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2020’s a Bust, but HIPAA Enforcement Is on a Roll!

October 15, 2020 – Dorsey Health Law

by Alissa Smith and Elizabeth Greiter

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The Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) has been actively enforcing HIPAA regulations this year, including a series of seven settlements under OCR’s Right of Access Initiative to enforce patients’ rights to timely access their medical records at a reasonable cost. This year, OCR has recorded more than $12.2 million in resolution agreements. This post summarizes OCR’s settlements in 2020 to date.  The OCR settlements have impacted a wide range of sectors in the health industry from health insurers, to hospital systems, physician clinics, FQHCs, mental health and substance abuse providers, business associates, and nonprofits serving those with AIDS/HIV.  Enforcement has been taken against all sizes of entities, including against solo practitioners and very small non-profits.  As with nearly all settlements with OCR, it was the initial breach notification that triggered the investigation.  However, the settlement ultimately resulted after OCR’s investigation discovered widespread non-compliance with HIPAA’s privacy and security requirements.  The following post provides a summary of these enforcement actions, and begins with an update about Anthem’s recent $39.5M settlement with 43 states and D.C. stemming from its massive data breach in 2014-2015, which resulted in a record $16 million settlement with OCR in 2018.

Health Insurer Enforcement

Anthem and 43-State Coalition Reach $39.5 Million Settlement Over Data Breach

On September 30, 2020, state attorneys general in 43 states and Washington D.C. announced that they had reached a $39.5 million settlement with Anthem Inc., an Indianapolis, IN-based health insurer.  This settlement stemmed from an investigation by the state attorneys general into the largest health data breach in history, a series of state-sponsored cyberattacks in December 2014 and January 2015 that exposed the ePHI of nearly 79 million individuals.  In 2018, Anthem agreed to pay $16 million to OCR and to take substantial corrective action to settle potential violations of the HIPAA privacy and security rules related to the 2014 data breach. See the HHS press release about the OCR settlement here. Anthem has also paid $115 million to settle a class action related to the breach, the largest-ever class action settlement related to a data breach.

Premera Blue Cross Pays $6.85 Million to Settle Data Breach Affecting Over 10.4 Million People

In March, in the second-largest HIPAA settlement ever, Premera Blue Cross (PBC), the largest health plan in the Pacific Northwest, agreed to pay $6.85 to OCR and to implement a corrective action plan to settle potential HIPAA privacy and security rules violations related to a data breach. Using malware installed through a phishing email, cyber-attackers gained access to PBC’s system in August 2014 and went undetected until January 2015, resulting in the exposure of over 10.4 million individuals’ electronic protected health information (ePHI). OCR’s investigation determined that PBC had “systemic noncompliance with the HIPAA Rules including failure to conduct an enterprise-wide risk analysis, and failures to implement risk management, and audit controls.” See the HHS press release here.

Hospital and Health System Enforcement

Lifespan Pays $1.04 Million to Settle Unencrypted Stolen Laptop Breach Affecting Over 20,000 People

In June, Lifespan Health System Affiliated Covered Entity (“Lifespan ACE”), a Rhode Island-based non-profit health system, agreed to pay a $1.04 million settlement to OCR and to adopt a corrective action plan to settle potential violations of the HIPAA privacy and security rules related to the theft of a hospital employee’s unencrypted laptop. The laptop contained the ePHI of more than 20,000 individuals. OCR’s investigation determined that there had been systematic noncompliance with the HIPAA Rules, including a failure to encrypt ePHI on laptops, a lack of device and media controls, and a failure to have a business associate agreement in place with the Lifespan Corporation, the parent company and business associate of Lifespan ACE. See the HHS press release here.

