What Happened, What You Missed: June 21-25

President, Senators Reach Tentative Deal on Infrastructure

On June 24, President Joe Biden and a bipartisan group of 21 Senators reached an agreement on a sweeping $1.2 trillion infrastructure package that includes $579 billion in spending on physician infrastructure projects to improve roads, rail, broadband internet, and utilities.  With the backing of 11 moderate Republican Senators and 10 Democratic Senators, the proposal could presumably pass the Senate with the 60 votes needed to overcome a filibuster, provided all Democratic Senators support the measure.  However, Biden announced will only sign a physical infrastructure bill if a “human infrastructure” bill that support investments in childcare, paid leave, and caregiving is advanced in tandem.  The latter proposal contains policies popular with Democrats that can only likely pass the Senate through budget reconciliation. 

White House Projects It Will Miss July 4th Vaccination Goal

On June 22, the White House Coronavirus Response Coordinator Jeff Zeints said the US is unlikely to meet its goal of at least partially vaccinating 70% of adults by July 4th.  In recent weeks, the pace of vaccinations has slowed, particularly in the South and Midwest and among Americans aged 19-26.  At the moment, 70% of Americans aged 30 and up have received at least one dose.  Public health officials are urging all Americans to get vaccinated as the more contagious Delta variant spreads. 

Senate Republicans Block Voting Rights Bill

Senate Republicans invoked the filibuster to block Democrats’ For the People Act, a sweeping voting rights package that aimed to create national standards for early voting, ban partisan gerrymandering of congressional districts, and create a new public campaign financing system.   According to Senate GOP leaders, the bill represents a “power grab” that would undermine states’ abilities to oversee elections and pave the way for permanent Democratic control of Congress.  While Democrats contend their efforts on voting reform are far from over, there does not appear to be a strategy to realistically advance voting rights legislation so as long as the filibuster remains in place.

CDC ACIP Says Heart Inflammation an “Extremely Rare Side Effect”

On June 23, members of the Center for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) determined cases of heart inflammation in adolescents and young adults are likely related to mRNA COVID-19 vaccines produced by Pfizer and Moderna.  According to the CDC, there have been 1,226 reports of heart inflammation following the administration of roughly 300 million mRNA vaccine doses.  Fortunately, the cases were reported to be mild and resolved quickly.  Based on this information, ACIP members concluded that the side effects are “extremely rare” and urged all eligible people to continue to be vaccinated.

ICYMI: Star Wars X-Wing Fighter Getting Prepped for Smithsonian Appearance

An X-Wing starfighter prop used in production of the Star Wars sequel trilogy (2015-2019) is currently undergoing conservation at the Restoration Hangar of the Smithsonian’s Steven F. Udvar-Hazy Center in preparation to be displayed in the National Air and Space Museum in late 2022.  While the National Air and Space Museum is closed to visitors until July 31, Star Wars aficionados can purchase timed tickets to view the X-Wing at the Udvar-Hazy Center.  The X-Wing is on loan to the Smithsonian from Lucasfilm indefinitely. 

Some Members of Congress Have Interesting Names. What Do They Mean?

Just like the people they represent, members of Congress hail from all sorts of backgrounds. With this diversity comes some interesting names.  Here, we take a look at the stories behind some of the more intriguing names among current Representatives and Senators.

Sen. Ron Wyden (D-OR)

Wyden is the son of Peter Wyden and Edith Rosenow, both of whom were Jewish and had fled Nazi Germany to avoid persecution.  The elder Wyden’s surname was originally Weidenreich, and he changed his surname after serving in the US Army in World War II and before embarking on a career in journalism.

Sen. Joe Manchin (D-WV)

Manchin’s paternal grandparents were Italian immigrants whose surname was originally Mancini.  The name comes from the Italian adjective mancino, which literally means “left-handed.”

Sen. Amy Klobuchar (D-MN)

Klobuchar’s paternal great-grandparents hail from Slovenia.  Her surname is derived from Klobučar, which means “hatter” in Slovenian. 

Sen. Mike Crapo (R-ID)

An ancestor of Crapo is Peter Crapaud, a young Frenchman who was shipwrecked off Cape Cod in 1680.  Crapaud means “toad” in French.

Rep. Debbie Dingell (D-MI)

Born Deborah Insley, the Michigan Congresswoman changed her surname to Dingell after her marriage to the late Rep. John Dingell (D-MI) in 1981.  Congressman Dingell’s father was the son of Polish immigrants who anglicized their surname from Dzięglewicz.

Rep. Steny Hoyer (D-MD)

The current Majority Leader’s father, Steen Theilgaard Høyer, is a native of Copenhagen, Denmark, and his first name is a variation of his father’s.  In May 2009, Queen Margrethe II of Denmark honored Hoyer by making him a Knight of the Order of the Dannebrog.

Rep. Bill Pascrell (D-NJ)

Pascrell is the grandson of Italian immigrants.  His paternal grandfather anglicized his last name from Pascrelli after arriving in America.

Rep. Frank Mrvan (D-IN)

Mrvan’s surname is Slovak in origin.  Mrvan is far from the only Slovak-American to serve in Congress – his predecessor, former Rep. Pete Visclosky (D-IN) is also of Slovak descent, as is former Rep. Joe Sestak (D-PA)

Rep. Devin Nunes (R-CA)

Nunes’s surname is Portuguese and pronounced NEW-ness.  Three of his four grandparents immigrated to California’s San Joaquin Valley from Portugal’s Azores islands.  Nunes is a patronymic surname meaning “son of Nuno.”  Unfortunately, Nunes is frequently mispronounced as the Spanish surname Nuñez (pronounced NOON-yez), even by other government officials

Rep. Ted Yoho (R-FL)

Yoho is an anglicized version of the Swiss-German surname Joho.  The earliest use of the name can be traced back to 1395, the birth year of Routschmann Joho in Switzerland’s Aargau Canton. 

Who Will Be the Next Drug Czar?

“We need a drug czar, Mr. President,” a young Senator repeatedly uttered in the early 1980s as illicit drug use surged in the nation’s cities.  There were several agencies fighting the war on drugs, and the Senator thought it would be best to have one person coordinating the federal response.  Then, in November 1988, President Ronald Reagan signed into law legislation to create an Office of National Drug Control Policy (ONDCP) to be headed by an official known colloquially as the “drug czar.”   

