Author: Sarah Farinelli

Post author By Sarah Farinelli
Post date February 12, 2021

Happy Lunar New Year!

Hot Topics | February 12th, 2021

Today is the start of the Lunar New Year, and to mark the occasion we are opening today’s newsletter with a few fun facts about one of Washington D.C.’s most dynamic neighborhoods: Chinatown!

Washington D.C.’s first Chinatown was established in the 1880’s along the south side of Pennsylvania Avenue NW between 4 ½ Street NW and 7^th Street NW. When city planners designated the area for redevelopment in the 1920’s, neighborhood aid organizations helped acquire land and relocate the community to the present Chinatown along H Street NW.
The Chinese Community Church at 500 I Street NW has been a fixture in the Chinatown community for nearly 90 years. The church building was designed by Thomas Ustick Walter, who also designed the dome of the U.S. Capitol.
The Friendship Archway at H Street NW and 7^th Street NW is the largest single-span archway of its type in the world.

We wish all our readers a happy and prosperous new year!

Guide to new CDC guidance

This week the Centers for Disease Control and Prevention (CDC) issued a wave of new guidance for the public:
- On Masks: Wearing a cloth mask over a medical procedure mask can significantly decrease the spread of COVID-19. (The Hill)
- On Quarantine: Individuals who have been fully vaccinated no longer need to quarantine if they are exposed to someone infected with COVID-19. (The Hill)
- School Reopening: The CDC is expected to issue guidance for the reopening of schools later today (Friday, February 12). (The Hill)

Industry agreement on ACA changes

Healthcare industry groups including America’s Health Insurance Plans (AHIP), the American Hospital Association (AHA), the American Medical Association (AMA) and the U.S. Chamber of Commerce lined up to support changes to the Affordable Care Act proposed by House Democrats. (The Hill) These changes would include subsidized coverage for Americans earning up to 150% of the federal poverty line and those on unemployment insurance, as well as ending the “subsidy cliff” for individuals earnings upwards of 400% of the federal poverty level. (POLITICO, Axios)

Driving back disparities

As the rollout of COVID-19 vaccines continues, disparities in access are becoming more stark with CDC data showing over 60% of vaccine doses in a number of states have been administered to white Americans. (Roll Call) Several efforts are actively underway to reduce these disparities, including a White House push to distribute vaccines directly to community health centers (The Hill, POLITICO) and an Uber/Walgreens partnership to offer free rides to COVID-19 vaccination sites. (The Hill)

Vaccine rollout full steam ahead

On Thursday, President Biden announced the purchase of an additional 200 million doses of COVID-19 vaccines. With this purchase, the United States secured enough doses to vaccinate every American by July. (The Hill) Meanwhile, Dr. Anthony Fauci estimated April will mark the start of “open season” for vaccinations, when any American who wants a shot will be able to get one. (The Hill)
- Read more: The United States could pay a cost for its efforts to rapidly vaccinate its own population. Experts argue life in the US will not return to normal until COVID-19 is tamed in all corners of the world, a feat that will be difficult to achieve as long as wealthier countries continue to secure the majority of the world’s vaccine supply. (The Hill)

If you enjoyed this excerpt from this week’s Policy News from Goodfuse, we invite you to email us at [email protected] to sign up the full weekly “insider only” newsletter featuring fun-to-read round-ups of Hot Topics, breaking news and some quirky facts to make your Fridays Goodfused.

Policy News

Post author By Sarah Farinelli
Post date February 5, 2021

Getting the Senate Organized

Hot Topics | February 5th, 2021

Following the election of Sens. Ossoff and Warnock (D-GA) in early January, you probably read headlines that the Democrats had retaken the Senate. While not false, those headlines omitted a small but significant nuance – a wonky Senate formality known as an “organizing resolution” – that would be a final hurdle on the Democrats’ path to reclaiming the Senate majority.

The organizing resolution outlines out how each Senate will set up committees, budgets and other key operating procedures. After Sens. Ossoff and Warnock were sworn in on January 20^th, Democrats controlled the Senate floor, but Republicans maintained control of Senate committees because the organizing resolution from the 116^thCongress was still in effect. This resulted in some committees operating without a chairperson, since the Senators who chaired these committees in the 116^th Congress had retired.

After two weeks of negotiations between Senate Majority Leader Schumer (D-N.Y.) and Minority Leader McConnell (R-Ky.), the Senate finally passed an organizing resolution on Wednesday to govern the 117^th (current) Congress.

