There are more than 100,000 people awaiting an organ with a new person added to the list every eight minutes, according to HHS.

A congressional committee will review the overhauling of the U.S. transplant system a year after it was ordered in law.

The House Energy and Commerce Oversight and Investigations Subcommittee will hold a hearing on Sept. 11, focusing on how successfully the federal government has implemented the law to reform the system.

Years of bipartisan congressional inquiry uncovered mismanagement in the organ transplant system, which has been run by a single nonprofit contractor since the 1980s.

Last September, President Joe Biden signed a law to decentralize the organ transplant network, restructuring the system into manageable parts. That allowed different entities to oversee certain functions of the system, and the appointment of a new board of directors. Just last week, the Biden administration awarded its first contract to a nonprofit to oversee the election of a new board of directors.

There are more than 100,000 people awaiting an organ with a new person added to the list every eight minutes, according to HHS. As POLITICO has reported, the reform has hit snags in recent months as members of Congress, the federal government and providers have sparred over oversight. Some of the questions revolved around how big a role the federal government should have and whether people who were involved in the previous setup should continue to work in the new one.

“Unfortunately, for years the organ transplant system has been hampered by inefficiencies, mismanagement, and risks to patient safety,” Committee Chair Cathy McMorris Rodgers (R-Wash.) and subcommittee chair Morgan Griffith (R-Va.) said in a statement. “This hearing will provide an opportunity to hear from experts and stakeholders about how the law is being implemented and what challenges remain.”

Witnesses have not been announced.

At the beginning of the post-Labor Day homestretch, the race is incredibly tight — Harris leads in national polls by between 2 and 4 percentage points, on average. The election, of course, is not decided by a national vote. The outcome will be determined in seven battleground states — Arizona, Georgia, Michigan, Nevada, North Carolina, Pennsylvania and Wisconsin. And there, the contest is exceptionally close as well.

Harris holds a narrow lead in six of the seven battlegrounds — all but North Carolina, according to FiveThirtyEight polling averages in those states. But the margin between the candidates is so slim that it’s under one percentage point in more than half of those states. At the moment at least, this is a margin of error contest wrapped in a photo-finish inside a dead heat.

For Democrats, the outlook is better than at any other point in the 2024 campaign. Before dropping out, Biden trailed in every battleground state. Even his own campaign conceded that his path back to the White House had narrowed to a harrowing ride through the Rust Belt, with no room for error. Today, Harris has two plausible routes, one through the Rust Belt and another through the Sun Belt. She’s even in striking distance of winning North Carolina, which would all but doom Trump’s chances.

Republicans also have reason for hope. Their nominee for president has weathered 88 alleged criminal offenses across four criminal cases and has been found guilty of 34. He still owes hundreds of millions of dollars in civil penalties to E. Jean Carroll and New York state. Despite all that, he remains essentially tied in the polls.

The GOP base remains wildly enthusiastic about voting for Trump. While Democratic enthusiasm has spiked in the aftermath of Harris’ ascension to the party nomination, Republican enthusiasm for Trump has kept pace — and even shows signs of improvement. According to an early August Pew Research Center survey, 72 percent of Trump supporters said they are extremely motivated to vote, up from 63 percent in July. In that same poll, 70 percent of Harris supporters said they are extremely motivated to vote.

Trump supporters have another reason to believe: polls have underestimated the level of support for Trump in both the 2016 and 2020 elections.

It’s been a campaign that has already witnessed a lifetime’s worth of October Surprises — indictments, convictions, an assassination attempt, a catastrophic debate performance, the withdrawal of a president from a reelection bid — and yet there are still some potentially catalytic moments to come.

A presidential debate between Trump and Harris is slated to take place just one week from today, on Sept. 10, hosted by ABC News. The two camps remain held up on the rules — including whether the microphones will be hot. Boiled down to its essence, the mic fight is a Harris campaign bet that an unmuted Trump is an unmoored Trump, easily baited into a spectacular act of self-immolation.

