The Timekeepers

Hot Topics | November 19, 2021

From getting to work on time to helping satellites stay in geosynchronous orbit, timekeeping is an essential function of modern life. In the United States, the responsibility of maintaining the master clock from which all other clocks are set falls to the United States Naval Observatory (USNO) located in Northwest D.C. At the facility, dozens of independent cesium atomic clocks and hydrogen maser clocks work together to provide a time so accurate, it does not change by more than 100 picoseconds (0.000 000 000 1 seconds) per day. While the atomic clocks are tucked away inside the facility, the USNO maintains a master clock display for the public at the gates on Massachusetts Ave NW and 34^th Street NW.

Now for the healthcare stories that made headlines this week:

Drug pricing reform: back from the dead

• Efforts to include drug pricing reform in the Democrat’s social spending bill came back to life this week. The majority caucus agreed on a measure that would permit Medicare to negotiate drug prices in select situations, cap out-of-pocket drug costs for seniors on Medicare at $2,000 annually, and prevent drug companies from raising prices faster than inflation. Drugs eligible for negotiation would include small molecules that are more than nine years old and complex biologics more than 12 years old. (The Hill, Axios)
  • Read more: STAT’s Washington Correspondent Rachel Cohrs breaks down who wins and who loses under this policy. (STAT)

Coming soon to a pediatrician near you

• On Tuesday, the Director of the Centers for Disease Control and Prevention (CDC) advisory committee unanimously approved the FDA advisory committee recommendation to authorize the Pfizer/BioNTech COVID-19 vaccine for children ages 5 to 11 years old. CDC Director Walensky quickly followed course signing off on the policy within hours. The director’s action paves the way for these shots to be administered as soon as this week, with the pediatric vaccination campaign reaching full capacity next week. (STAT, Axios)

More on mandates

• The Biden Administration announced that the Occupational Safety and Health Administration (OSHA) will begin enforcing the COVID-19 Vaccination and Testing Emergency Temporary Standard. The policy covers two-thirds of all U.S. workers, and will require covered workers to be vaccinated against COVID-19 by Tuesday, January 4, or face weekly testing. There are limited exceptions, and 17 million healthcare workers will not have the option to undergo weekly testing. (Axios, The Washington Post – full text below)

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The Curious Capitol Columns

Hot Topics | November 12, 2021

You’ve just left the National Bonsai & Penjing Museum at the National Arboretum, and a few hundred yards in front of you stand 22 Corinthian columns supporting nothing but air atop a grassy knoll. You’re looking at the National Capitol Columns, though perhaps ex-Capitol Columns would be a more appropriate name.

From 1828 to 1958, the columns had a structural purpose and graced the East Portico of the Capitol. The columns were removed when the east side of the Capitol was expanded to correct an aesthetic (not structural) oversight in the building’s design. After the columns were removed from the Capitol, benefactress Ethel Garrett campaigned to establish a permanent home for the columns at the National Arboretum.

Thank you for making us your home for the healthcare stories that made headlines this week:

Califf for Commissioner

• President Biden nominated Dr. Robert Califf, a cardiologist, to serve as Commissioner of the Food and Drug Administration (FDA). If confirmed by the Senate, Califf would return to the job he held in the last few months of the Obama administration and have another opportunity to execute his goals of transforming the way stakeholders across healthcare use data. However, Califf’s confirmation process may not be smooth, as Senators Joe Manchin (D-W.Va.) and Richard Blumenthal (D-Conn.) publicly voiced concerns over the Dr. Califf’s approach to regulating opioids. (STAT, Endpoints News)

Your guide to mandate madness

• It’s been a busy week for President Biden’s vaccine mandate. Last Saturday, the Fifth Circuit Court of Appeals temporarily blocked the mandate from going into effect. (POLITICO) The Administration responded by encouraging businesses to implement the mandate of their own accord, while the Department of Justice filed a brief arguing the mandate is legal. (The Hill [1], The Hill  [2]) As the legal challenges make their way through the courts, many American businesses are unsure of whether they should make preparations to implement the mandate. (Roll Call, The Hill)

Moderna’s patent problem

• A public disagreement regarding the development of Moderna’s COVID-19 vaccine intensified this week when Dr. Francis Collins, Director of the National Institutes of Health, told Reuters the company “made a serious mistake” by asserting three NIH scientists did not help invent a key component of the vaccine. Moderna has stated the company “reached the good-faith determination that these individuals did not co-invent” the component of the vaccine in question. The dispute may now go to court. (Endpoints News [1], Endpoints News [2])

Confusion in the courts

• Federal judges issued two conflicting verdicts on the 340B drug discount program, which requires pharmaceutical companies to offer discounts on all outpatient drugs sold to hospitals and clinics serving low income populations. One judge ruled the federal government did not have the authority to threaten to penalize Novartis and United Therapeutics for reducing 340B discounts. However, another judge asked the federal government to review how some hospitals participating in 340B use contract pharmacies. Following the verdicts, it remains unclear if the Department of Health and Human Services has the authority to force pharmaceutical companies to provide 340B discounts. (STAT)

