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PBM Audits – Is DSCSA Documentation The Next Trap for the Unwary?

PBMs are constantly expanding and changing the scope of their audits to find new avenues for revenue generation and new grounds for network termination.  One area that seems ripe for expanded scrutiny by the PBMs is Drug Supply Chain Security Act (DSCSA) track and trace documentation. In addition to checking the license status and FDA registration, …

PBM Audits Move Fast. Start Preparing Your Defense Today!

Don’t Wait! Build a relationship with an Experienced Pharmacy Law Team One of the more stressful parts of going through Pharmacy Benefit Manager (PBM) audit is that, by the time the average pharmacy hires experienced pharmacy law attorneys to defend their business, there may only be two weeks or less to formulate a successful response.  …

CMS Final Rule Phases Out PBM’s Ability to Retroactively Apply DIR Fees

CMS recently published “Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs; etc,”, effectively ending the retroactive application of direct and indirect renumeration (DIR) fees by Prescription Benefit Managers (PBM’s). DIR fees will now be required to be included in the negotiated price the patient pays at the …

FTC Reverses Previous Deadlock in Pivotal Vote to Probe Pharmacy Benefit Managers’ Practices

On June 7, 2022, in a unanimous 5-0 vote, The US Federal Trade Commission reversed a previous 2-2 deadlock vote that will result in the commissions probe of pharmacy benefit managers including the top six PBMs; CVS Caremark, Express Scripts, Inc. OptumRx, Inc., Humana Inc., Prime Therapeutics LLC and MedImpact Healthcare Systems, Inc. After the …

New York Enacts PBM Licensing and Oversight Laws

On January 2, 2022, New York Governor Kathy Hochul announced the signing of legislation S.3762/A.1396 that seeks to regulate pharmacy benefit managers (“PBM”). PBMs doing business in New York must immediately register with the Superintendent of Insurance, be licensed by the Department of Financial Services by 2022 and renew their licenses every three years. The …

PBM Updates Aberrant Product List

Effective January 1, 2022, at least one of the major PBMs has updated language related to the billing of specific NDC numbers the PBM considers “Aberrant.” The revised list of NDCs was sent to network pharmacies and includes a list of “Practices and Trends” prohibiting dispensing activities. The revised language, while vague, creates multiple pitfalls …

Boesen & Snow Law Successfully Overturns $1,000,000 in PBM Audit Findings for Specialty Pharmacy Client

Boesen and Snow successfully assisted an independent specialty pharmacy appeal the findings of a major PBMs desktop audit. The preliminary audit consisted of over $1,000,000 in discrepancies, most of which the PBM considered unappealable. Boesen and Snow utilized a multifaceted argument to appeal the “unappealable” claims including a unique presentation of prescription documentation, prescriber statements, …

PBM’s Continue Fight Against State Regulation

Pharmacy Benefit Managers (PBMs) are continuing to fight against state regulation. On Tuesday, the Pharmaceutical Care Management Association (PCMA) filed a new brief with the Eighth Circuit Court of Appeals in opposition to North Dakota Century Code sections 16.1 and 16.2. In 2017, the North Dakota passed legislation to regulate PBM practices including limiting the …

Board of Pharmacy Investigations: How Your PBM Audit May Put You in Hot Water with The State Boards of Pharmacy

PBM Audits commonly review prescription hard copies, signature/delivery logs, drug invoice purchases, proof of copayment collection, proof of prescriber/patient relationship, patient consent to fill, and non-resident state licensure. PBM Audits are just one of the many hurdles your pharmacy will inevitably face while you strive to serve patients. Poor audit findings lead to extensive financial …

How to Respond to a PBM Audit Notice

Pharmacies are plagued by the burdens of addressing the terms of their pharmacy benefit manager (PBM) agreements, whether those terms are reasonable or not.  Pharmacies are dogged with PBMs wielding their power by initiating a PBM audit – sometimes to root out actual discrepancies, sometimes to injure your business in favor of the PBM’s own affiliated …