Throughout the campaign thus far, Harris has stayed relentlessly on message while Trump has swung wildly at her identity; that’s a distinction that the vice president’s campaign is hoping they can show the American public in miniature next week.

A week after the showdown before a national audience, the first of three significant economic moments will arrive — occasions that could go a long way toward determining how Americans feel about the economy, and bolstering or undermining the candidates’ arguments.

On Sept. 17-18, the Federal Reserve is set to hold its September meeting, where Chair Jerome Powell is expected to recommend an interest rate cut. A 25 basis point cut is likely already priced in, but if Powell recommends a larger cut of 50 basis points — unlikely but not out of the question — it could spur optimism in the market about inflation, but also could mean that the Fed sees the labor market as particularly weak.

In October and early November, we’ll get final, pre-election looks at both the state of inflation and the strength of the job market, which will color the closing arguments in an election where inflation and the economy are the number one issue for many voters. On Oct. 10, the final Consumer Price Index — the most important measure of inflation — before the election will be released. Then, three weeks later on Nov. 1, just four days before voters go to the polls, the final jobs report will be released. Harris is trying to sell voters on an economy where inflation is under control and the job market remains robust. But if one of these indicators suggests otherwise right before Nov. 5, Republicans will have a key data point to leverage in their case against Biden-Harris economic policies.

Polls suggest Harris is closing the gap on Trump regarding how much voters trust each candidate to handle the economy. But as she claims more credit for the policies of the Biden administration, these three dates become essential as voters build their impression of how she might handle economic issues as president.

With just over two months to go, the race looks tighter than any in recent memory. And while the polls rarely change dramatically between Labor Day and Election Day, the fact that the contest is so close means that even a small atmospheric change could decide who will be the next president.

As Eli and ALEX ISENSTADT wrote Tuesday morning, KAMALA HARRIS’ team believes she is the underdog in a race against DONALD TRUMP, a former president seeking the office for a third straight time. But they also believe several dynamics in the revamped race are working in her favor.

DAVID PLOUFFE, the campaign manager on BARACK OBAMA’s 2008 bid, is now Harris’ senior adviser for path to 270 and strategy. He spoke to West Wing Playbook about how he and the vice president’s team see the 63 days ahead. This conversation has been edited for clarity.

How do you see these final nine weeks setting up?

I think the most important thing in the pursuit of 270 electoral votes is that Kamala Harris has multiple credible pathways to win. She has shown growing strength, which is important. You see both candidates have a pretty high vote share, so there’s a small but important number of undecided voters, and this is a campaign that’s well positioned to reach them.

Because of the enthusiasm she’s generated?

Right now, I think more voters than not see her as kind of a breath of fresh air. She’s handled herself exceedingly well in this hot spotlight. You know, at the end of the day, I think we were convinced there’s enough voters in each battleground state that, all things being equal, would rather Donald Trump not return for a second time.

We have a market of voters out there who want to know more about her, who are open to voting for [her] and we’ve got, I think, a campaign and a candidate who can meet those voters where they are.

How does that enthusiasm translate to her campaign, operationally?

I can’t overstate it — it makes impossible things possible. So say we want to go talk to [several] thousand voters today in Pittsburgh’s Allegheny County or in [Wisconsin’s] Dane County, or in Wake County, down in North Carolina, and the campaign can do that. Some people give dollars, and that’s amazing. People will share social media content, and that’s super important, because it creates kind of an army of people out there sharing good content. Those people reach other voters.

The debate is coming up in a week. How critical is that, especially given that it’ll be her chance to make a first impression with so many people watching?

Presidential debates do matter. … I would assume that the audience for this will be larger than the one in June. You have a lot of people going to vote who may not watch the debate, but they’ll see clips, of course. It’s a big moment. It’s not the only moment. I think a successful campaign does not over-rely on any one moment.

And don’t forget: No one in American history will have done more general election presidential debates than Donald Trump. This will be his seventh. Kamala Harris rightly says she’s an underdog in this race. I think she’ll be an underdog in this debate.

