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FDA Withdraws Proposed Rule for Generic Manufacturers

In a major development in the pharmaceutical industry, the FDA recently announced that it is withdrawing a proposed rule requiring generic drug manufacturers to independently update their drug labels with new information. Currently, generic manufacturers who hold Abbreviated New Drug Application (ANDA) are prohibited from making unilateral changes to their label prior to the corresponding branded Referenced Listed Drug (RLD) manufacturers make changes in the brand drug label. The proposed...

Little Known and Under-Utilized Tool Enables Pharmacies to Demand Network Terms and Conditions for Medicare Part D Networks

Too often, pharmacies are faced with the difficult proposition of seeking admission into Medicare Part D networks. With new and evolving pharmacy business models, along with ever-changing and contracting pharmacy networks, it can be challenging to determine the appropriate network(s) to seek access to. This can be further complicated by PBMs routinely seeking to push pharmacies into general "retail pharmacy" networks, while restricting access from networks that provide more opportunity...

Telemedicine and Value Based Care

https://youtu.be/n846Rf2c44o Attorneys John E. Morrone, Esq., and Jonathan E. Levitt, Esq. discuss telemedicine and Value Based Care, including:[00:00:00]: Opportunities: Value Based Care[00:02:21]: Biggest Opportunities in Telemedicine[00:05:02]: Practical Next Steps for Physicians to Add Telemedicine to Their Practice For assistance adding telemedicine to your practice or for help with telemedicine issues you are experiencing, contact Frier Levitt today to speak to an attorney.

PHARMACY ALERT: PSAOs Amending Pharmacy Participation Agreements

Recently, pharmacies have been finding that Pharmacy Services Administrative Organizations (PSAOs) are amending their pharmacy agreements. Pharmacies should closely review these revisions to determine how their rights may change under the new contract amendments. Reviewing there visions is made even more important due to numerous PSAOs seeking to withhold moneys for GER and DIR reconciliations at the close of 2018. Often, PSAO pharmacy amendments become binding if a pharmacy does...

Telemedicine and Medicare: Requirements, Billing, Audits, and Pitfalls

https://youtu.be/c8yviaxSQio Attorneys John E. Morrone, Esq., and Jonathan E. Levitt, Esq. discuss telemedicine medicare requirements, billing, audits trends, and pitfalls, including: [00:00:00]: Medicare Paying for Telemedicine[00:02:29]: Medicare Location Requirements: Where Should a Physician Be?[00:05:04]: Medicare’s Audit of Telemedicine[00:07:41]: Proper Billing of Telemedicine Services[00:08:37]: Medicare’s Telemedicine Billing Rules[00:10:40]: Telemedicine Pitfalls: Third Party Billing[00:12:24]: Federal and State Telemedicine Law: Who Pays the Physician? Contact Frier Levitt today to speak to an attorney...