DEA Buprenorphine Rule Delayed to December 31, 2025
The U.S. Department of Health and Human Services (HHS) and the Drug Enforcement Administration (DEA) have postponed the effective date of the final rule regarding telemedicine prescribing of buprenorphine (the final buprenorphine rule) to December 31, 2025. In its final rule postponing the effective date, the DEA notes that it received 32 comments. Of those, 13 commenters requested the effective date be finalized as soon as possible, while three urged an additional delay. Eleven commenters raised concerns about the final buprenorphine rule itself. The DEA states that, because of these comments, it will further delay the effective date to further review any questions of fact, law, and policy the rules may raise.
A Brief History
On January 17, 2025, in anticipation of the change of administration, the DEA and HHS finalized and published the final buprenorphine rule, which establishes a permanent pathway for the telemedicine prescribing of buprenorphine for opioid use disorder (OUD). The final buprenorphine rule was set to take effect February 18, 2025. (See our prior blog “DEA Tightens Buprenorphine Telemedicine Prescribing Rules” which discusses the requirements of the final buprenorphine rule.) On January 20, 2025, the Trump administration issued the Regulatory Freeze Pending Review Presidential Memorandum authorizing HHS and the DEA to delay the effective date of the final buprenorphine rule until March 21, 2025. The delay was intended to allow time to review any questions of fact, law, and policy the rule may raise, as well as to open a comment period to gather input from interested parties. On February 14, 2025, in accordance with the Presidential Memorandum, HHS and the DEA announced this delay and review of the final buprenorphine rule. (See our prior blog “DEA Delays Final Buprenorphine Rule” about the first delayed effective date of the final buprenorphine rule.)
Make Your Voice Heard
HHS and the DEA are not accepting formal comments with this final rule. However, stakeholders with concerns about the final buprenorphine rule and its effective date are encouraged to share their feedback by contacting their local Congressperson or the White House.
What Comes Next
With the delay of the final buprenorphine rule, stakeholders can continue relying on the current set of telemedicine prescribing flexibilities through the end of 2025 without uncertainty about whether the obligations of the final buprenorphine final rule will apply and potentially supersede the flexibilities now that the dates are aligned. As a potential permanent solution for prescribing OUD treatment via telemedicine, two U.S. Senators reintroduced the Telehealth Response for E-Prescribing Addiction Therapy Services (TREATS) Act in March 2025, as bipartisan legislation. The TREATS Act amends the Controlled Substances Act to make the buprenorphine-related telemedicine prescribing flexibilities permanent. It was previously introduced in June 2020, February 2021, and November 2023, but in each instance, it did not progress out of Committee.
Although the TREATS Act is more favorable to stakeholders than the final buprenorphine rule because it does not include the additional obligations of the final buprenorphine rule, its history suggests it is unlikely to be signed into law. However, because the current DEA stance on the issue is still unclear, there remains a possibility that the TREATS Act could be finalized in place of the final buprenorphine rule. We will continue to monitor developments regarding the final buprenorphine rule and the TREATS Act.
New Mexico Is the Next State With a Proposed Heat Illness Rule
New Mexico is the next state to propose a heat exposure rule for workers. The New Mexico Environment Department has proposed a rule aimed at preventing heat-related illnesses and injuries in the workplace. The proposed rule, titled “Heat Illness and Injury Prevention,” is designed to establish comprehensive standards for occupational health and safety, particularly in environments where employees are exposed to significant heat.
Quick Hits
The proposed rule would require a plan that incorporates control measures, acclimatization, emergency medical care, and training.
The proposed rule would apply to both indoor and outdoor locations.
There will be narrow exemptions for incidental heat exposures of fifteen minutes or less within a one-hour period, emergency response operations, telework, and environments where mechanical ventilation systems maintain a heat index below 80 degrees Fahrenheit.
The New Mexico Environment Department will open a portal in early April 2025 to accept comments on the rule.
The proposed rule is similar to other state rules with requirements for a plan, training, assessments, rest breaks, and cooling areas. The tentative effective date is July 1, 2025. Public comments will be accepted beginning in April 2025.
Details on the Proposed Rule
Heat Illness and Injury Prevention Plan
Employers would be required to establish, implement, and maintain a written heat illness prevention plan. The proposed rule would require each plan to be available in both English and the language understood by the majority of employees. The plan would need to include procedures for heat assessment, control measures, acclimatization methods, emergency medical care, and training.
Heat Exposure Assessment
Employers would need to conduct a heat exposure assessment when the heat index exceeds 80 degrees Fahrenheit. This assessment would consider factors such as direct sunlight, work intensity, acclimatization, personal risk factors, and the heat-retaining effects of protective clothing.
Control Measures
The proposed rule would mandate several control measures for environments where the heat index exceeds 80 degrees Fahrenheit.
Acclimatization methods: Employers would be required to provide a gradual increase in work duration in the heat for new or returning employees.
Provision of fluids: Employers would be required to provide sufficient hydrating fluids, including water and electrolyte drinks, and encourage regular fluid intake.
Regular rest breaks: Employers would be required to provide paid rest breaks, with schedules based on the heat index and work intensity.
Cooling areas: Employers would be required to establish cooling areas with shade or mechanical ventilation.
Personnel monitoring: Employers would be required to implement methods to promptly identify employees experiencing heat illness, such as regular communication, buddy systems, and self-monitoring.
Emergency Medical Care
Employers would need to ensure appropriate emergency medical care is available when the plan is in effect.
Training
Like other states with similar heat illness plans, employers would be required to provide training on environmental and personal risk factors, control measures, rest breaks, acclimatization methods, types of heat illness, and emergency procedures. Training would need to be conducted at the beginning of employment and annually thereafter.
Recordkeeping
The proposed rule would require employers to create and maintain records of acclimatization schedules, training, and heat illness incidents for at least five years.
Trump Administration’s Executive Orders Attempt To Reset Sex & Gender Identity Issues in Women’s Sports
In January 2025, the Republican Party took control of both houses of Congress and the White House, portending seismic policy shifts around women’s and college sports, as previously reported here. Indeed, in the days immediately following his inauguration, President Trump issued a slew of Executive Orders, including Executive Order 14201 (Keeping Men Out of Women’s Sports) (February 5, 2025) (“EO 14201”). EO 14201 declared it would now be the policy of the United States to rescind funding from educational programs that permit transgender women or girls to compete on female sports teams or in female sports (the “EO 14201”).
The Trump Administration’s Department of Education immediately followed EO 14201 by making two significant policy announcements concerning the application of Title IX of the Education Amendments of 1972 (“Title IX”), signaling that President is already following through on his campaign pledge to reset Biden-era rules and regulations regarding women’s sports.
Below, we review EO 14201 and subsequent developments to discern their meaning and assess their immediate and long-term impact on women’s sports.
Key Provisions of the Executive Order
EO 14201 is effectively an extension into women’s sports of the Trump Administration’s interpretation of biological sex pursuant to Executive Order 14168 (Defending Women from Gender Ideology Extremism and Restoring Biological Truth to the Federal Government), which declared that it is the policy of the Unites States to recognize two sexes, male and female. EO 14201 states that participation of males (i.e., transgender women) in female sports “is demeaning, unfair, and dangerous to women and girls, and denies women and girls the equal opportunity to participate and excel in competitive sports.” Accordingly, it is the United States’ policy to “rescind all funds from educational programs that deprive women and girls of fair athletic opportunities, which results in the endangerment, humiliation, and silencing of women and girls and deprives them of privacy” and “oppose male competitive participation in women’s sports more broadly, as a matter of safety, fairness, dignity, and truth.”
