H.R. 6082, Overdose Prevention and Patient Safety Act
On Wednesday, June 20, 2018, the House will consider H.R.6082, the Overdose Prevention and Patient Safety Act, under a closed rule. This bill was introduced on June 13, 2018 by Rep. Markwayne Mullin (R-OK) and was referred to the House Committee on Energy and Commerce. The Committee ordered a similar bill reported, H.R. 5795, on May 17, 2018 by a vote of 35-17.
H.R. 6082 amends the Public Health Service Act to permit substance use disorder (SUD) records to be shared among covered entities and Part 2 programs in accordance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), for the purposes of treatment, payment, and healthcare operations. In order to protect individuals seeking and receiving SUD treatment, the bill enhances the protections on the disclosure of SUD treatment records to non-covered entities and non-Part 2 programs by, except for authorization by court order or by consent of the patient, prohibiting the use of these records in any criminal, civil, or administrative investigations, actions, or proceedings. The legislation increases the penalties in the event of unlawful disclosure of SUD treatment records and establishes breach notification requirements in accordance with the Health Information Technology for Economic and Clinical Health (HITECH) Act. Finally, the bill requires the Secretary of Health and Human Services to issue regulations prohibiting discrimination based on data disclosed from such medical records, to issue regulations requiring covered entities to provide written notice of privacy practices, and to develop model training programs and materials for health care providers and patients and their families.
The Standards for Privacy of Individually Identifiable Health Information, or Privacy Rule, under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) sets national standards for the protection of health information. With the exception of SUD treatment information, the Privacy Rule applies to identifiable health information that is created or received by covered entities (health providers, payers, and clearinghouses). Federal confidentiality law and regulations (42 C.F.R. Part 2, or Part 2) related to SUD treatment information pre-date HIPAA and were enacted in the 1970s by the understanding that stigma and fear of prosecution might dissuade persons with substance use disorders from seeking treatment. Compared to the HIPAA Privacy Rule, Part 2 is much narrower in scope and permits fewer uses and disclosures of patient information without express written consent. Under Part 2, any information regarding 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 is confidential.
This information may be disclosed only with the patient’s written consent, pursuant to a court order, or if the disclosure falls within one of a few statutory exceptions. The regulations apply to any individual or entity that is federally assisted and holds itself out as providing, and provides, alcohol or drug abuse diagnosis, treatment or referral for treatment. Most drug and alcohol treatment programs are federally assisted.
According to the Substance Abuse and Mental Health Services Administration (SAMHSA), individuals with mental and substance abuse disorders die decades earlier than the average person — mostly from untreated chronic illnesses that are aggravated by poor health habits. SAMHSA has made clear that integrating mental health, substance abuse, and primary care services produces the best outcomes and proves the most effective approach to caring for people with multiple healthcare needs. However, Part 2 can serve as a barrier for initiatives that promote enhanced access and care continuity, such as health information exchanges, integrated care networks, health homes, and accountable care organizations. In addition, Part 2 is not uniformly applied to all providers treating patients with SUD. For-profit programs and private practitioners that do not receive federal assistance of any kind are not subject to Part 2 unless the State licensing or certification agency requires them to comply. Patient information maintained in connection with the Veterans’ Health Administration is also not subject to Part 2. Buprenorphine prescribers may or may not be subject to Part 2 depending on whether the provider considers itself as an entity that specifically provides SUD diagnosis, treatment, or referral for treatment.
On January 18, 2018, SAMHSA published a final rule to provide greater flexibility in disclosing patient identifying information within the health care system by making it easier to share these records within accountable care organizations and health information exchanges. Under the newly-created general designation process promulgated under final regulations, a patient may consent to share his or her information with an intermediary, such as a health information exchange (HIE), accountable care organization (ACO), or other integrated care setting. However, a recipient of this information within an HIE or ACO with a treating provider relationship is prohibited from re-disclosing that information to another provider in the same HIE or ACO without additional patient consent, rendering the process unworkable in practice. SAMHSA has stated that the agency is encouraged that Congress is reviewing the issue and has made clear that any further changes to align Part 2 with HIPAA would require a change to the underlying statute.
The legislation would ensure doctors have access to important information pertinent to treatment while still ensuring patient information is protected. Access to a patient’s entire medical record, including addiction records, helps ensure that health providers and organizations have all the information necessary for safe, effective, high quality treatment, and care coordination that addresses all of a patient’s unique health needs. Failure to integrate services and supports can lead to risks and dangers to individual patients, such as dangerous drug interactions and problems related to medication adherence. Obtaining multiple consents from a patient can be challenging, creating barriers to whole person, integrated approaches to care.
A Congressional Budget Office (CBO) estimate is not currently available. However, CBO estimated that enactment of a similar bill (H.R. 5795) would cost $1 million over the 2019-2023 period (page 23).
For questions or further information please contact Jake Vreeburg with the House Republican Policy Committee by email or at 2-1374.
 SAMHSA-HRSA Center for Integrated Health Solutions. “What is integrated care?” 2016. Available at http://www.integration.samhsa.gov/resource/what-is-integrated-care.
 American Psychiatric Association. “Final Rule: 42 CFR Part 2, Confidentiality of Substance Use Disorder Patient Records.” 2017. Available at https://www.psychiatry.org/psychiatrists/practice/practice-management/hipaa/42-cfr-part-2.
 42 CFR § 2.31(a)(4)(iii)(B). Consent requirements.
 United States Congress. House Energy and Commerce Committee, Subcommittee on Health. Improving the Coordination and Quality of Substance Use Disorder Treatment. May 8, 2018. 115th Congress, 2nd session. (2018) (statement of Gerald (Jud) E. DeLoss, Greensfelder Hemker & Gale P.C.). Available at https://docs.house.gov/meetings/IF/IF14/20180508/108271/HHRG-115-IF14-Wstate-DeLossG-20180508.pdf.
 McKance-Katz, Elinore F. (Substance Abuse and Mental Health Services Administration) Letter to the Honorable Markwayne Mullin. March 19, 2018. Available at https://docs.house.gov/meetings/IF/IF14/20180321/108049/HHRG-115-IF14-20180321-SD100.pdf.
 McCance-Katz EF, Sullivan L, Nallani S, Drug Interactions of Clinical Importance among the Opioids, Methadone and Buprenorphine, and other Frequently Prescribed Medications: A Review. Am J Addict. 19: 4-16 (2010). Available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3334287/.