December 6, 2022
Following is information regarding various state and/or federal issues pertaining to overdose prevention centers, addressing the health care and treatment needs of people during incarceration, and proposed changes to 42 CFR Part 2:
12/6: Politico on fed gov’t. position on “overdose prevention centers’
ANOTHER EXTENSION — New York harm-reduction advocates may have to wait another two months for an update on whether the federal government will drop its opposition to “overdose prevention centers,” a move that could allow such facilities to open across the state and country, POLITICO’s Shannon Young reports.
The Biden administration on Monday requested the extension in a Trump-era case challenging a Philadelphia supervised-consumption facility operated by Safehouse. That would give it until Feb. 6 to respond — a deadline that has already been extended several times over the last year.
Federal officials argued in court documents that “the discussions to date, which have involved coordination among multiple constituencies addressing a novel and complex subject matter, have been and continue to be productive.” The additional two months, they added, “are necessary to permit careful consideration of the government’s harm reduction and public safety goals.”
Safehouse, however, pushed back against the request , noting that it plans to file a motion in opposition today. “We are long overdue for a timeline as to when [the Department of Justice] evaluations will be complete so that a life-saving initiative can begin,” officials said in a Monday email.
The move comes just days after New York City’s two overdose-prevention centers — the first to open in the U.S. — celebrated their one-year anniversary. OnPoint NYC, which operates the East Harlem and Washington Heights facilities, announced that the two OPCs had been used a total of 48,284 times by 2,147 individuals as of Nov. 29, and averted 633 drug overdoses since opening on Nov. 30, 2021.
OnPoint NYC’s executive director, Sam Rivera, pointed to that data as he called on “government leaders and health officials across the country to consider implementing this life saving approach.” “In the three decades of practice, there has never been a recorded fatal overdose in a safe consumption program anywhere in the world,” he said in a recent statement. “People don’t have to die. We just need leaders that are committed to saving lives.”
News from the O’Neill Institute at Georgetown University and our colleague Shelly Weizman:
(See attached for the ‘Big Ideas’ Report discussed below. The link (embedded below) to The Hill article is live.
Policymakers at every level of government have begun a shift to a public health approach to addiction. This same shift must occur in correctional settings as we recognize that addressing the health care and treatment needs of people during incarceration can improve the health of these individuals and their communities.
In a new Big Ideas from the Addiction and Public Policy Initiative, Shelly Weizman, Joseph Longley, Taleed El-Sabawi, Regina LaBelle, Daniel Fishbein, and Andrea Goodman outline the legal framework on the right to adequate care and treatment for medical, mental health, and substance-related conditions in jails. They also highlight the findings of original research on litigation related to deaths in jail custody and provide recommendations for reform. In their newly issued report, they found that deaths related to behavioral health issues, including suicide, overdose, and substance use withdrawal complications, were present as the cause of death for 59% of the cases.
In a new piece published today in The Hill, Regina LaBelle and Shelly Weizman discuss these issues and highlight findings and recommendations from this new Report.
HHS on Substance Use Disorder Patient Records Regulations
On November 28, 2022, the U.S. Department of Health & Human Services, through the Office for Civil Rights (OCR) in coordination with the Substance Abuse and Mental Health Services Administration (SAMHSA), issued a Notice of Proposed Rulemaking to revise the Confidentiality of Substance Use Disorder Patient Records regulations. The regulations at 42 CFR part 2 (“Part 2”) protect the confidentiality of substance use disorder (SUD) treatment records. Part 2 protects “records of the identity, diagnosis, prognosis, or treatment of any patient which are maintained in connection with the performance of any program or activity relating to substance abuse education prevention, training, treatment, rehabilitation, or research, which is conducted, regulated, or directly or indirectly assisted by any department or agency of the United States.” Confidentiality protections help address concerns that discrimination and fear of prosecution deter people from entering treatment for SUD.
Section 3221 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act (enacted March 27, 2020) requires the Secretary to align certain aspects of Part 2 with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Rules and the Health Information Technology for Economic and Clinical Health (HITECH) Act. Section 3221 of the CARES Act also requires the Secretary to update the HIPAA Privacy Rule Notice of Privacy Practices requirements to address Part 2 protections and individual rights.