In furtherance of its stated policies, EO 14201 includes directives to:
The Department of Education (“DOE”), to (i) comply with a recent federal court ruling vacating the Biden Administration’s Final Rule that broadened Title IX’s prohibitions against discrimination on the basis of sex to include gender identity, (ii) take action, including through litigation, review of federal funding, rulemaking and policy, to protect “all-female athletic opportunities and all-female locker rooms” in the interest of securing the equal opportunity guarantees of Title IX and ensuring “women’s sports are reserved for women.”
The Assistant to the President for Domestic Policy, to (i) engage with large athletic organizations and governing and harmed female athletes in support of EO 14201’s purpose, and (ii), convene State Attorneys General to identify best practices to define and enforce equal opportunity for women in sports.
The Secretary of State – among other government officials – to (i) engage in a variety of acts, including but not limited to rescinding support for programs that categorize competition based on identity rather than sex and promote international rules governing sport to protect a female sports category that is sex-based; (ii) review and adjust immigration policies that would admit males to the United States to participate in women’s sports, and (iii) take efforts to ensure that the International Olympic Committee amend standard to protect women and eligibility for Olympic competition is determined by sex, not gender identity or testosterone reduction.
Related Developments
The effects of EO 14201 were immediate.
On February 4, 2025, the DOE followed through and issued a “Dear Colleague” letter stating that it would be enforcing Title IX, not under the above-referenced, recently vacated 2024 Rule, but rather under the 2020 Rule, which was promulgated during the prior Trump Administration and aligns with EO 14201’s biological definitions of sex, excluding gender identity.
On February 6, 2025, and pursuant to EO 14201, the NCAA implemented a new participation policy limiting competition in women’s sports only to student-athletes assigned female at birth, while allowing student-athletes either (x) assigned male at birth, or (y) assigned female at birth who has begun gender-affirming hormone therapy (e.g., hormone therapy) to practice with women’s teams.
Less than a week later, on February 12, 2025, the Department of Education announced that it was rescinding guidance issued by the Biden DOE on January 16, 2025, which had warned NCAA schools that payments to student-athletes for use of their name, image, and likeness (“NIL”), whether distributed by schools or third parties (e.g., collectives or brands), qualified as “financial assistance” and must be distributed under Title IX on a nondiscriminatory basis.
By rescinding that guidance, the Trump Administration appears to be signaling that the protection of women in sports does not extend to NIL pay and that disparities in NIL pay between male and female athletes will not trigger Title IX scrutiny, at least not from the DOE. Thus, at least in the eyes of Trump’s DOE, if and when schools ever begin making NIL or revenue-sharing payments to student-athletes, Title IX will not restrict them from directing those funds in disproportionate amounts to athletes in revenue-generating sports, which are predominantly male.
Looking Ahead
EO 14201 was unsurprising given President Trump’s stated positions during the 2024 election campaign. Also unsurprising is the wide-ranging responses to EO 14201, which will likely face legal challenges in implementation given conflicting state laws and deep political divide. Its practical impact will likely differ based on level of competition (e.g., youth versus college sports) and whether federal funding is involved in any particular circumstance. In the meantime, organizations involved in women’s or girls’ sports would be wise to consider its potential impact on their polices and practices and keep an eye out for related developments.
Telehealth Cliff Averted, for Now (But September is Six Months Away)
The potential plunge off the telehealth cliff that we warned you about in our March 3, 2025, blog post has been averted, for now.
With the passage of the Continuing Resolution (CR) by the House and Senate, and the subsequent signing by the president, current telehealth flexibilities and Medicare coverage for the benefit will not expire on March 31. With funding established through the end of the fiscal year—September 30, 2025—the CR provides at least a brief extension of telehealth flexibilities for those, particularly in rural areas or with mobility problems, who have come to rely on telehealth for access to critical health care services since March 2020.
As we noted on March 3, COVID-19 shifted perceptions of telehealth in a way that is not likely to ever return to pre-2020 notions, despite the wrangling over extensions. Between April and June of 2020, nearly half of all Medicare beneficiaries had at least one virtual medical visit. The COVID-19 public health emergency officially ended in May 2023, but the Medicare telehealth flexibilities have been extended several times.
The Continuing Resolution: Telehealth
Section 2207 of the CR, “Extension of Certain Telehealth Flexibilities,” is substantively identical to Section 3207 of the American Relief Act of 2025 (which granted the 90-day extension for telehealth flexibilities through March 2025). The new Section 2207, with the September 30 date,
Removes geographic requirements and expands originating sites for telehealth services (including patients’ homes);
Expands the list of practitioners who are eligible to furnish telehealth services (includes all practitioners who are eligible to bill Medicare for covered services, such as physical and occupational therapists, speech pathologists, audiologists, marriage and family therapists, and mental health services);
Extends telehealth services to federally qualified health centers (FQHCs) and rural health clinics (RHCs), who may serve as distant site providers;
Delays the Medicare in-person requirements for mental health services furnished through telehealth and telecommunications technology, including FQHCs and RHCs;
Allows for the payment/furnishing of audio-only telehealth services;
Extending use of telehealth to conduct face-to-face encounter(s) prior to recertification of eligibility for hospice care; and
Granting program instruction authority, meaning that the secretary of the Department of Health and Human Services may implement the amendments made by this section through program instruction or otherwise.
Utilization and Costs
Immediately following the passage and signing of the CR, the Center for Connected Health Policy and the National Telehealth Policy Resource Center issued an article pointing out that recent Medicare utilization and spending findings actually support Medicare telehealth expansions—and do not in fact support discontinuing the extensions on the grounds of increased patient utilization or costs.
As these organizations noted, the University of Michigan’s Institute for Healthcare Policy and Innovation has concluded—with respect to outpatient utilization—that while mental health is a high driver of telehealth use, and primary care is a moderate one, telehealth did not cause a rise in total post-pandemic evaluation and management visits among Medicare fee-for-service beneficiaries when compared to prepandemic levels (orthopedic surgery, for example, has low telehealth use).
A second study by the Institute for Healthcare Policy and Innovation similarly lends support for permanent telehealth coverage when examining the question of costs. This study found that telehealth-initiated visits were actually associated with lower 30-day spending compared to in-person-initiated visits. Though return visit rates were higher for telehealth, lab testing and imaging rates were lower, suggesting that telehealth may reduce overall Medicare spending.
The Next Six Months?
The American Telemedicine Association and its advocacy arm, ATA Action, have called the March 14 vote on the CR “a big victory for telehealth, and a huge relief for patients and clinicians in every state and region of the United States, especially those in underserved communities.” Yet Kyle Zebley, ATA Action’s executive director, called the short extensions “an impediment to long-term certainty.”
Certain provisions that were left out of the year-end funding package of December 2024 remain excluded, such as
First dollar coverage of High Deductible Health Plans/Health Savings Accounts (HDHP-HSA) tax provision;
In-home cardiology rehabilitation flexibilities;
Virtual diabetes prevention program suppliers in Medicare Diabetes Prevention Program (MDPP); and
SPEAK Act which facilitates guidance and access to best practices on providing telehealth services accessibly.
Some organizations, such as the National Consortium of Telehealth Resource Centers, are already preparing for the next telehealth policy cliff on October 1, 2025. For now, as the Telehealth Policy website of the Department of Health and Human Services states, telehealth services can still be provided by all eligible Medicare providers through September 30, 2025. Until that date:
There are no geographic restrictions for originating sites for Medicare telehealth services, and Medicare patients can receive these services in their home.
