In Landmark Ruling, Eastern District of Texas Strikes Down FDA’s Final Rule Regulating Laboratory Developed Tests
In the never-ending saga over the battle to regulate laboratory-developed tests (LDTs), the Eastern District of Texas took the wind out of FDA’s sails on Monday, vacating FDA’s Final Rule that intended to regulate LDTs as medical devices similar to in vitro diagnostic (IVD) tests, which are commercially manufactured and undergo pre-market review by FDA.1 Clinical laboratories can halt their plans, for now, to comply with the Final Rule’s May 6, 2025, deadline to implement certain features of FDA’s medical device quality system regulations.
As summarized in our May 6, 2024, client alert, FDA’s Final Rule was set to dramatically alter the regulatory landscape for LDTs with major regulatory and financial implications to clinical laboratories, patients and health care providers.
Clinical laboratories will see the ruling as a major victory for the laboratory industry. The district court’s ruling also comes as one of the first major checks on FDA’s power in the post-Chevron world following last year’s Supreme Court decision in Loper Bright.
Background and LDT Regulatory Timeline
In 1976, Congress enacted the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act (FDCA), granting FDA explicit authority to regulate medical devices, which included IVDs developed by manufacturers and sold for commercial purposes to laboratories, health care organizations and consumers.
Separate from FDA’s authority, in 1988 Congress passed the Clinical Laboratory Improvement Amendments (CLIA), creating a statutory framework to certify clinical laboratories through quality, proficiency standards and personnel requirements. The Centers for Medicare and Medicaid Services (CMS) oversees CLIA certification and compliance for most laboratories in the country2 that examine materials derived from the human body for the diagnosis, treatment or prevention of disease or to assess the health of human beings.
For decades, FDA did not attempt to assert authority or regulate laboratories or LDTs, which are defined as IVDs “intended for clinical use and that [are] designed, manufactured and used within a single laboratory that is certified under [CLIA].”3 Starting in 1992, FDA claimed that it could regulate LDTs as medical devices through the issuance of a draft Compliance Policy Guide.4 FDA declined to finalize the guidance, however, and assured laboratories that it did not intend to “routinely” exercise its authority over LDTs.5
FDA next asserted that it had jurisdiction over LDTs in a 1996 preamble to a proposed rule regarding device classification levels for certain active ingredients used for preparing LDTs.6 FDA also recognized in the same preamble that “significant regulatory changes in this area could have negative effects” and that FDA would therefore only focus its oversight on “ingredients . . . that moved in commerce” and other tangible articles. FDA never took any final regulatory action to assert its authority over these tests.
In 2010, FDA held a two-day public meeting soliciting feedback on LDT regulation, hinting that it may consider formally regulating LDTs. Four years later, FDA formally released two draft guidance documents proposing a framework for LDT regulation.7 The guidance documents were not well received by Congress, which criticized FDA for significantly shifting the way LDTs are regulated and directed FDA to suspend any efforts to finalize its guidance documents.8 FDA complied and retreated from enacting any final guidance document.
A few years later, Congress considered two different pieces of legislation — The Verifying Accurate Leading-edge IVCT Development Act (VALID) of 2020 and the Verified Innovative Testing in American Laboratories (VITAL) Act of 2020.9 Both bills proposed different approaches to regulating LDTs that would have created a new regulatory pathway under FDA premarket review or deemed LDTs as “services” to be regulated under CLIA. Both bills failed to pass even after being reintroduced in subsequent Congresses.
With failed attempts to regulate LDTs in Congress, FDA announced its attempt to move forward with regulating virtually all LDTs as medical devices in October 2023, which ultimately led to the Final Rule, effective May 6, 2024.
Shortly after the Final Rule went into effect, the American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathology (AMP) sued FDA in two separate lawsuits challenging that the Final Rule violated the Administrative Procedure Act (APA) because it exceeded FDA’s statutory authority and was arbitrary and capricious. The two cases were consolidated into one.
Summary of Court Ruling
Explaining the storied history of LDT regulation, the district court found no question that Congress had considered the unique regulatory issues raised by clinical laboratories and the tests that they develop and perform, and that Congress chose to regulate these tests as “services” under CLIA. This contrasts with the authority Congress granted FDA to regulate “devices,” which the district court concluded under the FDCA to mean “articles in commerce,” not “services” performed by doctors and laboratories.
Considering the distinct legislative history of medical devices and laboratory services, the district court agreed with the plaintiffs that LDTs are “professional medical services that are qualitatively and categorically different from the tangible goods that FDA may regulate as a ‘device,’” and that medical devices defined under the FDCA only refer to “tangible, physical products.” The district court was further unpersuaded by FDA’s argument that an LDT is an “IVD test system” made up of physical components that meet the definition of a medical device.
Rejecting FDA’s argument on two grounds, the court found that (1) FDA had no statutory authority to alter the definition of a device under the FDCA to expand the definition to include laboratory services, and (2) FDA’s self-created “IVD test system” conflates discrete tangible objects with an assortment of laboratory tools that professionals use to deliver a service. Relying heavily on last year’s Supreme Court decision in Loper Bright, the court closely scrutinized the statute and made it abundantly clear that it was not deferring to FDA’s interpretation of the statute and the authority that FDA was claiming from the statute. The court warned that should it accept FDA’s position, it would lead to limitless implications of FDA oversight on all surgical procedures and physical examinations that use “devices,” giving the term an “extraordinary, expansive meaning with far-reaching consequences.”
The court further noted that, should it accept FDA’s theory that an LDT does in fact meet the definition of a medical device under the FDCA, it would “render[] CLIA largely, if not entirely, pointless.” For these reasons, the court determined that FDA’s “asserted jurisdiction” over LDTs “defies the bedrock principles of statutory interpretation, common sense and longstanding industry practice.” Therefore, the court concluded that the Final Rule exceeds FDA’s authority, is unlawful and should be set aside pursuant to the APA.
Finally, in considering the appropriate remedy, the district court found that the circumstances in this case favor nullifying and revoking the Final Rule instead of remanding the Final Rule back to FDA to modify without vacating. In reaching this conclusion, the court considered the extreme financial impact the Final Rule would have on clinical laboratories as well as the unlikelihood that FDA could justify its decision on remand. Therefore, the Final Rule was vacated in its entirety.
What’s Next?
With the Final Rule now vacated, FDA’s “phaseout” policy to bring LDTs under the same regulatory scheme as IVDs is also terminated. Once the LDT Final Rule went into effect last year, laboratories were subject to a phaseout policy that would have required companies to begin complying with certain medical device requirements, such as medical device reporting and complaint handling, beginning on May 6, 2025.
While it is possible that FDA could appeal the decision, we do not expect the current Administration to do so. Experts had already predicted that President Trump was likely to order FDA to repeal, or not enforce, the Final Rule, as HHS under the first Trump Administration had revoked FDA’s guidance document claiming authority to regulate LDTs as devices.
