); and Agriculture, Rural Development, Food and Drug Administration, and Related Agencies (Ag-FDA).  LHHS dictates funding for all major components of HHS except for the Food and Drug Administration (FDA), which is covered under Ag-FDA. 

Recent Activity: The House Appropriation subcommittees have kicked off the process of reviewing and marking up spending bills for Fiscal Year (FY) 2022, whereas the Senate Appropriation subcommittees have not started.  The full House Appropriations is scheduled to vote this week on spending bills for several accounts, which includes LHHS and Ag-FDA..  As government funding runs out in 78 days, lawmakers may have to pass a stopgap measure, known as a Continuing Resolution (CR) to keep the government running if both chambers cannot agree on top line numbers and pass a long-term spending bill for FY 2022. 

Senate and House Budget Committees

These committees focus on the details of the federal budget, drafting of the budget resolution, and compiling and reconciling legislation for all areas including health care. These committees also oversee the Congressional Budget Office (CBO), which “scores” bills according to how much they would cost once enacted.  The Senate Budget Committee specifically reviews the nominee for the Director of the Office of Management and Budget.

Recent Activity: The Senate Budget Committee is working to finalize a budget resolution, which will include reconciliation instructions, to allow Democrats to advance a multitrillion-dollar package later this year.  Meanwhile, both the Senate and House Budget committees have held hearings to review the Administration’s FY 2022 budget request.

House Ways and Means Committee

This committee’s jurisdiction is very similar to that of the Senate Finance Committee in that it also oversees health programs under the Social Security Act, such as Medicare, Social Security, and TANF.  However, the committee does not have jurisdiction over Medicaid.  The committee is considered particularly impactful among congressional members because of its authority on tax issues. 

Recent Activity: The Ways and Means Committee has recently conducted oversight hearings on improving access to housing and expanding access to education.

House Energy and Commerce Committee

In addition to being the oldest standing committee in the House of Representatives, this committee has the broadest jurisdiction of any House committee.  On health care, it oversees a variety of issues, including Medicare (except Medicare Part A), Medicaid, health insurance (except for employer-sponsored plans), biomedical research and development, drug and device safety, and public health issues.  The health-related departments and agencies it oversees are HHS, FDA, the Centers for Disease Control and Prevention, and the National Institutes of Health.

Recent Activity: The House Energy and Commerce Committee has been working on a number of areas within its health care jurisdiction to advance legislation on expanding access to health care coverage, improving maternal health, enhancing behavioral health, addressing social determinants of health, lowering drug costs, and addressing health equity.

House Education and Labor Committee

This committee has jurisdiction over education and labor issues.   This includes all employment-related health and retirement security issues, including employer-sponsored health plans.  The committee is also interested in health care workforce issues. 

Recent Activity: Two subcommittees on the House Education and Labor Committee are set to review issues affecting the direct care workforce in a hearing on July 20.

What’s Taking FDA So Long to Fully Approve Pfizer’s COVID-19 Vaccine?

It took the Food and Drug Administration (FDA) just three weeks to issue an emergency use authorization (EUA) for Pfizer’s COVID-19 vaccine in December 2020 when Pfizer submitted the request.  In contrast, it’s been over two months since Pfizer initiated a “rolling submission” of its biologics license application (BLA) for its vaccine on May 7, and FDA has yet to comment on its timeline for approval.  Amid growing calls for FDA to fully approve Pfizer’s vaccine, what’s making the review process take so long?

Why the Push for Full Approval?

Many people believe full approval of Pfizer’s COVID-19 vaccine will help get more shots into arms, which is seen as vital to protecting Americans from the rapidly spreading Delta variant.  According to data from the Centers for Disease Control and Prevention posted on July 6, the Delta variant makes up 51% of new COVID-19 cases in the US.  Additionally, studies show the Delta variant is at least 40% more transmissible than the Alpha variant, which was previously the country’s dominant variant.  The surge in the Delta strain comes as many Americans remain vulnerable to COVID-19, as only 67% of Americans have received at least one COVID-19 shot, and the pace of vaccinations has dropped off considerably in recent weeks. 

Full approval of the COVID-19 vaccine is one way public health experts believe could convince more Americans to roll up their sleeves, which addresses vaccine hesitancy, a sentiment echoed by several major elected officials.   In June, President Joe Biden said going from “temporary approval to full approval” would “increase the number of people” willing to get vaccinated.  Similarly, Arkansas Governor Asa Hutchinson, whose state has some of the nation’s lowest vaccination rates, remarked in June that full approval is needed to combat vaccine hesitancy.  According to a Kaiser Family Foundation poll from May 2021, 32% of unvaccinated adults said full approval of one of the currently authorized vaccines would make them more likely to get vaccinated.

