Last month, the Substance Abuse and Mental Health Services Administration (SAMHSA) revised its rules and gave providers at substance abuse treatment centers increased access to patient information, including prescribing information, to help them make more informed decisions and avoid duplicative treatment.
SAMHSA changed its Part 2 Rule, first published in 1975, that originally limited the sharing of data about individuals receiving substance use disorder (SUD) treatment at federally-assisted programs. State policymakers have long argued the rule did not align with the Health Insurance Portability and Accountability Act (HIPAA) regulations, creating hurdles to care and, for some systems, restricting care coordination and integration.
The revised rule will especially benefit states’ opioid treatment programs (OTPs) and prescription drug monitoring programs (PDMPs) as they confront mounting overdoses resulting from the COVID-19 pandemic.
Increasing Disclosures to Prescription Drug Monitoring Programs
Nearly every state maintains a PDMP, a secure database that collects and maintains controlled substance prescription data on a statewide platform. Prescribers and pharmacists and, in some states, law enforcement and regulatory boards, may access these databases in order to prevent duplicative or harmful prescriptions and ensure appropriate prescribing practices.
PDMPs have been critical tools for states’ opioid responses, providing policymakers with data to help reduce opioid prescribing and decrease prescription opioid-related overdose deaths.
Until now, Part 2 has prevented states from including prescribing data from Part 2 providers, such OTPs, in PDMP information. In a 2011 guidance letter, SAMHSA indicated that while OTPs may access PDMPs, they may not disclose patient identifying information to them. PDMPs are designed to make patient information more readily available to authorized users, which necessarily involves the re-disclosure of patient-identifying information. This re-disclosure of patient-identifying information from a Part 2 program is generally prohibited by the Part 2 Rule.
Under the revised rule, OTPs are now permitted to enroll in a state PDMP and report data to it when prescribing or dispensing Schedule II to V controlled substances, so long as they have patients’ consent. SAMHSA explained, in its response to public comments, that excluding OTP data from PDMPs can result in providers inadvertently prescribing duplicative or contraindicated prescriptions, and that allowing Part 2 programs to enroll in PDMPs will improve treatment and promote more efficient care coordination among providers. SAMHSA also indicated that permitting OTP enrollment in PDMPs will strengthen the ability of PDMPs to achieve their core function of preventing misuse and potential overdose by including the most complete patient data available.
Disclosures to Central Registries
Central registries – used in some states – are defined by Part 2 rule as entities that maintain patient-identifying information about individuals who apply for withdrawal management or maintenance treatment, with the goal of avoiding enrollment in multiple treatment programs. Prior to the recent , only member organizations (i.e., other OTP providers) could access patient-identifying information through central registries.
Under the revised rule, any treating provider may now access central registries to review patient information, with the goal of preventing duplicative prescriptions and better coordinating care. In its comments, SAMHSA noted that all providers who work with patients with SUDs should have access to information that may aid in preventing duplicative treatment, and that non-OTP providers need to have the complete medical history of their patients in order to provide effective and safe care.
Applicability to Non-Part 2 Providers
With an increased focus on integrated and coordinated care, providers across a range of settings, including primary care, have experienced challenges in sharing, receiving, and segregating patient information related to SUD treatment. While SUD records sent by a Part 2 program to a non-Part 2 program remain protected and may not be re-disclosed without patient consent, recent rule changes do remove some burdens. The new rule clarifies that treatment records created by non-Part 2 providers based on their own patient encounters are not subject to Part 2. SAMHSA is encouraging non-Part 2 providers to segregate their patient records from any records received from Part 2 programs in order to ensure that their records do not become subject to Part 2.
Implications for States
States can use these new flexibilities to bolster their PDMPs and improve the tracking and analysis of prescribing data. Adding OTP data to the equation will help complete the picture of prescribed drugs at both state and clinical levels, supplying health officials with better data to drive program and policy decisions. Critically, improved access to prescribing information will give providers the clinical data they need to make informed decisions and avoid duplicative treatment. By implementing these changes, states can work toward coordinating and improving patient care and ensuring better patient outcomes.