In light of the district court’s ruling, it seems less likely that Congress, and in particular the Republican controlled House, will attempt to revive the bipartisan VALID Act.
In a town where we are taught to “never say never,” we will keep a watchful eye on the Administration and Congress’s reaction to the court’s ruling.
[1] American Clinical Laboratory Ass’n v. FDA, Case No. 4:24-cv-00479 (E.D. Tex.).
[2] New York and Washington are exempt from CLIA, as they have their own state law regulatory oversight framework, which is enforced by the applicable state agency.
[3] LDT Final Rule, 89 Fed. Reg. 37286, 37289 (May 6, 2024).
[4] See FDA, Draft Compliance Policy Guide: Commercialization of Unapproved In Vitro Diagnostic Devices Labeled for Research and Investigation (Aug. 1992).
[5] Food & Drug Admin., IVD Policy Will Not Include Exemptions for “Standard of Care” Tests, The Gray Sheet (Oct. 11, 1993).
[6] 61 Fed. Reg. 10,484, 10,485 (Mar. 14, 1996).
[7] Food & Drug Admin., FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs), and Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) (Oct. 2, 2014).
[8] H.R. Rep. No. 114-531, at 72 (2016).
[9] VALID Act of 2020, H.R. 6102, 116th Cong. (2020); VITAL Act of 2020, S. 3512, 116th Cong. (2020).
Thompson v. United States (No. 23-1095)
William Blake once observed that “a truth that’s told with bad intent, beats all the lies you can invent.” It turns out the Supreme Court agrees, at least for escaping liability under 18 U.S.C. § 1014. In Thompson v. United States (No. 23-1095), a unanimous court held that this statute criminalizes only false statements and not statements that are misleading but literally true.
Patrick Thompson took out three loans from the Washington Federal Bank for Savings at various times. He first borrowed $110,000 in 2011. Then in 2013, he borrowed an additional $20,000. The year after that, he borrowed $89,000 more. These three loans resulted in a total loan balance of $219,000. In 2017, however, the Washington Federal Bank for Savings failed, and the FDIC assumed responsibility for collecting the bank’s outstanding loans. As part of the FDIC’s collection attempts, Planet Home Lending, the FDIC’s loan servicer, sent Thompson an invoice for $269,120.58, reflecting his principal amount plus unpaid interest.
After receiving the invoice, Thompson called Planet Home Lending and professed confusion as to where the $269,120.58 figure came from. On the call (which, unfortunately for our supposedly befuddled borrower, was recorded) Thompson said “I borrowed the money, I owe the money—but I borrowed…I think it was $110,000.” Thompson later received a call from two FDIC contractors, whose notes of the call reflect that Thompson mentioned borrowing $110,000 for home improvement. He later settled his debt with the FDIC for $219,000—an amount that coincidentally reflected the exact principal amount of the loans he had taken out but apparently could not recall.
Any elation he felt over his $50,000 in interest savings was likely cut short, however, when he was indicted on two counts of violating 18 U.S.C. § 1014. That statute prohibits “knowingly mak[ing] any false statement or report . . . for the purpose of influencing in any way the action of . . . the Federal Deposit Insurance Corporation . . . upon any . . . loan.” One count related to his call to Planet Home Lending, and the second to his call with the FDIC contractors. Apparently secure in his belief in his own veracity, Thompson proceeded to trial. But the jury reached a different conclusion regarding his trustworthiness and convicted him of both counts.
He moved for acquittal or a new trial, arguing that a “conviction for false statements cannot be sustained where, as here, the alleged statements are literally true, even if misleading.” Thompson argued that his statements about borrowing $110,000 were literally true because he had in fact borrowed that amount of money from the Bank, even though he later borrowed more. Cf. Mitch Hedberg (“I used to do drugs. I still do, but I used to too.”). The district court denied the motion, finding that “literal falsity” was not required to violate section 1014 under Seventh Circuit precedent. The Seventh Circuit affirmed, holding that “misleading representations” were criminalized by that statute.
In a unanimous opinion by Chief Justice Roberts, the Supreme Court reversed and remanded. In their view, this was a simple case. The plain text of the statute criminalizes “knowingly mak[ing] any false statement or report.” But “false and misleading are two different things” because a “misleading statement can be true.” And because “a true statement is obviously not false,” misleading-but-true statements are outside the scope of the statute.
Much in the case ultimately turned on whether the natural reading of “false” includes a true but misleading statement. As one of many colorful examples of how even true statements can be misleading, Roberts discussed a hypothetical, which the Government conceded at oral argument, that “[i]f a doctor tells a patient, ‘I’ve done a hundred of these surgeries,’ when 99 of those patients died, the statement—even if true—would be misleading because it might lead people to think those surgeries were successful.” (The statement would be equally true—and equally misleading—if all 100 patients had died, but perhaps the Court thought that even its hapless hypothetical surgeon was unlikely to have botched all his operations). With that recognition in mind, Roberts quickly rejected the Government’s argument made with “dictionary in [one] hand” and “thesaurus in the other hand” that false can also simply mean “deceitful” and that “false and misleading have long been considered synonyms.” Unimpressed with the stack of books the Government brought to bear, the Court observed that this argument merely “point[ed] out the substantial overlap between the two terms.”
Finally, the Chief turned to context and precedent. Starting with the former, Roberts noted that many other criminal statutes do criminalize both false and misleading statements, including “[m]any other statutes enacted in the same period” as section 1014 (like such stalwarts of the federal code as the Perishable Agricultural Commodities Act). This gave rise to the presumption that Congress’s omission of the term “misleading” from section 1014 was deliberate. And as to precedent, Roberts found support in Williams v. United States (1982), where the Court stated that “a conviction under §1014 requires at least two things: (1) the defendant made a statement, and (2) that statement can be characterized as ‘false’ and not ‘true.’”
Justices Alito and Jackson each filed a brief concurrence. Justice Alito emphasized that “context” is key when assessing whether a misleading statement crosses the line into being false. Justice Jackson wrote separately to note that the jury instructions in Thompson’s case had actually been correct, referencing only false statements while making no mention of misleading statements. In her view, then, there was “little for the Seventh Circuit to do on remand but affirm the District Court’s judgment upholding the jury’s guilty verdict.”
Reproductive Health Under Trump: What’s New and What’s Next
Overview
Over the past two months, the second Trump administration has shifted federal policies and priorities regarding abortion, in vitro fertilization (IVF), contraception, and other reproductive-health-related matters – and it is expected to continue to do so. In addition to the federal policy agenda, many developments related to reproductive health likely will continue to occur at the state level. The Dobbs decision shifted policymaking in these areas toward the states, and lawmakers and advocates have expressed their intentions to either adhere to or protect against the new administration’s policies and agenda items. This article discusses some of the major recent trends in women’s health and reproductive health, and what is likely to come next under the new administration.
