Is Your Practice Set Up for Controlled Substances to Be Prescribed Electronically? New Law Taking Effect 2021 Requires It

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Make Sure Your Healthcare Practice is Aware of Protocols, Exceptions to SUPPORT Act

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:

    1. A prescription issued when the practitioner and dispensing pharmacy are the same entity;
    2. A prescription issued that cannot be transmitted electronically under the most recently implemented version of the National Council for Prescription Drug Programs SCRIPT Standard; and
    3. A prescription issued by a practitioner prescribing a drug under a research protocol, etc. (See section 1860D-4(e)(7) of the Act.)

Implementation of EPCS Will Take Time

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.

What the EPCS Protocols Call For

EPCS protocols will require:

    • Identity Proofing: This seeks to recognize the identity of the prescriber of the Schedule ll-V drugs. The intelligent software will mitigate the risk of unqualified doctors prescribing highly addictive substances.
    • Digital Signature: This gives the prescription authentication; thus, the patient is eligible for opioid use for pain management. It also prevents unqualified people from giving illegal prescriptions.
    • Two-Factor Authentication: This helps in verifying the credibility of the prescriber. The medical facility will have to adopt biometrics or tokens for correct integration.
    • Regular Monitoring by the DEA: On an occasional basis, the DEA will require well-audited reports on the prescription of regulated substances in health facilities. Monitoring of opioid use will be enabled.

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.

States Have Their Own Mandates

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 134135, 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.

Chapman Law Group’s National Healthcare Regulatory Compliance Attorneys Will Help with EPCS Matters

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.

Among the licensed medical professionals we work with:

We have four national offices: Detroit, MichiganMiami and Sarasota, Florida; and Los Angeles/Southern California. Contact us today for more information.

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Wedad Suleiman, LL.M.

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Healthcare Compliance, Civil Litigation

Michigan Office
1441 W. Long Lake Road, Suite 310
Troy, MI 48098
Phone: (248) 644-6326

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