Chris Esseltine

Chris Esseltine

Chris Esseltine

Of Counsel

Attorneys

Management

Staff

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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