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New HHS rule protects privacy of individuals seeking addiction treatment
HHS recently finalized changes to Confidentiality of Alcohol and Drug Abuse Patient Records, 42 CFR part 2, regulations to encourage integration and information exchange within new health care models while protecting the privacy and confidentiality of individuals who seek treatment for substance use disorders.
“Today’s changes will further enhance health services research, integrated treatment, quality assurance and health information exchange activities while at the same time safeguarding the essential privacy rights of people seeking treatment for substance use disorders,” Kana Enomoto, MA, deputy assistant secretary at HHS, said in a press release. “These efforts clear the way for integrated health care models that can provide a better, more cost-effective health care system that also empowers people to make key decisions about their health care.”
Provisions of the final rule include:
- Any lawful holder of patient information will be allowed to disclose part 2 patient information to qualified personnel for scientific research purposes if the researcher meets certain requirements;
- Part 2 rules will continue to apply for federally-assisted programs that provide substance use disorder diagnosis, treatment or referral to treatment;
- Patients may consent to disclosing their information using a general designation to individuals or entities in certain circumstances, which is intended to provide patients with benefits from integrated health care systems;
- An added requirement that provides patients who agree to the general disclosure designation the option to receive a list of who their information has been disclosed to;
- Changes to the audit or evaluation procedures to meet requirements of a CMS-regulated accountable care organization or CMS-regulated organizations, intended to ensure CMS-regulated entities can perform necessary audit and evaluation activities; and
- An updated and modernized rule regarding paper and electronic documentation.
Implementation of the final rule will be monitored by SAMHSA as the organization works to develop additional sub-regulatory guidance and materials for finalized provisions.
Additionally, HHS issued a Supplemental Notice of Proposed Rulemaking to obtain public input on additional clarifications and suggestions, particularly on payment of contractors, subcontractors and legal representatives in the health care system.
Provisions of the Supplemental Notice of Proposed Rulemaking include:
- A new provision that states disclosures to contractors, subcontractors and legal representations may receive and use part 2 data to complete the lawful holder’s payment and health care operation activities;
- Public feedback on an abbreviated alternative statement for the notice that accompanies disclosure; and
- A new provision that details the use of contractors, subcontractors and legal representatives to conduct audit and evaluation activities in CMS-regulated entities.
SAMHSA welcomes comments on the Supplemental Notice of Proposed Rulemaking. Comments must be received by 5:00 p.m. on Feb. 17.
For more information:
To view the new rule, published in Federal Register, visit: https://www.federalregister.gov/documents/2017/01/18/2017-00719/confidentiality-of-substance-use-disorder-patient-records.