Furthermore, fully approving the vaccine will allow for more businesses and organizations to mandate the COVID-19 vaccine, which could help increase vaccination rates.  While several hospitals and health systems such as Houston Methodist and Trinity Health have mandated the vaccine for their employees, some health systems like Beth Israel Leahy Health in Boston are holding off until a vaccine is fully FDA-approved.  Even though lawsuits against vaccine mandates have so far held up in court, many employers and organizations seem to be holding off on mandating  employees to get the vaccine out of fear of litigation.   Even the US Army has communicated to servicemembers that vaccination won’t be mandated until “full FDA licensure.”

What’s the Hold Up?

The reason for FDA’s longer process for fully-approving Pfizer’s COVID-19 vaccine is due to the fact that the business of issuing a BLA is more intensive than an EUA.   For an EUA to be issued, companies need to provide the FDA data that demonstrates efficacy and safety from a Phase 3 trial with a median follow-up period of at least two months.  In contrast, a BLA requires FDA to look through at least six months of clinical trial data as well as a close examination of the company’s manufacturing process, both of which take additional time.  Dr. Paul Offitt, a member of FDA’s Vaccines and Related Biological Products Advisory Committee,  commented in December 2020 that Merck’s BLA submission for its 70,000-person rotavirus vaccine trial contained enough pages to exceed the height of the Sears Tower, a 1,450-foot skyscraper in Chicago currently known as the Willis Tower.

There are benefits for drug manufacturers in getting their products fully approved.  According to former FDA Commissioner Dr. Robert Califf, a BLA would allow Pfizer to being marketing its vaccine directly to consumers.  Additionally, full approval would open the door to Pfizer increasing the price of its vaccine post-pandemic, potentially generally billions of dollars for the company.

When Will the Vaccine Be Fully Approved?

Unfortunately, FDA has yet to shed any light on its timeline for fully approving the Pfizer vaccine.  In late June, an FDA spokesperson  told The Hill that the agency “cannot comment on individual applications before it.”  More recently, the FDA told Army Times on July 2 that timelines for approval “may vary depending on a number of factors.” 

While fully approving a vaccine normally takes between 8-12 months, there is reason to believe Pfizer will receive a decision from the FDA soon. Former FDA scientist Jesse Goodman said in June that the FDA might not complete its review process for another 3-4 months, meaning a BLA might not come until  September or October.  Notably, Goodman cautions against fully approving the vaccine too quickly, as it could “undermine confidence” in the vaccine. 

Ultimately, FDA is in a tough position.  As a full review of the Pfizer vaccine continues, the agency must strike a balance between ensuring the American people can benefit from a fully approved vaccine in a timely manner without giving off the sense that the BLA was issued too quickly.  Absent any communication from FDA, however, vaccine observers have no choice but to sit and wait.

What Happened, What You Missed: July 5-9

CDC, FDA Counter Pfizer on Need for Booster Shot

On July 8, the Centers for Disease Control and Prevention, and the Food and Drug Administration issued a joint statement saying that vaccinated Americans “do not need a booster shot at this time.”  The agencies also affirmed that currently approved vaccines are still effective against variants such as Delta.  The statement was issued hours after Pfizer announced it will soon seek authorization for a COVID-19 booster to provide added protection against COVID-19 variants.  New research out of Israel suggest Pfizer’s vaccine is less effective against the Delta variant, which is prompting greater interest in booster shots. CDC and FDA have vowed to continue to review new data on vaccine efficacy as it becomes available.

Biden Outlines “Door-to-Door” Vaccination Push

On July 6, President Joe Biden announced a new community-focused effort to get more Americans vaccinated though door-to-door outreach, mobile clinics, and directing  more vaccine doses to workplaces, pharmacies, and doctor’s offices.  The President’s announcement comes as parts of the country with lower vaccination rates have seen an increase in new cases due to the Delta variant.  According to the CDC, the Delta variant comprises 51% of new COVID-19 cases in the US.  Biden also announced a goal to get as many adolescents aged 12 to 18 vaccinated as soon as possible before the school year begins as well as the mobilization of new “COVID-19 Surge Response teams” to aid communities with higher numbers of unvaccinated people. 

New Study: Vaccines Prevented 279K Deaths

According to a study released on July 7 by the Commonwealth Fund, the US vaccination campaign against COVID-19 prevented about 279,000 deaths and 1.25 million hospitalizations between December 12, 2020 and July 1, 2021.  The study also found that vaccines blunted the spread of the Alpha variant in the spring, preventing nearly 4,500 deaths per day.  However, the report warned that the Delta variant will continue to pose a “special threat” to unvaccinated populations in the coming months, requiring renewed commitment to vaccinations.

FDA Limits Use of New Alzheimer’s Drug to Early-Stage Patients

On July 8, Biogen announced that the FDA had updated the labeling for its recently approved Alzheimer’s drug so that it can only be usedfor patients with mild Alzheimer’s disease.  This change in labeling comes after the drug, known as Aduhelm, attracted criticism for being approved for all patients with all stages of Alzheimer’s when its clinical trials only included people in the earliest stages of Alzheimer’s.  The decision to narrow the number of people who can be treated with the drug could address the criticism of Aduhelm’s financial impact, which has a list price of $56,000.

