Category: Blog

Contingency Management: An Effective Framework for Treating Stimulant Use Disorder and Opportunities for State Medicaid Coverage

Between 2003 and 2022, drug overdose deaths in the United States drastically increased by 366%. The major culprit for the increase in narcotic-related mortality were opioids, a class of drugs including heroin, fentanyl, and oxycodone. In recent years, because of more effective treatment options and the availability of opioid overdose-reversal drugs such as Narcan, opioid overdose deaths have started to decline, including a 24% decrease between 2023 and 2024. This decline represents 27,000 fewer overdose deaths.

In recent years, however, stimulant overdose deaths have started to increase even as opioid overdoses flatlined and started to decline. Stimulants chiefly include cocaine and methamphetamine. Cocaine overdose deaths per 100,000 people increased by 661% between 2010 and 2023, while overdose deaths of psychostimulants (which include methamphetamine),increased by 1,325% per 100,000 people between 2008 and 2023. Treatment for individuals with stimulant use disorder is much more limited than for individuals with opioid use disorder. For example, there is no FDA-approved overdose reversal treatment for stimulants, in contrast to Narcan for opioid overdoses. At this time, there are zero FDA-approved pharmaceutical drugs on the market to treat stimulant use disorder.

Currently, one of the most effective treatments for individuals with stimulant use disorder is contingency management. Contingency management is a treatment that uses incentives (frequently financial) to assist people with stimulant use disorder by paying them for remaining abstinent and for adhering to medication or treatment regimens.

While contingency management trials were historically underfunded, these programs are still effective. For example, contingency management programs operated by the Department of Veterans Affairs showed strongly positive results in helping veterans with stimulant use disorder cease substance use and to stay connected to other treatment resources.

While contingency management programs have a robust history of coverage for veterans, they do not for Medicaid members. Medicaid, the joint federal and state public insurance program that predominantly covers low-income and disabled Americans, provides coverage to roughly one-quarter of Americans. However in 2020, Medicaid members constituted 48% of overdose deaths. In 2019,1.7% of Medicaid members had a diagnosis of substance use disorder, representing millions of Americans.

Section 1115 of the Social Security Act allows states to innovate within their state’s Medicaid program, subject to agreement with the federal government and meeting certain budgetary and programmatic requirements. In 2021, the federal Centers for Medicare and Medicaid Services (CMS)approved the first state 1115 Waiver Demonstration with a contingency management program. Currently, CMS has approved five Medicaid contingency management programs in California, Delaware, Hawaii, Montana, and Washington. Two other states, Michigan and Rhode Island, have submitted applications to CMS for authority to implement these programs in their states but are awaiting CMS action.

Programmatically, the five Medicaid contingency management demonstrations differ in scope. For eligible Medicaid members, members can receive contingency management financial incentives for as short as 12 weeks (Montana) to 24 weeks. Delaware extends contingency management services to pregnant and postpartum members with certain types of substance use disorder for as long as 64 weeks. The financial incentives differ from state to state, with members avoiding substance use eligible between $596 and $1,092 in financial incentives over the course of a member’s enrollment in a contingency management program.

While many Medicaid contingency management programs are in their infancy, initial results are available from California’s first-in-the-nation program. The Interim Evaluation Report from California’s 1115 Waiver Demonstration describes an enrollment of 8,500 members across 100 sites. Among members enrolled, there was a higher retention in other drug treatment programs, improved access to care, reduced emergency department visits, and a reduction in overdose deaths. Results were mixed regarding health equity goals and in reducing hospital readmissions among enrolled members.

While more data is needed, early indicators are that Medicaid coverage for contingency management programs will help to reduce overdose deaths and provide more effective treatment for Medicaid members with stimulant use disorder.

The Judiciary Jabs Back at RFK Jr.’s Changes to the Childhood Vaccine Schedule

On March 16, 2026, U.S. District Court Judge Brian E. Murphy granted an injunction preventing HHS from revising the childhood immunization schedule and staying the appointments of thirteen members of the CDC Advisory Committee on Immunization Practices (ACIP). A legal challenge to these changes to the vaccine schedule seemed all but inevitable when they were made, as Robert F. Kennedy Jr.’s actions as health secretary over the past year have grown more and more polarizing. Vaccine supporters began to sound the alarm in June 2025 after Secretary Kennedy suddenly fired all seventeen members of ACIP, citing a need for a “clean sweep” to “re-establish public confidence in vaccine science.” However, Secretary Kennedy’s actions as head of HHS have continued to amplify the Trump administration’s skepticism of vaccines rather than solidify confidence in them. In a press conference in September 2025, President Trump made comments on vaccines and the childhood vaccine schedule, claiming that groups of people who do not use vaccines do not have autism and that they are injecting “a vat of eighty different vaccines” into young children. Trump also noted his distrust in the presence of aluminum and mercury in vaccines and his desire for vaccines for mumps, measles, and rubella to be taken separately rather than all together in the MMR vaccine. Trump  provided limited scientific support for these views at that time, stating “this is based on what I feel,” yet a few months later in December 2025, he released a Presidential Memorandum directing Secretary Kennedy to review vaccine schedules from other peer countries which vaccinate for fewer diseases and revise the childhood vaccine schedule to conform to best practices. This memorandum prompted HHS to release a decision memo updating the childhood vaccine schedule on January 5, 2026. 

