In this final installment of “That Said”, Ariel Gonzalez discusses how best to execute a policy meeting when managing a coalition. The video covers key topics to include how to identify who will be speaking at the meeting, how to leverage principals, and how to best get your policy points to be heard during the meeting.
Administration Declares Monkeypox a Public Health Emergency
On Thursday, Health and Human Services (HHS) Secretary Xavier Becerra declared a public health emergency over the monkeypox outbreak, giving federal agencies access to emergency funding and other resources for efforts to fight the virus’ spread. Becerra is also considering a second declaration that would enable the Food and Drug Administration to issue emergency use authorizations for medical countermeasures like treatments and vaccines. So far, over 616 cases detected in the US, although that total is likely an undercount. Most cases in the US are concentrated in the gay and queer community, primarily among men who have sex with men.
Administration Releases National Research Plan on Long-COVID
The Biden administration released on Wednesday a national research plan outlining a government-wide agenda focused on improving prevention, diagnosis, treatment, and provision of services for people experiencing long-COVID. To meet the administration’s objectives, the research plan directs HHS to issue two reports within 120 days laying out an “actionable path forward” to address long-COVID and associated conditions. The administration also issued a report outlining services and supports for long-COVID patients and as well as resources for individuals confronting challenges related to mental health, substance use, and bereavement. According to a press release, the administration estimates that nearly one million Americans may be out of the workforce at any given time due to long-COVID, which equates to roughly $50 billion in lost earnings annually.
CMS Finalizes 4.3% Payment Increase for Inpatient Services in FY23
Medicare payments for hospital inpatient services will get a 4.3% boost in Fiscal Year 2023, according to a final inpatient prospective payment system (IPPS) rule released on Monday. The final rule also carries out the administration’s focus on health equity by adding health equity-focused measures to hospital reporting programs like the Hospital Inpatient Quality Reporting (IQR) Program. Among other provisions, the rule finalizes proposals to create a “birthing friendly” hospital designation, continue COVID-19 reporting requirements for hospitals, apply a budget-neutral 5% cap on any decrease to a hospital’s wage index from the prior fiscal year, and make prescription drug monitoring program queries mandatory under the Medicare Promoting Interoperability Program.
ICYMI: National Air and Space Museum to Partially Reopen in October
Since March, visitors to the Smithsonian museums in Washington, DC haven’t had the opportunity to view the Apollo 11 command module or the Spirit of St. Louis. That will change on October 14 when the National Air and Space Museum partially reopens to the public following a lengthy renovation period. In anticipation of strong interest, the museum will be requiring free timed entry passes that will be available on September 14. Come October 14, visitors to the museum will have the opportunity to see eight new exhibits, including ones on the Wright brothers and the planets of the Solar System.
The long 2022 primary season isn’t over yet. Starting today, 15 states will hold primary elections over the next 30 days, and the results of some races will be more impactful than others. By the beginning of September, American voters are sure to have a clearer idea of the importance of political dynasties, and more importantly, how much influence former President Donald Trump wields over the GOP electorate.
Michigan Democrats: Levin v. Stevens (August 2)
Michigan lost a congressional seat in the 2020 Census. The state’s new congressional map is the product of an independent commission, and while the commission has been successful in avoiding partisan gerrymandering, it wasn’t enough to stop a race between two incumbents. Both Rep. Andy Levin (D-MI) and Rep. Haley Stevens (D-MI) could have opted to run in the new 10th Congressional District, which leans slightly Republican and contains suburban communities northeast of Detroit. But instead, both Democratic incumbents chose to seek reelection in the 11th Congressional District, which features a more Democratic-leaning electorate in the suburb’s northwest of Detroit. While Levin resides in the new district, Stevens’ current district includes much of the new one she’s running in.
Both Levin and Stevens first entered Congress at the start of 2019, meaning they have been incumbents for the same length of time. However, Levin has one possible advantage in the form of name recognition. His father, Sander Levin, served in the House before retiring in 2019, and his uncle, Carl Levin, served in the Senate from 1979 to 2015.
