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HIPAA Compliance & Data Commercialization Attorneys for Healthcare Practitioners

When HIPAA Compliance and Data Commercialization Opportunities Arise, Get Expert Guidance

HIPAA compliance is essential for healthcare practitioners, as violations can result in significant fines, reputational damage, and legal liabilities. At the same time, the growing value of healthcare data presents opportunities for practitioners to leverage their data assets through compliant commercialization strategies. Your approach to HIPAA compliance and data commercialization is critical.

Do not wait until your compliance is questioned or opportunities are missed. Healthcare practitioners need to stay up-to-date with the latest HIPAA regulations and data commercialization trends.

Our attorneys have extensive experience advising healthcare practitioners on HIPAA compliance and data commercialization strategies. No one understands the legal landscape surrounding healthcare data better than us. Our nationally recognized team of healthcare data attorneys has decades of combined experience in the healthcare industry and legal field. Put our inside knowledge and expertise to work for your practice today. If you are seeking guidance on HIPAA compliance or data commercialization, act now.

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175+

PRACTITIONERS ADVISED ON HIPAA
Past Experience
HIPAA & DATA COMMERCIALIZATION EXPERTISE

Pharmacy Audit Defense Lawyers

Our HIPAA compliance and data commercialization team has helped healthcare practitioners protect patient privacy, avoid costly penalties, and capitalize on data commercialization opportunities. We provide expert legal advice tailored to your specific circumstances, using our knowledge of HIPAA regulations and data commercialization strategies. As lawyers, we leverage federal and state law to protect your interests. When your practice's compliance and data assets are at stake, our team of experienced attorneys is your trusted partner.

1200+

Clients served

2500+

matters handled

24/7

availability

100%

flexible rates
Our PBM audit defense team has helped clients avoid millions of dollars in recoupments, remain in-network, win reinstatement, and defend themselves against abusive PBM tactics.

When your license or livelihood is threatened, our team of pharmacy PBM audit attorneys is your fiercest ally.

1500+

Clients served

5000+

matters handled

24/7

availability

100%

flexible rates
"Anthony is the definition of a 'plug and play' athlete. Put him the game and he will change it."
- Former Acting U.S. Attorney, E.D.N.Y
HIPAA & DATA COMMERCIALIZATION CASE STUDIES
PBM Case
Studies

Recent HIPAA Compliance & Data Commercialization Successes

Learn directly from healthcare practitioners who navigated HIPAA compliance challenges and seized data commercialization opportunities—with our assistance, they achieved their goals and thrived.
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HIPAA Success 1

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Awards & Recognition
Our process

PBM Audit Defense Process

01

Initial Strategy Session

We use a free consultation to understand your specific HIPAA compliance needs and data commercialization goals, gather relevant information, and identify key opportunities and risk factors.
02

Detailed Compliance & Data Analysis

Our team conducts a thorough analysis of your current HIPAA compliance measures and data assets to identify areas for improvement and potential commercialization strategies.
03

Legal & Strategic Planning

We develop a comprehensive legal and strategic plan that addresses your HIPAA compliance obligations and outlines data commercialization opportunities in line with your practice's goals.
04

Implementation & Ongoing Support

We guide you through the implementation of HIPAA compliance measures and data commercialization strategies, providing ongoing support to ensure long-term success and regulatory compliance.
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FAQ

Frequently Asked Questions

What documents and data should I gather?

Initially, we'll need any existing HIPAA policies, procedures, and training materials, as well as information about your current data management practices and potential commercialization ideas. As we develop your compliance and commercialization strategy, additional documentation may be requested. We will provide specifics on supporting materials.

What recourse exists if a HIPAA breach occurs?

In the event of a HIPAA breach, we provide immediate guidance and support to mitigate the impact, comply with reporting requirements, and defend against any potential legal actions or penalties.

Do HIPAA compliance and data commercialization strategies vary by practice type?

While the core principles of HIPAA apply to all healthcare practitioners, the specific compliance measures and data commercialization opportunities may vary depending on your specialty and practice setting. We tailor our guidance to your unique circumstances.

Can you help if my practice faces a HIPAA investigation or penalty?

Yes. We provide robust defense and advocacy services for healthcare practitioners facing HIPAA investigations or potential penalties. Our goal is to minimize the impact on your practice and protect your reputation.

Will pursuing data commercialization impact my HIPAA compliance?

We ensure that any data commercialization strategies are developed and implemented in full compliance with HIPAA regulations. Maintaining the privacy and security of patient data is always our top priority.

What are the costs of legal representation?