An in-person visit within six months of an initial Medicare behavioral/mental telehealth service, and annually thereafter, is not required.
FQHCs and RHCs can serve as Medicare distant site providers for nonbehavioral/mental telehealth services.
Telehealth services in Medicare can be delivered using audio-only communication.
The End of the Self-Affirmed GRAS Pathway?
On March 10, 2025, Robert F. Kennedy, Jr., Secretary of the U.S. Department of Health and Human Services (“HHS”), in a seismic shift, announced that the U.S. Food and Drug Administration (“FDA”) would “explore potential rulemaking” to eliminate the pathway allowing companies to self-affirm that food ingredients are Generally Recognized as Safe (“GRAS”).
This means that companies seeking to introduce new food ingredients would be required to publicly notify the FDA of the ingredients’ intended use and underlying safety data. Presently, the FDA strongly encourages but does not require the submission of a GRAS notice. Given the importance of the issue, the food industry should closely monitor any change to the FDA’s regulation of GRAS ingredients.
Defining GRAS
Under the Federal Food, Drug, and Cosmetic Act, unless a substance is generally recognized among qualified experts as safe under the conditions of its intended use, food additives are subject to premarket review and approval by the FDA. The implementing regulations, 21 C.F.R. §§ 170.3 and 170.30, provide that the use of a food substance can be GRAS through scientific procedures or experience based on common use in food before 1958. Salt, pepper, vinegar, baking powder, and monosodium glutamate are some examples.
GRAS Pathways and FDA Procedures
Currently, manufacturers may determine a food ingredient is GRAS through one of two pathways: self-affirmation, or notification to the FDA by submission of a GRAS notice. But if the voluntary FDA notification pathway becomes mandatory through legislation or rulemaking, companies using the self-affirmation process would be well-served to familiarize themselves with current FDA GRAS procedures.
As mentioned above, 21 C.F.R. § 170.30 sets forth the eligibility for classification of a substance as GRAS.
Under 21 C.F.R. § 170.35, the Commissioner may affirm that a substance that directly or indirectly becomes a component of food is GRAS under the conditions of its intended use. If so, the Commissioner will publish a notice in the Federal Register and evaluate comments received following a 60-day comment period.
If there is convincing evidence that the substance is GRAS, the Commissioner will publish a notice listing the GRAS conditions of use.
If there is a lack of convincing evidence and the substance should instead be considered a food additive, the Commissioner shall publish a notice in accordance with 21 C.F.R. § 170.38.
In 2016, the FDA issued the final rule at issue, 81 Fed. Reg. 54960 (Aug. 17, 2016), that formalized the voluntary GRAS notification program. 21 C.F.R. Part 170, Subpart E provides the process for submission of a GRAS notice, including how to send a GRAS notice to the FDA, general requirements of a GRAS notice, the seven required parts of a GRAS notice, the FDA’s evaluation and response, and public disclosure of a GRAS notice. According to the HHS, the FDA evaluates 75 GRAS notices per year and has published over 1,000 notices, which are available in a public inventory.
Takeaways
In the HHS release, Secretary Kennedy commented, “For far too long, ingredient manufacturers and sponsors have exploited a loophole that has allowed new ingredients and chemicals, often with unknown safety data, to be introduced into the U.S. food supply without notification to the FDA or the public.” His proposal for addressing the “loophole” may involve more than rulemaking—the release also states that the HHS “is committed to working with Congress to explore ways legislation can completely close the GRAS loophole.” In the meantime, companies should familiarize themselves with FDA GRAS procedures.
Missouri’s Paid Sick Leave and Minimum Wage Increase: Legislature, Court Challenges Continue
On Nov. 5, 2024, Missouri voters approved Proposition A, which included a new statewide paid sick leave law and an increase to the minimum wage. The paid sick leave requirement is set to go into effect on May 1, 2025, while the $13.75 per hour minimum wage took effect on Jan. 1, 2025.
On March 13, 2025, the Missouri House of Representatives passed a bill (HB 567) that, if enacted, would repeal the paid sick leave requirement and delay the minimum wage increase. However, if passed by the Senate and signed by the governor in its current form, the bill would not become effective until Aug. 28, 2025, after the paid sick leave requirement is set to take effect on May 1, 2025. The bill has now been read twice in the Senate, and a public hearing is set for March 26, 2025.
On March 12, 2025, the Missouri Supreme Court heard oral argument on the constitutionality of Proposition A.
Opponents of the law, mostly business groups, argue that:
The fiscal note summary to the ballot initiative did not include the costs to state and private businesses or some local governments
The summary statement failed to notify voters of certain elements of the paid sick leave law
It included two different subject matters (paid sick leave and a minimum wage increase) in violation of the Missouri Constitution.
Proponents of the law dispute that Proposition A was misleading or violated Missouri’s Constitution. They argue that overturning the law would be denying the will of the Missouri voters who voted to approve Proposition A.
The Court’s questions focused on whether it has original jurisdiction to rule on the legal challenges or whether the trial courts were the proper venue to hear the matter. A decision should be forthcoming.
Barring extraordinary relief by the Missouri legislature or the Missouri Supreme Court, employers are required to provide written notice to their employees about the paid sick time by April 15. Employers should proceed as if the paid sick leave law will take effect on May 1, 2025, and they are able to provide the required notices by April 15.
Breaking Down the New No Surprises Act FAQs Post-TMA III
On January 14, 2025, the US Departments of Labor, Health and Human Services (HHS), and the Treasury (collectively, the Departments), along with the Office of Personnel Management (OPM), jointly issued Part 69 of a series of frequently asked questions (FAQs) designed to help stakeholders understand and adhere to the federal No Surprises Act (NSA). This installment of the FAQs discusses how health plans and issuers should calculate the qualifying payment amount (QPA) and provides updates to disclosure and patient cost-sharing requirements following rulings by the US District Court for the Eastern District of Texas and the US Court of Appeals for the Fifth Circuit in Texas Medical Association, et al. v. United States Department of Health and Human Services, et al. (together, the TMA III decisions).
In Depth
BACKGROUND: THE LONG HISTORY OF THE NSA
The NSA was enacted under the first Trump administration as part of the Consolidated Appropriations Act, 2021 (Public Law No: 116-260). The Departments and OPM jointly implemented provisions of the NSA through the issuance of two interim final rules (IFRs) in July 2021 and October 2021.
The NSA prohibits out-of-network (OON) providers from balance billing patients for certain services furnished at an OON facility (in the case of emergency services) or in-network facility (in the case of non-emergency services provided by OON providers). The NSA protects patients from receiving these “surprise” bills, effectively limiting patient responsibility for some services to no more than the patients’ in-network cost-sharing amounts. (The NSA includes separate considerations related to air ambulance providers, which we do not address in this article.)
Per the NSA and as further implemented in the October 2021 IFR, plans and issuers are required to determine whether claims for items or services submitted by an OON provider or facility and subject to the NSA are covered under the plan or coverage and must send an initial payment or notice of denial of payment to the OON provider or facility no later than 30 calendar days after the provider or facility submitted the claim to the plan or issuer.
