First Circuit Validates HHS Pre-Deeming of FQHC Providers’ Hospital On‑Call Care and Holds FTCA Accrual Began at Death in Maternal Mortality Case

Introduction

In O'Brien v. United States, the First Circuit affirmed the dismissal of a wrongful death medical malpractice action arising from emergency obstetrical care provided at Lowell General Hospital (LGH). The plaintiff, Brad O'Brien, acting as personal representative of Melissa Allen’s estate, alleged negligence by LGH and Dr. Fernando Roca, an obstetrician affiliated with Lowell Community Health Center (LCHC), a federally funded health center deemed a Public Health Service (PHS) entity under 42 U.S.C. § 233. The federal government substituted itself for Dr. Roca under the Public Health Service Act (PHSA), and the district court dismissed the action as untimely under the Federal Tort Claims Act (FTCA).

On appeal, O’Brien challenged: (1) the validity of the Department of Health and Human Services’ (HHS) regulation that categorically “pre-deems” certain non-patient services (including hospital on‑call coverage) for FTCA protection without a particularized application; (2) the application of that regulation to Dr. Roca’s treatment of Allen; (3) the district court’s accrual ruling under the FTCA’s statute of limitations; and (4) the inapplicability of the FTCA’s savings clause. The First Circuit rejected each challenge, holding that HHS’s pre-deeming regulation is consistent with the PHSA, that Dr. Roca’s on‑call services fell squarely within the “hospital-related activities” category, that O’Brien’s claim accrued at the time of death and was not tolled by the discovery rule, and that the FTCA’s savings clause did not revive the claim.

Summary of the Opinion

Regulatory validity: The court upheld 42 C.F.R. § 6.6(e)(4), which authorizes categorical, prospective determinations (“pre-deeming”) extending FTCA coverage to certain non-patient services without a case-specific application, as consistent with 42 U.S.C. § 233(g)(1)(D).
Coverage for on-call services: Dr. Roca’s on‑call care at LGH fit § 6.6(e)(4)(ii) (hospital-related activities), because on‑call coverage was a condition of hospital admitting privileges and documentation showed it was a condition of his employment at LCHC.
Substitution and dismissal: Substitution of the United States under the PHSA was proper; the claim was then subject to the FTCA’s presentment requirement and two-year limitations period.
Accrual and discovery rule: For FTCA medical malpractice/wrongful death claims, accrual begins when the plaintiff knows of the injury and its cause, not when negligence is suspected. The death of a generally healthy woman in childbirth is sufficiently unusual to trigger a duty of inquiry at the time of death; waiting over a year to consult counsel was not reasonable diligence. Presentment in June 2019 was untimely for an August 2016 death.
Savings clause: 28 U.S.C. § 2679(d)(5) did not apply because the state-court action was not filed within two years of accrual.
Result: Affirmed. The United States remains the substituted defendant; the case is dismissed for untimely FTCA presentment.

Analysis

Statutory and Regulatory Framework

The PHSA (42 U.S.C. § 233) shields PHS employees from personal liability for injuries arising from medical services rendered within the scope of employment by substituting the United States as defendant and channeling claims through the FTCA. The Federally Supported Health Centers Assistance Act (FSHCAA) extends this protection to covered community health centers and their clinicians when “deemed” PHS employees by the HHS Secretary.

FTCA coverage for non-patient services generally requires either: (1) a particularized determination by HHS that the services satisfy one of the statutory criteria (42 C.F.R. § 6.6(d)); or (2) that the services “fit squarely” within one of several pre-identified, categorically covered scenarios (42 C.F.R. § 6.6(e)(4)). One such scenario is “Hospital-Related Activities,” including periodic hospital call or ER coverage required as a condition of hospital privileges, with documentation that such coverage is a condition of the clinician’s employment at the health center (§ 6.6(e)(4)(ii)).

