Impacts of the Opioid Crisis Response Act

THE FINAL VERSION of the Opioid Crisis Response Act (H.R. 6) has been signed into law to address the nationwide opioid crisis by expanding and creating programs for prevention, treatment and recovery. Its far-reaching provisions affect health insurance, law enforcement, the pharmaceutical industry and IT capabilities and offerings. By temporarily eliminating the cap on Medicaid payments for large treatment facilities, the bill allows states to receive federal Medicaid matching funds for up to 30 days per year for services provided in institutions for mental diseases to adults aged 21 years to 64 years for substance-use disorders. It addresses health insurance for former foster youth, maternal and infant health, and parity in Children’s Health Insurance Program (CHIP) mental health and substance-use disorder benefits. It also seeks to stymie illicit opioids shipped to the United States from other countries by helping the U.S. Postal Service better screen packages for illegal drug shipments, especially synthetic fentanyl and its analogs that are fueling the rise in overdose deaths.

Impacts on Pharma

The bill encourages the pharmaceutical industry to pursue the development of nonaddictive painkillers and other medication-assisted treatment. It provides manufacturers and wholesale distributors access to information about pharmacies’ controlled substance orders. And, it clarifies the term “suspicious order” and adds requirements for wholesale distributors, manufacturers and the drug enforcement agency related to detection and reporting of suspicious orders. In addition, the use of medication therapy management (MTM) to address cost-effective means for disposal of controlled substances is required by January 2021. Lastly, certain states will be provided with grant funding for disposal of controlled substances.

Impacts on Providers

At the facility level, the bill creates a demonstration program to promote alternatives to opioids in emergency departments and care coordination for drug overdose patients. Most important arerevisions to the Hospital Consumer Assessment of Healthcare Providers and Systems questions about pain management and improvements in coordination of prescription drug monitoring programs. In July, facilities will be provided access to telehealth to expand treatment of substance use disorders. The Centers for Medicare and Medicaid Services is charged with issuing guidance to states about options for federal reimbursement for substance-use disorder services and treatment using telehealth, including assessment, medication-assisted treatment, counseling, medication management and medication adherence with prescribed medication regimens under Medicaid. At the clinician and healthcare practitioner level, the bill permits more providers to prescribe therapies with medication-assisted treatments by permanently allowing nurse practitioners and physician assistants to prescribe buprenorphine, as well as allowing nurse anesthetists, nurse midwives and clinical nurse specialists to prescribe it for the next five years. An increase in innovative research on pain treatment is supported as well.

Implementation of the Act

Many of the federal requirements have phase-in dates, especially those that fall under Medicare. As of January 2021: 1) Electronic prescribing is required for Schedule II-V controlled-substance prescriptions (under Medicare Advantage [MA] and Part D plans), but that does not affect pharmacists’ ability to dispense prescriptions that are not electronically prescribed or the plans’ ability to cover otherwise valid written, oral or faxed prescriptions; 2) Prescription drug plan sponsors and MA organizations must provide standardized electronic prior authorization requests from prescribers and subsequent responses; and 3) At-risk beneficiaries are eligible for MTM under Part D; however, mandatory drug management programs (lock-ins) for at-risk beneficiaries are delayed until January 2022. Since some responsibilities fall to the states, implementation may vary. The Centers for Disease Control and Prevention is tasked with providing support for prescription drug monitoring program (PDMP) enhancements, and providers must check the PDMP before prescribing Schedule II controlled substances. States are also being encouraged by Medicaid to administer a “qualified” PDMP that satisfies minimum criteria related to the timeliness of information, content and workflow. In addition, states are permitted to create plans to impose certain drug review and utilization requirements intended to prevent “doctor shopping.” These include safety edits (prescriber overrides) for opioid refills and the maximum morphine equivalent that can be prescribed for chronic pain, as well as an automated claims review process that monitors concurrent opioid and benzodiazepine or antipsychotic prescriptions.

Education and Evidence-Based Resources

On a federal level, the U.S. Department of Health and Human Services (HHS) is charged with developing educational materials for pharmacists, healthcare providers and patients related to the pharmacists’ ability to decline to fill controlled substance prescriptions. HHS will consult with pharmacists pertaining to a report to House and Senate committees that will contain options for revising payment to providers and suppliers of services and coverage-related to the use of multidisciplinary, evidence-based, nonopioid treatments for acute and chronic pain management for Medicare beneficiaries. And, the U.S. Food and Drug Administration (FDA) will consult with pharmacists and other stakeholders to develop evidence-based opioid analgesic prescribing guidelines for indication-specific treatment of acute pain.

Approved Risk Evaluation and Mitigation Strategies(REMS)

The FDA Amendments Act of 2007 gave FDA the authority to require REMS from manufacturers to ensure the benefits of a drug or biological product outweigh its risks. This bill expands FDA’s REMS authority to potentially require safety-enhancing packaging and disposal features.

In addition, FDA has determined a REMS is necessary for all opioid analgesics intended for outpatient use to ensure the benefits of these drugs continue to outweigh the risks. The Opioid Analgesic REMS, approved on Sept. 18, 2018, is one strategy among multiple national and state efforts to reduce the risk of abuse, misuse, addiction, overdose and deaths due to prescription opioid analgesics. The extension of the REMS program for opioids includes “all immediate-release (IR) medications for outpatient use and requires new labeling for IR products detailing healthcare provider educational information related to safe use of these drugs.”

The REMS program also requires training be made available to all healthcare providers involved in managing patients with pain, including nurses and pharmacists. The goal is to reduce unnecessary and/or inappropriate exposure to opioids by making certain healthcare providers are properly informed about appropriate prescribing recommendations, understand how to identify abuse by individual patients and know how to get patients with opioid use disorder into treatment.

To meet this requirement, drug companies with approved opioid analgesics must provide unrestricted grants to accredited continuing education providers to develop education courses for healthcare providers based on FDA’s Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain. These new training programs and modules will be created by March 2019 for all clinicians who treat patients for pain, including nonprescribers such as pharmacists. However, there is no mandatory federal requirement that prescribers or other healthcare providers take the training, and there is no precondition to prescribing or dispensing opioid analgesics to patients. But, FDA’s Opioid Policy Steering Committee is considering whether there are circumstances when FDA should require some form of mandatory education for healthcare providers, and how the agency would pursue that goal.