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.

A federal court on Aug. 20 struck down the Federal Trade Commission’s sweeping noncompete ban, claiming that it was “unreasonably overbroad” and that the FTC lacks authority to implement nationwide rules defining unfair methods of competition. 

The rule, which was initially set to take effect Sept. 4, would have invalidated tens of millions of existing noncompete agreements and banned hospitals and other employers from entering into or attempting to enforce any new noncompetes. 

The FTC told Becker’s it is considering a potential appeal of the federal court’s ruling, which has received mixed reactions from hospital and physician groups. 

Chip Kahn, president and CEO of the Federation of American Hospitals, stands by the federal court’s decision to prevent the noncompete rule from taking effect. 

“We have been clear from the start that this rule would threaten patient access to care by making it more difficult for hospitals to recruit and retain physicians and invest in training and technology,” Mr. Khan said in a statement shared with Becker’s. “In addition, this rule would create an unlevel playing field for tax-paying hospitals, an outcome completely at odds with FTC’s mission to promote competition. Especially at a time of workforce shortages and other challenges, this was the right decision.”

Some physician groups take the opposite view, arguing that noncompete agreements create an unlevel playing field for providers and hurt their ability to provide long-term, high quality care for their patients. 

The American Academy of Family Physicians, which has more than 130,000 members, said it is disappointed by the decision to block the rule nationwide. 

“Noncompetes harm family physicians and their patients by jeopardizing long-term patient-physician relationships and creating an uneven playing field for physicians,” AAFP President Steven Furr, MD, said in a statement, “The AAFP will continue to support the FTC’s mission to eliminate noncompetes in healthcare that prioritize the interests of organizations over those of patients and their physicians.”

Noncompete agreements can be more nuanced for other providers, such as anesthesiologists, who often employ other anesthesiologists. 

Most of the American Society of Anesthesiologists’ members supported bans on noncompete agreements, but small and mid-sized groups said they would be disadvantaged by a general ban on noncompetes, a spokesperson for the ASA told Becker’s. Those same anesthesia groups also expressed that the noncompete structure should be addressed in a more targeted way to rid such clauses of unreasonable and sometimes egregious practices.

The American Hospital Association, which filed an amicus brief in July urging the federal court to vacate the noncompete rule, said the FTC decision was an overreach of the agency’s power and argued that it did not attempt to understand the disruptive effect the ban would have on hospital, health systems and their patients. 

“We are pleased that Judge Brown vindicated what the AHA predicted when this unlawful regulation was first released — the ‘only saving grace is that this rule will likely be short-lived, with courts almost certain to stop it before it can do damage to hospitals’ ability to care for their patients and communities,'” Mr. Golder said in a statement.

Becker’s has also reached out to the American Medical Association, America’s Essential Hospitals and the American Academy of Orthopaedic Surgeons for comment.

Hospitals and other health providers will shift their attention to how states opt to police non-compete agreements now that a federal court has blocked a Federal Trade Commission ban on the widely used contracts.

Why it matters: The FTC’s contentious effort had far-reaching implications for health care — and raised the profile of an issue that was already getting attention in statehouses, experts say.

The big picture: The wide-ranging ban blocking employers from restricting workers’ ability to work for rivals would have taken effect Sept. 4.

• Large employers, including health systems, were largely expecting an injunction before then, but were making some preparations as the deadline closed in.
• But the ruling, alongside previous preliminary injunctions in Pennsylvania and Florida, are likely to be appealed.
• Beyond the legal machinations, the FTC “managed to bring this issue to the fore” by showing how the arrangements affected about 1 in 5 U.S. workers, or around 30 million people, Faegre Drinker labor and employment partner Matt Fontana told Axios.

Driving the news: California, Minnesota, North Dakota and Oklahoma have blanket noncompete bans.

• Starting in 2025, Pennsylvania and Louisiana will see limits to noncompetes specifically for certain health care workers.
• They’re following the lead of Iowa, Kentucky and Massachusetts, which saw health care-specific noncompete bans take effect within the last two years.
• Even though New York Gov. Kathy Hochul vetoed late last year a measure that would’ve outlawed noncompetes in her state, it’s expected a narrower version of that law could come back up, Fontana said. New York City began considering its own legislation earlier this year.

Between the lines: Law firms have been advising health systems and other health care clients with the uncertainty to review and “future proof” their agreements as more states “look to take up the banner,” Kevin Goldstein, lead antitrust lawyer for Winston & Strawn, told Axios.

• That’s particularly important with “increasing judicial skepticism” of the traditional noncompete, Peter Steinmeyer of Epstein Becker Green told Axios.
• They may want to consider alternative arrangements such as non-solicitation agreements, confidentiality agreements or an arrangement known as garden leave, or a period during which an employee is paid while being required to stay away from work.
• They may also want to more narrowly tailor noncompetes to a shorter duration of time or smaller geographic areas.

What they’re saying: This week’s ruling was praised by the industry, with the American Hospital Association saying the judge was right to set aside the FTC’s “breathtaking assertion of regulatory power.”

• “Commissioners did not attempt to understand the disruptive impact it would have on hospitals, health systems, and the patients they serve,” the AHA said in a statement.

The other side: The FTC is weighing an appeal. “Today’s decision does not prevent the FTC from addressing noncompetes through case-by-case enforcement actions,” a spokesperson said.

A Health Affairs study released this week, says nurse staffing legislation is becoming increasingly diverse across the country, and some of the state solutions could provide a guide for federal policy. The study, titled “Hospital Nurse Staffing Legislation: Mixed Approaches In Some States, While Others Have No Requirements,” identified state policies across the country that dealt with staffing mandates as of January 2024.

California and Oregon had the most detailed policies, with required minimum staff-to-patient ratios for multiple specific hospital units. Five other states — Arizona, Massachusetts, New York, Ohio and Oklahoma — mandate ratios for only one unit type each.

Nithya Krishnamurthy, one of the study’s authors, says federal legislation is trending toward California and Oregon’s multi-ratio model. The Nurse Staffing Standards for Hospital Patient Safety and Quality Care Act of 2023, House bill introduced by Democrats in the House Energy & Commerce Committee last year, includes minimum staffing ratios for multiple different hospital units.

Eight states require nurse staffing committees, and 11 states have adopted staffing plans. Out of the 23 states without final staffing mandate policies, five have introduced such legislation. Idaho, however, has passed a statute prohibiting minimum staffing ratios.

But none of the state bills touch on funding, which Krishnamurthy and co-author Neha Mukherjee, both at the Icahn School of Medicine at Mount Sinai, see as a solution to factors that drive the nurse staffing issue. Staffing mandate policies should include stipulations about how funds should be acquired and used, Mukherjee told Inside Health Policy.

“Without any adjustment to reimbursement systems, it may remain continually difficult for hospitals to invest in nurse staffing or to comply with legislation requiring minimum staffing ratios,” the study claims. “Cost considerations are particularly relevant, given the national legislation on the horizon.”

Krishnamurthy told IHP she hopes the research will serve as a resource for policymakers looking to implement staffing mandates at the federal level. The study argues the diversity of state staffing mandate policies provides opportunity for comparison when evaluating efficacy of different types of policies.