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Legal Considerations for Pharmacy Services Payors: Tips for Compliance

by Global Link Law
Apr 10, 2024
pharmacy services compliance

According to data from Fortune Business Insights, the size of the American pharmaceutical industry is expected to reach nearly $900 billion in the next few years. Europe also has a very large pharmaceutical industry. The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents more than 1,900 businesses. 

For the payors (payers) of pharmaceutical services, full compliance with all federal (national) and state regulations is a must. Compliance is a big issue in all aspects of the healthcare industry, including payment. In this blog post, we will highlight some compliance tips for pharmacy service payors.  

Compliance Tips for Pharmacy Services Payors

Tip #1: Develop Clear, Comprehensive Policies 

Pharmacy service payors must have well-crafted, clear, and comprehensive compliance policies in place. Indeed, these written policies help to form the foundation of effective compliance. They can ensure understanding of and adherence to all relevant legal standards. In order to be truly effective, compliance policies should be detailed, accessible, and digestible to all members of the organization who need access to that information. Typically, compliance policies will cover all aspects of pharmacy service payments—from payment proceedings to all aspects of pharmacy services, from prescription processing and privacy protocols to data security. 

Tip #2: Designate a Compliance Officer 

Who is responsible for compliance? It is a question that pharmacy service payors should be able to answer. Obviously, compliance is rarely a one-person job—especially for larger organizations. That being said, it is a best practice to designate a compliance officer to act as the steward of an organization’s compliance program. The officer is the person who is responsible for overseeing the development, implementation, and maintenance of policies and procedures. Most often, their role will involve monitoring compliance with laws and regulations, providing training to staff, serving as a point of contact for compliance-related inquiries, and a wide range of other organization-specific matters. The designation of a knowledgeable, trustworthy compliance officer is vital. 

Tip #3: Conduct Regular Compliance Audits 

Compliance for pharmacy services payors is not a static process. Even with the most well-drafted written policies in place, a business or organization could still fall out of compliance without regular action. For this reason, regular compliance audits are essential for identifying and addressing potential vulnerabilities within an organization’s operations. As a general matter, these audits involve a systematic review of procedures, practices, and documents to ensure alignment with all applicable legal and regulatory requirements. By identifying discrepancies and finding areas for improvement, organizations can take corrective action before minor issues escalate into more serious legal problems. The general protocol is that compliance audits should be conducted at least annually. Though, audits may need to be more frequently for certain organizations with more complex needs. 

Tip #4: Respond Proactively to Any Issues that May Arise

For pharmacy payors, compliance-related issues can arise for a wide variety of different reasons. Any matter that raises concerns about compliance should be addressed in a swift, proactive manner. You do not want to allow relatively small compliance concerns to blow up into big problems because they were allowed to persist unaddressed. A prompt and comprehensive response generally involves investigating the issue thoroughly, reviewing compliance, taking corrective action to remedy the situation (if needed), and potentially implementing measures to prevent future occurrences. Compliance, transparency and accountability are key. All stakeholders should be informed about the issue and the steps taken to address it. 

Tip #5: Seek Professional Guidance and Support

The legal landscape surrounding pharmacy service payors is notoriously complex. Healthcare is a highly regulated industry—and pharmaceutical services are certainly no exception. Any business or organization operating in this realm needs to put a high priority on compliance. Of course, that means putting the right internal structure in place—from developing written policies to designating a compliance officer. It also means seeking the right professional guidance and support. A lawyer and law firm with experience in health care and pharmacy compliance can provide valuable insights and advice. The right legal advisor can help you ensure that your organization remains in full compliance with all regulatory requirements. 

Contact Our Senior Health Tech Lawyer Today

At Global Link Law, our healthcare tech attorney has the skills, experience, and industry-specific legal expertise that you can rely on. Our firm helps innovative companies protect their interests. If you have any questions or concerns about compliance for pharmacy services payors, we are here as a resource. Contact us today to set up your confidential, no-obligation initial consultation.


The information provided on this website is for general informational purposes only and should not be considered legal advice. No attorney-client relationship is created by accessing or using this website. Please consult with a qualified attorney before making any legal decisions. Global Link Law is not liable for any reliance on the information provided. Prior results do not guarantee a similar outcome.

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