Physician and Clinic Enforcement

Solo Practice Pays $100,000 for Failing to Implement HIPAA Security Rule Requirements

In February, Steven A. Porter, M.D., a Utah gastroenterologist and solo practitioner, agreed to pay $100,000 to OCR and to adopt a corrective action plan to settle a potential violation of the HIPAA security rule. OCR determined that Dr. Porter’s practice had demonstrated significant noncompliance with the HIPAA rules, specifically, failing to conduct any risk analysis and failing “to implement security measures sufficient to reduce risks and vulnerabilities to a reasonable and appropriate level.” See the HHS press release here.

Orthopedic Clinic Pays $1.5 Million to Settle Systemic Noncompliance with HIPAA Privacy and Security Rules

In July, Georgia-based Athens Orthopedic Clinic PA (“Athens Orthopedic”) agreed to pay $1.5 million to OCR and to implement a corrective action plan to settle potential violations of the HIPAA privacy and security rules. A hacker used a vendor’s credentials to access Athens Orthopedic’s electronic medical record system and exfiltrated patient health data, then demanded money from Athens Orthopedic in return for the return of the stolen records. Nearly 210,000 individuals were affected by the breach. OCR’s investigation found noncompliance with the HIPAA privacy and security rules, including “failures to conduct a risk analysis, implement risk management and audit controls, maintain HIPAA policies and procedures, secure business associate agreements with multiple business associates, and provide HIPAA Privacy Rule training to workforce members.” See the HHS press release here.

FQHC Pays $25,000 for Failing to Implement HIPAA Security Rule Requirements

In March, Metropolitan Community Health Services (“Metro”), doing business as Agape Health Services, agreed to pay $25,000 to OCR and to implement a corrective plan to settle potential violations of the HIPAA security rule. In 2011, Metro reported impermissible disclosure of PHI to an unknown email account, which affected over 1,200 patients. OCR’s investigation found that Metro had failed to conduct any risk analysis, failed to implement any HIPAA security rule policies and procedures, and not provided workforce members with security awareness training until 2016. Metro is a Federally Qualified Health Center that provides medical services in underserved areas in rural North Carolina on a sliding fee scale, which was taken into account in reaching this agreement. See the HHS press release here.

Business Associate Enforcement

CHSPSC Agrees to Pay $2.3 Million to Settle Data Breach Affecting Over 6 Million People

In March, CHSPSC LLC (“CHSPSC”) agreed to pay $2.3 million and to adopt a corrective action plan to settle potential violation of the HIPAA privacy and security rules related to a breach affecting more than 6 million people. CHSPSC is based in Tennessee and provides a variety of business associate services, including IT and health information management. In 2014, the Federal Bureau of Investigation (FBI) notified CHSPSC that it had traced a cyber-attack to CHSPSC’s information system.  OCR’s subsequent investigation found “longstanding, systematic noncompliance” with the HIPAA security rule, including “failure to conduct a risk analysis, and failures to implement information system activity review, security incident procedures, or access controls.” See the HHS press release here.

Right of Access Initiative Enforcement

In 2019, OCR announced the Right of Access Initiative as an enforcement priority to support individuals’ right to timely access to their health records at a reasonable cost and in the readily producible format of their choice under the HIPAA privacy rule’s right of access provision, 45 CFR § 164.524. The HIPAA Rules generally require covered health care providers to provide medical records within 30 days of the request and providers can only charge a reasonable cost-based fee. This right to patient records extends to parents seeking access to their minor children’s medical records.

To date this year, OCR has completed seven enforcement actions totaling $396,500 in settlement payments under the Right of Access Initiative, bringing the total number of enforcement settlements under this initiative to nine.