But if she does well, you see this is a real chance to solidify and expand her support?

Where the race stands today is there’s still a bunch of voters out there that want to know more about Kamala Harris, that will learn more about her, that are curious about her, and that’s a big advantage. I don’t think people pay enough attention to that, people who are watching this race: These candidates aren’t similar in terms of their ability to grow.

Campaign chair Jen O’Malley Dillon wrote a memo this weekend touting, among other advantages, your superior organization. How does that factor in at the end of the day?

Basically the presidential campaign is seven gubernatorial races and one congressional race. Yes, television ads are important. And yes, national coverage is important. But you’ve got to think about it that way, which is, you want to be in as many corners of the state as you can, communities large, medium and small.

You want surrogates in those places; you want as good a ground operation as a state-based candidate would have. I mean, to me, that’s the standard you need to set … Can you run just an incredibly intensive presidential campaign as if you were running a dead heat battleground state governor’s campaign? And I think we can.

And you need to do that in these seven key states you’re talking about. That, essentially, is where this race will be won or lost.

Yes. You’ve got seven states and the congressional district in Nebraska. And you’ve got different ways to win them.

I mean, a month, 40 days ago, the Trump campaign was spending as much time talking about New Jersey and New Mexico as North Carolina. … That ridiculous notion that he was going to expand the map has now been laid to rest.

The list, known as “anomalies,” details funding exceptions the White House is seeking amid otherwise stagnant budgets under a continuing resolution.

The administration is pushing for an extra $15.4 billion to help the Social Security Administration deal with staffing and customer service issues, as well as $12 billion in mandatory funding to address a major looming shortfall for veterans medical care. The White House also seeks $7.7 billion to ensure that women, infants and children can continue receiving federal food assistance through WIC, nearly $2 billion for Navy shipbuilding and $2.4 billion to help manage federal student aid operations and more.

What’s next: The list of “anomalies” essentially kicks off the debate over what federal programs will receive a boost beyond the static spending levels in a stopgap.

Once they return next week, lawmakers will have just three weeks to pass a continuing resolution that staves off a shutdown on Oct. 1, likely with a number of other priorities in the mix, such as disaster aid and money to rebuild the Francis Scott Key Bridge in Baltimore.

House conservatives are pushing for a funding patch through March, with a standalone citizenship voting bill known as the SAVE Act attached, hoping for maximum leverage to influence the appropriations process next year if former President Donald Trump wins a second term. Democrats have already rejected that plan, preferring to fund the government before the end of the calendar year.

First up is a visual from our Data & Graphics team looking at new priorities outlined in the Democratic Party’s platform during the DNC last month. The party’s platform highlighted economic growth along with investments from the bipartisan infrastructure law and the Inflation Reduction Act, and proposed expanding protections for workers and unions.

The platform also touched on tax policy, social spending on things like Medicaid expansion and rural health care, border security and immigration, foreign policy, criminal justice, energy policy and more. Data reporter Taylor Miller Thomas has everything you need to know in one handy graphic.

Next, health care reporter Sophie Gardner teamed up with data reporter Madi Alexander to take a look at what health care legislation and rules the administration and lawmakers hope to tackle before the new Congress gets sworn in early next year. Federal health agencies still have a few critical rules to finalize and propose — like the 2025 physician fee schedule and the DEA’s telemedicine rule — by the end of the 2024. There are also two key health care-related bills that could still become law: the Kids Online Safety and Privacy Act and the Improving Seniors’ Timely Accesss to Care Act.

And last but certainly not least, our Legislative Compass team just published a Pro Bill Analysis on Senate Majority Leader Chuck Schumer‘s No Kings Act (S. 4973), which would essentially reverse the Supreme Court’s decision on presidential immunity. SCOTUS ruled in July that Donald Trump had immunity from criminal prosecution for certain actions he took as president while attempting to subvert the 2020 election.

