Chris Esseltine

Chris Esseltine

Chris Esseltine

Of Counsel

Attorneys

Drew Barnholtz
Randy Berholtz
Michael H. Cohen
Albert Meyer
Matthew M. Stokke

Management

Patrick Bacani
Mirachelle Cepe
Dana Porcalla
Maria Clara Salvai

Staff

Christian Maniquis
Amybelle Nepomuceno
Sharon Riordan

Chris Esseltine is a Healthcare and FDA attorney with 16 years of experience representing a wide range of healthcare entities and companies governed by the FDA. He counsels clients on matters including HIPAA, Anti-Kickback Statute, Stark, Medicare Fraud, FDA/FTC marketing and labeling issues, and creating corporate compliance programs. He has represented clients ranging from startups to Fortune 500 companies. He also ran the legal department for a billion-dollar health network and an international nutraceutical company, where he gained deep experience in operations and business development.

Chris Esseltine is experienced on the following topics:

Pharmaceutical
  1. PMAs
  2. Sunshine Act
  3. Sales/Marketing/Advertising/Labeling
  4. Off-label promotion
  5. Clinical Trials
  6. OTC
  7. current Good Manufacturing Practices (cGMP)
  8. Claims/FTC
Medical Device
  1. 510K
  2. Sales/Marketing/Advertising/Labeling
  3. Claims/FTC
  4. PMA/IDE
  5. Class II and III devices
  6. cGMP
Food and Beverage
  1. Packaging/Labeling
  2. cGMP/Safety
  3. Claims/Advertising/FTC
  4. FDA inspections
Nutraceutical/Supplement
  1. Packaging/Labeling
  2. Claims/FTC
  3. cGMP
  4. FDA inspections
  5. Multilevel Marketing
Cosmetic
  1. Packaging/Labeling
  2. Claims/FTC
  3. cGMP
  4. FDA inspections
  5. Multilevel Marketing
Hospital/Health Systems
  1. Physician/Provider contracts
  2. Professional Services Agreements
  3. Risk management, regulatory violation litigation
  4. Medical staff bylaws
  5. Stark, Anti-kickback, HIPAA
  6. Rural/Underserved Areas
  7. Risk Management/Mitigation
Hospice/Home Health
  1. Stark, Anti-kickback, HIPAA
  2. Medicare fraud
  3. Risk Management/Mitigation
SNF
  1. Stark, Anti-kickback, HIPAA
  2. Medicare fraud
  3. Risk Management/Mitigation
Pharmacy
  1. Telepharmacy
  2. Medicaid
  3. Opioid/Marijuana/Narcotics
Telemedicine/Telehealth
  1. Marketing/Relationships with marketing companies
  2. Licensing/State requirements
MSOs
  1. Corporate Practice of Medicine
  2. Independent medical judgment
  3. Corporate structure/agreements
Physician Practices/Clinics
  1. Provider agreements
  2. Staff issues
  3. Billing
  4. Licensing
Laboratories
  1. Marketing agreements/relationships
  2. Stark, Antikickback, HIPAA
  3. Licensing
  4. Payor agreements
Chris Esseltine

Chris Esseltine

Of Counsel

Chris Esseltine is a Healthcare and FDA attorney with 16 years of experience representing a wide range of healthcare entities and companies governed by the FDA. He counsels clients on matters including HIPAA, Anti-Kickback Statute, Stark, Medicare Fraud, FDA/FTC marketing and labeling issues, and creating corporate compliance programs. He has represented clients ranging from startups to Fortune 500 companies. He also ran the legal department for a billion-dollar health network and an international nutraceutical company, where he gained deep experience in operations and business development.

Chris Esseltine is experienced on the following topics:

Pharmaceutical
  1. PMAs
  2. Sunshine Act
  3. Sales/Marketing/Advertising/Labeling
  4. Off-label promotion
  5. Clinical Trials
  6. OTC
  7. current Good Manufacturing Practices (cGMP)
  8. Claims/FTC
Medical Device
  1. 510K
  2. Sales/Marketing/Advertising/Labeling
  3. Claims/FTC
  4. PMA/IDE
  5. Class II and III devices
  6. cGMP
Food and Beverage
  1. Packaging/Labeling
  2. cGMP/Safety
  3. Claims/Advertising/FTC
  4. FDA inspections
Nutraceutical/Supplement
  1. Packaging/Labeling
  2. Claims/FTC
  3. cGMP
  4. FDA inspections
  5. Multilevel Marketing
Cosmetic
  1. Packaging/Labeling
  2. Claims/FTC
  3. cGMP
  4. FDA inspections
  5. Multilevel Marketing
Hospital/Health Systems
  1. Physician/Provider contracts
  2. Professional Services Agreements
  3. Risk management, regulatory violation litigation
  4. Medical staff bylaws
  5. Stark, Anti-kickback, HIPAA
  6. Rural/Underserved Areas
  7. Risk Management/Mitigation
Hospice/Home Health
  1. Stark, Anti-kickback, HIPAA
  2. Medicare fraud
  3. Risk Management/Mitigation
SNF
  1. Stark, Anti-kickback, HIPAA
  2. Medicare fraud
  3. Risk Management/Mitigation
Pharmacy
  1. Telepharmacy
  2. Medicaid
  3. Opioid/Marijuana/Narcotics
Telemedicine/Telehealth
  1. Marketing/Relationships with marketing companies
  2. Licensing/State requirements
MSOs
  1. Corporate Practice of Medicine
  2. Independent medical judgment
  3. Corporate structure/agreements
Physician Practices/Clinics
  1. Provider agreements
  2. Staff issues
  3. Billing
  4. Licensing
Laboratories
  1. Marketing agreements/relationships
  2. Stark, Antikickback, HIPAA
  3. Licensing
  4. Payor agreements
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