Going big, possibly bipartisan, on COVID relief

On Tuesday President Biden prodded Senate Democrats to “go big” and advance legislation on a COIVD-19 relief bill. Biden’s direction came after he rejected a $618 billion proposal from ten Republican Senators, which was substantially smaller than the $1.9 billion figure the president has floated. (The Hill, Associated Press – Washington Bureau) While House Democrats started the legislative process that would allow them to advance a COVID-19 relief bill without the threat of a Republican filibuster, the door on bipartisanship has not yet closed. (Roll Call) On Thursday, a bipartisan group of 16 senators drafted a non-binding amendment that calls for the next round of direct payments to target the neediest Americans. (The Hill)

Schools, seniors and the squeeze on vaccines

Centers for Disease Control and Prevention Director Dr. Rochelle Walensky cited data from her agency on Wednesday to make the case that vaccinating teachers is not required to safely reopen schools as long as other precautions are followed. (The Hill) Dr. Walkensky’s remarks were made during a week that saw several outlets report that teachers are being pushed further back in line for COVID-19 vaccines as many states prioritize elderly populations. (Axios, Roll Call). Setting aside vaccinations, there are concerns from some White House political advisors that President Biden may not be able to fulfill his goal of resuming in-person instruction during the first 100 days of his presidency. (Axios)

Drug pricing proposal delayed

The Biden administration has delayed the implementation of a signature Trump administration proposal that would have prevented pharmaceutical companies from negotiating rebates on prescription drug prices with pharmacy benefit managers (PBMs). PhRMA and drug makers were in favor of the policy, and were prepared to work with the government to implement the rule. However, PBMs and their trade association, the Pharmaceutical Care Management Association, were vigorously opposed to the rule and filed a lawsuit to kill the policy. (STAT)

Updates on team Biden

STAT published a detailed profile of Eric Lander, a key figure in the Human Genome Project and founding director of the Broad Institute who President Biden tapped as the White House science advisor. As detailed by STAT’s Lev Facher, Lander will advise the president on climate change, COVID-19, public confidence in science, and other pressing issues. Meanwhile, the rumor mill was a-swirling with hints that Chiquita Brooks-LaSure (a longtime Democratic health policy expert) and North Carolina health secretary Dr. Mandy Cohen have emerged as frontrunners to helm the Centers for Medicare and Medicaid. (POLITICO)

Policy News

Post author By Sarah Farinelli
Post date January 29, 2021

The Highest Court in All the Land

Hot Topics | January 29th, 2021

Quick, what is the highest court in the United States?

If you answered the Supreme Court of the United States, then you may be in for a surprise.

There is one court higher than SCOTUS, and that is the basketball court that sits above the main courtroom where SCOTUS hears cases. Once upon a time the basketball court (which is smaller than regulation size) was a spare room used to house journals, but during the 1940’s it was converted into a small gym for SCOTUS employees. The basketball court has seen more than just b-ball: Justice Sandra Day O’Connor was known to hold yoga classes in the space.

Today, clerks, off-duty police officers and other SCOTUS employees are allowed to use the court and the adjacent full-service gym and weight room. However, the basketball court is closed when court is in session since the sounds of sneakers and basketballs disturb proceedings in the courtroom below.

Biden hits Ctrl + Z

On Thursday, President Biden signed two orders that aimed to “undo the damage” done by President Trump. The first executive order required federal agencies to (1) open a special enrollment period for Obamacare from February 15 to May 15 and (2) review existing policies implemented by the Trump administration that could be limiting access to healthcare. Another presidential memorandum rescinded the Mexico City policy, which prevented federal funds from being allocated to foreign aid groups that provide abortion-related services. (The Hill)
- Read more: Roll Call summarizes President Trump’s healthcare agenda: his accomplishments, his shortcomings and what President Biden might undo.

But do we have to?

On January 1, 2021, a new rule from the Trump administration took effect requiring hospitals to publicly post prices for every service, drug and supply they offer. As reported by The Washington Post, hospitals have been dragging their feet and compliance is inconsistent one month into 2021. According to the American Hospital Association, compliance officers are stretched thin. No matter the reason for non-compliance, the $300 per day penalty is insignificant for America’s large hospital systems.

Who gets the vaccines?