Shortly after the decision was announced, Schumer indicated that Democrats were planning to move forward with a measure to classify Trump’s acts as “unofficial,” and therefore not immune from prosecution. Check out Jordan William’s coverage of the No Kings Act here.

Red-meat appetizer — The pre-election funding sprint begins next week, when both chambers reconvene after a month of recess. The House and Senate are scheduled to be in session for just three weeks between now and Election Day. And thanks to that impending election, Congress is expected to easily thwart a government shutdown with passage of a bipartisan funding patch before midnight on Sept. 30. But as we reported last week, House Republicans are ready for a partisan flex prior to a cross-party compromise, as the House Freedom Caucus presses GOP leaders to tee up a vote next week on a stopgap that punts into 2025 and is loaded with conservative policies like the SAVE Act that requires proof of citizenship for voter registration.

Key bridge caboose — Extra disaster aid, along with funding to rebuild the Francis Scott Key Bridge in Baltimore, remains a likely ingredient in whatever continuing resolution Congress clears before month’s end. And Maryland Gov. Wes Moore is planning a Capitol field trip to restate his case for both the funding and a 100 percent federal cost-share for rebuilding, rather than the typical 90 percent. Our Chris Marquette reported the details of Moore’s impending visit, after a Q&A with the Maryland governor and a chat with the state’s transportation secretary.

The authorizing piece — The cost-share measure for rebuilding the Baltimore bridge is S. 4114 (118), authored by Sen. Ben Cardin (D-Md.), who told reporters two weeks ago that he has gotten signoff from the relevant Senate committees to include the language in a stopgap, including appropriators and the Environment and Public Works Committee.

The House-version of the HHS fiscal 2025 budget includes a 7 percent cut to the department, proposes a reorganization of the NIH and makes deep cuts to CDC funding. The Senate version also cuts HHS funding overall, curbs the NIH reorganization and restores money for HIV/AIDS programs cut in the House bill.

Lawmakers are expected to pass a stopgap that keeps spending levels steady, POLITICO’s Jordain Carney reports.

One year of organ transplant reform: September marks one year since President Joe Biden signed an overhaul of the nation’s organ transplant system into law, allowing different entities to oversee certain functions instead of awarding a single contractor. Last week, the administration announced the first new contractor, the American Institutes for Research, a nonprofit behavioral and social science research organization, which will set up an election for a new board of directors.

HHS expects to award the next round of contracts — to keep organ donations and transplants running smoothly as it transitions into a multivendor system — by the end of September.

Title X ruling: The Supreme Court is expected to rule soon in a case to decide whether HHS must dispense millions in federal family-planning grants to Oklahoma that the Biden administration withheld over the state’s refusal to provide abortion referrals to patients who request them.

It would be the high court’s biggest abortion decision since Roe v. Wade was overturned and could fuel other challenges to the Title X family-planning program.

Under rules the Biden administration finalized in 2021, clinics that get Title X funding are required to offer nondirective counseling for pregnant patients about their options, including abortion — even if the state has banned the procedure.

Oklahoma sued the administration in 2023 after it lost roughly $4.5 million in funds for refusing to comply with the abortion counseling and referral requirements.

Medicare Part D plan details: Medicare plans will soon send their annual notices of change to beneficiaries, detailing how premiums, deductibles and copays might change next year. This year, it will be crucial to watch how the impacts of the Inflation Reduction Act, including a $2,000 cap on out-of-pocket spending on drugs, will play out on premium costs.

The U.S. Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), recently awarded $68 million in grants for suicide prevention and mental health care programs. Addressing the U.S. mental health crisis and preventing suicide are top priorities of the Biden-Harris Administration and part of President Biden’s Unity Agenda.

“Every September we recognize Suicide Prevention Month as a time to raise awareness—to remind those struggling that they are not alone and that there is hope. Many people who have experienced suicidal thoughts are alive today because they got help,” said HHS Secretary Xavier Becerra, “The Biden-Harris Administration is deeply committed to expanding and improving suicide prevention in order to save lives. That is why we launched the 988 Suicide & Crisis Lifeline two years ago and why we continue to invest in suicide prevention programs that help save lives across this country.”

