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Timestamp: 2018-02-22 04:52:49
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SAMHSA Provides Additional Clarification on Rules Applicable to Substance Use Disorder Records under Part 2 | HealthCenterCompliance.com
Compliance News › SAMHSA Provides Additional Clarification on Rules Applicable to Substance Use Disorder Records under Part 2
On January 3, 2018, the Substance Abuse and Mental Health Services Administration (SAMHSA) published a Final Rule (“2018 Final Rule”) that makes additional changes to the regulations governing the Confidentiality of Substance Use Disorder Patient Records (42 CFR Part 2 or “Part 2”). The 2018 Final Rule is available here. It builds on SAMHSA’s recent efforts to modernize Part 2. Health centers covered by Part 2 should carefully review the entire 2018 Final Rule and make appropriate adjustments to organizational policies and procedures. Below we have highlighted some of the clarifications made in the 2018 Final Rule:
Alignment with HIPAA: Throughout the comments to the 2018 Final Rule, SAMHSA once again stressed that, while the agency has attempted to align the Final Rules with HIPAA, the HITECH Act, and their implementing regulations, Part 2 is a separate and distinct law and set of regulations. Compliance with the HIPAA Rules does not equate to compliance with Part 2.
Abbreviated Notice on Re-Disclosure: The 2018 Final Rule creates an abbreviated statement that may be used as an alternative to the 140-word statement that must be provided to a recipient of records protected by Part 2. Under the 2018 Final Rule, this shorter statement may accompany the disclosure: 42 CFR part 2 prohibits unauthorized disclosure of these records. When using the abbreviated notice, SAMHSA encourages Part 2 programs and other lawful holders of Part 2 information to discuss the requirements of Part 2 with those to whom they are disclosing patient identifying information.
Disclosures to Certain Contractors, Subcontractors and Legal Representatives: The 2018 Final Rule establishes the scope and requirements for permitted disclosures to certain contractors, subcontractors and legal representatives. If a patient consents to a disclosure of their records under Section 2.31 for payment and/or health care operations activities , the recipient of those records, known as a “lawful holder” under the regulations, may further disclose the records to its contractors, subcontractors, or legal representatives to carry out payment and/or health care operations on behalf of the lawful holder. The lawful holders are required to have a contract or comparable legal instrument with the contractor or voluntary legal representative which meets the requirements detailed under 42 CFR § 2.33(b) and (c). Similarly, the 2018 Final Rule also allows auditors and evaluators to disclose records protected by Part 2 to their contractors, subcontractors or legal representatives to carry out audit and evaluation services on behalf of the auditor or evaluator. A written agreement meeting the requirements detailed under 42 CFR § 2.53 is required.
The 2018 Final Rule goes into effect on February 2, 2018. Contracts and comparable legal instruments between lawful holders, auditors and evaluators and their contractors, subcontractors, and legal representatives must come into compliance within two years of the effective date of the 2018 Final Rule.
SAMHSA announced that it will convene relevant stakeholders for a listening session to determine the effects Part 2 on patient care, health outcomes, and patient privacy on January 31, 2018. The listening session, required by the 21st Century Cures Act, will provide stakeholders with an opportunity to provide input on SAMHSA regarding implementation of Part 2, including changes adopted in the recent Final Rules. Stakeholders may also submit written comments through February 28, 2018. For additional information on participating in the listening session or submitting comments, click here.