Category: Policy News

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A City so Nice, Did They Name it Twice?

Hot Topics | May 7th, 2021

You may have noticed that sometimes our nation’s capital is listed under “D” for “District of Columbia” while other times it is listed under “W” for “Washington, D.C.” Perhaps you even refer to the city colloquially as simply “Washington.” If you have ever wondered why our nation’s capital seems to go by a few different names, then wonder no more:

While Washington and the District of Columbia might be interchangeable in everyday conversation, the two names refer to different entities: The District of Columbia is the federal district Congress established under Article I, Section 8 of the U.S. constitution, while Washington is the name of the capital city that sits inside the federal district. While the Constitution enabled the federal government to establish a district to house the nation’s capital, it did not specify how Congress had to organize the federal territory. As such, the original federal district was mostly farmland but included three independent cities: Georgetown, Alexandria, and the nation’s new capital city: Washington City.

In the early 19^th century, the city of Washington occupied but a small sliver of the District of Columbia. In 1846, the District of Columbia shrank when Alexandria and the portions of the district west of the Potomac were retroceded to Virginia. A few decades later, Washington City grew to absorb Georgetown along with the remaining lands in the federal district east of the Potomac. This created the modern city of Washington that is contiguous with the District of Columbia.

You can address your thoughts on this week’s headlines to our team in the city of Washington in the District of Columbia:

The shot (policy) heard ‘round the world

• U.S. Trade Representative Katherine Tai announced the Biden administration would support a proposal before the World Trade Organization that would temporarily waive international patent protections for COVID-19 vaccines, saying “extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures.” (The Hill, STAT, Amb. Tai’s statement) While lower income nations and their supporters have argued the move would increase vaccine production and access, others including industry trade organizations BIO and PhRMA have issued sharp rebukes of this policy proposal. They argue that waiving intellectual property protections would not result in increased access to vaccines, as additional hurdles such as raw material shortages and pharmaceutical manufacturing expertise would prevent would-be competitors from reverse engineering the approved vaccines. (Axios)

Vaccine goal posts moved again

• On Tuesday, the Biden administration announced a new goal in the national campaign to vaccinate Americans against the COVID-19 virus. The federal government is now aiming to have 70% of American adults at least partially inoculated against COVID-19 by July 4^th. While the U.S. has enough vaccine supply to reach this goal, declining interest among the American populace threatens to make this goal more difficult to achieve than previous ones. (Axios, The Hill) Recognizing the decline in demand for COVID-19 vaccines, the federal government is shifting its inoculation strategy away from mass-vaccination sites to walk-up vaccination appointments at pharmacies and mobile vaccination clinics. (STAT)

Pallone pushes drug pricing reform forward

• House Energy and Commerce Committee Chairman Frank Pallone Jr. (D-N.J.) announced he would use “whatever vehicle I can” to pass the Democrats’ drug pricing bill, also known as H.R. 3. If passed, the bill would enable the federal government to negotiate lower drug prices on behalf of Medicare. The announcement comes after President Biden called on Congress to pass drug pricing reform, but decided not to include these policy reforms in his multi-trillion dollar American Families Plan. (The Hill, The Washington Post)

Obamacare’s healthy enrollment numbers

• Officials from the Biden administration announced that almost 940,000 Americans took advantage of the Affordable Care Act special enrollment period from February 15 to April 30 to sign up for health insurance. When announcing this news, federal officials also touted that premiums have decreased about 40% from $100 to $57 on average for almost 2 million Americans enrolled in plans offered under the Affordable Care Act. (The Hill)

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The Nation’s River: How the Potomac Got its Name

Hot Topics | April 30th, 2021

While Washingtonians may be “only intermittently in love with their rivers,” the Potomac River is an enduring and defining feature of the Washington, D.C.’s geography. Before the first European settlers arrived in Virginia, the area around our nation’s capital was home to the Patawomeke tribe, and it is from this tribe that the Potomac river derives its name. Over the years, Patawomeke was Anglicized and of the many different spellings that were used including Potomach, Pittomack, Pottomeek, Potomac rose above the rest.

