Opioid misuse, abuse, and overdose have reached epidemic proportions in the United States and have created a crisis in health care for patients, their families, and the entire country. Unfortunately, a more than 40-year-old law around substance use disorder privacy records stands in the way of the effort to stem the tide of opioid misuse and prevent related adverse events. These outdated regulations, 42 CFR Part 2 (Part 2), set requirements limiting the use and disclosure of patients’ substance use records from certain substance use treatment programs and run counter to new, innovative delivery models that rely on providers’ ability to share health information to effectively and safely coordinate high quality treatments patients need.
The Partnership to Amend 42 CFR Part 2 (Partnership) is a coalition of more than 40 organizations representing stakeholders across the health care spectrum committed to aligning Part 2 with the Health Insurance Portability and Accountability Act (HIPAA) to allow appropriate access to patient information that is essential for providing whole-person care. The Partnership urges House members to support the Overdose Prevention and Patient Safety Act (OPPS Act), H.R. 6082, introduced by Reps. Markwayne Mullin (R-OK), Earl Blumenauer (D-OR), Jim Renacci (R-OH), Buddy Carter (R-GA) and Pat Meehan (R-PA) and Senate members to support the Protecting Jessica Grubb’s Legacy Act (Legacy Act), S. 1850, introduced by Sens. Joe Manchin (D-WV) and Shelley Moore Capito (R-WV). 6082. 1850 will align Part 2 with HIPAA for the purposes of health care treatment, payment, and operations (TPO) and strengthen protections against the use of substance use disorder records in criminal proceedings. The legislation will grant appropriate sharing of substance use disorder records to ensure persons with opioid use disorder and other substance use disorders receive accurate diagnoses and effective treatment.
Why is the Overdose Prevention and Patient Safety Act and Legacy Act needed?
- Now, more than ever, legislative action is necessary to bring the appropriate sharing of substance use records into the 21st century. Access to a patient’s entire medical record, including addiction records, ensures that providers and organizations have all the information necessary to provide safe, effective, high quality treatment and care.
- Substance use disorders can have complicated ripple effects on a patient’s health that need to be carefully identified and coordinated. The current outdated rule poses a serious safety threat to persons with substance use disorders due to risks from multiple drug interactions and co-existing medical problems.
- Persons with substance use disorders are at a distinct disadvantage over other patients, as providers cannot deliver the informed, coordinated care that is the cornerstone of integrated delivery system models. In particular, these outdated regulations run counter to new, innovative delivery care models in which healthcare providers must use patient data and analytics to manage the health of a population and identify patients for targeted outreach.
- The Substance Abuse and Mental Health Services Administration (SAMHSA), the agency within the U.S. Department of Health and Human Services (HHS) that leads public health efforts to reduce the impact of substance use and mental illness on America’s communities, recently released a final rule which takes important steps to modernize Part 2, but it does not go far enough.
Who We Are
The Partnership to Amend 42 CFR Part 2 is a coalition of more than 40 national health care organizations representing a wide range of health care stakeholders, including patients, clinicians, hospitals, biopharmaceuticals, the mental health community, pharmacists, electronic health record vendors, and payers, committed to aligning Part 2 with HIPAA to allow appropriate access to patient information that is essential for providing whole-person care.
- Coalition applauds bipartisan passage of The Overdose Prevention and Patient Safety Act
- Coalition Letter of Support for the Legacy Act (S. 1850)
- Coalition Press Statement on introduction of S. 1850
- Coalition Press Statement on introduction of OPPS Act
- ABHW Part 2 Whitepaper
- Coalition Letter of Support for OPPS Act
- Shared Principles of the Partnership to Amend 42 CFR Part 2
- Letter to the White House Commission on Combating Drug Addiction and the Opioid Crisis
- Partnership recommendations to Senate Finance Committee
- Coalition letters urging Senate Health, Education, Labor and Pensions Committee leaders to include S. 1850 in opioids legislation (April 11 letter; April 23 letter)
- Coalition letter urging House Energy & Commerce Committee leaders to include OPPS Act in opioids legislation
- Coalition 4/23/18 press statement urging Congress to Include Protections in Opioid Package
- House Energy and Commerce Health Subcommittee hearing on Improving the Coordination and Quality of Substance Use Disorder Treatment
Members of The Partnership to Amend 42 CFR Part 2
Academy of Managed Care Pharmacy
Alliance of Community Health Plans
American Association on Health and Disability
American Dance Therapy Association
American Hospital Association
American Psychiatric Association
American Society of Addiction Medicine
American Society of Anesthesiologists
America’s Essential Hospitals
America’s Health Insurance Plans
American Health Information Management Association
Association for Ambulatory Behavioral Healthcare
Association for Behavioral Health and Wellness
Association for Community Affiliated Plans
Blue Cross Blue Shield Association
Catholic Health Association of the United States
Corporation for Supportive Housing
Employee Assistance Professionals Association
Global Alliance for Behavioral Health and Social Justice
Hazelden Betty Ford Foundation
Health IT Now
Healthcare Leadership Council
The Joint Commission
The Kennedy Forum
Medicaid Health Plans of America
Mental Health America
National Association of ACOs
National Alliance on Mental Illness
National Association of Psychiatric Health Systems
National Association of State Mental Health Program Directors
National Rural Health Association
Otsuka America Pharmaceutical, Inc.
