Resources

Client Alerts, News Articles, Blog Posts, & Multimedia

Everything you need to know about BMD and the industry.

Substance Use Disorder Providers: 42 CFR Part 2 Now Enforceable

Client Alert
April 15, 2026

Does your practice treat patients with substance use disorders? Does your practice retain substance use disorder records? If the answer to one of those questions is “yes,” you will want to be aware of the recent updates to 42 CFR Part 2 (“Part 2”) requirements.  

Part 2 extends patient privacy protections by applying stringent protections to a patients’ substance use disorder (“SUD”) medical records. Modifications to Part 2 under the Confidentiality of Substance Use Disorder Patient Records Final Rule (“Final Rule”) went into effect on April 16, 2024, with a compliance date of February 16, 2026. The Final Rule modifications better aligned HIPAA and Part 2 standards and clarified previous Part 2 regulations. The following lists key changes that providers should be aware of:

Updated Penalties and Safe Harbor

The new Part 2 regulations apply HIPAA penalties to violations of Part 2. The regulations also create a “safe harbor” for investigative agencies (or those working on behalf of an investigative agency) that act with reasonable diligence before making a demand for records.[1]

Single Consent

The Final Rule “allows a single consent for all future uses and disclosures for treatment, payment, and healthcare operations.”[2]

Updated Content Requirements for Notice of Privacy Practices

The Final Rule creates specific content requirements that a Part 2 program must include in its Notice of Privacy Practices (“Notice”).[3]

A Part 2 Program must include specific information in the header of its Notice, including notifying patients of (1) how their health information may be used and disclosed; (2) their rights with respect to their health information; (3) how to file a complaint concerning a violation of the privacy or security of their health information; (4) their rights concerning their information, and (5) their right to have a copy of the Notice upon request.

In addition, a Part 2 program must include specific descriptions of how it will use and disclose patient records, a list of patients’ rights, such as the right to request restrictions of certain disclosures, a description of how a patient may exercise those rights, and a statement detailing the duties of the Part 2 program.

SUD Counseling Notes

Part 2 creates a new definition describing SUD counseling notes. Under Part 2, SUD counseling notes are “notes recorded (in any medium) by a Part 2 program provider who is a SUD or mental health professional documenting or analyzing the contents of conversation during a private SUD counseling session or a group, joint, or family SUD counseling session and that are separated from the rest of the patient's SUD and medical record.” [4]

The Final Rule mandates that a Part 2 program must obtain consent for any use or disclosure of SUD counseling notes, except:

  • To carry out the following treatment, payment, or health care operations:
    • Use by the originator of the SUD counseling notes for treatment;
    • Use or disclosure by the Part 2 program for its own training programs in which students, trainees, or practitioners in SUD treatment or mental health learn under supervision to practice or improve their skills in group, joint, family, or individual SUD counseling; or
    • Use or disclosure by the Part 2 program to defend itself in a legal action or other proceeding brought by the patient.
  • Use or disclosure that is required or permitted with respect to the oversight of the originator of the SUD counseling notes.[5]

The Final Rule also adds clarification that a written consent for a use or disclosure of SUD counseling notes may only be combined with another written consent for a use or disclosure of SUD counseling notes.[6]

Next Steps

Practices and providers will want to ensure that any policies are up to date and reflect the changes that are now enforceable under Part 2. We recommend engaging an attorney to review or update your current policies in order to ensure compliance with Part 2 updates.

To learn more about how the updates to 42 CFR Part 2 could impact your practice, please contact BMD Member Jeana Singleton at jmsingleton@bmdllc.com or 330-253-2001. 

[1] 42 CFR Sec. 2.3. See also, 89 Fed. Reg. 12474 (February 16, 2024), available at https://www.govinfo.gov/content/pkg/FR-2024-02-16/pdf/2024-02544.pdf.

[2] 42 CFR Sec. 2.33. See also, 89 Fed. Reg. 12476 (February 16, 2024), available at https://www.govinfo.gov/content/pkg/FR-2024-02-16/pdf/2024-02544.pdf. See also, Fact Sheet 42 CFR Part 2 Final Rule, U.S. Department of Health and Human Services, available at https://www.hhs.gov/hipaa/for-professionals/regulatory-initiatives/fact-sheet-42-cfr-part-2-final-rule/index.html#ftn1.

[3] 42 CFR Sec. 2.22, See also, 89 Fed. Reg. 12475 (February 16, 2024), available at https://www.govinfo.gov/content/pkg/FR-2024-02-16/pdf/2024-02544.pdf.

