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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.

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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.

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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.

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.

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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.

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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.

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