Although Secretary Kennedy and President Trump’s stated policy goal of these actions was to improve confidence in vaccines, in practice these actions actually may lead to less confidence in vaccines and the government entities that govern public health. Physicians are noticing that they are getting more questions from families regarding the childhood vaccine schedule due to the changes. Physicians report that changes have caused confusion and anxiety for parents regarding which vaccines are appropriate and when they should be administered, and this confusion is leading some physicians to disregard the changes altogether and follow recommendations made by the American Academy of Pediatrics. The American Academy of Pediatrics was one of many groups who sued HHS to block the changes to the vaccine schedule and stay the appointment of other vaccine skeptics to the ACIP,  arguing that these actions violated the Administrative Procedure Act because they constituted arbitrary or capricious agency action not in accordance with statutory authority. Although Judge Murphy granted the injunction staying the appointments due to their likelihood of success on the merits, likelihood of suffering irreparable harm in the absence of preliminary relief, balance of equities in their favor, and the fact that injunction would be in the public interest, this decision is not necessarily permanent. Whether or not the changes to the vaccine schedule and the appointments to ACIP are allowed to stand will come down to the result of a trial or a decision for summary judgment. No matter the final outcome of the litigation, the changes and associated legal challenges alone may worsen public confidence in vaccines more than these policies could ever improve it. The resulting instability in policy highlights the importance of following the appropriate protocols for agency rulemaking.

Continued Uncertainty in Title X Funding for Family Planning Services

The Title X Family Planning Program has been a major part of reproductive health care in the United States for over 50 years. It was established in 1970 when Congress passed the Public Service Act, and it remains the only federal program focused entirely on family planning and preventative health services. The program is run by the Office for Population Affairs within the United States Department of Health and Human Services, and it provides funding to a wide network of public and nonprofit clinics across the country. With an annual budget of approximately $286.5 million, Title X has served around 195 million people over its history,  making it a critical part of our country’s health care safety net. 

Title X clinics offer a variety of important services, especially for people who might not otherwise have access to care. These services include birth control (both FDA-approved methods and natural family planning), pregnancy testing and counseling, help for people who are trying to become pregnant, STI testing and treatment, and other pre-pregnancy health care. One of the most important aspects of Title X is that it provides care regardless of a person’s income, insurance status, location, or immigration status. Because of this, Title X often serves as a first point of contact within the health care system for many low-income individuals. 

According to the FPAR 2023 report, Title X served 2.8 million people, which was a 7% increase from the previous year. The program also plays a big role in providing STI and HIV testing, as well as cancer screenings. Most people who use Title X services are low-income; about 60% have incomes below the Federal Poverty Line (FPL), and another 23% are just above the FPL. These services are vital for people who may not be able to afford care. In addition to providing services, Title X helps set a standard for quality of care and healthy equity.

Despite its history and importance, Title X is currently facing uncertainty. Under the current Trump administration, several changes could seriously impact the program. In Trump’s 2026 budget proposal, there was an effort to defund Title X. Additionally, $65.8 million in funding was withheld from some of the program’s grants, affecting clinics that rely on that money to operate. 

Things became more complicated in late 2025, when HHS told clinics that new guidelines would be coming. Usually, clinics have several months (three to four) to prepare for changes, but this time they were given only one week to respond after the new guidance was released on March 13, 2026. The updated rules removed earlier requirements that focused on maintaining high-quality family planning standards and promoting equity and inclusion. These changes have raised concerns among providers about the future direction of the Title X program. 

At the same time, funding for Title X is set to expire on April 1, 2026, and the new guidance was released only one week ago. Normally, the funding review process takes months and involves a careful evaluation of each clinic’s services and plans. The delay has left many clinics unsure about what will happen next. Clare Coleman, a leader representing many Title X providers, has pointed out that there has been little to no explanation from the Trump administration, which only adds to the confusion. 

If funding is not continued, the effects on services could be serious. Many clinics may have to cut back services or even close, and patients who previously received free or low-cost care may suddenly have to pay out of pocket. This could lead to individuals skipping important health services like birth control, STI testing, or cancer screenings. There is also concern that policies from Trump’s previous presidency could return, including rules that removed over 1,000 clinics from the program because of their connection to abortion services. 