Fencing Around Capitol to Come Down Soon

According to a memo from the House Sergeant at Arms to all members of Congress and staff, the remaining fencing surrounding the US Capitol Building will start being removed as early as July 9.  The black perimeter fencing was initially put up to bolster security at the Capitol in the wake of the January 6 riot.  The memo states that the Architect of the Capitol has the ability to “expeditiously reinstall” the fencing, if it is needed.  An outer perimeter fence that closed off several blocks around the Capitol was already removed in March.  Despite pending removal of the remaining fence, which is expected to take about three days, the Capitol still remains closed to visitors. 

ICYMI: New Book Looks at the Role of Presidents’ Friends

A new book by journalist and former political operative Gary Ginsburg was published on July 6, tells the story of nine friends to  US presidents and the impact of their relationships.  For example, Eddie Johnson, a longtime Jewish friend of President Harry Truman, may have played a pivotal role in lobbying the 33rd president to make the US the first nation to recognize the statehood of Israel.  Other friendships profiled include President Franklin Pierce and Nathaniel Hawthorne, author of The Scarlet Letter, and President Bill Clinton and Vernon Jones, his golfing partner.

Will August Recess Be Canceled This Year?

Summer has arrived, and once again, some members of Congress are calling for August recess to be scrapped.  Does this mean lawmakers will be working through the summer on infrastructure and other high-priority legislative items, or are calls to keep members of Congress in Washington throughout August nothing but noise? 

The History of August Recess 

The practice of lawmakers leaving town in August goes back to 1970, when Congress enacted the Legislative Restoration Act.  The law created a mandatory five-week break for lawmakers beginning in the first week of August and concluding after Labor Day, partly in response to the growing length of legislative sessions.  From the late 19th Century to the 1930s, Congress convened only five or six months out of the year.  By the 1950s, however, Senators and Representatives found themselves in Washington most of the year, prompting calls to “modernize Congress” and give lawmakers a break.  At the time the Legislative Restoration Act was passed, Congress had many younger members with children who sought a more predictable legislative schedule with time set aside to spend with family.

August Recess Isn’t Really Recess

Just because Representatives and Senators aren’t in Washington to convene hearings or cast votes doesn’t meaning August is essentially a month-long vacation.  What’s commonly referred to as “recess” is really a “district work period” according to the House and a “state work period” in the Senate.  It should be noted that state and district work periods are not limited to August and occur throughout the year, although in shorter durations and scheduled closer to federal holidays.  While members are Congress do take advantage of August for some R&R, most of their month is spent engaged in the following activities:

  • Meeting with constituents.  Members of Congress consider connecting with voters to be the most important way to spend their time when outside of Washington.  Specific activities include having meetings in in their local offices; visiting schools, hospitals, and businesses; hosting townhalls; and taking interviews with local media.  Representatives and Senators also use work periods to reconnect with state and district staff who facilitate valuable constituent services.
  • CODELs.  Shorthand for “Congressional Delegation,” CODELs are privately funded trips that members take in their official capacities as lawmakers, often overseas. 
  • Campaigning and fundraising.  The month of August is often used by members to connect face-to-face with donors and supporters.  But these activities are conducted on their own time since political activities are not allowed under congressional rules.  

The Push for Canceling the August State/District Work Period in 2021

This year, some Senate Democrats including Sens. Chris Van Hollen (MD), Jeff Merkley (OR), Ed Markey (MA), and Richard Blumenthal (CT) are leading the charge for continuing legislative business through at least part of August.  Their justification for shortening or eliminating this year’s August state/district work period is to provide more time for Democratic lawmakers to advance their legislative goals.  With August less than a month away, congressional Democrats are already behind on several priorities, including passing a bipartisan infrastructure bill, a reconciliation package, police reform, immigration reform, and gun violence legislation.  Regardless, prospects for even cutting back the month-long break from Washington appear dim at this point.  Some members of the Senate Democratic leadership don’t seem keen on the idea, with Majority Whip Dick Durbin (D-IL) publicly throwing cold water on the idea.  However, Durbin did acknowledge that Senate Democrats have a lot of unfinished legislative business to attend to.   

Pros and Cons

Canceling or at least reducing recess has some legislative benefits for Democrats, as it would give members more time to work on bills, offer amendments, and debate.  Outside of legislative goals, working through August in Washington would provide Senate Democrats more time to confirm the Biden Administration’s executive and judicial nominees.  But there are plenty of reasons to keep the month-long state and district work period in 2021, too. 

As discussed, this period provides valuable opportunities for members to connect in-person with constituents through meetings, town halls, and other events.  This is especially valuable for members who live far away from Washington, DC and are limited in how they can utilize their weekends due to travel times.  And given that midterm elections tend to be unfavorable to the party that won the White House two years prior, Democrats would be wise to use August 2021 to connect with voters.

