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Federal Rule Change Allowing Providers to Share Data Poised to Improve Substance Use Disorder Treatment

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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.

Other major changes under the new Part 2 Rule:

  • Part 2 program employees may now “sanitize” their personal phones or computers by simply deleting a message that an SUD patient accidentally sends them.
  • Declared emergencies (e.g., natural disasters) qualify as “bona fide medical emergencies” for purposes of disclosing SUD records without patient consent.
  • Disclosures for research under Part 2 are permitted under certain circumstances.
  • It also clarifies scope of permissible disclosures for audits and/or program evaluation purposes.
  • The changes extends court-ordered placement of an undercover agent or informant within a Part 2 program to 12 months.
  • An SUD patient may now identify an entity (instead of an individual) when consenting to the disclosure of his or her Part 2 treatment records.
  • It clarifies what qualifies as a disclosure for the purpose of “payment and health care operations” and expands the list to include care coordination and case management.

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.

Lessons from Project LAUNCH: Promoting Healthy Child Development through Behavioral Health Integration and Mental Health Consultation Where Children Live, Learn, and Grow

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The first few years of life are critical to a child’s development, setting the foundation for success in school and overall health and well-being later in life. Recent research proves that providing early, skilled behavioral and mental health interventions in venues where young children and their families live and play is highly effective at improving wellness and reading scores, and in decreasing grade retention in early elementary school.
Project LAUNCH (Linking Actions for Unmet Needs in Children’s Health), an initiative of the Substance Abuse and Mental Health Services Administration (SAMHSA), has helped state and local partners to promote the wellness of children from birth to age eight and to support pediatricians, child care providers, teachers and home visitors to identify and address behavioral issues before problems become severe.
To accomplish this, states and local programs funded by Project LAUNCH are implementing a range of strategies, including early childhood mental health consultation and integration of behavioral health services into pediatric primary care settings. The National Academy for State Health Policy (NASHP) explored these Project LAUNCH strategies and the impact they have had on children, families, and providers in two new issues briefs – The Use of Mental Health Consultation in Home Visiting and Early Care and Education Settings and The Integration of Behavioral Health into Pediatric Primary Care Settings – with support from SAMHSA under a sub-contract with NORC at the University of Chicago. The reports offer valuable insights into the challenges and successes of the Project LAUNCH grantees that states can use to strengthen their own child-serving systems.
Providing Mental Health Consultation Where Children Play and Learn
The places where young children and their families live, play, and learn provide important opportunities and venues to promote healthy social-emotional development and to intervene early when problems arise. Too often, child care providers, preschool teachers, home visiting program staff, and others who work with young children and their families are not trained to foster social-emotional development and may be ill-equipped to manage behavioral health issues when they arise. Early childhood mental health consultation (ECMHC) fosters a team approach by pairing a mental health consultant with professionals in child-serving settings to strengthen their knowledge of and build their capacity to support the social-emotional and behavioral health of children. Typical ECMHC supports include teaching behavior management strategies, creating behavior support plans for individual children in collaboration with families and child care staff, and facilitating linkages to mental health professionals.
State and local Project LAUNCH grantees were able to demonstrate that ECMHC had a positive impact on children and their families, and the providers who serve them. They found that:

  • ECMHC services sharply reduced the number of children held back in the second grade and improved second grade reading scores.
  • ECMHC services helped early childhood education and home visiting staff better identify children with social-emotional and behavioral challenges and provide support to these children and their families.
  • The longer child care and home visiting providers were supported by ECMHC, the greater the gains for both children and programs.

Integrating Behavioral Health into Pediatric Primary Care Settings
Researchers found that the primary health care office was another key venue for supporting children’s social-emotional and behavioral health. Primary care providers have regular contact with young children and families and are often trusted by the family, making them well-positioned to proactively support social-emotional development and detect the early onset of behavioral health issues. However, primary care providers often:

  • Lack training in the use of standardized screening tools;
  • Have too little time to conduct additional screenings during appointments; and
  • Are not always able to receive reimbursement for the full spectrum of behavioral health services required to meet a child’s needs.

Additionally, the physical and behavioral health systems in the United States have traditionally been highly fragmented, forcing families to navigate multiple systems in order to obtain appropriate care.
Behavioral health integration in pediatric primary care settings refers to a model of care where a practice team of primary care and behavioral health clinicians work in concert to provide a systematic, cost-effective, coordinated, and patient- and family-centered approach to care. While behavioral health integration can take a variety of forms, it ultimately is designed to equip primary care providers with the knowledge and skills needed to:

  • Support children’s social, emotional, and behavioral health;
  • Detect issues and intervene early; and
  • Enhance coordination and collaboration among providers.

Project LAUNCH grantees implemented a variety of strategies to achieve greater integration of behavioral health services into pediatric primary care settings. The key integration strategies included:

  • Training primary care providers in the routine use of developmental and social-emotional screenings;
  • Establishing enhanced referral and care coordination systems;
  • Providing parenting education and support groups within primary care settings; and
  • Embedding an infant and early childhood mental health specialist in primary care settings.

Evaluations of the Project LAUNCH grantees found these efforts increased early screenings and referrals; boosted patient, family, and provider satisfaction levels; and improved children’s social-emotional functioning.
The work of the Project LAUNCH grantees clearly reinforces the role ECMHC and behavioral health integration can play in promoting healthy child development, supporting the whole family, and improving long-term outcomes. Implementing ECMHC across child-serving settings and integrating behavioral health services into primary care practices were significant undertakings by the Project LAUNCH grantees, and they faced numerous challenges in launching and expanding these initiatives.
For example, grantees had to obtain buy-in and commitments from providers, and cultivate acceptance and engagement among families. These initiatives also required a significant amount of resources, including time, funding, and staff capacity, and many grantees continue to grapple with how to sustain and expand them. However, the grantees demonstrated the positive impact that comprehensive, integrated, and coordinated systems can have on children, their families, and providers, and they offer valuable lessons for other states.