Overall, the future of the Title X program seems uncertain at best. These recent funding issues and policy changes have created stress and fear in both patients and providers. A program that has helped millions of people access health care is now facing challenges that could limit its ability to continue working. 

Ethical Considerations in Plasma Donations Across the United States

For the past twelve years, William Jacques has visited CSL Plasma twice a week to donate his plasma. He brings in $460 a month, likening it to a part-time job. He’s not the only one. Across the United States, Americans are consistently frequenting plasma donation centers in exchange for a quick buck. 

The number of these centers continues to rise. Currently, the United States has more plasma donation centers, at 1,247, than community colleges. The number of centers varies per state, largely due to differences in regulations. However, one thing is consistent– the presence of these centers in economically disadvantaged neighborhoods. The average plasma seller is low-income, under 35, unemployed, and lacking a college degree. Over two-thirds of donors are motivated to donate to pay for day-to-day essentials and emergencies.   

The United States’ paid-donor plasma system supplies 75% of the world’s plasma, despite North America accounting for 44% of the demand. This is largely because the FDA allows individuals to donate plasma more frequently and at higher annual volumes than in any other country. In the United States, donors are remunerated $50-75 per donation. In 2025 alone, more than $4.7 billion was spent on donor compensation. 

However, paid donations are not the only way. 64 countries have reached over 99% of their blood supply by unpaid donors, and 54 countries have reached over 50%. In fact, the World Health Organization has set a goal to achieve 100% voluntary non-renumerated donors by 2030. The World Health Organization advises countries against rumination, raising concerns about the harmful consequences of frequent donation. 

This is especially concerning, considering the vulnerability of poor Americans who historically have worse health outcomes than their wealthier counterparts. There is a gap in knowledge about the effects of frequent plasma donation, raising serious ethical questions. Without this knowledge, how can an individual fully understand the risks of selling their plasma, and how can we determine the fair market value of plasma? One comparative study found that in countries with donor remuneration (causing more frequent donations), donor safety is at risk, and the infectious burden of donated plasma is higher, and plasma-derived medicinal product prices increased less in countries with a volunteer-based system.

It is imperative that we do not exploit the financial deprivation of poor Americans while also balancing the growing need for plasma donations. It is time for the FDA to reconsider the regulations regarding the frequency and remuneration of plasma donors. Some suggest regular audits of donation centers to monitor compliance with ethical standards and address possible exploitation. There must be research into the long-term health effects of frequent donation on vulnerable donors to ensure the long-term health and safety of donors and a sustainable blood and plasma supply for the United States and beyond. 

A Year in Review: The Dissolution of USAID

It has now been just over one year since the dissolution of the United States Agency for International Development (USAID), one of the first agencies affected by the Trump Administration’s government efficiency cuts. USAID, prior to absorption into the State Department, was the United States’ foremost agency for humanitarian aid, and a key implementation partner to multiple global public health campaigns, such as vaccination and AIDS relief programming. Two decades of USAID services, specifically targeting low and middle-income countries (LMIC), were associated with a 15% reduction in age-standardized all-cause mortality, with those numbers higher when looking at a reduction in mortality from HIV/AIDs, malaria, and nutritional deficiencies.

In the year since USAID’s dissolution, the cessation of humanitarian aid has spread beyond the U.S., with multiple European countries rolling back their international development funding, leading to what is now known as the “Great Aid Recession.” For the first year following the funding cuts, multiple non-profits tracked the fallout in terms of human casualties, most notably the Impact Counter Dashboard, which has since retired in early 2026.  At the one-year mark, the Impact Counter Dashboard estimated a mortality count of 781,343 deaths directly attributed to the funding cuts, with millions more estimated from the spread of diseases such as malaria, which were previously on the road to eradication in certain regions. Another study conducted by The Lancet Global Health projected that USAID funding cuts to global health programs could result in an additional 22.6 million deaths by 2030, should an alternative not be found.

Just as the global health impact is not slowing any time soon, neither is the legal fallout from the Trump Administration’s decision to abruptly dissolve the agency. In the immediate aftermath of the closure, hundreds of lawsuits were filed by affiliated NGOs fighting against the funding freeze, most notably the case of Department of State v. Aids Vaccine Advocacy Coalition. In this case, the Supreme Court, in a narrow 5-4 decision, barred the Administration from withholding $2 billion, allotted by Congress for humanitarian aid, from USAID contractors. A similar case, Global Health Council v. Trump, also consisted of several non-profits seeking an injunction barring the implementation of an Executive Order that would cut their funding from USAID prior to their contracts being fulfilled. However, this case is still ongoing, despite an initial injunction filed by the D.C. District Court based on the decision in Department of State v. Aids Vaccine Advocacy Coalition. Multiple USAID partners are still fighting funding freezes with the hopes of retaining their programs and impact.

