Broad opioid legislation is ready for president’s signature

Several provisions will have a direct effect on pharmacists

Congress demonstrated that tackling the opioid epidemic remains a priority by passing a comprehensive opioid bill on Wednesday, October 3, 2018. The bill now awaits the president’s signature. The legislation encompasses a wide range of issues, including increasing access to treatment, and some of the bill’s provisions will affect pharmacists.

The provisions related to pharmacists show that Congress and federal agencies recognize that pharmacists have a role in combating the opioid epidemic, but fail to fully acknowledge the full scope of the services pharmacists could provide to better manage patients’ pain and help to identify and treat substance use disorders. As a result, in a disappointment for the pharmacy community, the bill passed yesterday did not address Medicare Part B coverage of pharmacists’ opioid-related services.

“It just makes sense—if patients had better access to the services pharmacists can provide, medications’ impact can be better optimized, and risks of abuse or misuse minimized,” said APhA CEO Tom Menighan, BSPharm, MBA, ScD.

The provisions that could have an impact on pharmacists span the realms of Medicare, Medicaid and states more broadly, the supply chain, education and evidence-based resources, and the development of FDA activities. Upon the president’s signature, some provisions will take effect immediately, while others will become effective by 2022.

When the bill becomes law, it will


  • Require electronic prescribing for Medicare Advantage and Part D Schedule II–V controlled substance prescriptions. This would 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.
  • Require Part D plan sponsors and Medicare Advantage organizations to provide for standardized electronic prior authorization requests from prescribers and subsequent responses.
  • Require drug management programs (otherwise known as “lock-ins”) for at-risk beneficiaries.
  • Make at-risk beneficiaries eligible for medication therapy management (MTM) under Part D.
  • Make MTM delivered under Medicare, which would address cost-effective controlled-substance disposal methods.
  • Expand treatment of substance use disorder via telehealth.

States and Medicaid

  • CMS would issue guidance to states on options for federal reimbursement under Medicaid for substance use disorder services and treatment using telehealth, including assessment, medication-assisted treatment, counseling, medication management, and medication adherence with prescribed medication regimes.
  • The bill would require providers to check the state’s PDMP before prescribing schedule II controlled substances.
  • The bill would encourage states to administer a “qualified prescription drug monitoring program,” which would satisfy minimum criteria related to timeliness of information, content, and workflow.
  • State plans would impose certain drug review and utilization requirements, including safety edits for subsequent opioid fills, safety edits on the maximum morphine equivalent that can be prescribed for chronic pain, and a claims-review automated process monitoring concurrent opioid and benzodiazepine or antipsychotic prescriptions.

Supply chain

  • The bill would provide certain states with grant funding for safe drug disposal programs.
  • Manufacturers and wholesale distributors would gain access to information about pharmacies’ controlled-substance orders.
  • Would clarify the term “suspicious order” and add requirements for wholesale distributors, manufacturers, and DEA related to detection and reporting of suspicious orders.

Education and evidence-based resources

  • The Department of Health and Human Services (HHS) would develop educational materials for pharmacists, health care providers, and patients related to pharmacists’ ability to decline to fill prescriptions for controlled substance.
  • Pharmacists would be consulted by HHS for a report to House and Senate committees comprising 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.

FDA activities

  • FDA would consult with pharmacists and other stakeholders to develop evidence-based opioid analgesic prescribing guidelines for indication-specific treatment of acute pain where such guidelines do not exist.
  • FDA would gain expanded Risk Evaluation and Mitigation Strategy (REMS) authority to potentially require safety-enhancing packaging and disposal features.

The estimated cost of expanding patient access to pharmacists’ services has been a lingering concern for Members of Congress, and during the development of this year’s opioid legislative package, Congressional leadership expressed its intention to exclude measures with significant budget implications. Consequently, the final opioid bill is estimated to have a negligible impact on the federal deficit.

“APhA wants to reiterate its thanks and appreciation to the thousands of you who have reached out to your legislators over the past year asking for the passage of the Pharmacy and Medically Underserved Areas Enhancement Act (H.R. 592/S. 109), and for related language to be added in opioid legislation,” Menighan said.