Prescribing Controlled Substances

Purpose:  

To establish the standards and expectations for prescribing controlled substances for Headway providers, ensuring compliance with applicable laws and patient safety

Applicability:  

This Policy applies to Therapymatch, Inc., d/b/a Headway, and its affiliates and subsidiaries (collectively, “Headway,” “we,” “us,” or “our”) and all of its associated Professional Corporations (PCs), including but not limited to all current and future PCs’ employees, contractors, temporary workers, contingent workers, the Senior Leadership Team, and the Board of Directors.

Definitions:

• Controlled Substance — means any drug, substance, or immediate precursor that is regulated under the federal Controlled Substances Act, 21 U.S.C. § 801 et seq., or listed, scheduled, or otherwise designated as a controlled substance under the laws or regulations of any state, territory, or other jurisdiction.
• Inappropriate Prescribing — prescribing that is not done for a legitimate medical purpose by individual practitioners acting in the usual course of their professional practice, which includes but is not limited to: inconsistent or insufficient documentation to support the clinical rationale; high-dose prescribing without documented justification; prescribing patterns suggestive of diversion; failure to adhere to evidence-based guidelines or regulatory requirements; failure to identify, assess, or adequately respond to high-risk indicators of controlled substance misuse or diversion (e.g., aberrant drug-related behaviors, concerning PDMP findings, escalating requests); and failure to document that the benefits of continued controlled substance prescribing outweigh the risks, particularly when risk factors or warning signs are present.
• Prescription Drug Monitoring Program (PDMP) — a state-run electronic database that tracks prescriptions for controlled substances to support clinical decision-making and prevent misuse.
• Headway Formulary — the list of medications providers may prescribe through Headway's platform, including controlled substances.

Policy:

Headway does not dictate how clinicians prescribe medications, but clinicians must follow certain minimum standards when prescribing medication on our platform to ensure patient safety and prevent fraud, waste, and abuse. Accordingly, Headway reserves the authority to audit provider prescribing patterns, request supporting documentation, and take corrective action when non-compliance with this policy is identified.

Procedures:

