New Agreement to Accelerate Importation of Health Products Through PAHO
On June 11, 2025, was published in the DOF the “AGREEMENT recognizing as equivalent the requirements established in the Health Regulation and the technical evaluation procedures carried out by the Federal Commission for the Protection against Sanitary Risks for the granting of the marketing authorization of health products, to the requirements, tests and evaluation procedures carried out by the regulatory authorities of reference to allow the sale, distribution and use of health products in their country, and to the evaluations of the World Health Organization’s Prequalification Program, as well as the criteria for the importation of products for the treatment of emerging, unattended diseases or in cases of national emergency“.
The Agreement establishes the criteria for the importation of products for the treatment of emerging and unattended diseases or in situations of national emergency. Among its provisions, it highlights that certain products such as vaccines, medicines and medical devices may be acquired by the Ministry of Health through the Strategic Fund and the Revolving Fund of the Pan American Health Organization (PAHO), without the need to have a marketing authorization in Mexico.
It should be recalled that this is not the first agreement of this nature, the last similar agreement was published in the DOF on December 4, 2024, “AGREEMENT to obtain the import permit for health products destined to guarantee the supply of the public sector”, which allows obtaining more expedited import permits for products that already have a marketing authorization or sanitary registration issued by recognized regulatory authorities. (See our newsletter editions: SEP 19, 2024; FEB 2020; JUN 30, 2021).
In comparison, the new pathway through PAHO could represent an even more expeditious mechanism to try to “secure” the health sector’s supply in priority cases than the one established by the agreement of December 4, 2024. In addition, this new agreement leaves without effect those previously published on March 29, 2019, January 28, 2020, and the June 22, 2021, amendment, although it does not repeal the December 4, 2024, agreement.
This new agreement does not define or specify the terms “emerging or neglected diseases or cases of national emergency”, nor does it clearly establish the timeframe or the conditions for its application, which generates uncertainty regarding the scope and operability of the Agreement. Likewise, there is a possible affectation due to possible conditions of competitive disadvantage, discrimination and inequity to the suppliers of health products, due to the entry of products acquired from PAHO, at their discretion.
HSE Begins Public Consultation on CLP Reform Proposal
The United Kingdom’s (UK) Health & Safety Executive (HSE) has begun a public consultation on a legislative proposal to reform the Great Britain (GB) Classification, Labelling and Packaging (CLP) Regulation. HSE notes that GB CLP Article 37 links mandatory classification and labeling (MCL) in GB to evaluation activity in the European Union’s (EU) harmonized classification and labeling (CLH) system by creating a statutory obligation to consider the European Chemicals Agency’s (ECHA) Committee for Risk Assessment’s (RAC) opinions on harmonized classification proposals made under the EU CLP. This consideration is required “even for those which consider substances or hazard classes not authorised for use in GB.” The requirement to consider RAC opinions that are not relevant to GB adds additional burdens for the regulator and is exacerbated by the recent EU CLP revisions. The European Commission (EC) introduced six new hazard classes into the EU CLP, and these classes are prioritized for consideration under the EU CLH system. HSE states that this revision to the EU CLP “will result in a greater proportion of RAC opinions featuring non-GB CLP hazard classes.” HSE notes that the statutory timelines in Article 37 of the GB CLP are currently triggered when a RAC opinion is published, “requiring evaluations to be sequenced by the RAC opinion publication date determined for the EU.” According to HSE, the current timelines restrict its ability to prioritize its GB MCL evaluation work appropriately and to provide regulatory clarity to a timescale dictated by relevance to the GB market.
HSE states that it believes amending the GB CLP is necessary to provide greater certainty for duty holders and to ensure that future GB MCL evaluation activity can be delivered “predictably and sustainably.” HSE proposes to consolidate GB CLP Articles 37 and 37A into one procedure under which MCL proposals would be evaluated, thereby simplifying the process for substance and mixture classification in GB. HSE notes that the consolidated procedure would include a fast-track evaluation pathway for assessing classification proposals from territories that adopt the United Nations (UN) Globally Harmonized System of Classification and Labelling of Chemicals (GHS).and have a transparent classification process. Classification proposals from jurisdictions that do not adopt the UN GHS and do not have a transparent classification process would be evaluated under a full process, similar to that currently described in Article 37A. HSE provides a flowchart showing a possible route to fast-track evaluation for assessing classification proposals from UN GHS adopting territories that have a transparent classification process:
HSE also proposes to omit from the consolidated procedure the legal requirement for it to send a copy of its ministerial recommendation to devolved government (DG) ministers. According to HSE, “[t]his would reduce the administrative burdens arising from this aspect of delivery of the GB MCL system and ensure that resource is used proportionately.” HSE notes that it “remains committed to the evaluation of classification proposals that focus on carcinogenic, mutagenic, reproductive toxic and respiratory sensitising hazards” and states that these proposals would be prioritized for fast-track evaluation where they originate from the EU. Comments are due August 18, 2025.
Federal Court Nullifies HHS Rule Granting Extra Protections to Reproductive Health Information
On June 18, 2025, a federal district court struck down a regulation from the U.S. Department of Health and Human Services (HHS) that restricted disclosure of reproductive health information in connection with investigations and prosecutions of patients who receive, or people who help them receive, reproductive health care.
Quick Hits
The U.S. District Court for the Northern District of Texas recently invalidated an HHS rule that imposed additional limits and conditions on disclosure of a person’s reproductive health information for the purpose of criminal and civil investigations and prosecutions.
The court ruled that health plans and healthcare providers can disclose a person’s reproductive health information to comply with state reporting mandates.
The court left intact part of the regulations that implemented notice of privacy practices requirements for Part 2 substance abuse disorder protections.
On June 18, 2025, the U.S. District Court for the Northern District of Texas struck down a 2024 HHS rule that bestowed extra privacy protections on reproductive health information that is personally identifiable. The ruling applies nationwide.
As a result, the modifications to the privacy rule under the federal Health Insurance Portability and Accountability Act (HIPAA) that further limited situations in which health plans and healthcare providers could disclose reproductive health information in the context of criminal or civil prosecutions is no longer in effect.
In Purl v. U.S. Department of Health and Human Services, the court reasoned that the HHS rule is “contrary to law” because it “unlawfully limits” state public health laws. In particular, the court found the HHS rule “impermissibly redefines ‘person’ and ‘public health’ in contravention of federal law and in excess of statutory authority.” Furthermore, the court stated, “HHS regulations cannot preempt a contrary state law with more stringent health-information protection requirements.”
HIPAA states that federal law does not “invalidate or limit the authority, power, or procedures established under any law providing for the reporting of disease or injury, child abuse, birth, or death, public health surveillance, or public health investigation or intervention.”
