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A coalition of over 50 health care organizations come together and urge HHS to modernize health information laws to help stem the tide of opioid misuse.

Opioid misuse and overdoses have reached epidemic proportions in the United States (U.S.) and created a health care crisis for patients, families, and the entire country. The onset of the COVID-19 pandemic, which led to social isolation, high unemployment, and diversion of public health resources, has highlighted the urgent need to address the ongoing addiction crisis. According to the Centers for Disease Control and Prevention (CDC), over 93,000 lives were lost to overdose during 2020 – a nearly 30% increase from the previous year.

Amidst this challenging environment, Congress took decisive action in 2020 and passed the Coronavirus Aid, Relief, and Economic Security (CARES) Act Download PDF that included the Protecting Jessica Grubb’s Legacy (Legacy Act). Download PDFThe CARES Act takes great strides to align 42 CFR Part 2 (Part 2), a law that governs the confidentiality of substance use disorder (SUD) records, with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) for the purposes of health care treatment, payment, and operations (TPO). This alignment will allow appropriate access to patient information that is essential for providing an accurate diagnosis, effective treatment, and whole-person care. This law also strengthens protections against the use of SUD records in any civil, criminal, administrative, or legislative proceedings conducted by any Federal, State, or local authority.

The Partnership to Amend 42 CFR Part 2 (Partnership) applaud the champions of the Legacy Act Download PDF, Senators Shelley Moore Capito (R-WV) and Joe Manchin (D-WV) and the Overdose Prevention and Patient Safety Act (OPPS Act), H.R. 2062 opens in a new tab, introduced by Representatives Earl Blumenauer (D-OR) and Markwayne Mullin (R-OK) for their tireless work and dedication to combatting the opioid epidemic.

Next Phase: Regulations
As the U.S. Department of Health and Human Services (HHS) and the Substance Abuse and Mental Health Services Administration (SAMHSA) move forward with drafting the Notice of Proposed Rule Making (NPRM), the Partnership recommends that the provisions mandated by the CARES Act are appropriately addressed to ensure that the next Part 2 rule is effective and aligned with HIPAA, as intended by Congress.

PARTNERSHIP RECOMMENDATIONS FOR THE NEXT 42 CFR PART 2 RULE

  • Ensure that the consent requirements in the next rule are simple and straightforward so additional administrative processes are not imposed on patients, providers, or payers (including health plans and their subcontractors). The consent process should be easily folded into existing HIPAA compliance processes, preferably with the patient’s acknowledgement of HIPAA practices and the patient’s Part 2 consent incorporated into the same document at intake where feasible. Furthermore, include language to address the conflict with Part 2’s list of disclosures requirement.
  • Include specific language directing covered entities and business associates to disclose and redisclose data in accordance with HIPAA regulations.
  • Specify that once Part 2 data is transmitted or retransmitted, there is no requirement to segregate a patient’s Part 2 data from the rest of a HIPAA database, with the regulatory requirement for data segmentation terminating upon transmission or retransmission.
  • Specifically state that the revocation of consent for Part 2 data transmission is effective only from the point of revocation going forward and the responsibility for seeing that the Part 2 data is not being transmitted either to another covered entity or business associate belongs to the Part 2 treatment entity that contributed the data and to the Part 2 program.
  •  HHS and SAMHSA should explore, in partnership with stakeholders, how to exclude behavioral health data from the Part 2 data and incorporate the findings into the rule and any subsequent frequently asked questions or guidance. Similarly, HHS and SAMHSA should explore, in conjunction with the States and stakeholders, policy mechanisms for promoting the use of behavioral health data for care coordination purposes when state privacy laws may impose restrictions beyond both Part 2 and HIPAA.
  • Include a provision in the next rule, consistent with the 2020 rule, to ensure that disclosures for the purposes of research from a HIPAA covered entity to a non-HIPAA covered entity are permissible.
  • Include specific language to ensure that patient privacy rights are protected in accordance with the CARES Act and HIPAA.
  • Provide SUD-related claims data to providers practicing in alternative payment models to help support their work in population health management.

WHO WE ARE

The Partnership to Amend 42 CFR Part 2 is a coalition of more than 50 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.

Members of The Partnership to Amend 42 CFR Part 2

For more information, contact: Maeghan Gilmore/202.449.7660

RESOURCES

COALITION MEMBER RESOURCES

STUDIES

The Journal of American Medical Association: Ten Steps the Federal Government Should Take Now to Reverse the Opioid Addiction Epidemic opens in a new tab

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 opens in a new tab

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 U.S. 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 opens in a new tab

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.

Milliman: Economic Impact of Integrated Medical-Behavioral Health Care, Implications for Psychiatry opens in a new tab

The additional health care costs incurred by people with behavioral comorbidities are estimated to be $293 billion in 2012 across commercially-insured, Medicaid and Medicare beneficiaries in the U.S. Based on our literature review on the results of effective integration of medical and behavioral health care programs, we calculate that 9-16 percent ($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.

Health Affairs: The Impact of Medicare ACOs on Improving Integration And Coordination Of Physical And Behavioral Health Care opens in a new tab
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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.

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