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What Happened, What You Missed: March 21-25

Moderna to Seek EUA for COVID-19 Vaccine for Children under Age 6

Moderna announced on Wednesday that it will ask the Food and Drug Administration (FDA) to grant emergency use authorization (EUA) for its COVID-19 vaccine “as soon as possible.” Moderna’s initial data demonstrated that the vaccine is 44% effective at preventing infection from the Omicron variant in children ages 6 months to under 2 years and about 38% effective for children 2- to 5-years-old. Importantly, none of the children who participated in the trial developed severe disease.  The announcement is promising news for parents of young children and toddlers who’ve been previously disappointed by setbacks on vaccine development for this age group.  It’s unclear when the FDA advisory panel will hold a meeting to discuss approving vaccines for children under age 6.

Fauci: Surge Unlikely Despite Uptick in Infections

According to recent data from the Department of Health and Human Services (HHS), COVID-19 cases have increased in nine states in the past 14 days, with the most growth in Arkansas, New York, and Connecticut.  The uptick in cases is largely driven by the more transmissible Omicron variant BA.2, which the Centers for Disease Control and Prevention estimates accounts for more than one-third of COVID-19 cases nationwide and more than half of cases in the Northeast.  Despite the growth of BA.2, nationwide COVID-19 cases still saw a 19% decrease over the past 14 days.  While White House Chief Medical Advisor Anthony Fauci has acknowledged that the more transmissible subvariant is likely to cause case numbers to grow and he believes another major surge resulting in high levels of hospitalization is unlikely.

Airlines Push Administration to Drop Mask Mandates

Leaders of 10 major commercial and cargo airlines sent a letter to President Joe Biden on Wednesday urging his administration to end the federal transportation mask mandate as well as pre-departure COVID-19 testing requirements for international flights.  According to the letter, declining hospitalization and death rates from COVID-19, the high level of immunity in the US, and the widespread availability of effective vaccines have rendered federal travel restrictions that were put in place two years ago unnecessary.  Several British airlines dropped mask mandates in the past few weeks, despite a recent rise in COVID-19 cases in the United Kingdom.  Current federal travel mandates are set to expire on April 18, and CDC is still reviewing how best to proceed.

HHS Doles Out $413 Million in New Provider Relief Fund Payments

On March 22, HHS announced more than $413 million in Provider Relief Fund payments to over 3,600 providers across the country.  This recent distribution is part of the fourth round of Phase 4 payments, which targeted  smaller providers that took on a higher percentage of financial losses during the pandemic.  To date, HHS has delivered $12 billion in Phase 4 funds to over 82,000 providers nationwide.  Providers will have until the end of June 2023 to use this latest round of payments.  Despite the additional payments, providers are still calling for more financial relief.  On Wednesday, LeadingAge sent a letter to congressional leaders urging $28 billion in additional Provider Relief Fund support citing continued  COVID-19 expenses on aging services providers.

ICYMI: Cherry Blossoms Hit Peak Bloom in DC

On Monday, Washington’s famous cherry blossoms hit peak bloom – the eighth earliest peak bloom since records were first taken in 1921.  Peak bloom is defined when 70% of the cherry trees’ buds are flowering. The March 21 peak bloom coincides with the National Cherry Blossom Festival, which runs this year from March 20 to April 17.  The cherry blossoms’ peak bloom is expected to pass this weekend due to cooler temperatures and windy conditions, so be sure to check them out before it’s too late.

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Can Lawmakers Pass Comprehensive Drug Pricing Reform This Year?

The White House is not giving up hope on Congress passing legislation this year to allow Medicare to negotiate on drug prices, according to a White House domestic policy advisor who spoke at  AHIP’s National Conference on Health Policy and Government Health Programs in March.  But if a recent Senate Finance Committee hearing is any indication, the odds of this proposal passing in Congress this year are slim to none.

A Brief History of Recent Drug Pricing Proposals

Allowing Medicare to negotiate with drug manufacturers on prices has been a cornerstone of Democrats’ drug pricing proposals for some time now.  Negotiation was a major health care provision of the Build Back Better Act and President Biden reiterated the need for negotiation in his State of the Union on March 1.