In Depth
THE TRUMP ADMINISTRATION WILL CONTINUE TO WEAKEN BIDEN-ERA POLICIES THAT PROTECT REPRODUCTIVE HEALTH
The Hyde Amendment
During its first month, the second Trump administration signed several executive orders (EOs) and otherwise signaled its approach to certain reproductive health measures that were previously in place. For instance, in the first week of his presidency, US President Donald Trump signed an EO entitled “Enforcing the Hyde Amendment,” which called for an end to federal funding for elective abortions and revoked two previous EOs that permitted such funding. The EO charged the Office of Management and Budget with providing guidance around implementing the mandate. While the EO was not a surprise, it referred to the Hyde Amendment and “similar laws,” leaving some ambiguity in its scope and the way in which it will be implemented in practice (e.g., it could be used to target federal funds for abortion and perhaps related services by other federal agencies, such as the US Departments of Defense, Justice, and State). In response to this EO, federal agencies could revoke Biden-era policies and reinstate or expand upon Trump administrative policies. Such efforts may include recission of Biden-era regulations that authorized travel for reproductive-health-related needs for servicemembers and their families and permitted abortion services through the US Department of Veterans Affairs.
The Comstock Act
Although we have not seen activity in this respect to date, the new administration will likely rescind the Comstock Act Memo, which was published by the US Department of Justice (DOJ) Office of Legal Counsel. This memo was issued in December 2022 by the Biden administration following the Dobbs decision. The Comstock Act is a federal criminal statute enacted in 1873 that prohibits interstate mailing of obscene writings and any “article or thing designed, adapted, or intended for producing abortion.” Violations of the Comstock Act are subject to fines or imprisonment. The Comstock Act Memo sets forth the opinion of the DOJ Office of Legal Counsel that the Comstock Act does not prohibit mailing abortion-inducing medication unless the sender explicitly intends for it to be used unlawfully. If the new administration revokes this memo or attempts to apply the Comstock Act to the mailing of abortion-inducing medication (and, perhaps, any abortion-inducing implements, which could have even wider-reaching implications) regardless of intent, it could become very difficult for patients to obtain abortion-inducing medication. Such actions also could lead to complications related to the provision of such medications via the mail (and potentially in person, depending on the attempted interpretation). At the time of publication, the DOJ website still included the Comstock Act Memo, noting that 18 U.S.C. § 1461 does not prohibit the mailing of abortion-inducing medication when the sender does not intend for the recipient to use the drugs unlawfully.
The 2024 HIPAA Final Rule on Access to Reproductive Health Records and Related State Activity
In 2024, the US Department of Health and Human Services Office for Civil Rights (OCR) published a Health Insurance Portability and Accountability Act (HIPAA) final rule to support reproductive healthcare privacy (2024 final rule). The 2024 final rule prohibits a covered entity or business associate from disclosing protected health information (PHI) for conducting an investigation into or imposing liability on any person for seeking, obtaining, providing, or facilitating reproductive healthcare where the reproductive healthcare is lawful. The 2024 final rule also prohibits disclosure of PHI to identify any person for the purpose of conducting an investigation or imposing liability. The enforcement mechanism of the 2024 final rule includes an attestation component under which a requesting party must certify that the use of the PHI is not prohibited when requested for health oversight activities, judicial or administrative proceedings, law enforcement purposes, or disclosures to coroners and medical examiners under 42 C.F.R. § 164.512. The Trump administration likely will not enforce (and may reverse) protections around reproductive health data under the 2024 final rule, which would leave a bigger gap for the states to potentially fill, as evidenced by the EO regarding enforcement of the Hyde Amendment and rollback of other Biden-era reproductive health protections.
In response to increased scrutiny of reproductive healthcare, several states have enacted laws protecting healthcare providers, patients, and others involved in providing or receiving reproductive healthcare. Although these laws vary from state to state, they generally prohibit disclosure of data and other information related to reproductive healthcare that was lawfully obtained by a patient and provided by a healthcare provider. These laws can provide a certain level of comfort to providers that provide care to patients who travel across state lines to receive care that may be unavailable to them in their home state but is accessible and lawfully provided in another state. States that do not have such laws may seek to enact similar protections under the new administration as federal protections become less certain, particularly if the layer of protection afforded by the 2024 final rule is revoked or otherwise diminished.
ABORTION POLICY WILL CONTINUE TO BE LARGELY DICTATED BY STATES AND MAY EXPAND INTO NEW AREAS OF FOCUS
Following the Dobbs decision, many states quickly took action to enshrine abortion protections in their laws and constitutions. Some states, such as Michigan, moved to overturn old, unenforced abortion bans on their books. Michigan further implemented laws, executive actions, and eventually a ballot measure to amend its state constitution. This trend has continued; in the November 2024 presidential election, seven states passed ballot measures to protect abortion access. However, the 2024 election also marked the first three abortion protection ballot referendums that failed to pass. Voters in South Dakota and Nebraska rejected proposed constitutional amendments, and a measure in Florida received only 57% of the vote where a 60% majority was required.
In the years since Dobbs, new laws and court cases have largely sorted the states into two categories: states that are more protective and states that are more restrictive regarding abortion. However, the law remains unsettled in a few states, such as Georgia and Wisconsin, where pending court cases, legislative action, and gubernatorial executive action may result in different outcomes. In the 2024 election, Missouri voters passed a ballot initiative to overturn the state’s strict ban on abortion and enshrine reproductive rights in the state constitution, effectively switching the state from more restrictive to more protective. More constitutional ballot measures could come in states such as Pennsylvania, New Mexico, Virginia, and New Hampshire, where abortion rights are currently supported under state law but not enshrined in state constitutions. Abortion advocates may also focus on Iowa, South Carolina, and Florida, where recent court decisions have largely settled the law, but further litigation is possible. Restrictive states also continue to legislate additional restrictions on access to abortion.
The majority of states can be expected to continue on their current trajectory: more protective states may continue to enact abortion protections, and more restrictive states may continue to enforce existing bans and expand prohibitions. In 2025, the focus of both protective and restrictive laws likely will continue to expand. The initial wave of post-Dobbs policymaking primarily focused on a healthcare provider’s ability to perform an abortion and a patient’s right to receive an abortion. New laws and proposals now focus on topics such as assisting others in obtaining an abortion, telehealth prescribing of abortion medications, abortion funding, abortion rights of minors, and patient data privacy.
Trump administration policies and initiatives may impact more protective states’ abilities to provide abortion services. For instance, if the Comstock Act Memo is revoked, abortion-inducing medication may become scarce or difficult to obtain through the mail, even from a provider in a protective state to a patient in another protective state. If interpreted even more broadly by the administration, the Comstock Act could serve as a catalyst for a national abortion ban, which would almost certainly face legal challenges. While the Trump administration has not yet asked Congress for a national abortion ban, the EO that Trump signed recognizing two sexes includes personhood language regarding life beginning “at conception,” signaling that additional changes may be proposed at both the federal and state policy levels regarding fetal personhood and attendant rights. Such changes would likely result in legal challenges in federal and state courts.
