April 28, 2020
The Honorable Alex M. Azar
Secretary
U.S. Department of Health and Human Services
330 C Street SW
Washington, DC 20416
Re: 42 CFR Part 2 – Request to Expedite Revising Rule Pursuant to the CARES Act
Dear Secretary Azar,
The undersigned organizations of the Partnership to Amend 42 CFR Part 2 (Partnership), write to make an urgent request that the Department of Health and Human Services (HHS) issue a rule as soon as possible on the 42 CFR Part 2 (Part 2) provisions in the Coronavirus Aid, Relief, and Economic Safety Act (CARES Act).
The Partnership is a coalition of nearly 50 organizations committed to aligning Part 2 with the disclosure requirements of the Health Insurance Portability and Accountability Act (HIPAA) for the purposes of treatment, payment, and health care operations (TPO).
First and foremost, we want to take this opportunity to thank you and Deputy Secretary Hargan for your ongoing engagement with the Partnership to address the issues regarding the current Part 2 regulations. We appreciate your continued attention to patient care for those with substance use disorders (SUDs).
Given the longstanding nature of the issue, compounded with the potential for increase in SUDs during the current pandemic, it is more important than ever that the roadblocks to providing care for patients with SUDs are removed. We believe the recent changes to Part 2 in the CARES Act will greatly help in coordinating care for patients with SUDs. Specifically, Sec. 3221 changes the requirement to a one-time written consent and aligns Part 2 with HIPAA. More importantly, Sec. 3221 permits re-disclosures made in accordance with HIPAA following that initial written consent. The CARES Act also directs the Secretary of HHS to revise any pertinent regulations.
While the Substance Abuse and Mental Health Services Administration (SAMHSA), prior to the passage of the CARES Act, issued guidance suspending the prohibitions on use and disclosure of patient information under Part 2 for medical emergencies, more specificity will be needed to implement the flexibilities provided by the CARES Act. Additionally, it has been reported that opioids may be used during the treatment of some patients with COVID-19 [1], making it paramount that physicians have access to all patient records, especially SUD records, to formulate appropriate treatment plans. We believe HHS can use the SAMHSA guidance as a stepping stone when revising the Part 2 rule and we encourage HHS to act quickly to update the Part 2 rule to ensure patients with SUDs do not experience a disruption in their care.
Please feel free to contact Deepti Loharikar, Director of Regulatory Affairs, Association for Behavioral Health and Wellness, at [email protected] or (202) 449-7659 with any questions.
Sincerely,
| Academy of Managed Care Pharmacy | Hazelden Betty Ford Foundation |
| Alliance of Community Health Plans | Healthcare Leadership Council |
| American Association on Health and Disability | Health Innovation Alliance |
| American Health Information Management Association | The Joint Commission |
| American Hospital Association | The Kennedy Forum |
| American Psychiatric Association | National Alliance for Mental Illness |
| American Society of Addiction Medicine | National Association of ACOs |
| America’s Essential Hospitals | National Association of Addiction Treatment Providers |
| America’s Health Insurance Plans | National Association of County Behavioral Health and Development |
| AMGA | National Association of Rural Mental Health |
| Association for Behavioral Health and Wellness | Netsmart |
| Association for Community Affiliated Plans | OCHIN |
| Blue Cross Blue Shield Association | Opioid Safety Alliance |
| Catholic Health Association of the United States | Otsuka America |
| Centerstone | Pharmaceutical Care Management Association |
| College of Healthcare Information Management Executives | Population Health Alliance |
| Confidentiality Coalition | Premier Healthcare Alliance |
| Global Alliance for Behavioral Health and Social Justice | Strategic Health Information Exchange Collaborative |
Cc: Deputy Secretary Eric D. Hargan
[1] Owermohle, S., America’s new opioid crisis, https://www.politico.com/news/2020/04/10/america-new-opioid-crisis-179270.
Last visited April 15, 2020.