In this case, a healthcare clinic owner in Texas sued, claiming the HHS rule impaired her ability to fulfill a state-mandated obligation to report child abuse to authorities. Many states mandate that certain professions, such as teachers, social workers, and healthcare providers, report to the police when they have reasonable cause to suspect child abuse or child neglect.
Background on the Rule
The HIPAA Privacy Rule to Support Reproductive Health Care Privacy took effect on June 25, 2024, and covered entities were required to comply by December 23, 2024.
That regulation was published after the Supreme Court of the United States decided in 2022, in Dobbs v. Jackson Women’s Health Organization, that states could ban abortions. A few states passed laws to permit criminal charges against women for getting an abortion, or against individuals who helped women travel to obtain an abortion. In response, the Biden administration issued an executive order requiring HHS to find methods to protect and expand access to reproductive healthcare services. HHS issued regulations to restrict the disclosure of reproductive health information for certain purposes.
The final rule specifically added “reproductive health care” to the types of medical information protected by HIPAA, if the medical care was lawful where and when it was provided. This term includes abortion, contraception, emergency contraception, pregnancy-related conditions, miscarriage management, and infertility diagnosis and treatment.
The final rule restricted HIPAA-regulated entities when disclosing reproductive health information for the following purposes:
to conduct a criminal, civil, or administrative investigation;
to impose criminal, civil, or administrative liability on a person for seeking, obtaining, providing, or facilitating reproductive health care; or
to identify any person for the purpose of conducting such an investigation or imposing such a liability.
At least sixteen states challenged the final rule in court. They argued the Biden-era rule exceeded HHS’s statutory authority and unlawfully restricted state-mandated reporting obligations, particularly those related to child abuse. The Trump administration revoked the previous executive order but has issued no further guidance. As of the date of publication, HHS has flagged the court’s vacatur of most of the regulations and the retention of the Part 2 provisions related to the notice of privacy practices, and it has stated that it “will determine next steps after a thorough review of the court’s decision.”
Next Steps
HIPAA-regulated entities may wish to review their policies and practices related to disclosing information about reproductive health care, including abortion. Pursuant to Purl v. U.S. Department of Health and Human Services, they will not be held liable for revealing a person’s reproductive health information to cooperate with a criminal or civil investigation.
The court decision upheld one part of the 2024 final rule that required HIPAA-regulated entities to communicate Part 2 requirements, when applicable, to obtain written consent before disclosing any information that identifies an individual as having a substance use disorder. Thus, health plans and healthcare providers are still required to amend their notice of privacy practices by February 16, 2026, to comply with the regulation related to Part 2’s substance use disorder information requirements.
McDermott+ Check-Up – June 27, 2025
THIS WEEK’S DOSE
Senate Reconciliation Process Continues. Republicans are adjusting language to comply with Senate rules and appease various wings of the party.
HHS Secretary Kennedy Testifies at House Energy and Commerce Health Subcommittee. Secretary Kennedy was there to address the US Department of Health and Human Services (HHS) fiscal year (FY) 2026 budget request, which contains a large restructuring effort.
House Ways and Means Committee Holds Hearing on Digital Health Data. The conversation highlighted the role of wearable technology.
Senate HELP Committee Considers CDC Director Nomination. Dr. Susan Monarez is nominated to be Centers for Disease Control and Prevention (CDC) director.
House Appropriations Committee Advances FDA Spending Bill. The bill includes significant cuts to the US Food and Drug Administration (FDA), among other provisions.
House Budget Committee Examines Waste and Fraud. The focus was on the dignity of work and the utility of work requirements.
CMS Releases ACA Program Integrity Final Rule. The Centers for Medicare and Medicaid Services (CMS) rule related to Affordable Care Act (ACA) marketplaces was largely finalized as proposed, although it is only effective for plan year 2026.
CMS Announces Industry Commitment to Fix Prior Authorization. Participating health insurers voluntarily pledged to implement six changes to their prior authorization practices.
Office of Science and Technology Policy Issues Guidance on Science Standards. The guidance implements an executive order on the same subject.
Major SCOTUS Rulings Released. The Supreme Court of the United States (SCOTUS) released opinions related to Planned Parenthood, the US Preventive Services Task Force (USPSTF), and nationwide injunctions.
CONGRESS
Senate Reconciliation Process Continues. Language from committees has been undergoing the “Byrd Bath,” which is when the majority and minority parties bring their disputes forward to the Senate parliamentarian over which provisions are “extraneous” and therefore not allowed to be included in the reconciliation bill. The parliamentarian is a non-partisan official who advises the Senate on rules and procedural issues. If she determines that a provision – large or small – does not meet the Byrd rule test, it can be struck from the bill. For more information on the Byrd rule, read our +Insight.
At the same time, Republican leadership has also been working to address other concerns that various Republican senators have with the bill. Senate Majority Leader Thune (R-SD) and House Speaker Johnson (R-LA) have received several letters about the Senate’s proposed changes to the House-passed bill, including a group of 16 moderate House Republicans expressing concern with the Senate’s Medicaid provisions related to the provider tax and state directed payments, and a group of 24 House Republicans asking to reinstate the health savings account provisions that were included in the House-passed bill. In an attempt to assuage worries about the coverage losses, House Budget Committee Chair Arrington (R-TX) and House Energy and Commerce Committee Chair Guthrie (R-KY) requested an additional analysis of the population that would become uninsured because of this bill. The Congressional Budget Office found that of the 7.8 million uninsured individuals in 2034:
4.8 million would be able-bodied adults, ages 19 – 64, who have no dependents and do not meet the proposed work requirements.
1.4 million would be individuals who would not meet proposed immigration status requirements.
2.2 million would become uninsured due to other provisions, including verification of eligibility proposals.
To understand the health provisions at risk from the Byrd Bath, view these press releases from the Budget Committee Democrats: Senate Finance Committee provisions and Senate HELP Committee provisions. Importantly, it is possible that the language can be modified to address the concerns of the parliamentarian in certain cases. That means the ultimate outcome of these provisions remains uncertain.
The changes include:
Provider Taxes. The parliamentarian ruled that this provision is subject to the Byrd rule. The Senate text stated that provider taxes would be frozen at current rates, but starting in 2027, Medicaid expansion states would see their hold-harmless threshold incrementally decrease from 6% to 3.5% by 2031.
Medicaid Spread Pricing. The parliamentarian ruled that this provision is subject to the Byrd rule. This section would have required Medicaid managed care contracts with pharmacy benefit managers to adopt state reimbursement methodologies for pharmacy reimbursement.
Immigration Status and Eligibility. Several provisions related to immigrant utilization of benefits were ruled subject to the Byrd rule, including provisions that limited eligibility for Medicaid, advanced premium tax credits, and Medicare for certain legal non-citizens, required Medicaid eligibility checks for immigration status, and lowered Medicaid federal matching funds for states that use their own funds to provide Medicaid to undocumented immigrants.