Certified Community Behavioral Health Clinics:  What’s in It for States?

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When it comes to behavioral health systems, many states struggle with the lack of “system.” Services provided are often a compilation of available Medicaid state plan options, with little in the way of unifying structures to ensure coordination of care or linkages to other systems. The Substance Abuse and Mental Health Services Administration (SAMHSA) recently announced Certified Community Behavioral Health Clinic (CCBHC) program seeks to address these challenges through the development of community behavioral health organizations that offer a comprehensive array of services, with standards designed to foster continuity and coordination.
On May 20, SAMHSA released the Request for Applications (RFA) for its CCBHC program. The two-phase program includes a RFA for one-year planning grants (of up to two million dollars) to support states in developing CCBHCs.  States will use the planning grants to certify community behavioral health clinics based on SAMHSA criteria, develop a prospective payment system for reimbursement of CCBHCs, and prepare an application for the demonstration phase of the program. Phase two, slated to begin in 2017, will engage eight states in a two-year demonstration to implement CCBHCs and evaluate the impact of these new providers on access, cost, and quality of community behavioral health care. States that participate in the two-year demonstration will receive matching federal funding at their state’s Children’s Health Insurance Program (CHIP) Federal Medicaid Assistance Percentage (FMAP) for services delivered by the CCBHCs during the two-year demonstration. Note, this CHIP FMAP rate for CCBHC services does not include the 23 percentage point bump that applies to CHIP between October 1, 2015 and September 30, 2019. Higher FMAP rates do apply to CCBHC services provided to CHIP expansion enrollees and certain newly eligible Medicaid enrollees, however.
Advocates welcomed the announcement of the CCBHC program as one of the most significant investments in behavioral health system transformation in decades, citing the opportunity to create a more standardized and high-performing community mental health system nationwide.
Does the CCBHC program provide solutions to critical state mental health systems issues, and if so, at what cost? The answer for each state may depend on both the existing community mental health infrastructure and the state’s broader healthcare context:
Is your state’s community behavioral health system able to deliver?  
State community behavioral health systems are increasingly viewed as a key piece of the health reform puzzle. Whether we are talking about integrating with physical health care, addressing the needs of Medicaid’s most expensive and complex populations, or being the go-to system for high-visibility public health issues (suicide prevention, opioid addition) more is expected of community behavioral health systems than ever before. However, these systems often lag behind in critical areas such as workforce, HIT, common quality measurement tools, and other infrastructure.  The CCBHC program, with its focus on establishing standards, beefing up services and systems, and the potential for enhanced Medicaid funding during the demonstration phase, could provide a very timely vehicle for states to do some comprehensive system planning and reform.
Are CCBHCs a good fit with your state’s regulatory framework?
CCBHCs are required to provide – either directly or through formal arrangements with other providers – a comprehensive set of behavioral health services, including crisis services (unless the state has an existing system), screening, assessment, and diagnosis, treatment planning, outpatient mental health and substance use services, targeted case management, psychiatric rehabilitation services, peer and family supports, and community-based mental health care for members of the armed forces and veterans.   Although states are ultimately responsible for certifying CCBHCs based on state criteria, SAMHSA has also laid out some fairly detailed baseline requirements, covering topics such as staffing, cultural competence, access and care coordination.  All of this creates a fairly robust regulatory structure, which may or may not align with a state’s existing behavioral health services and systems. States will want to think about how this overlay could help them leverage and strengthen what is already on the ground.
Who (and what) is currently covered?
States that are selected for the CCBHC demonstration must ensure that their CCBHCs are ready to provide a mandated minimum set of services to all in need, regardless of ability to pay or residency requirements. The CCBHC prospective payment, however, may only include costs related to serving eligible Medicaid recipients. States, especially those that have not expanded Medicaid coverage, will need to understand how CCBHCs will support delivery of services to this uninsured/self-pay population. Similarly, states whose benefit package does not currently include all mandated CCBHC services will want to think about how this set of services can be sustained post-demonstration. 
Does the CCBHC framework align with other reform efforts and initiatives?
States are engaged in a multitude of delivery system and payment reform initiatives, from improving care coordination to the development of system-wide, value-based purchasing strategies.  Behavioral health, while often included in these efforts, can sometimes feel like a sideshow to the main event: carved out, lacking data, and limited by state plan option restrictions.  States that have struggled with how to bring behavioral health into the big tent of payment reform may find an opportunity in the CCBHC program. The Centers for Medicaid and Medicare Services lays out two different prospective payment strategies for the CCBHCs, both of which permit states to use quality bonus payments to incentivize good care.  States may certify as few as two CCBHC sites as a way to explore these changes while minimizing disruption or conflict with existing reform efforts.  CCBHCs may also provide health home services, so these initiatives need not be mutually exclusive.
High-performing behavioral health systems are critical to broader state health reform efforts, and opportunities for major investment in these systems have been few and far between.  The CCBHC program may be an important tool for state policymakers to consider as they think about improving these important systems of care; states will want to review this opportunity to see if it’s a good fit.
Applications from states for CCBHC planning grants are due to SAMHSA on August 5th, 2015. For more information on the program, visit the SAMHSA CCBHC webpage.

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