Month: March 2021

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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• This week the Centers for Disease Control and Prevention (CDC) announced they had identified and rescinded guidance documents released by the Trump administration that were “not grounded in science” and not “primarily authored” by CDC staffers.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)

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.