A recent analysis of data from the CDC shows that an estimated 107,375 people in the United States died from drug overdoses over a 12-month period.
Several developments in federal policy could have a significant impact on access to treatment for substance use disorders (SUDs) in 2023. These include (1) new legislation allowing all providers registered by the Drug Enforcement Administration (DEA) to prescribe buprenorphine; (2) proposed regulations to provide new operational flexibility to methadone clinics, the primary drug for the treatment of opioid addiction; This includes greater flexibility to dispense take-home doses to patients when clinically relevant. (3) Suggested rules to better coordinate SUDs. Treatment data confidentiality requirements due to the Protected Health Information (PHI) regulation under the Health Insurance Portability and Accountability Act (HIPAA).
Given the ongoing and worsening epidemic of substance use disorders in the United States, which is exacerbated by the COVID-19 pandemic, these newly proposed flexibilities are of great importance. The latest analysis of data available from the Centers for Disease Control and Prevention (CDC) shows that in the 12 months to January 2022, an estimated 107,375 people in the United States died from drug overdoses. Many of these changes complement the strategy.that is 2022 CMS Behavioral Health Strategythe Biden administration continues to explore ways to enhance access to quality mental health and substance use disorder services.
Deprecation of X-Waiver
as part of Consolidated Appropriations Act Congress in 2023 (PL 117-328) responded to a long-standing call to remove the requirement for providers to obtain a special exemption to prescribe buprenorphine.
Historically, most patients with opioid use disorder (OUD) were treated in opioid treatment programs (OTPs, sometimes called methadone clinics). In 2000, Congress passed the Drug Addiction and Treatment Act (DATA). This allowed a provider who had completed professional training to waive her right to prescribe buprenorphine to treat a certain number of her OUD patients non-OTP. This exemption was also known as the DATA exemption or X exemption (because providers who obtained it had an X appended to their DEA registration number). Regulators have proposed greater flexibility over time regarding the types of providers that can obtain the X waiver and the level of restriction on the number of patients they can treat, but the requirements to obtain the X waiver vary by many. It remained a barrier that hinders people. Providers from the treatment of OUD patients.
On January 12, 2023, the Drug Enforcement Administration (DEA) will letter to registrant Congress repealed the DATA-Waiver Program. This legislative change, effective immediately, means that practitioners authorized by the DEA to prescribe Schedule III controlled substances may prescribe OUD’s buprenorphine within their license, scope of practice, and state law. Removing the exemption requirement also means that there is no longer any specific limit on the number of patients a practitioner can treat with buprenorphine. Guidance on training requirements to provide these services will be published soon.
This new flexibility is important because primary care and other office-based providers are accessible to a much wider range of Americans than the facility-based OTP providers that have traditionally made up the backbone of the SUD care system. Lack of specific expertise or training, lack of access or referral relationships to facility-based providers offering a more intensive level of care, and stigma that may prevent qualified providers from treating OUD Many obstacles remain, but the ability to prescribe vast amounts of buprenorphine for additional providers is a radical overnight change.
Greater flexibility in opioid treatment programs
On December 13, 2022, the Substance Abuse and Mental Health Services Administration (SAMHSA) announced that: Proposed Rules for Enhancing Access to OTP Services.
Methadone is a safe and effective treatment for OUD, but until now patients had to visit an OTP almost every day. The majority of patients on OUD medication are treated with buprenorphine because many patients are unable to get to a methadone clinic every day due to employer or family responsibilities, or lack of transportation or motivation. .
In response to the COVID-19 public health emergency (PHE), SAMHSA is offering up to 28 days’ worth of methadone at home, or up to 14 days’ worth of methadone, to patients deemed stable by OTP practitioners. issued guidance to allow OTPs to dispense Dose to patients considered by physicians to be less stable. The PHE guidance also expanded the definition of “practitioner” to include non-physician clinicians with prescribing authority, such as nurses and physician assistants. Under the proposed regulations, these PHE flexibility will be permanent. The proposed rule would also eliminate hard restrictions on access to home-taken medications based on length of treatment and drug test results, instead allowing treating practitioners to access home-taken medications. Allows more discretion to be exercised to determine clinical validity. The proposed rule would also, among other changes, make permanent the current flexibility under her PHE guidance for OTPs to initiate buprenorphine via telemedicine without an in-person visit.
Despite this significant expansion of OTP flexibility, the real impact on patient access to treatment may be muted. First, there are currently only about 1,900 Her OTPs in the United States, most of which are located in urban areas, so many patients cannot get services directly from Her OTPs. Second, some states cannot amend relevant state laws, and some providers may choose not to exercise their new powers. Additionally, for most patients, the requirement for daily clinic visits still applies during the early stages of methadone treatment.
The deadline for public comments on this proposed rule is February 14, 2023.
Increased alignment with HIPAA for privacy and confidentiality requirements for SUD treatment data
On 2 December 2022, the Department of Health and Human Services (HHS) Proposed Rule to Update Confidentiality Requirements for SUD Patient Records To better align with data privacy and confidentiality requirements under HIPAA.
The proposed rule aims to improve access to health data, support care coordination, and improve interoperability of electronic health record systems, thereby enabling entities subject to these restrictions to access SUD treatment. to improve our ability to use, disclose, and redisclose information. The difference between the more stringent requirements for SUD treatment records and the more familiar HIPAA requirements creates a significant administrative burden for plans, providers, and other entities that require access to these data. This proposed rule would generally significantly reduce the scope of these differences, as Congress requires under his CARES Act of 2020.
Unfortunately, the CARES Act does not amend a key requirement for healthcare providers to obtain patient consent to disclose SUD treatment information to third parties. Additionally, the current and proposed rules are stricter than the underlying legislation in many ways, including the ability for a patient to verbally withdraw consent to share her SUD information. HIPAA does not require patients to consent to sharing protected health information for treatment, payment, and medical service purposes, but the SUD requirements do require consent. Despite increased integrity, providers and other entities continue to have to separate her SUD information from other health information. Unfortunately, the complexity and administrative burden of this regulation will prevent many providers from providing her SUD treatment services.
Another regulatory development to watch in 2023
Beyond the recent legislation and proposed regulations discussed above, health care plans and providers should be aware of potential guidance from the DEA to provide medical care via telemedicine without an in-person visit by a qualified practitioner. A special registry must be created to prescribe buprenorphine.
RELATED: How Employers Can Help Prevent Substance Abuse
Under the Ryan Haight Act and many state laws, providers are required to conduct an in-person evaluation of their patients before prescribing controlled substances via telemedicine. In 2018, Congress passed her SUPPORT Act. This included her DEA having to promulgate a rule that would allow qualified telemedicine providers to obtain special registration to forgo this in-person visit requirement. rice field. However, his one-year deadline for the DEA to create these rules expired in 2019, and to date no rules have been published. Meanwhile, during the COVID-19 pandemic, the DEA and many states have waived this in-person visit requirement in accordance with public health emergency officials.Congress also introduced legislation to make current exemptions permanent, including a bipartisan bill S. 4103: Telemedicine Response to the Electronic Prescription Drug Addiction Services (TREATS) Act, but to date no statutory amendment has been passed. As the end of the public health emergency is likely nearing, patients and providers need a permanent solution to make SUD treatment telemedicine accessible to patients in remote and underserved areas. Without action, I fear the current exemption will end.
Epstein Becker-Green PC, Senior Counsel, David Sircutt
