The SUPPORT Act (“the Act”) — the major law passed in 2018 that addressed the opioid crisis — requires there to be electronic prescribing for controlled substances (“EPCS”) in the Medicare Part D Prescription Drug Program beginning in 2021.
Specifically, Section 2003 of the Act mandates that the prescribing of a Schedule II, III, IV, or V controlled substance under Medicare Part D be done electronically in accordance with an electronic prescription drug program beginning January 1, 2021, subject to any exceptions that HHS may specify.
The Act, however, does indicate there are circumstances under which the Secretary of HHS may waive the electronic prescribing requirement with respect to controlled substances that are covered Part D drugs. It also permits HHS to develop other appropriate exceptions. Some of the exceptions articulated in the Act include:
While Section 2003 of the Act mandates that EPCS begin on January 1, 2021, CMS is encouraging all prescribers to conduct EPCS as soon as is feasible for them, though it will not begin to enforce EPCS until January 1, 2022.
Implementing EPCS will take additional time. It requires prescribers to follow all DEA guidance, as well as ensuring that their current ePrescribing software can support EPCS and is accredited by the DEA. CMS notes that prescribers will be required to use the National Council for Prescription Drug Programs (NCPDP) SCRIPT 2017071 standard for EPCS prescription transmissions. Part D plans are already required to support this standard.
EPCS protocols will require:
The COVID-19 pandemic added additional EPCS challenges for some prescribers, as some organizations indicated that updates to their current Electronic Health Record (EHR) would need to be rescheduled. CMS recognized the challenges prescribers are facing during the pandemic, so it indicated that requiring EPCS by January 1, 2022, strikes the balance between not providing too large of a burden on providers and helping ensure that the benefits of EPCS are still leveraged appropriately.
The extension in requiring EPCS by 2022 has now allowed for additional feedback and discussion with Request for Information from prescribers. CMS released a Request for Information on how it should implement the requirement going forward. In this RFI, CMS sought comment on three issues:
1) Compliance with the requirement;
2) Enforcement and penalties; and
3) Potential exceptions to the requirement.
On December 1, 2020, CMS finalized the Requirement for EPCS for a Covered Part D drug under a Prescription Drug Plan or an MA-PD plan rule indicating the compliance date has been set for January 1, 2022.
While the federal mandate only concerns Medicare Part D prescribers, states legislatures have begun developing their own electronic prescribing for controlled substances mandates in an effort to standardize the prescribing practices across all providers.
In the State of Michigan, Gov. Whitmer recently signed into law legislation (Public Acts 134, 135, and 136 of 2020) to require prescribers to electronically transmit all prescriptions, including those for controlled substances, to the patient’s chosen pharmacy, beginning October 1, 2021. Some states have current EPCS mandates in effect, while others have future dates of compliance.
Our national healthcare regulatory compliance attorneys encourage you to reach out to us. We will work with you to be sure you are following your state’s e-prescribing mandates and federal compliance with the EPCS.
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In “Physician Guide to Basic Compliance Concepts,” Chapman Law Group’s national healthcare compliance attorneys cover how to spot and avoid healthcare fraud, handling investigations and audits, and keeping your staff in the right.
Chapman Law Group’s Ronald W. Chapman Sr. and Juan Santos hosted a CLE session on DOH, DEA, Medicaid at the Florida Pharmacy Association Law & Regulatory Conference in Sarasota.
Since the U.S. Department of Justice’s Criminal Division created the Appalachian Regional Prescription Opioid (ARPO) Strike Force, which focuses on illegal opioid prescriptions, it has
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