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Policy News

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 17th). 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  • This week the Centers for Disease Control and Prevention (CDC) announced they had identified and rescinded guidance documents released by the Trump administration that were “not grounded in science” and not “primarily authored” by CDC staffers.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 Postfull 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 YourTeam@goodfuse.com 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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Policy News

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 YourTeam@goodfuse.com 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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Policy News

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 YourTeam@goodfuse.com 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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Policy News

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). (POLITICOThe 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 HillSTATAxios)

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. (POLITICOThe 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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Leading Thinking

The Quest for Truth

It’s now a year since the novel coronavirus first arrived in the United States. As we look back at 2020 and move further into 2021, we ask the question of whether the media has done its job getting accurate information to the American public during the worst public health crisis in modern history. As communications professionals, perhaps the more important question we need to ask ourselves is: did we do our job to be a resource they can trust or did we just add to the noise, creating potential more confusion and even distrust?

The only beat in 2020 was healthcare.

Mainstream media in the U.S. completely turned on its axis in February 2020. Regardless of their beat, every reporter essentially became a healthcare journalist. National and local reporters were assigned coronavirus stories without any foundational knowledge of science, medical information or how the healthcare and pharmaceutical industry operated. Not to mention, this was a novel virus and even trusted sources didn’t have all of the answers. However, there was really no room for error if you wanted to build trust. It was incumbent upon the press to get it right. The media were almost becoming a public health agency in their own right.

Journalists for the most part understood the weight of this responsibility. We saw some of them leaning on biotech and health trades to get up to speed fast. However, the sheer volume of information put news directors and editors in the position of having to choose speed over accuracy. The pressure to break COVID-19 related news first also at times sacrificed in-depth coverage that would have clarified a lot of misconceptions. Additionally, many news outlets found themselves relying on the same sources over and over again simply because there wasn’t time to explore other expert opinions. There were so many gaps in knowledge. While it is the job of the press and their expert sources to talk about what they know, rarely do they openly say what they don’t know simply due to the dynamic of reporting the facts as they are in the moment.

This brings us to the issue of trust.

Trust is critical when you’re communicating medical information. It has been argued and data shows that Americans started losing trust in the media before the pandemic even started. News has been highly editorialized and politically charged. Growing consumption of opinion-based journalism and increased reliance on social media for facts has led to increased confusion and distrust.

Americans craved reassurance and guidance from outlets they could trust during this difficult time which required consistent and accurate communication. There was a lot of “noise” which became confusing to the American public. As information about coronavirus evolved, many articles written earlier in the year were proven to be inaccurate. We forgive the press for this as the global community kept learning about this virus on the fly and information was constantly evolving. The volume of breaking news was relentless in 2020 and newsrooms were so overwhelmed that it became difficult to properly vet new sources and question existing ones. Additionally, we still wonder if the news media was going deep enough. Were reporters not asking the right questions or in some instances could it also be they just didn’t know the questions to ask?

Moving forward and focusing on facts.

Facts are critical when disseminating scientific information but what do you do in an America where everyone is questioning what the truth even is? As healthcare communications professionals, we also have to question the impact of politicizing medical information and how we navigate this landscape with a new President and a new Congress in 2021.

The good news is America has a growing appetite to now understand science which presents a golden opportunity for the healthcare industry. As a result of the speed of getting the coronavirus vaccine to market, people are going to start asking more questions about why cancer hasn’t been cured or why Parkinson’s research hasn’t progressed. COVID-19 has lit a spark for the exploration of science. Medical advances like the mRNA vaccines have a good shot at leading major medical breakthroughs in other disease categories. As healthcare communications professionals, we look forward to witnessing the new wave of innovation in biotechnology and paving the way for telling powerful stories in the next era of modern medicine. To do that successfully, we as healthcare PR pros have to acknowledge the fragility of trust and take on the same burden of responsibility as the news media to get it right when communicating scientific information at a time when American lives depend on it.

Jenifer Slaw is Senior Vice President of Media Relations at Goodfuse Communications