The regulatory environment is dynamic, and 2023 is proving to be no different as the Biden administration is deep into its first full term. There are rules and policies taking shape for prescribers with an urgency to be released this year as to avoid the challenges posed by the Congressional Review Act. The CRA was first established in 1996 and has allowed twenty rules to be overturned in its history, most common when the Congress is divided and there are narrow victory margins.

So, what should prescribing dentists be on high alert for in 2023? Here is what we are watching:

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

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]

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. HIPAA Administrative Simplification

One of the key tenets of HIPAA is the adoption, and continued maintenance, of standards to enable health information to be 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:

• Pharmacy Standards. In November 2022, the U.S. Department of Health and Human Services (HHS), through CMS, proposed to adopt updated versions of the retail pharmacy standards for the following key electronic transactions: (1) health care claims or equivalent encounter information; (2) eligibility for a health plan; (3) referral certification and authorization; and (4) coordination of benefits. These modifications would replace Version D.0 with the NCPDP Telecommunication Standard Implementation Guide, Version F6, and equivalent NCPDP Batch Standard Implementation Guide, Version 15. While these proposals are not final, prescribers should review these standards and plan for their implementation in the coming years.[5]

• Health Care Attachment Transactions and Electronic Signatures. In December 2022, HHS, again through CMS, proposed a significant expansion of HIPAA standard transactions to extend to healthcare attachment transactions and e-signatures. Despite a mandate in the 2010 Affordable Care Act to establish these standards, the advancement in electronic transactions in health care attachments to support a claim, prior authorization, or referral is largely a manual process that, as many prescribers are aware, adds a significant burden and time away from patient care. To help ameliorate these burdens, CMS is making both policy and operational changes particularly focused on prior authorization, so prescribers should be vigilant when this rule is finalized. Operationally, this proposed rule would adopt X12 standards with respect to the transmission of attachment information and HL7 standards with respect to the clinical content of attachments. Regarding electronic signatures, CMS proposes to adopt the HL7 Implementation Guide for CDA® Release 2: Digital Signatures and Delegation of Rights, Release 1 (Digital Signatures Guide), which has 3 attributes: (1) digital signature technology; (2) encryption requirements; and (3) multiple signed elements to support non-repudiation. These standards have been in use today as part of the DEA’s EPCS requirements.[6]

These three rules are a sampling of what we’re keeping an eye on in the regulatory space. If you are a dentist who also serves telemedicine, there are additional rules in the making with the expiration of the COVID-19 emergency orders on May 11, 2023.

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[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
[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
[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