Another slew of lawsuits against the Administration came from the USAID workers themselves. One such case is American Foreign Service Association v. Trump, in which a representative of USAID workers argued that the reduction in force and subsequent funding cuts violated the Civil Service Reform Act. The arguments in front of the DC Circuit Court of Appeals are due to be heard on April 23, 2026. Another case, Greene v. USAID, consists of three former USAID employees fighting the force reduction on the grounds that their jobs were unlawfully terminated because their duties involved DEI-related compliance. This case was filed in February 2026, and is scheduled to be heard by the D.C. District court later this year.

In the midst of both worsening global health challenges and unending legal battles throughout the last year, health advocates and humanitarian organizations have been waiting to see what the Trump Administration will implement in place of USAID. According to the 2025 America First Global Health Strategy, the Administration plans to move away from federal partnerships with NGOs and towards providing direct funding to target nations. The Administration did not act on the plan until March 19, 2026, when they released an executive order, announcing the signing of a five-year bilateral health cooperation agreement between the United States and Angola. It remains to be seen whether the Administration’s new strategy can match the reach and efficacy of USAID.

A New Era for Medical Device Regulation: Inside FDA’s QMSR Transition

Medical device regulation is an imperative yet cumbersome process that spans throughout a product’s lifecycle, from initial development and premarket approval and ending with post-market surveillance. Since 1978, the FDA has steadily improved U.S.-centered regulations governing medical device manufacturing to ensure companies remain compliant with an array of evolving safety requirements. 

On February 2, 2026, the Food and Drug Administration (“FDA”) promulgated a new Quality Management System Regulation (“QMSR”) in 21 C.F.R. Part 820, which reflects a groundbreaking shift in medical device regulation. Abandoning the Quality System Regulation (“QSR”), the QMSR harmonizes domestic standards of medical device quality management with international standards established by the International Organization of Standardization (“ISO”). While the QMSR aligns with the foundational requirements under the ISO, it also contains “FDA-specific requirements” that yield various implications for companies entering the medical device space. 

One of the most prominent changes under the QMSR in its effort to align with ISO standards is the adoption of a risk-based inspection approach. Essentially, medical device inspections will now orbit around patients and users throughout a product’s lifecycle, making risk management paramount. Under this new model, FDA investigators will review medical device products “based on product-specific risks, complaint histories, prior compliance issues, and other risk indicators.” Additionally, FDA investigators can access company “audit reports, management review documentation, and supplier audit reports” to evaluate the company, its leadership, and its internal approaches to mitigating risk. 

Another key shift under the QMSR is the FDA’s emphasis on post-market surveillance, which works in-tandem with the risk-based inspection model. The heightened degree of oversight regarding post-market evaluation holds companies to more stringent expectations, as FDA investigators will now closely monitor recall trends, design changes, supplier conflicts, and ongoing compliance concerns. This robust escalation requires companies to move beyond managing risk-based decisions and instead show post-market responsiveness to field changes and various emerging risk factors.

Lastly, in response to rapid technological advancements, the FDA will also inspect “cyber devices” and other digital software installations. Specifically, the FDA seeks to verify that cyber devices have a sufficient structural design and maintain a requisite degree of security and threat management. Cyber devices and software will also be viewed from a patient-focused lens, and companies are encouraged to modernize internal technology throughout the manufacturing process. 

Ultimately, this regulatory paradigm shift, coupled with the recent increase in warning letters, signals an expansive pivot in medical device regulation. FDA’s new patient-centered requirements are sweeping, effectively requiring companies to implement a holistic approach to product development, active risk-management, and post-market review. The FDA’s position under the QMSR heavily emphasizes that quality radiates throughout a company and is perpetuated by effective management that oversees continuous risk-based decisions. FDA advises against treating quality as merely a “compliance exercise for inspection day.” Failure to adhere to new QMSR requirements poses substantial risks, including potential denial of product applications. 

In response to these instrumental changes, leading FDA regulatory attorneys advise medical device companies to continue evaluating their current manufacturing and development practices with a gap analysis (a corporate comparison of current practices and future goals) to ensure they are compliant with the new QMSR requirements. Companies should also consider scheduling pre-approval FDA inspections earlier to avoid discovering inadequacies late in the approval process, which can decrease investor confidence, derail market entry timelines, and even result in FDA’s denial of the application. In addition, companies are encouraged to collaborate with stakeholders, suppliers, and advisors to show a proactive quality culture and acknowledge FDA’s heightened risk-based analysis that demands more than only preparing for inspection day.