The young Senator who pushed for this position is none other than Joe Biden of Delaware.  Now as the 45th President, Biden is confronting another drug crisis, and to turn the tide, he needs a permanent drug czar.  Who will that be?

A New Drug War

Just as in the 1980s, a surge in drug use has ushered in a public health crisis that makes it more important than ever for the US to have a permanent drug czar.  This time around, the nation’s drug epidemic is being driven by a surge in opioid use that has only been made worse by the COVID-19 pandemic.  According to the Centers for Disease Control and Prevention (CDC), there were 88,295 predicted overdose deaths September 2019 through August 2020, a record high that is almost 19,000 more deaths, or 27% higher than the total for the previous 12-month period.  Experts say job losses, social isolation, anxiety, financial problems, and other pandemic-induced issues have made it difficult for people with substance use disorders to manage their addiction, leading to a sharp uptake in drug use. 

What Does the Drug Czar Do?

As part of the Executive Office of the President, ONDCP is tasked with coordinating the nation’s drug control policy through development and oversight of the National Drug Control Strategy and Budget, an annual report that is required by law.  In addition to running ONDCP, the Director evaluates, coordinates, and oversees both the international and domestic anti-drug efforts of executive branch agencies.  The Director also advises the President on anti-drug efforts.

The Director of National Drug Control Policy was notably a cabinet-level position from 1993 until 2009, when then-President Obama downgraded the position to a presidential appointment in the Executive Office with seemingly no explanation.  While advocates against substance use disorders have been pushing Biden to restore the position to its former level, the new Administration  has yet to make a decision on changing the drug czar’s status.  Interestingly enough, Biden criticized then-President George H. W. Bush in 1989 for declining to make ONDCP Director a cabinet-level position.

Who’s in the Mix to Lead ONDCP?

A top contender to lead ONDCP is Rahul Gupta, an internal medicine physician who currently serves as Chief Medical & Health Officer at the March of Dimes.  Gupta is no stranger to addiction issues, having previously served as Commissioner for the West Virginia Department of Health and Human Resources, where he was lauded for his efforts to slow overdose deaths in the state.  Gupta also has ties to the current Administration through his leadership of Biden’s transition efforts for ONDCP.  One factor that gives Gupta an edge is his strong relationship with Sen. Joe Manchin (D-WV), who has become a key swing vote in a divided Senate and could likely be counted on to vote to confirm Gupta.  However, Gupta has attracted some criticism for his perceived failure to address a 2017 HIV outbreak in West Virginia that resulted from a safe needle-exchange program.

Another notable contender is Regina LaBelle, who is currently serving as ONDCP’s Acting Director.  LaBelle formerly served as Chief of Staff of ONDCP during the Obama Administration, where she oversaw the Agency’s efforts to address the opioid epidemic and implement the National Drug Control Strategy.  Between serving in the Obama and Biden administrations, LaBelle led the Addiction and Public Policy Initiative at Georgetown University. 

Other contenders for the top job at ONDCP include former Rep. Patrick Kennedy (D-RI), a mental health advocate who has struggled with substance abuse in the past, and H. Westley Clark, a professor at Santa Clara University with extensive experience in addiction psychiatry. 

Slow Progress on Confirmations

The drug czar isn’t the only Administration post to go unfilled for some time.  While the Biden Administration has been nominating appointees at a faster pace than recent administrations, the Senate has been slow to confirm the Administration’s picks.  As of June 10, 2021, the Senate has only confirmed 42 of the current Administration’s nominees.  In contrast, by the end of May of their first year in office, Barack Obama had 145 confirmations, while George W. Bush logged 126 and Bill Clinton secured 151.

A major reason for the slow progress on nominations is a divided Senate.  Control in the upper chamber is currently split 50-50, and with Vice President Kamala Harris tilting the majority in Democrat’s favor with her tie-breaking vote, the Biden Administration needs unanimous support from the Democratic caucus to advance a nominee.  While President George W. Bush also began his first term with a 50-50 Senate, the current Senate is much more polarized, meaning Biden’s chances of attracting votes from Republicans on controversial nominees are slim to none.  The new Administration experienced this polarization firsthand when Neera Tanden, its nominee for Director of Office of Management and Budget, withdrew her name after Sens. Manchin and Susan Collins (R-ME) announced they would oppose her nomination.  Given the 50-50 split and highly polarized environment, it’s no surprise why the current Administration is facing a longer timeline to fill key positions. 

The Week in Review: June 14-18

ACA Survives Latest Legal Challenge

On June 17, the Supreme Court ruled 7-2 to overturn an appeals court ruling that found the Affordable Care Act’s (ACA) individual mandate to be unconstitutional.  The opinion by Justice Stephen Breyer was joined by the court’s two remaining liberal justices and four of the court’s six conversative justices, while justices Samuel Alito and Neil Gorsuch dissented.  In his opinion, Breyer argued that Texas and the other states that challenged the ACA’s individual mandate failed to show that they were harmed by enforcement of the mandate, which was zeroed out in 2017’s Tax Cuts and Jobs Act.  The ruling, which marks the third time the ACA has been reviewed by the Supreme Court, comes as the Biden Administration seeks to expand the ACA through financial subsidies and Medicaid expansion.    

NIH Study Finds COVID-19 in US Earlier Than Initially Thought

A recent study by the National Institutes of Health (NIH) found COVID-19 may have reached the US as early as December 2019, nearly a month before the World Health Organization announced the discovery of a new coronavirus in Wuhan, China.  By testing for the presence of COVID-19 antibodies in blood collected via the All of US research program between January and March 2020, NIH researchers confirmed the results of a Centers for Disease Control and Prevention study of American Red Cross blood donations that found COVID-19 may have cropped up in the West Coast in December 2019. 

Federal Government Purchases 200M Additional Moderna Doses

On June 16, Moderna announced that the US government purchased 200 million additional doses of its COVID-19 vaccine, bringing the total number of government-ordered doses to 500 million.  According to the company, the additional doses could be used as booster shots or primary vaccinations of children.    Moderna filed for full approval of its vaccine with the Food and Drug Administration (FDA) earlier this month and asked FDA last week to authorize its emergency use in adolescents aged 12 through 17.

