Proposed Rule to Clarify Existing Problems with 42 CFR Part 2 and Increase Interoperability

Patient records created by federally-assisted, substance use disorder (SUD) programs are governed by 42 CFR Part 2, or simply “Part 2.”

On August 22, 2019, The Department of Health and Human Services (HHS) and The Substance Abuse and Mental Health Services Administration (SAMHSA) released a Proposed Rule to update and clarify some of the existing problems with Part 2. This latest revision comes on the heels of two others, released in 2017 and 2018 respectively.

Learn more about the Proposed Rule, the challenges it presents, the changes it makes, and how it plays into whole person care and community care coordination.

What are the newest changes to 42 CFR Part 2?

HHS and SAMHSA’s Proposed Rule suggests a variety of changes to increase interoperability, make the exchange of health information easier, and protect patient privacy, but there are four recommendations that are particularly important.

First, the Proposed Rule provides clarification on when and how medical records become subject to Part 2. Under the Proposed Rule, oral statements made by a SUD provider to a non-SUD provider are not subject to Part 2, because the non-SUD provider isn’t writing them down.

This enables non-SUD providers to access information from a protected SUD record legally. Non-SUD providers can use this information to discuss treatment with patients and incorporate the information into the patient’s medical records without the record being subject to Part 2.

If a non-SUD provider receives written records about a patient, those records are still subject to Part 2. However, the new proposed rule clarifies that a receiving provider can segregate those records to avoid the patient’s entire medical history being subject to Part 2.

Second, if adopted, the Proposed Rule would enable non-SUD providers to access a centralized database to determine if their patients are undergoing treatment from a SUD provider. SAMHSA says that providing access to this type of information will reduce the risk of opioid abuse, improve patient outcomes, and increase communication between medical entities and social services organizations.

Third, the Proposed Rule suggests streamlining consent requirements. Under existing Part 2 regulations, consents for disclosures to entities without a provider relationship are required to name the individuals to whom disclosures are made. The Proposed Rule allows patients to name individuals or entities. SAMHSA says this change will make it easier for patients to apply for federal, state, and local benefits.

Lastly, the Proposed Rule helps clarify provisions related to the disclosure of SUD information to specific entities for payment and healthcare operational activities. In addition, SAMHSA provided a list of permitted activities to help providers prepare. The list isn’t comprehensive, but SAMHSA says disclosure would be allowed for:

  • Billing, claims management, and collection activities
  • Clinical professional support services
  • Patient safety activities
  • Third party liability coverage
  • Resolution of internal grievances
  • And more

The proposed rule also includes a catch-all for “other payment/healthcare operations activities not expressly prohibited.”

What are some challenges the Proposed Rule presents?

The Proposed Rule makes significant progress toward interoperability and comes close to harmonizing Part 2 and HIPAA for health care operations disclosures. However, the Proposed Rule retains prohibition on disclosures to contractors, subcontractors, and legal representatives related to a patients’ diagnosis and treatment. This is different from HIPAA policy, which allows for disclosures related to case management and care coordination under the provisions related to healthcare operations.

Although SAMHSA intended for these revisions to make communication between entities easier, experts say Part 2 and HIPAA regulated entities will have to develop a subset of health care communications to comply with Part 2 and HIPAA.

How does this play into whole person care and community care coordination?

To help fund state efforts to fight the opioid epidemic, The Centers for Disease Control and Prevention (CDC), released another $1.8 billion on September 4, 2019 as part of their Overdose Data to Action initiative.

That total includes $932 million in state opioid response grants from SAMHSA, guaranteed by congressional opioid legislation passed in 2018. The only requirement is that any grant recipient provide patients with access to medication-assisted treatment.

Another $900 million from the CDC is being used to help states build out drug-use surveillance programs. The goal of these surveillance programs is to limit over-prescription, addiction, and overdose rates while finding an appropriate response to the opioid epidemic.

“Strengthening our nation’s public health infrastructure is essential to capturing the predictive data needed to prevent drug overdose deaths and their devastating effects on families,” said CDC Director Robert Redfield, MD, in a written statement.

The CDC says the goal of the Overdose Data Action initiative is to acquire “high-quality, more comprehensive and timelier data on overdose morbidity and mortality.” In addition, the program positions states to strengthen their prescription drug monitoring programs, establish linkages to care, and improve provider and health system support.

The Proposed Rule: moving forward

The Proposed Rule makes progress toward easing privacy restrictions and boosting community care coordination. However, as it stands, the requirements under Part 2 are far more stringent than HIPAA and many state privacy laws, making compliance a challenge. To prevent fines and penalties, providers of SUD treatment services must stay informed of the restrictions of sharing patient information.

The comment period on SAMHSA’s Proposed Rule will close on October 25, 2019. Health care providers are encouraged to contribute their opinions and thoughts.

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