Premier healthcare alliance
For more information, contact:
- Legislative text of the Legacy Act (S. 1850)
- One-pager on the Legacy Act
- Legislative text of the OPPS Act
- Press Release: Capito, Manchin Urge Opioid Commission to Include Legacy Act in Final Report
- April 21, 2016 bipartisan House Ways and Means letter to CMS
- Mullin explains urgency of passing H.R. 3545 and its robust patient privacy protections during House Ways & Means Health Subcommittee hearing
- Sen. Manchin questioning of Patrick Kennedy on needed reform of 42CFR Part 2 during Senate Labor & HHS Appropriations Subcommittee hearing on opioids (12/5/17)
- National Governors Association letter urging House passage of OPPS Act
- Washington State Legislature letter urging Senate to adopt provision consistent with OPPS Act
Coalition member resources
The Journal of American Medical Association: Ten Steps the Federal Government Should Take Now to Reverse the Opioid Addiction Epidemic
Early identification and treatment of opioid-addicted individuals reduces the risk of overdose, psychosocial deterioration, transition to injection opioid use, and medical complications…..The federal privacy law known as 42 CFR Part 2 (Confidentiality of Substance Use Disorder Patient Records) should be amended so that opioid addiction can be treated like other medical conditions, improving patient safety and continuity of care
Early identification and treatment of opioid-addicted individuals reduces the risk of overdose, psychosocial deterioration, transition to injection opioid use, and medical complications…..The federal privacy law known as 42 CFR Part 2 (Confidentiality of Substance Use Disorder Patient Records) should be amended so that opioid addiction can be treated like other medical conditions, improving patient safety and continuity of care.
The New England Journal of Medicine: Protection or Harm? Suppressing Substance-Use Data
What if it were impossible to closely study a disease affecting 1 in 11 Americans over 11 years of age — a disease that’s associated with more than 60,000 deaths in the United States each year, that tears families apart, and that costs society hundreds of billions of dollars? What if the affected population included vulnerable and underserved patients and those more likely than most Americans to have costly and deadly communicable diseases, including HIV–AIDS? What if we could not thoroughly evaluate policies designed to reduce costs or improve care for such patients? These questions are not rhetorical. In an unannounced break with long-standing practice, the Centers for Medicare and Medicaid Services (CMS) began in late 2013 to withhold from research data sets any Medicare or Medicaid claim with a substance-use–disorder diagnosis or related procedure code.
The American Journal of Accountable Care: Treating Behavioral Health Disorders in an Accountable Care Organization
Despite the physical, economic, and societal consequences of behavioral health conditions, about one-third of individuals with these disorders receive no treatment, and the vast majority of the rest receive substandard treatment. Legislative changes in the federal regulation that prohibits sharing patient information related to alcohol and drug treatment without additional patient consent (beyond the standard HIPAA form) are needed. Without these data, ACOs are unable to provide the level of analytics required to manage the health of a population and identify patients for targeted outreach.
The additional healthcare costs incurred by people with behavioral comorbidities are estimated to be $293 billion in 2012 across commercially-insured, Medicaid, and Medicare beneficiaries in the United States. Based on our literature review on the results of effective integration of medical and behavioral healthcare programs, we calculate that 9-16% ($26 – $48 billion) can potentially be saved annually through effective integration of medical and behavioral services. Unfortunately, many individuals with chronic medical conditions and co-occurring MH/SUD disorders are never diagnosed and treated for their behavioral conditions. Since this study used administrative claim data to identify illnesses and costs, these patients were not identified as suffering from these conditions.
The ACO model holds the promise of reducing costs and improving the quality of care by realigning payment incentives to focus on health outcomes instead of service volume. One key to managing the total cost of care is improving care coordination for and treatment of people with behavioral health disorders. We examined qualitative data from ninety organizations participating in Medicare ACO demonstration programs from 2012 through 2015 to determine whether and how they focused on behavioral health care. The biggest challenges included a lack of behavioral health care providers, data availability, and sustainable financing models. Nonetheless, we found substantial interest in integrating behavioral health care into primary care across a majority of the ACOs.