August Recess Has Been Canceled Before…

If Senate Democratic leadership opt to cancel August’s state work period this year, it wouldn’t be the first time Congress eschewed its month-long summer break from Washington. 

…But It’s Still Rare for Recess to Be Canceled

However, instances of lawmakers actually canceling or drawing back on August state/district work periods appear to be the exception, not the rule.  Nearly every year, at least one lawmaker appears to make the case for Representatives and/or Senators to continue working through the eighth month of the year in Washington.

When Congress does cut short its month-long summer break, it’s generally to deal with a major crisis, such as a global pandemic or a natural disaster.  In most cases, calls to waive August recess are mostly forgotten, mainly because a one-month stretch to connect with voters is simply too valuable for Representatives and Senators to forgo.  While Senate Democrats might find themselves under pressure to make progress on various legislative goals this summer, they’re most likely to find themselves outside of Washington come next month.

What You Need to Know about Medicare Insolvency

Medicare is in trouble.  The Hospital Insurance (HI) trust fund, which finances Medicare Part A, already spends more than it brings in, and without help from Congress, the trust fund is projected to become insolvent in just a few years.  Unfortunately, the HI trust fund has been down this road before, requiring Congress to take action to stave off insolvency and extend the lifespan of the trust fund at several points in the past.  What exactly does insolvency mean for Medicare, and how can lawmakers put the program on solid financial footing?

The State of the Trust Fund

Concerns over Medicare insolvency aren’t exactly new.  Since the program’s creation in 1965, Medicare has faced insolvency on a fairly regular basis.  Even before the start of the COVID-19 pandemic, the HI Trust Fund was projected to hit insolvency by 2030.  However, the pandemic has exacerbated the trust fund’s financial outlook considerably.  Since payroll taxes are the chief source of revenue for the trust fund, job losses from COVID-19 have resulted in less incoming revenue for Part A.  Another factor which hastened the fund’s depletion is the fact that $60 billion of funding provided to the Provider Relief Fund under the CARES Act came from the HI trust fund.

What Does Insolvency Actually Mean?

Contrary to what many believe, insolvency wouldn’t mean the HI trust fund had completely run out of money or would be unable to pay out claims.  Rather, it would mean the trust fund would no longer have any assets.  Once the trust fund depletes, the Congressional Budget Office (CBO) projects annual program revenues from payroll taxes will only cover about 92% of annual program outlays.  Absent any congressional action, insolvency would mean Medicare payments to providers would be reduced to levels that could only be covered by incoming tax revenues.  This could affect providers through one of two scenarios.  In the first scenario, the Centers for Medicare and Medicaid Services (CMS) would reimburse claims as revenue comes into the trust fund, but as tax revenues come in at a slower rate than provider claims, the amount of time between the filling of claims and reimbursement would grow, resulting in delayed payments for providers.  Under the second scenario, CMS would pay a decreased rate for all Part A care.  According to a CBO report from September 2020, Part A would only have enough tax revenue to pay 83 cents for each dollar billed upon the trust fund reaching insolvency.  This means that for every $100 owed to providers for Part A-covered services, CMS would only be able to reimburse $83. 

It should also be noted that the HI trust fund’s exact date of insolvency is unknown.  In September 2020, CBO initially projected the trust fund would become insolvent by 2024.  However, improved estimates for job growth and the employment rate in a February 2021 report from CBO prompted many analysts to push the anticipated date on insolvency back two years.  

Déjà Vu All Over Again

Lawmakers have come to Medicare’s rescue in the past when the program faced similar financial problems, only to take back or delay some of the financial pain the laws inflicted on providers.  When Medicare approached insolvency in the 1990s, Congress ushered in major changes to the program via the Balanced Budget Act (BBA) of 1997, which increased cost sharing for beneficiaries, reduced the growth of payments to providers, and expanded prospective payments to post-acute care facilities.  In 2002, Congress began a 13-year run of delaying the resulting cuts to physicians and other Part B providers through legislative efforts commonly known as the “doc fix.”  Congress once again took action in 2009 to shore up the trust fund via the Affordable Care Act (ACA). Under the landmark health law, a growth in payroll taxes for high-income Americans and a Medicare net investment income tax increased the program’s solvency to a total of 19 years.  However, Congress ended up repealing many of the ACA’s revenue-generating policies like the “Cadillac Tax” and medical device tax, as well as the hugely unpopular Independent Payment Advisory Board, meaning the trust fund was once again facing hard times.  The Budget Control Act of 2011 ushered in an era of automatic Medicare payment cuts, which Congress continues to suspend, doing so through December 31, 2021 in the most recent COVID-19 relief law. 

How to Address Medicare’s Finances

There is no shortage of proposals to delay Part A’s insolvency, most of which revolve around either reducing spending or increasing revenue.  Many of these ideas would require statutory changes.  Below are some key proposals summarized.