Cost-Sharing Reduction Payments. A provision prohibiting federal cost-sharing reduction payments to qualified health plans that cover abortion services was ruled subject to the Byrd rule.
AI Moratorium. In the original Senate language, the 10-year moratorium on state enforcement of artificial intelligence (AI) laws and regulations was made a condition of receiving federal funds for the construction and deployment of broadband and AI infrastructure. To ensure Byrd rule compliance, the Senate Commerce Committee added language that sets aside $25 million of the federal funds for states to negotiate master services agreements and makes other conforming amendments. Though this appears to have satisfied the parliamentarian, there is still disagreement among Republican senators about this provision, so its fate remains uncertain.
Public Service Loan Forgiveness (PSLF) for Doctors and Dentists. The parliamentarian ruled that a provision changing the PSLF Program so that payments made by doctors and dentists during their residency would no longer count toward loan forgiveness was subject to the Byrd rule.
Gender-Affirming Care. A provision prohibiting Medicaid and CHIP coverage of gender-affirming care was ruled subject to the Byrd rule.
Not related to the Byrd rule, lawmakers have started discussion of a rural health fund to address concerns about the bill’s Medicaid impacts on rural hospitals. Whether such a fund will be included is still not known, but a version that provided $15 billion to states across five years has been circulating.
Though a deal seems far away, Republicans remain determined to meet the July 4th self-imposed deadline to send the bill to the president. That means that if the Senate passes the legislation this weekend, the House will need to reconvene (during the scheduled July 4th recess) to consider the bill.
HHS Secretary Kennedy Testifies at the House Energy and Commerce Health Subcommittee. The hearing focused on the administration’s FY 26 budget request. Republican members largely praised Kennedy’s efforts to restructure HHS, reduce bureaucratic inefficiencies, and return focus to patient-centered care. They strongly supported the expansion of digital health tools, telemedicine, AI, and regenerative medicine as means to modernize healthcare delivery. Democratic members expressed deep concern over the politicization of science and the restructuring of expert advisory committees, particularly tied to vaccine policy and public health guidance, and they criticized HHS for a lack of transparency and responsiveness, citing numerous unanswered letters and oversight requests. Kennedy emphasized the need to realign healthcare incentives toward outcome-based and value-based care, aiming to reduce chronic disease and improve overall health outcomes.
House Ways and Means Committee Holds Hearing on Digital Health Data. During the hearing, witnesses urged continued support and investment in healthcare technology and wearable products, while members of both parties expressed concerns regarding the privacy of health data. Democrats also used the opportunity to discuss the impact H.R. 1 would have on Americans’ access to healthcare and healthcare technology, while Republicans emphasized the low costs associated with them and noted the positive impact they could have on rural communities.
Senate HELP Committee Considers CDC Director Nomination. During the nomination hearing, the president’s nominee, Dr. Susan Monarez, emphasized CDC’s new focus on emerging threats and communicable disease. She expressed support for Secretary Kennedy’s mission to make America healthy again and reduce rising chronic disease rates, as well as for integrating new technologies, including AI, to improve healthcare, but noted the need for monitoring and safeguards. Democrats expressed concerns about agency restructuring, HHS Secretary Kennedy’s leadership, and the elimination of specific programs related to lead poisoning, smoking, and global health. They also focused on the impact of cuts to the Medicaid program and changes to the Advisory Committee on Immunization Practices (ACIP). Republicans primarily focused on chronic disease, AI, and health technology, and restoring public trust in the CDC, while a few members also expressed concerns about ACIP.
House Appropriations Committee Advances FDA Spending Bill. The final committee print, which included appropriations for agriculture, rural development, FDA, and related agencies, passed 35 – 27, along party lines, with all Republicans voting in favor. Six amendments were adopted and, of those, three were introduced by Democrats and passed with bipartisan support; these included amendments related to youth vaping and tobacco use education, maternal health services, and infant formula access. During the hearing, Democrats argued that the bill’s significant cuts to FDA, the Supplemental Nutrition Assistance Program, and the Special Supplemental Nutrition Program for Women, Infants, and Children would be detrimental to the health of Americans. They also stated that cuts to grants for telemedicine would harm rural communities and criticized the use of FDA resources to review mifepristone. Republicans supported the bill, arguing that it is fiscally responsible and will help reduce the federal deficit. To view the bill summary, report, amendments, and roll call votes, refer to the committee webpage.
House Budget Committee Examines Waste and Fraud. In the hearing, witnesses presented sharply contrasting views; some emphasized the need to curb fraud and prioritize the needy, while others warned that work requirements and administrative hurdles would harm working families, reduce access to care, and enrich private contractors at taxpayer expense. Members were similarly split. Democrats argued that H.R. 1 would strip healthcare and nutrition assistance from millions of working Americans, disproportionately harming low-income families, children, and older Americans, while delivering tax breaks to the wealthy and increasing bureaucratic burdens. Republicans contended that the current structure of Medicaid and SNAP is unsustainable, rife with fraud and abuse, and in need of reform through work requirements and eligibility verification.
ADMINISTRATION
CMS Releases ACA Program Integrity Final Rule. While the final rule was largely finalized as proposed, the rule modifies policies on a temporary basis to provide some flexibility to state-based marketplaces. Key policies include:
Temporary provisions (effective through 2026):
Ending availability of the monthly special enrollment period (SEP) for individuals with household incomes below 150% of the federal poverty level.
Requiring all marketplaces to reinstitute pre-enrollment verifications of eligibility for SEPs and require further verifications of income when there is no tax data available for verification.
Eliminating the fixed-dollar and gross percentage-based premium payment thresholds, allowing issuers to only adopt the net percentage-based threshold.
Permanent provisions:
Standardizing the annual open enrollment period starting with the 2027 plan year so that it ends by December 31 for all health insurance exchanges. (This has been shortened to December 15 in the proposed rule. The final rule clarifies that it will be December 15 for the federal marketplaces, but state-based marketplaces have the option to extend through December 31.)
Updating the methodology for calculating the premium adjustment percentage to establish a premium growth measure that captures premium changes, in both the individual and employer-sponsored insurance markets, for the 2026 plan year and beyond.
Requiring that when an enrollee does not proactively verify their ongoing eligibility for a fully subsidized plan, marketplaces must continue to re-enroll that individual into the same plan but must also reduce the amount of advance payment of the premium tax credit by $5.
Adding sex-trait modification to the list of items and services that may not be covered as essential health benefits beginning in plan year 2026.
Amending the definition of “lawfully present” to exclude Deferred Action for Childhood Arrivals recipients for purposes of enrolling in marketplace coverage.
