Errors in prescription dispensing, incorrect billing codes, duplicate claims, missing documentation, medication storage and handling issues – all can lead to financial penalties, loss of contracts and regulatory actions. One poor audit can cripple a pharmacy.

Harris Beach Murtha will help interpret regulations, appeal audit findings, conduct discrepancy analysis and evaluation, coordinate alleged invoice shortage reconciliation, develop corrective action plans and handle network termination reconsideration requests.

Our attorneys have extensive experience with government audits, third-party payer audits and internal audits designed to verify compliance with laws and regulations, errors in billing and dispensing, fraud and abuse, pharmacy performance and quality of care. We routinely work with government agencies (NYS OMIG, for example), insurance companies, health plans and pharmacy benefit managers (PBMs), including OptumRx, Envision Rx (Elixir), Humana, Express Scripts, MedImpact, Prime Therapeutics, and CVS Caremark.

We are familiar with Medicare, Medicaid and Drug Enforcement Agency (DEA) regulations, as well as state laws and pharmacy board rules. We have extensive experience reviewing pharmacy records, conducting on-site inspections and interviewing pharmacy staff to better defend you in an audit. We also have experience representing pharmacies undergoing NYS OMIG Compliance Program Reviews.

Harris Beach Murtha attorneys help pharmacies and other healthcare providers establish best practices, such as strong internal controls and quality assurance programs, compliance training and system tracking to stay compliant with state and federal regulations and avoid negative audit findings.

Our attorneys, led by a pharmacist-attorney, understand the myriad regulations set forth by governmental bodies, including the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA) and state pharmacy boards. We help navigate the complex regulatory landscape, assist with obtaining and maintaining licenses, address disciplinary actions and stay current with regulations that impact pharmacy operations.

Our services include preparing for audits and investigations; ensuring Pharmacy Benefit Manager (PBM) compliance; advising on compliance with the Controlled Substances Act and Drug Enforcement Administration (DEA) regulations; assisting with recordkeeping requirements; counseling on diversion control, prescription fraud monitoring, DEA red flags, opioid stewardship and interception of prescribing practices; developing copayment collection policies; reviewing medical necessity and other prior authorization support; supporting fraud waste and abuse compliance efforts; counseling on drug ordering, inventory management, and third-party billing hygiene; tailoring standard operating procedures for specialty pharmacies; assessing compliance programs through internal auditing; and designing corrective action plans.

We routinely help our pharmacy industry clients with transactional matters, mergers, acquisitions and contractual agreements, including supplier agreements, employment contracts and partnership agreements.

We advise on Pharmacy Benefit Manager (PBM) and Pharmacy Services Administrative Organizations (PSAO) contracting; counsel on Medicare and Medicaid enrollment, reactivation, revalidation, change in ownerships; handle purchases, sales, lease negotiations and modifications; and asset and stock sales.

Our goal is to provide legally sound counsel that protects your property brand and interests.

Harris Beach Murtha attorneys have deep experience helping clients defend pharmacy malpractice allegations, product liability matters, medical malpractice, regulatory actions, intellectual property matters, breach-of-contract cases and other commercial litigation.

Because pharmacy law intersects with broader health care law, our attorneys possess a comprehensive understanding of health care regulations, patient privacy laws and insurance matters. This enabling us to defend pharmacy industry clients in litigation related to the False Claims Act, the Anti-Kickback Statute and similar matters, using our knowledge of both legal and pharmaceutical practices to build strong defense strategies