HHS NPRM Seeks to Align 42 CFR Part 2 with HIPAA

A new “Notice of Proposed Rulemaking” (NPRM) would Update 42 CFR, empowered by a provision of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), to make the sharing of Substance Use Disorder (SUD) records more flexible and enable care coordination among providers while still protecting a client’s data for continued privacy.

The proposed rule looks to bring 42 CFR Part 2 more in alignment with HIPAA. The U.S. Health and Human Services Department’s Office for Civil Rights (OCR) and the Substance Abuse and Mental Health Services Administration (SAMHSA) said the proposed rule increases coordination among providers in treatment for substance use challenges and increases protections for patients concerning records disclosure to avoid discrimination in treatment.

Currently, sharing important health information for people with SUD is challenging, which makes true interoperability difficult to attain. According to the HIPAA Journal, primary care doctors are “reluctant to treat SUD patients because in some cases, physicians are required to fill out 11 different kinds of paperwork related to 42 CFR Part 2.” In an era when holistic care is key and interoperability makes that possible, a complete snapshot of a patient’s health (with valid consent) is critical for comprehensive healthcare. 42 CFR Part 2 limits SUD record visibility even for providers in the same organization using the same EHR, siloing SUD and BH health records to support compliance, limiting a cross-disciplinary team’s full understanding of a patient’s history and needs.

The proposed 42 CFR Part 2 changes are as follows:

  • Permitted use and disclosure of Part 2 records based on a single patient consent given once for all future uses and disclosures for treatment, payment, and health care operations.
  • Permitted redisclosure of Part 2 records in any manner permitted by the HIPAA Privacy Rule, with certain exceptions.
  • New patient rights under Part 2 to obtain an accounting of disclosures and to request restrictions on certain disclosures, as also granted by the HIPAA Privacy Rule.
  • Expanded prohibitions on the use and disclosure of Part 2 records in civil, criminal, administrative, and legislative proceedings.
  • New HHS enforcement authority, including the imposition of civil money penalties for violations of Part 2.
  • Updated breach notification requirements to HHS and affected patients.
  • Updated HIPAA Privacy Rule Notice of Privacy Practices requirements to address uses and disclosures of Part 2 records and individual rights with respect to those records. 

Background for 42 CFR Part 2

The rules around sharing of SUD treatment records under Rule 42 CFR Part 2 vary from how other medical records are managed and protected under HIPAA. Rule 42 CFR Part 2 further safeguards the privacy of SUD records, partially to protect people from the gross stigma still attached to that diagnosis and the harm it could cause to their life prospects and opportunities.

The 42 CFR Part 2 regulations were first published in 1975 and apply to federally assisted providers.  The main purpose of 42 CFR Part 2 was to ensure that a person who seeks help and receives treatment for substance use disorder is not placed at any greater risk or is made more vulnerable than a person who does not seek treatment. The law encouraged people with SUD to seek out and participate in treatment, assuring that their information would be protected and only released with their explicit written consent. There are only four exceptions where this information could be released without written consent:

  1. Medical emergencies
  2. Research
  3. Audits and evaluations
  4. Special court orders

Amendments were released in 2017 and 2018 to make it easier for patients to disclose and manage SUD information with relevant providers, by defining a timeframe and allowing the revocation of consent to disclose at any time.

Although intended to protect the privacy of people with SUD, 42 CFR Part 2 has resulted in putting up barriers to sharing information by patients themselves as well as among their shared healthcare providers. The rule also causes compliance challenges for the regulated entity due to two distinct sets of rules that serve people with coexisting conditions — a substance use disorder and a behavioral health diagnosis.

Why Is 42 CFR Part 2 Important?

The National Institute for Health reports that 10% of adults in the U.S. have a drug use disorder at some point in their lives. On October 22, 2019, the American Society of Addiction Medicine published a post saying 90% of the people who need SUD treatment don’t get it.

There are many reasons a person with SUD does not seek treatment and stigma is one of them. Research has shown that addiction is more highly stigmatized than other health conditions. One recent study, conducted by the Johns Hopkins Bloomberg School of Public Health, found that drug addiction is viewed much more negatively than mental illness.  Findings from the survey include:

  • 90% are unwilling to have a person with drug addiction marry into their family, compared to 59% for a person with mental illness.
  • 62% will work with someone who has a mental illness, whereas only 22% will work with someone who has a drug addiction.
  • 64% feel that employers should be able to deny employment to people with drug addiction, compared to 25% for people with mental illness.
  • 43% are opposed to giving drug addicts equivalent health insurance benefits to those afforded the public at large, while only 21% are opposed to giving the same benefits to people with mental illness.
  • 54% believe landlords should be allowed to deny housing to a person with drug addiction, compared to only 15% for persons with mental illness.
  • 3 in 10 believe that recovery from drug addiction is impossible.

42CFR Part 2 Final Thoughts 

Ideally, the proposed changes, should they be finalized, would:

  • improve care coordination among the stakeholder providers.
  • ease patient privacy concerns for the client.
  • break down barriers to information sharing by easing compliance complexities and providing patients with additional rights.

Making it easier to share health information with all the stakeholders in patient with SUD’s life is critical to that person receiving the best care, as long as the regulation continues to protect the privacy of the SUD patient. The stigma continues to be a major concern today as much as it was in the 1970s when the 42CFR Part 2 was published.

If you would like to share your thoughts on these proposed changes or on how the current 42CFR part 2 impacts your ability to serve people with SUD, please email me at mary.givens@qualifacts.com. I’d love to hear your thoughts and start a conversation about this critical topic.

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