New Laws and ReguIations Impacting Pharmacies in 2025

As we move into 2025, independent pharmacy owners face a dynamic legal landscape shaped by new regulations that could influence operations, reimbursement, and patient care. 

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Staying informed about these changes is essential for navigating potential challenges and maximizing opportunities for your practice.

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Let’s dive into some of the legal changes in 2025 that could affect your practice. 

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Telemedicine Flexibilities Extension

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The DEA and the Department of Health and Human Services (HHS) previously extended COVID-era telemedicine flexibilities through the end of 2024 — and in November of 2024 — they pushed this extension through December 31, 2025. 

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This extension allows for continued flexibility in how some controlled medications are prescribed in order to best serve patients. 

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New Policies in the PFS Final Rule

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As of November 2024, the Centers for Medicare & Medicaid Services (CMS) is finalizing a coverage expansion of the hepatitis B vaccine. According to the CMS site, “This policy enables people with Medicare to get the hepatitis B vaccine from pharmacies and also allows pharmacies and mass immunizers to roster bill Medicare consistent with current billing for flu, pneumococcal, and COVID-19 vaccines.”

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In addition, the agency is also expanding coverage for colorectal cancer screening and finalizing payment under Part B as an additional preventive service for PrEP.

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Implementation of the Inflation Reduction Act

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Starting in 2025, the Inflation Reduction Act will require that all Medicare prescription drug plans (Medicare Part D plans) offer enrollees the option to pay out-of-pocket prescription drug costs in the form of capped monthly installment payments instead of all at once at the pharmacy.

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This legislation also caps 2025 yearly out-of-pocket costs at $2,000 for people with Medicare Part D and mandates the establishment of a Part D manufacturer discount program. This follows the change in 2023 for patients with Medicare Part D and B that capped monthly costs for covered insulin products to $35 and made recommended vaccines free to patients with Medicare prescription drug coverage.

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Adapting to the Changes

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To prepare for these new laws/ regulations and state-specific legal changes:

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• Conduct a compliance audit of your pharmacy’s policies and procedures.
• Invest in staff training and updated technology.
• Collaborate with pharmacy associations to advocate for fair and workable regulations.

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Navigating 2025’s legal shifts will require strategic planning, but with proactive steps, independent pharmacies can turn challenges into opportunities and continue thriving in 2025 and beyond.