  • In June, Housing Works Inc. (Housing Works), a New York City-based non-profit organization providing a range of services to individuals living with and affected by HIV/AIDS, including health care, agreed to pay $38,000 to OCR and to take corrective actions to settle a potential right of access violation. In complaints filed with OCR in July and August 2019, a patient alleged that he had not received his records in response to a June 2019 request. OCR opened an investigation, found a possible violation, and the patient received his medical records in November 2019.
  • In July, All Inclusive Medical Services (AIMS), a California-based multi-specialty family medicine clinic, has agreed to pay $15,000 to OCR and to adopt a corrective action plan to settle a potential right of access violation. A patient alleged that in January 2018, AIMS had denied her requests to inspect and receive a copy of her records, in an April 2018 complaint filed with OCR. The patient ultimately received her medical records in August 2020.
  • In August, Beth Israel Lahey Health Behavioral Services (BILHBS), the largest network of mental health and substance use disorder services in eastern Massachusetts, agreed to pay $70,000 to OCR and to take corrective actions following a potential right of access violation. A personal representative filed a complaint with OCR in April 2019 alleging that she had requested her father’s medical records in February 2019 and BILHBS had failed to provide them. BILHBS provided the requested medical records in October 2019.
  • In August, Patricia King, M.D. (King MD), a small provider of psychiatric services in Virginia, agreed to pay $3,500 to OCR and to adopt a corrective action plan to settle a potential right of access violation. OCR received a complaint from a patient in October 2018, alleging that King MD failed to respond to her August 2018 request for her medical records. After OCR provided King MD with technical assistance on right of access requirements, a second complaint, and an OCR investigation that found that the failure to provide the requested medical records was a potential violation, the patient received her medical records in July 2020.
  • In August, Wise Psychiatry, PC (Wise Psychiatry) a small provider of psychiatric services in Colorado, agreed to pay $10,000 to OCR and to take corrective actions to settle a potential right of access violation. A father requested his minor son’s medical records in November 2017, and following two complaints to OCR, OCR providing technical assistance to Wise Psychiatry on the HIPAA right of access requirements, and OCR opening an investigation, Wise Psychiatry sent the requested medical records in May 2019.

See HHS’s press release about OCR’s first five right to access settlements of 2020 here.

  • In September, Dignity Health, doing business as St. Joseph’s Hospital and Medical Center (SJHMC), agreed to pay $160,000 and to adopt a corrective action plan to settle a potential right of access violation. SJHMC is based in Arizona and is a large, acute-care hospital with several hospital-based clinics. A mother made several requests for her son’s medical records, as his personal representative, beginning in January 2018, but did not receive all of the requested records until December 2019. See the HHS press release here.
  • In September, NY Spine Medicine (NY Spine), a private medical practice specializing in neurology and pain management with offices in New York and Florida, agreed to pay $100,000 and to take corrective actions to settle a potential right of access violation. A patient requested a copy of her medical records in June 2019, and NY Spine provided some records in response, but did not provide the diagnostic films that the patient had specifically requested until October 2020, after OCR had initiated an investigation. See the HHS press release here.

OCR’s enforcement of the HIPAA security and privacy rules this year is increasingly aggressive. Per HHS, OCR’s enforcement actions are “designed to send a message to the health care industry about the importance and necessity of compliance with the HIPAA Rules.”   If you have questions about HIPAA compliance, please contact the authors, your regular Dorsey attorney or any attorney in the Dorsey & Whitney health transactions and regulations practice group.