  • Raise Medicare Taxes.  Congress could consider raising payroll taxes by 0.38% each on employees and employers to stave off insolvency.  However, such a move would be politically unpopular and inopportune as the economy continues to recover from the pandemic.  As an alternative, Congress could consider using the proceeds of the net investment income tax to finance the HI Trust Fund.  Under the Affordable Care Act (ACA), high-income Americans have a 3.8% net investment income tax, and bumping this up to 4% would provide the trust fund $490 billion in additional revenue over 10 years.
  • Build an Integrated Benefit and Trust Fund Structure.  Instead of having two separate insurance plans for Medicare – one for inpatient services (Part A) and one for ambulatory care (Part B) – Congress could integrate benefits covering inpatient and outpatient care with a simplified cost-sharing structure for patients.  Revenue sources would remain the same, although general fund payments to cover Medicare’s costs would be indexed in future years to a measure of economic growth or another measure not tied to Medicare’s costs.
  • Turn Medicare into a Premium Support Program. Beneficiaries would choose a plan each year, with the federal contribution determined by the second-lowest bid for all plans.  Instead of defining benchmarks by spending growth in the fee-for-service program, benchmarks would be defined by the second-lowest bid.  Competition among plans to be the second-lowest bidder would incentivize plans to keep premiums low.
  • Advance Health Equity.  Health inequities cost the US $83 billion each year and contribute to poor health outcomes for Medicare beneficiaries, subsequently driving greater spending.  Medicare could utilize telehealth, implicit bias training, regular screening for social and nonmedical needs, and enhanced data on beneficiaries to reduce chronic conditions and improve beneficiaries’ health.
  • Expand Promising Alternative Payment Models.  Alternative payment models create incentives for providers to collaborate to provide high-value care.  Since most alternative payment models have failed to produce noticeable savings, CMS could double down on the most promising models and encourage long-term investment in them. 

Medicare is very popular among beneficiaries, and lawmakers have repeatedly vowed to ensure the program has a future.  With potentially only a few years until the program faces a financial reckoning, Congress may yet take up the mantle to make changes to Medicare to ensure its long-term sustainability.  What those changes may be – and whether Congress can stick to its plan – are far from certain.

What Happened, What You Missed: June 28-July 2

Walensky: Vaxxed People Don’t Need to Mask Up for Delta

In a June 30 interview on Good Morning America, Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky said fully vaccinated people are safe from the Delta variant of COVID-19 and do not need to wear masks.  Walensky’s comments follow recommendations issued by the World Health Organization (WHO) on June 25 that urge even fully vaccinated people to wear masks and practice social distancing.  According to former Senior Advisor to the COVID-19 Response Coordinator Andy Slavitt, the differences between the WHO and CDC guidance can be attributed to the fact that the former concerns the entire globe, where vaccination rates in most countries are rather low, while the latter concerns the US, where vaccination rates are relatively higher.  Still, some jurisdictions are adding their own recommendations on top of the CDC’s.  On June 28, Los Angeles public health authorities recommended that all residents wear masks indoor regardless of vaccination status out of concern for the more transmissible Delta variant.  Similarly, Illinois Governor J. B. Pritzker suggested on June 29 that Illinois vaccinated residents consider masking up if they enter a “very crowded area.”  However, neither jurisdiction has officially reinstated a mask mandate. 

Researcher Say It’s Okay to Mix COVID-19 Vaccines

A study from Oxford University released on June 29 found mixing doses of Pfizer’s mRNA vaccine and AstraZeneca’s viral vector vaccine yielded a strong immune response against COVID-19.  According to the study, a dose of AstraZeneca and a dose of Pfizer administered four weeks apart regardless of order generated higher T-cells and antibodies than the standard two-dose AstraZeneca regimen.  The study’s findings come as more and more public health experts say a booster shot of Pfizer or Moderna’s mRNA vaccine may be needed to augment the protection offered from Johnson & Johnson’s single-dose vaccine, which is also based on viral vector technology. 

Biden Administration Announces New Proposals to Boost ACA Enrollment

On June 28, the Centers for Medicare and Medicaid Services (CMS) announced several plans to bolster the Affordable Care Act (ACA) in its proposed rule, which sets forth the proposed revised 2022 user fees for insurers offering plans on the ACA exchanges.  Among the changes the Administration is proposing includes extending open enrollment season by 30 days, eliminating the sign-up window for Americans who earn under 150% of the federal poverty level, and providing navigators $80 million for the next enrollment season by increasing insurers’ user fees by half a percentage point.  CMS is also notably proposing to reverse a policy finalized earlier this year by the previous Administration that would have allowed states to turn their insurance marketplaces over to private brokers and agents. 