IVF SERVICES WILL CONTINUE TO EXPAND BUT MAY FACE FRICTION WITH ABORTION PROHIBITIONS AND CERTAIN TRUMP ADMINISTRATION PRIORITIES
State abortion laws have somewhat solidified following Dobbs, but many laws remain unclear as to their impact on IVF providers. Many states have abortion prohibitions that predate IVF, some of which define “unborn child” from the moment of fertilization or conception. Other laws are ambiguous but contain language that arguably protects a fetus at any stage of development. Since Dobbs, state attorneys general in Arkansas, Oklahoma, Wisconsin, and other states have indicated that they will not pursue IVF providers using state abortion bans, and the Trump administration has issued an EO calling for expanded access to IVF. However, the state-level laws remain ambiguous, and there is a risk that courts may interpret such laws to apply to embryos or otherwise impact IVF access. Moreover, the EO raising the issue of fetal personhood may create friction for efforts to expand access to IVF.
In February 2024, the Alabama Supreme Court became the first state supreme court to definitively rule that “unborn children” includes cryogenically frozen IVF embryos. The court held an IVF clinic liable under the state’s wrongful death statute after an incident in which frozen IVF embryos were destroyed. The decision initially caused several IVF providers in the state to pause services until two weeks later, when the legislature passed a specific exception to the statute for IVF providers. Even though the status quo was quickly restored, both providers and patients were significantly impacted by the period of uncertainty. In 2025 and beyond, other states could face similar test cases. In response to public support for reproductive technology, some restrictive states have proposed legislation to address, for example, the use of assistive reproductive technology and selective reduction.
At the same time, insurance coverage for IVF and other fertility treatments has expanded and will likely continue to do so in 2025. Approximately 22 states now mandate that insurance plans provide some combination of fertility benefits, fertility preservation, and coverage for a number of IVF cycles. After July 1, 2025, all large employers in California must provide insurance coverage for fertility treatments, including coverage for unlimited embryo transfers and up to three retrievals. 2025 will also bring expanded IVF coverage options for federal employee insurance plans.
THE RIGHT TO CONTRACEPTION WILL REMAIN VULNERABLE TO STATE LAWMAKING AND COURT CHALLENGES
Although the Dobbs majority opinion states that the “decision concerns the constitutional right to abortion and no other right,” and that “nothing in [the Dobbs] opinion should be understood to cast doubt on precedents that do not concern abortion,” doubt remains as to other women’s health rights. In his concurrence in Dobbs, Justice Clarence Thomas expressed interest in revisiting prior Supreme Court of the United States decisions upholding rights other than the right to abortion, such as the right to contraception upheld in Griswold v. Connecticut.
In response to the Thomas concurrence, the federal Right to Contraception Act was introduced. The act would have enshrined a person’s statutory right to contraception and a healthcare provider’s right to provide contraception. The act passed the US House of Representatives, but the US Senate version was unable to overcome a filibuster in June 2024. Federal efforts to protect the right to contraception are unlikely to pass in the new Congress.
Although federal action is unlikely, certain states have already protected the right to contraception under state law. Approximately 15 states and the District of Columbia currently have some form of protection for the right to contraception either by statute or under the respective state’s constitution. Under the new administration, state legislative action likely will increase with respect to the right to access contraception. Certain states with restrictive abortion policies, such as South Carolina, have proposed modifications to their abortion restrictions to explicitly protect the use of contraceptives.
WHAT STEPS SHOULD STAKEHOLDER CONSIDER TAKING?
Any company whose services touch on reproductive health or women’s health should engage in a risk assessment of their business and the ways in which the Trump administration may affect their ability to operate without complications. Although the first two months of EOs and other actions from the administration have not drastically altered the landscape for reproductive health across the country, access to reproductive and women’s health is likely to evolve over the next four years. We are closely monitoring these developments and will continue to forecast the ways in which this could impact stakeholders in the industry.
HUD’s Enforcement of the Violence Against Women Act: What Housing Providers Should Know
The Violence Against Women Act (VAWA), enacted in 1994, was most recently amended in 2022. As part of its 2022 reauthorization, the U.S. Department of Housing and Urban Development (HUD) and the Attorney General of the United States are now mandated to implement and enforce the housing provisions of VAWA consistently and in a manner that affords the same rights and remedies as those provided for in the Fair Housing Act (FHA). This is reflected in new forms updated from HUB in February 2025 regarding the protections for victims of domestic violence.
Pursuant to VAWA, anyone who has experienced domestic violence, dating violence, sexual assault, and/or stalking:
Cannot be denied admission to or assistance under a HUD-subsidized or -assisted unit or program because of VAWA violence/abuse.
Cannot be evicted from a HUD-subsidized unit or have their assistance terminated because of VAWA violence/abuse.
Cannot be denied admission, evicted, or have their assistance terminated for reasons related to the VAWA violence/abuse, such as having an eviction record, criminal history, or bad credit history related to the VAWA violence/abuse.
Must have the option to remain in their HUD-subsidized housing, even if there has been criminal activity directly related to the VAWA violence/abuse.
Can request an emergency transfer for safety reasons related to VAWA violence/abuse.
Must be allowed to move with continued assistance (if the victim has a Section 8 Housing Choice Voucher).
Must be able to self-certify using the HUD VAWA self-certification form (Form HUD-5382) and not be required to provide additional proof unless the housing provider has conflicting information about the violence/abuse.
Must receive HUD’s Notice of VAWA Housing Rights (Form HUD-5380) and HUD’s VAWA self-certification form (Form HUD-5382) from the housing provider when:
Denied admission to a HUD-subsidized unit or HUD program
Admitted to a HUD-subsidized unit or HUD program and/or
Issued a notice of eviction from a HUD-subsidized unit or a notice of termination from a HUD program.
Has a right to strict confidentiality of information regarding their status as a survivor.
Can request a lease bifurcation from the owner or landlord to remove the perpetrator from the lease or unit.
Cannot be coerced, intimidated, threatened, or retaliated against by HUD-subsidized housing providers for seeking or exercising VAWA protections.
Has the right to seek law enforcement or emergency assistance for themselves or others without being penalized by local laws or policies for these requests or because they were victims of criminal activity.
EnforcementAs such, HUD’s Office of Fair Housing and Equal Opportunity (FHEO) now enforces VAWA by accepting and investigating complaints thereunder using its FHA complaint process. If a housing provider is found by HUD to have violated VAWA and the matter is not settled via HUD’s conciliation process, HUD may refer the matter to the Department of Justice (DOJ) for litigation and/or enforcement.
HUD issued a press release regarding two settlements of VAWA cases pursuant to its enforcement authority under the VAWA Reauthorization Act of 2022 in September of 2023.