Firm Highlights

Insights

Energy Law: Month in Review - September 2026

Welcome to Dorsey’s Energy Law: Month in Review. We provide this update to our clients to identify significant developments in the previous month. Please reach out to any of the authors, listed above, to discuss these issues. Regulatory Developments Massachusetts Ratchets Up State and Local Regulation of AI Data Centers In early September, Governor Maura Healey of Massachusetts signed an executive order requiring that artificial intelligence data centers secure the approval of local communities as a precondition to proceeding with a given project. According to the terms of the order, data center developers will need to secure a “community benefits agreement” as a precondition to receiving permits from numerous state agencies, including the Department of Environmental Protection, the Energy Facilities Siting Board, and the Massachusetts Environmental Policy Act Office. Beyond requiring community benefits agreements, the order also mandates that developers mitigate utility costs to consumers, prohibits the use of nondisclosure agreements, and requires various state agencies to develop measures to limit data center impacts on the environment. North Carolina Regulators Decline Approval of Duke Energy Gas Turbine On September 18, 2026, North Carolina Utilities Commission (NCUC) denied Duke Energy’s application for a certificate of public convenience and necessity required to construct a gas-fueled combustion turbine at its Smith Energy Complex in North Carolina. The NCUC objected strongly to the $584 million price tag and noted that Duke appeared to be constructing the facility “based on anticipated data center customer additions.” The NCUC rejected that anticipated growth as “insufficiently reliable for the Commission to act at this point.” In rejecting Duke’s application, the NCUC also noted that Duke had signed the White House Ratepayer Protection Pledge, in which it represented that it would not shift data center costs to consumers. The NCUC observed that the record did not demonstrate how Duke “intends to adhere to its commitments under the Ratepayer Protection Pledge with regard to the Proposed Facility.” Notably, commission staff had actually supported the construction of the turbine, citing concerns about Duke’s reserve margins. The NCUC noted that it “understands the Public Staff’s expressed concerns,” but those concerns were outweighed by the NCUC’s reservations, including questions of demand. Department of Energy Approves Funds for Grid Improvement The U.S. Department of Energy (DOE) recently announced that it would fund 31 grid-improvement projects in 26 states. The funding initiative is part of the DOE’s “SPARK” initiative. The funding will include $1.9 billion in federal funding from DOE and $3.35 billion in recipient cost-sharing funding. The funds will go to projects designed to improve grid reliability and lower electricity costs. Recipients plan to reconductor over 1,500 miles of transmission lines and will deploy grid-enhancing technologies across approximately 21,000 miles. DOE stated that this initiative will make available over 23 additional gigawatts of electricity. Texas Moderates Rules Governing Data Center Interconnection The Texas Public Utility Commission adopted new regulations governing large-load interconnections. The rules impose a flat study fee of $100,000 for all proposed interconnections, which departs from the initial proposal to impose study fees using a tiered system based on project size. Additionally, the final rule eliminates the PUC’s previous proposal to impose a non-refundable interconnection fee of $50,000 per MW of contracted peak demand. The final rule also moderates the initially proposed regulations governing Electric Reliability Council of Texas (ERCOT) notifications for large-load customers’ non-utilized capacity. The proposed rules would have required notifying ERCOT within 30 days of missing a scheduled energization milestone by six months. The final rules, however, do not require informing ERCOT unless a scheduled energization milestone is missed by 24 months. FERC Denies TransAlta 202(c) Cost-Recovery Plan The Federal Energy Regulatory Commission (FERC) recently rejected TransAlta’s plan to recover $19.9 million in expenses stemming from a DOE order in which DOE prohibited TransAlta from retiring its coal-powered Centralia power plant. TransAlta had previously intended to retire the facility at the end of 2025. TransAlta’s cost recovery plan proposed spending an additional $23 million on repairs to continue operating the unit. FERC’s main objection had to do with geographic scope. TransAlta’s recovery plan called for recovering costs from California Independent System Operator (CAISO) and the Southwest Power Pool (SPP), but the DOE’s order requiring operation of the plant was designed to ensure reliability in the Northwest assessment area (Montana, Oregon, Washington, and parts of northern California and northern Idaho). Accordingly, FERC was unwilling to allow cost recovery from CAISO and SPP when the order that precipitated the additional costs only related to the Northwest assessment area. FERC informed TransAlta that it would only approve cost recovery from load-serving entities in the Northwest assessment area. FERC’s decision comes amid a rush of DOE emergency orders requiring the continued operation of coal-fired generating units. Litigation Appeals Court Upholds Washington Hydropower Plant With Caveats In a September 21, 2026, opinion, the Washington Court of Appeals largely upheld a Clean Water Act water quality certification by the Washington Department of Ecology for the Goldendale Energy Storage Project, a proposed pumped-water storage hydropower system adjacent to, but off-stream from, the Columbia River. A nonprofit (Columbia Riverkeeper) and the Confederated Tribes and Bands of the Yakama Nation appealed the certification, contending that it failed to impose necessary conditions and monitoring requirements to protect the water quality of the Columbia River. Most saliently, the plaintiffs argued that the project had the potential to leak 100 acre-feet of water per year into tributaries of the Columbia River. The Court of Appeals broadly rejected plaintiffs’ challenge to the state’s conclusion that “the project was designed not to leak.” That said, the Court of Appeals did reverse on one narrow issue. Specifically, the court determined that the state’s conclusion that “leakage from the project’s tunnels would be monitored and reported” was not supported by the evidence because the certification “does not explicitly require monitoring and reporting to determine whether there is any leakage.” Accordingly, the court remanded the matter to the state to impose monitoring and reporting requirements but otherwise affirmed the certification. Legislative Developments California Legislates Restrictions on Data Center Energy Use and Grid Costs On September 21, 2026, California Governor Gavin Newsom signed seven bills broadly regulating data centers in the state. SB 1168 directed the California Public Utilities Commission to assess the energy used by data centers. It also requires the PUC to pass costs of transmission and distribution upgrades and load increases on to data centers, rather than customers. SB 886 and SB 887 compel data centers to pay for infrastructure upgrade and generation costs, and wildfire mitigation costs, in addition to imposing environmental review. The statutes additionally increase local oversight of data centers. AB 1577 imposes a monthly reporting requirement that requires data centers to supply energy consumption and efficiency data to the California Energy Commission. AB 2383 contains incentives for data centers to use onsite clean energy generation. Finally, AB 2469 and AB 2619 require data center developments to assess water supply and develop a water scarcity plan. The statutes also mandate statewide water reporting as a precondition to obtaining and renewing business licenses.