Missouri Republicans: Greitens v. Schmitt (August 2)
Eric Greitens was elected Governor of Missouri in 2016, but he resigned in 2018 following allegations of sexual misconduct and violations of campaign finance laws. Having secured Trump’s endorsement back in 2016, Greitens threw his hat in the ring as a Trump-friendly candidate in the 2022 Republican primary to replace the retiring Sen. Roy Blunt (R-MO) amid a crowded field consisting of Missouri Attorney General Eric Schmitt, Rep. Vicky Hartzler (R-MO), and Rep. Billy Long (R-MO). While Trump has yet to formally endorse a candidate in the race, he has positively commented on Greitens as recently as July 8. However, Greitens’ initial lead in the polls seems to have has fallen after allegations of domestic abuse became public and the release of a controversial ad about hunting “Republicans-in-name-only,” or RINOs.
Currently, one poll has Greitens in third place behind Schmitt and Hartzler, while another has all three candidates tied for first. As voters in Missouri head to the polls, many Republicans including members of the former president’s inner-circle are currently divided over whether to support Greitens or Schmitt. However, given Trump’s 15-point victory margin in Missouri two years ago, whichever GOP Senate candidate prevails on Tuesday is all but certain to win in November.
Arizona Republicans: Brnovich v. Masters (August 2)
Arizona State Attorney General Mark Brnovich led the polls for months as the Republican candidate in the primary race for the Senate. However, Brnovich began to lose ground after former President Trump criticized the attorney general for not supporting him during the 2020 election audit of Maricopa County. In June, Trump endorsed Blake Masters, bringing the 35-year-old venture capitalist to first place in the polls. A critic of the validity of the 2020 presidential election, Masters has been also questioning whether the results of the 2022 midterm election will be legitimate, which some Republicans worry could backfire and dissuade some GOP voters from showing up at the polls this November. Whoever secures the Republican Primary will take on freshman Sen. Mark Kelly (D-AZ) this fall in a race that the Cook Political Report currently rates as a “toss-up.” But the nomination of a hardcore Trump loyalist and election skeptic like Masters to the GOP ticket could turn off moderate and independent voters, leaving Kelly with a slight edge in November.
Wyoming: Cheney v. Hageman (August 16)
Rep. Liz Cheney (R-WY) was a rising star in the Republican Party, having been elected House GOP Conference Chair in August 2019. However, Cheney lost her leadership position in May 2021 after drawing the ire of House Republicans for her criticism of former President Donald Trump. Since then, Cheney has only doubled down on her criticism of Trump by serving as the Vice Chair of the January 6th Committee.
Wyoming voters picked Trump over then-candidate Joe Biden in 2020 by a 40-point margin, so it’s no surprise that Cheney is trailing the Trump-endorsed attorney Harriet Hagemen by nearly 20 points in the GOP primary. Cheney’s current situation is a sharp contrast from 2020, when she won reelection with 70% of the vote. Cheney could theoretically find a narrow pathway to victory if she secures the votes of independents and Democrats over the coming days, but a landslide loss would mean the former president is still capable of commanding influence in states that strongly lean red.
The Rest of Primary Season
After August 31, only four states have primaries left: Massachusetts’ primary is scheduled for September 6, while Delaware, New Hampshire, and Rhode Island have their primary elections on September 13. Given the number of consequential primaries in August, however, voters won’t have to wait until the end of the month to get a sense of what the midterm election in November will look like – and how much of an influence the former president has on the GOP.
Administration Mulls Additional Boosters as Part of BA.5 Strategy
Biden administration officials are considering whether to allow all US adults to receive a second COVID-19 booster as part of a broader strategy to lessen brunt against a BA.5 wave this summer. Currently, only adults over age 50 are eligible for a second booster, as well as individuals 12 years of age or older who are immunocompromised. While some administration officials say a second booster would provide additional protection against hospitalization and death, others are concerned about the limited data on the benefits of an additional booster and warn too many boosters of the same vaccine could prevent the immune system from adapting to new variants. While discussions on a second booster continue, any final decision would be up to the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC). On Tuesday, White House Coronavirus Response Coordinator Ashish Jha told reporters that if FDA and CDC officials sign off on a second booster, individuals who receive it will still be eligible for Omicron-specific boosters this fall.