To the extent the claim is covered, the NSA also sets forth a methodology by which plans or issuers must calculate the OON rate for OON providers or facilities that rendered items or services subject to the NSA. Plans and issuers must pay the provider or facility an amount determined by an applicable All-Payer Model Agreement, and if none exists, an amount determined by applicable state law. If state law does not set forth a mechanism by which the OON rate should be determined, the plan or issuer may negotiate the rate with the provider or facility through an “open negotiation” process, which lasts 30 days.
If the parties are unable to agree to an OON rate by the expiration of the open negotiation period, either party may initiate a dispute under the federal independent dispute resolution (IDR) process established by the NSA. The IDR process involves several steps:
The disputing parties must agree on and select a third-party entity (referred to as a certified IDR entity) to oversee the process.
Each party must then submit payment offers to the IDR entity.
The IDR entity evaluates the payment offers and determines each party’s payment responsibility. The NSA requires that the IDR entity consider, among other factors, the QPA, defined as the median of the contracted rates that a plan or issuer recognizes for the same or similar service by a provider in the same or similar specialty in the same geographic area as the service at issue.
Once the IDR entity makes a payment determination, the plan or issuer must make the payment to the OON provider or facility within 30 calendar days.
In August 2022, the Departments issued final rules implementing provisions regarding certain disclosure requirements for plans and issuers (discussed further below) and modifying certain requirements pertaining to how IDR entities can take into account the QPA in determining the OON rate through the IDR process.
In theory, the IDR process is straightforward. However, the NSA and the IDR process, including the significance of the QPA in determining the OON rate, have been the subject of consistent litigation and operational issues, suggesting that in practice, providers and health plans continue to encounter implementation challenges.
HISTORY OF TMA LITIGATION
A string of litigation continues to shape the NSA and the related IDR process, which originated with a suit filed by the Texas Medical Association (TMA) against HHS in October 2021. In Texas Medical Association v. United States Department of Health and Human Services, et al. (TMA I), the district court vacated the Departments’ IFR requiring IDR entities to use a rebuttable presumption in favor of the QPA. The court held that the presumption conflicted with the NSA’s plain meaning, which lists a set of factors for consideration when determining the appropriate OON rate, only one of which is the QPA.
After the TMA I decision, the Departments issued the August 2022 final rules, which specified elements that IDR entities must consider in resolving OON payment disputes, including the extent to which the QPA should be taken into account. The August 2022 rules required that IDR entities:
First consider the QPA for the same or similar service.
Limit factors to information provided by the disputing party.
Document non-QPA factors relied upon in making a payment determination.
However, TMA challenged this rule in Texas Medical Association v. United States Department of Health and Human Services, et al. (TMA II), which the Fifth Circuit eventually vacated in TMA III. The Fifth Circuit stated that the Departments exceeded their authority by instructing IDR entities to prioritize one factor over others.
In August 2023, the district court issued a decision in TMA III, overturning key parts of the method set forth by the Departments to calculate the QPA. Following this ruling, the Departments have exercised their discretion in enforcing how QPAs are calculated, leading to uncertainty for plans and issuers as well as providers and facilities. The federal government appealed part of this decision, and on October 30, 2024, the Fifth Circuit issued a ruling on the TMA III case, partially reversing the district court’s decision, while upholding other parts.
The district court’s TMA III opinion found that the Departments’ methodology for calculating the QPA did not comply with the NSA. This noncompliance was due to:
The inclusion of “ghost rates” (i.e., contacted rates for services not actually provided by the contracting provider during the contract period).
The exclusion of risk-based incentive payments.
The allowance for self-insured plans administered by a third-party administrator to use other plans administered by the third-party administrator to calculate QPAs.
The district court also found that rules related to the timing and deadline for payment of OON claims subject to the NSA did not comply with the statute, because they started the 30-day payment clock on the date the plan or issuer received sufficient information to determine whether the submitted claim was a “clean claim,” rather than the date the provider or facility transmitted a “claim.”
Reversing the district court’s decision in part, the Fifth Circuit held that single-case arrangements will no longer be included in QPA calculations. The Fifth Circuit also reversed the district court’s decision that non-fee payments, such as quality bonuses and other incentives, must be included in QPA calculations. Regarding the timing of OON payments subject to the NSA, the Fifth Circuit affirmed the district court’s decision that starting the 30-day payment clock upon receipt of a “clean claim” conflicts with the text of the NSA. As decided by the district court, the 30-day prompt payment clock for NSA-eligible claims will begin on the date the provider transmits the bill, not when the plan or issuer receives the information necessary to determine whether the claim is a “clean claim.”
Regarding the QPA calculation, the Fifth Circuit reversed the district court’s decision to exclude from QPA calculations any contracts for items or services that contracting providers did not actually furnish under said contract during the designated plan year. Contracted rates can now be included in QPA calculations regardless of whether the provider actually furnished those services. However, the Fifth Circuit reiterated the statutory requirement that QPAs be calculated using contracts for the “same or similar item or service that is provided in the same or similar specialty.” This implies that “ghost rates” (e.g., anesthesia rates included in a primary care physician’s contract) must be excluded from QPA calculations.[1]
Following the TMA III decisions, the Departments stated on the Centers for Medicare and Medicaid Services’ NSA webpage in October 2024 that they were reviewing the Fifth Circuit’s decision and intended to “issue further enforcement guidance in the near future.”
NEW GUIDANCE ISSUED FOR QPA CALCULATIONS POST-TMA III DECISIONS
In the wake of the TMA III decisions, the Departments issued the FAQs addressing implementation of certain provisions of the NSA and responding to questions from stakeholders. Under the FAQs, the Departments and OPM will require health plans and issuers to calculate QPAs using a “good faith, reasonable interpretation of the applicable statutes and regulations that remain in effect following the decisions of both the Fifth Circuit and the district court in TMA III (the 2024 methodology)” once the Fifth Circuit issues its final order. Under Federal Rule of Appellate Procedure 41, a court of appeals’ mandate usually issues seven days after the deadline for rehearing petitions, unless a petition is filed. In this case, the Fifth Circuit withheld the mandate after the plaintiffs in TMA III filed a petition for rehearing en banc. Until the mandate is issued, the district court’s judgment continues to bind the Departments.
The Departments and OPM acknowledged the challenges of recalculating QPAs because of the Fifth Circuit’s decision and recognized the time and resources required for this task. Therefore, the Departments opted to prolong the existing period of “enforcement discretion” for any health plan or issuer that calculates a QPA using either the 2021 methodology (based on the IFRs and guidance issued in July 2021) or the 2023 methodology (based on the statutes and regulations that remained in effect after the district court’s decision in TMA III). Both methodologies can be used for items and services furnished before August 1, 2025, as long as they are based on a good faith, reasonable interpretation.
Once the mandate is issued, the Departments and OPM will also use their discretion to enforce the NSA for any health plan, issuer, or party involved in a payment dispute that uses a QPA calculated with the 2023 methodology for services provided before August 1, 2025. This enforcement discretion applies to patient cost-sharing, required disclosures with initial payments or notices of denials, and submissions under the IDR process. Similarly, HHS will exercise enforcement discretion for providers and facilities that bill patients based on a QPA calculated with the 2021 or 2023 methodology for services provided before August 1, 2025. Thus, the FAQs clarify that the enforcement discretion extends to providers in addition to health plans.
The FAQs encourage states, which primarily enforce the NSA, to adopt a similar approach, including that states will be considered compliant if they follow this approach. The Departments and OPM will reassess whether additional enforcement relief time is needed as health plans and issuers work to comply with the applicable laws and regulations following the TMA III decisions.