Again, as noted above, many of these changes are only effective for plan year 2026. H.R. 1 (the House reconciliation bill) codifies all of the provisions permanently. The Senate version of reconciliation has no such provisions included at this time. We are watching to see if the Senate now chooses to codify the rule for 2027 and beyond in the budget reconciliation bill, which would produce additional savings that could help offset potential losses from the Byrd rulings.
The press release can be found here, and the fact sheet can be found here. See table 7 in the final rule (linked above) for a quick “cheat sheet” on the policy changes in the rule.
CMS Announces Industry Commitment to Fix Prior Authorization. To help streamline and speed up the prior authorization process, health insurance industry leaders committed to a voluntary pledge:
Standardizing electronic prior authorization submissions using Fast Healthcare Interoperability Resources (FHIR®)-based application programming interfaces.
Reducing the volume of medical services subject to prior authorization by January 1, 2026.
Honoring existing authorizations during insurance transitions to ensure continuity of care.
Enhancing transparency and communication around authorization decisions and appeals.
Expanding real-time responses to minimize delays in care with real-time approvals for most requests by 2027.
Ensuring medical professionals review all clinical denials.
Following this announcement, Secretary Kennedy and CMS Administrator Oz hosted a roundtable and held a press conference to highlight the pledge. While the commitments are voluntary, CMS noted that the reforms complement ongoing regulatory efforts and that the agency reserves the right to pursue additional regulatory actions if necessary.
OSTP Issues Guidance on Science Standards. In a memo, OSTP provided guidance on implementing executive order (EO) 14303, “Restoring Gold Standard Science,” to federal department and agency heads. The memo defines the key tenets of gold standard science outlined in the EO and specifies that agencies should work to implement these tenets while minimizing administrative burden through the use of AI and other technologies. It also requires that, by August 22, 2025, agencies submit to OSTP and post on their website a report outlining their implementation plans, which must include:
Descriptions of how the agency is addressing each of the tenets.
Development of standardized metrics and evaluation mechanisms to assess adherence to these tenets and their impact on scientific quality.
Plans for providing training and resources to ensure agency personnel understand and adhere to the tenets.
Discussion of how technology will be leveraged.
Descriptions of any challenges encountered in implementation.
Annual agency reports will then be due to OSTP by September 1 of each year.
COURTS
Major SCOTUS Rulings Released. This week, SCOTUS issued rulings for the rest of the cases in the current term. Several had significant implications for healthcare, the Trump Administration, and power of federal judges:
Kennedy v. Braidwood Management. In a 6 – 3 ruling, the Court held that the appointment of USPSTF members is consistent with the Constitution. The ACA requires insurers to cover USPSTF recommended preventive services with no cost sharing, which includes screenings for lung, cervical and colorectal cancers, as well as diabetes and statin medications to reduce the risk of heart disease and stroke. The opinion also stated that the HHS Secretary can review USPSTF recommendations before they take effect and can remove USPSTF members at will.
Trump v. CASA. In a case about President Trump’s EO prohibiting birthright citizenship, the justices ruled 6 – 3 along ideological lines to limit national injunctions to apply only to states, groups and individuals that sued. This opinion will have broad ramifications for almost all litigation on EOs, including nationwide injunctions on EOs related to gender-affirming care, the National Institutes of Health, and more.
Medina v. Planned Parenthood South Atlantic. At issue in this case was whether Medicaid beneficiaries have an individual right to challenge state Medicaid actions in federal court for failing to comply with the Medicaid “free choice of provider” provision – a requirement that beneficiaries may choose any willing and qualified provider. In a 6 – 3 ruling along ideological lines, the Court ruled that a South Carolina woman and Planned Parenthood did not have their civil rights violated and therefore do not have standing. Instead, litigants will need to go through an administrative process and, if necessary, state courts. This case, however, could have broader implications for Medicaid patient rights and will likely prompt other states to pursue similar efforts to defund Planned Parenthood.
QUICK HITS
GAO Publishes Reports on Medicaid. The US Government Accountability Office’s (GAO’s) first report, focused on Medicaid unwinding, found that of the 89 million completed redeterminations by states, about 27 million individuals were disenrolled during the first year and a half of unwinding. The second report evaluated the effectiveness of Medicaid managed care incentives for child screenings and treatment.
HRSA Announces Action on Drug Prices. The Health Resources Services Administration (HRSA) issued updated award terms for HRSA-funded health centers that require the centers to provide insulin and injectable epinephrine to low-income patients at or below the price paid by the center through the 340B Drug Pricing Program.
NEXT WEEK’S DIAGNOSIS
The Check-Up will be on hiatus next week for the Fourth of July holiday. Congress is also scheduled to be in recess, though that could be delayed or cancelled if reconciliation consideration is ongoing. We also await the release of the calendar year 2026 proposed rules from CMS, including the Physician Fee Schedule and Outpatient Prospective Payment System proposed rules.
Upholding State Exclusion of Planned Parenthood from Medicaid, and Three Other Split Decisions – SCOTUS Today
The U.S. Supreme Court decision yesterday that likely will get the most attention is Medina v. Planned Parenthood South Atlantic, in which a 6–3 Court that lined up according to the conservative vs. liberal stereotype, held that “Section 1396a(a)(23)(A) of the Medicaid Act does not clearly and unambiguously confer individual rights enforceable under 42 U.S.C. §1983.”
Medina v. Planned Parenthood South Atlantic
The question before the Court was whether individual Medicaid beneficiaries may sue state officials under §1983, the venerable civil rights statute, for failing to comply with the “any qualified provider” provision of the Medicaid law. Planned Parenthood South Atlantic operates two clinics in South Carolina, serving both Medicaid and other patients alike. Among the services it provides is performing abortions. In 2018, South Carolina, citing state law prohibiting public funds for abortion, expelled Planned Parenthood from the state’s Medicaid program. At the same time, the state took steps that it claimed would ensure that other providers would continue offering necessary medical care and family planning services. Planned Parenthood and a patient named Julie Edwards brought a class action suit, claiming that the exclusion of Planned Parenthood violated the any-qualified-provider provision of the statute by depriving her and others of their preferred providers of gynecological care.
Justice Gorsuch, writing for himself and the other five jurisprudential conservatives, noted that §1983 allows private parties to sue state actors that violate their “rights” under the federal “Constitution and laws.” “But federal statutes do not automatically confer §1983-enforceable ‘rights.’ This is especially true of spending-power statutes like Medicaid, where ‘the typical remedy’ for violations is federal funding termination, not private suits.”
While Congress sometimes allows private enforcement through §1983, spending-power legislation cannot predicate a §1983 enforcement suit unless Congress “speaks with a clear voice, and manifests an unambiguous intent to confer individual rights.” The requirement of “unmistakable” notice assures that grantees know that they might be subject “to private suits . . . whenever they fail to comply with a federal funding condition.” Here, citing other recent decisions, the Court concluded that the statute at issue did not clearly and unambiguously confer a “right to support a cause of action under §1983.”