FDA Approves Novavax’s COVID-19 Vaccine for Emergency Use
On Wednesday, the FDA issued an emergency use authorization (EUA) for Novavax’s COVID-19 vaccine for individuals 18 years of age and older. . Unlike the mRNA vaccines from Pfizer and Moderna, Novavax’s vaccine utilizes a more traditional protein-based model that may be more appealing to people who are skeptical of new mRNA technology or are allergic to the components of mRNA vaccines. The Biden administration has already purchased 3.2 million doses from Novavax in anticipation of the EUA. Novavax shots could become available as soon as next week, after Centers for Disease Control and Prevention (CDC) advisory panel convenes on July 19 to vote on whether to recommend the vaccine.
New National Suicide Hotline Goes Live This Weekend
The new 988 mental health hotline is schedule to go live on Saturday, replacing the 800-273-TALK National Suicide Prevention Lifeline network that was launched in 2005. For the past few months, the Department of Health and Human Services (HHS) has been providing states millions in dollars of funding to ensure their crisis call centers are adequately staffed. However, both federal and state officials are concerned that some states will be unable to handle a high volume of incoming calls once the new hotline is live. While some states have fully staffed call centers that operate 24/7, others rely on volunteers and are forced to route their calls out-of-state when incoming call volume is high. Additionally, many states have encountered challenges requesting permanent call center funding from their state legislatures due to the difficulty of predicting long-term demand.
House Aims to Approve FY23 Spending Bills by August
The House is hoping to pass all 12 of its Fiscal Year (FY) 2023 appropriations bills before August, according to House Appropriations Committee Chairwoman Rosa DeLauro (D-CT). Next week, the House is schedule to vote on a package to fund six accounts (Transportation-HUD; Agriculture; Energy-Water; Financial Services; Interior-Environment; and Military Construction-VA), with votes for three of more spending bills expected for the week of July 25. However, disagreements between both parties on abortion access and closing the Guantánamo Bay detention facility threaten to thwart DeLauro’s goal of finishing all spending bills before August recess. Meanwhile, Senate appropriators are awaiting a bipartisan, bicameral topline agreement before introducing their own FY 2023 spending bills.
ICYMI: House Votes to Make It Easier to Report UFOs
The House voted Wednesday to create a secure government system for reporting unidentified flying objects (UFOs) via a bipartisan amendment to the National Defense Authorization Act (NDAA). Reps. Ruben Gallego (D-NM) and Mike Gallagher (R-WI) proposed the amendment to offer a way for military and intelligence officials to discreetly report UFOs without fear of stigma or reprisal. Gallego said that gathering more reports on UFO sightings is important from a national security standpoint because it will ensure the military has the best possible intelligence. Of note, the amendment would allow people bound by non-disclosure agreements to submit reports on UFOs.
FDA Wants COVID-19 Boosters to Target Omicron Subvariants
The Food and Drug Administration (FDA) told drug manufacturers on Thursday that any new COVID-19 vaccines to be used in a fall booster campaign should be tailored to target the Omicron BA.4 and BA.5 subvariants as well as the original COVID-19 strain in order to provide the broadest possible level of protection. The agency’s proclamation follows Wednesday’s announcement that the administration has reached an agreement with Pfizer to purchase 105 million vaccines doses for a fall booster campaign. In a press release, Pfizer announced that its updated doses are planned to be delivered as soon as late summer 2022. While it remains possible that BA.4 and BA.5 will be overtaken by newer subvariants by fall, scientists and regulators are hopeful that the new shots will provide much better protection against symptomatic infection than the vaccines that are currently available.
Health Sector Leaders Commit to Halve Carbon Emissions
61 of the largest US hospital and health sector companies signed on to a Biden administration agreement to reduce greenhouse gas emissions by 50% by 2030. Known as the Health Sector Climate Pledge, the agreement calls private entities in the health care sector to mitigate the effects of climate change and increase their climate resilience. Major commitments include two of the five largest US private hospital and health systems, Ascension and CommonSpirit Health, large drug manufacturers like Pfizer and AstraZeneca, and major associations like the America’s Essential Hospitals and the American Association of Medical Colleges (AAMC). According to the White House, the health care sector contributes 8.5% of the total US carbon emissions.
