The Food and Drug Administration (“FDA”) regulates and categorizes human cell and tissue products (“HCT/Ps”) based on the public health risks they pose. HCT/Ps are biological products that are used to repair, replace or regenerate human... Read More
Articles | Chain Pharmacies | Community, Retail Pharmacies | Digital Pharmacies | Federal and State Fraud and Abuse Counseling | Fertility Pharmacies | Long-Term Care Pharmacies | National Board of Pharmacy Matters | Pharmaceutical Manufacturers | Regulatory Compliance, including FDA, DEA and HIPAA | Specialty Pharmacies | State Board of Pharmacy Hearings and Professional Discipline | Supermarket Pharmacies | White Collar Criminal Defense & Government Investigations | White Collar Defense and Government Investigation

Last month, Cerebral, Inc., notified the Department of Health and Human Services Office for Civil Rights (“OCR”), and issued a public notice, that nearly 3.2 million individuals may have been affected by a breach of data, including protected... Read More
Articles | Data Transactions | Digital Pharmacies | Federal and State Fraud and Abuse Counseling | Federal and State Fraud and Abuse Counseling | Healthcare Practice Compliance | HIPAA Compliance | Management Services Organizations (MSO) | Regulatory Compliance, including FDA, DEA and HIPAA | Risk Assessment Mitigation Strategy | Telehealth and Telemedicine | Telehealth and Telemedicine

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

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

The healthcare and life science industries should be aware of the recent increase in False Claims Act (“FCA”) or “whistleblower” cases. In fiscal year 2022, the Department of Justice (“DOJ”) recovered $2.2 billion under the FCA. In 2021,... Read More
Articles | Federal and State Fraud and Abuse Counseling | Federal and State Fraud and Abuse Counseling | Healthcare Practice Compliance | Professional Practice Representation | White Collar Criminal Defense & Government Investigations | White Collar Defense and Government Investigation

Combatting opioid diversion remains a top priority for regulators and enforcement agencies.  In that vein, there continues to be enhanced scrutiny on healthcare professionals over opioid prescriptions.  As highlighted by recent Department of... 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 | Hospitals and Healthcare Systems | Integrated Delivery Network and Hospital System Pharmacy | Long-Term Care Pharmacies | Pain Management Compliance | Provider Relationship | Regulatory Compliance, including FDA, DEA and HIPAA | Specialty Pharmacies | Supermarket Pharmacies | Traditional Compounding Pharmacies (503A) | White Collar Criminal Defense & Government Investigations | White Collar Defense and Government Investigation

Frier Levitt Partner Guillermo J. Beades was quoted in a Part B News article, “Be Careful About Upcoding; DOJ May Come After it as a False Claim” by Roy Edroso. “It’s very rare for audits to be converted to civil or criminal actions,”... Read More
Administrative and Insurance Defense Law | Articles | Federal and State Fraud and Abuse Counseling | Federal and State Fraud and Abuse Counseling | Healthcare Practice Compliance | Medicare and Insurance Audits | News | Payor Network Access and Defense of Network Terminations | White Collar Criminal Defense & Government Investigations | White Collar Defense and Government Investigation

On February 22, 2023, the U.S. Department of Justice (“DOJ”) issued a corporate Voluntary Self-Disclosure policy (the “Policy”) that applies to all United States Attorney’s Offices (“USAOs”), effective immediately. The articulated goal... Read More
All types of single and multi-specialty medical practice groups | Ambulatory Care Facilities | Ambulatory Surgery Facilities | Articles | Behavioral Health Practitioners | Clinically Integrated Networks | Dental Practices | Dispensing Physician Practices and Dispensing Physicians | Federal and State Fraud and Abuse Counseling | Federal and State Fraud and Abuse Counseling | Healthcare Practice Compliance | Hospitals and Healthcare Systems | Laboratories | Management Services Organizations (MSO) | Medical Spas and Cosmetic Services | Palliative Care, Hospice Care and Home Care | Physicians and Medical Practices of all Specialties | White Collar Criminal Defense & Government Investigations | White Collar Defense and Government Investigation

As physician practices are in the midst of calculating and distributing 2022 year-end bonuses to physician employees and profits to owners, practices providing Designated Health Services ("DHS"), such as laboratory testing, diagnostic radiology... Read More
All types of single and multi-specialty medical practice groups | Ambulatory Care Facilities | Ambulatory Surgery Facilities | Articles | Behavioral Health Practitioners | Clinically Integrated Networks | Dental Practices | Federal and State Fraud and Abuse Counseling | Hospitals and Healthcare Systems | Laboratories | Medical Practice Representation | Medical Spas and Cosmetic Services | News | Palliative Care, Hospice Care and Home Care | Physicians and Medical Practices of all Specialties | White Collar Criminal Defense & Government Investigations