Otsuka Supports Enhancing Safety and Promoting Innovation in the Delivery of Behavioral Healthcare Services via Legislative Action

Otsuka America Pharmaceutical, Inc. (Otsuka), a U.S.-based indirect subsidiary of Otsuka Pharmaceutical Co., Ltd., has worked closely with community-based behavioral health providers to enhance care coordination and information-sharing to ensure they have access to accurate information about their patients’ physical and behavioral health needs.

Based on this experience, we believe legislation is needed to align the confidentiality requirements of 42 CFR Part 2 (“Part 2”) with the Health Insurance Portability and Accountability Act’s (HIPAA’s) patient privacy and security protections. Although the Substance Abuse and Mental Health Services Administration (SAMHSA) took steps to modernize Part 2 earlier this year,[1] the changes did not go far enough. Part 2 continues to silo substance use disorder treatment records and stifles innovation in the delivery of coordinated patient care. Behavioral health providers cannot safely and effectively treat patients when key parts of those patients’ medical records are withheld because of outdated regulations.

The need to harmonize Part 2 with HIPAA is particularly acute in light of the current opioid crisis. Between 2005 and 2014, the rate of opioid-related emergency department visits increased 99.4 percent.[2] According to the Centers for Disease Control and Prevention (CDC), 62 Americans died each day from prescription opioid overdoses in 2015, a year in which there was a total of approximately 52,000 overdose deaths.[3] Health and Human Services (HHS) Secretary Tom Price recently noted that preliminary data for 2016 indicate this number increased to almost 60,000 in 2016.[4] Given the seriousness of the opioid crisis, immediate action is needed to modernize Part 2 so as to allow providers to share health information so they can safely and effectively coordinate high quality care for those with substance use disorders.

Case Study: Otsuka’s Experience with Part 2 in Miami-Dade County

Otsuka understands first hand that provider access to necessary health and substance use disorder data is essential to effective treatment and care coordination. Several years ago, over a three-year period, we (along with a major information technology vendor) collaborated with providers in the South Florida Behavioral Health Network (SFBHN) to create an innovative data system to facilitate care coordination among more than 60 mental health service providers in Miami-Dade County.

Otsuka worked with highly motivated providers to enhance patient access to care, eliminate redundancies, and improve the overall functioning of behavioral health services in Miami-Dade, which has a serious mental illness rate almost three times the national average. To accomplish these goals, SFBHN needed to develop a data system that would combine information on individual patients who sought services across multiple community-based providers, including substance use disorder providers. Despite a very willing provider community, integrated patient records were not achieved due to the restrictions Part 2 imposes both on the consent process and on the types of data that can be shared, with whom it can be shared, and for what period of time.

We know from our Miami-Dade County experience that community-based mental health providers need access to full patient records if they are to work effectively with the patients they serve. The data segmentation and consent management functionalities required by the revised Part 2 will continue to impede development of the robust patient data systems needed by providers to coordinate care, and patients will continue to be deprived of treatment in fully integrated care models.

The January 2017 Final Rule Does Not Go Far Enough to Modernize Part 2

30 years after last amending Part 2, SAMHSA published a Final Rule intended to update the regulations “to facilitate health integration and information exchange within new health care models while continuing to protect the privacy and confidentiality of patients seeking treatment for substance use disorders.”[5] While Otsuka appreciates the agency’s intent, the changes unfortunately do not go far enough to modernize the outdated Part 2 regulations.

“To Whom” Consent Form Requirements Create Burden and Impede Patient Care

Although the revised regulations allow, in certain circumstances, a patient to include a general designation in the “To Whom” section of the consent form, they distinguish between information recipients that do and do not have a treating provider relationship with the patient. For a Part 2 program to disclose substance use disorder-related information to a third party that does not have a treating provider relationship with the patient, the consent must contain detailed information which is often confusing or unavailable to patients and challenging for providers to collect and interpret.
It is a confusing set of requirements confronting patients who may want their information in the substance use disorder program to be disclosed to those with whom they do not have a “treating provider” relationship. Part 2 prevents them from doing so without specifying in painstaking detail what information may or may not be disclosed. Otsuka is concerned that these restrictions will delay orimpede patients and their providers from making treatment decisions thataddress all their health care needs.

List of Disclosures Requirement

Part 2 providers are prohibited from using a broad or general consent designation until they have a methodology in place to track such subsequent disclosures. Otsuka believes, based on its own experience in Miami-Dade County, that the technology challenges to implementing such tracking are real and insurmountable, given the requirements in the Final Rule. We also are concerned that other health and behavioral health providers may decide not to risk being “unlawful holders”[6] of Part 2 data by inadvertently receiving substance use disorder treatment information or impermissibly using re-disclosed information on patients in Part 2 programs. This could result in continued barriers to coordination that would otherwise help integrate care for patients with health conditions, mental health needs and substance use disorders.

Prohibition on Re-Disclosure of Information

The Final Rule’s prohibition on re-disclosure of information effectively prevents providers participating in an HIE, health home, ACO, or care coordination entity (CCE) from disclosing substance use disorder treatment information among each other for treatment and care coordination purposes. Otsuka believes re-disclosure of such information should be permitted by and among participants in these integrated care settings with a direct treatment relationship for the purposes of treatment, payment, and health care operations (TPO), as permitted under HIPAA.