White House Lays Out Monkeypox Vaccination Strategy
The Department of Health and Human Services (HHS) will send nearly 300,000 vaccines over the next few weeks as part of a new monkeypox outbreak response strategy announced Tuesday. The administration is immediately providing 56,000 doses from the National Strategic Stockpile (NSN) to communities most at-risk of monkeypox, with a combined 1.6 million doses expected to become available over the next few months. The Centers for Disease Control and Prevention (CDC) has counted about 300 cases of monkeypox nationwide, although the actual number is estimated to be much higher. The virus has been disproportionately spread among men who have sex with men, although health officials stress that everyone should be informed on the risks of the virus.
Ketanji Brown Jackson Sworn In as Newest SCOTUS Justice
Ketanji Brown Jackson was sworn in as the 116th Supreme Court justice on Thursday, making her the first Black woman to serve on the high court. A federal judge since 2013, Jackson is now the fourth woman serving on the nine-member court – the highest number of female justices ever to serve concurrently. President Joe Biden initially nominated Jackson in February as his choice to relace outgoing Justice Stephen Breyer, who formally announced his retirement in a letter on Wednesday. Justice Jackson will have to decide on a number of consequential cases next term regarding affirmative action, religious freedom, and independent legislature theory.
ICYMI: Smithsonian Folklife Festival Returns to National Mall
If you’re in Washington, DC over the long weekend, there’s more to do than just watch fireworks. The Smithsonian Folklife Festival returned to the National Mall last week after two years of virtual events. Visitors will have until Monday, July 4 to catch this year’s festivities, which explore the culture of the United Arab Emirates. Over the weekend, festivalgoers will have the opportunity to make their own fragrance, learn about the symbolism of henna, craft their own pottery, and cook slabs of marinated goat or lamb.
CDC Advisory Committee Poised to Vote on Vaccines for Toddlers
The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) is likely to vote to recommend Pfizer and Moderna’s COVID-19 vaccines for children six-months to four-years old today or tomorrow. A recommendation from ACIP and sign-off from CDC Director Rochelle Walensky means toddlers could get start getting their shots as soon as Tuesday, June 21, marking the culmination in a long and often delayed process to approve vaccines for the youngest Americans. The ACIP vote will follow Wednesday’s unanimous vote by a Food and Drug Administration (FDA) advisory committee to recommend authorizing both companies’ vaccines for young children.
During the FDA meeting, some advisors voiced concern that the different dosage regimens for the two vaccines could confuse parents. While Moderna’s vaccine requires two doses over a five-week period, Pfizer’s requires three doses over 11 weeks. However, Pfizer’s vaccine is 80% effective in preventing symptomatic disease from the Omicron variant, while Moderna’s is 50% effective in kids six months to two years and 37% in kids ages 2 to 5.
New EO to Offer Health Care Protections, Access for LGBTQI+
The Department of Health and Human Services (HHS) will now be able to deny funding to programs that offer conversation therapy for lesbian, gay, bisexual, transgender, queer, and intersex (LGBTQI+) Americans, according to an executive order signed on Wednesday. The order also directs HHS to issue a “Bill of Rights for LGBTQI+ Older Adults,” expand youth access to suicide prevention resources, and bolster non-discrimination practices for LGBTQI+ children in foster care. The EO is likely a response to newly enacted laws in Texas and Florida that limit access to gender-affirming care for minors. Upon signing the EO, President Joe Biden urged Congress to pass the Equality Act, which would prohibit discrimination based on gender and sexual identity. Some Republican-controlled states are expected to initiate legal challenges against the EO.
SCOTUS: 340B Payment Cuts to Hospitals Are Unlawful
HHS does not have the authority to change 340B reimbursement rates without gathering data on what hospitals pay for outpatient drugs, according to a unanimous Supreme Court ruling issued on Wednesday. A district court initially ruled that HHS lacked the authority to cut Medicare payment for 340B drug by nearly 30% in 2018. However, an appeals court disagreed, arguing HHS could reduce payment without first obtaining the necessary data. In its opinion, the high court ruled that HHS’ power to change reimbursement to hospitals is distinct from its ability to set different rates, and that the department can’t offer different rates for hospitals without first conducting a survey. The court’s decision only applies to cuts in 2018 and 2019, although lawsuits are currently pending for cuts in 2020, 2021, and 2022.
