2023 Regulatory Changes: 6 ePrescribing Rules That Providers Should be Monitoring
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.”
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. 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. 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. 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.
 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:
- 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.
- 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 health care 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 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.
4. Drug Enforcement Agency (DEA) Regulations
- Telemedicine. The DEA is expected to release three rules this year. One pending proposed rule is the highly anticipated “Ryan Haight Act” regulation to implement a special registration for prescribers that engage in the “practice of telemedicine” under the Act. This rule has been under review at the White House’s Office of Management and Budget (OMB) office for nearly a year. The law’s definition of the ‘‘practice of telemedicine’’ includes seven distinct categories that involve circumstances in which a prescriber might be unable to satisfy the Act’s in-person medical evaluation requirement yet nonetheless has sufficient medical information to prescribe a controlled substance for a legitimate medical purpose in the usual course of professional practice. One specific category within the Act’s definition of the ‘‘practice of telemedicine’’ includes ‘‘a practitioner who has obtained from the [DEA Administrator] a special registration under [21 U.S.C. 831(h)].’’ 21 U.S.C. 802(54)(E). Given the evolution of telemedicine in recent years and the high volume of prescribers who engage in it, what the DEA proposes under these special registration requirements will be highly important to providers.
- A Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications
On May 3rd, 2023, ahead of the expiration of the COVID-19 Public Health Emergency (PHE), the DEA and the Substance Abuse and Mental Health Services Administration (SAMHSA) issued the “Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications” – a temporary rule that extends telemedicine flexibilities adopted during the COVID-19 public health emergency.
This will take effect on May 11, 2023, and extends the full set of telemedicine flexibilities adopted during the COVID-19 public health emergency for six months – through November 11, 2023. For any practitioner-patient telemedicine relationships that have been or will be established up to November 11, 2023, the full set of telemedicine flexibilities regarding EPCS established during the COVID-19 PHE will be extended for one year – through November 11, 2024.
- A Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications
- Initiation of Buprenorphine via Audio-Only Telemedicine. The Biden Administration and DEA Administrator Anne Milgram have placed a major focus on expanding access to medication for opioid use disorder (MOUD) since taking office. This proposed rule, which has been under review by OMB since July 2022, is expected to address that issue by clarifying guidelines for prescribers seeking to prescribe buprenorphine to patients for the first time over the phone. Prescribers should expect the proposed rule to outline guardrails that they must follow, which early documentation indicates may include a requirement for the patient to have an in-person visit with a clinician at some point following the initiation of the treatment in order to receive future prescriptions of the drug.
- Schedule II Partial Fills. Prescribers will also want to keep an eye out for a final rule that is expected to implement a provision of the Comprehensive Addiction and Recovery Act (CARA) of 2016 to facilitate partial fills of controlled substances to reduce the volume of unused medications that could be prone to misuse. Specifically, CARA allows a pharmacist, if certain conditions are met, to partially fill a prescription for a Schedule II controlled substance when requested by the prescribing practitioner or the patient. The pending DEA regulations will dictate how prescribers should indicate that such a prescription must be partially filled and will pave the way for DEA audits.
5. SAMHSA Regulations
- Medication Assisted Treatment for Opioid Use Disorders. In December 2022, HHS’s Substance Abuse and Mental Health Services Administration (SAMHSA) proposed several significant updates to 42 CFR Part 8’s MOUD prescribing and administration and standards for certification and accreditation of opioid treatment programs (OTPs). One of the major proposals of the rule would make permanent flexibilities that were announced in response to the COVID-19 public health emergency to prescribe take-home doses of methadone to certain patients deemed sufficiently stable as determined by the practitioner. The prescriber must follow certain guardrails to ensure patient safety and reduce diversion specified in the rule. The proposed rule also makes changes surrounding the ability to prescribe buprenorphine, including eliminating the requirement that practitioners who have a waiver to prescribe buprenorphine for up to 275 patients, mandating practitioners to provide annual reports to SAMHSA, and allowing waivered practitioners within OTPs to initiate buprenorphine via telehealth. In reflection of the role of essential non-physician practitioners for OTPs, SAMHSA also proposes to modify the definition of a “qualified practitioner” to expand to any provider who is appropriately licensed by the state to prescribe and dispense covered medications and who possesses an appropriate waiver. As the end of the COVID-19 public health emergency nears, prescribers should look forward to having additional clarity and business certainty when this rule is finalized.
- Elimination of the DATA Waiver. The omnibus appropriations bill signed into law in December 2022 included a provision known as the Mainstreaming Addiction Treatment (MAT) Act, which removes the federal requirement for practitioners to obtain a DATA Waiver (X-Waiver) in order to prescribe MOUD treatments like buprenorphine. The law also removes patient caps, which were previously set at 275 patients per prescriber, for all eligible practitioners. Moving forward, all practitioners will need to prescribe buprenorphine is a standard DEA registration number. Notably, the law eliminating the DATA Waiver was passed after SAMHSA released their MOUD proposed rule in December 2022. Practitioners can expect several changes to the SAMHSA MOUD final rule to ensure compliance with the new law.
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.