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Where the Tiny Trees Are

Hot Topics | November 5, 2021

The grandeur of Washington, D.C.’s most famous attractions can easily distract from its smaller gems. Case in point: the National Bonsai & Penjing Museum which is the world’s first (and self-proclaimed finest) museum devoted to Bonsai. Located on the grounds of the National Arboretum in Northeast D.C., the museum has received numerous accolades including “Best Place to Take an Out-of-Towner” and “Best First Date Activity.” The museum boasts a collection that includes examples of Japanese Bonsai, Chinese Penjing and plants native to North America cultivated in these East Asian styles. Oh, and did we mention admission is free?

Now for the big healthcare stories that made headlines this week:

Drug pricing reform: back from the dead

• Like a corpse on Halloween, efforts to include drug pricing reform in the Democrat’s social spending bill came back to life this week. The caucus agreed on a measure that would permit Medicare to negotiate drug prices in select situations, cap out of pocket drug costs for seniors on Medicare at $2,000 annually, and prevent drug companies from raising prices faster than inflation. Drugs eligible for negotiation would include small molecules that are more than nine years old and complex biologics more than 12 years old. (The Hill, Axios)
  • Read more: STAT’s Washington Correspondent Rachel Cohrs breaks down who wins and who loses under this policy. (STAT)

Coming soon to a pediatrician near you: shots for tots

• On Tuesday, the Director of the Centers for Disease Control and Prevention (CDC) approved a unanimous recommendation from an advisory committee to authorize the Pfizer/BioNTech COVID-19 vaccine for children ages 5 to 11 years old. The Director’s action paves the way for these shots to be administered as soon as this week, with the pediatric vaccination campaign reaching full capacity next week. (STAT, Axios)

More news on mandates

• The Biden Administration announced that the Occupational Safety and Health Administration (OSHA) will begin enforcing the COVID-19 Vaccination and Testing Emergency Temporary Standard. The policy covers two-thirds of all U.S. workers, and will require covered workers to be vaccinated against COVID-19 by Tuesday, January 4, or face weekly testing. There are limited exceptions, and 17 million healthcare workers will not have the option to undergo weekly testing. (Axios, The Washington Post – full text below)

If you enjoyed this week’s excerpt from Policy News 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.

 

The Tall Tail of Washington’s Hometown Ghost

Hot Topics | October 29, 2021

Late at night when members of Congress have retired to their crash pad or office for the night, a terrifying specter haunts the halls of the U.S. Capitol. Known as the Grimalkin, Demon Cat or simply DC, the phantom feline is a local legend that has been a fixture in Washington lore since the Civil War.

The first recorded mention of the Demon Cat dates to 1862 when Union troops were defending the Capitol during the Civil War. Soldiers who were assigned night rounds reported seeing an ordinary black cat grow to the size of a tiger before pouncing and disappearing. Since then, additional sightings have coincided with national emergencies such as the assassinations of Abraham Lincoln and John F. Kennedy.

Demon Cat deniers (a.k.a. historians) are quick to point out that the Capitol was historically home to a horde of (non-demon) cats who helped control the rodent population, and the men who were assigned the Capitol night watch were often political appointees and were known to drink on the job.

Now for the not-so-scary healthcare stories that made headlines this week:

Drug pricing reform dies on eve of Halloween

• President Biden has abandoned efforts to include drug pricing reform in the Democrats’ multi-trillion dollar domestic spending bill. While progressive elements of the Democratic party pushed hard for reforms, a compromise could not be found. Other progressive priorities such as expanding Medicare to include dental coverage have also been removed from the bill. (STAT, The Washington Post)

Shots for tots

• On Tuesday, the Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee recommended that the Pfizer/BioNTech COVID-19 vaccine be authorized for children aged 5 to 11 years old. 17 committee members voted to issue the non-binding recommendation to authorize the vaccine with one member abstaining. The decision to authorize the vaccine now rests with the FDA Commissioner, who typically accepts the recommendation of the advisory committee. The Director of the Centers for Disease Control and Prevention (CDC) would also have to authorize the shot following a recommendation from a similar advisory committee before doctors could administer the vaccine to children. (STAT, Axios)

Have a spooky and safe Halloween!

• Dr. Rochelle Walensky, Director of the CDC, went on Fox News Sunday earlier this week to share that trick-or-treating “should be very safe for your children.” Her remarks were similar to those of Dr. Anthony Fauci, Director of the National Institute for Allergy and Infectious Disease, who said the annual Halloween tradition is relatively safe because “You’re outdoors for the most part.” (The Washington Post)

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Old World eerie in a New World city

Hot Topics | October 15, 2021

Did the pandemic dash your dreams of embarking on a religious pilgrimage to Europe or the Middle East? Not to worry, because you can experience the best of Ancient Rome and the Holy Land in the heart of Washington, D.C courtesy of Franciscan monks.