ICER: New Alzheimer’s Drug Not Effective Enough to Justify High Price

The Institute for Clinical and Economic Review (ICER) issued a revised evidence report on June 30 saying that Biogen’s recently approved Alzheimer’s drug, Aduhelm (aducanumab), isn’t effective enough to legitimize its $56,000 price tag.  Instead, the group says the drug should be valued at $3,000 to $8,400 per year for patients with early-stage Alzheimer’s disease.  The group also found that Aduhelm’s “harms outweigh any potential benefits” for patients with more severe Alzheimer’s.  Aduhelm has come under increased scrutiny after the Food and Drug Administration (FDA) approved the drug despite the fact that one of the Aduhelm’s two phase 3 clinical trials failed to show positive efficacy. 

Pew: Suburban Voters, White Men, and Independents Helped Biden Win

A new analysis of the 2020 president election by Pew Research Center found  that a larger share of suburban voters, white men, and independents helped deliver a victory to Joe Biden, while Republicans gained the support of more Hispanic voters.  Pew’s report is considered more accurate than exit polls because it matches survey data with state voter records. 

ICYMI: Intelligence Officials Can’t Explain UFOs

On June 25, the Office of the Director of National Intelligence released a highly-anticipated report on UFOs, or unidentified ariel phenomena (UAP) in the military’s parlance.  Out of 144 UAP sightings listed, the report was only able to come up with an explanation for one, which was ultimately identified as a “large, deflating balloon.”  According to the report, the other 143 unexplained sightings fall into one of five categories: airborne clutter, natural atmospheric phenomena, US government developmental programs, foreign adversary systems, and a “catchall ‘other’ bin.”  The report notably states that UAPs may pose a challenge to national security, and the number of incidents may be under-reported due to the stigma associated with UFOs.

Should Hill Staffers Be Paid More?

On June 29, House appropriators signed off on a report to look into whether Members of Congress deserve a pay raise.   Does that mean their staff should get a pay raise, too? 

In Washington, DC, the median rent for a one-bedroom apartment is $1,630.  That’s a tough pill to swallow if you’re a young congressional staffer barely making over $30,000 a year.  The cost of living in the Washington, DC metropolitan area has soared in recent years while salaries for Hill staffers have barely budged, contributing to what some have observed as high turnover and low diversity among congressional staff. 

How Staff Are Paid

Each Member of the House of Representatives receives a Members’ Representational Allowance (MRA), which supports Representatives in their official duties.  The MRA is funded through the House “Salaries and Expenses” account in the annual Legislative Branch appropriations bill.  It is calculated into three components: personnel, official office expenses, and official (franked) mail.  Each component is combined into a single MRA reauthorization that can be used to pay for any type of expense, such as staff or travel.  While the personnel amount is the same for each member, official office and franked mail expenses vary depending on the distance between the Representative’s district and Washington, DC.  Each Representative may use the MRA to employ no more than 18 permanent employees, an amount that been unchanged since 1975.   Members are permitted to distribute staff salaries as they see fit and usually  interns and entry-level staff receive the lowest compensation, while senior staff receive higher salaries.  For many House staffers, maximum salaries have been unchanged since 2009.

Similar to their counterparts in the House, Members of the Senate receive a Senators’ Official Personnel and Office Expense Account (SOPOEA) to assist in official duties that is funded through the “Contingent Expenses of the Senate” account in the annual Legislative Branch appropriations bill.  The SOPOEA also consists of three categories (administrative and clerical assistance, legislative assistance, and official office expense) that are combined and may be used for any official expense, including staff salaries.  Typically, salaries for Senate staffers are higher than those for House staffers.  The SOPOEA saw a decrease in funding from FY 2010 to FY 2014 and remained the same from FY 2014 to FY 2017 before seeing a small increase in FY 2018.

Below is a chart listing average salaries for key House and Senate staff positions.

PositionHouseSenate
Chief of Staff$153,302$170,278
Press Secretary$62,515$75,842
Scheduler$56,270$78,420
Legislative Director$89,589$141,886
Legislative Counsel$70,871$95,611
Legislative Assistant$56,741$80,594
Legislative Correspondent$45,457$49,221
Staff Assistant$41,961$42,814

Again, these figures are averages, and actual salaries can vary widely between congressional offices.  In the House, for example, staff assistants surveyed made between $29,000 and $67,333 per year as of 2019.  Additionally, not all House and Senate staffers receive their salaries from MRAs and SOPOEAs respectively, as the Legislative Branch appropriations bill provides separate funding accounts for both leadership and committee staff.  In the House and Senate, leadership offices are funded as individual line items, such as the Office of the Speaker and the Offices of the [Senate] Majority and Minority Leaders.  Additionally, House committees are funded under a “Committee Employees” account, while the Senate has separate accounts for the Appropriations Committee, Conference Committees, and Policy Committees. 

The Impact on Staffers

While salaries for congressional staff have barely changed over the past decade, financial pressures on Hill staffers have grown considerably.  In addition to the National Capital Region’s skyrocketing housing costs, many staffers are seeing more and more of their hard-earned dollars go towards paying off student loan debt to cover rising college tuition.  High childcare costs in the Washington, DC area are an additional financial burden on staffers who are parents of young children.

