Pharmacy Compliance in 2024: Staying Current with Regulations

The past few years have brought monumental changes to the world of healthcare — and especially to independent pharmacies. With rollbacks of COVID-era regulations and new laws and policies constantly hitting the books it can be difficult to keep up.

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Nimble is a committed partner to community pharmacies and their growth. And while we create technology that improves the patient experience and improves outcomes for independent pharmacies, we also ensure we remain up-to-date on all the different aspects of running a pharmacy in 2024. 

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Here’s our round-up of top changes to pharmacy and healthcare policy in 2024 and how your practice can stay compliant!

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Updates to Drug Pricing and Reimbursement

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Effective as of the beginning of 2024, the Centers for Medicare and Medicaid Services (CMS) has modified its Medicare Part D plan to include all Direct and Indirect Remuneration Fees (DIR) at the point of sale.

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This means that pharmacies will no longer be billed retroactively (sometimes up to 6 months after) for these fees. This has caused independent pharmacies to see high DIR fees and low POS reimbursement during the transition period of early 2024. 

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Staying Compliant with Controlled Substances

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The regulations surrounding controlled substances continue to evolve, requiring pharmacies to maintain strict protocols for dispensing, record-keeping, and reporting. Pharmacists are incredibly familiar with the Controlled Substances Act (CSA), which is the main body of regulations that control how classes of medications are divided, filled, and dispensed.  

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But, 2024 has seen the extension of the COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications, which changed the ways in which patients can get the medications they need through digital avenues. This provision was made effective through December 31, 2024, according to a joint statement from the DEA and HHS.

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In addition to federal regulations, the state in which you operate may have passed new legislation for 2024 to be aware of. For example, in the state of California, dispensers will now be required to report dispensations to the Controlled Substance Utilization Review and Evaluation System (CURES) using version 4.2B of the American Society for Automation in Pharmacy (ASAP) format beginning August 1, 2024.

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To get more detailed information on your state’s laws and new legislation so you can stay compliant, we suggest regularly visiting your state Board of Pharmacy’s website or subscribing to their email or print communications.

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Keeping Up with Telepharmacy and Telehealth Regulations

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After the flurry of activity with government provisions and acts in 2020 to address healthcare needs during COVID-19 shutdowns, we’re seeing a bit of a slowdown in terms of net new telehealth and telepharmacy regulations — but that’s likely to change in 2024 and beyond.

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In late 2023 some COVID-era provisions for telehealth, including the Telemedicine Flexibilities for Prescription of Controlled Medications and the Centers for Medicare & Medicaid Services’ waiver of geographic and originating site restrictions for telehealth have been extended through the end of 2024.

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But, with acts like H.R.4189 - CONNECT for Health Act of 2023 being introduced to the United States Congress, we could see more permanent changes coming in 2024 that solidify protections of telehealth and allow medical professionals more freedom to conduct their practice through digital avenues.

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Changes to Data Privacy and Security Laws

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Following heightened concerns around consumer privacy and taking direction from the European Union’s legislation (GDPR), United States regulatory agencies and legislative bodies have explored expanding the protection of digital activities and data.

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And while COVID-era policy changes, such as the ones mentioned above, allowed for more expansions to how healthcare data is handled online we may also see retractions of these allowances in an effort to protect patient data and privacy.

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In November of 2023, the U.S. Senate introduced the Digital Accountability and Transparency to Advance Privacy Act, or DATA Privacy Act, to establish national data privacy standards. Individual states, including California, Colorado, Connecticut, Utah, Delaware, Florida, Indiana, Iowa, Montana, Oregon, Tennessee, Texas, and Virginia, have passed protections for consumer privacy and data — and the number of states with laws on the books regarding the use of data is expected to increase in 2024 and on.

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As of now, it’s prudent to brush up on your state’s laws to ensure that the systems you use and the communications you send are both HIPAA and state-compliant.

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While it can be overwhelming to understand all the regulatory changes that come with running a pharmacy in 2024, we’re here to help you. Check back with the Nimble blog for more industry updates, or book time to chat with our team to learn how Nimble can supercharge your pharmacy’s revenue with effective patient communications and digital checkout.

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