The river has gone by other names as well. George Washington called it “the Nation’s River” while Lyndon B. Johnson called it “the national disgrace,” taking a swipe at how polluted the waterway had become in the mid-20^th century. If Johnson were alive today, he would be happy to hear that the city is upgrading infrastructure as part of the multi-billion dollar Clean Rivers Project that will significantly improve water quality in the Potomac and Anacostia Rivers, as well as the Chesapeake Bay downstream. 

And now we take you three miles east from our Nation’s River to our nation’s Capitol for this week’s healthcare policy news headlines:

Washington’s white whale

• Last week we told you that House Speaker Nancy Pelosi (D-Calif.) was encouraging lawmakers to include a measure on drug pricing reform in President Biden’s American Families Plan (AFP). (The Hill) On Wednesday night, President Biden unveiled the AFP, which notably did not include a provision on drug pricing policy. President Biden asked Congress to allow Medicare to negotiate drug prices, but the nation’s legislature is under no obligation to respond to the President’s request. (STAT, The Hill)
  • Read more: The White House and Congressional Democrats are not seeing eye to eye on drug pricing reform, prompting comparisons to President Trump’s relationship with the 116^th Congress on the issue. (STAT)

FDA to move against menthols

• On Thursday, the FDA announced it would issue a new proposal in the next 12 months to ban menthol-flavored cigarettes, and all flavors in cigars. The move was hailed by public health groups which have long pushed for such a ban. Even once the proposal is issued, any ban is likely years away as the tobacco industry is all but certain to contest the new regulations. (Axios, The Hill, STAT)

Updated mask guidance

• With the COVID-19 vaccination campaign in the United States making strides in vaccinating huge swathes of the population, the Centers for Disease Control and Prevention (CDC) issued new mask-wearing guidance for those who are fully vaccinated. According to the latest guidance, it is safe for fully vaccinated people to participate in the following activities outdoors without wearing a mask: exercise with members of your household, attend a small outdoor gathering with others who are fully vaccinated and dine outdoors at restaurants. (Axios, Roll Call, The Hill)
  • Read more: The CDC’s guidance can be reviewed in full, here. 

Biden expands access to buprenorphine

• The Department of Health and Human Services (HHS) has updated federal guidelines that will allow more healthcare providers to prescribe buprenorphine, an FDA-approved treatment for opioid use disorder. Previously, medical professionals had to undergo an eight hour training course before they could prescribe the drug, a training that fewer than 100,000 providers out of an eligible one million completed. Deaths from opioid overdoses rose sharply during the past year, and public health experts hope expanded access to buprenorphine will help combat this alarming trend. (STAT, 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.

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Meet me on J Street…or Not…

Hot Topics | April 23rd, 2021

In Washington, D.C., streets running east to west are assigned letters. However, look closely at a map and you’ll notice something appears amiss: the streets are lettered “G…H…I…K…L.” A popular (but untrue) urban legend claims that city planner Pierre L’Enfant left J Street out of his plans because he disliked Chief Justice John Jay. The real reason has nothing to do with personal squabbles with founding fathers and everything to do with the evolution of the English language. J emerged in English as a variant of the letter I, and in the late 1700’s, these two letters were often interchanged and indistinguishable when written by hand. For Americans living in our nation’s capital in the late 18^th Century, omitting J Street from the city’s plans would have helped avoid confusion and would not have raised eyebrows as it might today. 

Drug pricing reform: now or later?