1. Compliance with Laws and Regulations
   1. Providers are expected to comply with all applicable federal, state, and local laws, regulations, and guidelines concerning the prescribing of controlled substances. This includes, but is not limited to, compliance with Drug Enforcement Administration (DEA) regulations, State Licensing (MD/DO, NP, PA, etc.) Boards, and Substance Abuse and Mental Health Services Administration (SAMHSA) guidelines.
   2. In accordance with applicable federal law, including the Ryan Haight Online Pharmacy Consumer Protection Act, prescribing controlled substances via telemedicine generally requires a two-way, real-time audio-visual encounter or a qualifying in-person evaluation. Audio-only encounters generally do not meet this standard, except for limited, time-bound exceptions (e.g., initiation of buprenorphine for opioid use disorder). When relying on such exceptions, providers must comply with current federal and state requirements and document the clinical rationale. See the Audio-Only Telehealth Policy for more detail.
2. State-Specific Requirements
   1. Some states impose additional requirements for telehealth prescribing of controlled substances beyond federal baseline standards. Providers are responsible for knowing and complying with the laws applicable in every state where they are licensed and see patients through Headway.
3. Evidence-Based Practice
   1. Prescribing of controlled substances must be based on evidence-based clinical guidelines as described in guidelines published by reputable organizations (e.g., American Psychiatric Association, American Academy of Child and Adolescent Psychiatry, Substance Abuse and Mental Health Services Administration) and the individual clinical needs of the patient. Providers must demonstrate sound clinical judgment and use controlled substances only when they are medically necessary, as part of an integrated treatment plan, and when other therapeutic options are insufficient or inappropriate. Headway acknowledges the continued and quick evolution of the field and that FDA approval may lag behind clinical implementation and acceptance; prescribers are urged to be thoughtful and to document their reasoning when prescribing outside of established guidelines.
   2. Prescribers are strongly encouraged to take the Headway Academy course, “Controlled Substances: Documentation and Compliance for Providers.” Individual prescribers may be assigned this course on a mandatory basis as part of a personalized remediation pathway for inappropriate prescribing.
4. Informed Consent
   1. Providers must ensure that patients are fully informed about the risks, benefits, and potential side effects of prescribed controlled substances, as well as alternative treatment options.
   2. Informed consent should be obtained from the appropriate person, including the parent, legal guardian, or conservator, when prescribing to minors or patients who otherwise lack the capacity to consent for themselves.
   3. Informed consent must be documented in the patient's record, as well as any practice policies related to the medications being prescribed.
5. Headway Formulary Requirements and Restricted Substances
   1. Providers may only prescribe controlled substances that are included on the Headway formulary when providing care on the Headway platform.
   2. For the avoidance of doubt, practices and providers may not prescribe the following substances as part of their practice on Headway's platform: 
      1. Ketamine
      2. Medical cannabis
      3. Opioids/opiates other than buprenorphine
      4. Buprenorphine and its derivatives may not be prescribed for any indication other than management of opioid and kratom use disorder
   3. Clinicians must clearly document when controlled substances or other clinically significant medications are prescribed by an outside provider or practice. Risk management, polypharmacy justification, and monitoring obligations extend to the patient's full medication regimen, regardless of prescriber.
   4. Practices that prescribe esketamine (FDA-approved Spravato) must undergo review by Headway's Clinical team to ensure prescribing patterns are compliant with FDA protocols and best practices, and appropriate for Headway's platform. Practices interested in prescribing esketamine can review our billing and documentation policy and apply for clinical approval here.
   5. Practices that prescribe buprenorphine above a certain threshold (10 or more patients in a 90-day period) must undergo review by Headway's Clinical team to ensure prescribing patterns are compliant with FDA protocols and best practices, and appropriate for Headway's platform. Practices interested in applying for clinical approval can apply here.
6. Patient Assessment and Documentation
   1. A thorough and ongoing assessment of the patient's medical history, current health status, and treatment needs is required before prescribing controlled substances. Providers must document:
      1. The rationale for the use of controlled substances.
      2. Clear treatment goals and expected outcomes.
      3. A plan for monitoring and reassessing the patient's condition.
      4. Documentation of informed consent, including acknowledgment of risks, benefits, side effects, and alternative treatment options.
7. Monitoring and Risk Management
   1. Providers are expected to implement and adhere to protocols for monitoring patients on controlled substances, including:
      1. Substance screening, as clinically appropriate.
      2. Documenting appropriate checking of the Prescription Drug Monitoring Programs (PDMPs) in line with legal requirements.
      3. Regular follow-up assessments to evaluate the effectiveness and safety of the prescribed medication.
      4. Complying with legal requirements for in-person assessments when applicable.
      5. Complying with Headway monitoring initiatives, including accurate reporting of prescribed controlled substances and dosages.
      6. Discontinuation or tapering of medications when appropriate.
8. Documentation Response Timelines
   1. When Headway requests documentation related to prescribing practices, providers must respond promptly per the terms of the Provider Communication Policy. Failure to respond within the specified timeframe may result in corrective actions, up to and including removal from the platform.
9. Avoiding Over-Prescribing and Diversion
   1. Providers must take all reasonable measures to prevent the over-prescribing or diversion of controlled substances, including avoiding the prescription of controlled substances purely for convenience, and addressing any signs of misuse, diversion, or use disorder promptly.
10. Continued Education and Knowledge
    1. Providers are required to stay current with evolving best practices, guidelines, and regulatory requirements related to the prescribing of controlled substances, including attending Continuing Education (CE) programs and training on topics such as opioid stewardship, substance use disorder management, and safe prescribing practices.
    2. Headway will provide resources and courses for clinicians. While encouraged, these are not mandatory, and providers are recommended to seek additional education and resources outside of what Headway provides, including the Headway Academy course, Controlled Substances: Documentation and Compliance for Psychiatric Providers.
11. Collaboration with Other Healthcare Providers and Continuity of Care
    1. Providers should work collaboratively with other members of the care team, including primary care providers, specialists, and substance use counselors, to ensure comprehensive patient care and minimize risks associated with polypharmacy and drug interactions. Appropriate care coordination should be documented in the patient's chart.
    2. Providers are responsible for providing continuity of care and/or facilitating appropriate referrals for patients on controlled substances if their contractual relationship with Headway is ended for any reason.
12. Documentation and Audits
    1. Providers are required to maintain thorough and accurate records of all prescriptions for controlled substances, including patient assessments, treatment plans, informed consent forms, and follow-up notes. Headway may conduct audits to ensure that prescribing practices follow this policy.
    2. Headway uses defined analytic methods to identify providers with potential high-risk controlled substance prescribing patterns that warrant review to ensure proper safeguards and appropriate clinical rationale. Providers identified via these risk indicators may be subject to additional clinical review and remediation as outlined in section 15. Examples of the indicators Headway may consider include, but are not limited to, the following:
       1. Percentage of a provider's panel prescribed a controlled substance
       2. Prevalence of polypharmacy of controlled substances
       3. Prescribing potentially dangerous combinations of controlled substances
       4. Prescribing controlled substances at doses above FDA-recommended limits

13. Reporting Concerns
    1. Any provider who suspects improper use or diversion of controlled substances, or who observes a pattern of unsafe prescribing, is encouraged to report such concerns through appropriate company channels, e.g., by emailing compliance@findheadway.com. 
14. Company Support and Resources
    1. Headway will provide access to up-to-date clinical guidelines, educational materials, and decision-support tools to assist providers in making informed prescribing decisions, including:
       1. Access to evidence-based treatment guidelines for mental health conditions and substance use disorders.
       2. Access to training resources on the appropriate prescribing of controlled substances.
       3. Regular updates on new regulations and policy changes related to controlled substances.
    2. Headway will facilitate access to Continuing Education programs, webinars, and workshops to ensure that providers remain well-informed about safe prescribing practices, emerging research, and evolving regulatory standards.
15. Escalation and Corrective Action
    1. When non-compliance with this policy is identified, Headway may take corrective actions, which can include, but is not limited to, the following:
       1. Mandatory remediation training (e.g., Headway Academy course).
       2. Mandatory meeting with Headway's Clinical team to discuss documentation deficiencies and provide education.
       3. Curative Action Plan.
       4. Temporary suspension from the Headway platform.
       5. Termination of the contractual relationship with Headway.
    2. Non-compliance may also lead to external reporting to regulatory bodies or law enforcement, as required by law.

References:

• Ryan Haight Act
• APA Explanation of Ryan Haight Act
• DEA Telemedicine Flexibilities
• SAMHSA Buprenorphine Guide
• FDA Warning on Ketamine for Treatment of Psychiatric Disorders
• CMS Preventing Diversion Guide
• DEA Practitioner's Manual

Relevant Headway Policies and Procedures:

• Provider Communication Policy
• Audio-Only Telehealth Policy
• Disallowed Treatment Modalities