The Ninth Circuit ruled that a pharmaceutical manufacturer cannot sue a 503B compounding facility for compounding versions of its commercially available product in Nexus Pharmaceuticals, Inc v. Central Admixture Pharmacy Services (CAPS), Nexus... Read More
Articles | Life Sciences | Outsourcing Facilities (503B) | Pharmacy Law

Pharmacy Benefit Managers (“PBMs”) regularly review network pharmacies to ensure that they are meeting terms and conditions identified in their Provider Agreements and Pharmacy Manuals. One mechanism for this review includes audits and... Read More
Antitrust Tools Available to Combat PBM Abuse of Pharmacies | Articles | Chain Pharmacies | Community, Retail Pharmacies | Defending Pharmacies in PBM Audits | Digital Pharmacies | Fertility Pharmacies | Specialty Pharmacies | Supermarket Pharmacies | Traditional Compounding Pharmacies (503A)

As previously reported, Frier Levitt filed suit against the New York Department of Health and the New York State Department of Education on behalf of an independent New York oncology practice in an effort to void the State’s new and legally... Read More
Articles | Community Oncology Practices & Other Dispensing Physician Practices | Healthcare | Healthcare Law | Life Sciences | Pharmacy Law

In the past week alone, Frier Levitt has seen a sudden increase in actions by pharmaceutical manufacturers against pharmacies related to the use of certain patient savings programs, such as copay coupon programs.  These programs are designed to... Read More
Articles | Chain Pharmacies | Community, Retail Pharmacies | Digital Pharmacies | Fertility Pharmacies | Integrated Delivery Network | Integrated Delivery Network and Hospital System Pharmacy | Long-Term Care Pharmacies | Specialty Pharmacies | Supermarket Pharmacies | Traditional Compounding Pharmacies (503A)

In May 2022, Johnson & Johnson (“JNJ”) filed a lawsuit against Save On SP, LLC (“SaveOnSP”), essentially alleging that SaveOnSP illegally pilfered co-payment coupon and manufacturer assistance programs offered by JNJ to help patients... Read More
Articles | Manufacturers | Pharmaceutical Manufacturers | Plan Sponsor PBM Contract Services

In preparation for the final complex interoperable electronic tracking phase for the Drug Supply Chain Security Act (“DSCSA”)  provisions, FDA released two Guidances the week of July 5, 2022. DSCSA Standards for Interoperable Exchange... Read More
Articles | Life Sciences | Pharmacy Law | Regulatory Compliance, including FDA, DEA and HIPAA

In a recent trend, compounding pharmacies have been receiving notices of audit from the Office of Inspector General (“OIG”) of the U.S. Department of Health and Human Services (“HHS”). In the notice, OIG requests that the pharmacies submit... Read More
Antitrust Review and Compliance | Articles | Federal and State Fraud and Abuse Counseling | Federal and State Fraud and Abuse Counseling | Regulatory Compliance, including FDA, DEA and HIPAA | Traditional Compounding Pharmacies (503A) | White Collar Criminal Defense & Government Investigations

Last week, the Federal Trade Commission (“FTC”) fired a warning shot across the bow of PBMs, but Manufacturers and Plan Sponsors must also take note. On June 16, 2022, the FTC announced that it will “ramp up enforcement against any illegal... Read More
Antitrust Tools Available to Combat PBM Abuse of Pharmacies | Articles | Life Sciences | Pharmacy Law | Plan Sponsor PBM Contract Services

The New York Department of Health (NYDOH) has promulgated enrollment requirements for pharmacies seeking to participate in the Medicaid program which are unrelated to many of the actual operations of pharmacies within the state of New York.... Read More
Articles | Chain Pharmacies | Community, Retail Pharmacies | Digital Pharmacies | Fertility Pharmacies | Life Sciences | Medicare, Medicaid, and Other Commercial Payor Audits & Appeals | Pharmacy Law | Specialty Pharmacies | Supermarket Pharmacies | Traditional Compounding Pharmacies (503A)

On May 17, 2022, the United States District Court for the District of Columbia issued an opinion granting Summary Judgment to Pharmaceutical Research and Manufacturers of America (“PhRMA”), and setting aside the December 2020 Medicaid Best Price... Read More
Articles | Life Sciences | Manufacturers | Pharmaceutical Manufacturers