The COVID-19 pandemic has taken a devastating toll on Americans across the country, whether in lives lost or economic impacts, and it has particularly affected our fellow citizens who have the most vulnerabilities, including the elderly and communities of color. CMS forced to adjust and adapt our daily lives in innumerable ways, while significant public health resources have had to be redirected to help us meet and beat this unprecedented pandemic.
In 2018, President Trump signed the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, or the SUPPORT for Patients and Communities Act, into law, which mobilized Federal efforts to address the nation’s ongoing opioid crisis. Section 2003 of the SUPPORT Act mandates that the prescribing of a Schedule II, III, IV, or V controlled substance under Medicare Part D should be done electronically in accordance with an electronic prescription drug program, beginning 2021, subject to any exceptions, which the Department of Health and Human Services (HHS) may specify.
The circumstances that are listed in the statute under which the Secretary may waive the EPCS requirement are at section 1860D-4(e)(7) of the Act, as added by section 2003 of the SUPPORT Act, and include:
- A prescription issued when the practitioner and dispensing pharmacy are the same entity;
- A prescription issued that cannot be transmitted electronically under the most recently implemented version of the National Council for Prescription Drug Programs SCRIPT Standard;
- A prescription issued by a practitioner who received a waiver or a renewal thereof for a period of time as determined by the Secretary, not to exceed one year, from the requirement to use electronic prescribing due to demonstrated economic hardship, technological limitations that are not reasonably within the control of the practitioner, or other exceptional circumstance demonstrated by the practitioner;
- A prescription issued by a practitioner under circumstances in which, notwithstanding the practitioner’s ability to submit a prescription electronically as required by this subsection, such practitioner reasonably determines that it would be impractical for the individual involved to obtain substances prescribed by electronic prescription in a timely manner, and such delay would adversely impact the individual’s medical condition involved;
- A prescription issued by a practitioner prescribing a drug under a research protocol;
- A prescription issued by a practitioner for a drug for which the Food and Drug Administration requires a prescription to contain elements that are not able to be included in electronic prescribing, such as a drug with a risk evaluation and mitigation strategies that include elements to assure safe use;
- A prescription issued by a practitioner
CMS recently announced a proposed rule for Medicaid (CMS-2482-P) that builds on current policies to help ensure that opioid prescribing is appropriate, medically necessary, and avoids adverse medical events. The proposal would address a requirement in the SUPPORT for Patients and Communities Act (the SUPPORT Act) that states have systems in place to identify or limit inappropriate prescribing of opioids under certain conditions, such as if a beneficiary is already receiving medication-assisted treatment for substance use disorder (SUD). We’re also seeking input from Medicaid stakeholders on proposals for future rulemaking that would require additional review of opioid prescribing, medication-assisted treatment and naloxone prescribing.
CMS has taken a number of steps to identify and stop inappropriate prescribing to help prevent the development of new cases of OUD while balancing the need for continued access to prescription opioids for appropriate, individualized pain management. For example, the SUPPORT Act requires all Medicare Part D sponsors to have a Drug Management Program (DMP) for plan years beginning on or after January 1, 2022.
As of January 2020, 87% of Part D plans have already implemented a voluntary DMP. Thanks to policies promoting safer opioid use, the percent of Medicare beneficiaries receiving higher than recommended doses of opioids declined by 45% between 2016 and 2019.
As CMS enhanced their prevention activities, they’ve also made great strides in expanding access to evidence-based OUD treatment. As of January 2020, for the very first time, Medicare covers methadone furnished by opioid treatment programs (OTPs) for beneficiaries suffering from OUD. This new benefit will also cover other OUD treatment services as part of a bundled payment.
These services include dispensing and administration of medications used in medication-assisted treatment (MAT); substance use counseling; toxicology testing; as well as intake activities and periodic assessments. Additionally, the coverage includes substance use counseling and individual and group therapy services furnished by OTPs either in-person or via two-way interactive audio-video technology, which broadens access to these critical services particularly for those living in rural areas that have been among the hardest hit by the opioid crisis.
CMS coverage policies now ensure some form of MAT across all CMS programs. Starting January 1, 2020, for the first time, Medicare covers methadone for MAT and related services furnished by opioid treatment programs (OTPs). On January 21, 2020, Medicare coverage expanded to include acupuncture for certain beneficiaries with chronic low back pain.