Congress Passes New Opioid Package; Awaiting Presidential Signature

Earlier this week Congress reached agreement on legislation to address the opioid epidemic with the passage of the “SUPPORT for Patients and Communities Act,” which President Donald Trump is expected to sign. The legislation touches on almost every aspect of the epidemic and includes numerous provisions to expand access to substance-use disorder (SUD) prevention and treatment programs.

Below are some of the legislations significant provisions:

• Expand existing programs and create new programs to prevent SUDs and overdoses, including reauthorization of the Office of National Drug Control Policy.
• Expand programs to treat SUDs, including medication-assisted treatment (MAT); partially lift (for five years) a current restriction that blocks states from spending federal Medicaid dollars on residential addiction treatment centers with more than 16 beds by allowing payments for residential substance-use disorder services for up to 30 days; and allow Medicare to cover MAT, including methadone, in certain settings, to treat SUDs.
• Increase funding for residential treatment programs for pregnant and postpartum women; and require the Centers for Disease Control and Prevention (CDC) to develop educational materials for clinicians to use with pregnant women for shared decision making regarding pain management during pregnancy.
• Authorize an alternative payment model demonstration project developed by the American Society of Addiction Medicine, with support from the AMA, to increase access to comprehensive, evidence-based outpatient treatment for Medicare beneficiaries with opioid-use disorders.
• Authorize CDC grants for states and localities to improve their Prescription Drug Monitoring Programs (PDMP), collect public health data, implement other evidence-based prevention strategies, encourage data sharing between states, and support other prevention and research activities related to controlled substances, including education and awareness efforts.
• Expand the use of telehealth services for Medicaid and Medicare SUD treatment.
• Provide loan repayment for SUD-treatment professionals, including physicians, who agree to work in mental health professional shortage areas (HPSAs) or counties that have been hardest hit by drug overdoses, and clarify that mental and behavioral health providers participating in the National Health Service Corps can provide care at a school or other community-based setting located in an HPSA as part of their obligated service requirements.
• Help stop the flow of illicit opioids into the country by mail, especially synthetic fentanyl and its analogs.
• Provide funding to encourage research and development of new non-addictive painkillers and non-opioid drugs and treatments.
• Require the U.S. Department of Health and Human Services (HHS) to study and report to Congress on the impact of federal and state laws and regulations that limit the length, quantity, or dosage of opioid prescriptions.

The final bill also retained some provisions which may cause some concerns in the medical community, primarily related to mandates on physicians and duplicative requirements in state and federal programs. These provisions would:

• Create a federal mandate for physicians to electronically prescribe controlled substances (EPCS) by January 2021 for Schedule II, III, IV, and V controlled substances covered under a Medicare Part D Prescription Drug Plan or Medicare Advantage (MA) prescription drug plans. The final language did, however, include the requirement that the Drug Enforcement Administration update its regulations pertaining to how prescribers authenticate prescriptions using biometrics to keep up with changing technology.
• Require the HHS Secretary to establish a standard, secure electronic prior authorization system (ePA) for covered Part D and MA drugs but allow plans to continue to operate their individual proprietary online portals.
• Require the U.S. Food and Drug Administration (FDA) to develop prescribing guidelines for the indication-specific treatment of acute pain where such guidelines do not exist. A provision was retained that requires the FDA Commissioner to publish a clear statement of intent to accompany the guidelines stating that they are intended to inform clinical decisions by prescribers and patients and are not intended to restrict, limit, delay or deny coverage or access by individual health care professionals.

One proposal not in the final legislation would remove patient privacy protections under federal law related to the confidentiality of SUD records. The Medical Association, AMA and other health care groups opposed the efforts to include this proposal partly out of concern that allowing more access to such records could discourage patients from seeking treatment for SUD. However, we are committed to working with Congress and other stakeholders to develop a solution that balances the need for health professionals to have the information they need to provide appropriate treatment to patients with SUD, while ensuring appropriate privacy protections for patients.