McConnell Rejects Manchin’s Voting Rights Counteroffer

Senate Majority Leader Mitch McConnell (R-KY) said on June 17 that Republicans are likely to oppose Sen. Joe Manchin’s (D-WV) voting rights compromise, dashing any hopes for Democrats to advance comprehensive voting reforms.  Manchin introduced his proposal as a counteroffer to Democrats’ For the People Act that could potentially win the support of some moderate Republicans.  Manchin’s proposal includes some reforms which are already popular among Democrats, such as ending partisan gerrymandering and making election day a federal holiday, as well as others which are more appealing to Republicans, like a national voter ID law and allowing maintenance of voter rolls.  However, Senate Republican leaders say the proposal would undermine the authority of state legislatures, taking away their power to set congressional districts.   

Administration Invests $3.2B in COVID Antivirals

On June 17, National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci announced the Administration is investing over $3 billion to advance the development of antiviral pills that could be used to treat COVID-19.  The plan, known as the Antiviral Program for Pandemics, will provide support for clinical trials of promising COVID-19 treatments, with the goal of gaining FDA approval for some antivirals and making them available to the public within a year.  During a press briefing, Fauci said the antivirals could prove helpful for immunocompromised people for whom COVID-19 vaccines are less effective. While the federal government has invested billions of dollars in the development of vaccines, considerably fewer resources have been invested in COVID-19 treatments until now. 

ICYMI: Amazon Pledges $125M for Workforce Housing in DC Area

Amazon announced on June 16 it will provide $125 million in financing to build or preserve approximately 1,000 units of affordable housing in the DC area on land owned by Metro, the region’s mass rail transit system.  The tech giant has already committed $2 billion to its Housing Equity Fund, which will finance affordable housing construction in regions that contain the company’s corporate offices, including the metropolitan areas of Seattle, Nashville, and Washington, DC.  Housing prices have notably climbed in the DC area since Amazon selected Arlington, Virginia as the site of its second headquarters.

Meet Melissa Bartlett, Health Policy Veteran

Over the course of her 20-plus years in Washington, Melissa Bartlett has worked on nearly every kind of health policy issue, ranging from Medicare to prescription drugs.  She draws on her experience with insurers, pharmaceutical companies, and two branches of government to help clients achieve their goals and navigate the legislative and regulatory landscape.  We spoke with Melissa about her various roles and some great advice that’s proven helpful in her career.

What are some of the highlights of your career?

After graduating from the University of Kentucky College of Law and doing a fellowship with the Reporters Committee for Freedom of the Press, I took a job as legislative counsel with the American Medical Group Association and then later with AHIP (which was then AAHP) in regulatory policy. Both of these positions served as good primers on health care policy and allowed me to really understand the healthcare ecosystem – how health care services are access by patients and how those providing services are ultimately paid for their services and all of the specific policy levers that are at play along the way.  I then moved on to the Department of Health and Human Services (HHS) Office of Civil Rights, where I focused on implementation of the HIPAA privacy rule and issues pertaining to it. .  In 2004, I left HHS and joined the House Energy and Commerce Committee staff as the Medicare counsel for Republicans, where I remained until 2010.  The committee has enormous health care jurisdiction so while my main focus was on Medicare legislative and regulatory policies, throughout the years I also had the privilege to work on a variety of other health care issues concerning health insurance reforms, mental health parity, privacy, quality incentives and value-based payment reforms, health IT, and the reauthorization of the Ryan White HIV/AIDS Program, to name a few.  After I left the committee, I spent several years working as an in-house lobbyist for two drug companies and large health insurer before joining the Chamber Hill Strategies team. 

How has advocacy changed since you first started your career?  How has advocacy changed over the last 10 years?

You cannot discount the value of innovative technology and being able to effectively communicate with the Hill.  When I started my career, one of the first things I got was a beeper, so if you had to reschedule a meeting, you had to leave a pager number.  That over time evolved into the use of the Blackberry, which was first issued to me when I was first on the Hill.  The way we’ve done business has changed to become so much more instantaneous, whether it’s emailing somebody documents, sending a calendar invitation, or sending a text message.  The nature of the work has changed thanks to technology, and it will continue to evolve. 

Within the last 10 years, I do think there has been a shift in appreciation in advocacy being more than just getting someone a meeting.  In the past, people might have measured success in lobbying in terms of how many members and staff a lobbyist knows.  Now, clients are more focused on wanting a more substantive relationship with their lobbyist in that they want the lobbyist to understand their business, understand risk and opportunities to hit strategic objectives, and to provide advice.  The bar has shifted, and that’s a good thing. 

What are some of the biggest challenges lobbyists and advocates face in 2021?

A return to a post-COVID normalcy, however that is defined, and adjusting to that new normal presents a challenge.  Pre-COVID, we were meeting with people face-to-face in congressional offices, agency meeting rooms, and in the cafeterias in the House and Senate office buildings.  Casual information-gathering as well as the more formalized lobbying has really changed.  While offices and buildings continue to reopen, challenges remain, for instance, whether and when to pursue in-person meetings versus virtual meetings or calls. There are some benefits to the virtual meeting or call in terms of expediency and efficiency.   So, I think navigating that return to normalcy will be the big challenge for 2021.

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

Take every meeting requested of you, and return every phone call, even if it’s not right away.  No matter how busy you are, this town remembers.  A lot of what we do is relies heavily on reputation and relationships.  It’s critical to maintain a level of respect for your colleagues and to command that respect too.  You may not get an answer right away, but you sure do appreciate when you hear back from someone.  Fostering such respect can go a long way in serving as a trusted resource for colleagues, clients and the Hill.   

What else should we know about you?

I’m a mother of a rising first grader and I’m a co-leader of a daisy troop. I play the piano, which I’ve been doing since second grade, and at one point, I wanted to study the piano in college and play professionally.  I have a dog and a cat, both of whom I rescued.  I like spending time with my family, and I value my roles as a mother, wife, sister, sister-in-law, and daughter.

What the Rulemaking Process Means for Surprise Billing

The battle among healthcare stakeholders over how to address the issue of surprise medical bills isn’t over.  The FY 2021 omnibus appropriations bill passed at the end of last year included the No Suprises Act, language designed to alleviate financial burdens on patients that can result largely when patients see out-of-network providers.  The next step will be the Department of Health and Human Services’s (HHS) release of a rule to implement the new federal law that sets up guardrails for providers and insurers alike.    Patient groups and health care stakeholders have been working with the agency  to try shape the law in their favor.  What can we expect?