The Court went on to note that this standard is a “demanding” and “significant hurdle” that will be cleared only in the “atypical case.” The Court also noted that, in the past, it had sometimes “taken an expansive view of its power to imply private causes of action to enforce federal laws.” Both Justice Thomas, concurring, and Justice Jackson (along with Justices Sotomayor and Kagan), dissenting, are aware of this history. Thomas cites it, urging that the Court go further in narrowing the application of §1983. Jackson would have the Court return to that lenient application, given the remedial intention of the post-Civil War legislation.
There is little question that the Medina decision will be controversial. Putting aside any discussion of which side of the Court might have the better of the argument, I note that this is another in a series of unrelated cases in which the Court is taking a narrow view of standing. We can expect to see comparable assertions of private rights of action and text-based oppositions to them coming up in areas far afield from reproductive rights, such as cybersecurity and data privacy.
Hewitt v. United States
Hewitt v. United States involves the application of the “First Step Act,” a federal enactment that eliminated a harsh provision of earlier law that required the “stacking” of 25-year periods of incarceration for first-time violators of 18 U.S.C. §924(c), a law that criminalized possessing a firearm while committing other crimes. Congress not only rejected the harsh stacking provision, but also made the statute’s more lenient penalties partially retroactive, providing that the statute applies if a sentence “has not been imposed” upon an eligible §924(c) offender as of the date of the First Step Act’s enactment.
The question presented concerned an “edge case,” asking, “What penalties apply when a §924(c) offender had been sentenced as of the Act’s enactment, but that sentence was subsequently vacated, such that the offender must face a post-resentencing?” The Supreme Court held that, under those circumstances, a sentence “has not been imposed” for purposes of §403(b).
Interestingly, the government agreed with the petitioners, so an amicus was appointed to defend the judgment of the U.S. Court of Appeals for the Fifth Circuit, which held (as the amicus and the dissent contend) “that §403(b) excludes any defendant who was sentenced prior to the enactment date of the First Step Act—even if his sentence was later vacated.” They argue that, because the statute applies only “if a sentence for the offense has not been imposed as of ” the First Step Act’s enactment date, and a sentence “has . . . been imposed” upon that defendant as a matter of historical fact,” the statute therefore does not apply.
However, Justice Jackson, writing for a majority that included, as to the key operative sections of the opinion, the Chief Justice and Justices Sotomayor, Kagan, and Gorsuch, concluded that, based on “the text of §403(b) and the nature of vacatur, . . . a sentence has been imposed for purposes of that provision if, and only if, the sentence is extant—i.e., has not been vacated.”
Justice Alito, joined by Justices Thomas, Kavanaugh, and Barrett, accused the majority of manipulating the language of the statute to reach a desired result. The majority, as one would expect, held that theirs was a literal reading of the actual text. An outside observer might suggest that Justice Kagan’s proclamation, several terms ago, that “we’re all textualists now” likely applies. However, that fact doesn’t guarantee that all the Justices will read a text in the same way.
Gutierrez v. Saenz
In contrast to several other cases discussed in this blog post, a somewhat lenient approach both to standing and to redressability under 42 U.S.C. §1983 governed the outcome in Gutierrez v. Saenz. Ruben Gutierrez, a convicted murderer who claimed that potentially favorable DNA evidence had been withheld by the state of Texas, filed suit under §1983 against Luis Saenz, the district attorney who has custody of the untested evidence. Gutierrez argued that Texas’s DNA testing procedures violated his liberty interests. The U.S. District Court for the Southern District of Texas agreed with him, “finding it fundamentally unfair that Texas gives prisoners the right to challenge their death sentence through habeas petitions but prevents them from obtaining DNA testing to support those petitions unless they can establish innocence of the underlying crime.” However, the Fifth Circuit disagreed, holding that Gutierrez lacked standing to bring his §1983 suit because his claimed injury was not redressable, since a declaratory judgment in his favor “would be unlikely to cause the prosecutor to ‘reverse course and allow testing.’”
In another split decision, the Supreme Court reversed, with Justice Sotomayor writing for herself, the Chief Justice and Justices Kagan, Kavanaugh, and Jackson, and with Justice Barrett concurring in the judgment, that Gutierrez has standing to bring his §1983 claim challenging Texas’s postconviction DNA testing procedures under the Due Process Clause. State court defendants “have a liberty interest in demonstrating [their] innocence with new evidence under state law. . . . For that reason, a state-created right to postconviction procedures can sometimes create rights to other procedures essential to realizing the state-created right.”
The majority opinion criticizes the dissenting opinions of Justice Thomas and Justice Alito, which Thomas and Gorsuch joined, as faultily addressing redressability by focusing on the declaratory judgment of the district court rather than on what Gutierrez was actually complaining about. Contrary to the lower court’s holding, which was dependent upon its belief that Gutierrez would be unable to demonstrate his innocence, the proper focus of the inquiry was Gutierrez’s complaint.
“First, to the extent the Fifth Circuit based its assessment of redressability on the declaratory judgment the District Court later issued, rather than Gutierrez’s complaint, it turned the Article III standing inquiry on its head. Gutierrez’s standing does not depend on the relief the District Court ultimately granted on the merits.” The proper focus of the standing inquiry should thus have been the complaint, which challenges not only Texas’s limitation to actual innocence claims, but also the other barriers erected to Gutierrez’s DNA testing as well. “Second, and more fundamentally, the Fifth Circuit erred in transforming the redressability inquiry into a guess about whether a favorable court decision will ultimately result in the prosecutor turning over the DNA evidence.” Its decision, therefore, was reversed, and the case remanded.
Riley v. Bondi
Another split decision was delivered in Riley v. Bondi, although the split here was somewhat different from those in some other of the Court’s most recent cases. Instead, a 5–4 Court, in an opinion by Justice Alito, joined in the operative part by Justices Sotomayor, Kagan, Gorsuch (who also dissented in part), and Jackson, with Justice Thomas separately concurring, held that an order from the Board of Immigration Appeals denying deferral of removal in a “withholding only” proceeding is not a “final order of removal” under 8 U.S.C. § 1252(b)(1). In other words, the 30-day filing deadline to challenge a final order of removal is a “claims-processing rule,” not a jurisdictional requirement.
The distinction between the two is important not just to immigration lawyers but to the rest of us as well. The consequences of miscategorizing a rule as jurisdictional can be very consequential with respect to the adjudication of cases in federal courts. Supreme Court precedent thus “shows reluctance to label rules ‘jurisdictional’ unless Congress clearly signals that intent. While Congress need not use ‘magic words’ to indicate that a rule is jurisdictional, . . . the Court’s recent decisions require an exceedingly strong signal for jurisdictional classification. That demanding requirement is not met here.” However, yielding to the government’s argument as to the outcome of the case, the lower court’s order as to jurisdiction was dismissed, and the case was allowed to proceed on remand.
