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CONFIDENTIALITY (42 CFR PART-2)

Confidentiality is a fundamental aspect of the physician-patient relationship, and it is especially important for patients with addiction. Unfortunately, because of the legal and social ramifications associated with addiction, patients are often reluctant to tell their doctor that they may have addiction or consent to the disclosure of information about their addiction treatment. This is an unfortunate aspect of the stigma that surrounds this disease, and it exacerbates the addiction treatment gap that exists in this country.

To address this issue, federal regulations known as "42 CFR Part 2" protect the confidentiality of addiction treatment records of any person who has sought treatment for or been diagnosed with addiction at a federally assisted program.  42 CFR Part 2 aims to encourage people to seek treatment without fear of legal or social consequences. Improper sharing of a patient's addiction treatment information can lead to: negative perceptions and discrimination; criminal legal consequences, such as probation or jail time; and civil legal consequences, such as loss of child custody, employment or housing.

ASAM appreciates the heightened need for confidentiality protections of a patient's addiction treatment records as well as the need for complete and accurate medical information to be shared among a patient's treating clinicians. ASAM strives to strike this critical balance in its advocacy activities and will continue to call for needed privacy protections as 42 CFR Part 2 regulations and the underlying statute are updated.

Changes to 42 CFR Part 2 in the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020

The CARES Act includes the Protecting Jessica Grubb’s Legacy Act, which makes substantial changes to the statute underlying the substance use disorder (SUD) treatment record confidentiality regulations at 42 CFR Part 2:

  • Initial Consent: Once prior, written consent from a patient is obtained, the content of a patient's SUD treatment record may be used or disclosed by a covered entity, business associate, or program subject to Part 2 for the purposes of treatment, payment, and health care operations permitted by the Health Insurance Portability and Accountability Act (HIPAA).
  • Redisclosure: Any information disclosed pursuant to the initial written consent may be redisclosed in accordance with HIPAA regulations.
  • Revocation of Consent: It is permissible for a patient’s prior written consent to be given once for all such future uses or disclosures for purposes of treatment, payment, and health care operations, until such time as the patient revokes such consent in writing.
  • Disclosure of De-Identified Information to a Public Health Authority: Information may be shared with a public health authority as long as requirements for de-identification of protected health information are met as established under the HIPAA privacy regulation.
  • Patient Education: The Secretary of Health and Human Services (HHS) is directed to update regulations within one year so that covered entities and entities creating or maintaining SUD patient records provide notice, written in plain language, of privacy practices including a statement of the patient's rights and a description of each purpose for which the covered entity is permitted or required to use or disclose protected health information without the patient’s written authorization.
  • Requirement for Breach Notification: Enforcement moves under Office for Civil Rights (OCR) in HHS and penalties for breach will be assessed in accordance with HIPAA.
  • Use of Records in Criminal, Civil, or Administrative Investigations or Proceedings: Except when authorized by a court order or patient consent, records may not be disclosed or used in any civil, criminal, administrative, or legislative proceedings conducted by any Federal, State, or local authority with respect to the following activities:
    • evidence in any criminal prosecution or civil action before a Federal or State court;
    • proceeding before a Federal, State, or local agency;
    • for a law enforcement purpose or to conduct any law enforcement investigation; and
    • any application for a warrant
  • Anti-Discrimination: Expands existing patient protections to prevent discriminatory behavior towards patients suffering from a substance use disorder in relation to:
    • admission, access to, or treatment for health care;
    • hiring, firing, or terms of employment, or receipt of worker’s compensation;
    • the sale, rental, or continued rental of housing; and
    • social services and benefits provided by Federal, State or local governments.

The Secretary of HHS is directed to revise regulations that are necessary to implement and enforce these changes so that they apply to uses and disclosures of SUD patient records beginning one year after the enactment of the CARES Act.