“Data shows that people of all ages continue to experience suicidal thoughts and other mental health challenges, and our communities experience one death every eleven minutes,” said Miriam E. Delphin-Rittmon, Ph.D., HHS Assistant Secretary for Mental Health and Substance Use and the leader of SAMHSA. “These critical investments in early interventions for young people improve mental health outcomes and improve protective factors across the lifespan. Congratulations to these new grantees who will be performing vital work to address this urgent public health crisis.”

SAMHSA’s 2023 National Survey on Drug Use and Health – PDF reported that 5% of adults – about 12.8 million people – had serious thoughts of suicide; 1.4%, or 3.7 million, people made a suicide plan; and 0.6%, or 1.5 million people, attempted suicide in the past year. Among adolescents ages 12 to 17, 12.3% or 3.2 million, had serious thoughts of suicide, 5.6% made a suicide plan, and 3.3% attempted suicide. About 21.9 million adults and 4.5 million youth ages 12 to 17 reported having a major depressive episode in the past year. Over 49,000 people died by suicide in 2023, that is 1 death every 11 minutes. This is why the Biden-Harris Administration named tackling the mental health crisis a core pillar in the Unity Agenda.

The awards announced today include:

• $15.3 million for Cooperative Agreements for the Garrett Lee Smith State/Tribal Youth Suicide Prevention and Early Intervention Program to support states and Tribes with implementing youth and young adult suicide prevention (up to age 24) and early intervention strategies in schools, educational institutions, juvenile justice systems, substance use and mental health programs, foster care systems, pediatric health programs, and other child- and youth-serving organizations;
• $2.2 million for Garrett Lee Smith (GLS) Campus Suicide Prevention to assist colleges and universities in enhancing mental health services for all college students, including those at risk for suicide, depression, serious mental illness and/or substance use disorders that can lead to academic challenges. The GLS Campus program assists colleges and universities to identify students who are at risk for suicide and suicide attempts, increase protective factors that promote mental health, reduce risk factors for suicide, and ultimately reduce suicide attempts and deaths;
• $7.5 million for a new National Center for Mental Health: Dissemination, Implementation, and Sustainment (MHDIS), awarded to Stanford University, that will provide training and technical assistance to SAMHSA grantees and others for planning, implementation, adaptation, and sustainment of new and existing services, as well as localized, targeted, and intensive technical assistance to improve the process of implementation, dissemination, and sustainment of services; and
• $42.9 million for Grants for Expansion and Sustainability of the Comprehensive Community Mental Health Services for Children with Serious Emotional Disturbances (SED), also known as the Children’s Mental Health Initiative (CMHI), to provide resources to improve the mental health outcomes for children and youth, birth through age 21, at risk for or with serious emotional disturbances (SED), and their families.

In April, the Biden-Harris Administration launched a new National Strategy for Suicide Prevention and first-ever Federal Action Plan, which provide concrete recommendations for addressing gaps and meeting the needs of populations disproportionately impacted by suicide and more than 200 actions to be initiated and evaluated in the next three years.

When the 340B drug pricing program was established in 1992, Congress intended for the program to help low-income and uninsured patients with their prescription drugs. The pharmaceutical companies whose drugs are covered by Medicaid are required to participate in the program, offering discounts for drugs to patients on average at 25 to 50 percent of the wholesale acquisition cost.  

Unfortunately, today, the 340B program is failing those it was meant to serve. There is ample evidence that special interests have hijacked the program and exploited its loopholes for their own profit. 

Take for example the fact that the 340B program has increased in size substantially since the Affordable Care Act passed in 2010, allowing 340B hospitals to contract with unlimited pharmacies to reach more low-income communities. Due to a lack of accountability in the program, the result of the expansion was hospitals profiting off the program with no benefit to their patients.