As I’ve suggested previously, the end of the term is often characterized by a flurry of opinions, some significant (such as Medina), in which the Court is divided. In part, that relates to a “secretarial” problem occasioned by the circulation of multiple majority, concurring, and dissenting opinions and attempts by the Justices to harmonize their views, if possible. In any event, while Washington weather and the calendar indicate that summer is here, the Court’s summer hasn’t quite started.
Texas SB 1318: Changes to Healthcare Non-Competes Effective September 1, 2025
Healthcare employers in Texas face new requirements for non-competition agreements following the passage of Senate Bill 1318. The Texas Legislature passed this legislation on May 28, 2025, and on June 20, 2025, Governor Abbott signed the bill into law.
The legislation modifies existing requirements for physician non-competes under Section 15.50 of the Texas Business & Commerce Code and creates a new Section 15.501, which extends certain non-compete restrictions to dentists, nurses, and physician assistants for the first time.
Key Takeaways
Effective Date: September 1, 2025 – applies to non-competes entered into or renewed on or after September 1, 2025.
New Coverage: Dentists, nurses, and physician assistants are now subject to certain non-compete restrictions.
Buyout Cap: All non-compete buy-outs are capped at annual salary and wages.
Geographic Limit: Maximum five-mile radius restriction.
Duration Limit: Maximum one-year non-compete period.
“Good Cause” Voidance: Physician non-competes are “void and unenforceable” if the physician is involuntarily discharged without good cause.
When Does SB 1318 Take Effect?
The law takes effect September 1, 2025, and applies only to non-compete agreements “entered into or renewed” on or after that date. Non-compete agreements entered into or renewed before September 1 are governed by the law in effect on the date the covenant was entered into or renewed. The statute does not define what constitutes a “renewal.”
What Does SB 1318 Change for Physicians?
SB 1318 makes several significant modifications to existing Texas law in Section 15.50 of the Texas Business & Commerce Code regarding physician non-compete agreements:
New Buyout Cap and Geographic Limits: The law now requires all physician non-competes to include a buyout provision capped at the physician’s total annual salary and wages at the time of termination. Previously, the law allowed buyouts at a “reasonable price” or at an amount determined through arbitration. The geographic scope is also now strictly limited to no more than a five-mile radius from the location where the physician primarily practiced before termination.
New Duration Cap: The duration of physician non-competes is now capped at one year from the date of contract or employment termination. The previous law did not specify a maximum duration.
New Automatic Voidance Provision: SB 1318 establishes a provision that renders non-compete agreements “void and unenforceable” if a physician is involuntarily discharged from contract or employment “without good cause.” This is an entirely new requirement. The statute defines “good cause” as “a reasonable basis for discharge of a physician from contract or employment that is directly related to the physician’s conduct, including the physician’s conduct on the job or otherwise, job performance, and contract or employment record.”
New Writing Requirement: The “terms and conditions” of a physician non-compete must now be “clearly and conspicuously stated in writing.” The previous law contained no such writing requirement.
Administrative-Role Exception: SB 1318 adds a new provision in Section 15.50(b-1) stating that “managing or directing medical services in an administrative capacity for a medical practice or other health care provider” does not qualify as the “practice of medicine” for purposes of triggering the physician non-compete requirements in Section 15.50(b) of the Texas Business & Commerce Code. These administrative activities still remain subject to the broader non-compete requirements that apply to all employees under Section 15.50(a).
The existing exception in Section 15.50(c) exempting a physician’s “business ownership interest” in hospitals or ambulatory surgical centers from the non-compete requirements in Section 15.50(b) is unchanged.
Unchanged Requirements: SB 1318 maintains the existing requirements for patient access provisions, including access to patient lists and medical records, and continues to prohibit restrictions on providing continuing care during acute illnesses.
Who Is Covered Under the New § 15.501?
Senate Bill 1318 creates Section 15.501 to Texas Business & Commerce Code, which extends certain non-compete restrictions to non-physician “health care practitioners” for the first time in Texas. Health care practitioners include:
Dentists licensed by the State Board of Dental Examiners
Professional and vocational nurses licensed under Chapter 301 of the Texas Occupations Code
Physician assistants licensed under Chapter 204 of the Texas Occupations Code
SB 1318 Non-Compete Requirements for Other Practitioners: Non-competes for these healthcare practitioners are now subject to some of the same core restrictions placed on physician non-competes, including:
Buyout options capped at their annual salary and wages at termination
One-year maximum duration limit
Five-mile geographic restriction
Terms that must be clearly and conspicuously stated in writing
Previously, Texas law contained no specific restrictions on non-compete agreements for dentists, nurses, or physician assistants.
Preemption of Other Law (§ 15.52)
Expanded Preemption: SB 1318 amends Section 15.52 to make the criteria in both Sections 15.50 and 15.501 exclusive, displacing any common-law or equitable bases for enforcing healthcare non-competes. The procedures and remedies in Section 15.51 also remain exclusive.
Cross-Reference Updates: Various sections of the law have been updated to reference both the existing Section 15.50 and the new Section 15.501, ensuring the new healthcare practitioner restrictions are integrated into Texas’s overall non-compete framework.
Conclusion
Senate Bill 1318, effective September 1, 2025, amends § 15.50 and adds § 15.501 to impose buy-out caps, geographic and duration limits, voidance rules, and writing requirements on non-competes for physicians and selected healthcare practitioners.
FDA Requesting Comments on Proposed Guidance Regarding 510(k) Transfers
On June 5, 2025, the U.S. Food and Drug Administration (“FDA”) issued draft guidance (the “510(k) Transfer Guidance”) related to the transfer of a Premarket Notification (510(k)) Clearance. The 510(k) Transfer Guidance discusses the FDA’s recommendations on handling the purchase, sale, or other transfer of a medical-device 510(k) clearance, and requests public comments. Stakeholder comments are due by August 4, 2025. Stakeholders submitting comments should consider the 510(k) Transfer Guidance from both a regulatory and transactional perspective.
The 510(k) Transfer Guidance reiterates that, under section 510(k) of the Federal Food, Drug, and Cosmetic Act (“FD&C Act”), and 21 C.F.R. Part 807, a person who introduces a non-exempt device into U.S. commercial distribution for the first time must obtain a 510(k) clearance; once obtained, that person becomes the singular “510(k) holder” for the device. Because only one entity can be the 510(k) holder at any given time, the transfer or sale of clearance does not create multiple holders; instead, it shifts holder status to the transferee.