In the late 19^th century, the Franciscan Monastery of the Hold Land in America sought to recreate a number of holy sites and relics for Americans who could not afford to see the originals overseas. This included a number of alters, chapels and grottos, but apropos for the month of October are their catacombs. Meant to evoke the early Christian catacombs of Ancient Rome, the Catacombs of Washington, D.C. are a replica of the burial tunnels that lie under the streets of the Italian capital. The catacombs come complete with an official Papal endorsement as well as the bones of Saint Innocent, a child martyr. If you’re looking to get your spook on this October, tours of the catacombs are available.

Before you rebook your European vacation to Washington, D.C., catch up with the healthcare stories that were making headlines this week:

Drug pricing’s Groundhog Day

• The intraparty stalemate between proponents of drug pricing reform and moderates entered another week. Democratic party leaders are now exploring changes that could potentially break the impasse, but reports indicate there is no guarantee that key moderates could be swayed by proposed changes. (The Hill, The Washington Post – full text below)

FDA first: e-cigarette receives marketing authorization

• In a first for the agency, the Food and Drug Administration (FDA) granted marketing authorization to some electronic nicotine delivery systems (ENDS), more commonly known as e-cigarettes. In granting the marketing authorization, the FDA said “the potential benefit to smokers who switch completely or significantly reduce their cigarette use, would outweigh the risk to youth” provided the ENDS manufacturer, R.J. Reynolds, complies with the terms of the post-marketing requirements. (FDA Alert, Endpoints News, Associated Press – Washington Bureau)

Update on Commissioner search 2021

• Sources close to the White House told media this week that President Biden is likely to nominate Dr. Robert Califf to serve as FDA Commissioner. If nominated and confirmed, Califf would return to the position he held for about one year during the second Obama administration. Over the past ten months, Dr. Janet Woodcock has served as Interim FDA Commissioner. (POLITICO, Endpoints News, The Washington Post – full text below)

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Luke! It’s Darth Vader!

Hot Topics | October 8, 2021

Nestled among the leafy streets of Cathedral Heights in Northwest D.C. stands the stately Washington National Cathedral. If you visit the cathedral, you may encounter a famous father on your spiritual journey. We aren’t talking about the Heavenly Father, but the galaxy’s most notorious villain: Carved into the northwest tower of the world’s sixth-largest cathedral is the head of Darth Vader.

Lord Vader holds such a prominent perch upon a place of worship thanks to a boy named Christopher Rader. In 1980, the cathedral held a contest that allowed schoolchildren to design a sculpture to be incorporated into the cathedral’s renovations. Rader, who was in the third grade at the time, submitted a drawing of Darth Vader. As the winner of the third place prize in the contest, Rader’s drawing was incorporated into the cathedral’s renovations as a grotesque. (Since the carving of Darth Vader’s head is not used to drain water, architects refer to the design flourish as a grotesque instead of a gargoyle.)

Stick with us. You don’t have to look to a galaxy far far away for a roundup of public policy news:

NiXing Title X regulation

• On Monday, the White House revoked a Trump-era rule that prevented clinics from referring patients for abortions if they elected to receive federal funding for family planning. Title X supports healthcare facilities that offer infertility treatment, contraception counseling and routine cancer screenings to Americans with lower incomes. About a quarter of clinics who had previously received Title X funding, including Planned Parenthood, withdrew from the program when the rule was implemented in 2018. The rule is slated to be revoked on November 8. (The Hill, Axios, Roll Call)

Testing, testing, COVID-19 testing

• President Biden announced a $2 billion investment in rapid, at-home COVID-19 tests. The cash infusion will roughly quadruple the nation’s supply of tests by December, which is likely to be welcome news for the millions of Americans who must undergo frequent COVID-19 testing as part of efforts to reopen the country. The news will also likely be welcomed by the U.S. Senators who questioned the Secretary of Health and Human Services on why affordable, rapid tests were not widely available in the United States. (STAT, The Hill, POLITICO)
  • Read more: Earlier this week the Food and Drug Administration (FDA) authorized another rapid COVID-19 test. (FDA Press Release)

The difficult decision facing Democrats

• After Democrats reached an impasse on the size of their reconciliation package, the party is now looking to pare back the size of the $3.5 trillion bill to appease Senators Joe Machin (D-W. Va.) and Kyrsten Sinema (D-Ariz.). Representative Pramila Jayapal (D-Wash.), chairwoman of the Congressional Progressive Caucus (CPC), has said CPC lawmakers will accept a bill between $1.5 trillion and $3.5 trillion. The question now becomes what healthcare priorities are included and excluded from the bill. Some moderates have proposed introducing a “means test” that would make wealthy Americans ineligible for Medicare. Others have proposed “sunsetting” certain policies after three to five years as a cost-saving measure. (The Hill, POLITICO)

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