On June 27, 2022, FDA issued a Proposed Rule which would facilitate Rx to OTC switches. While OTC products are typically for acute self-limiting conditions, OTC use of certain prescription medications for chronic diseases or conditions would be... Read More
Articles | Manufacturers | Regulatory Compliance, including FDA, DEA and HIPAA | White Collar Criminal Defense & Government Investigations

Frier Levitt was recently successful in having a Board of Pharmacy case against a pharmacist and retail pharmacy dismissed. Underlying the Board of Pharmacy action was a PBM audit that alleged unprofessional conduct against the pharmacy and its... Read More
Community, Retail Pharmacies | Defending Pharmacies in PBM Audits | Life Sciences | Pharmacy Law | Recent Results | State Board of Pharmacy Hearings and Professional Discipline

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

Earlier this week, the U.S. Supreme Court ruled that to secure convictions under the federal Controlled Substances Act (“CSA”) for excessive prescribing of controlled substances, including opioids, prosecutors must prove beyond a reasonable... Read More
All types of single and multi-specialty medical practice groups | Articles | Behavioral Health Practitioners | Dispensing Physician Practices and Dispensing Physicians | Healthcare | Healthcare Law | Healthcare Practice Compliance | Pain Management Compliance | Physician Dispensing | Physicians and Medical Practices of all Specialties | Professional Practice Representation | Provider Relationship | White Collar Defense and Government Investigation

In part one of this article series, Frier Levitt dissected the May 9, 2022, Centers for Medicare and Medicaid Services (CMS) Final Rule (Final Rule) entitled, “Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare... Read More
340B Covered Entity and Contract Pharmacy Regulatory and Contract Support | Administrative and Insurance Defense Law | Antitrust Tools Available to Combat PBM Abuse of Pharmacies | Articles | Healthcare Law | Life Sciences

Frier Levitt recently received an impressive $3.6 million arbitration award against Caremark and SilverScript on behalf of a specialty pharmacy client, Mission Wellness, arising from improper DIR Fees. Despite repressive "gag clauses" imposed by... Read More
Antitrust Tools Available to Combat PBM Abuse of Pharmacies | Community, Retail Pharmacies | DIR Fees | Long-Term Care Pharmacies | News | Recent Results | Recent Successes | Specialty Pharmacies

The Department of Justice (“DOJ”) recently established the Elder Justice Initiative (“EJI”), which directs Government efforts to combat elder abuse, neglect, and financial fraud. The EJI seeks to address several schemes affecting older... Read More
Articles | Federal and State Fraud and Abuse Counseling | Healthcare | Healthcare Law | Healthcare Practice Compliance | Management Services Organizations (MSO) | Palliative Care, Hospice Care and Home Care | White Collar Defense and Government Investigation

Two practices in Connecticut recently settled large six-figure lawsuits with federal and state agencies resolving allegations of improperly employing an individual who was excluded from all federal healthcare programs. In both instances, the... Read More
Administrative and Insurance Defense Law | Articles | Employment Matters | Federal and State Fraud and Abuse Counseling | Healthcare | Healthcare Law | Healthcare Practice Compliance | Medical Practice Representation | Medicare and Insurance Audits | Physicians and Medical Practices of all Specialties | Professional Practice Representation | White Collar Defense and Government Investigation