Republicans have never been receptive to negotiation over fears that it would amount to price controls and leave pharmaceutical companies with fewer resources to develop new drugs.  However, in 2019, there was a sense of cautious optimism that a bipartisan compromise on drug pricing policy could be reached. That year, Sens. Ron Wyden (D-OR) and Chuck Grassley (R-IA) introduced a sweeping bipartisan measure that would cap out-of-pocket drug costs under Part D once a beneficiary hits a certain threshold.  But this legislation fell apart after then-Senate Majority Leader Mitch McConnell (R-KY) said he had no interest in bringing the bill up for a vote in the Senate, prompting Wyden to withdraw his support.

The Drug Pricing Debate in 2022

As the 2022 midterm elections approach, many Democrats believe their window of opportunity to pass comprehensive drug pricing reform is rapidly closing.  Despite this, Democrats don’t seem to be in any mood to compromise.  During the March 16 hearing of the Senate Finance Committee, Democrats were unanimous in their support for lowering drug prices through negotiation, which the committee’s Republican members continually opposed.

Instead, committee Republicans including Ranking Member Mike Crapo (R-ID) voiced support for the Lower Costs, More Cures Act, which would establish an annual out-of-pocket cap of $3,100 for Medicare Part D enrollees – similar to the Grassley-Wyden bill – and allow certain patients to pay in monthly installments.  But Democrats on the Finance Committee didn’t seem interested in half-measures.  For instance, Wyden said out-of-pocket caps would simply “pass higher prices to someone else, like taxpayers.”

It’s not as if Democrats are completely opposed to the idea of price caps.  During the hearing, Sen. Raphael Warnock (D-GA) touted his bill to cap copayments for insulin at $35 a month – a proposal Biden endorsed in his State of the Union.  However, Republicans seem opposed to this stand-alone measure, even though it’s similar to the Lower Costs, More Cures Act provision that would make permanent the Center for Medicare and Medicaid Innovation model that enables Part D enrollees who take insulin to limit out-of-pocket costs to $35.  During the hearing, Sen. Pat Toomey (R-PA) suggested rising insulin costs over the years have contributed to “tremendous innovation” of insulin products.

What happens next? Warnock said he wants to get his insulin pricing cap bill to the Senate floor by Easter.  The chances of this bill passing don’t look good at the moment and barring a break in the logjam between Democrats and Republicans on negotiation, progress on overall drug pricing reform doesn’t seem likely, either.  Both parties seem entrenched on their preferred legislative solutions to tackle high drug prices to the point that relatively bipartisan proposals like the Grassley-Wyden bill of 2019 wouldn’t stand a chance in passing.

But if Congress can’t do it, maybe the administration can, according to some Democrats.  Seemingly having lost hope in Congress to deliver on major Democratic policy proposals, many Democratic lawmakers are urging President Biden to sidestep Congress and take whatever executive actions necessary to lower the cost of prescription drugs. (Ambien online)   On March 17, the Congressional Progressive Caucus issued a list of recommendations for executive action that includes drug pricing, among other issues.

However, the Biden administration has yet to comment on which specific actions it could take, and any new executive orders on drug pricing could be subject to change – either in the courts or by the next administration.   Therefore, any serious attempt at drug pricing reform this year may still only be through Congress, no matter how slim the odds may be.

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Congress’s Long-Standing History of Delaying Medicare Cuts

Medicare cuts are coming.  Automatic spending cuts like Medicare sequestration and PAYGO were initially put in place with the goal of reigning in federal spending, but time after time, Congress has delayed them to shield the popular health care program from payment cuts.  These cuts are nothing new – in fact, they’re part of a long-standing tradition that began with the Sustainable Growth Rate (SGR).

PAYGO and Sequestration: A Brief History

Two laws currently trigger mandatory cuts to Medicare if lawmakers pass legislation that adds to the deficit.  The first, the Statutory Pay-As-You-Go (PAYGO) Act of 2010, requires the president to implement spending cuts to mandatory programs like Medicare and farm support if the Office of Management and Budget (OMB) determines there is a deficit on six- or 11-year PAYGO scorecards.

The second law is the Budget Control Act (BCA) of 2011, which sets off across-the-board cuts to both mandatory and discretionary spending if spending exceeds explicitly set limits, or “caps.”  These cuts included a maximum 2% reduction in payments to Medicare providers known as Medicare sequestration.