Pelosi: Reconciliation Package Alive, but May Not Include Enhanced Premium Subsidies
Speaker Nancy Pelosi (D-CA) told reporters on Thursday that talks continue on a budget reconciliation legislation that address climate change and social issues. However, Pelosi noted that the legislation may not include an extension to the Affordable Care Act (ACA) premium subsidies, which are set to expire at the end of the year. If Congress fails to renew subsidies anytime soon, 13 million Americans currently receiving the subsidies would start receiving notices about pending premiums increases in October – just weeks from the midterm election. While House Democrats have been urging party leaders in the Senate to reach a filibuster-proof deal to avert sharp premium rate hikes, a deal remains elusive. Recently, Sen. Joe Manchin (D-VW) has been so far non-committal on whether enhanced subsidies should be included in a reconciliation bill, instead focusing on lowering prescription drugs.
ICYMI: Aggressive Wild Turkey No Longer a Threat on DC Trails
Visitors enjoying the Anacostia Riverwalk Trail in Washington, DC can rest easy knowing that they no longer face the threat of an aggressive wild turkey that attacked several people over a three-month period this spring. After multiple attempts at finding the bird, local park rangers say they haven’t heard of any attacks or sightings in a few weeks. Wildlife experts say the turkey may have wandered to a more remote location or “settled down” now that the springtime breeding season is over.
The Advanced Research Projects Agency for Health (APRA-H) has come a long way since the Biden administration first proposed a new biomedical research agency back in April 2021. Since then, Congress and the administration have started laying the foundation for the new agency. The Fiscal Year (FY) 2022 appropriations omnibus provided $1 billion in funding for the nascent agency and directed the president to appoint an ARPA-H director. In congressional hearings last spring on the administration’s FY 2023 budget request for the Department of Health and Human Services (HHS), Secretary Xavier Becerra offered a few more details, like the administration’s preference to make ARPA-H a part of the National Institutes of Health (NIH).
There are still more questions than answers about what ARPA-H could one day look like. However, more details have come into focus in recent weeks as authorizing legislation for ARPA-H progresses through Congress and the administration makes new decisions about ARPA-H personnel.
A New Acting Deputy Director
While the search for a permanent director remains under way, the administration has at least made headway in naming a temporary member of the new agency’s leadership team. On May 25, HHS Secretary Becerra appointed Adam H. Russell, DPhil, to be ARPA-H’s acting deputy director. With experience managing research projects at the Defense Advanced Research Projects Agency (DARPA), Russell is tasked with building out the administrative structure of the new agency and hiring initial staff until the president appoints a permanent director. It remains unclear if Russell is under consideration for a permanent role either as director or deputy director.
The ARPA-H Director: Appointment or Confirmation?
When the administration finally taps someone to permanently lead ARPA-H, will the appointment require Senate confirmation? Recently, Rep. Anna Eshoo (D-CA) revised her ARPA-H authorizing legislation to require the Senate to confirm the ARPA-H director. The Senate’s legislation on ARPA-H and previous versions of Eshoo’s bill did not address whether the individual appointed by the president would require confirmation. The House is set to vote on the bill during the week of June 20, while a Senate panel already approved its ARPA-H bill in March.
The Continued Debate over Placement within NIH
To date, the question of whether APRA-H should be an independent agency within HHS or a part of the organizational structure of the National Institutes of Health (NIH) remains unsettled. The Senate’s legislation aligns with the administration’s preference of placing the new agency within NIH, which Becerra explained over multiple congressional hearings would allow ARPA-H to focus on developing breakthroughs from day one by delegating administrative functions to the parent agency. However, Eshoo and other lawmakers have been firm in their stance that ARPA-H must be independent to successfully carry out its mission, and her bill maintains this position.
Where Will the ARPA-H Headquarters Be?
While certain lawmakers and the administration have yet to agree on whether the Senate should confirm the ARPA-H director and the placement of e the organization, there is a universal agreement that the new biomedical research agency should not be physically located on the NIH campus in Bethesda, Maryland. Over the past few months, several states have been jockeying to be selected as the home base for the new agency. Members of the Texas and Massachusetts congressional delegations have recently sent letters to the administration urging their states to be considered as the location for ARPA-H due to their existing infrastructure in medical research and life sciences.
In Massachusetts, business and academic leaders have joined public officials on efforts to lure ARPA-H to the Bay State. Several members of the Ohio congressional delegation are also urging the administration to select Cleveland as the new ARPA-H home, and other states vying for the headquarters include California, North Carolina, and Maryland. However, the administration has yet to announce a timeline for its headquarters selection process or provide any details on how a location will be chosen.
