C.F.R. » Title 45 » SUBCHAPTER B—REQUIREMENTS RELATING TO HEALTH CARE ACCESS › PART 150—CMS ENFORCEMENT IN GROUP AND INDIVIDUAL INSURANCE MARKETS › Subpart C—CMS Enforcement With Respect to Issuers and Non-Federal Governmental Plans—Civil Money Penalties

45 C.F.R. § 150.301

General rule regarding the imposition of civil money penalties

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If any health insurance issuer that is subject to CMS's enforcement authority under § 150.101(b)(2), or any non-Federal governmental plan (or employer that sponsors a non-Federal governmental plan) that is subject to CMS's enforcement authority under § 150.101(b)(1), fails to comply with PHS Act requirements, it may be subject to a civil money penalty as described in this subpart.

[64 FR 45795, Aug. 20, 1999, as amended at 78 FR 13440, Feb. 27, 2013]
Notes of Decisions
Cited in 11 cases (11 in the last 5 years), 2025–2026 · leading case: Guardian Flight v. Health Care Serv., 140 F.4th 271 (5th Cir. 2025).
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Guardian Flight v. Health Care Serv., 140 F.4th 271 (5th Cir. 2025). “§ 300gg-22(b)(2)(A); 45 C.F.R. § 150.301 et seq. The Centers for Medicare and Medicaid Services (CMS), an agency within HHS, has acted on that authority by soliciting provider complaints and compelling payors to pay IDR awards where appropriate.”
Freeman Pain Inst. P.A. v. Horizon Blue Cross Blue Shield of New Jersey, No. 2:25-cv-02507 (D.N.J. Nov. 24, 2025). “§ 300gg- 22(a)-(b); 45 C.F.R. § 150.301 et seq. Pursuant to the NSA, the HHS set up an office within the Centers for Medicare and Medicaid Services (“CMS”), which is tasked with administering the IDR process.”
Ne. Neurosurgical Assocs. v. Horizon Blue Cross Blue Shield of New Jersey, No. 2:25-cv-06288 (D.N.J. Nov. 25, 2025). “§ 300gg- 22(a)-(b); 45 C.F.R. § 150.301 et seq. Pursuant to the NSA, the HHS set up an office within the Centers for Medicare and Medicaid Services (“CMS”), which is tasked with administering the IDR process.”
Garden State Pain Mgmt. v. Horizon Blue Cross Blue Shield of New Jersey, No. 2:25-cv-05679, 2025 WL 3443243 (D.N.J. Dec. 1, 2025). “§ 300gg- 22(a)-(b); 45 C.F.R. § 150.301 et seq. Pursuant to the NSA, the HHS set up an office within the Centers for Medicare and Medicaid Services (“CMS”), which is tasked with administering the IDR process.”
Complete Med. Wellness LLC v. Horizon Blue Cross Blue Shield of New Jersey, No. 2:25-cv-04177 (D.N.J. Dec. 1, 2025). “§ 300gg- 22(a)-(b); 45 C.F.R. § 150.301 et seq. Pursuant to the NSA, the HHS set up an office within the Centers for Medicare and Medicaid Services (“CMS”), which is tasked with administering the IDR process.”
Tamagnini, No. 2:25-cv-02022 (D.N.J. Dec. 2, 2025). “§ 300gg- 22(a)-(b); 45 C.F.R. § 150.301 et seq. Pursuant to the NSA, the HHS set up an office within the Centers for Medicare and Medicaid Services (“CMS”), which is tasked with administering the IDR process.”
Douglas Spiel v. Horizon Blue Cross Blue Shield of New Jersey, No. 2:25-cv-14769 (D.N.J. Dec. 2, 2025). “§ 300gg- 22(a)-(b); 45 C.F.R. § 150.301 et seq. Pursuant to the NSA, the HHS set up an office within the Centers for Medicare and Medicaid Services (“CMS”), which is tasked with administering the IDR process.”
Interventional Pain Mgmt. v. Horizon Blue Cross Blue Shield of New Jersey, No. 2:25-cv-12032 (D.N.J. Dec. 3, 2025). “§ 300gg- 22(a)-(b); 45 C.F.R. § 150.301 et seq. Pursuant to the NSA, the HHS set up an office within the Centers for Medicare and Medicaid Services (“CMS”), which is tasked with administering the IDR process.”
Worldwide Aircraft Servs. Inc. v. Freedom Life Ins. Co. of Am., No. 8:25-cv-01158, 2025 WL 3551397 (M.D. Fla. Dec. 11, 2025). “§ 300gg-22(b)(2)(A); 45 C.F.R. § 150.301 et seq.). As such, the “NSA’s structure conveys Congress’s policy choice to enforce the statute through administrative penalties, not a private right of action.”
NeuroShield Network SE, LLC v. Phoenix Administrators, LLC (d/b/a Performance Health), No. 1:25-cv-01277 (N.D. Ohio Mar. 30, 2026). “§ 300gg- 22(b)(2)(A); 45 C.F.R. § 150.301 , et seq.). CMS, “an agency within HHS, has acted on that authority by soliciting provider complaints and compelling payors to pay IDR awards where appropriate.”
PHI Health, LLC v. Optimum Choice, Inc. D/B/A/ United Healthcare, No. 1:25-cv-02320, 2026 WL 850453 (D. Md. Mar. 27, 2026). “§ 300gg-22(b)(2)(A); see also 45 C.F.R. § 150.301 (“General rule regarding the imposition of civil money penalties” under the Public Health Service Act); see, e.”
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