In an ongoing effort to battle the opioid crisis, Kentucky House Bill 342 was signed into law on March 26, 2019. This bill created a new statute, KRS 218A.182, to require that all prescriptions for controlled substances be submitted electronically, unless certain exceptions apply (the “EPCS Mandate”). Effective January 1, 2021, practitioners who prescribe controlled substances to be dispensed by a Kentucky pharmacy must issue the prescription electronically (“e-prescribe”) directly to the pharmacy unless an exception applies.
This EPCS Mandate closely follows the proposed regulations implementing Section 2003 of the Federal SUPPORT Act, which requires that prescriptions for controlled substances covered under a Medicare Part D prescription drug plan be transmitted by a health care practitioner electronically (also effective January 1, 2021), but the Kentucky EPCS Mandate will apply regardless of payor.
E-prescriptions for controlled substances are not required when issued:
(a) By veterinarians;
(b) In circumstances where e-prescribing is not available due to temporary technological or electrical failure;
(c) By a practitioner to be dispensed by a pharmacy located outside the state;
(d) When the prescriber and dispenser are the same entity;
(e) That include elements that are not supported by the most recently implemented version of the National Council for Prescription Drug Programs Prescriber/Pharmacist Interface SCRIPT Standard;
(f) By a practitioner for a drug that contains certain elements that cannot be incorporated as required by the United States Food and Drug Administration with electronic prescribing, including extemporaneous compounding;
(g) By a practitioner allowing for the dispensing of a nonpatient specific prescription under a standing order, approved protocol for drug therapy, or collaborative drug management or comprehensive medication management, in response to a public health emergency;
(h) By a practitioner prescribing a drug under a research protocol;
(i) By practitioners who have received a waiver or a waiver renewal, from the requirement to use e-prescribing due to economic hardship, technological limitations that are not reasonably within the control of the practitioner, or other exceptional circumstance demonstrated by the practitioner. The initial waiver and each subsequent waiver renewal shall not exceed one (1) year per waiver or waiver renewal;
(j) By a practitioner under circumstances where, notwithstanding the practitioner’s present ability to issue an e-prescription as required by the EPCS Mandate, the practitioner reasonably determines that it would be impractical for the patient to obtain substances prescribed by e-prescription in a timely manner, and delay would adversely impact the patient’s medical condition;
(k) By a practitioner for an individual who receives hospice care; or
(l) By a practitioner for an individual who is a resident of a nursing facility.
A pharmacist who receives a non-e-prescription for a controlled substances (i.e., a written, oral, or faxed prescription) is not obligated to verify whether the prescription falls under one of these exceptions.
Although not an exception to e-prescribing, prescribers should note that e-prescriptions may not interfere with a patient’s freedom to select a pharmacy. See KRS 218A.171.
Practitioners who are unable to comply with the EPCS Mandate may apply for a temporary waiver from the Kentucky Cabinet for Health and Family Services based on economic hardship, technological limitations, or other exceptional circumstances. Practitioners must complete a Temporary Exemption Form by November 1, 2020 and thereafter request up to two waiver renewals at least sixty days before the expiration of the current waiver. The initial waiver and each renewal may be granted for up to a year each. See 902 KAR 55:130.
Failure to comply with the EPCS Mandate, failure to request an initial or renewed exemption, or falsification of a Temporary Exemption Form can result in fines of up to $2,000 per twelve month period and referral to the practitioner’s licensing board. See 902 KAR 55:130.
Prescribers of controlled substances to be dispensed by a Kentucky pharmacy should begin evaluating how to bring themselves into compliance with the EPCS Mandate, including selecting an e-prescribing software vendor if the prescriber’s current electronic health record system is not EPCS certified.
To read an earlier article that we published to the Wyatt HITECH Law blog about the Drug Enforcement Administration (DEA) EPCS Interim Final Rule with Request for Comment, which became effective June 1, 2010, click here. Ten years after publishing the EPCS Interim Final Rule, the DEA received questions and requests for clarification on various issues concerning the implementation and technical requirements for the e-prescribing of controlled substances. On April 21, 2020, the DEA reopened its EPCS Interim Final Rule for additional comments in anticipation of issuing a final rule on the topic of EPCS. The comment period closed on June 22, 2020.
Post-script (12/16/2020): On August 4, 2020, HHS issued a Request For Information (RFI) seeking comments from stakeholders on how the EPCS requirements in the SUPPORT for Patients and Communities Act (SUPPORT Act) can be imlemented with minimal burden to those prescribers participating in the Medicare Part D program during and after the Public Health Emergency (PHE) declared due to COVID-19. 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 HHS may specify. To be assured for consideration, comments were to have been received no later than October 5, 2020. To read the RFI, click here.