The new FAQs essentially preserve the existing circumstances, as the enforcement discretion has been operative since fall 2023 after the district court’s TMA III decision. Alongside the enforcement guidance, the Departments and OPM offer further clarifications regarding the existing QPA disclosure requirements and patient cost-sharing obligations.
DISCLOSURE REQUIREMENTS
In line with previous guidance, which remains unaffected by the TMA III decisions, health plans and issuers must continue to disclose information about the QPA. The QPA is used to determine the “recognized amount” for cost-sharing under the NSA. This recognized amount is calculated using the All-Payer Model Agreement, specified state law, or the lesser of the billed charge or QPA. A health plan or issuer may certify that a QPA was determined in compliance with applicable rules by using a good faith, reasonable interpretation of the statutes and regulations that remain in effect following the TMA III decisions.
The FAQs address questions regarding the 30-day notice and IDR process discussed earlier, and how the timing is affected when a plan sends the initial payment or denial notice electronically but provides the required disclosures in paper form. This can result in the provider receiving the payment or denial notice earlier than the disclosures. The Departments and OPM clarify that a plan must transmit the required disclosures on or near the date that it sends the initial payment or notice of denial of payment, and must ensure that both the initial payment or notice of denial of payment and the required disclosures are sent no later than 30 calendar days after the plan receives the information necessary to decide a claim for payment for the services billed by the provider.
The Departments and OPM also state in the FAQs that they recognize that sometimes providers and facilities receive required disclosures days after receiving the initial payment or denial notice. Since the 30-business-day period to start open negotiation begins when the payment or denial notice is received, this delay can shorten the time available to review the disclosures. If the disclosures are sent in paper form and arrive later than the electronic payment or denial notice, the 30-business-day period to start negotiations will be considered to begin once both the payment or denial notice and the disclosures are received. Providers can still choose to start negotiations after receiving the payment or denial notice but before receiving the disclosures.
PATIENT COST-SHARING
The Departments and OPM reiterate in the FAQs that patient cost-sharing rules under the NSA and the July 2021 IFR for OON emergency services and certain non-emergency services are based on the “recognized amount.” According to the Departments and OPM, some health plans have been found to increase cost-sharing amounts after an IDR payment determination, which is not allowed. Once an IDR entity makes a payment determination, plans cannot recalculate or increase the cost-sharing amount if it exceeds the permitted amount. The rules ensure that disputes between providers and payers do not affect the cost-sharing amount for individuals. Nonparticipating providers cannot bill individuals more than the allowed cost-sharing amount. Any payment owed to nonparticipating providers after an IDR determination must be paid in full without reducing the amount based on prohibited cost-sharing increases.
CONCLUSION/KEY TAKEAWAYS
As stated earlier, Part 69 of the FAQs extends the status quo of enforcement discretion around the calculation of the QPA. Any new regulations related to the QPA calculation will need to be drafted under the Trump administration, although the timing for issuing such regulations is unclear. If the Trump administration decides to draft new QPA regulations, it could make additional changes to the QPA methodology beyond those that have been the subject of litigation. While the courts have provided direction on what is permissible under the NSA and what aspects of previous regulations can and cannot stand, the rulings do not prevent the Trump administration from making other permissible regulatory changes as it deems appropriate, especially as stakeholders have challenged implementation of the law under the previous administration.
Beyond issuing this new set of regulations, the Trump administration also may need to deal with open operational questions and issues, including proposed regulations from the Biden administration that have yet to be finalized and whole provisions of the NSA that are yet to be implemented.[2] All of this means that, if it chooses to act, the Trump administration could decide to make its own imprint on the current NSA operations and policy.
Safety Basics X: Unpacking the Process of Effective Workplace Safety Self-Audits [Podcast]
In this installment of Ogletree Deakins’ Safety Basics podcast series, John Surma (shareholder, Houston) is joined by Robert Rodriguez (shareholder, Sacramento) to discuss the important process of workplace safety audits, specifically focusing on voluntary self-audits. In their discussion, Robert (who is co-chair of Ogletree’s Workplace Violence Prevention Practice Group) and John emphasize the value and benefits of these audits, such as the ability to identify potential hazards, ensure compliance, and enhance safety culture. They also address key considerations for maintaining confidentiality and privilege throughout the audit process.
PFAS Bans Go into Effect; Manufacturers Attempt to Push Back on Regulations
Many states have enacted or plan to enact new regulations regarding the manufacturing of products containing per- and polyfluoroalkyl substances (“PFAS”), also known as “forever chemicals,” because they do not easily break down in the environment and human body. For example, on January 1, 2025, both New York[1] and California[2] banned the sale of any new, not previously used, apparel and certain other products containing added PFAS, while Minnesota[3] banned broad categories of products containing PFAS. More specifically, the Minnesota statute, titled Amara’s Law, prohibits the sale or distribution of the following products if the product contains intentionally added PFAS: (1) carpets or rugs; (2) cleaning products; (3) cookware; (4) cosmetics; (5) dental floss; (6) fabric treatments; (7) juvenile products; (8) menstruation products; (9) textile furnishings; (10) ski wax; and (11) upholstered furniture. The law makes no exceptions for products in these categories, provides no extensions, even if no PFAS alternatives are available, and allows expansion to include additional products if the products contain intentionally added PFAS that are likely to harm Minnesota’s environment and natural resources. Violations of the statute can result in fines, civil penalties, or criminal prosecution. Other states have similar bans set to take effect over the next several years.[4]
Like many similar regulations, Amara’s Law is currently being challenged. The Cookware Sustainability Alliance (“CSA”), a national conglomerate of members who manufacture, offer, and sell cookware containing PFAS, recently filed a complaint in the United States District Court for the District of Minnesota.[5] CSA alleges that Amara’s Law violates the Constitution’s commerce clause and dormant commerce clause, imposes an undue burden on interstate commerce, and that its disclosure requirement (which goes into effect in 2026 and requires reporting PFAS products to the Minnesota Pollution Control Agency) violates the First Amendment in addition to being preempted by federal trade secret law. CSA filed a motion seeking a preliminary injunction to enjoin the enforcement of Amara’s Law, which was denied February 26, 2025. CSA has until March 28, 2025, to appeal the Judgment.
Thousands of lawsuits have already been filed across the country focused on the alleged harm caused by PFAS exposure, while state regulators, such as those noted above, attempt to limit their use. Some have called the proliferation of PFAS litigation the “next asbestos,” with significant potential liability to insurers and their corporate policyholders. With similar PFAS bans set to take effect in other states in the coming years, mounting litigation surrounding the use of PFAS, and an insurance landscape that is seeing a spike in PFAS-related claims leading to new PFAS-specific exclusions in policies, all eyes will surely be tracking these hot-button topics in 2025 and beyond.
[1] NY ECL §§ 37-0121, 71-3703.
[2] CA HLTH & S §§ 108970, 108971.
[3] Minn. Stat. § 116.943.
[4] See, e.g., Colo Rev Stat §§ 25-15-601 to 25-15-605, Me Rev Stat T. 38 § 1614, RI Gen Laws § 23-18.18-1, et seq.
[5] Cookware Sustainability Alliance v. Kessler, Civ. No. 0:25-cv-41, ECF No. 1.