However, Medicare is an incredibly popular program, with over 61 million beneficiaries.  Lawmakers are certainly sensitive to the political consequences of cutting funding to the popular federal health care program, which is why they’ve taken action to avoid automatic cuts as much as possible.  To date, neither the Medicare sequester nor the PAYGO cuts have ever gone into effect.

The SGR’s Precedent for Delaying Medicare Cuts

Congress’s strong tradition of delaying cuts to Medicare goes back to the SGR, which was implemented as part of the Balanced Budget Act of 1997.  The SGR created a formula that was intended to prevent Medicare spending growth for the Physician Fee Schedule (PFS) from exceeding GDP growth.  However, health care spending was continually outpacing GDP growth, making it clear that cuts to the PFS were inevitable.  To avoid the reimbursement cuts for physician services, Congress passed legislation to prevent the cuts from going into effect 17 times between 2003 and 2015.

The need for Congress to keep kicking the can down the road to prevent PFS cuts came to an end in 2015, when lawmakers enacted the Medicare Access and CHIP Reauthorization Act (MACRA).  It replaced the SGR formula with the Merit-Based Incentive Payments System (MIPS), which measures Medicare providers based on performance.  While MIPS hasn’t been without its faults, the new law means Congress no longer has to take action every year to address the SGR.

It’s worth noting the SGR is not the same as PAYGO and sequestration – while the former only impacted physician payment, the latter affects reimbursement to Medicare providers more broadly. However, both have negative implications for providers and patients if they’re carried out, which is why Congress has regularly prevented such cuts from going into effect.

Fortunately, Congress no longer has to deal with the SGR on an annual basis because after 15 years, lawmakers finally stepped up to pass legislation to make structural changes to the way physicians are paid.  Does that mean lawmakers will one day step up to make the structural necessary to stop kicking the can down the road every year with Medicare sequestration and PAYGO cuts?

Congress last took action to address the Medicare sequester and PAYGO when it enacted the Protecting Medicare and American Farmers from Sequester Cuts Act in December 2021.  The law waives a 4% PAYGO cut until 2023, and it imposes a moratorium on the Medicare sequester until April 1, when a 1% cut goes into effect.  In July, the Medicare sequester then increases to 2%.

While structural changes to address Medicare sequestration and PAYGO are possible, Congress is more polarized now than it was when passed MACRA seven years ago, leaving little room to pass comprehensive legislation to reform the budgeting process.  Additionally, the BCA and the PAYGO Act are far more complex than the legislation that eventually replaced SGR and would require significantly more effort for lawmakers to advance.  Therefore, until there’s widespread agreement among both parties on how to reform Medicare’s payment system, the near-annual ritual of delaying Medicare cuts is likely to continue to for some time.

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What Happened, What You Missed: March 14-18

Ashish Jha to Replace Jeff Zients as White House COVID-19 Task Force Chair

On Thursday, President Joe Biden announced that White House Coronavirus Response Coordinator Jeff Zients will step down from his post next month.  President Biden also announced that Zients’ replacement will be Ashish Jha, dean of the Brown University School of Public Health and a practicing physician.  Jha has served as an outside advisor for administration officials over the past several months, particularly on the development of the new COVID-19 roadmap that was released earlier this month.  Zients’ departure comes at a time when case numbers have plummeted since the start of the Omicron wave and the administration forges ahead on a new strategy that focuses on living with the virus.

Pfizer, Moderna Seek EUA for Second COVID-19 Booster Shot

This week, both Pfizer and Moderna submitted applications to the Food and Drug Administration (FDA) for an emergency use authorization (EUA) for a second booster dose of their respective COVID-19 vaccines.  While Pfizer is specifically seeking an EUA for adults over age 65, Moderna is requesting an EUA for anyone over 18 years of age.  However, Pfizer noted in press release that it’s currently conducting a clinical trial in Israel for health care workers aged 18 years or older who have already received three doses of the company’s COVID-19 vaccine.  The submission of both applications comes days after Pfizer CEO Albert Bourla said a fourth vaccine dose will probably be needed for everyone.