Insights

SEC Proposes Expansion of Investment Adviser Performance-Based Compensation Rule

On September 30, 2026, the Securities and Exchange Commission (the “SEC”) proposed amendments to Rule 205-3 under the Investment Advisers Act of 1940, as amended (the “Advisers Act”), which provides an exemption from the general prohibition under Section 205(a)(1) of the Advisers Act on registered investment advisers receiving performance-based compensation (the “Proposal”) so long as performance-based compensation is limited to “qualified clients”.1 Most notably for private fund sponsors, the Proposal would expand the definition of “qualified client” to include any investors that satisfy the “accredited investor” definition under Regulation D. The Proposal may also have implications for private fund managers that rely on exemptions from investment adviser registration under state law because certain state-level investment adviser registration exemptions incorporate or otherwise reference the federal qualified client definition. Expansion of the Qualified Client Definition Under the current Rule 205-3, an investor generally may qualify as a qualified client if, among other alternatives, the investor has at least $1.4 million under management with the adviser or has a net worth exceeding $2.7 million. These thresholds are higher than the financial thresholds applicable to many accredited investors under Regulation D. As a result, an investor may currently qualify as an accredited investor for purposes of investing in a private offering without qualifying as a qualified client for purposes of paying performance-based compensation. The Proposal would expand the qualified client definition to include any natural person or legal entity investor that satisfies the accredited investor definition under Regulation D. The Proposal would also remove the assets under management and net worth thresholds under the current Rule 205-3 qualified client test. For private funds relying on Section 3(c)(1) of the Investment Company Act of 1940, this change could reduce the need to apply a separate qualified client standard to investors that already qualify as accredited investors. Dorsey Observations and Next Steps If adopted as proposed, the expanded qualified client definition could be particularly significant for private fund managers. Most private fund offerings are already limited to accredited investors under Regulation D. However, the Proposal could expand the pool of prospective investors available to emerging private fund managers while reducing the regulatory burden associated with complying with Rule 205-3. The Proposal could also benefit advisers operating below the SEC registration threshold that rely on a state private fund adviser exemption. A number of states have adopted exemptions modeled on the North American Securities Administrators Association (“NASAA”) private fund adviser exemption, which may condition relief for advisers to certain funds relying on Section 3(c)(1) on each beneficial owner satisfying the federal qualified client definition. However, state requirements vary, and any effect of the Proposal would depend on the text of the applicable state exemption and how it incorporates Rule 205-3. Many emerging private fund managers may have a larger network of accredited investor relationships than qualified client relationships during the early stages of their investment advisory business. Currently, under Rule 205-3, private fund managers may receive performance-based compensation from investors who do not satisfy the qualified client definition if those investors were admitted to their private funds prior to registration with the SEC. Following registration with the SEC, however, managers may continue to permit investors that are not qualified clients to invest in future private funds but may not receive performance-based compensation from those investors with respect to such investments. In addition, because the net worth and assets under management thresholds for qualified client status are adjusted for inflation every five years, the pool of qualified client investors may diminish over time as previously eligible investors no longer satisfy the applicable thresholds. The Proposal could provide the dual benefit of greater flexibility for private fund managers to establish and maintain relationships with accredited investors as their businesses scale and they become registered with the SEC, and greater flexibility for certain accredited investors to participate in investment strategies that historically have been restricted to much larger institutional investors. Unless and until the Proposal is adopted, investment advisers should continue to comply with the existing qualified client requirements. If the Proposal is adopted, private fund sponsors should consider whether corresponding changes are appropriate for their subscription documents, investor questionnaires, and other offering materials. Advisers that are state-registered or rely on a state-level exemption should also consult the laws and regulations of each relevant jurisdiction before changing investor eligibility standards or performance-based compensation practices, because adoption of the federal amendments may not automatically modify state requirements. Comments on the Proposal will be due 60 days after publication in the Federal Register. 1 Investment Adviser Performance-Based Compensation Modernization, Investment Advisers Act Release No. IA-7022 (Sept. 30, 2026), available at https://www.sec.gov/rules-regulations/2026/09/s7-2026-28#33-11443proposed.