The 510(k) Transfer Guidance clarifies that a transferee generally does not need to submit a new 510(k) if the underlying device has not undergone significant changes or modifications in design, components, manufacturing method, or intended use. Instead, the new holder must satisfy certain post-transfer administrative obligations, including updating the registration and listing information in the FDA establishment registration database. In the transaction context, companies should consider whether any manufacturing, supplier or other technical changes as part of the transaction warrant submission of a new 510(k), and whether these processes, or associated timing considerations, merit submitting comments for consideration by FDA.
Importantly, the 510(k) Transfer Guidance also emphasizes the importance of updating the Global Unique Device Identification Database (GUDID) when information such as the labeler’s name changes. These types of updates are similarly important in the transaction context, as labeling changes can take time and require planning. Failure to properly register, list, or update required GUDID information may render a device adulterated or misbranded.
Finally, the 510(k) Transfer Guidance distinguishes the responsibilities of various entities in the device supply chain, specifying which entities can use a 510(k) holder’s 510(k) number to list a device. Contract manufacturers, contract sterilizers, repackagers, and relabelers must use the cleared 510(k) number when listing, whereas initial importers may satisfy listing obligations by identifying the foreign manufacturer if they neither relabel nor repackage the device. The 510(k) Transfer Guidance emphasizes that, generally, the specification developer, not the contract manufacturer, is responsible for submitting the 510(k).
HRSA Announces New Requirements for FQHCs to Provide Insulin and Epinephrine at or below 340B Price
On June 24, HRSA announced that it had issued new grant award terms to its HRSA-funded health centers to provide insulin and injectable epinephrine at or below the 340B price paid by the health center for the drugs. HRSA encouraged health centers to “begin implementing these updated award terms immediately to ensure full compliance and maximize patient benefit.” The announcement comes in response to the Trump Administration’s April 14, 2025 Executive Order on “Lowering Drug Prices by Once Again Putting Americans First” (the “Executive Order”).[1] The Executive Order had instructed the Secretary of the Department of Health and Human Services to, within 90 days, ensure grants available under section 330(e) of the Public Health Services Act are conditioned upon health centers establishing practices to make insulin and injectable epinephrine available to low-income patients at or below the 340B price paid by the health center.
In a Q&A session hosted by HRSA on June 24, 2025, HRSA representatives clarified that this requirement does not currently apply to FQHC Look-Alikes, nor does it apply to any grantees that do not participate in the 340B Program. HRSA also stated that grantees would be required to report and demonstrate on their Form 1C (in conjunction with the annual Budget Period Progress Report (or “BPR”)) that they have the necessary practices and policies in place to comply with these requirements.
Although HRSA issued this condition to its grant terms, HRSA did not specify how HRSA grantees must implement this requirement. Thus, HRSA grantees must individually come up with internal practices and methods to ensure that low-income patients obtain the insulin or injectable epinephrine at the 340B price paid. Because 340B drug prices typically change on a quarterly basis, HRSA grantees should consider methods that update the patients’ cost of these drugs based on the mostly recent 340B price paid.
FOOTNOTES
[1] Exec. Order No. 14273, 90 Fed. Reg. 16441 (April 18, 2025).
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Texas Federal Court Vacates Most of 2024 HIPAA Rule on Reproductive Health Information
In 2024, the U.S. Department of Health and Human Services’ (“HHS”) implemented a new privacy rule under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) that applied specifically to reproductive health information (the “2024 Rule”). On June 18, 2025, Judge Matthew J. Kacsmaryk of the U.S. District Court for the Northern District of Texas issued an opinion largely vacating the 2024 Rule. The decision in Purl v. U.S. Department of Health and Human Services nullifies the 2024 Rule, except for technical provisions unrelated to reproductive health information.
Judge Kacsmaryk held that HHS exceeded its statutory authority when it created “special protections for medical information produced by politically favored medical procedures…” without a clear congressional mandate. Relying on the major questions doctrine and principles of federalism, the opinion concludes that HIPAA does not authorize HHS to distinguish among categories of protected health information to advance policy goals. The court further found that the 2024 Rule impermissibly: limited state public health and child abuse reporting laws; redefined the terms “person” (to exclude unborn humans) and “public health”; required an attestation prior to the release of certain information; and forced HIPAA covered entities to ascertain the lawfulness of the reproductive services provided before responding to information requests (an obligation Judge Kacsmaryk deemed unworkable).
Because the court vacated the 2024 Rule based on the Administrative Procedure Act, the HIPAA framework in place prior to the 2024 Rule is back in effect. Under that framework, disclosures of protected health information for law enforcement and public health purposes are permissible, but not mandatory (without the need for an attestation regarding how the information will be used), subject to the existing HIPAA Privacy Rule conditions and any state law protections more stringent than HIPAA.
Judge Kacsmaryk’s ruling is effective nationwide, but HHS could seek a stay or pursue an appeal to the Fifth Circuit.
FDA Opens Public Comment Period for Chemical Post-Market Assessment Regulation
On June 18, 2025, FDA announced its proposed “method for post-market assessments of chemicals in the food supply.” This “Post-market Assessment Prioritization Tool” will give chemicals an overall score that will be used to rank each post-market chemical assessment in order of priority. We previously reported on FDA’s proposed systematic process for post-market assessment of chemicals in foods, which had its comment period extended to January 21, 2025.
According to FDA’s proposed method, a chemical’s overall score will be calculated from a Multi-Criteria Decision Analysis (MCDA) which will use four Public Health Criteria and three Other Decisional Criteria. The Public Health Criteria are toxicity, change in exposure, effects on a susceptible subpopulation (e.g., children), and availability of new scientific information. The Other Decisional Criteria are external stakeholder attention, other government decisions, and public confidence in the U.S. food supply.
The total score of the Public Health Criteria is given equal weight to that of the Other Decision Criteria, as they both get a score of 1-9 and then the two are averaged to calculate the chemical’s overall score. FDA’s press release points to how the Environmental Protection Agency (EPA) similarly prioritizes certain substances for risk evaluation, though notably the EPA criteria are already specified in the Toxic Substances Control Act (TSCA) § 2605(b)(1)(B) and are “without consideration of costs or other nonrisk factors.”
The proposed prioritization method will be open to public comments until July 18, 2025 under Docket No. FDA-2025-N-1733. In a departure from past practice, there is no Federal Register notice announcing the establishment of this docket for receipt of public comments, only a link in FDA’s announcement to the docket on www.regulations.gov. By way of contrast, see FDA’s August 2024 Federal Register notice announcing a public meeting and soliciting public comment on FDA’s Post-Market Assessment of Chemicals in Food (89 Fed. Reg. 65633, Aug. 12, 2024).
The Importance of a Life Care Plan: Securing Your Future and Protecting Your Loved Ones
As we age, planning for the future becomes more than just creating a will or assigning power of attorney. While an estate plan ensures that your assets are distributed according to your wishes after you pass, it doesn’t address the critical question: How will you be cared for while you’re still alive? This is where a Life Care Plan comes in.