Precedents Cited and Their Influence

Hui v. Castaneda, 559 U.S. 799 (2010): Clarifies that under the FTCA and PHSA, suits against covered federal medical providers must proceed against the United States as the exclusive remedy when the provider acted within scope of employment.
O’Brien v. United States, 56 F.4th 139 (1st Cir. 2022): Earlier appeal vacating substitution premised on the Westfall Act, instructing that PHSA (not Westfall) governs community health center deeming and that further factual development was needed.
Bray v. Bon Secours Mercy Health, Inc., 97 F.4th 403 (6th Cir. 2024): Persuasive authority recognizing that health-center clinicians’ hospital on‑call obligations can fall within § 6.6(e)(4) categorical coverage when contractually required for privileges and connected to grant-supported activities.
Morales-Melecio v. United States (HHS), 890 F.3d 361 (1st Cir. 2018): Explains FTCA’s limited waiver, proper procedural vehicle for statute-of-limitations dismissals (Rule 12(b)(6)/Rule 56), and accrual principles; rejects tolling where the claimant had sufficient facts to trigger diligent inquiry.
United States v. Kubrick, 444 U.S. 111 (1979): FTCA medical malpractice accrues when the plaintiff knows of the injury and its cause; knowledge of negligence is not required to start the clock.
Skwira v. United States, 344 F.3d 64 (1st Cir. 2003), Donahue v. United States, 634 F.3d 615 (1st Cir. 2011), Gonzalez v. United States, 284 F.3d 281 (1st Cir. 2002), McIntyre v. United States, 367 F.3d 38 (1st Cir. 2004): Define and apply the FTCA accrual/discovery rule in malpractice and wrongful-death settings; focus on objective knowledge triggering a duty to inquire.
Sanchez v. United States, 740 F.3d 47 (1st Cir. 2014): A maternal death is sufficiently rare to prompt a reasonable person to investigate causation; retaining counsel signals the need for diligence.
Cascone v. United States, 370 F.3d 95 (1st Cir. 2004): Contrasts situations where a natural cause of death does not necessarily trigger suspicion; used to delineate the limits of inherent suspicion.
3137, LLC v. Town of Harwich, 126 F.4th 1 (1st Cir. 2025), Rivera-Rosario v. LSREF2 Island Holdings, Ltd., 79 F.4th 1 (1st Cir. 2023), McIntyre ex rel. Estate of McIntyre v. United States, 545 F.3d 27 (1st Cir. 2008), Aversa v. United States, 99 F.3d 1200 (1st Cir. 1996): Standards of review (de novo) for dismissals and substitution/scope determinations.

Legal Reasoning

1) Validity of HHS “Pre-Deeming” Regulation for Non‑Patient Services

The court upheld 42 C.F.R. § 6.6(e)(4), which identifies categories of non-patient services that are covered “without the need for specific application for an additional coverage determination.” O’Brien argued that 42 U.S.C. § 233(g)(1)(D) requires a case-specific application before deeming may be “appl[ied] to services” for non-patients. The First Circuit disagreed, emphasizing three points:

The statute’s reference to “an application … in such form and such manner as the Secretary shall prescribe” (singular) authorizes the Secretary to define the application process. It does not compel a second, event-specific application for every non-patient encounter.
HHS permissibly exercised that delegated discretion by identifying commonly recurring, predictable scenarios where, as a class, non-patient services meet § 233(g)(1)(C)’s criteria.
Pre-deeming avoids impractical and burdensome serial applications for routine, foreseeable activities (e.g., hospital on‑call coverage required for privileges), while maintaining a particularized application pathway for arrangements that do not “fit squarely” within the listed categories.

The court therefore found the regulation consistent with the PHSA’s text and structure and within the Secretary’s prescribed authority.

2) Application to Dr. Roca’s On‑Call Care at LGH

Section 6.6(e)(4)(ii) categorically covers periodic hospital call or ER coverage that a hospital requires as a condition of admitting privileges, provided there is documentation that such coverage is a condition of the clinician’s employment at the health center. The record satisfied both prongs:

Privileges-and-on‑call linkage: LGH required on‑call participation as a condition of admitting privileges.
Condition of health-center employment: Dr. Roca’s LCHC employment contract required him to maintain hospital privileges and to participate in the departmental call schedule, and to conform to hospital bylaws and regulations (which included on‑call obligations). That documentation tied on‑call coverage to his employment at LCHC.

Because the activity “fit squarely” within § 6.6(e)(4)(ii), no particularized application was needed. The court’s analysis parallels the Sixth Circuit’s reasoning in Bray, and the documentary nexus between privileges and employment proved decisive.

3) Accrual and the FTCA Discovery Rule

FTCA claims must be presented to the appropriate federal agency within two years after accrual (28 U.S.C. § 2401(b)). A claim generally accrues when the injury occurs, subject to the medical-malpractice “discovery rule,” which delays accrual until the plaintiff knows, or in the exercise of reasonable diligence should know, the injury and its cause (not the negligence). Applying Kubrick, Skwira, Donahue, Gonzalez, and Sanchez, the court held:

Allen died on August 6, 2016. A maternal death, particularly where the decedent appears generally healthy, is sufficiently uncommon to put a reasonable person on notice to inquire into causation at the time of death.
O’Brien waited more than a year to consult counsel (first meeting on September 6, 2017), and after that still had eleven months before August 2018 to timely present his claim. His eventual presentment in June 2019 was untimely unless accrual were tolled until September 2017, which the court rejected.
The death certificate listing eclampsia and intracranial hemorrhage did not render the causal basis “inherently unknowable.” The objective duty of inquiry was triggered at death. Knowledge of negligence or standard-of-care deviation was not required to start the limitations clock.