In a press conference with reporters, President Biden said he believes any American who would like a COVID-19 vaccine should be able to get one by the spring. (The Hill) That being said, a report from Axios found the U.S. neighborhoods hit hardest by COVID-19 are being vaccinated at a slower rate than wealthier, whiter areas. These disparities can be found in cities and states across the country, and showcase the tradeoff between speed and equity in the vaccine rollout.

Getting schooled

A report authored by three researchers at the Centers for Disease Control (CDC) and published in JAMA found there is “reassuring” evidence that widespread COVID-19 transmission is not occurring schools. Republicans have cited this report as evidence to exert pressure on President Biden to reopen schools. For his part, President Biden has called for schools to reopen, and has asked $130 billion to cover the costs associated with safe reopenings. (The Hill, The Hill, The Washington Post)

Policy News

Post author By Sarah Farinelli
Post date January 22, 2021

It’s About the Journey and the Destination

Hot Topics | January 22nd, 2021

Last week security concerns led President Biden to scuttle his plans to travel to Washington, DC for Inauguration Day via Amtrak. That being said, there was little question Biden would be at the U.S. Capitol on the morning of January 20 to be sworn in as the 46^th president of the United States.

The same cannot be said for George Washington. Though our nation’s first president had a reputation as a wealthy man, he was what 18^th century society referred to as “land-poor.” Despite owning his valuable 500 acre Mount Vernon estate, Washington had few liquid funds. In order to pay for his journey to New York City (the capital of the U.S. in 1789) for his inauguration, Washington had to borrow £600 at 6% interest.

Who’s in and who’s out

In: Former FDA Commissioner David Kessler was tapped to serve as chief science officer of the COVID-19 response effort (which will no longer be called Operation Warp Speed).
- Out: Moncef Slaoui. (Roll Call)
In: If confirmed by the Senate as the Assistant Secretary of Health and Human Services, Dr. Rachel Levine would become the first openly transgender Senate-confirmed federal official. (The Hill, Associated Press D.C. Bureau)
In: Eric Lander was nominated to serve as President Biden’s science advisor and director of the Office of Science and Technology Policy. (STAT)
In: Janet Woodcock, Director of Center for Drug Evaluation and Research, has been tapped to lead the FDA on an interim basis. (The Wall Street Journal)
- Out: Dr. Stephen Hahn, who told POLITICO on his way out that COVID-19 created a “clash of cultures” between the FDA and the White House. (POLITICO)
Out: Surgeon General Dr. Jerome Adams resigned his post at the request of Joe Biden this week. (The Washington Post)

Changes to healthcare policy on Day 1

Biden’s Chief of Staff Ron Klain issued a regulatory freeze memo which will halt a number of last minute Trump administration regulations governing FDA authority over medical devices, changes to certain Medicare drug coverage rules and consent requirements for researchers working with tissue from aborted fetuses. (STAT)
Roll Call and POLITICO published roundups of the new administration’s executive orders on healthcare, which among other things, created the office of COVID-19 response coordinator, required masks to be worn on all federal properties and reversed the U.S. withdrawal from the World Health Organization.

COVID: Priority number 1

It’s clear that COVID is the top priority of Democrats in Washington. This week the American public got a first look at President Biden’s COVID-19 strategy, which notably promises 100 million doses of COVID-19 vaccines administered in 100 days. (The Hill, The Washington Post). Meanwhile, Speaker Nancy Pelosi said that the House will move immediately to pass another COVID-19 relief package. (The Hill)

It’s not all Biden news

Talks between the FDA and industry continue on the reauthorization of the Prescription Drug User Fee Act (PDUFA). PDUFA VII will be in effect FY 2023 through FY 2027. There are several subgroups meeting to align on their priorities for this legislation including finance, post-market, manufacturing and inspections, and digital health and informatics. Expect more updates in the coming months. (Regulatory Focus)

Policy News

Post author By Sarah Farinelli
Post date December 23, 2020

A Giant Stamp and The Weather Girls: How Washington D.C. Tried to Become America’s New Year’s Eve Party

Hot Topics | December 23rd, 2020

1983 was to be the first year of a grand new Washington D.C. tradition: A 14-by-21 foot replica of the January 1984 “Love” U.S. Postal Service stamp was to be lowered from the spire atop the Old Post Office Building while the public was treated to a party with all the pomp and circumstance of Times Square. Performers included Lee Greenwood and The Weather Girls, with Tony Geary emceeing the festivities. In 1985, Mayor Marion Barry was quoted in The Washington Post saying, “Times Square has more of a history, tradition, but we’re gaining on them…We’re going to outdo New York. We think we might just take over and become the best single event [on New Year’s Eve].”