We offer flexible fee arrangements based on the scope of representation required and the complexity of your HIPAA compliance and data commercialization needs. The earlier we are involved, the better, as we can proactively address compliance issues and capitalize on commercialization opportunities, making our services more cost-effective.

Can your guidance help prevent future HIPAA violations?

Absolutely. We provide comprehensive HIPAA compliance recommendations and training to help you and your staff maintain the highest standards of patient privacy and data security. Ongoing compliance is critical to avoiding costly HIPAA violations.

Can data commercialization generate revenue for my practice?

Potentially. Depending on the nature and value of your data assets, compliant data commercialization strategies can provide additional revenue streams for your practice. Our specialists help you identify and capitalize on these opportunities while maintaining HIPAA compliance.

Health Law Alliance

Book a Free Consultation

We help healthcare practitioners navigate the complex landscape of HIPAA compliance and data commercialization. Do not wait until your compliance is questioned or opportunities are missed. Schedule a free consultation now.

PBM AUDIT STRATEGY

PBM Audit Information

The Role of Pharmacy Benefit Managers in Pharmacy Audits

To design an effective PBM audit response strategy, providers must understand the chain of events both prior to the initiation of a PBM audit and afterwards. For example, Special Investigative Units (SIUs) are often the genesis of a pharmacy audit, and the presence or absence of "audit risk factors" is informative on potentially broader exposure beyond the claims under audit. Any decision to resolve an audit should be informed and result in a full and final settlement of all liability, but PBM audit settlements need to be structured carefully to achieve this goal.

PBMs that Conduct the Most Pharmacy Audits


CVS Caremark, OptumRx, and Express Scripts, control at least 80% of the market, making them the three biggest PBMs. Humana also ranks among the largest. In addition, these PBMs regulate access to networks for smaller competitors, such as ESI's partnership with Prime. Plan sponsors, such as United Health, Cigna and Aetna, are vertically integrated with these PBMs, increasing audit risk for pharmacies because network sanctions are more likely to affect a significant aspect of a pharmacy's business across both government and commercial claims.

Common Pharmacy Audit Areas


PBMs and payors use artificial intelligence and data mining across medical and pharmacy claims to identify areas of potential inquiry. Among other areas, these inquiries typically involve high-reimbursing medicines, brand/generic substitution, inventory discrepancies, co-payment collection, prior authorization, and telehealth relations. Separately, DEA conducts audits and inspections for compliance to controlled substance regulations.  

Types of Pharmacy Audits


Common types of PBM audits include desk audits; on-site audits; invoice audits; and prescription audits. Irrespective of the type of PBM audit, all interactions with PBMs should be taken extremely seriously and can lead to severe consequences if not handled appropriately. For example, there has been a sharp increase in the federal prosecution of pharmacists for audit-related conduct, including answering PBM questions incorrectly. Accordingly, pharmacies should consider using outside audit counsel to avoid these pitfalls.

Preparing for Pharmacy Audits


Pharmacies can take various steps to prepare to meet PBM audits, including routine self-audits. In fact, the government publishes comprehensive guidance and a checklist to assist pharmacies in their audit planning, including self-audits around prescribing practices, controlled substance management, invoice management, and billing practices. If you need assistance designing or implementing an audit protection plan, please do not hesitate to contact us.

Defending Pharmacy Audits


Defending against a PBM audit requires comprehensive knowledge of the rights, responsibilities, and intricacies of pharmacies and their laws and regulations.  If your pharmacy has been identified for a PBM audit, there are a number of potential defenses available to you. The first defense against a PBM audit is to be proactive, and audit planning can lessen the chance of unfavorable findings. That said, it is often necessary to involve an attorney to hold PBMs to their obligations under law and provider agreements. For this reason, national audit services and pharmacy audit consultants are often ineffective.

Pharmacy Audit Appeals


Audit discrepancies and findings can be appealed based on the specific procedures outlined in the provider manuals. It is important to follow these requirements exactly, within the timeframes established, or your appeal rights could be lost and further review denied. In an appeal, it is critically important to make a complete record of why the audit findings or sanctions should be reversed, including through documentation, legal arguments, and corrective actions, if any. Depending on the outcome of the appeal, you may have further legal recourse against the PBM.

Potential Consequences of Pharmacy Audits

PBM audits can have severe repercussions depending on the results of the pharmacy audit, including recoupments, network sanctions, and criminal, civil and administrative investigations involving jail time, significant fines, and license revocation or exclusion. We publish a 10-part PBM Audit Guide that discusses the overlap between PBM audits and government investigations and how to successfully manage audit risk. This resource is complimentary to subscribers HERE.