On May 9, 2022, the Centers for Medicare and Medicaid Services (CMS) released a Final Rule (Final Rule) entitled, “Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs.” ... Read More
All types of single and multi-specialty medical practice groups | Articles | Community Oncology Practices & Other Dispensing Physician Practices | Community, Retail Pharmacies | Digital Pharmacies | DIR Fees | Dispensing Physician Practices and Dispensing Physicians | Healthcare | Healthcare Law | Healthcare Practice Compliance | Life Sciences | Medicare and Insurance Audits | Medicare Audit Appeals | Medicare, Medicaid, and Other Commercial Payor Audits & Appeals | Pharmaceutical Wholesalers | Physician Dispensing | Physician Dispensing | Physicians and Medical Practices of all Specialties | Specialty Pharmacies | Supermarket Pharmacies | Traditional Compounding Pharmacies (503A)

A recent lawsuit and appellate division decision provide guidance to industry stakeholders on copayment assistance programs.  Pfizer filed a lawsuit against the U.S. Department of Health and Human Services (“HHS”) Office of Inspector... Read More
Articles | Life Sciences | Pharmaceutical Manufacturers | Pharmaceutical Wholesalers | Pharmacy Law | White Collar Criminal Defense & Government Investigations

Frier Levitt Pharmacist-Attorney, Martha M. Rumore, PharmD, JD, MS, LLM, FAPhA has authored an article for Pharmaceutical Commerce published on October 14th, 2021 titled "2023 challenges of the Drug Supply Chain Security Act implementation on... Read More
Articles | Life Sciences | News | Pharmaceutical Manufacturers | Pharmaceutical Wholesalers | Pharmacy Law

Increasing complexities in the pharmaceutical supply chain have led to challenges in the purchase and distribution of pharmaceutical products directly to medical practices. While the traditional role of MSOs is centralization of administrative and... Read More
Articles | Healthcare | Life Sciences | Management Services Organizations (MSO) | Pharmaceutical Manufacturers | Pharmaceutical Wholesalers | Pharmacy Law | Regulatory Compliance, including FDA, DEA and HIPAA

As a follow-up to our previous article on the CREATES ACT, other types of clinical trials for which we seek comparator drugs are mostly for head-to-head comparisons for new indications, or non-inferiority trials, and generally fall under 505(b)(1),... Read More
Articles | Biotech Companies | Life Sciences | Manufacturers | Pharmaceutical Wholesalers | Pharmacy Law | Regulatory Compliance, including FDA, DEA and HIPAA

The refusal to provide comparator products violates federal and state antitrust laws and the CREATES Act. Although the Supreme Court has expressed caution about imposing antitrust liability based on a monopolist’s unilateral refusal to deal, the... Read More
Articles | Biotech Companies | Life Sciences | Manufacturers | Pharmaceutical Wholesalers | Pharmacy Law | Regulatory Compliance, including FDA, DEA and HIPAA

Some PBMs require that pharmacies purchase diabetic testing supplies from “authorized distributors.” While the term varies from manufacturer to manufacturer, an authorized distributor is essentially an approved wholesaler that is contracted with... Read More
Articles | Life Sciences | Manufacturers | Pharmaceutical Wholesalers

Value Based Care is the future of the United States healthcare system and the Office of the Inspector General (OIG) for the US Department of Health and Human Services is in full agreement. The OIG recently issued a Notice of Proposed Rulemaking that... Read More
Life Sciences | Pharmaceutical Wholesalers | Pharmacy Law | Physician Dispensing | Value Based Care