Timeline

With the first part of the interim final rule due July 1, 2021, it looks like the government is likely to meet its statutory deadline. The Centers for Medicare and Medicaid Services (CMS) sent the draft to the Office of Management and Budget for review on June 8.  By law, the ban on surprise billing is scheduled to go into effect on January 1, 2022. 

Surprise Billing Part One

The law sets up a multi-part regulatory process — the July 1st rule is expected to contain details on how plans will calculate the qualifying amount to determine a patient’s cost-sharing obligation for out-of-network medical bills.  The rule is also anticipated to include guidance regarding notice and consent requirements that government how an out-of-network providers should obtain a patient’s consent before treating the patient.  Two additional deadlines for agency rulemaking this year are: 1) October 1, to establish a process to audit health plans for compliance; and 2) December 27, creating an independent dispute resolution (IDR) process.

Questions for the Rulemaking Process

Many provisions of the new law will depend on regulatory interpretation and guidance, leaving the agency to  fill in the details. Two key policy areas stakeholders are closely watching including how rates will be calculated and patient consent to treat by out-of-network providers will be obtained.   

Rates.  CMS will determine how insurers should calculate the initial payment to out-of-network providers before either party agrees on a final cost.  Determining this rate will be no easy feat, as provider payment rates for health care services are the result of negotiations between insurers and providers and can vary plan by plan and provider by provider.  Providers may favor leverage gained in these negotiations under the new law that could result in higher payments.

Dispute Resolution Process.  If a provider and a health plan fail to reach an agreement on an out-of-network rate, either party can opt for a binding, baseball-style IDR process whereby the arbitrator must select one party’s offer.  During the IDR process, the arbitrator may consider several kinds of information, including median in-network rates, case mix, and the complexity of the service. The HHS, Labor and Treasury departments face the challenge of setting up an IDR process that is considered fair but doesn’t drive providers and insurers to overuse the process.  Based on experiences with New York state’s IDR process, some experts fear an overreliance on arbitration could lead to higher health care costs.     

Consent.  Out-of-network providers must obtain consent from patients seeking treatment for non-emergency services before treatment can begin.  Exceptions apply to anesthesiologists, pathologists, radiologists and other specialists that are among the largest sources of surprise bills.  There is concern about the potential for loopholes that might still allow patients to receive surprise bills, especially in the case where an out-of-network provider must obtain consent from a patient before treatment.  While requiring patients to provide consent may be well-intended, the US Public Interest Research Group points out that requiring consent essentially puts the patient back in the middle, counter to the goals of thelaw.

Other areas of regulatory interpretation are expected to include how to monitor and punish providers who violate the ban, and how to address situations where patients cannot meaningfully consent to out-of-network care, such as emergency care.

What Stakeholders Are Saying

From the beginning of the year, health care stakeholders have shifted their lobbying efforts from the Hill to federal agencies.  Since March, HHS has been holding calls with stakeholder organizations to obtain feedback.  Additionally, several organizations have written to HHS with their recommendations for implementation.  Below are some key requests from organizations that have written to the Department. 

The American Association of Orthopaedic Surgeons (AAOS) voiced support for using an in-network median rate based on the rate for all local health plans and not simply the products of the insurer during the IDR process.  AAOS also suggested creating specific criteria for determining what constitutes “good faith” to show that physicians have adequately engaged in the IDR process.

The Association of American Medical Colleges (AAMC) asked that HHS provide language or a template that out-of-network providers may use when obtaining permission from patients to provide medical services, as well as allow providers and health plans a minimum 30 days to kick off the IDR process and 30 days to submit their offer.  Notably, AAMC also recommended that HHS delay implementation of the surprise billing ban by at least one year due to the complexity of the law. 

A group of 30 patient and disease organizations including the American Cancer Society and the American Heart Association recommend that states and HHS engage in enforcement action when cost estimates provided to a patient in advance of a medical procedures differ significantly from the billed charges.  The organizations also argue  that states should be required to report enforcement activities related to the law to the federal government.

Insurers are equally concerned about the implementation of the law.  A recent survey of 100 executives representing 85 different health payers found 64% are concerned about the timeline of implementation, echoing AAMC’s concerns.  Additionally, 95% expressed concern about the health care system’s ability to achieve compliance by the January 1, 2022 deadline.

All Eyes on the Administration

With critical rulemaking expected to begin to come out this year, , the fight over surprise billing is far from overHospitals and insurers are directing their attention at regulators and top agency officials to shape the new surprise billing law in their favor and will likely call upon Capitol Hill for help resolving any ongoing concerns.  This means the conversation in Washington on surprise billing is sure to continue even beyond the implementation of thenew law, as stakeholders continue to scrutinize it and the Administration releases guidance related to the law.  The outcome of the Administration’s rulemaking is also important because it will send a signal about how aggressively the Administration plans to regulate the health care industry.

The Week in Review: June 7-11

Administration to Donate Half a Billion Pfizer Vaccine Doses

On June 9, President Joe Biden announced the purchase of 500 million doses of Pfizer’s COVID-19 vaccine to contribute to the global vaccination effort.  The first 200 million doses will be distributed this year, and the subsequent 300 million doses will be sent out in the first half of next year.  COVAX, the World Health Organization initiative to vaccinate the global population, will facilitate distribution efforts and target allocations to low- and middle-income countries.  The President’s announcement comes at the heels of a G-7 summit where world leaders will discuss efforts to end the pandemic. 

White House Takes Action to Bolster Medical Supply Chain

On June 8, the White House announced new initiatives to strengthen the supply chains of four key goods: semiconductor manufacturing and advanced packaging, large capacity batteries, critical minerals and materials, and both pharmaceuticals and active pharmaceutical ingredients.  The new initiatives follow the completion of a 100-day review the President ordered in February to identify disruptions and weaknesses in the supply chain for critical goods that could threaten the nation’s economic and national security.  A principal initiative requires the Department of Health and Human Services to create a public-private partnership to ensure essential medicines are produced domestically.  Additionally, the Administration will establish a Supply Chains Disruption Task Force to address near-term supply changes to the economic recovery.