Insights

The Supreme Court Update - October 8, 2026

On September 29, 2026, the Supreme Court granted certiorari in one case: Department of Homeland Security v. D.V.D., No. 26-426: This case concerns the Trump Administration’s “third-country removal” procedures, where immigrants are deported to countries not listed in the removal orders. In granting certiorari, the Court granted the Government’s application to stay a lower court decision halting the practice, which will allow third-country removals to continue pending resolution of the case. The issues presented are: (1) Whether the district court had jurisdiction over respondents’ claims; (2) whether the district court had authority to enter class-wide declaratory relief and APA vacatur under 8 U.S.C. § 1252(f)(1); (3) whether the Government’s guidance on third-country removals is unlawful under 8 U.S.C. § 1231(b), the due process clause, or FARRA/CAT and its implementing regulations; and (4) such other questions that the Government determines are appropriate for the proper disposition of the case. On October 1, 2026, the Court granted certiorari in three additional cases: Rhoney v. Barbosa da Cunha, No. 26-104: Immigration officials detained Ricardo Aparecido Barbosa da Cunha—a Brazilian citizen who had lived in the United States for approximately twenty years after entering without inspection—and denied him a bond hearing under 8 U.S.C. § 1225(b)(2)(A). The Second Circuit held that his detention was instead governed by § 1226(a), which permits release on bond, because § 1225(b)(2)(A)’s mandatory-detention requirement applies only to noncitizens apprehended while entering the country or shortly thereafter. The question presented is: Whether 8 U.S.C. § 1225(b)(2)(A) mandates the detention pending removal proceedings of aliens who, like Barbosa da Cunha, are present in the United States without having been admitted. Missionaries of St. John the Baptist, Inc. v. Frederic, No. 25-113: A Catholic religious organization sought to build a shrine to the Virgin Mary on land the organization owned adjacent to its church in Park Hills, Kentucky. Local zoning restrictions prohibited the proposed construction. The question presented is: Whether a land-use regulation that prohibits a religious institution from building a religious structure on its own property constitutes a “substantial burden” on religious exercise under the Substantial Burden Provision of the Religious Land Use and Institutionalized Persons Act, 42 U.S.C. § 2000cc(a). Marschner v. Marschner, No. 25-1349: Under the Uniformed Services Former Spouses’ Protection Act (“USFSPA”), a veteran’s longevity-based retirement pay can be divided in a divorce, but retirement pay based on disability and retirement pay that was waived to receive disability pay are indivisible. The question presented is: Does the USFSPA require state courts to refuse enforcement of indemnification provisions in a divorce settlement agreement?

