Insights & Analysis
Practical guidance on PBM audits, federal investigations, compounding defense, DEA enforcement, telehealth compliance, and the regulatory pressures facing pharmacies and providers nationwide.
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Compounding for Physician Office Use Under 503B
How 503B outsourcing facilities supply physician office stock without patient-specific prescriptions, and the labeling and FDA rep…
Palmetto GBA Medicare Audits: What Providers in Its Jurisdictions Face
Palmetto GBA runs Medicare medical review, Targeted Probe and Educate, and documentation-request deadlines across Jurisdiction M a…
Noridian Healthcare Solutions Medicare Audits and Appeals
Noridian's Medicare jurisdictions, its Targeted Probe and Educate process, and how its redetermination unit handles appeals and de…
Controlled-Substance Anesthetic Prescribing by Telehealth Clinics
Telehealth clinics prescribing a Schedule III dissociative anesthetic off-label face DEA telemedicine rules, FDA oversight, and me…
The Zafirov Challenge: Is the Qui Tam Mechanism Constitutional?
The Eleventh Circuit rejected the Appointments Clause challenge to qui tam in Zafirov, but left two constitutional questions unres…
Responding to a Voluntary Document Request From Federal Agents
A federal agent's letter or office visit asking for records without a subpoena is not a legal command, but preservation duties can…
Compounded GLP-1 Sourcing: Active Ingredient Suppliers Under Scrutiny
FDA detains noncompliant GLP-1 API shipments at the border, and 503A requires compounding pharmacies to verify supplier registrati…
Dentist License Investigations: State Dental Board Complaints
What triggers a state dental board complaint, how California, Texas and New York investigate, and what a dentist should say before…
Virtual Direct Supervision in Telehealth Billing
CMS permanently allows virtual direct supervision in 2026, but audio-only coverage and some surgical procedures remain excluded fr…