When Will We Know More about ARPA-H?
Once the House votes on ARPA-H legislation during the week of June 20, stakeholders will have to keep an eye on the Senate. While minor differences around the provision of whether the Senate confirms the ARPA-H director seem reconcilable, other issues like whether to place ARPA-H within NIH will continue to garner significant debate. Until a final agreement can be reached, further details on ARPA-H will probably be sparse, as the administration will likely hold off on major announcements on items like personnel and a headquarters location until legislation is close to the finish line.
White House: Kids under 5 Could Get Vaccinated as Soon as June 21
COVID-19 vaccinations for children under age five could start as soon as June 21, said White House COVID-19 Response Coordinator Ashish Jha on Thursday. The Food and Drug Administration (FDA) is likely to approve Moderna and Pfizer’s vaccines for young kids after the agency’s vaccine advisory committee meeting on June 15, with the Centers for Disease Control and Prevention (CDC) issuing its recommendation shortly thereafter. Jha said the administration will initially make 10 million doses of Pfizer and Moderna vaccines available to the states, and while the vaccination program is expected to take some time to ramp up, Jha expects that every parent should be able to schedule an appointment within weeks of approval. According to an April 2022 poll from the Kaiser Family Foundation (KFF), 18% of parents say they will get their children under five vaccinated as soon vaccines become available, while 38% said they would “wait and see” before deciding.
CMS to Lower Part B Premiums in 2023
The Centers for Medicare and Medicaid Services (CMS) announced last Friday that seniors can expect lower Medicare Part B premiums for 2023. The announcement follows a recent review of Part B premiums that determined CMS had overestimated the cost of Aduhelm, an expensive Alzheimer’s drug, in calculating its 2022 premiums. In November 2021, CMS announced a 14% increase in Part B premiums – one of the highest ever increases – from $148.50 a month to $170.10. However, Biogen made the surprise decision to lower its list price for Aduhelm in December 2021, setting the stage for CMS to subsequently review how the agency was pricing the Alzheimer’s drug. CMS ultimately determined to lower Part B premiums in 2023 because it would have been too difficult to lower premiums or reimburse seniors mid-year.
Senate HELP Committee to Mark Up FDA User Fee Bill on July 8
The Senate Health, Education, Labor, and Pensions (HELP) Committee scheduled a markup for its bipartisan FDA user fee bill on June 8. Initially released on May 27, the HELP Committee’s user fee bill includes several provisions that would improve the FDA’s oversight of cosmetics and dietary supplements, enhance regulation of laboratory-developed tests (LDTs), and reform the agency’s accelerated approval pathway. The House Energy and Commerce Committee advanced its own FDA user fee reauthorization measure on May 18. While the House bill has many commonalities with the Senate bill like changes to the accelerated approval pathway, it lacks the Senate bill’s provisions on LDTs and cosmetics and dietary supplements.
Medicare Trustees Report Shows Slightly Improved Outlook
According to the Social Security and Medicare Board of Trustees report released on Thursday, the Hospital Insurance (HI) Trust Fund for inpatient care will be unable to pay full benefits starting in 2028, two years later than reported last year. However, the trustees warned that the HI Trust Fund still faces long-term financing shortfalls, thus necessitating “significant changes” to Medicare financing. The trustees also concluded that the COVID-19 pandemic will not have any long-term effect on Medicare spending. If the HI Trust Fund does become insolvent, the report projects that the program would be able to pay 90% of expected costs in 2028.
ICYMI: DC Gets Ready to Celebrate the Queen’s Platinum Jubilee
This month, Queen Elizabeth II is celebrating her platinum jubilee, which marks her 70th year on the throne as head of state of the United Kingdom. Over the next few days, people in the Washington, DC area will have opportunities to join the British people in celebrating Her Majesty’s historic milestone. Aside from an invite-only party hosted by the British embassy, the Fairmont in Georgetown will host a jubilee celebration on June 8, and the British Officers Club of Washington, DC will host a garden party with food and games at Lloyd House in Alexandria on June 18. Meanwhile, numerous British pubs and restaurants like The Queen Vic and Brixton DC will host their own events throughout the upcoming weekend.