Insights

EPA Limits Title V Re-Litigation of NSR Permits

Overview On September 25, 2026, the U.S. Environmental Protection Agency (“EPA”) published a final rule that significantly limits the ability of third parties to use the Clean Air Act (“CAA”) Title V permitting process to revisit New Source Review (“NSR”) permitting decisions years after those decisions were made. The rule establishes that NSR permitting determinations generally must be challenged during the original permitting proceeding, thereby providing regulated sources with greater permitting certainty and finality for major capital projects. Published in the Federal Register titled Clarifying the Scope of “Applicable Requirements” Under State Operating Permit Programs and the Federal Operating Permit Program (Docket ID No. EPA-HQ-OAR-2023-0401), the rule amends 40 C.F.R. Parts 70 and 71 to codify EPA’s interpretation regarding when requirements established under other CAA programs may be reviewed, modified, or implemented through the Title V operating permit program. The rule becomes effective 30 days after publication. The rule addresses two principal issues: (1) the relationship between NSR preconstruction permitting and Title V operating permits, and (2) the treatment of the General Duty Clause under CAA section 112(r)(1). Most significantly, the rule provides greater certainty for sources navigating the NSR permitting process. EPA’s amendments are intended to ensure that NSR permitting decisions made through an approved public process are generally not revisited later through Title V permit proceedings. The rule responds to a circuit split between the U.S. Courts of Appeals for the Fifth and Tenth Circuits. In Environmental Integrity Project v. EPA, 969 F.3d 529 (5th Cir. 2020), the Fifth Circuit upheld EPA’s interpretation, concluding that it was consistent with the text, structure, and purpose of Title V. In contrast, the Tenth Circuit reached the opposite conclusion in Sierra Club v. EPA, 964 F.3d 882 (10th Cir. 2020), finding that the then-existing regulatory definition of “applicable requirement” did not support EPA’s position. By amending the regulatory language on which the Tenth Circuit relied and codifying the interpretation approved by the Fifth Circuit, EPA has established a nationwide framework governing the interaction between NSR and Title V. NSR and Title V: EPA Establishes a Uniform Nationwide Framework At the core of the rule is EPA’s effort to define the respective roles of NSR and Title V. The rule codifies the approach EPA has applied since 2017: once a source obtains an NSR permit under an EPA-approved permitting program, and that permit was issued following public notice with an opportunity for comment and judicial review, the permit establishes the NSR-related “applicable requirements” of the State Implementation Plan (“SIP”) or Federal Implementation Plan (“FIP”) for Title V purposes. Under this framework, Title V is not a vehicle for re-examining underlying NSR permitting decisions. EPA does not intend to use the Title V process to revisit applicability determinations, emissions calculations, control technology determinations, permit conditions, or other issues resolved through the NSR permitting process. This principle applies regardless of the stage of the Title V proceeding; whether the NSR permit was issued pursuant to a SIP or FIP; the type of NSR issue involved; or whether the NSR permit is incorporated into Title V sequentially or concurrently. Limited Exceptions EPA recognizes several circumstances in which NSR issues may still be reviewed through the Title V program: No NSR permit was issued at all; The permit was issued without public notice and an opportunity for comment and judicial review; or The issue involves substantive overlap between Title V and NSR requirements, such as the adequacy of monitoring provisions. As a result, the rule does not insulate unpermitted projects or foreclose review of matters that independently arise under Title V. Key Regulatory Amendments The rule revises the definition of “applicable requirement” in 40 C.F.R. §§ 70.2 and 71.2. Paragraph (1): Where an NSR permit is issued with public notice and an opportunity for comment and judicial review, the permit establishes and defines the applicable SIP or FIP requirements for Title V purposes. Paragraph (2): All NSR permit terms, including terms contained in minor NSR permits, constitute applicable requirements that must