45 C.F.R. § 162.1002

Medical data code sets

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The Secretary adopts the following maintaining organization's code sets as the standard medical data code sets:

(a) For the period from October 16, 2002 through October 15, 2003:

(1) International Classification of Diseases, 9th Edition, Clinical Modification, (ICD-9-CM), Volumes 1 and 2 (including The Official ICD-9-CM Guidelines for Coding and Reporting), as maintained and distributed by HHS, for the following conditions:

(i) Diseases.

(ii) Injuries.

(iii) Impairments.

(iv) Other health problems and their manifestations.

(v) Causes of injury, disease, impairment, or other health problems.

(2) International Classification of Diseases, 9th Edition, Clinical Modification, Volume 3 Procedures (including The Official ICD-9-CM Guidelines for Coding and Reporting), as maintained and distributed by HHS, for the following procedures or other actions taken for diseases, injuries, and impairments on hospital inpatients reported by hospitals:

(i) Prevention.

(ii) Diagnosis.

(iii) Treatment.

(iv) Management.

(3) National Drug Codes (NDC), as maintained and distributed by HHS, in collaboration with drug manufacturers, for the following:

(i) Drugs

(ii) Biologics.

(4) Code on Dental Procedures and Nomenclature, as maintained and distributed by the American Dental Association, for dental services.

(5) The combination of Health Care Financing Administration Common Procedure Coding System (HCPCS), as maintained and distributed by HHS, and Current Procedural Terminology, Fourth Edition (CPT-4), as maintained and distributed by the American Medical Association, for physician services and other health care services. These services include, but are not limited to, the following:

(i) Physician services.

(ii) Physical and occupational therapy services.

(iii) Radiologic procedures.

(iv) Clinical laboratory tests.

(v) Other medical diagnostic procedures.

(vi) Hearing and vision services.

(vii) Transportation services including ambulance.

(6) The Health Care Financing Administration Common Procedure Coding System (HCPCS), as maintained and distributed by HHS, for all other substances, equipment, supplies, or other items used in health care services. These items include, but are not limited to, the following:

(i) Medical supplies.

(ii) Orthotic and prosthetic devices.

(iii) Durable medical equipment.

(b) For the period on and after October 16, 2003 through September 30, 2015:

(1) The code sets specified in paragraphs (a)(1), (a)(2),(a)(4), and (a)(5) of this section.

(2) National Drug Codes (NDC), as maintained and distributed by HHS, for reporting the following by retail pharmacies:

(i) Drugs.

(ii) Biologics.

(3) The Healthcare Common Procedure Coding System (HCPCS), as maintained and distributed by HHS, for all other substances, equipment, supplies, or other items used in health care services, with the exception of drugs and biologics. These items include, but are not limited to, the following:

(i) Medical supplies.

(ii) Orthotic and prosthetic devices.

(iii) Durable medical equipment.

(c) For the period on and after October 1, 2015:

(1) The code sets specified in paragraphs (a)(4), (a)(5), (b)(2), and (b)(3) of this section.

(2) International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) (including The Official ICD-10-CM Guidelines for Coding and Reporting), as maintained and distributed by HHS, for the following conditions:

(i) Diseases.

(ii) Injuries.

(iii) Impairments.

(iv) Other health problems and their manifestations.

(v) Causes of injury, disease, impairment, or other health problems.

(3) International Classification of Diseases, 10th Revision, Procedure Coding System (ICD-10-PCS) (including The Official ICD-10-PCS Guidelines for Coding and Reporting), as maintained and distributed by HHS, for the following procedures or other actions taken for diseases, injuries, and impairments on hospital inpatients reported by hospitals:

(i) Prevention.

(ii) Diagnosis.

(iii) Treatment.

(iv) Management.

[65 FR 50367, Aug. 17, 2000, as amended at 68 FR 8397, Feb. 20, 2003; 74 FR 3362, Jan. 16, 2009; 77 FR 54720, Sept. 5, 2012; 79 FR 45134, Aug. 4, 2014]
Notes of Decisions
Cited in 10 cases (5 in the last 5 years), 2009–2026 · leading case: United States v. Lorne Semrau, 693 F.3d 510 (6th Cir. 2012).
United States v. Lorne Semrau, 693 F.3d 510 (6th Cir. 2012). “45 C.F.R. § 162.1002 . Dr. Semrau’s attorney himself acknowledged during the trial that CPT codes “are simply a shorthand way of incorporating the description of the service.”
United States ex rel. Riedel v. Bos. Heart Diagnostics Corp., 332 F. Supp. 3d 48 (D.C. Cir. 2018). “"Federal regulations, specifically 45 C.F.R. § 162.1002 (a)(5), (b)(1), designate the American Medical Association's Current Procedural Terminology ('CPT') and the Centers for Medicare & Medicaid Services Common Procedure Coding System ('HCPCS') as the standard codes to be used…”
United States v. Marder, 208 F. Supp. 3d 1296 (S.D. Fla. 2016). “45 C.F.R. § 162.1002 ; see also United States v.”
Montcrief v. Peripheral Vascular, 133 F.4th 395 (5th Cir. 2025). “” 45 C.F.R. § 162.1002 (a)(5), (b)(1), (c)(1).”
United States v. Grp. Health Coop. (W.D.N.Y. 2023). · cites it 3× “See 45 C.F.R. §§ 162.1002 (a)(1)(i), (b)(1), (c)(2), and (c)(3); Complaint at ¶¶ 72, 74.”
Riedel v. Boston Heart Diagnostics Corp. (D.D.C. 2018). ““Federal regulations, specifically 45 C.F.R. § 162.1002 (a)(5), (b)(1), designate the American Medical Association’s Current Procedural Terminology (‘CPT’) and the Centers for Medicare & Medicaid Services Common Procedure Coding System (‘HCPCS’) as the standard codes to be used…”
Osinek v. Kaiser Permanente (N.D. Cal. 2022). “, 45 C.F.R. § 162.1002 (c)(2)(i) (“The Secretary adopts the following 16 maintaining organization’s code sets as the standard medical data code sets: .”
Virginia Hosp. & Healthcare Ass'n v. Roberts (E.D. Va. 2023). “Under the CPT system, every healthcare procedure or service is assigned a five-digit code corresponding to a description of the service furnished. See AMA, CPT Overview and Code Approval, https://www.”
United States of Am. v. Gen. Med., P.C., et al. (S.D. Ill. 2026). “” 45 C.F.R. § 162.1002 (a)(5), (b)(1), (c)(1).”
Dubin Orthopaedic Ctr., P.S.C v. Commonwealth, State Bd. of Physical Therapy, 294 S.W.3d 421 (Ky. 2009). “45 C.F.R. § 162.1002 . The CPT listings are organized under six broad headings and numerous subheadings, but *423 according to the introduction to the 2006 edition, [i]t is important to recognize that the listing of a service or procedure and its code number in a specific…”
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