• House Speaker Nancy Pelosi (D-Calif.) is encouraging lawmakers to include a measure on drug pricing reform in President Biden’s American Families Plan (AFP). On Thursday, House Democrats reintroduced their drug pricing reform legislation (H.R. 3) in a signal to the White House that they want the upcoming legislation to address drug pricing. The push comes as the White House signaled it plans to leave drug pricing reform out of the AFP, preferring instead to tackle the issue as part of a separate legislative initiative. (The Hill)
  • Read more: Republicans are organizing their opposition to the Democrats’ proposed drug pricing reforms. (The Washington Post)

Lights, camera, vaccines

• As of Monday, April 19, all American adults over the age of 16 are eligible to receive a COVID-19 vaccine. To coincide with this milestone in the nation’s vaccine rollout, the White House launched a “media blitz” to encourage Americans to take the shot. The initiative is targeting groups where research suggests there might be higher rates of vaccine hesitancy such as Latino and Black communities, as well as conservatives. Millennials: keep an eye on Snapchat where Dr. Anthony Fauci is scheduled to make an appearance. (Axios, The Hill)

CMS nominee stalled in committee

• Senator John Cornyn (R-Texas) has placed a hold on the nomination of Chiquita Brooks-LaSure, the White House’s nominee for Administrator of the Centers for Medicare and Medicaid Services. Cornyn announced he acted in opposition to the Biden administration, which rejected Texas’ request to extend its Medicaid waiver that had been approved by the Trump administration. The waiver would have allowed Texas to keep its existing Medicaid arrangements for another decade, and the rejection of the waiver was seen as an attempt to pressure Texas to expand its Medicaid program. Despite delays caused by the hold, Brooks-LaSure still has a path to be confirmed by the Senate. (STAT, The Hill)

Veep calls for action on maternal health

• On Monday, Vice President Kamala Harris called for “sweeping action” to address racial inequities in pregnancy and childbirth in an e-mail interview with STAT News. In the interview, Harris pointed to specific policy actions that could address this issue including: implicit bias trainings, state pregnancy medical home programs and Maternal Mortality Review Committees to provide data on the deaths of mothers who die one year postpartum. (STAT)

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.

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Washington D.C., squared

Hot Topics | April 16th, 2021

Do you love Washington, D.C. but sometimes wish there was even more to love? What if we told you that for nearly five decades, there was? When searching for a location to host the nation’s capital, the Founding Fathers originally earmarked ten square miles of land shaped like a rhombus straddling both banks of the Potomac. During the first half of the 19^th century, our nation’s capital included not only the land within the modern-day borders of Washington D.C., but also Arlington County, Va. and portions of Alexandria, Va. In 1846, Congress returned or “retroceded” half of the federal district south of the Potomac river back to Virginia giving our nation’s capital its present borders.

First COVID, then cancer

• The White House unveiled a proposal to create a new $6.5 billion medical research agency housed within the National Institutes of Health that would be tasked with fast-tracking cures for difficult-to-treat diseases including Alzheimer’s disease, cancer and diabetes. The agency, modeled on DARPA and ARPA-E would be dubbed ARPA-H, or “Advanced Research Projects Authority – Health.” At this time, ARPA-H is only a proposal, as Congress would have to appropriate the funds necessary to create the agency. (STAT)

Don’t you, forget about us

• PhRMA, the pharmaceutical industry lobby, is trying out a new digital and print marketing campaign inside the Beltway that can be summarized as: “Don’t take us for granted – we brought medicines and vaccines for COVID-19 to the world in record time.” PhRMA also debuted a new policy agenda that includes “unprecedented” endorsements for drug pricing reforms that would impact the Industry’s bottom line. (STAT)
  • Read more: STAT sat down with PhRMA President Stephen Ubl who explained the lobbying group’s new approach to drug pricing reform in greater detail. (STAT)

White House: J&J is a bump in the road

• Even before a Centers for Disease Control advisory committee recommended that the rollout of the Johnson & Johnson (Janssen) COVID-19 vaccine remain paused, the White House announced that the suspension of the shot would not have a “significant impact” on the United States’ vaccination campaign. (The Hill, POLITICO) To date, the Johnson & Johnson vaccine has accounted for less than 5% of COVID-19 inoculations in the United States.