be incorporated into Title V permits. Paragraph (4): CAA section 112(r)(1) (the General Duty Clause) is expressly excluded from the definition of “applicable requirement,” while section 112(r)(7) Risk Management Program requirements remain included. EPA also amended 40 C.F.R. §§ 70.8 and 70.12 to clarify that alleged defects in requirements established outside the Title V process generally do not provide a basis for EPA objection to a Title V permit or for a Title V citizen petition. General Duty Clause Exclusion The rule also codifies EPA’s longstanding position that the General Duty Clause in CAA section 112(r)(1) is not an “applicable requirement” for Title V purposes. EPA points to several considerations supporting that conclusion, including the distinction between the General Duty Clause and Title V permit terms, the provision’s origins in the Occupational Safety and Health Act’s general duty clause, and the different enforcement structures applicable to the General Duty Clause and Title V permit requirements. Importantly, excluding section 112(r)(1) from the definition of “applicable requirement” does not eliminate EPA’s authority to enforce the General Duty Clause independently of the Title V program. The final rule instead clarifies that the General Duty Clause need not—and should not—be incorporated into Title V permits as an applicable requirement. Practical Implications for Regulated Sources Greater Finality for NSR Permits  For projects requiring PSD, nonattainment NSR, or minor NSR permits, the permitting process becomes the primary forum for resolving disputes regarding applicability determinations, emissions calculations, control technology requirements, offsets, and permit conditions. Once an NSR permit is issued through a qualifying public process, regulated sources should face substantially reduced risk that those same issues will be challenged years later through Title V permit proceedings. Reduced Risk of Collateral Permit Challenges Stakeholders have sometimes sought to use Title V permit issuance, renewal, revision, or citizen-petition proceedings to challenge underlying NSR determinations. The final rule makes clear that Title V is not the appropriate vehicle for challenging whether an applicable requirement was correctly established in the first instance. This should reduce the risk of permit delays and uncertainty associated with collateral challenges to previously issued NSR permits. The rule does not, however, eliminate all Title V challenges relating to an NSR permit. Challenges concerning the Title V permit itself—including whether it appropriately incorporates applicable requirements or contains adequate compliance provisions—remain possible. Increased Importance of the Initial NSR Proceeding Because Title V generally will not provide a second opportunity to challenge the substantive validity of an NSR determination, the administrative record developed during the NSR process becomes increasingly important. Permit applicants should ensure that applicability analyses, emissions calculations, control technology evaluations, modeling demonstrations, and supporting technical documentation are thoroughly developed during the original permitting proceeding. For significant projects, applicants may therefore have an additional incentive to identify and resolve potential permitting issues before the NSR permit is issued rather than assuming that unresolved issues can be addressed during a subsequent Title V proceeding. Potential Incentive for Broader Public Participation EPA also notes that permitting authorities may choose to provide public notice and an opportunity for comment for a broader range of NSR permits because permits issued through a qualifying public process receive the benefit of the finality framework established by the rule. Some permitting authorities may conclude that greater public participation at the NSR stage is preferable to uncertainty during subsequent Title V proceedings. Conclusion The final rule is principally a permitting-certainty measure. For sources that obtain NSR permits through a public process, EPA has substantially limited the ability of third parties to revisit underlying NSR determinations through the Title V program. As a result, regulated entities should benefit from greater finality regarding key permitting decisions, reduced risk of collateral permit challenges, and increased certainty when planning and implementing capital projects.