3 FDA Advisory Committee Members Quit after Approval of Alzheimer’s Drug

This week, Aaron Kesselheim, a professor at Harvard Medical School, David Knopman, a neurologist at the Mayo Clinic, and Joel Perlmutter, a neurologist at Washington University in St. Louis, resigned from the Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Drugs Advisory Committee following FDA’s controversial decision to approve a new Alzheimer’s drug on June 7.  The drug, known as aducanumab, is the first new FDA-approved Alzheimer’s treatment since 2003 and the first treatment intended to slow the progression of Alzheimer’s.  When the advisory committee convened in November 2020, 10 of the 11 panelists found that there was not enough evidence that the drug could slow cognitive decline.  The FDA notably cleared aducanumab under accelerated approval, which allows for earlier approval of a drug for a serious illness without meeting the normal conditions for safety and effectiveness.

FDA Extends Shelf Life for J&J Vaccine to 4.5 Months

On June 10, Johnson & Johnson (J&J) announced FDA had authorized an extension of the shelf life for J&J’s COVID-19 vaccine from 3 months to 4.5 months when refrigerated at temperatures of 36-46 degrees Fahrenheit.  The announcement comes as many unused J&J doses were set to expire at the end of the month.  According to data from the Centers of Disease Control and Prevention, 11 million of the 21 million J&J vaccine doses distributed to states remain unused. 

Demings Launches Bid against Rubio for Florida Senate Seat

Rep. Val Demings (D-FL) kicked off her campaign to unseat Sen. Marco Rubio (R-FL) on June 9.  Demings, who served as a manager during then-President Donald Trump’s first impeachment, is considered an early favorite in the Democratic primary race.  Democrats are hopeful that Demings’s background in law enforcement including a four-year stint as Orlando’s police chief will help deflect GOP attacks that attempt to tie Democrats to the “Defund the Police” movement.  Given the Senate’s 50-50 split, flipping Senate seats such as Rubio’s is seen as critical to Democrats’ bid to maintain control of the chamber. 

ICYMI: DC Area Metro to Reduce Fares, Expand Service to Lure Back Riders  

On June 10, the DC Metro Board of Directors approved a new fare and service plan aimed at bringing riders back to the system and help low-income riders.  Most of the changes will take place in the fall when more downtown office workers are expected to at least partially resume their commutes.  Major changes include running Metro until 1 AM on Friday and Saturday nights and charging a flat $2 fare on weekends.  The recently announced changes by Metro reflect efforts other transit system aimed at recouping pandemic-related drops in ridership.  Since last month, Amtrak has restored daily service to 10 routes and New York City’s MTA has reinstated 24-hour service.

Can Democrats Scrap the Filibuster?

The filibuster is a time-honored tradition in the Senate that allows any Senator to prolong debate and delay or prevent a vote on a bill.  Currently, 60 votes are needed in the Senate to end debate and pass most pieces of legislation, a threshold that requires Democrats to have the support of at least 10 Republicans to advance bills through the 50-50 Senate.  It has been difficult thus far for Senate Democrats to win over enough Republicans which is severely limiting what Democrats can accomplish legislatively.  This begs the question: why don’t Democrats simply scrap the filibuster?

Changing the Rules

Rules are made to broken, right?  Well, it’s not that simple.

There are 2 options to end the filibuster rule.  One option is to move forward to change Senate Rule 22, the rule that requires 60 votes to end debate.  BUT, Senate Democrats need a super-majority – 67 votes – to change the rule.  The other option is to create a new precedent in the Senate.  Changing the precedent, also known as the “nuclear option,” would require only a simple majority.

Not Enough Democratic Support

While Senate Democrats only need 50 votes to create a new precedent on the filibuster, the biggest hurdle is that not all 50 Senate Democrats are on board.  The most vocal supporters of the filibuster are Sens. Joe Manchin (D-WV) and Kyrsten Sinema (D-AZ), who have repeatedly voiced their opposition to removing the filibuster since Democrats narrowly regained control of the Senate in January 2021. 

Manchin most recently affirmed his filibuster support on June 6 when he wrote, “I will not vote to weaken or eliminate the filibuster” in an op-ed in the Charleston Gazette-Mail.  In his op-ed, Manchin pointed out that Senate Democrats were quick to defend the filibuster when then-President Donald Trump called for the tactic to be thrown out in 2017 when the GOP controlled both chambers of Congress and the White House.  Similarly, Sinema declared on June 2 that the filibuster “protects the democracy of our nation rather than allowing our country to ricochet wildly every two to four years.”  More so, Sinema has expressed support for restoring the 60-vote threshold to advance nominations. 

Other Senate Democrats have conveyed some hesitancy to remove the filibuster.  When asked in January 2021 if he supported keeping the filibuster, Sen. Mark Kelly (D-AZ) declined to answer specifically and instead stated that he supports bipartisanship.  Additionally, Sen. Mark Warner (D-VA) also said in January that “it would take an awful, awful lot for me to end the filibuster.”

What About Reforming the Filibuster?

Between keeping or throwing away the filibuster, reforming the filibuster as we know it could be a third option and a compromise for Manchin and Sinema to consider.  On March 7, Manchin did state that he supports making the filibuster more “painful” if senators want to use it.  The scenario Manchin referred to is the “talking filibuster,” whereby members of the minority party can filibuster only as long as they are on the floor.  Once a senator relents, there would be a simple majority threshold.  The talking filibuster used to be the norm in the Senate until it was scrapped in 1975 because senators thought it was too time-consuming.

There is more recent precedent for reforming the filibuster.  In 2013, then-Majority Leader Harry Reid (D-NV) led the way to allow all nominees except for Supreme Court justices to advance in the Senate with a simple majority.  It should be noted that Reid accomplished this following a strong 2012 midterm election that saw the number of Democratic Senators grow from 53 to 55, while then-President Barack Obama publicly admonished Senate Republicans for consistently blocking his agenda.  In 2017, Republicans expanded on this when then-Majority Leader Mitch McConnell (R-KY) permitted Supreme Court nominees to also be approved with a simple majority.  McConnell proceeded to strike the filibuster in this scenario after Senate Democrats blocked the confirmation of Supreme Court nominee Judge Neil Gorsuch.

However, it’s unclear to what extent Manchin and Sinema would be open to even reforming the filibuster.  Manchin’s June 6 op-ed clearly states an opposition to “weakening” the filibuster, while Sinema’s comments on restoring the 60-vote requirement to advance all nominees suggests an unwillingness to change.

What Does Biden Say?