THE FIRST CASE involved a tenant in Nevada who requested an emergency transfer after being stalked by a former partner. The complaint alleged that the respondent public housing agency in Nevada and its housing specialist (a) demanded confusing and contradictory documentation from the charging party that it was not permitted to request under VAWA, (b) threatened to revoke the charging party’s Housing Choice Voucher, (c) denied her request to extend her voucher, and (d) stopped paying its portion of the rent when the charging party prepared to move to protect her safety.
HUD found that the housing authority lacked an emergency transfer plan that would allow survivors who qualify to move quickly without losing their assistance. The case settled for an agreement to implement an emergency transfer plan, to hire outside experts to provide VAWA training, and to pay the charging party monetary compensation.
THE SECOND CASE cited in the 2023 press release involved a housing provider and property manager in California who were alleged to have denied the charging party’s application due to a history of violations of previous rental agreements that were allegedly related to her status as a survivor of dating violence. The housing provider maintained that the charging party did not disclose her status as a dating violence survivor, but acknowledged that it failed to provide information about her rights under VAWA or advise her about how she might appeal when it sent her the denial letter.
This settlement agreement involved (a) some monetary amount, (b) placing the charging party on the top of a waitlist for the next available unit at the property or a companion property, (c) a revision of the housing provider’s policies to include a VAWA policy, (d) the establishment of a VAWA Rights Coordinator position, and (e) the requirement that its employees undergo annual VAWA training.
HUD issued press releases regarding two more cases it settled under VAWA in 2024.
THE FIRST CASE addressed claimed violations of VAWA as well as Section 504 of the Rehabilitation Act, which prohibits discrimination in housing for residents in communities that receive federal funding. This matter involved multiple allegations that reasonable accommodation and modification requests were denied by housing providers in Tennessee, as well as allegations of failure to provide requested VAWA transfers. In addition to non-monetary components similar to those in the cases mentioned previously, this case settled for $50,000.
THE SECOND CASE, in June 2024, involved a HUD-negotiated settlement with a Michigan housing provider alleged to have violated VAWA.. That matter involved a landlord who allegedly did not respond to the charging party’s rental application due to her vision impairment and because she disclosed that a previous landlord had terminated her tenancy due to dating violence and stalking. The monetary component of that settlement agreement was $8,500, in addition to VAWA-related training and an agreement to ensure that the housing provider’s policies and procedures complied with VAWA.
TakeawaysAs noted above, housing providers should ensure that their employees are familiar with VAWA requirements and should incorporate these requirements into their regular fair housing training sessions. They also should take advantage of the website HUD released in 2023 to help navigate VAWA’s housing protections, as it features the latest updates, frequently asked questions about VAWA, and VAWA training resources. It appears that HUD’s enforcement of rights of domestic violence victims to housing pursuant to VAWA will continue to grow absent an indication from the new HUD Secretary of a change in this policy, which to date has not been announced.
A Final Rule Bites the Dust: Federal Court Rules FDA Lacks Authority to Regulate LDTs
The order is in, and the LDT Final Rule is out.
In May 2024, the U.S. Food & Drug Administration (“FDA” or the “Agency”) published its Final Rule establishing its regulatory framework over laboratory developed tests (“LDTs”) as medical devices and, in effect, announced the end to decades of enforcement discretion by the Agency. The deadline to comply with the first phase of the Final Rule was set for May 6, 2025. On Monday, March 31, however, a federal judge in the U.S. Eastern District of Texas ordered that “FDA’s final rule exceeds its authority and is unlawful” and that “[t]herefore, consistent with controlling circuit precedent, the proper remedy is vacatur of the final rule and remand to FDA for further consideration in light of this opinion.”
Epstein Becker & Green’s Life Sciences Team is continuing to review and digest this order and its impact on the clinical lab industry, and we plan to release a more fulsome analysis in the coming days.
In the meantime, we draw stakeholders’ attention to a few key takeaways from the order—namely, the judge’s statement that (1) “the [federal Food, Drug, & Cosmetic Act]’s relevant text is unambiguous and cannot support FDA’s interpretation” and (2) “FDA’s asserted jurisdiction over laboratory-developed test services as ‘devices’ under the FDCA defies bedrock principles of statutory interpretation, common sense, and longstanding industry practice.”
These findings—along with other elements of the district court’s legal analysis—arguably leave little to no room for FDA to salvage its effort to regulate LDTs, absent either a successful appeal of the court’s order or congressional action.
We Never Know How High We Are Until We Are Called to Rise: Protecting Alabama’s Medical Cannabis Program
There’s a great scene in the movie Wall Street when the up-and-coming Charlie Sheen (pre-Tiger Blood and now that I think about it maybe the precursor to the “winning!” mantra that seems to resonate today) is playing the role of Bud Fox, an eager trader looking to land a job with the biggest whale of them all, Gordon Gecko (played perhaps only as peak Michael Douglas could). Right before his one and only shot at impressing Gecko, Bud looks into the mirror, straightens his tie, fixes his hair, and says “life comes down to a few moments; this is one of them.”
At the risk of being slightly melodramatic, I’m reminded of that scene when I take stock of Alabama’s medical cannabis program as it sits at the intersection of a narrowing legislative window and a judicial proceeding on the brink of success (or failure).
A brief recap of where we stand at this moment. First, on the court side:
Earlier this month, the Alabama Court of Civil Appeals ruled that the Montgomery County Circuit Court lacked jurisdiction to hear the complaints of Alabama Always – an applicant for a medical cannabis license that has not been awarded a license during any of the three rounds of awards – because Alabama Always (and, presumably by extension, any other disappointed applicant for an integrated facility license) had not exhausted its administrative remedies before filing suit. As a result, the Alabama Court of Civil Appeals instructed the circuit court to lift the injunction prohibiting the AMCC from issuing integrated licenses.
And to the Legislature, we recently wrote:
As has become an annual tradition as the medical cannabis program has been in existence, there are a number of proposals currently pending in the Legislature that purport to fix what ails the program.
Sen. Tim Melson has introduced a substitute to Senate Bill 72. As a reminder, the original version of SB72 would have, in relevant part: (1) expanded the total number of integrated licenses from five to seven; (2) shifted the authority of issuing licenses from the AMCC to a consultant; and (3) shielded the decision from any judicial review. And, just as important, licenses wouldn’t be issued until well into 2026, assuming there was no litigation – an assumption I defy any serious person to tell me with a straight face is valid.
After unanimous public disapproval of the proposal, Sen. Melson introduced a substitute bill that would change the agencies tasked with appointing the consultant and would allow for the Alabama Court of Civil Appeals to review the award of licenses if the award was arbitrary or capricious or constituted a gross abuse of discretion. It would also move up the time to issue licenses, but it would still be in 2026, again assuming no lawsuits. While the substitute is a small step in the right direction and an acknowledgment of the flaws in the original bill, I still do not see it as the right path forward.
And here’s why: I reject that Alabama’s medical cannabis program requires a “legislative fix.” I believe that the original medical cannabis law, passed four years ago, isn’t broken.