Family planning policy blitz

• The White House observed Black Maternal Health Week by issuing the first presidential proclamation marking the occasion. (Axios)  
• On Monday, Illinois became the first state to extend Medicaid coverage for new mothers to one year postpartum. The policy will remain in effect until at least December 31, 2025. (Axios, The Hill)
• The FDA used its regulatory discretion to end restrictions on mailing abortion pills (mifepristone) to women during the pandemic. The future of the policy after the end of the public health emergency remains unclear. (The Hill, Endpoints News)
• On Wednesday, the Biden administration released a proposed rule that would make organizations that provide abortions or abortion referrals eligible for family planning funds under Title X. The proposed rule would reverse a rule finalized by the Trump administration in 2019 that prevented these groups from receiving Title X funds. (Roll Call, POLITICO, 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.

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Caution: Handle Cargo with Care

Hot Topics | April 9th, 2021

Every so often shipping giants UPS and FedEx will make headlines for shipping outlandish cargo such as whales or panda bears. However, these stories almost seem pedestrian when you consider the U.S. Postal Service once allowed people to mail…other people. In 1913 at the inception of the parcel post, there was no USPS policy banning the practice. According to Smithsonian Magazine, “an Ohio couple named Jesse and Mathilda Beagle ‘mailed’ their 8-month-old son James to his grandmother, who lived just a few miles away in Batavia.” Being the doting parents they were, the Beagles insured young James for $50.

Children who were sent via post were treated with more care than the average parcel. Far from being stuffed in a box or a mail sack, children were generally chaperoned on their voyage by a USPS employee.

The last documented account of a child mailed via USPS comes from 1915, and by 1920 the Postmaster General had outlawed the practice. Our sincerest apologies to all the parents out there who thought this sounded like a pretty sweet alternative to a 5:30 AM flight out of Dulles with a fussy toddler in tow.

Your guide to the latest CDC guidance

• The Centers for Disease Control and Prevention (CDC) updated two important pieces of COVID-19 guidance in the past week:
  • People who are fully vaccinated can travel “at low risk to themselves” as long as they continue to wear masks, wash their hands, avoid crowds and social distance. According to CDC guidelines, Americans are fully vaccinated two weeks after receiving their last recommended dose of vaccine. (CDC)
  • In a move many experts called overdue, the CDC issued updated guidance confirming the risk of contracting COVID-19 through contact with contaminated surfaces is “generally considered to be low.” (The Hill, CDC)

Vaccine rollout accelerates again

• On Tuesday, President Biden announced he was pushing states to expand universal COVID-19 vaccine eligibility even earlier. He is now directing states to offer COVID-19 vaccines to any American 16 years of age or older by April 19, two weeks earlier than his original universal eligibility date of May 1. (The Hill)

Trump-era policy rollbacks continue

• This week the Biden administration announced it was rescinding Medicaid work requirements in Michigan and Wisconsin authorized by former President Trump. The move came after similar authorizations were rescinded in Arkansas and New Hampshire. According to the Centers for Medicare and Medicaid Services (CMS), most Medicaid recipients either work or are exempt from work due to illness or disability. (The Hill)

Racism: not just a sociopolitical issue

• In a move that garnered support from the American Medical Association, the CDC declared racism to be a “serious public health threat.” In a statement published on the CDC’s website, the agency noted, “A growing body of research shows that centuries of racism in this country has had a profound and negative impact on communities of color.” The declaration is part of an agency-wide initiative dubbed “Racism and Health” which is a hub for a push to achieve health equity. (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.

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Here’s the situation

Hot Topics | April 2nd, 2021

In January 2021, ex-POLITICO reporters Jake Sherman, Anna Palmer and John Bresnahan launched their new media venture Punchbowl. The new media outlet is “focused on the several dozen people who have power in Washington, and exercise it, how they exercise it and why.” The trio chose the name Punchbowl because it is the Secret Service codename for the U.S. Capitol, and reflects their focus on the main levers of power in Washington.