White House Urged Congress to Provide Additional COVID-19 Relief Funding

The Biden administration is pushing for Congress to pass legislation to provide more funding for COVID-19 after lawmakers nixed $15.6 billion in COVID-19 funding from the Fiscal Year (FY) 2022 omnibus appropriations bill due to disagreements over how the additional funds would be paid for.   Without additional funding, the administration warns that it will soon have to wind down federal subsidies that guarantee free COVID-19 treatments for patients like oral antivirals and monoclonal antibodies.  Additionally, administration officials are fearful that a lack of additional funding would mean the government may not be able to supply enough booster doses and antivirals in the event of another surge in cases.  The stalemate over COVID-19 funding comes as public health officials worry that an uptick in COVID-19 cases in Europe could indicate cases number may soon begin to rise again in the US.

Nashville, Milwaukee Are Finalists to Host the 2024 GOP Convention

The Republican National Committee (RNC) has narrowed down its list of possible locations for its 2024 convention to two cities: Milwaukee and Nashville.  Pittsburgh and Salt Lake City were initially in the running, although the latter was dropped because its main arena will be undergoing renovations in 2024.  If selected, Milwaukee would be the first city to host back-to-back conventions since New York City hosted the Democrats’ conventions in 1976 and 1980.  The Democratic National Committee held its virtual national convention in Milwaukee for 2020.  A final decision regarding the location of the Republicans’ 2024 convention is expected by August.

ICYMI: Smithsonian Vetting Locations for Two New Museums The Smithsonian is currently considering 24 potential sites for two new museums that Congress approved in its FY 2021 omnibus appropriations bill: the National Museum of the American Latino and the Smithsonian American Women’s History Museum.  While the spending bill lists fours potential sites near that National Mall that could be used for either museum, the final decision on where to break ground will be up to the Smithsonian Board of Regents.   Consultants are working with the Smithsonian to find potential sites; however, a lack of available, empty land near the National Mall means other potential locations are in play, like the Corcoran Gallery of Art building, the J. Edgar Hoover Building, and L’Enfant Plaza.

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For the 2022 Midterms, the GOP’s Future Is Female

Republicans are favored to do well in the 2022 midterm elections – after all, the party that occupies the White House historically almost always loses seats in Congress.  But Republicans don’t just want to rely on tried-and-true historical trends to win more seat this fall.  Instead, they’re focused on replicating a strategy that delivered better-than-expected gains for 2020 – supporting female candidates for congressional seats.

The 2018 midterms marked a low point for female Republican lawmakers, especially in the House.  That year, the number of GOP women holding House seats declined from 23 to 13 – which was the same number of Republican women serving in the House in 1989.  In contrast, 2018 saw 36 new Democratic women elected to the House.

To reverse the trend, Republicans adopted a new strategy: support GOP women running at the primary level.  Numerous organizations and political action committees (PACs) like Republican Women for Progress, Elevate PAC, Winning for Women, VIEW PAC, and Elise Stefanik’s E-PAC stepped up to offer their support, based on how the Democrats used Emily’s List to back their female candidates.  Additionally, more GOP women opted to run in 2020, probably in reaction to Democrats’ success in 2018.

Issues matter, too.  With more and more college-educated men and women increasingly voting for Democratic candidates, many of the Republican women who ran for Congress in 2020 focused less on typical pro-business, main street policies that typically won over moderate voters.  Instead, they focused more on issues related to gun control and abortion that are more popular with the Republican Party’s base.

The new strategy paid off.  The number of GOP lawmakers in the House rose from 23 to 38 in the House after November 2020, beating the previous record high of female Republican representatives of 30.  In contrast, the number of Democratic female lawmakers grew from 89 to 106.  More so, every Republican who flipped a Democratic House district in 2020 was a woman or person of color.  There are now 144 women who are  members of the 117th Congress, compared to 127 in the 116th Congress

Based on the GOP’s success in 2020, the Republican Party is now trying to replicate its strategy of supporting female candidates to regain control of Congress this November.  According to the National Republican Congressional Committee, a record high number of 253 female Republicans have filed to run for House seats, with key recruits in competitive districts like Monica De La Cruz (Texas), Esther Joy King (Illinois), and Jen Kiggans (Virginia).  Additionally, Republicans are also keen on keeping female freshman of the 117th Congress in their seats.

There are many factors that will affect the midterm elections, like the state of the economy and President Biden’s approval ratings.  However, given historical trends favoring Republicans and the success of Republican women in the 2020 elections, the GOP may have found a winning combination to ensure success in 2022.  And with the Senate split 50-50 and Democrats only having a five-seat majority in the House, it won’t take much for a record high number of female Republican candidates to move the needle and shake up Congress this fall.

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