Studies clearly show that hospital participation in 340B has not improved health outcomes for low-income patients. A July 2023 report on the location of 340B disproportionate share hospitals (DSH) shows only 35 percent are located in medically underserved areas, exacerbating the issues caused by 340B hospitals siphoning resources from low-income areas to benefit wealthier regions.

Due to a lack of transparency and oversight, bad actors continue to manipulate the system. Consumers and taxpayers pay for the diversion and waste of 340B funds through higher drug prices, taxes and premiums. 

A 2022 New York Times article about a Richmond, Va. hospital, owned by Bon Secours, found that instead of reinvesting profits from 340B drug sales into its DSH and improving patient care, the money was invested in facilities in the city’s wealthier neighborhoods. Dr. Lucas English, who worked in the hospital’s emergency department, said, “Bon Secours was basically laundering money through this poor hospital to its wealthy outposts … It was all about profits.”  

This exploitation not only undermines ethical standards but also jeopardizes the health care safety net for millions. 

Clearly defining who is a 340B patient and limiting eligibility to only low-income patients is crucial to the future of the program. Pharmacies must check eligibility before receiving a discount. And, patients must be under the care of a physician at the 340B hospital. Covered entities and contract pharmacies must be prohibited from profiteering from 340B discounts. These commonsense measures will prevent multiple covered entities from claiming the same benefits under the 340B program.

While the House Energy and Commerce Committee passed H.R. 3290 on May 24, 2023, to improve 340B program transparency and the Oversight and Investigations Subcommittee held a hearing on 340B on June 4, 2024, no such progress has been made in the Senate. The most prominent effort there is being led by the bipartisan Gang of Six. They released a discussion draft on Feb. 2, 2024, and there were reports that turned out to be incorrect that legislation was going to be introduced before the August recess. 

The senators should act quickly following their return and move the bill to the floor of the Senate before the end of the 118th Congress. Further delays in acting on 340B reform are unacceptable. Taxpayers and patients should not continue to lose while special interests continue to abuse the program and win.

It’s time to get back to work. Congress must swiftly consider and enact legislation to reform the 340B program and reclaim its original purpose to provide affordable medications to those most in need. Implementing these reforms ensures that 340B discounts directly benefit patients rather than enrich special interests. The health and well-being of millions of Americans depend on fixing the mess in 340B.

The House Energy and Commerce Committee was scheduled to mark up a bill to re-up the program in June, but the meeting was canceled over an unrelated disagreement concerning privacy legislation. The Health Subcommittee approved the measure on a party-line vote in May after it was wrapped into separate legislation to expand children’s access to cancer drug trials.

Committee Chair Cathy McMorris Rodgers (R-Wash.) has said reauthorization of the program is a high priority, making it likely she’ll continue pushing for it before she retires at the end of this Congress. And the White House has included the program on its so-called anomalies list of expiring programs it wants lawmakers to extend alongside an appropriations package, an industry lobbyist granted anonymity to share sensitive information told Prescription Pulse.

BIOSECURE Act: House leadership placed the legislation, which would effectively ban Chinese biotech firms from doing business in the U.S., on the suspension calendar for when the chamber returns next week. That means it can’t be amended on the floor and needs a two-thirds majority vote to pass.

Industry analysts tracking the bill expect it to pass this year, likely alongside the annual defense authorization package.

FDA funding: Agency appropriations run out on Oct. 1, and the prospects of lawmakers advancing a standalone Agriculture-FDA spending measure before then are nil.

A continuing resolution would hold agency activities not funded by user fees at fiscal 2024 levels. The White House’s funding anomalies list doesn’t include any extra money for agency programs.

PBM oversight: The consensus we’ve heard from industry sources tracking various legislative efforts targeting pharmacy benefit managers is that their best chance at getting through Congress in some form is on a catchall spending package. Those measures include the House-passed bill tackling both hospital and PBM transparency and a Senate Finance-backed bill aimed at increasing PBM oversight within Medicare.

If lawmakers punt an omnibus until sometime before Christmas as expected, that’ll give proponents an opening for one last push before a new Congress takes over in January.