Congress has recently increased its scrutiny of Pharmacy Benefit Managers (“PBMs”), coinciding with a crucial policy shift by the Federal Trade Commission (“FTC”) that appears promising for independent pharmacies and other providers seeking... Read More
Antitrust Tools Available to Combat PBM Abuse of Pharmacies | Articles | Chain Pharmacies | Community Oncology Practices & Other Dispensing Physician Practices | Community, Retail Pharmacies | Defending Pharmacies in PBM Audits | Digital Pharmacies | DIR Fees | Fertility Pharmacies | Integrated Delivery Network and Hospital System Pharmacy | Long-Term Care Pharmacies | MAC Pricing & Appeals | Manufacturers | Maximum Allowable Cost Pricing & Appeals | Pharmaceutical Manufacturers | Pharmaceutical Wholesalers | Plan Sponsor PBM Contract Services | Specialty Pharmacies | Supermarket Pharmacies | Traditional Compounding Pharmacies (503A)

In February, the Office of Inspector General (“OIG”) issued an advisory opinion regarding a pharmaceutical manufacturer’s proposal to provide a free 14-day supply of its drug to patients experiencing delays in the insurance approval process.... Read More
Articles | Chain Pharmacies | Community, Retail Pharmacies | Digital Pharmacies | Federal and State Fraud and Abuse Counseling | Federal and State Fraud and Abuse Counseling | Fertility Pharmacies | Integrated Delivery Network and Hospital System Pharmacy | Long-Term Care Pharmacies | Manufacturers | Pharmaceutical Manufacturers | Specialty Pharmacies | Supermarket Pharmacies | Traditional Compounding Pharmacies (503A) | White Collar Criminal Defense & Government Investigations | White Collar Defense and Government Investigation

Enacted on December 29, 2022, the  Modernization of Cosmetics Regulation Act ("MoCRA") applies more of a drug-like regulatory framework to cosmetics. The landmark legislation significantly overhauls the Food and Drug Administration’s (“FDA”)... Read More
Articles | Drug and Device Advertising, Marketing & Promotion Legal Review | Intellectual Property Services | Manufacturers | Pharmaceutical Manufacturers | Regulatory Compliance, including FDA, DEA and HIPAA

PRESS RELEASE – New Jersey/New York, March 28, 2023 – Jonathan Levitt, a renowned trial attorney in the healthcare and life sciences industries and the co-founding partner of Frier Levitt, has been invited to testify before the U.S. Senate... Read More
Antitrust Tools Available to Combat PBM Abuse of Pharmacies | Articles | Biotech Companies | Chain Pharmacies | Community Oncology Practices & Other Dispensing Physician Practices | Community, Retail Pharmacies | Defending Pharmacies in PBM Audits | Digital Pharmacies | DIR Fees | Dispensing Physician Practices and Dispensing Physicians | Fertility Pharmacies | Home Infusion Providers | Integrated Delivery Network | Integrated Delivery Network and Hospital System Pharmacy | Long-Term Care Pharmacies | Manufacturers | National Board of Pharmacy Matters | News | Outsourcing Facilities (503B) | PBM Qui Tam Lawsuits | Pharmaceutical Manufacturers | Pharmaceutical Wholesalers | Pharmacy Transactions | Physician Dispensing | Plan Sponsor PBM Contract Services | Section 340B In-House and Contract Pharmacies | Specialty Pharmacies | State and National Pharmacy Associations | State Board of Pharmacy Hearings and Professional Discipline | Supermarket Pharmacies | Traditional Compounding Pharmacies (503A) | Urologist | Veterinary Compounders

Frier Levitt attorneys speak with prosecutors, Boards of Pharmacies, PBM auditors, wholesalers, and the like on a daily basis on behalf of pharmacies nationally. We regularly spot trends and report back to the industry. We are closely monitoring... Read More
All types of single and multi-specialty medical practice groups | Articles | Behavioral Health Practitioners | Biotech Companies | Chain Pharmacies | Community, Retail Pharmacies | Data Transactions | Digital Pharmacies | Drug and Device Advertising, Marketing & Promotion Legal Review | Federal and State Fraud and Abuse Counseling | Federal and State Fraud and Abuse Counseling | Healthcare Practice Compliance | Manufacturers | Pharmaceutical Manufacturers | Pharmaceutical Wholesalers | Physicians and Medical Practices of all Specialties | Professional Practice Representation | Provider Relationship | Regulatory Compliance, including FDA, DEA and HIPAA | Telehealth and Telemedicine | Telehealth and Telemedicine | White Collar Criminal Defense & Government Investigations | White Collar Defense and Government Investigation

On February 9, 2023, the Centers for Medicare and Medicaid Services (“CMS”) released a memorandum (the “Memorandum”) setting forth CMS’s proposed methods for calculating so-called “Inflation Rebates” as mandated by the recent Inflation... Read More
Articles | Manufacturers | Medicare and Insurance Audits | Medicare Audit Appeals | Pharmaceutical Manufacturers | Pharmaceutical Wholesalers | Professional Practice Representation

On January 15, 2023, the Vermont Department of Financial Regulation (the “Department”) issued a report titled “Act No. 131 (2022) Report: Pharmacy Benefit Management” (the “Report”). As the title suggests, the Department was required... Read More
Antitrust Review and Compliance | Antitrust Tools Available to Combat PBM Abuse of Pharmacies | Articles | Biotech Companies | Chain Pharmacies | Clinically Integrated Networks (CINs) | Community Oncology Practices & Other Dispensing Physician Practices | Community, Retail Pharmacies | Defending Pharmacies in PBM Audits | Digital Pharmacies | DIR Fees | Dispensing Physician Practices and Dispensing Physicians | Fertility Pharmacies | Hospitals and Healthcare Systems | Integrated Delivery Network | Integrated Delivery Network and Hospital System Pharmacy | Long-Term Care Pharmacies | Manufacturers | Outsourcing Facilities (503B) | PBM Qui Tam Lawsuits | Pharmaceutical Manufacturers | Pharmaceutical Wholesalers | Physician Dispensing | Plan Sponsor PBM Contract Services | Specialty Pharmacies | Supermarket Pharmacies | Traditional Compounding Pharmacies (503A) | Urologist | Veterinary Compounders

In an effort to gain market access for new drugs and to shift the conversation from one of “volume” to one of “value,” pharmaceutical manufacturers are increasingly offering and agreeing to alternative payment models that set the price of a... Read More
Articles | Biotech Companies | Manufacturers | Pharmaceutical Manufacturers | Value Based Care | Value Based Care

On January 25, 2023, the Court in Johnson & Johnson v. SaveOnSP dismissed SaveOnSP’s motion to dismiss, allowing Johnson & Johnson’s (“JNJ”) claims to proceed. As we reported here, JNJ filed a lawsuit against SaveOnSP alleging that... Read More
Articles | Manufacturers | Pharmaceutical Manufacturers | Plan Sponsor PBM Contract Services

Earlier this month, the Centers for Medicare and Medicaid (“CMS”) released a Memorandum overviewing next steps in the federal government’s implementation of the Medicare Drug Price Negotiation Program. Though CMS has only just “set the... Read More
Articles | Manufacturers | Medicare, Medicaid, and Other Commercial Payor Audits & Appeals | Pharmaceutical Manufacturers