In short, accrual occurred no later than the date of death. The discovery rule did not postpone accrual until O’Brien consulted an attorney.

4) FTCA Savings Clause

The FTCA’s savings provision (28 U.S.C. § 2679(d)(5)) can forgive a failure to exhaust administrative remedies if: (A) the tort claim would have been timely had it been filed on the date the state action commenced; and (B) the plaintiff presents to the agency within 60 days after dismissal. O’Brien’s state suit (filed March 2021) was not commenced within two years of accrual (August 2016). Because he failed prong (A), the savings clause did not apply.

Impact

The decision has meaningful implications for community health centers, affiliated hospitals, clinicians, and plaintiffs considering medical negligence claims involving hospital care delivered by federally supported health center clinicians.

Validation of pre-deeming: By endorsing HHS’s categorical pre-deeming under § 6.6(e)(4), the First Circuit provides clear support for FTCA coverage of routine hospital on‑call arrangements involving FQHC clinicians without a case-specific application, so long as the scenario fits the regulation’s text.
Documentation focus: Coverage for on‑call care turns on paperwork. Health centers should ensure employment contracts and credentialing files explicitly document: (a) maintenance of admitting privileges; (b) hospital bylaws requiring on‑call/ER coverage as a condition of privileges; and (c) that such on‑call coverage is a condition of employment at the center.
Broader alignment: The opinion aligns the First Circuit with the Sixth Circuit’s approach in Bray, reducing the risk of a circuit split and lending predictability to FQHC-hospital collaborations nationwide.
Accelerated limitations analysis: In maternal death contexts, Sanchez’s presumption that such deaths prompt reasonable inquiry at the time of death is reaffirmed. Plaintiffs must act quickly: identify potential federal status, request records, and present FTCA claims within two years of the injury/death even if negligence is not yet confirmed.
Litigation posture: Once substitution occurs, late presentment is fatal. The savings clause will not rescue claims where the state action was filed beyond two years of accrual.
Practical compliance: Hospitals and FQHCs should coordinate to maintain clear, contemporaneous documentation of on‑call requirements and ensure their credentialing and employment terms align with § 6.6(e)(4)(ii). Plaintiffs’ counsel should investigate deeming status early and consider dual-track strategies (timely FTCA presentment plus state filings when appropriate) to preserve claims.

Complex Concepts Simplified

Deeming (PHSA/FSHCAA): A process by which HHS “deems” federally supported health centers and their clinicians to be PHS employees. When deemed, malpractice claims must be brought against the United States under the FTCA rather than against the individual or the center in tort.
Pre-deeming vs. particularized determination: For non-patient services, HHS can either (a) declare certain recurring scenarios categorically covered (pre-deeming in § 6.6(e)(4)); or (b) conduct a case-specific coverage review upon application (§ 6.6(d)).
Hospital on‑call coverage: Many hospitals require physicians to participate in on‑call rotations as a condition of maintaining admitting privileges. Under § 6.6(e)(4)(ii), such coverage is categorically covered if there is documentation that on‑call duties are also a condition of the clinician’s employment at the health center.
Substitution: When a deemed PHS clinician is sued, the Attorney General may certify scope of employment and the United States is substituted as defendant. The suit then proceeds, if at all, solely under the FTCA.
FTCA presentment and accrual: A claimant must present a written claim to the appropriate federal agency within two years after accrual (generally the injury/death). In medical cases, accrual may be delayed until the claimant knows, or should know with reasonable diligence, the injury and its cause—knowledge of negligence is not required.
Discovery rule (medical malpractice): This rule delays the start of the limitations period until sufficient facts exist to put a reasonable person on notice to investigate. Unusual outcomes (like maternal death) typically trigger immediate inquiry.
FTCA savings clause: A narrow provision that can forgive a failure to exhaust administrative remedies only if the state action was commenced within two years of accrual and the federal presentment is made within 60 days after dismissal.

Conclusion

O’Brien v. United States establishes two important propositions in the First Circuit. First, it validates HHS’s authority to pre-deem categories of non-patient services for FTCA coverage, specifically confirming that hospital on‑call/ER coverage required for hospital privileges—and documented as a condition of health-center employment—falls within § 6.6(e)(4)(ii) without any additional, case-specific application. Second, it reinforces FTCA accrual principles in medical malpractice and wrongful death actions: accrual begins when the plaintiff knows of the injury and its cause, and the unusual nature of a maternal death generally triggers a duty to inquire at death. Because presentment here occurred well beyond two years from accrual, and the state action was filed outside the same window, the savings clause could not revive the claim. The decision provides clear guidance for structuring FQHC-hospital relationships and offers a cautionary timeline for plaintiffs to act promptly when potential federal coverage may apply.