The surge of GLP-1 medications, from semaglutide products – such as Ozempic® and Wegovy® – to new therapies in the pipeline, has created one of the most dynamic and challenging environments pharmacies have faced in years. These medications are reshaping the treatment of diabetes and obesity, but their rapid growth has also brought increased regulatory oversight, payer restrictions, and cost pressures.
For pharmacies, the central question is no longer whether to engage with GLP-1s, but how to do so responsibly and sustainably while maintaining compliance.
At the GLP-1 Law & Policy Inaugural Summit hosted by the American Conference Institute in July 2025, healthcare industry leaders explored these issues in depth. Frier Levitt Partner Jesse Dresser, who served as Co-Chair of the Summit and co-presented on market access and compliance challenges, helped guide discussions that directly affect providers. While the Summit set the stage, the takeaways extend far beyond the event itself. For pharmacy owners and pharmacists, the themes of compliance, PBM contracting, business model innovation, and Medicare price negotiations will shape the future of patient access and provider sustainability.
Rising Compliance Pressures for Pharmacies
GLP-1s are attracting intense scrutiny from regulators. Federal agencies, including the Department of Justice and state attorneys general, are investigating payer fraud, contracting practices, and prescribing patterns tied to these high-cost drugs.
For pharmacies, several widespread activities, such as telehealth collaborations or product sourcing, can now carry significant legal risk. Telehealth prescribing has been a particular focus, with prosecutors questioning whether medical necessity is properly documented, as well as the financial relationship between the pharmacies and the prescribers. At the same time, counterfeit products have hit the market, making rigorous supply chain controls and chain-of-custody safeguards critical for pharmacies.
For pharmacies, the message is clear: robust compliance programs, consistent training, and detailed documentation are essential to operating safely in the GLP-1 space.
The Growing Challenge of Coverage Restrictions
Despite skyrocketing demand, patient access to GLP-1 therapies remains difficult due to payer-imposed restrictions. Many health plans are limiting use through restrictive formulary placement and utilization management practices. Prior authorization has become standard, often requiring patients to first try metformin or other therapies. Coverage criteria may also hinge on body mass index, documented comorbidities, or participation in structured weight-management programs.
Reauthorization rules are also becoming more demanding. Some payers now require evidence of at least five to ten percent weight loss before continuing to cover GLP-1 prescriptions. These hurdles create heavy administrative burdens for pharmacies, which must coordinate with prescribers, ensure proper documentation, and support patients throughout the process.
Cost-shifting mechanisms such as copay accumulators and maximizers, along with specialist referral requirements, further complicate patient access. Without careful navigation, pharmacies risk rejected claims, reimbursement delays, and dissatisfied patients.
PBM and Insurance Strategies Affecting GLP-1 Access
The influence of PBMs was a recurring topic at the Summit. PBM contracting and coverage decisions are playing a central role in determining access to GLP-1s. Coverage often varies by indication, with diabetes treatment more widely supported than obesity management. Medicare Advantage plans, for example, generally require prior authorization to ensure these drugs are dispensed only to patients with type 2 diabetes.
Meanwhile, employers and PBMs are experimenting with new models to contain costs. Some employers are capping patient copays, while others tie coverage to participation in lifestyle programs. Pharmacist-led initiatives that include patient education, dose titration, and reauthorization support are gaining traction, highlighting the critical role pharmacies play in balancing adherence and affordability.
These developments underscore the importance of approaching PBM relationships strategically. Contract terms involving rebate structures, audit rights, and formulary design can no longer be viewed as administrative details. They directly affect a pharmacy’s ability to remain viable in the GLP-1 marketplace.
Adapting Pharmacy Business Models in the GLP-1 Era
Pharmacies cannot rely exclusively on traditional dispensing models to build a sustainable GLP-1 business. As highlighted during the Summit, providers must look at creative strategies. Value-based care arrangements, where reimbursement is tied to patient outcomes, are one option. Others include leveraging 340B opportunities, employer-sponsored compounding programs, and even international sourcing, though each comes with its own regulatory complexities.
Subscription-style pricing models are also attracting attention. For chronic disease management, flat-fee or membership-based programs can create predictable revenue while helping patients remain adherent. To pursue these opportunities, pharmacies must carefully evaluate compliance risks and regulatory frameworks, but forward-thinking providers will find that innovation is essential to remaining competitive.
Preparing for IRA Price Negotiations and Medicare Reimbursement
The Inflation Reduction Act (IRA) is reshaping the drug pricing landscape. For the first time, the federal government is negotiating prices directly with manufacturers of high-spend Medicare drugs. In January 2025, CMS announced that semaglutide, marketed as Ozempic®, Wegovy®, Rybelsus®, was among the therapies selected for price negotiation.
By 2027, “maximum fair prices” will apply, requiring formulary inclusion for Wegovy and likely expanding access for obesity-related use. While this will improve availability, reimbursement frameworks are expected to shift as payers and PBMs adapt to the new pricing benchmarks. Because commercial insurers often follow Medicare’s lead, ripple effects are likely across private markets as well.
Pharmacies should begin preparing now by reviewing payer contracts, forecasting reimbursement adjustments, and strengthening patient communication strategies to address evolving coverage rules.
Charting the Path Forward
For pharmacies, the GLP-1 boom represents both opportunity and risk. Compliance obligations are growing more complex, coverage restrictions are tightening, and reimbursement structures are being rewritten under the IRA. Yet pharmacies are also uniquely positioned to become indispensable partners in patient care, helping to navigate authorizations, ensuring safe dispensing, and piloting innovative service models.
As Co-Chair of the GLP-1 Law & Policy Inaugural Summit, Jesse Dresser emphasized that the future of GLP-1 access will be determined as much by law, policy, and strategic adaptation as by clinical science. Pharmacies that act now to strengthen compliance and adapt their business models will be the ones best positioned to thrive.
How Frier Levitt Supports Pharmacies
At Frier Levitt, we work closely with pharmacies and pharmacists to address both the challenges and opportunities in the GLP-1 market. Our team advises on a wide range of issues, from compliance with federal and state fraud and abuse laws, PBM audits, and telehealth prescribing risks, to navigating PBM and insurance strategies such as contract reviews and reimbursement disputes. We also help providers explore innovative business models, including subscription pricing, value-based arrangements, and participation in the 340B program. In addition, our attorneys guide pharmacies through the complexities of IRA price negotiations, preparing them for reimbursement changes and helping them take advantage of new coverage opportunities.
Pharmacies that take proactive steps today will be best prepared to succeed, and Frier Levitt stands ready to provide the legal and strategic support needed to move forward with confidence.
Frier Levitt provides strategic, industry-focused legal counsel tailored to your needs. Contact our team today to learn how we can help you.