It is in this spirit that we have decided to change the name of our weekly “insider only” newsletter from Policy News from Goodfuse to Cement Mixer from Goodfuse, with Cement Mixer being the Secret Service codename for the White House Situation Room. The name change reflects our aspirations to one day move into broadcast news and take over Wolf Blitzer’s Situation Room on CNN. For more on this name change, please read to the very end of this week’s newsletter excerpt.

“Right now I’m scared”

• Dr. Rochelle Walensky, Director of the Centers for Disease Control and Prevention (CDC), issued an emotional plea to Americans this week to follow public health precautions just a little bit longer as cases of COVID-19 appeared to be on the verge of another spike. (STAT, The Hill) The plea comes as several states continue to lift mask mandates and relax other public health measures put in place to combat the spread of the pandemic. Following Dr. Walensky’s appeal, President Biden implored states to follow federal guidance and reconsider their rollbacks of restrictions related to COVID-19. (POLITICO, The Hill)

The race to herd immunity

• The Biden administration will scale back efforts to vaccinate Americans at large mega-sites after data showed Americans prefer to get their jabs at small retail pharmacies. (POLITICO) This news comes as President Biden announced “90 percent of U.S. adults will be eligible for the coronavirus vaccine and will have a vaccination site within 5 miles of where they live by April 19.” (The Hill) To further build America’s confidence in the COVID-19 vaccines, the Biden administration also announced the “COVID-19 Community Corps” network of volunteer health experts and community leaders who will help combat vaccine hesitancy in their communities. (POLITICO, The Hill)

The patent protection predicament

• A spokesperson for the U.S. Trade Representative confirmed that the Biden administration is exploring the possibility of weakening patent protections on COVID-19 vaccines as a means of expanding access. About 100 countries led by India and South Africa are asking the World Trade Organization to temporarily suspend patent protections. PhRMA and BIO have vigorously opposed any measure that would impact vaccine patent protections. (Axios)

Behind the scenes at the Trump administration

• This week new details and accusations emerged regarding the conduct of former Trump administration officials who were responsible for coordinating the country’s response to COVID-19. First, former CDC Director Dr. Robert Redfield told an interviewer he was pressured by former Health and Human Services Secretary Alex Azar to revise data reports on COVID-19. (The Hill) Then on Wednesday, the House Select Subcommittee on the Coronavirus Crisis released documents showing senior officials, including former trade advisor Peter Navarro, sounded an early alarm bell in March 2020 when COVID-19 in the United States was limited to a few isolated cases. Senior officials like Navarro then pushed federal agencies to offer non-competitive contracts to preferred companies to produce personal protective equipment. (POLITICO, The Hill)

If you enjoyed this excerpt from this week’s Cement Mixer from Goodfuse, we invite you to email us at [email protected] to sign up for 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.

P.S. – April Fool’s! Our newsletter will continue to be published under the name Policy News from Goodfuse starting next week.

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The only two certainties in life are death and taxes

Hot Topics | March 26th, 2021

Procrastinators rejoice! On Wednesday, the IRS announced it would give Americans an extra month to file their tax returns (the new deadline is May 17^th). This news might have some wondering what it would take to have the deadline extended…indefinitely. What would cause the IRS to stop collecting taxes? The answer is nothing, except perhaps the complete extinction of mankind.

The IRS has continuity plans in place that require the agency to resume Mission Essential Functions (MEFs) within 12 hours of a catastrophic event. MEFs include processing tax remittances, tax refunds and yes, your tax returns. The continuity plan confirms that neither natural disasters nor terrorist attacks nor biological warfare nor a nuclear strike will prevent Uncle Sam from taking his cut. So if you need more time to file your return in the event of a nuclear apocalypse and the IRS doesn’t grant an extension as it did on Wednesday, consider filing Form 4868. Benjamin Franklin wasn’t kidding around when he said the only two certainties in life are death and taxes.