In light of the Court of Civil Appeals’ decision, we may be mere months away from issuing licenses to dispensaries and integrated facilities.
Once a single dispensary license is issued, Alabama doctors can begin obtaining certifications to qualify patients for medical cannabis and Alabamians with qualifying conditions can begin to obtain medical cannabis cards. So, if you believe that the appellate court offers a path forward that may allow medical cannabis in 2025, why would you press for a bill that would ensure that it isn’t? Put simply, if it ain’t broke, don’t legislatively “fix” it.
Loyal readers of Budding Trends will recall that multiple proposals were voted out of the same committee last legislative session and did not become law. They will also recall that it took more than one legislative session to pass a medical cannabis law in the first place. Is past prologue or is this another example of reform taking time?
Sometimes the hardest course of correct action is inaction. I don’t blame anyone who looks around at Alabama’s medical cannabis landscape and thinks that something (anything) has to be done to fix what they see as a broken program. But I think they are wrong.
I believe that any efforts to engage in any sort of purported compromise legislation, no matter how well-intentioned those proposals may be, is doing a disservice to all applicants and the patients seeking access to medical cannabis in Alabama. The reasoning is simple: If both sides propose legislative changes, then both sides are at least implicitly agreeing that something needs to be done by the Legislature. I reject that premise. I think we are currently on the precipice of launching a medical cannabis program. The appellate courts appear unwilling to abide any further delays from the lower court, and investigative hearings should begin soon. That would allow for the possibility of all licenses being issued in 2025, when the so-called legislative fixes being proposed push us into 2026 at the earliest. Hold the line. Stay the course. And let’s get this program launched. Onward. Forward.
As always, thanks for stopping by.
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FDA’s New Transparency Tool Addresses Chemical Contaminants
Recently, the Food and Drug Administration (FDA) introduced a new online resource called the Chemical Contaminants Transparency Tool (CCT Tool) which allows the public to search for information about different chemical contaminants that may be found in human food. This online, searchable database provides a consolidated list of contaminant levels such as tolerances, action levels, and guidance levels used to evaluate potential health risks in human foods. This tool is part of the FDA’s efforts to modernize food chemical safety and has been launched as part of the administration’s Make America Healthy Again initiative.
Key Features and Objectives of the Transparency Tool
Prior to launch of the CCT tool, tolerances, action levels, guidance levels, derived intervention levels, recommended maximum levels, and advisory levels were to be found (or defined) in 21 C.F.R. parts 109 and 509, and also in guidances for industry. The CCT Tool consolidates this information into one resource, with the goal of making it easier to find information about the contaminants by commodity type.
Here is a snapshot of some data available through the tool:
The levels above show the safety limits for contaminants in food, but do not imply that the presence of these chemical at the specified level is necessarily permissible. FDA’s prior guidances on these chemicals remains an important resource to understand the levels shown in the chart. As explained by acting FDA Commissioner Sara Brenner, M.D., M.P.H., “While it’s ideal to have no contaminants in our food, they can sometimes occur. Eating a variety of nutrient-rich foods from all major groups – vegetables, fruits, grains, dairy, and protein – can help minimize exposure.”
The introduction of the CCT Tool is a useful reminder of the importance of compliance for food manufacturers and distributors. It also highlights the new administration’s focus on transparency for and within the food system, and could be a harbinger of new tools that FDA may develop as part of the new administration’s goals.
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FDA Announces “Operation Stork Speed”
On March 18, 2025, FDA announced that, at the direction of Health and Human Services Secretary Robert F. Kennedy Jr., it is “taking steps to enhance its efforts to ensure the ongoing quality, safety and nutritional adequacy” of infant formula products as part of a broader review of the U.S. food supply, in what is being referred to as “Operation Stork Speed.”
Key measures include:
Nutrient Review: FDA will soon issue a Request for Information to begin a comprehensive review of infant formula nutrients.
Increased Testing: There will be increased testing for heavy metals and other contaminants in infant formula and other foods consumed by children.
Encouraging Innovation: FDA is urging companies to develop new infant formulas and improve transparency in labeling to better inform consumers and will collaborate with the National Institutes of Health on researching the long-term health outcomes associated with formula feeding of infants.
The announcement comes as part of a broader effort to stabilize the supply of infant formula following severe shortages in 2022. FDA has since implemented a national strategy to increase the resilience of the U.S. infant formula market, including measures to prevent future shortages and improve the integrity of the supply chain. Operation Stork Speed builds on these efforts, aiming to ensure that families have access to safe and nutritious formula for their infants.
Effective Risk Management for Nursing Facilities: Insurance Insights on Retaliation Claims
This is the first in a series of articles addressing critical issues in risk management and insurance for skilled nursing facilities.
Owners and operators of skilled nursing facilities know that a claim or lawsuit against their facility is not a matter of if, but when. Procuring the proper insurance is critical to effectively managing and mitigating these risks. A professional liability insurance policy should provide coverage for the facility and its directors, administrators, and employees from claims of negligent care.
Unfortunately, merely purchasing a professional liability policy without further scrutiny can leave a facility uninsured for certain claims. These policies incorporate exclusions and conditions that insurers could cite to attempt to limit coverage, particularly for claims that allege intentional injury to a patient resident. For example, an injured patient could allege that her injury was not the result of mere negligence, but instead resulted from retaliation by the facility or the facility’s employee in response to a prior complaint. These retaliation claims pose an increased risk to a facility and its insurance coverage, regardless of whether they are alleged as an intentional tort under a state’s common law or as a violation of a state’s anti-retaliation statute.
In states where retaliation is specifically barred by statute, state laws can create additional liability and damages exposure for claims brought by residents who file formal complaints or bring regulatory actions against nursing facilities alleging retaliation. Earlier this year, for example, the Illinois Legislature passed a new anti-retaliation statute for nursing facilities, House Bill 2474, that broadens the scope of anti-retaliation protections. The Illinois bill, which has passed both houses and been sent to the governor’s office for signature, does not require a formal complaint, but can be triggered by a resident taking more informal action, such as making a request to the facility related to the resident’s care. In addition to potential liability for consequential damages, Illinois HB 2474 also makes nursing facilities liable to the plaintiff for attorneys’ fees and additional damages “in an amount equal to the average monthly billing rate for Medicaid recipients in the facility.” The damage provisions of Illinois HB 2474 differentiate it from other broad anti-retaliation statutes. For example, Minnesota expanded its Patients’ Bill of Rights in 2020 to protect nursing facility residents from retaliation for a host of actions, including advocating “for necessary or improved care or services” (M.S.A. § 144.6512). However, Minnesota’s statute does not provide for a private cause of action for residents to sue the facility.
Even if a state’s anti-retaliation statute does not specify additional damages or provide a private cause of action, retaliation claims brought as common law torts can nevertheless pose the risk of enhanced damages based on the facility’s perceived culpability – a risk not found in ordinary negligence actions.