Over the course of his long career in Washington, President Joe Biden has evolved from being a staunch supporter of the filibuster to embracing calls for reform.  In the wake of the Sandy Hook mass shooting, then-Vice President Biden referred to the filibuster as a “perverted” rule after the Senate failed to advance gun violence legislation in 2013.  More recently, Biden expressed support for restoring the talking filibuster in an April 2021 interview.    

On June 2, Biden took a rare move to say “two members of the Senate who voted more with my Republican friends” when asked why progress on a voting rights bill has stalled.  Biden was of course referring to Manchin and Sinema, who still technically vote with Democrats more often than not.  Biden’s move to publicly call out the two suggests a willingness to use the power of the bully pulpit to condemn Democrats opposed to changing the filibuster, especially if his agenda continues to face staunch GOP opposition.

What Happens Next?

So far, the filibuster hasn’t totally derailed the Biden Administration’s agenda.  The Administration and congressional Democrats have already scored a policy victory by advancing the American Rescue Plan Act, and most of the Senate’s business has focused on nominations.  However, if Senate Republicans continue to oppose key Democratic proposals on voting rights, infrastructure, and other issues, Biden and other top Democrats could turn up the pressure on Manchin, Sinema, and other Senate Democrats to support changes to the filibuster.  Whether the President or Senate Majority Leader Chuck Schumer (D-NY) are willing to do that remains to be seen.

Is an Effective Alzheimer’s Treatment Around the Corner?

More than 6.2 million Americans currently have Alzheimer’s disease, a number that is projected to double by 2050.  Despite a growing need to treat Alzheimer’s, some four decades of research have yet to yield any effective therapeutics.  This could change as soon as June 7, 2021, which is the date the Food and Drug Administration (FDA) may decide to approve a new Alzheimer’s treatment from Biogen.  Why has it been so hard to develop an effective Alzheimer’s treatment, and does Biogen’s drug mark a breakthrough?

Failed Research Efforts So Far

Since the National Institute on Aging first began studying ways to treat Alzheimer’s disease in earnest in 1978, progress on effective therapeutics has been extremely limited.  A major reason for the lack of progress is the newness of the field of neurobiology, especially as it applies to Alzheimer’s, dementia, and other complex brain disorders.  Most of the knowledge on the human brain has only been acquired within the last 40 years, while a better understanding of genetic and biologic pathways has only occurred within the last 30 years.  Additionally, brain lesions and biomarkers associated with Alzheimer’s could not be visualized until 2004.  As a result, meaningful research and development of  Alzheimer’s treatments could not accelerate until a quarter-century worth of understanding could be attained.

Since the 1990s, research pertaining to  Alzheimer’s treatments has focused on how the disease develops and progresses.  Alzheimer’s develops when toxic plaques clump together between neurons in the brain, resulting in inflammation and cell death in the brain.  Many potential drug treatments have failed while under development and at a higher rate than other drugs —  99.6% for Alzheimer’s drugs in development have failed, compared to an 80% failure rate for cancer drugs.  Among those failed potential therapies were a a pair of therapeutics from Eli Lilly and Roche, which saw their clinical trials end in February 2020.  Researchers point to the complexity of Alzheimer’s as one of the reasons why so many promising treatments have gone to the wayside.  The last Alzheimer’s therapeutic to receive FDA approval was Forest Labs’ Namenda in 2003, which along with the handful of other Alzheimer’s drugs, only alleviates symptoms temporarily

Enter Stage-Right: Aducanumab

Like other recent drug development programs, Biogen’s aducanumab is an injectable, monoclonal antibody treatment that targets plaque build-ups between neurons.  If approved, aducanumab would be the first disease-modifying drug for Alzheimer’s, meaning it is effective in slowing cognitive decline.  This could open the door to Alzheimer’s becoming a chronic disease that people live with for many years, similar to diabetes and cancer

According to data discussed during an FDA advisory committee meeting in November 2020, aducanumab proved effective in a small phase 2 clinical trial and one of two large phase 3 clinical trials. 

Will FDA Give Aducanumab the Nod?

Mr. Barker, the answer is “not sure.”  While the experimental drug was shown effective in the small phase 2 and large phase 3 trials, a second phase 3 trial failed to yield positive results.  As a result, some members of the panel have expressed a desire to see more data from an additional phase 3 trial, although such an undertaking would require another three to five years of research.  Additionally, there is some concern about the actual benefits of aducanumab, which showed only modest changes on two objective measures used in the clinical trials: the Mini-Mental State Examination and the Alzheimer’s Disease Assessment Scale. 

Also, there are concerns about side effects which may not only impact patients but also  the health care system as a whole.  30% of clinical trial participants who took the drug were found to have a reversible swelling of the brain, while over 10% had small brain bleeds.  These side effects were detected using amyloid positron emission tomography (PET) scans, and given the millions of Alzheimer’s patients, the large number of PET scans necessary to monitor for side effects would test the limits of neurologists, radiologists, and other clinicians.

What’s the Cost?

Aducanumab will be sure to have a high price tag if approved.  One year’s worth of aducanumab treatment could be priced as high as $50,000 per year, and if only a third of the 6 million Americans with Alzheimer’s were to take the drug, sales could reach $36 billion a year.  Since most people with Alzheimer’s begin noticing symptoms in their mid-60s, Medicare is likely to pick up the tab for most aducanumab treatments, not to mention the PET scans and other health care services required to monitor for side effects.

What Could Happen?

FDA is not in an enviable position on aducanumab.  The agency may determine that it cannot sign off on the safety and efficacy of the drug, or at least request more data before making a decision, despite the clear and significant need such a drug for those currently affected by Alzheimer’s and their loved ones.  As such,the projected growth in the number of Alzheimer’s patients and a lack of existing therapeutics mean any decision on June is sure to impact millions of people.

The Week in Review: June 1-4

Biden Calls Out Manchin, Sinema for Holding Back Democrats’ Agenda

During a June 2 event marking the 100th anniversary of the Tulsa race massacre, President Joe Biden said “two members of the Senate who voted more with my Republican friends” is the reason why the Senate has been unable to advance a bipartisan voting rights bill.  The President was referencing Sens. Joe Manchin (D-WV) and Kyrsten Sinema (D-AZ), whose strong support of the filibuster means Democrats are unable to advance key proposals with a simple majority.  Notably, Manchin and Sinema’s record indicates they vote with other Democrats most of the time.