All these pressures have implications for the congressional workforce, including:

  • High turnover.  Many staffers find salaries on Capitol Hill to be unsustainably low, leaving them to seek out better paying positions in the private sector, especially with lobbying firms, law firms, consulting firms, and trade associations.  Many staffers also seek higher paying positions in the executive branch.  High turnover also limits the ability of congressional offices to retain institutional knowledge, as staffers who gain expertise in a particular policy take what they’ve learned off the Hill.
  • Lack of diversity.  Staffers from more affluent backgrounds are better able to afford the Washington, DC area’s high cost of living, while staffers from lower-income backgrounds may eschew continued service on Capitol Hill out of economic necessity.   

Despite salary concerns, staff may find that there are certain benefits to working on the Hill. For instance, staff may have access to a student loan repayment program that provides up to $10,000 in assistance per year, similar to a program for executive branch employees.  The loan repayment program comes with a number of caveats, however,  only federal student loans are applicable, and staffers participating in the program must stay in their offices for at least a year.  Additionally, individual offices may have their own policies on loan repayment, like giving all staff members a set amount of money or using a sliding scale based on tenure or income.  Furthermore, the more staff an office has, the fewer dollars it is able individually offer for loan repayment.

Staff also have access to childcare centers affiliated with the House, Senate, Library of Congress, and Government Accountability Office.  However, these childcare centers have very long waitlists.

It should be noted that people do not pursue jobs on Capitol Hill only because of the pay.  Being a congressional staffer is highly desirable due to the unique experience the position offers, and it’s not uncommon for vacancies for entry- and junior-level positions in the House or Senate to attract dozens or hundreds of qualified applicants.  Working on the Hill can be seen as a steppingstone to a more lucrative positions in the private sector or the Executive Branch.  Despite the strong desirability of congressional jobs, low salaries are still likely to contribute to high turnover, as the average tenure for a Capitol Hill staffer is just over three years.

What’s Being Done?

Fortunately, concerns over staff salaries have yielded some changes.  By 2019, paid internships once again became a reality for many House and Senate offices after cuts to MRAs and SOPOEAs in 2011 forced offices to make many internships unpaid  as a cost-cutting measure.  Thanks to the  FY 2019 Legislative Branch appropriations bill, each individual House office has a pool of $20,000 it can spend on intern compensation annually, while the amount offered to Senate offices depends on state size.  The reintroduction of paid internships to Capitol Hill was part of a multi-year effort to allow individuals from a more diverse range of socioeconomic backgrounds to be introduced to a career in public service.   However, workforce diversity issues remain a concern.  According to a report issued in May 2021, most interns on Capitol Hill were white and had attended private universities. 

Some Members have taken it upon themselves to pay staff more.  In 2019, then-freshman Rep. Alexandra Ocasio-Cortez (D-NY) announced that all of her staff would be a paid a minimum of $52,000 to handle high living expenses in the Washington, DC area.  To make this high minimum salary possible, Ocasio-Cortez capped salaries for senior positions in her office at $80,000.  Other House offices have yet to adopt Ocasio-Cortez’s compensation model, possibly out of concern that lower salaries for senior positions could make it more challenging to attract top talent.  However, the New York Congresswoman may be in a better position to attract high-quality senior staff due to her status has a high-profile Representative.

Recently, House Democratic leaders have been making a more substantive push to boost staff salaries.  In April 2021, House Majority Leader Steny Hoyer (D-MD) and House Democratic Caucus Chair Hakeem Jeffries (D-NY) sent a letter to top Democrats on the House Appropriations Committee requesting a 20% increase in the MRA.  In their letter, Hoyer and Jeffries say higher salaries would allow House offices to compete with better-paying private sector employers for top talent and allow current staff a better shot at achieving economic security in the Washington, DC metropolitan area. 

Additionally, in May 2021, Hoyer and Jeffries teamed up with House Administration Committee Chair Zoe Lofgren (D-CA) to study whether expanded benefits should be included in the FY 2022 Legislative Branch appropriations bill to further boost staff recruitment and retention efforts. Some of the benefits under consideration include reimbursement for adoption or fertility treatment, first-time homebuyer assistance, and a 529 college savings plan.

What Will Happen Next?

It seems that calls to increase staffer pay are finally being heard, at least in the House.  On June 29, the House Appropriations Legislative Branch Subcommittee favorably report its  FY 2022 appropriations bill, which contains a 21% increase to the MRA, as well as a boost to the paid internship program.  This might prove to be the first step in ushering in higher pay for Hill staffers.  On the Senate side, there doesn’t appear to be much momentum to increase staff salaries, which are still somewhat higher than they are in the House.  Some members may be concerned about the optics of raising the MRA, as it could lead to criticism that congressional staffers are getting a pay boost at the expense of taxpayers.  Still, if a desire to address the high cost-of-living in the DC area and increase diversity was enough to provide funding for interns, it might be enough to provide a much-needed pay raise for Hill staffers.