Resources

  • The Legal Action Center (LAC) has created several sample consent forms for the release of confidential substance use disorder patient records. The new forms comply with changes made to the federal regulations governing 42 CFR Part 2 by a Final Rule issued in January 2017. The Final Rule took effect on March 21, 2017.
  • Privacy and Confidentiality Free Webinar: This CME webinar was developed in response to Final Rule changes made by the Substance Abuse and Mental Health Services Administration (SAMHSA) to the 42 CFR Part 2 confidentiality rule. To access the recording and informational materials from the webinar, visit the ASAM eLearning Center or click here.

  • ASAM has a sample Appendix D Consent to Release of Information under 42 CFR Part 2 form for physicians for educational and informational purposes only.

Appendix D Consent to Release of Information Under Title 42

  • SAMHSA has two fact sheets regarding 42 CFR Part 2 regulations:
  1. Does Part 2 Apply to me?
    • This fact sheet explains a 42 CFR Part 2 Program and how healthcare providers can determine how Part 2 applies to them.
  2. How do I exchange Part 2 data?
    • This fact sheet describes how 42 CFR Part 2 applies to the electronic health records with a Part 2 Program.
  • It is permissible for state laws, for the disclosure of confidential information on substance use disorder care, to be more restrictive than these federal regulations. However, state laws may not override them. If a state law is not stricter and conflicts with federal regulations, then the state law must yield to the federal regulations. The below resources from the George Washington University’s Hirsh Health Law and Policy Program and the Robert Wood Johnson Foundation's website, Health Information and the Law, can help treatment clinicians know if their state laws are more restrictive than the federal regulations.

Partnership to Amend 42 CFR Part 2

A coalition of over 20 health care stakeholders committed to aligning 42 CFR Part 2 with HIPAA to allow appropriate access to patient information that is essential for providing whole-person care.

Related News

ASAM Joins Letter Expressing Support for Legislation to Align Part 2 with HIPAA for TPO

by | Nov 06, 2017

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Press Release

 

The Partnership to Amend 42 CFR Part 2 (Partnership) applauds your affirmation of support for the Overdose Prevention and Patient Safety (OPPS) Act, H.R. 3545. We also thank Congressman Mullin for becoming the lead republican sponsor of the legislation. We are grateful for your leadership on the issue of substance use disorder privacy records and strongly support your bill to align 42 CFR Part 2 (Part 2) with the Health Insurance Portability and Accountability Act (HIPAA) for the purposes of health care treatment, payment, and operations (TPO). We especially appreciate the provision in your bill that strengthens protections against the use of substance use disorder records in criminal proceedings.

 

The Partnership is a coalition of nearly 40 health care stakeholder organizations committed to aligning Part 2 with HIPAA to allow appropriate access to patient information that is essential for providing whole-person care. 

 

The federal regulations governing the confidentiality of drug and alcohol treatment and prevention records, Part 2, set requirements limiting the use and disclosure of patients’ substance use records from certain substance use treatment programs. Obtaining multiple consents from the patient is challenging and creates barriers to whole-person, integrated approaches to care, which are part of our current health care framework. Part 2 regulations may lead to a doctor treating a patient and writing prescriptions for opioid pain medication for that individual without knowing the person has a substance use disorder. Separation of a patient’s addiction record from the rest of that person’s medical record creates several problems and hinders patients from receiving safe, effective, high quality substance use treatment and coordinated care. 

 

We are pleased that your bill would align Part 2 with HIPAA’s consent requirements for the purposes of TPO, which will allow for the appropriate sharing of substance use disorder records to ensure persons with opioid use disorder and other substance use disorders receive the integrated care they need. Additionally, as we do not want patients with substance use disorders to be made vulnerable as a result of seeking treatment for addiction, this legislation strengthens protections of their records. 

 

As you know, earlier this year, the Substance Abuse and Mental Health Services Administration (SAMHSA) released a final rule which takes some steps to modernize Part 2; but it does not go far enough. Legislative action is also necessary in order to modify Part 2 and bring substance use records into the 21st Century. We thank you for leading that effort and look forward to working with you to advance this important bipartisan legislation.