Biden’s All-Out Push to Get 70% of Adults Vaccinated by July 4

President Joe Biden on June 2 announced a “national month of action” to help his Administration meet its goal of having 70% of American adults at least partially vaccinated for COVID-19 by July 4.  Some of the key actions Biden outlined to spur more vaccinations include partnering with child-care providers to offer free services to all parents getting vaccinated or recovering from the shots and requesting pharmacies to extend their hours for the month of June.  The Administration also announced an initiative to provide vaccinations at Black-owned barbershops.  Currently, 63% of US adults have received at least one COVID-19 vaccine shot.

Moderna Files Application for Full FDA Approval of COVID-19 Vaccine

On June 1, Moderna began filing for a Biologics License Application (BLA) with the Food and Drug Administration (FDA) that would allow full approval of its COVID-19 vaccine.  Full approval would allow Moderna to directly market its vaccine as well as make it easier for companies and government agencies to mandate vaccinations for employees.  Full approval is also seen as an important step in addressing vaccine hesitancy.  Pfizer became the first drug maker to seek full FDA approval for its vaccine on May 7.  However, FDA has yet to comment on the timeline for reviewing the BLA for either vaccine.

Administration Announces Plans for Sending 25 Million Vaccines Abroad

On June 4, the Biden Administration formally laid out a plan to send out an initial wave of 25 million COVID-19 doses to help countries that have been hit hard by the virus.  According to the plan, 19 million doses will be distributed via worldwide vaccination initiative COVAX to Central and South America, Africa, and Asia.  Additionally, the US will separately supply 6 million doses to over a dozen countries including Canada, Mexico, and Ukraine.  The first wave of doses is part of a broader Administration effort first announced on May 17 to contribute 80 million COVID-19 vaccine doses as part of a global vaccination effort.

ICYMI: DC Museum Features George Washington’s Whiskey Writing

Every Friday from now until the end of July, the Stephen Decatur House Museum in downtown DC will have on display a letter penned by George Washington in 1799.  The letter, which is on loan from the Distillery Spirits Council, focuses on Washington’s pre- and post-presidential career as a whiskey distiller.  In the letter, Washington asks his nephew to assist with purchasing with purchasing enough grain to produce 200 gallons of whiskey. 

All About OMB

The Office of Management and Budget (OMB) may not get as much attention as other Cabinet-level agencies like the Departments of Defense and the Treasury, but that doesn’t mean OMB is any less important.  In fact, OMB plays a critical role in managing the operations of the federal government and the budget process.  More so, OMB is responsible for reviewing regulations that shape Americans’ daily lives.  So, how does OMB do this?

The History of OMB

OMB’s origins date back to 1921, when the Budget and Accounting Act of 2021 established the Bureau of the Budget at the Department of the Treasury.  The bureau was eventually moved to the Executive office of the President in 1939, where it was reorganized into the Office of Management and Budget in 1970. 

OMB Today

Comprised of nearly 500 career staff, The mission of OMB is to “assist the President in meeting policy, budget, management, and regulatory objectives and to fulfill the agency’s statutory responsibilities.”  OMB mainly carries out this mission through 5 main functions:

  1. Preparing a budget proposal to Congress;
  2. Supervising executive branch agencies;
  3. Reviewing all rulemaking and regulatory actions;
  4. Reviewing agency testimony, legislative proposals, and other communications with Congress; and
  5. Clearing Presidential Executive Orders.

Current Leadership

The organization is led by three-Senate confirmed positions: Director, the Deputy Director, the Deputy Director for Management.  The current Acting Director of OMB is Shalanda Young, who was confirmed as Deputy Director in March 2021.  The Biden Administration’s latest nominee for OMB Director is Kiran Ahuja, who previously served as Chief of Staff of the Office of Personnel Management and Executive Director of the White House Initiative on Asian Americans and Pacific Islanders during the Obama Administration.   While Ahuja, was favorably reported by the Senate Homeland Security and Governmental Affairs Committee, the Senate has yet to schedule a floor vote to consider her nomination. 

Extension of the President with Congress

OMB play 3 key roles for the President as the Administration interacts with Congress:  the budget, statements on legislation, and the Congressional Review Act. 

Budget.  While the Presidential budget submission to Congress typically happens around February each year, OMB is active long before the annual tome hits the streets.  OMB works on average six months prior by sending budget instructions to agencies and later reviewing and analyzing agencies’ formal budget proposals.  Additionally and throughout the year, OMB provides guidance on a range of budgetary topics, including government shutdowns, continuing resolutions, and agencies use of discretion with mandatory spending. 

SAPs.   OMB prepares Statements of Administration Policy (SAPs) on any pending legislative proposals that are not related to appropriations that communicate the President’s position on the affected legislation.  SAPs typically serve as a strong indicator of whether the President will veto or sign a bill into law.  OMB also reviews and clears congressional testimony, congressional correspondence, and draft bills from the agencies to ensure the documents are aligned with the Administration’s agenda. 

              Congressional Review Act.  The Congressional Review Act (CRA) is an oversight tool Congress can use to overturn a rule by a federal agency or department.  OMB is tasked with determining whether a rule is considered a “major rule” under the CRA.  In the case of major rules, Congress can pass a joint resolution of disapproval, which would veto the rule if signed into law by the President or approved by two-thirds of both chambers of Congress.

Role in Rulemaking

OMB plays a pivotal role in rulemaking, primarily through the Office of Information and Regulatory Affairs (OIRA).  Like its parent agency, OIRA is currently without a permanent leader; former National Labor Relations Board member Sharon Block has been serving as OIRA’s Acting Administrator since April 2021.  Under the current framework, OIRA is charged with reviewing all regulatory actions and determining whether the regulations are “significant” or “economically significant,” meaning they have an annual effect on the economy of $100 million or more.  For rules deemed significant and economically significant, however, agencies must submit several documents, including the draft text of the rule, an explanation of how the rulemaking will address a particular need, the potential costs and benefits of the rule, and in the case of rules considered economically significant, a regulatory impact analysis.

After receiving all necessary documents from agencies on significant rules, OIRA has 90 calendar days to review, with the option of extending the review period for one time by up to 30 days.  OIRA then proceeds to review the agency’s documents and return the rule to the agency in one of three ways:

  1. Consistent without change.  This means OIRA did not alter the proposed rule.
  2. Consistent with change.  This means OIRA generally agrees with the intent of the rule but made some substantive changes. This is the most common type of action OIRA takes.
  3. Returned.  This means OIRA has serious concerns with the agency’s proposed rule and does not approve the publication of a Notice of Proposed Rulemaking (NPRM). Returned rules are always accompanied by a return letter which is posted on OIRA’s online docket.   An example of a returned letter is a 2002 letter to the Office of Personnel Management rejecting proposed changes to the Federal Employee Health Benefits Program due to concerns over cost measurement and accounting principles.