Everything You Need to Know about COVID-19 Booster Shots

Every year, you get your flu shot.  Will the same be said for COVID-19 shots?  No one knows for sure, but federal officials and public health experts are weighing in on whether certain people might need COVID-19 booster shots as soon as this fall.  With questions about the longevity of vaccine-induced immunity and the potential for vaccine-eluding variants still unanswered, it certainly does not hurt to prepare.

What Is the Administration Planning?

On May 11, David Kessler, MD, Chief Science Officer of the White House COVID-19 Response Team, told a Senate panel that the Biden Administration is preparing for the possibility of booster shots for people who do not have a robust or long-lasting immunity, or if new variants evade protection from previously-administered vaccines.  Kessler said the booster shots would likely be a third shot of Pfizer or Modern’s mRNA vaccine rather than a new shot tailored to emerging variants.  He also confirmed that the booster shots would be free to Americans and funded by congressional appropriations through the end of Fiscal Year (FY) 2021.  Since Kessler’s testimony, the Administration purchased 200 million additional doses of Moderna’s COVID-19 vaccine in June to vaccinate children or to serve as a booster shot for adults.  Any decision to use booster shots would be up to the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC).

Kessler’s testimony was not the first time someone raised the possibility that people vaccinated against COVID-19 could need booster shots in the future.  In February, Johnson & Johnson CEO Alex Gorsky said COVID-19 booster shots may be needed annually, like flu shots.  Similarly, Pfizer CEO Albert Bourla said in April that people will likely need a third dose of a COVID-19 vaccine within 12 months of being fully vaccinated. 

How Long Does Immunity from Vaccines Last?

Since the vaccines were just developed in 2020, experts say only time will tell how long protection from the vaccines will last.  Of the few studies conducted so far, research from the New England Journal of Medicine published in April 2021 found Moderna’s COVID-19 vaccine can produce strong antibody protection for at least six months following the second dose.  Pfizer also announced research findings in April confirming its vaccine’s efficacy six months after the second dose.  

However, new research suggests it could be for a year or longer.  A pair of studies published in May 2021 found that the B-cells of people infected with COVID-19 still continued to mature and strengthen one year after infection, suggesting some type of immune response.  More recently, a study published in the journal Nature in June suggested immunity from mRNA vaccines could last for years.

What about the Variants?

However, many of these studies were conducted before the Delta variant became more prevalent.  Public health experts say the Delta variant, which was first discovered in India in October 2020, is 43-90% more transmissible than previous COVID-19 variants, leading some to believe that currently-approved vaccine are less efficacious against the  Delta variant.  A recent study said the Delta variant could become dominant in the US by mid-July.

Fortunately, the vaccines still offer strong protection.  According to a study by Oxford University researchers, two doses of the Pfizer vaccine appears to provide 79% protection against the Delta variant, compared to 92% against the Alpha variant, which is currently the dominant variant in the US, and was first discovered in the United Kingdom in September 2020.  Since the Moderna vaccine uses the same mRNA technology as Pfizer’s, it can be inferred that two Moderna doses offer the same levels of protection as the Pfizer vaccine provides against the Delta variant. 

But what about the Johnson & Johnson vaccine?  Compared to its Moderna and Pfizer counterparts, the single-dose vaccine has been administered far less, meaning public health officials have little data regarding its effectiveness against the Delta variant.  However, experts say a Johnson & Johnson vaccine is better than no vaccine at all, and that one dose is likely effective at protecting a recipient against serious illness or death.  Additionally, former Senior Advisor to the COVID-19 Response Coordinator Andy Slavitt has said that recipients of the Johnson & Johnson could take a single mRNA booster shot now for added protection.

Nonetheless, just because the current vaccines remain effective against the Delta variant does not  mean they are  necessarily guaranteed to be effective against future variants.  As explained by CDC Director Rochelle Walensky on June 22, the Delta variant represents a “set of mutations” of COVID-19, and future mutations could produce a variant that evades protection from vaccines.  However, scientists say it’s unlikely a variant will arise that will make COVID-19 vaccines totally unless.  While vaccines appear to offer diminishing protection from being infected from newer COVID-19 variants, they still appear effective at preventing hospitalization and death.    

The Jury Is Still Out

The point of vaccines is to protect people from serious illness and death, and until fully vaccinated individuals are finding themselves with infections severe enough to require hospitalization, is it difficult to predict when booster shots will be needed and how often.  In an interview on May 21, National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci said the need for booster shots is still unclear.  The CDC Advisory Committee on Immunization Practices reached a similar conclusion on June 24, saying there currently is not enough data to determine booster shots are needed, although the panel did not rule out the possibility of requiring booster shots if immunity wanes or new variants render existing vaccines less effective.  Considering this risk, the evolving nature of the virus, and the pain the world has already experienced at the hand of COVID-19, the US government has every reason to prepare for the worst and continue this conversation around COVID-19 booster shots.