Megamergers under the microscope

• The Federal Trade Commission (FTC) issued a press release announcing the formation of a multinational working group that will analyze the impact of pharmaceutical company mergers on industry competition. In the release, FTC Acting Chair Rebecca Kelly Slaughter said, “Working hand in hand with international and domestic enforcement partners, we intend to take an aggressive approach to tackling anticompetitive pharmaceutical mergers.” (The Hill)

Becerra crosses the finish line

• After what many have described as a bruising nomination process, Xavier Becerra was confirmed as the Secretary of Health and Human Services (HHS) in a 50-49 vote on Thursday. During hearings, Republicans attacked Becerra for his views on abortion and Medicare-for-all, as well as his qualifications for the post. Susan Collins (R-Maine) was the only Republican to vote to confirm Becerra. (Axios, The Hill)

Policy reviews underway at HHS

• This week the Centers for Disease Control and Prevention (CDC) announced they had identified and rescinded guidance documents released by the Trump administration that were “not grounded in science” and not “primarily authored” by CDC staffers. The move was part of a move by CDC director Rochelle Walensky to restore public confidence in the agency. (The Hill, The Washington Post – full text below) Meanwhile, HHS has postponed its review of FDA regulations due to a last-minute rule enacted by the Trump administration that would have required the agency to review over 95% of its regulations on the books at a time when the agency wants to focus on the COVID-19 response. (Endpoints News)

Questions as May 1 looms

• Many states responded with caution last Friday when President Biden announced he would direct states to make all adults eligible to receive a COVID-19 vaccine by May 1. Although Mississippi moved quickly to open eligibility to all adults on Wednesday, other states have expressed concerns: In Oregon, officials are exploring whether they will need federal assistance to bolster their online appointment system, and Oklahoma officials are working to open new sites to administer the vaccine. (POLITICO) There are also concerns that increasing access to the vaccine too soon will compromise equity in the rollout process. (Axios)  

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.

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Cherry Blossoms: The Harbingers of Spring

Hot Topics | March 19th, 2021

Spring in Washington D.C. would hardly seem complete without the city’s famous cherry blossoms, yet these trees did not always line the shores of the Potomac.

The origins of Washington’s cherry trees can be traced back to Mrs. Eliza Ruhamah Scidmore, a woman who made it her personal mission to see these trees planted in the nation’s capital after returning from a trip to Japan in 1885. For 25 years, Mrs. Scidmore unsuccessfully petitioned every Superintendent of the Office of Public Buildings and Grounds to plant Japanese cherry trees along the Potomac. Eventually, Scidmore found a supporter in First Lady Helen Taft who took up the cause. Just one day after Taft wrote a letter expressing her support for planting the trees, the Japanese consul in New York got wind of the plan and proposed the City of Tokyo donate the trees. After some fits and starts with trees that were infested with pests, the city was able to plant the thousands of trees that tourists and locals alike gather to gawk at each spring.

Washington D.C. is closing off many of the most popular cherry blossom viewing areas this year as a public health precaution, but you can follow the virtual cherry blossom celebrations here: https://nationalcherryblossomfestival.org/

Who’s in and who’s out

• This week the Senate voted to confirm Dr. Rachel Levine as the assistant secretary for health at the Department of Health and Human Services (HHS). (The Hill, Axios) With her confirmation, Levine became the first openly-transgender person confirmed by the Senate to a federal appointment. The Senate also confirmed Dr. Vivek Murthy as Surgeon General, returning the physician to the role he held during the Obama administration. (The Washington Post) Amid these confirmations, the FDA’s second-highest ranking official (principal deputy commissioner of food and drugs) Amy Abernethy announced she would be leaving the agency. (Endpoints News)

