Resources

Client Alerts, News Articles, Blog Posts, & Multimedia

Everything you need to know about BMD and the industry.

Enhancing Privacy Protections for Substance Use Disorder Patient Records

Client Alert
February 16, 2024

On February 8, 2024, the U.S. Department of Health and Human Services (“HHS”) finalized updated rules to 42 CFR Part 2 (“Part 2”) for the protection of Substance Use Disorder (“SUD”) patient records. The updated rules reflect the requirement that the Part 2 rules be more closely aligned with the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) privacy, breach notification, and enforcement rules as mandated by the Coronavirus Aid, Relief, and Economic Security Act of 2020.

Part 2 protects the SUD treatment records of patients who are treated at a Part 2 program. Part 2 programs are those that are (1) federally assisted (they receive federal funding) and (2) hold themselves out as providing, and do provide, substance use disorder diagnosis, treatment, or referral for treatment. The final rules released by HHS this month reflect the inclusion of the public comments from providers, trade associations, health information exchanges, health plans and others.

The final rules make the following modifications to Part 2 regulations, effective February 16, 2026:

  • Patient Consent: One single Part 2 consent will be sufficient for all future disclosures for payment, treatment, and health care operations. All disclosures made with patient consent must include a copy of the consent or a clear explanation of the scope of consent. Previously, a separate consent was needed for each disclosure of Part 2 information. However, the final rules do retain a prohibition on the use of Part 2 records in legal proceedings and testimony in civil, criminal, administrative, and legislative proceedings against a patient without specific consent or a court order.
  • Counseling Notes: Like HIPAA psychotherapy records, a separate patient consent for the use and disclosure of SUD counseling notes is now required. SUD counseling notes include those analyzing the conversation in a SUD counseling session that the clinician voluntarily maintains separately from the rest of the patient’s SUD treatment and medical record.
  • Patient Notice: Part 2 patient notice requirements now align with the requirements of the HIPAA Notice of Privacy Practices.
  • Redisclosure: HIPAA covered entities and business associates that receive records under a Part 2 consent may redisclose those records according to HIPAA regulations. Previously, Part 2 regulations required a specific disclosure that was stricter than HIPAA redisclosure regulations.
  • Public Health: Part 2 records may now be disclosed to public health authorities without patient consent as long as the records are de-identified.
  • Breach Notification: The HIPAA Breach Notification Rule requirements will also apply to breaches of records under Part 2.
  • Segregation of Part 2 Data: Part 2 records are no longer required to be segregated or segmented from other medical records.
  • Fundraising: Patients will be able to opt out of receiving fundraising communications from Part 2 programs.
  • Complaints: Patients will have a right to file a complaint directly with the Secretary of HHS for an alleged violation of Part 2 in addition to filing a complaint with the Part 2 program.
  • Penalties: Part 2 penalties will be aligned with HIPAA by replacing criminal penalties currently in Part 2 with civil and criminal enforcement authorities that also apply to HIPAA violations.

The text of the final rule can be found on the Federal Register. All Part 2 programs must comply with the new requirements by February 16, 2026. The BMD healthcare team can help ensure that you are compliant. Please reach out to Daphne Kackloudis (dlkackloudis@bmdllc.com) or Jordan Burdick (jaburdick@bmdllc.com) for questions or assistance.

Health LawHealthcare Policysubstance abuseDaphne KackloudisJordan Burdick
Client Alert

Bankruptcy Law Changes - 2020 Recap And What To Expect In 2021

January 11, 2021In a year of health challenges and financial distress to many individuals and businesses affected by the pandemic, the year 2020 brought some significant changes to the bankruptcy laws. Some of these changes were in place prior to the pandemic; others were a direct response to the pandemic with the goal of helping struggling businesses and individuals. Ahead, we can likely expect further changes to the Bankruptcy Code with the incoming Congress.Client Alert

UPDATE - SBA Releases Rules and Guidance for Second Round PPP Funding

January 7, 2021Late yesterday (January 6, 2021), the U.S. Small Business Administration released rules and guidance for businesses wishing to take part in the long awaited second round of Paycheck Protection Program (“PPP”) funding. As most businesses are aware, the rules governing PPP loans have been updated as part of The Economic Aid to Hard-Hit Small Businesses, Nonprofits, and Venues Act (“Act”). The Act was just one section of the massive 2021 Consolidated Appropriations Act that was passed by Congress and signed into law by the President on December 27, 2020. To combat the ongoing disruptions caused by the COVID-19 pandemic, the Act generally provides (a) first time PPP loans for businesses that did not obtain a loan in the first instance, (b) PPP second draw loans for businesses that already obtained a loan but need additional funding, and (c) additional funding for businesses that returned their first PPP loan or did not get the full amount for which they qualified.Client Alert

UPDATE - Vaccine Policy Considerations for Employers

January 4, 2021If you read our post from November, you’re already an informed employer. This first post of 2021 is to share good news, give a few updates, and answer some other common questions. Q: What’s the Good News? First, the EEOC confirmed that employers may require employees receive the COVID-19 vaccine. Second, polling indicates that the number of Americans who said they will receive a vaccine has increased from around 63% to over 71%. The number of Americans who are strongly opposed to a vaccine is about 27%. Third, initial returns show that the efficacy rate for certain vaccines is as high as 95% for some at-risk recipients.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.
Older posts
Newer posts