However, in 1988 Mayor Barry canceled the city’s participation in the New Year’s Eve party. With crime rates rising in the District across the board, Barry declared “it’s no time to celebrate. It’s time to work hard and to pray.” By 1990, nearly all of the ceremony surrounding Washington’s public New Year’s Eve party had evaporated. Today, Washingtonians will watch Dick Clark’s New Year’s Rockin’ Eve broadcast from New York, Los Angeles and New Orleans thinking about what could have been.

Shots, shots, shots, shots, shots, shots

In a bid to increase confidence in the COVID-19 vaccines being administered under Emergency Use Authorizations (EUA), several prominent American politicians received their shots in public. This included:
- Friday, December 18: Vice President Mike Pence, Speaker Nancy Pelosi (D-Calif.) and Majority Leader Mitch McConnell (R-Ky.). (AP Washington Bureau)
- Monday, December 21: President-Elect Joe Biden (Axios, The Hill)
- Tuesday, December 22: National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci and Health and Human Services (HHS) Secretary Alex Azar (The Hill)

Who’s next in line?

On Sunday, a Centers for Disease Control (CDC) advisory panel recommended that adults over the age of 75 as well as essential frontline workers receive access to COVID-19 vaccines in Phase 1b of the vaccine rollout. (Phase 1a includes healthcare workers as well as long-term care facility residents and staff.) Frontline workers were defined as “first responders, teachers and other education workers including day care workers, food and agriculture workers, correctional facility staff, postal workers, public transit workers, and people who work in manufacturing and in grocery stores.” (STAT)

COVID-19 relief bill: Are we there yet?

Congress came to an agreement on a 5,593 page bill with $900 billion earmarked for COVID-19 relief and $1.4 trillion in government funding. While the future of the bill is up in the air after President Trump announced his intent to veto the current iteration on Tuesday night, Roll Call’s Mary Ellen McIntire broke down the top three healthcare policy implications that are tucked into the bill approved by the House and Senate:
- Public health funding: The government funding portion of the bill provides the National Institutes of Health and CDC with increased funding for Alzheimer’s Research, public health preparedness and improvements to laboratory capacity, among other initiatives. Through the COVID-19 relief package, these agencies would receive appropriations for vaccine manufacturing and distribution, contact tracing, COVID-19 research and more.
- Surprise medical billing: Beginning in 2022, patients would be protected from surprise medical bills. Notably exempted from the surprise medical billing ban are ambulance trips.
- Extend health programs: The bill extends existing funding levels for community health centers, teaching health centers and the national health service corps through the 2023 fiscal year. The bill also extends access to telehealth under Medicare.
  - Read more: POLITICO published a more detailed summary of the bill.

Holiday homework for HHS and CDC

On Monday, the House Select Subcommittee on Coronavirus released new documents which detail the efforts of political appointees to modify and suppress reports from the CDC. Subcommittee chair Jim Clyburn (D-S.C.) also subpoenaed HHS Secretary Alex Azar and CDC Director Robert Redfield to provide additional “full and unredacted” documents relevant to the ongoing the inquiry by December 30. (POLITICO, The Hill)

Policy News

Post author By Sarah Farinelli
Post date November 13, 2020

Welcome to this week’s Hot Topic from Goodfuse’s weekly email newsletter, Policy News from Goodfuse!

Hot Topic | November 13th, 2020

This January when President-Elect Joe Biden takes up residence at the White House, he will be joined by his two German Shepherds Champ and Major. The future First Pets will join a long line of furry and not-so-furry friends that accompanied past presidents to the White House. While the Biden’s dogs likely won’t raise many eyebrows, several past presidents kept pets that were a little more on the wild side. This notably includes Theodore Roosevelt whose menagerie included a lizard, a pig, a badger, a hyena and a pony, among others. Other notable presidential pets included Thomas Jefferson’s grizzly bear cubs and Calvin Coolidge’s pet raccoon named Rebecca.

The takeaway here is that the real animal house is 1600 Pennsylvania Avenue NW.

We invite you to email us at [email protected] to sign up for our weekly “insider only” newsletter featuring fun-to-read round-ups of Hot Topics, breaking news and some quirky facts to make your Fridays Goodfused.