The FDA has delayed the verification of salable returns requirement under the Drug Supply Chain Security Act (DSCSA) until November 27, 2023. On October 22, 2020, FDA released a Guidance delaying enforcement of the provision that requires wholesale... Read More
Articles | Life Sciences | Pharmacy Law | Regulatory Compliance, including FDA, DEA and HIPAA

On October 26, 2020, the Food and Drug Administration (FDA) issued its long awaited final MOU which describes the conditions under which certain compounded drugs by a pharmacist in a state-licensed pharmacy, or by a licensed physician, are exempt... Read More
Community Oncology Practices & Other Dispensing Physician Practices | Integrated Delivery Network and Hospital System Pharmacy | Life Sciences | State and National Pharmacy Associations | Traditional Compounding Pharmacies (503A)

Frier Levitt’s Co-Chair of Healthcare John E. Morrone, Esq. recently contributed to a Hospital Peer Review article titled “Assess Quality and Compliance as Telehealth Use Expands”.  In the article, he discusses the quality standards, metrics... Read More
Healthcare Law | Telehealth and Telemedicine

A compounding pharmacy based in Kentucky, and its owner, admitted on October 29, 2020 in federal court to unlawful distribution of compounded prescription drugs.  The Pharmacy pleaded guilty to unlawful distribution of substances that the FDA had... Read More
Articles | Life Sciences | Pharmacy Law | Traditional Compounding Pharmacies (503A) | White Collar Criminal Defense & Government Investigations

On Wednesday, October 28, the Cybersecurity and Infrastructure Security Agency (“CISA”) and the FBI announced an “increased and imminent cybercrime threat to U.S. hospitals and healthcare providers.” Preliminary news reports have identified... Read More
Healthcare | HIPAA Compliance | Hospitals and Healthcare Systems | Regulatory Compliance, including FDA, DEA and HIPAA

On September 30, 2020, the Department of Justice (“DOJ”) announced a nationwide healthcare fraud and opioid takedown resulting in charges against more than 100 physicians for over $4.5 billion in losses connected to allegedly fraudulent... Read More
Healthcare | Telehealth and Telemedicine

In FTC v. Surescripts, the Federal Trade Commission (“FTC”) has sued Surescripts alleging illegal vertical & horizontal restraints to maintain monopolies over “e-prescribing” markets.  The FTC alleges Surescripts’ imposition of... Read More
Antitrust Review and Compliance | Articles | Life Sciences | Pharmacy Law

A Frier Levitt team comprised of Co-Chair of Healthcare John E. Morrone, Esq., and Senior Counsel Theresa M. DiGuglielmo, Esq., recently achieved an unprecedented “Self-Disclosure” settlement with the Department of Health and Human Services’... Read More
Hospital/Physician Negotiations and Joint Ventures | Hospitals and Healthcare Systems | Recent Results

On April 9th, 2019, U.S. Department of Health and Human Services Office of the Inspector General (HHS-OIG) and Department of Justice (DOJ) announced one of the largest health care fraud schemes involving several telemedicine companies, dozens of... Read More
Healthcare | Healthcare Law | Telehealth and Telemedicine

The U.S. Attorney’s Office, Western District of Louisiana, recently announced that the owner and operator of the Monroe-based Specialty Drug Testing, LLC (“Specialty”) was indicted by a Federal grand jury for violating the Federal... Read More
Healthcare | Healthcare Law | Hospitals and Healthcare Systems | Laboratories | Medicare, Medicaid, and Other Commercial Payor Audits & Appeals