[4] 42 CFR Sec. 2.11. See also, 42 CFR Sec. 2.12. See also, 89 Fed. Reg. 12474-12475 (February 16, 2024), available at https://www.govinfo.gov/content/pkg/FR-2024-02-16/pdf/2024-02544.pdf.

[5] 42 CFR Sec. 2.31. See also, 89 Fed. Reg. 12476 (February 16, 2024), available at https://www.govinfo.gov/content/pkg/FR-2024-02-16/pdf/2024-02544.pdf.

[6] Id.

HealthcareHealth LawHealthcare PolicyJeana Singleton
Client Alert

Changes to FFCRA Paid Leave: Congress’ Revisions to Employment COVID-19 Leave Benefits Signals the Light is at the End of the Tunnel

December 28, 2020Late in the evening on December 27th, President Trump signed into law the government’s $900 billion COVID-19 relief package (the “Stimulus Bill”). Among other economic stimulus benefits, the Stimulus Bill contains the $600 stimulus checks that will be issued to eligible individuals as well as, relevantly, changes to the Families First Coronavirus Response Act (“FFCRA”). The FFCRA was implemented in April 2020 and provided benefits to individuals who missed work as a result of an actual or suspected COVID-19 illness or to care for a child when their school or childcare service was closed because of COVID-19. Importantly, the Stimulus Bill extends eligibility for employer payroll tax refunds for leave payments made to employees on or before March 31, 2021 under the FFCRA, signaling to the American people that Congress believes many of the employed public will be vaccinated by this time, the light at the end of the tunnel. However, the Stimulus Bill does contain a caveat that employers are no longer required to provide FFCRA leave benefits after December 31, 2020, but if they do, they will receive the payroll tax credits, up to the maximums provided in the FFCRA, for payments made prior to April 1, 2021. Below we provide a list of questions and answers we received to date following the passage of the Stimulus Bill. We expect the U.S. Department of Labor (“DOL”) to issue additional questions and answers as the Stimulus Bill is implemented, and we will update this Client Alert as these are received.Client Alert

Healthcare Speaker Programs: New OIG Alert

December 11, 2020In a rare Special Fraud Alert issued on November 16, 2020 (the “Alert”), the Office of Inspector General (“OIG”) urged companies who host speaker programs to reassess their programs in light of the “inherent risks” associated with these activities. The Alert reports that, in the last three years, drug and device companies have reported paying nearly $2 billion to health care professionals for speaker-related services.Client Alert

Value-Based Care Advances – CMS Issues New Final Rules for Stark and Anti-Kickback Statutes

December 11, 2020The Centers for Medicare & Medicaid Services (“CMS”) and the Department of Health and Human Services (“HHS”) Office of the Inspector General (“OIG”) issued two highly anticipated (and quite extensive) Final Rules to reform the Stark Law and Anti-Kickback Statute (“AKS”) regulations. The Final Rules generally take effect on January 19, 2021. The Final Rules include new safe harbors for the AKS and new exemptions to the Stark Law to allow for greater flexibility. According to the HHS, the goal of updating both laws is to make it easier for providers to engage in care coordination and value-based care programs without running afoul of the statutes. Please note that this client alert could not cover the full extent of the Final Rule changes so please contact your BMD Healthcare attorney with questions.Client Alert

Mandatory Filings Under CFIUS New Rules

December 11, 2020On September 15, 2020, the Committee on Foreign Investment in the United States (“CFIUS”) promulgated a final rule modifying its mandatory declaration requirements for certain foreign investment transactions involving “TID US businesses” (sensitive U.S. businesses dealing in critical technologies, critical infrastructure and sensitive personal data) dealing in “critical technologies” – i.e., U.S. businesses that produce, design, test, manufacture, fabricate, or develop one or more critical technologies. The new rule also makes amendments to the definition of the term “substantial interest” (used to determine whether a foreign government has a substantial interest in an entity). The final rule became effective on October 15, 2020.Client Alert

IRS Guidance on Employee Retention Credit

December 11, 2020The Employee Retention Credit created under Section 2302 of the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act is a refundable tax credit against certain employment taxes equal to 50 percent of the qualified wages an eligible employer pays to employees after March 12, 2020, and before January 1, 2021. Since the adoption of the CARES Act, employers have expressed concern that if one employer acquires another employer that previously received a PPP loan, the acquirer’s entire aggregated group may no longer be eligible to claim the Employee Retention Credit.
Older posts
Newer posts