A Life Care Plan is a comprehensive roadmap for aging, focusing on healthcare, financial security, and legal protection to ensure that you receive the right care at the right time. It is designed not just for you, but also for your family members, giving them clarity and peace of mind during what can be a challenging time.
Why a Life Care Plan is Essential
Aging is unpredictable. Health conditions can change suddenly, and without a plan in place, families often scramble to make last-minute decisions. A Life Care Plan anticipates potential care needs and outlines solutions for:
Aging in place with in-home support
Transitioning to assisted living or nursing home care if needed
Coordinating medical care and benefits
By having a structured plan, you ensure that your care preferences are followed while avoiding unnecessary stress and confusion.
Reducing the Burden on Family Caregivers
Many seniors rely on a spouse or adult children to provide care, but this can be emotionally and physically overwhelming. A Life Care Plan helps alleviate the stress on caregivers by:
Identifying professional home care options
Establishing emergency plans including respite care or adult day programs
Ensuring financial and legal protections are in place
By taking a proactive approach, families can make decisions with confidence instead of reacting in crisis mode.
Protecting Your Assets While Securing Quality Care
Long-term care can be expensive, and without proper planning, the costs of assisted living, nursing homes, or in-home care can quickly deplete savings. A Life Care Plan helps protect your financial security by:
Developing a strategy for Medicaid eligibility without spending down all assets
Using trusts, annuities, or other tools to preserve wealth
Ensuring that a surviving spouse remains financially stable
With the right financial planning, you can receive the care you need without sacrificing your financial legacy.
Legal & Healthcare Coordination for Peace of Mind
A Life Care Plan ensures that all critical legal documents are in place before a crisis arises. These include:
Power of Attorney for legal and finances
Living Wills and Healthcare Proxies
Asset protection strategies and estate planning integration
By proactively managing these aspects, you avoid court intervention and unnecessary legal complications. We then combine our legal planning with healthcare advocacy to ensure you get the best and most appropriate care throughout your long-term care journey.
Avoiding the Medicaid Crisis
Many families assume Medicare will cover long-term care without understanding that Medicaid is the primary payor and has strict eligibility requirements. If you wait too long to plan, you may be forced to spend down your assets or face a lengthy penalty period before qualifying.
A Life Care Plan helps you:
Navigate Medicaid rules and application processes
Legally shelter assets to avoid unnecessary spend-down
Plan ahead to maximize benefits while preserving financial security
With proper planning, you can avoid last-minute financial stress and ensure care is covered when you need it most.
Who Needs a Life Care Plan?
A Life Care Plan is beneficial for:
Seniors who want to stay at home as long as possible
Individuals managing chronic health conditions or cognitive decline
Spouses and adult children seeking structured support for caregiving
Anyone wanting to protect assets while ensuring quality care
If you or a loved one falls into one of these categories, now is the time to start planning.
How to Get Started with a Life Care Plan
Creating a Life Care Plan doesn’t have to be overwhelming. As experienced elder care attorneys, we guide families through the process by:
Assessing your current and future care needs
Exploring financial solutions, including Medicaid planning
Establishing legal protections for healthcare and finances
Connecting you with trusted professionals for caregiving support
Plan Ahead for Peace of Mind
The best time to create a Life Care Plan is before a crisis occurs. Taking control now means having more choices, reducing financial stress, and ensuring your wishes are honored.
Texas SB 1318 Tightens Physician Non-Compete Rules, Extends Restrictions to Other Healthcare Practitioners
Takeaways
More stringent requirements for physician non-compete agreements, including a five-mile geographic limit and a one-year duration cap, will take effect 09.01.25.
Non-compete buyouts for physicians are capped at the physician’s total annual salary and wages at termination.
New restrictions apply to non-compete agreements with dentists, nurses, and physician assistants.
Related link
Texas SB 1318 (bill)
Article
Texas Governor Greg Abbott has signed a bill that imposes more limitations on employers’ covenants not to compete with physicians and extends similar restrictions to agreements with other healthcare practitioners, including dentists, nurses, and physician assistants. The new law goes into effect Sept. 1, 2025, and applies to non-compete agreements entered or renewed on or after its effective date.
Senate Bill 1318 (SB 1318) amends Sections 15.50 and 15.52 of the Texas Business and Commerce Code. The amendment affects healthcare employers by narrowing the scope of enforceable non-compete provisions and enhancing physician mobility.
Key Changes to Physician Non-Compete Agreements
SB 1318 updates the criteria for enforceable non-compete agreements with physicians licensed by the Texas Medical Board. It also clarifies that the practice of medicine does not include managing or directing medical services in an administrative capacity for a medical practice or other healthcare practitioner.
SB 1318 introduces specific limitations for non-compete agreements:
Geographic scope restriction: Non-compete agreements must limit the restricted area to a five-mile radius from the physician’s primary practice location at the time of termination.
Temporal limitation: Non-compete restrictions must expire no later than one year after termination of the physician’s contract or employment.
Buyout cap: The buyout provision, which allows a physician to pay to be released from the non-compete, is capped at the physician’s total annual salary and wages at the time of termination. This replaces the previous “reasonable price” standard and eliminates the option for arbitration to determine the buyout amount.
Clear writing: The terms and conditions of the agreement must be stated clearly and conspicuously in writing.
Termination without good cause: If a physician is terminated without “good cause” (defined as a reasonable basis related to the physician’s conduct, job performance, or contract record), the non-compete becomes void and unenforceable.
Restrictions for Other Healthcare Practitioners
SB 1318 introduces Section 15.501, extending non-compete restrictions to healthcare practitioners licensed to practice as a:
Dentist;
Professional or vocational nurse; or
Physician assistant.
Previously, it was unclear whether the restrictions applied to healthcare professionals other than doctors.
The criteria for enforceable non-compete agreements with dentists, nurses, and physician assistants are similar to those for physicians.
Action Steps for Employers
To comply with SB 1318, healthcare employers should take proactive steps to update their agreements. Employers should consider the following:
Review form agreements to ensure they comply with the new geographic, temporal, and buyout requirements for new agreements or renewals after Sept. 1, 2025.
For practitioners working at multiple locations or remotely, clearly document the “primary practice location” in contracts to avoid disputes over the five-mile radius restriction.
Ensure all agreements clearly and conspicuously state the terms and conditions in writing, including the five-mile geographic limit, one-year duration, and buyout cap.
Establish clear protocols for documenting terminations, particularly to demonstrate “good cause” when applicable, to avoid the risk that the restrictions are void and unenforceable.
SB 1318 aligns with a growing trend across states to limit non-compete agreements in healthcare to balance employers’ business interests, practitioners’ mobility, and patients’ access to care. Employers should act promptly to ensure compliance and minimize litigation risks.