Once OIRA has completed its review process, the proposed rule is published in the Federal Register in the form of a NPRM. The rule is opened to a public comment period generally lasting 60 days.  When the public comment period concludes, the agency makes any changes to the rule and resubmits it to OIRA for another round of review. Again, OIRA has 90 days to conducts its review process. When OIRA completes its final review, the agency may set a date for promulgation of the rule and publish the final rule in the Federal Register.  Members of the public can track rules under the review of OIRA at www.reginfo.gov.

Does OMB Matter?

Absolutely.  Even if OMB may not be mentioned as frequently as other agencies, its power cannot be understated.  OMB oversees a number of multi-trillion-dollar budgets that impact every aspect of American life, and OMB’s role in supervising federal agencies means it’s more or less in charge of 4.3 million federal employees.  Based on the goals of the Administration, OMB is an important partner with Congresson how much will be spent on health, defense, housing, and other key areas. 

Furthermore, OMB’s role in coordinating and reviewing regulatory action makes it a key player in the day-to-day actions in government.  Whether it pertains to Medicare reimbursement, FDA user fees, price transparency, or otherwise, all rulemaking and regulatory action is subject to OMB’s review.  Despite a lack of attention, OMB’s impact is far-reaching.

Did You Know?

Did you know that you can meet with OMB?  OIRA has an open door policy, which means the office takes meetings with outside stakeholders on regulations under review.  Meeting participants and materials are publicly disclosed and provide an interesting window into additional input the agency receives beyond formal written comments on the rule.  This month’s hot topic appears to be the physician fee schedule, among other health care related ruled. 

The Promise of Non-Profit Drug Companies

With trust in pharmaceutical companies waning and drug prices climbing, it’s clear providers and patients are frustrated with drug manufacturers.  Out of this frustration, providers and philanthropists have banded together to form non-profit drug companies, which aim to deliver low-cost generics by eschewing the profit-driven focus of other drug makers and embracing a mission to make drugs accessible and affordable.  But in an industry dominated by for-profit players, do non-profit drug companies stand a chance at making a difference?

The Major Non-Profit Players

Over the past few years, a handful of non-profit companies have emerged. 

  • Civica Rx, the most prominent non-profit drug maker, formed in September 2018 when several major health systems teamed up to manufacture their own generics.  The company grew out of a need to bring competition to the pharmaceutical industry, with the hopes of reigning in high prices for generics.  Civica first began manufacturing two antibiotics in March 2019 and signed agreement to produce injectable medications later that year.  In January 2021, Civica announced plans to build a 120,000 square foot facility just south of Richmond, VA to produce sterile injectable drugs for hospitals.  Civica has also expanded into drug development – in  January 2020, it signed a deal with Thermo Fisher Scientific to develop and manufacture its own drugs.  The company also notably partnered with 18 Blue Cross and Blue Shield companies in January 2020 to form a new subsidy to reduce the cost of generics.
  • Phlow Pharmaceuticals formed in January 2020 to produce active pharmaceutical ingredients (APIs) used in drug manufacturing.  Beginning in May 2020, the federal government awarded Phlow a total of $812 million to manufacture medicines at risk of shortage, including medicines for the COVID-19 response.  Notably, Phlow partnered with Civica on the new facility near Richmond, VA.
  • Harm Reduction Therapeutics formed in 2017 with the goal of preventing opioid overdose deaths by bringing a low-cost, over-the-counter naloxone spray to market.  In June 2020, the company received $6.5 million in financial support from Purdue Pharma, which produces opioids for prescription use. 
  • Medicines360 formed in 2015 to develop and provide low-cost contraceptives to women.  In October 2019, the Food and Drug Administration (FDA) approved a hormonal intrauterine device (IUD) Medicines360 developed with Allergan that prevents pregnancy for six years, the longest approved duration for IUD use in the US.

Advantages of Non-Profit Drug Makers

When it comes to delivering lower-cost drugs, non-profit pharmaceutical companies have several advantages

  • Non-profit drug companies focus on generic drugs, meaning they are out of the patent protection period and in the public domain. 
  • Additionally, thanks to their non-profit model, these companies don’t need to raise prices to honor fiduciary obligations to shareholders.  Excess funds can also be invested back into the organization to enable it to continue its non-profit mission.
  • Civica specifically operates on a membership model for hospitals that allows the company to make long-term commitments to members at a fair price.  This arrangement also allows Civica to offer the same price per unit to each hospital member.

Challenges for Non-Profit Drug Makers

Success for non-profit drug companies is not guaranteed, and they face major obstacles to fulfilling their mission.

  • Despite financial assistance from philanthropy, grants, and other means, non-profit companies lack access to capital through multiple investment streams that for-profit companies can more readily access.  This leaves non-profits at a serious disadvantage when it comes to research and development, which involves raising large amounts of capital.
  • When it comes to certain rules and regulations, the non-profit status of companies like Civica doesn’t entitle them to many breaks or special treatment.  For instance, the FDA imposes user feels on all drug manufacturers, regardless of their status or mission. 
  • Some reimbursement and payment policies may present obstacles  for non-profits to offer lower prices, particularly Medicaid’s “best price” rule.  To remain sustainable, non-profit drug makers may offer higher prices for some purchasers while keeping prices low for uninsured or low-income patients.  By offering low prices to the aforementioned groups, non-profits would be required to offer the same low price across Medicaid. 

Will Non-Profit Drug Companies Make a Difference?

Non-profits like Civica Rx and Phlow are new entrants to the drug market, and only time will tell if their efforts will pay off in the form of lower drug prices.  However, non-profits could follow a few strategies to increase their odds of success.  While Civica Rx and Medicines360 have become involved in drug development, non-profit drug manufacturers would be better off focusing on generics given their disadvantage in research and development.  Additionally, non-profit drug makers could push for policy and regulatory changes to give them a more favorable position in the market, such as reducing or waiving user fees for non-profits, increasing price transparency, or creating an exemption under the Medicaid “best price” rule.