At the intersection of infrastructure and drug pricing

• Drug pricing is back in the spotlight as Congress turns its attention to its next legislative priority: infrastructure. The two policy issues are being discussed in tandem, as Congress would like to use the cost savings from drug pricing reforms to pay for an infrastructure package. While the Industry has become adept at weathering these types of challenges, POLITICO notes, “Pharma may not be able to fight it off this time.” However, it is still unclear if the drug pricing measures would satisfy reconciliation requirements and could be included in an infrastructure bill. (POLITICO, The Hill)

Sign up season extended

• The Biden administration announced it would extend the Obamacare special enrollment period to August 15. The announcement gives Americans additional time to enroll or change their coverage, as well as access new subsidies made available through the American Rescue Plan (the 2021 COVID-19 relief bill). (The Hill, The Washington Post)

Vaccine makers in the hot seat

• Just hours after AstraZeneca announced data from the U.S. trial of its COVID-19 vaccine, the National Institute of Allergy and Infectious Diseases (NIAID) issued a statement that the Data and Safety Monitoring Board (DSMB) expressed concerns the company may have included outdated information in its analysis. (Axios, STAT) AstraZeneca issued another press release Wednesday evening with new figures that had been shared with the DSMB confirming the vaccine’s efficacy. Meanwhile, the Biden administration expressed concerns Johnson & Johnson will not be able to fulfill its obligation to deliver 20 million doses of COVID-19 vaccine by the end of March. (POLITICO, Roll Call)
  • Read more: Go deeper to understand why the credibility of AstraZeneca’s vaccine matters. (Axios)

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.

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One year later: A light at the end of the tunnel

Hot Topics | March 12th, 2021

Yesterday the world solemnly observed the one-year anniversary of the COVID-19 pandemic. While pandemic start and end dates are not clear cut, on March 11, 2020 the World Health Organization declared COVID-19 a pandemic. Roll Call reporters Lauren Clason and Mary Ellen McIntire said it best when earlier this week they wrote: “More than 500,000 American deaths and trillions of taxpayer dollars later, the virus has reshaped the health care landscape for years to come.”

Headlines such as “America’s nightmarish year is finally ending” from Axios and “Planning for a post-pandemic Congress underway” from Roll Call suggest we are finally heading for the exit. As we start to think about life after the pandemic, we’ll continue bringing you the updates and policies that will come to define the future of America’s healthcare system.

Taking a victory lap

• Yesterday President Biden signed the American Rescue Plan Act (a.k.a. the COVID-19 relief bill or ARP) into law. A few hours after the signing ceremony, Biden addressed the nation during prime-time to announce he will direct states to make the COVID-19 vaccine available to all Americans by May 1, and that the country may be able to “mark our independence from this virus” by the Fourth of July. (Axios) Next week the president is planning a “Help is Here” tour that will see the president and his surrogates tour the country to convince the American public the ARP is a net positive. (Axios, Roll Call, The Washington Post)
  • Read more: Axios sums up the provisions of the $1.9 trillion bill.
  • Read more: The White House launched a website that helps Americans understand how the ARP will impact their bottom line. (The White House)

Guide to new COVID guidance

• For Americans who are fully vaccinated against COVID-19: The CDC has issued interim public health guidelines that allow Americans who are fully vaccinated to relax certain precautions. However, all Americans should continue masking and practice social distancing in congregate and higher-risk settings. (STAT, The Hill, Axios)
• Nursing home visits: The Centers for Medicare and Medicaid Services issued new guidance allowing nursing homes to resume indoor visits regardless of the vaccination status of the resident or visitor (barring exceptional circumstances). (The Hill)

New guidelines = more lung screenings

• The US Preventative Services Task Force issued new lung cancer screening recommendations that call for a major expansion of who should be screened for lung cancer. The recommendation is an update to guidance from 2013, and was based on a systematic review to assess the benefits and risks of low-dose computed tomography (LDCT) screenings to find the optimum age to begin routine lung cancer screenings. Under the new recommendations, about 15 million additional Americans would be screened for lung cancer, which is nearly twice the current number undergoing routine screenings. (The Washington Post, The Hill)

Protect our patents

• Letters from PhRMA and BIO make it clear the pharmaceutical and biopharmaceutical industries want the Biden administration reject a proposal pending before the World Trade Organization (WTO) that would temporarily waive their COVID-19 vaccine patents. The World Health Organization has called for patent rights to be waived in a bid to increase supply, a move the WTO is considering following a request from South Africa and India. (STAT, Associated Press)

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.

