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2023 Regulatory Changes: 6 ePrescribing Rules That Providers Should be Monitoring

CMS DEA e-Prescribing Controlled Substances Electronic Prescribing of Controlled Substances EPCS health policy Healthcare Software HIPAA Legislation Medicare ONC Opioid Abuse Opioid Prescriptions Prescription Monitoring Programs Schedule II Medications
Updated, May 2023

2023 is shaping up to be an active year for prescribers. The Biden administration’s first term is in full swing and is facing a divided Congress, affording a very narrow opportunity for major legislative wins. Further, most major regulations will need to be released this year in order to be protected from a congressional clawback power known as the Congressional Review Act.

So, what should prescribers be on the lookout for in 2023? Here is what we are watching:

1. Electronic Prescribing of Controlled Substances (EPCS) Deadlines and Compliance

Over the past twenty years, electronic prescribing of controlled substances (EPCS) rules have evolved. Section 2003 of the 2018 Substance Use-Disorder Prevention that Promotes Recovery and Treatment for Patients and Communities (SUPPORT) Act generally requires most prescribers to electronically prescribe all Schedule II-V controlled substances for a covered Part D drug under the Medicare Part D program. CMS administers the Medicare Part D program, which covers approximately 50 million Medicare beneficiaries. Almost 80 percent of Medicare Part D prescribers electronically prescribed 70 percent or more of their Medicare Part D controlled substances prescriptions in 2021. In November 2022, CMS finalized rulemaking that lays out how CMS will enforce these new EPCS requirements when they take effect in 2023.

First, CMS clarified the “small prescriber” exception. This exception exempts prescribers with 100 or fewer issued Part D controlled substances prescriptions. CMS plans to retrospectively analyze prescription drug event data to determine whether a prescriber meets this exception. Importantly, prescribers will not have certainty in advance regarding whether they are exempt because CMS will not analyze PDE data until the year following the evaluated period. Even if a prescriber issued less than 100 controlled substances Part D prescriptions in 2022, prescribers may need to actively track their prescriptions in 2023 if they believe their volume could reach 100 or more in 2023 due to changed circumstances.

Second, CMS clarified how it will exempt a prescriber who is not able to ePrescribe due to the prescriber’s location in an area affected by an emergency, pandemic, natural disaster, or similar uncontrollable circumstance. Specifically, CMS will rely on the prescriber’s address data located in Medicare’s PECOS, or if PECOS data is unavailable, the NPPES address. CMS notes that these data sources are often not updated timely, making it especially important for prescribers to update their addresses in these databases if they do not make this part of their normal course of business.

Lastly, CMS provided a glimpse regarding how it will enforce these new requirements. CMS’s compliance actions will consist of sending notices to non-compliant prescribers from the CY 2023 EPCS program implementation year (January 1, 2023, through December 31, 2023) to the CY 2024 year (January 1, 2024, through December 31, 2024). The notice will inform the prescriber that they are violating the EPCS requirement, provide information about how they can come into compliance, the benefits of EPCS, an information solicitation as to why they are not conducting EPCS, and a link to the EPCS dashboard to request a waiver. At least for 2023 and 2024, CMS will emphasize compliance assistance rather than imposing penalties. However, CMS undoubtedly is eyeing stepped-up enforcement in future years, observing that “States with enforcement mechanisms have faster EPCS adoption rates than States without enforcement mechanisms.”[1]

Medicare participating prescribers who are subject to the Traditional MIPS reporting and performance requirements should also keep in mind that ePrescribing is a required reporting measure of the 2023 Promoting Interoperability performance category, which comprises 25% of a clinician’s score.[2]

[1] https://www.govinfo.gov/content/pkg/FR-2022-11-18/pdf/2022-23873.pdf

[2] https://qpp.cms.gov/mips/promoting-interoperability?py=2023

2. Drug Cost Transparency

Drug affordability remains front and center for regulators. There is increased pressure on prescribers to be more engaged in conversations with their patients about whether the cost of a drug will be a barrier to adherence to their treatment plan. Specifically, within the Traditional MIPS improvement measures reporting category (which comprises 15% of a clinician’s score), CMS has implemented reporting a “drug cost transparency” measure where a prescriber attests to the use of a real-time benefit tool to counsel patients and/or their caregivers regarding the cost of medication in real-time with information about formulary alternatives.[3] This measure leverages the launch of a prescriber-facing and beneficiary-facing real-time benefit tool now required by all Medicare Part D plans, and Medicare Advantage plans offering Part D benefits.[4] Using an RTBT provides a tremendous opportunity for clinicians to be empowered about the actual financial impact a drug has on their patients and to identify lower cost options that are clinically appropriate, thereby facilitating opportunities for prescribers to also perform better on payer and other value-based payment quality initiatives.

[3] https://qpp.cms.gov/mips/improvement-activities?=py2023

[4] 42 C.F.R. §§423.128(d)(4) and 160(b)(7). Note that CMS proposed to require Part D sponsors to use the NCPDP Real-Time Prescription Benefit (RTPB) standard version 12 proposed for adoption at 45 CFR 170.205(c) as the standard for prescriber real-time benefit tools (RTBTs). https://www.govinfo.gov/content/pkg/FR-2019-05-23/pdf/2019-10521.pdf

3. HIPAA Administrative Simplification

One of the key tenets of HIPAA is the adoption, and continued maintenance, of standards to enable health information is exchanged more efficiently and to achieve greater uniformity in the transmission of health information. These standards apply across providers regardless of whether they participate in a federal government program. After the COVID-19 pandemic disrupted health care for over two years, long-overdue regulations to update health care transaction infrastructure are on the horizon for 2023:

[5] https://www.govinfo.gov/content/pkg/FR-2022-11-09/pdf/2022-24114.pdf

[6] https://www.govinfo.gov/content/pkg/FR-2022-12-21/pdf/2022-27437.pdf

4. Drug Enforcement Agency (DEA) Regulations

[7] https://www.reginfo.gov/public/do/eoDetails?rrid=232312

5. SAMHSA Regulations

[8] https://www.govinfo.gov/content/pkg/FR-2022-12-16/pdf/2022-27193.pdf

6. Updated REMS for Medication Abortion

In January 2023, the U.S. Food and Drug Administration (FDA) released an update to their Risk Evaluation and Mitigation Strategies (REMS) for Mifepristone, more commonly known as medication abortion. The update creates a pathway for retail pharmacies to seek certification to dispense mifepristone for the first time to consumers in states where abortion remains legal following the Dobbs v. Jackson Women’s Health Organization Supreme Court decision released in June 2022. In order to prescribe the medication, prescribers must fill out a Prescriber Agreement Form from one of the drug sponsors and submit it to any pharmacy where they plan to send a mifepristone prescription. Patients must also fill out a Patient Agreement Form. Pharmacy chains, including CVS and Walgreens, have already indicated that they plan to seek certification for pharmacies to dispense mifepristone in states where it remains legal.

With these upcoming changes, DoseSpot is committed to partnering with practice management groups, healthcare software companies, digital health, and providers to achieve compliance in ePrescribing activity. Stay in touch with us to keep informed of important regulatory developments.