Risks Posed by SAMHSA’s Failure to Align Part 2 with HIPAA

A. Lack of Substance Use Disorder Treatment Information Can Lead to Relapse, Overdose, and Even Death

The risks posed by Part 2’s unduly restrictive confidentiality limits are more than theoretical. Absent access to a patient’s substance use disorder treatment records, physicians are writing prescriptions for opioid pain medication without knowing whether their patients have a substance use disorder. One recent study found that physicians continued to prescribe opioids for 91 percent of patients who suffered anon-fatal overdose, with 63 percent of those patients continuing to receive high doses. Seventeen percent of these patients overdosed again within two years.[7] Presumably if physicians knew these patients suffered from substance use disorders, they would not continue to prescribe opioids for them.

Increasing physician access to information about patient treatment histories would clearly help prevent some tragic overdose deaths from occurring. As mental health advocate Rep. Tim Murphy (R-PA) has noted, “this deadly segregation of medical records is wreaking havoc on our nation’s ability to respond to the ongoing opioid crisis. You cannot treat the whole patient with half of their medical record.”[8]

B. Patients with Multiple Conditions Suffer Because Plans and Providers Cannot Effectively Coordinate Their Health Care

Many individuals have a dual diagnosis, living with both a mental illness and a substance use disorder. Recent studies suggest that almost one-third of people with mental illness and approximately half of those with serious mental illness (including schizophrenia and bipolar disorder) also experience substance abuse. Conversely, over one-third of alcohol abusers and half of all drug abusers are also struggling with mental illness.[9]

Organizations such as the American College of Physicians and the American Society of Addiction Medicine recommend integration of substance use-related and mental health services with primary care. Part 2 must be aligned with HIPAA requirements to ensure that patients with substance use disorders no longer fall through the cracks of our health care system.

Conclusion: Part 2 Should be Aligned with HIPAA to Ensure Patient Safety and Facilitate Care Coordination for Individuals with Substance Use Disorders

Otsuka believes that Part 2 should be aligned with HIPAA to maintain privacy protections without perpetuating treatment silos between substance use disorders and other health conditions. In its recent interim report, the White House opioid commission likewise proposed a better alignment of Part 2 with HIPAA “to ensure that information about substance-use disorders be made available to medical professionals treating and prescribing medication to a patient.”[10] At a time when the U.S. health care system is moving toward service integration and more efficient information sharing, we oppose the restrictive barriers that Part 2 places on coordinating care for individuals with substance use disorders, many of whom have co-occurring conditions.

It is important, however, to ensure that disclosures of confidential substance use disorder treatment information are not permitted for reasons unrelated to the provision of health care. We believe that Part 2 information should not be disclosed to law enforcement, employers,divorce attorneys, or others seeking to use the information against the patient, which the HIPAA privacy framework already accommodates. 

To achieve both of these objectives, Otsuka supports legislation sponsored by Reps. Tim Murphy and Earl Blumenauer (D-OR) to align Part 2 with HIPAA for the purposes of health care treatment, payment,and operations (TPO). In addition, the“Overdose Prevention and Patient Safety Act” (H.R. 3545) would strengthen existing Part 2 protections that prevent the disclosure of addiction treatment records in a manner that could lead to prosecution, discrimination or loss of employment, housing, or child custody.

Otsuka also supports S. 581(“Jessie’s Law”), which would ensure that medical professionals have full knowledge of a patient’s previous opioid addiction when consent is given by the patient or the patient’s parent, legal guardian, or spouse. This bill,sponsored by West Virginia Senators Joe Manchin (D) and Shelley Moore-Capito (R),would help prevent tragic losses like the death of Jessie Grubb. The Senate passed Jessie’s Law by unanimous consent on August 3, 2017, and the bill is now under consideration in the House Energy and Commerce Committee.

We would not blindfold a surgeon before sending him into the operating room, but that is effectively what Part 2 does to primary care and emergency room physicians by denying them the information they need to safely and effectively treat their patients. The time has come to bring antiquated Part 2 rules into the 21st century and facilitate the provision of innovative, comprehensive, and coordinated care for individuals with substance use disorders.

September 2017 01US17EUC0170


[1] HHS, Confidentiality of Substance Use Disorder Patient Records, 82 Fed. Reg. 6052 (Jan. 18, 2017).
[2] AHRQStatistical Brief #219, Opioid-RelatedInpatient Stays and Emergency Department Visits by State, 2009-2014 (Dec.2016).
[3] Opioid Data Analysis, (Feb. 9,2017),
[4] JohnMuir, Sessions Addresses Opioid Crisis inGreen Bay, (August 29, 2017), available at
[5] See SAMHSA, New rule improves the exchange ofmedical information in ways that protect the privacy of people receivingsubstance use treatment (press release) (Jan. 13, 2017); HHS, Confidentiality of Substance Use DisorderPatient Records, 82 Fed. Reg. 6052 (Jan. 18, 2017).
[6] Id. at 6997.
[17 See Larochelle,M.R., Liebschtuz et al. (2016). Opioid prescribing after nonfatal overdoseand association with repeated overdose: A cohort study. Annals of Int. Med.,164(1), 1-9.
[8] Murphy Introduces Legislation to PreventOverdose Deaths, Protect Patients (press release) (July 28, 2017).
[9] QuantumUnits Education, Dual Diagnosis at 2(July 2015), available at
[10] Draft Interim Report of the Commission on Combating Drug Addiction andthe Opioid Crisis at 8 (July 31, 2017), availableat