Canada Releases Final State of PFAS Report and Proposed Risk Management Approach
On March 5, 2025, Environment and Climate Change Canada (ECCC) announced the availability of its final State of Per- and Polyfluoroalkyl Substances (PFAS) Report (State of PFAS Report) and proposed risk management approach for PFAS, excluding fluoropolymers. The State of PFAS Report concludes that the class of PFAS, excluding fluoropolymers, is harmful to human health and the environment. To address these risks, on March 8, 2025, Canada published a proposed order that would add the class of PFAS, excluding fluoropolymers, to Part 2 of Schedule 1 to the Canadian Environmental Protection Act, 1999 (CEPA). ECCC states in its March 5, 2025, press release that it will prioritize the protection of health and the environment while considering factors such as the availability of alternatives. Phase 1, starting in 2025, will address PFAS in firefighting foams to protect better firefighters and the environment. Phase 2 will focus on limiting exposure to PFAS in products that are not needed for the protection of human health, safety, or the environment. ECCC notes that this will include products like cosmetics, food packaging materials, and textiles. ECCC states that it will publish a final decision on the proposed addition of 131 individual PFAS to the National Pollutant Release Inventory (NPRI) with reporting to take place by June 2026 for PFAS releases that occurred during the 2025 calendar year. ECCC states that these data will improve its understanding of how PFAS are used in Canada, help it evaluate possible industrial PFAS contamination, and support efforts to reduce environmental and human exposure to harmful substances. Comments on the proposed risk management approach and the proposed order to add the class of PFAS, excluding fluoropolymers, to CEPA Schedule 1 Part 2 are due May 7, 2025.
State of PFAS Report
The State of PFAS Report provides a qualitative assessment of the fate, sources, occurrence, and potential impacts of PFAS on the environment and human health to inform decision-making on PFAS in Canada. The term PFAS refers to the Organisation for Economic Co-operation and Development’s definition, which is: “fluorinated substances that contain at least one fully fluorinated methyl or methylene carbon atom (without any H/Cl/Br/I atom attached to it), that is, with a few noted exceptions, any chemical with at least a perfluorinated methyl group (–CF3) or a perfluorinated methylene group (–CF2–) is a PFAS.” The class of PFAS is comprised of substances meeting this definition. ECCC states that the definition captures substances with a wide range of structures and properties, from discrete chemicals, such as perfluorocarboxylic acids, perfluorosulfonic acids, and fluorotelomer alcohols, to side-chain fluorinated polymers, perfluoropolyethers, and fluoropolymers. According to ECCC, some PFAS on the market also possess structural attributes other than perfluoroalkyl chains (for example, inclusion of ether linkages or chlorine atoms in the fluorinated hydrocarbon chains).
The State of PFAS Report notes that there is evidence to suggest that fluoropolymers may have significantly different exposure and hazard profiles when compared with other PFAS in the class. ECCC defines fluoropolymers as “polymers made by polymerization or copolymerization of olefinic monomers (at least 1 of which contains fluorine bonded to 1 or both of the olefinic carbon atoms) to form a carbon-only polymer backbone with fluorine atoms directly bonded to it.” According to ECCC, given information suggesting their differences from the other PFAS in the class, additional work on fluoropolymers is warranted. ECCC does not address PFAS meeting the definition of fluoropolymers within the State of PFAS Report. ECCC plans to consider them in a separate assessment.
According to the State of PFAS Report, the following is known on the basis of current information:
The broad use of PFAS, their transport in the environment, and their ubiquitous presence have resulted in continuous environmental and human exposure to multiple PFAS, a finding that is supported by both environmental monitoring and human biomonitoring studies, including higher exposures in certain human subpopulations;
Given that PFAS are extremely persistent and have a broad range of uses leading to continued releases to the environment, the amount of PFAS in the environment is expected to increase;
Exposure to well-studied PFAS can affect multiple systems and organs in both humans and wildlife. Recent information demonstrates that effects on human health occur at lower levels than indicated by previous studies;
Some well-studied PFAS have demonstrated the potential to bioaccumulate and biomagnify in food webs to an extent that can cause adverse effects in biota, even at low environmental concentrations; and
Potential for cumulative exposure and effects are important considerations as most humans and wildlife exposures occur to unknown mixtures of PFAS.
On the basis of what is known about well-studied PFAS and the potential for other PFAS to behave similarly, and on the expectation that combined exposures to multiple PFAS increase the likelihood of detrimental impacts, ECCC states that it concludes that the class of PFAS, excluding fluoropolymers, meets the criteria under CEPA Section 64(a) as these substances are entering or may enter the environment in a quantity or concentration or under conditions that have or may have immediate or long-term harmful effects on the environment or its biological diversity. ECCC concludes that the class of PFAS, excluding fluoropolymers, does not meet the criteria under CEPA Section 64(b), however, as these substances are not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger to the environment on which life depends.
According to the State of PFAS Report, on the basis of what is known about well-studied PFAS and the potential for other PFAS to behave similarly, and on the expectation that combined exposures to multiple PFAS increase the likelihood of detrimental impacts, ECCC concludes that the class of PFAS, excluding fluoropolymers, meets the criteria under CEPA Section 64(c) as these substances are entering or may enter the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.
ECCC therefore concludes that the class of PFAS, excluding fluoropolymers, meets one or more of the criteria set out in CEPA Section 64.
According to the State of PFAS Report, well-studied PFAS meet the persistence criteria set out in the Persistence and Bioaccumulation Regulations of CEPA. Based on available information and structural similarities, ECCC expects that other substances within the class of PFAS are also highly persistent or transform to persistent PFAS. ECCC states that it therefore determines that the class of PFAS meets the persistence criteria as set out in the Persistence and Bioaccumulation Regulations of CEPA. ECCC notes that given that fluoropolymers have been excluded from this assessment, they are also excluded from this determination with regard to the Persistence and Bioaccumulation Regulations of CEPA.
ECCC states that there is a high concern identified for the biomagnification (BMF) and trophic magnification (TMF) potential of well-studied PFAS in air-breathing organisms; the numeric criteria for bioaccumulation, outlined in the Persistence and Bioaccumulation Regulations, however, are based on bioaccumulation data for freshwater aquatic species that do not account for biomagnification potential. Therefore, application of the criteria would not reflect the concern for dietary-based biomagnification, the primary route of food web exposure identified for well-studied PFAS. As a result, according to ECCC, the bioaccumulation potential of PFAS cannot reasonably be determined according to the regulatory criteria set out in the Persistence and Bioaccumulation Regulations of CEPA.
Proposed Risk Management Approach
ECCC concludes that the class of PFAS, excluding fluoropolymers, meet the criteria under CEPA Sections 64(a) and (c), as these substances are entering or may enter the environment in a quantity or concentration or under conditions that have or may have immediate or long-term harmful effects on the environment or its biological diversity, and that constitute or may constitute a danger in Canada to human life or health.
For the purpose of CEPA Section 77(6)(c)(i), ECCC proposes the following new risk management actions through a phased prohibition under CEPA:
Phase 1: Prohibition of the use of PFAS, excluding fluoropolymers, not currently regulated in firefighting foams, due to high potential for environmental and human exposure.
Phase 2: Prohibition of the uses of PFAS, excluding fluoropolymers, not needed for the protection of health, safety, or the environment, which includes consumer applications. ECCC states that prioritization of uses for prohibition is based on, and will take into account, costs and benefits, availability of suitable alternatives, and other socio-economic considerations. Proposed uses to be regulated in Phase 2 include:
Cosmetics;
Natural health products and non-prescription drugs;
Food packaging materials, food additives, and non-industrial food contact products such as paper plates, bowls, and cups;
Paint and coating, adhesive and sealant, and other building materials available to consumers;
Consumer mixtures such as cleaning products, waxes, and polishes;
Textile uses (including in personal protective equipment (PPE) such as firefighting turnout gear); and
Ski waxes.
