HHS has announced a series of actions to address the nation’s opioid epidemic, as Congress has cleared the Comprehensive Addiction and Recovery Act for the President’s signature. As part of the HHS activities, the Substance Abuse and Mental Health Services Administration (SAMHSA) has published a final rule to expand from 100 to 275 the number of patients that qualified practitioners may treat with buprenorphine, a medication to treat opioid use disorder. Furthermore, as noted in a separate post, the proposed 2017 OPPS rule would remove certain pain management questions from consideration for purposes of Hospital Value-Based Purchasing (VBP) Program payment adjustments “to mitigate even the perception that there is financial pressure to overprescribe opioids.” In addition, HHS announced its research priorities regarding opioid misuse and pain treatment, and the Indian Health Service adopted a requirement that prescribers and pharmacists check state Prescription Drug Monitoring Program (PDMP) databases before prescribing or dispensing opioids for pain.

These actions come as the OIG has highlighted significant Medicare Part D spending on commonly-abused opioids, which the OIG estimates exceeded $4 billion in 2015. In fact, almost one in three Medicare Part D beneficiaries received a commonly-abused opioid in 2015, according to the OIG. The OIG recommends that CMS take additional actions to prevent opioid abuse within the Medicare program, signaling the potential for additional policies in this area.

In another related development, this month both the House and Senate approved the conference report to accompany S 524, the Comprehensive Addiction and Recovery Act. Among many other things, the bipartisan legislation would:

  • authorize various grants for programs to address heroin and prescription opioid addiction and implement prescription drug monitoring programs;
  • coordinate related federal prevention, education, and research efforts;
  • expand access to opioid overdose reversal drugs and medication-assisted treatment programs;
  • allow Medicare Advantage and Medicare Part D prescription drug plans to establish programs, for plan years beginning in 2019, restricting “at-risk” beneficiaries’ access to drugs that are frequently abused or diverted (as identified by the Secretary of HHS) to drugs prescribed by one or more prescribers and obtained from one or more pharmacies, but only after the Secretary of HHS develops, in consultation with various stakeholders, clinical guidelines for identifying “at-risk” beneficiaries and promulgates various related regulations, subject to beneficiary notice and appeal rights and various other requirements and exemptions; and
  • exempt abuse-deterrent formulations of prescription drugs, as determined by the Secretary of HHS, from the Medicaid additional rebate requirements applicable to “line extensions” of existing drugs.

The legislation now moves to the President’s desk.