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This One’s (Not) for the Byrds

Hot Topics | March 5th, 2021

You may have seen the Byrd Rule mentioned in connection with the COVID-19 relief package working its way through Congress. The Byrd Rule has come into play since the relief package is tied to a budget resolution that is being legislated using reconciliation, a rule created by Congress in 1974 that allows the Senate to avert a filibuster and pass a budget resolution with a simple majority. Named for former Senator Robert Byrd (D-W.Va), the rule limits what can be included in reconciliation legislation in the Upper Chamber by outlining six criteria that can be used to identify “extraneous” provisions. The Senate Parliamentarian, an unelected official, ultimately has the power to decide what provisions are extraneous or not. Notably, the Senate Parliamentarian recently ruled that Democrats’ proposal to raise the federal minimum wage to $15 an hour as part of the COVID-19 legislation did not pass the Byrd test.

Much more to follow on COVID-19 relief news in this week’s headlines:

COVID-19 relief legislation: what’s in and what’s out

• In (as of 3/5):
  • Funds to subsidize health insurance for unemployed workers through COBRA. (Roll Call)
  • $400 per week in unemployment benefits for workers. (POLITICO)
  • A 29% increase in spending on Obamacare subsidies, which is projected to boost enrollment by about 15%. (The Washington Post)
  • $8.5 billion to help rural healthcare providers pay for the cost of COVID-19 care. (STAT)
• Out (as of 3/5): Stimulus payments for Americans who earn more than $80,000 ($160,000 for couples). (POLITICO, The Hill)
• TBD:
  • President Biden has urged Democrats to stay unified as the legislation from the House meanders through the Senate. Time will tell how unified the caucus remains as moderates continue to push for more targeted relief. (The Hill)
  • The provisions of the legislation are still subject to change as the bill works its way through the Senate.

An EUA hat trick

• Following a thumbs up from an independent Advisory Committee, the FDA granted the Janssen (Johnson & Johnson) COVID-19 vaccine an Emergency Use Authorization (EUA) on Saturday. (FDA) The EUA was quickly followed by a unanimous endorsement from a CDC vaccine advisory panel on Sunday. (The Washington Post)
  • Read more: How do the three vaccines (Pfizer/BioNTech, Moderna, Janssen) being administered under EUA compare? It’s complicated. Axios breaks down the differences, but here’s Dr. Anthony Fauci’s hot take: “We have three highly efficacious vaccines that are safe and efficacious. That’s the bottom line.” (The Hill)

You get a shot and you get a shot…

• This week President Biden announced the United States would have enough COVID-19 vaccine stock to vaccinate all adults by the end of May (though getting shots into arms will take longer). The announcement came on the cusp of the FDA granting an EUA to the Janssen COVID-19 vaccine, as well as an agreement that will see Merck & Co. produce the Janssen vaccine. (The Hill, STAT, Axios)

Becerra’s bruising confirmation battle

• President Biden’s Health and Human Services Secretary Nominee Xavier Becerra narrowly advanced out of his Senate Health, Education, Labor and Pensions (HELP) committee on a deadlocked 14-14 vote. Becerra will now go before the full Senate for a confirmation vote, where he is expected to be confirmed by the Democratic majority. However, Senate Republicans are calling the deadlocked committee vote a victory, seeking to ratchet up the pressure on Democrats from swing states who are up for reelection in 2022. (POLITICO, The Hill)
  • Read more: If confirmed, Becerra said he would conduct a “thorough review” of executive mechanisms that could be used to lower drug prices. (The Hill)

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