§ 2.4 - Complaints of noncompliance.

§ 2.4 Reports Complaints of violations.

Cross Reference

Link to an amendment published at 89 FR 12618, Feb. 16, 2024.

noncompliance.

(a) The report of any violation of the regulations in this part may be directed to the United States Attorney for the judicial district in which the violation occurs.

(b) The report of any violation of the regulations in this part by an opioid treatment program may be directed to the United States Attorney for the judicial district in which the violation occurs as well as to the Substance Abuse and Mental Health Services Administration (SAMHSA) office responsible for opioid treatment program oversight.

Receipt of complaints. A part 2 program must provide a process to receive complaints concerning the program's compliance with the requirements of this part.

(b) Right to file a complaint. A person may file a complaint to the Secretary for a violation of this part by a part 2 program, covered entity, business associate, qualified service organization, or lawful holder in the same manner as a person may file a complaint under 45 CFR 160.306 for a violation of the administrative simplification provisions of the Health Insurance Portability and Accountability Act (HIPAA) of 1996.

(c) Refraining from intimidating or retaliatory acts. A part 2 program may not intimidate, threaten, coerce, discriminate against, or take other retaliatory action against any patient for the exercise by the patient of any right established, or for participation in any process provided for, by this part, including the filing of a complaint under this section or § 2.3(c).

(d) Waiver of rights. A part 2 program may not require patients to waive their right to file a complaint under this section or § 2.3 as a condition of the provision of treatment, payment, enrollment, or eligibility for any program subject to this part.

[89 FR 12618, Feb. 16, 2024]