The HHS Fact Sheet on this topic: https://www.hhs.gov/hipaa/for-professionals/regulatory-initiatives/hipaa-part-2/index.html
Here is the announcement in the Federal Register:
Among other items, the proposal includes:
- Permit Part 2 programs to use and disclose Part 2 records based on a single prior consent signed by the patient for all future uses and disclosures for treatment, payment, and health care operations.
- Permit the redisclosure of Part 2 records as permitted by the HIPAA Privacy Rule by recipients that are Part 2 programs, HIPAA covered entities, and business associates, with certain exceptions.
- Expand prohibitions on the use and disclosure of Part 2 records in civil, criminal, administrative, or legislative proceedings conducted by a federal, state, or local authority against a patient, absent a court order or the consent of the patient.
- Create two patient rights under Part 2 that align with individual rights under the HIPAA Privacy Rule:
- Right to an accounting of disclosures
- Right to request restrictions on disclosures for treatment, payment, and health care operations.
Comments due on or before January 31, 2023.
Full Press Release from 11/28:
HHS Proposes New Protections to Increase Care Coordination and Confidentiality for Patients With Substance Use Challenges
New Proposed Rule to Implement the Bipartisan CARES Act Legislation
Recently, the U.S. Health and Human Services Department, through the Office for Civil Rights (OCR) and the Substance Abuse and Mental Health Services Administration (SAMHSA), announced proposed changes to the Confidentiality of Substance Use Disorder (SUD) Patient Records under 42 CFR part 2 (“Part 2”), which protects patient privacy and records concerning treatment related to substance use challenges from unauthorized disclosures. Specifically, today’s 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.
“Varying requirements of privacy laws can slow treatment, inhibit care, and perpetuate negative stereotypes about people facing substance use challenges,” said Secretary Xavier Becerra. “This proposed rule would improve coordination of care for patients receiving treatment while strengthening critical privacy protections to help ensure individuals do not forego life-saving care due to concerns about records disclosure.”
This Notice of Proposed Rulemaking (NPRM) would implement provisions of Section 3221 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) that, among other things, require HHS to bring Part 2 into greater alignment with certain aspects of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy, Breach Notification, and Enforcement Rules.
“HHS understands how critical it is for patients to better align the Part 2 rules and program with HIPAA,” said OCR Director Melanie Fontes Rainer. “This proposed rule helps decrease burdens on patients and providers, improves coordination and increases access to care and treatment, while protecting confidentiality of treatment records.”
“One of SAMHSA’s priorities is working to make effective treatments and recovery supports for SUD more accessible to all Americans,” said Miriam E. Delphin-Rittmon, Ph.D., the HHS Assistant Secretary for Mental Health and Substance Use and the leader of SAMHSA. “Bringing Part 2 requirements into closer alignment with HIPAA will support more effective coordination for people accessing care. At the same time, the proposed rule mitigates the discrimination and stigma that we know too often people with SUDs experience.”
Part 2 currently imposes different requirements for SUD treatment records protected by Part 2 than the HIPAA Privacy Rule, which can create barriers to information sharing by patients and among health care providers and create dual obligations and compliance challenges for regulated entities. That’s why Congress required that privacy protections for this program be more closely aligned with the HIPAA Privacy rule. Today’s proposed rule outlines several important changes that can help safeguard the health and outcomes of individuals with SUD and create greater flexibility for information sharing envisioned by Congress in its passage of Section 3221 of the CARES Act. Proposed changes include:
- 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.
HHS encourages all stakeholders, including patients and their families, health insurance issuers, health care providers, health care professional associations, consumer advocates, and state and local government entities, to submit comments through regulations.gov.
Public comments on the NPRM are due on or before January 31, 2023.
The NPRM may be viewed or downloaded at: https://www.federalregister.gov/public-inspection/2022-25784/confidentiality-of-substance-use-disorder-patient-records.
A fact sheet may be found at: https://www.hhs.gov/hipaa/for-professionals/regulatory-initiatives/hipaa-part-2/index.html.