Phase 3: Prohibition of the uses of PFAS, excluding fluoropolymers, requiring further evaluation of the role of PFAS for which currently there may not be feasible alternatives and taking into consideration socio-economic factors, including:
Fluorinated gas applications;
Prescription drugs (human and veterinary);
Medical devices;
Industrial food contact materials;
Industrial sectors such as mining and petroleum; and
Transport and military applications.
ECCC states that at each phase of risk management it will consider exemptions, when necessary, with attention to feasible alternatives and socio-economic factors. To inform ECCC’s risk management decision-making, information on the following topics should be provided by May 7, 2025):
Availability of alternatives to PFAS, or lack thereof, in products and applications in which they are currently used;
Estimated timeframe to transition to alternatives to PFAS, including any challenges;
Socio-economic impacts of replacing PFAS, including costs and feasibility of elimination or replacement; and
Quantities and concentrations of PFAS (including Chemical Abstracts Service Registry Number® (CAS RN®), units of measurement, and applications) in products manufactured in, imported into, and sold in Canada (if not already provided through the July 27, 2024, Section 71 notice).
Commentary
Canada’s release of the State of PFAS Report, proposed risk management approach, and proposed order to add PFAS, excluding fluoropolymers, to Part 2 of CEPA Schedule 1 follows soon after the January 29, 2025, deadline for mandatory reporting for 312 PFAS. In its July 27, 2024, Canada Gazette notice, Canada stated that it required information for the purpose of assessing whether the 312 PFAS listed in the notice “are toxic or are capable of becoming toxic, or for the purpose of assessing whether to control, or the manner in which to control the listed substances.” The March 8, 2025, proposed order acknowledges that “[t]he annual quantity of PFAS used in Canada is unknown, as the information required to estimate this parameter (for example type and concentrations of PFAS in products available to consumers and in commercial and industrial applications) was not identified at the time of this analysis.” Canada states that it anticipates that the mandatory survey will “provide insight on annual quantities of PFAS used in Canada,” but it may be more likely that the survey will highlight the complexity of the supply chain and the difficulty in obtaining information from suppliers.
Stakeholders should carefully review the proposed risk management approach. Canada requests information on the availability of PFAS alternatives, the estimated timeframe to transition to alternatives, the costs and feasibility of elimination or replacement, and the quantities and concentrations of PFAS in products manufactured in, imported into, and sold in Canada (if not already reported through the mandatory survey). It is unlikely many entities will volunteer such specific information on PFAS in their products and companies that were not subject to the mandatory survey may not know. Yet without evidence on the critical use of PFAS in products and the lack of alternatives, Canada may begin prohibiting uses.
Most agree that ultimately the proposal will succeed, and PFAS will be deemed CEPA toxic and listed on Part 2 of CEPA Schedule 1. Given the PFAS risk evaluations of many other authoritative bodies, it is more likely than not that ECCC’s scientific determination is defensible. That the proposal seeks to exempt fluoropolymers is noteworthy, however, and stakeholders may wish to support the exemption.
Healthcare Preview for the Week of: March 24, 2025 [PODCAST]
Congress Returns for Three Weeks
Lawmakers are back in Washington, DC, after a week-long recess. Both chambers will be in town for three weeks before a two-week Easter recess in mid-April. With the government funded through the end of this fiscal year, focus will be on advancing reconciliation and confirming Trump appointees.
The bulk of work this week will happen behind the scenes. House Speaker Mike Johnson (R-LA) and Senate Majority Leader John Thune (R-SD) will meet on Tuesday to discuss aligning their budget resolutions. The House and Senate each passed differing resolutions earlier this year, and now they must pass a unified budget resolution through both chambers of Congress in order to move the reconciliation process forward. The House version included an extension of Trump-era tax cuts and a minimum of $1.5 trillion in spending cuts, including at least $880 billion from House Energy and Commerce Committee jurisdiction. Given the committee’s jurisdiction, many of those savings would come from Medicaid. The Senate’s “skinny” budget resolution focused on energy and immigration policy, with the goal of completing an additional reconciliation package later this year that would include tax cut extensions. Republicans aim to pass their aligned budget resolution before the Easter recess, in order to complete reconciliation as expeditiously as possible.
The Congressional Budget Office is also expected to release its debt limit prediction this week, which will include the “X date” when the United States is predicted to reach the debt limit. That date is expected to fall as early as this summer, and it will influence reconciliation. The House budget resolution included raising the debt limit, but if the reconciliation timeline slips, lawmakers may have to address the debt limit through separate legislation, which would likely need bipartisan support to pass.
The Senate Finance Committee is scheduled to vote Tuesday on the nomination of Mehmet Oz, MD, to serve as administrator of the Centers for Medicare & Medicaid Services (CMS). He is expected to advance out of committee. He will join other healthcare nominees – including Martin Makary, MD, nominated for US Food and Drug Administration commissioner, and Jay Bhattacharya, MD, PhD, nominated for director of the National Institutes of Health – who await full Senate confirmation. Their floor votes could happen as early as next week and are likely to be advanced before the Easter recess.
Today’s Podcast
In this week’s Healthcare Preview, Debbie Curtis and Rodney Whitlock join Maddie News to discuss what’s brewing on Capitol Hill, including budget reconciliation, the debt limit, and pending agency leadership nominations.
CMS’s ACA Marketplace Integrity and Affordability Proposed Rule – What it may mean for Health Plans
Earlier this month, the Centers for Medicare & Medicaid Services (CMS) released its 2025 Marketplace Integrity and Affordability Proposed Rule (Proposed Rule), proposing a number of enrollment and eligibility policies impacting both Federal and State Exchanges. While CMS frames these policies as necessary to combat fraud and abuse, the impact will be a reduction in enrollment in the ACA Marketplace – with the Proposed Rule estimating that between 750,000 and 2 million fewer individuals enroll in health insurance plans on the Exchanges in 2026.
The effective date of most of these provisions also coincides with the expiration of the enhanced premium subsidies, which the Biden administration extended through December 31, 2025 through the Inflation Reduction Act (IRA). These enhanced subsidiaries increased the amount of financial assistance individuals received and expanded eligibility for assistance. On December 5, 2024, the Congressional Budget Office wrote a letter to Congress indicating that the failure to extend these subsidies would result in 2.2 million individuals losing coverage in 2026 and an increase in premiums by 4.3%.
This article outlines the major provisions of the Proposed Rule, followed by a discussion of their potential impact on plans participating in the ACA Marketplace.
Key Provisions of the Proposed Rule
Income Verification Policies. In its Proposed Rule, CMS proposes several changes to the income verification process for applicants to apply through the Exchanges. Although CMS stated that these policies are necessary to combat fraud, CMS provided limited examples and evidence of fraud. Such policies include:
Removing the exception allowing Exchanges to rely on an applicant’s self-attestation of projected income, if the Internal Revenue Service (IRS) does not have tax return data to verify household income and family size. Exchanges would need to verify individuals’ enrollment, requiring enrollees to provide additional documentation.
Requiring additional income verification in instances where an applicant’s self-reported projected household income is between 100% and 400% of the Federal poverty level (FPL) but federal tax or other data shows that an applicant’s prior year’s income was below 100%. Individuals would have to prove that their income for the upcoming year is between 100% to 400% of the FPL or be unable to enroll in a plan on an Exchange. This change intends to attempt to identify individuals who may “overinflate” their income to be eligible for coverage. Currently, no income verification is required if the applicant projects a higher income than in their tax return.