Retaliation claims are a significant and thorny example of circumstances where allegations of negligent and intentional conduct can intertwine. Unless a statute identifies certain acts that constitute retaliation per se, the patient must necessarily prove an intent to retaliate – retaliation cannot be the result of mere negligence. But ordinary negligence and intentional retaliation could manifest in factually identical ways – with intent being the only distinguishing factor. For example, a resident allegedly injured in a fall while being helped out of bed by a facility employee could assert negligence. But if that same resident had complained to management about the quality of their care prior to the fall, the resident could also allege retaliation, asserting that they were allowed to fall in retaliation for the complaint.
Insurers could seize on retaliation allegations to deny coverage under several exclusions, including exclusions for expected and intended conduct and for willful violations of laws or regulations. Depending on the scope of the policy exclusions, insurers could assert that otherwise insured negligence claims are excluded retaliation claims.
To maximize the potential coverage for claims of retaliation or other intentional conduct bolted on to ordinary negligence claims, insureds should understand that the expected and intended exclusion does not exclude claims that an insured acted intentionally; the insurer must also prove that the insured intended to cause the alleged harm. Unfortunately, a retaliation claim arguably alleges that intent to cause harm if the actions can be attributed to the insured entity or individual.
Insureds can take four steps to mitigate anticipated insurer defenses to coverage for retaliation claims:
First, insureds should seek language limiting the intentional conduct exclusion. The best limiting language would require a final adjudication of intentional conduct at trial (and after exhaustion of all appeals). Insurers could not invoke this exclusion in cases settled before trial.
Second, insureds should confirm that any exclusions based on alleged willful statutory violations do not inadvertently encompass statutory retaliation claims.
Third, because insurers may attempt to allocate liability among the negligence and retaliation claims to reduce their obligations for a settlement prior to trial, insureds should insist on favorable allocation provisions that do not leave the allocation to insurers’ discretion but instead require reasonable allocation based on an objective assessment of the claim.
Finally, insureds should insist on policy provisions requiring the insurer to defend (or preferably pay the defense of) all asserted claims – including arguably excluded claims – as long as at least one claim potentially falls within coverage.
These four steps will provide insureds with additional insurance protection against statutory retaliation claims by limiting the defenses that insurers could otherwise assert in response to these claims. And as always, policyholders should scrutinize their professional liability insurance policies during renewal to maximize the coverage available to them. Many coverage enhancements do not impact premium – but they do require insureds’ diligence and awareness of coverage quagmires before binding insurance, as this discussion of retaliation claims shows.
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What Would John Wilkes Booth Do? Mandatory COVID Vaxes for Actors
Although the threat of COVID-19 (remember that?) seems to have diminished considerably over the past five years, once upon a time in Hollywood many production companies (along with other employers) required employees to be vaccinated upon pain of losing their job.
In early 2022, Apple Studios LLC conditionally offered actor Brent Sexton the role of U.S. President Andrew Johnson in its production of Manhunt, a limited series about the hunt for John Wilkes Booth following the assassination of Abraham Lincoln. One of the conditions for Sexton’s casting was that he be fully vaccinated, in compliance with Apple’s mandatory on-set vaccination policy. Sexton refused to get vaccinated, seeking an exemption on medical grounds. After considering Sexton’s request, Apple ultimately decided that an unvaccinated actor could not safely be accommodated on set and withdrew Sexton’s offer. Sexton sued Apple for disability discrimination and related claims.
In response, Apple filed a motion to strike Sexton’s complaint under California’s anti-Strategic Lawsuit Against Public Participation (“anti-SLAPP”) law, which authorizes early dismissal of “lawsuits brought primarily to chill the valid exercise of the constitutional rights of freedom of speech and petition for the redress of grievances.” The trial court denied Apple’s motion, but the Court of Appeal reversed, holding that (1) Apple’s decision not to cast Sexton was in fact “protected expressive conduct” under the First Amendment; and (2) Sexton’s claims lacked merit because, by remaining unvaccinated, he failed to meet the “safety” qualification required for the job he sought.
To Jab, or Not to Jab: That Is the Question
The Court found that Apple’s decision not to cast Sexton furthered free speech in two ways. First, the choice of how to portray Andrew Johnson—a controversial and important historical figure—was a creative endeavor in and of itself, with the selection of different actors “contribut[ing] to the public issue of how contemporary viewers might conceive of Johnson.” Second, by making vaccination mandatory on the Manhunt set, “Apple took a stand” on the still-live public debate about vaccination policy.
While legal protections for casting decisions is a remote issue for most employers, the second “speech” element that the Court identified in Apple’s conduct—its decision to make vaccines mandatory on the Manhunt set—has potentially sweeping implications. Noting that there is still “a public debate over vaccination policy,” the Court found that by implementing and enforcing an on-set vaccine mandate, Apple “contributed to public discussion of vaccination policy.”
“Safety” as a Bona Fide Occupational Qualification?
In addition to finding Apple’s actions protected as expressive conduct, the Court also concluded that Sexton’s discrimination claims failed on the merits. A key element for a meritorious employment discrimination claim is that the plaintiff must show that they are qualified for the position. Here, the Court found that, because Sexton was unvaccinated, he was not qualified for the job he sought. How this decision will be harmonized with established case law on religious and medical exemptions remains to be seen. As always, we will continue to monitor this topic for any updates. (In the meantime, Manhunt (which is excellent!) is still streaming, featuring actor Glenn Morshower in the role of Andrew Johnson.)
Pedestrian Fatalities Up Almost Half from a Decade Ago
During the first half of 2024, drivers killed 3,304 pedestrians in the United States, a 2.6% decrease from the same period in 2023, according to a new study from the Governors Highway Safety Association (GHSA). However, this decline does not overshadow the alarming trend of rising pedestrian fatalities over the past decade, which have increased by 48% since 2014, translating to 1,072 more deaths.
Pedestrian Fatality Trends
Each year, the GHSA releases the first comprehensive look at pedestrian traffic death trends for the first six months of the year, using preliminary data from State Highway Safety Offices (SHSOs). The analysis indicates that while pedestrian fatalities decreased slightly from last year, they remain 12% higher than in 2019, emphasizing a concerning trajectory for road safety.
The slight decrease in pedestrian fatalities in early 2024 aligns with a broader trend in overall traffic deaths. According to the National Highway Traffic Safety Administration (NHTSA), total roadway fatalities dropped 3.2% during the first half of 2023. Nevertheless, the overall numbers remain significantly higher than those recorded five and ten years ago. In the first half of 2024, there were 18,720 roadway deaths, showing a 10% increase from 17,025 in the same period of 2019 and a 25% rise from 15,035 in 2014.
At the state level, the GHSA report reveals mixed results: pedestrian fatalities decreased in 22 states, while 23 states and the District of Columbia (D.C.) saw increases. Five states reported no change in their numbers. Notably, seven states experienced consecutive decreases in pedestrian fatalities, whereas four states faced two significant increases.