Eliminating an automatic 60-day extension (in addition to the general 90-day deadline) when documentation is needed to verify household income in instances of income inconsistency.
Allowing Insurers to Deny Coverage for Past Due Premiums. CMS proposes to repeal a provision which currently prohibits insurers from requiring enrollees to pay past-due premium amounts in order to receive coverage under a new insurance policy or contract term. CMS consequently proposes, subject to state law, to allow insurers to add an enrollee’s past-due premium amount to the initial premium amount the enrollee must pay to effectuate coverage under a new policy or contract term and allow insurers to deny coverage to individuals if the total of past-due premiums and the initial premium amount are not paid in full. The stated purpose of this policy is (i) to curtail individuals from taking advantage of guaranteed coverage and seeking coverage when they need health care services, and (ii) to strengthen the risk pool and lower gross premiums.
Revision of Premium Payment Thresholds. CMS proposes to remove flexibilities that currently allow insurers to implement a fixed dollar and/or gross percentage-based premium payment threshold. Under current rules, insurers may consider enrollees to have fully paid their premiums if (i) under the fixed-dollar premium payment threshold, the enrollee has paid a total premium amount such that the unpaid remainder is $10 or less (adjusted for inflation), or (ii) under the gross percentage-based premium payment threshold, the enrollee has paid a total premium amount sufficient to achieve 98% or greater of the total gross monthly premium of the policy before the application of the advance premium tax credit (APTC). Under the Proposed Rule, insurers would only be allowed to implement a net premium percentage-based payment method where enrollees can meet the threshold by paying a total premium amount sufficient to achieve 95% or greater of the total net monthly premium amount owed.
Ineligibility for APTCs after one Year of Failing to Reconcile. CMS proposes to revise the “failure to file and reconcile process” by reinstating a 2015 policy that requires Exchanges to determine whether an individual is ineligible for the APTC if he or she did not file a Federal income tax return and reconcile their APTC amount in any given year. Currently, individuals will be deemed ineligible for failure to file and reconcile for a two-year span.
Changes to Open and Special Enrollment Periods. Under the Proposed Rule, CMS also seeks to shorten the Open Enrollment Period (OEP) and make several changes to Special Enrollment Periods (SEPs), including:
Shortening the OEP for all individual market Exchanges and off-Exchange individual health insurance (that are non-grandfathered) from November 1st to January 15th to November 1st to December 15th.
Removing the “low-income SEP” from both the Federal and State Exchanges. Currently, individuals whose projected household income is at or below 150% of the FPL have a SEP under the Federal and most State-based Exchanges whereby they can enroll or change plans on a monthly basis. CMS is proposing to remove this SEP. The stated purpose of this action is to reduce adverse selection (i.e., reduce the number of enrollees who sign up for health insurance only when they need coverage).
Requiring pre-enrollment verifications for applicants seeking coverage through a SEP. Currently, the Exchanges allow applicants to self-attest that, due to a change of circumstance, they qualify for a SEP (e.g., loss of employer coverage, marriage). The Proposed Rule would change the ability to self-attest and require applicants to submit documentation to the Exchanges.
Requiring Active Re-Enrollment. CMS also seeks to eliminate automatic re-enrollment for fully subsidized enrollees by proposing to require that enrollees whose premium payment amount would be $0 after application of the APTC, would be required to pay a $5 monthly premium until they update their Exchange application with an eligibility redetermination confirming their eligibility for the APTC.
Repeal of Bronze to Silver Plan Cross-Walking. CMS proposes to repeal regulations that currently allow Exchanges to move enrollees eligible for cost sharing reduction, which covers the cost of out-of-pocket healthcare costs and deductibles, from a bronze Qualified Health Plan (QHP) to a silver QHP for an upcoming plan year if a silver QHP is available (i) in the same product, (ii) with the same provider network, and (iii) with a lower or equivalent net premium post APTC-application.
Ineligibility of DACA Recipients. CMS proposes to remove Deferred Action for Childhood Arrivals (DACA) recipients from the definition of “lawfully present,” which in effect renders DACA recipients ineligible for enrollment in a QHP through the Exchange.
Prohibition of Coverage of Gender Affirming Care. CMS proposes to prohibit health insurance plans subject to the ACA’s essential health benefits (EHBs) from providing sex-trait modification, also commonly known as gender-affirming care, beginning Plan Year 2026. EHBs are ACA required minimum coverage categories that plans subject to the ACA must cover; EHBs are state or region specific and are determined based upon comparison to an EHB-benchmark plan that all other plans must mirror. This prohibition would in effect restrict all non-grandfathered insurance plans in the individual and small group markets, on- and off- Exchange, from covering sex-trait modification services.
Updates to the Premium Adjustment Methodology. CMS further seeks to update the premium adjustment methodology, which is used to set several different coverage parameters, including maximum out-of-pocket cost-sharing (MOOP), premiums, and tax credits. By way of background, the current premium adjustment methodology took a more stable approach given the uncertainty of premiums during the end of the COVID-19 Public Health Emergency. Under the Proposed Rule, beginning in 2026, CMS is proposing using an adjusted private individual and group market health insurance premium measure. Such a change will likely cause an increase of MOOP and an increase in premiums.
Updating De Minimis Thresholds. Plans on the Exchange are considered bronze, silver, gold, and platinum based on their actuarial value – whereby bronze plans must cover 60% of an average enrollee’s costs, silver plans cover 70%, gold plans cover 80%, and platinum plans cover 90%. Insurers may offer a specific plan if it is within a “de minis range” of this target value – for example, insurers may offer bronze plans so long as the actuarial value is within +5% and -2% of 60%. Similarly, insurers can offer a silver, gold, and platinum plan, if its value is within +2/-2 percentage points. CMS proposes to change the de minimis ranges to +2/-4 percentage points for all individual and small group market plans subject to the actuarial value, except expanded bronze plans. Further, CMS seeks to include a de minims range of +1/-1 percentage points for income-based silver cost-share reduction plan variations (which was previously −0/+1 percentage points). In the Proposed Rule, CMS estimates that this proposal would decrease premiums by one percent; however, it is likely to reduce the APTCs available.
Evidentiary Standard for Terminating Agents and Brokers. The Proposed Rule seeks to revise the standard for the Department of Health and Human Services (HHS) to terminate for-cause agents, brokers, and web-brokers from the Federally-facilitated Exchange by adding a “preponderance of the evidence” standard of proof regarding issues of fact. HHS may terminate its agreements with agents, brokers, and web-brokers for-cause for instances of non-compliance, fraud, and abusive conduct. Currently, regulations do not indicate an evidentiary standard HHS must apply; instead, the regulation states that HHS may terminate “in HHS’s determination.” CMS states that this change would “improve transparency in the process of holding agents, brokers, and web-brokers accountable for compliance.”
Potential Impacts to Plans
This Proposed Rule will have a direct impact on enrollment in the Exchanges. By adding measures that will increase premiums, reduce APTCs, and increase the administrative burden of applying and verifying enrollment, CMS will in effect discourage enrollment and decrease the number of individuals eligible for enrollment. Further, the changing rules may specifically discourage younger and/or healthier individuals from enrolling. This decrease in enrollment, coupled with the expected decrease in enrollment due to the expiration of the enhanced subsidies, could threaten the stability of the ACA Marketplace in the long run.