Why Are Roads So Dangerous for Pedestrians?
There is a combination of factors contributing to this rising danger for pedestrians. A decline in traffic enforcement since 2020 has allowed dangerous driving behaviors—such as speeding, distracted driving, and driving under the influence—to grow rapidly. Additionally, many roadways are designed primarily for fast-moving vehicles, often neglecting the needs of pedestrians. Many communities lack infrastructure – such as missing sidewalks and poorly lit crosswalks – that also help protect pedestrians. Furthermore, the growing presence of larger, heavier vehicles on roads increases the risk of severe injuries or fatalities in pedestrian accidents.
What Can Be Done?
To tackle this pedestrian safety crisis, the GHSA advocates for an approach that establishes a strong safety net that can protect everyone on the road. A crucial part of this strategy is traffic enforcement focused on dangerous driving behaviors – like speeding, and impaired or distracted driving – that disproportionately endanger pedestrians.
In summary, while there are signs of progress in addressing pedestrian safety, the statistics reveal a pressing need for ongoing efforts to protect those who walk on our roads. By strengthening enforcement, improving infrastructure, and promoting safe practices among both drivers and pedestrians, we can work toward reversing this tragic trend and ensuring safer streets for everyone.
HHS Job Cuts: FDA, CDC, NIH and CMS Impacted Amidst Significant Restructurings
On March 27, 2025, the United States Department of Health and Human Services (HHS) announced a “dramatic restructuring” that will result in a reduction in agency workforce combined with significant internal restructuring.1 The department plans to cut approximately 20,000 positions, bringing its headcount in line with HHS’s pre-2002 level of around 62,000 employees. The anticipated restructuring involves consolidating 28 divisions into 15, citing prior budget and staffing increases of 38 percent and 17 percent, respectively.2
In connection with this restructuring, the Administration announced the following changes:
Creation of the Administration for a Healthy America (AHA), which will consolidate the Office of the Assistant Secretary for Health (OASH), the Health Resources and Services Administration (HRSA), the Substance Abuse and Mental Health Services Administration (SAMHSA), the Agency for Toxic Substances and Disease Registry (ATSDR) and the National Institute for Occupational Safety and Health (NIOSH);
Transfer of the Administration for Strategic Preparedness and Response (ASPR) to the Centers for Disease Control (CDC);
Creation of a new Assistant Secretary for Enforcement to oversee the Departmental Appeals Board (DAB), Office of Medicare Hearings and Appeals (OMHA) and Office for Civil Rights (OCR);
Merging the Assistant Secretary for Planning and Evaluation (ASPE) with the Agency for Healthcare Research and Quality (AHRQ) to create a new Office of Strategy to provide research enhancing HHS’s various initiatives;
Reorganizing the Administration for Community Living (ACL) programs that support older adults and people of all ages with disabilities into other parts of HHS; and
10 HHS Regional Offices will be consolidated into 5.3
These cuts and restructurings follow the February 11, 2025, Executive Order which placed much of the federal government’s human resource management under the purview of the Department of Government Efficiency (DOGE)4 and the February 12, 2025 termination of “Fork in the Road,” a deferred resignation program for government employees.5 This latest announcement adds to the growing number of federal staff reductions—62,000 jobs were cut across 17 different agencies in February alone.6 With HHS’s designation of a new Assistant Secretary of Enforcement to combat purported fraud, waste and abuse across its divisions, more job cuts could be on the horizon.
As a result of this latest announcement, the anticipated amount of job cuts and resulting reduced employee pools are as follows: the U.S. Food and Drug Administration (FDA) will cut 3,500 employees (about 20 percent of its workforce); the Centers for Disease Control and Prevention (CDC) will cut 2,400 employees; the Centers for Medicare and Medicaid Services (CMS) will cut 300 employees; and the National Institutes of Health (NIH) will cut 1,200 employees. These cuts, along with another 2,600 employees slated for dismissal, amount to a total of 10,000 HHS jobs cut. These cuts, combined with another 10,000 employees who have left the agency due to buyouts or other voluntary resignations, add up to the 20,000 total employee reduction.7
Potential Impacts
The sweeping job cuts, department re-organization and consolidation are in line with Secretary Kennedy’s vision of “doing more with less” resources, while a former HHS employee anonymously expressed concerns that “the cuts will weigh heavily on caseworkers and account management teams,” ultimately leading to a declination in “[s]ervice standards for Medicare Advantage beneficiaries,” due to both “a reduction in the people that handle their cases” and “diminished oversight of the Medicare Advantage plans.”8
Healthcare providers and other organizations that rely on regular interaction with HHS and its subagencies should be on the lookout for disruptions or delays in service as HHS implements these cuts and departmental reorganizations. For example, several senior FDA drug reviewers have already announced their resignations, and more are expected, raising the distinct possibility that the FDA’s ability to perform its public health functions will be impaired.9 The full impact of the March 27th announcements will not be known for some time, but potentially impacted stakeholders should keep a watchful eye over the coming months as HHS implements the announced changes.
[1] U.S. Dep’t of Health and Human Servs., HHS Announces Transformation to Make America Healthy Again (Mar. 27, 2025), https://www.hhs.gov/about/news/hhs-restructuring-doge.html.
[2] U.S. Dep’t of Health and Human Servs., Fact Sheet: HHS’ Transformation to Make America Healthy Again (Mar. 27, 2025), https://www.hhs.gov/about/news/hhs-restructuring-doge-fact-sheet.html.
[3] Id.
[4] Exec. Order No. 14,210, 90 Fed. Reg. 9669 (Feb. 14, 2025); see also Exec. Off. of the President, Implementing The President’s “Department of Government Efficiency” Workforce Optimization Initiative (Feb. 11, 2025), https://www.whitehouse.gov/presidential-actions/2025/02/implementing-the-presidents-department-of-government-efficiency-workforce-optimization-initiative/.
[5] U.S. Off. of Pers. Mgmt., Fork in the Road: Program Closed, https://www.opm.gov/fork/ (last visited Mar. 27, 2025).
[6] Janet Nguyen, Federal workers’ salaries represent less than 5% of federal spending and 1% of GDP, Marketplace (Mar. 6, 2025), https://www.marketplace.org/2025/03/06/federal-workers-salaries-represent-less-than-5-of-federal-spending-and-1-of-gdp/.
[7] Phil Taylor, HHS plans 10,000 more job cuts, taking target to 20,000, pharmaphorum (Mar. 27, 2025), https://pharmaphorum.com/news/hhs-plans-10000-more-job-cuts-taking-target-20000.
[8] Meg Tirrell et al., HHS cuts 10,000 employees in major overhaul of health agencies, CNN (Mar. 27, 2025, 6:46 PM), https://www.cnn.com/2025/03/27/health/hhs-rfk-job-cuts/index.html.
[9] See @steveusdin1, X (Mar. 27, 2025, 4:54 PM), https://x.com/steveusdin1/status/1905377827836624915.