identifying compliance issues raised by e-health transactions and strategies guy collier, esq. gadi...
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Identifying Compliance Issues Raised By E-Health Transactions and Strategies
Guy Collier, Esq.
Gadi Weinreich, Esq.
Shaw Pittman
September 27, 2000
Hospital PhysicianWebsiteVendor
Patient
Supplier/Provider
Example
Laws
• Anti-Kickback Laws • Physician Self-Referral Laws • Beneficiary Inducement Laws• Patient Privacy Laws • Physician Licensure Laws• Provider Licensure Laws• Supplier Licensure Laws• State Fee Splitting Laws
PhysicianWebsiteVendor
Hospital
Hospital-Vendor-PhysicianArrangement
Analysis
• Arrangement– Hospital wants to provide websites to
affiliated physicians– Website will have hospital logo and link
to hospital website on home page– Hospital hires third party vendor to
establish/ maintain physician websites– Vendor furnishes “data mining”
services for hospital and reports results
Analysis• Potential Legal Issues
– Kickback: Payment for “referrals”• Payment = free website• Is one purpose to induce referral of
patients?• If not, why is hospital giving
physician website?• Other explanations (e.g., marketing
hospital to physician’s patients)• Exceptions/Safe Harbors: personal
services?• Nominal value issue
Analysis
– Kickback: Payment for “recommendation”• Discussed below
– Physician Self-Referral (“Stark”)• Compensation arrangement between
hospital and physician? Direct? Indirect?
• Remuneration = website• Exceptions: personal services/other?
– Patient Privacy• Data mining; reports
Physician
Supplier/Provider
Supplier/Provider-Physician Relationship
Analysis• Arrangement
– Pharmacy places banner advertisement and link on physician’s website
– Pharmacy compensates physician:• Flat fee• Traffic volume; “hits” on pharmacy
link/website• Percentage of on-line purchases (Rx
versus non-Rx)• Other
Analysis• Legal Issues
– Kickback• Payment for “referrals” (same as
above)• Payment for “recommendation”
– Recommendation = advertisement/link» Exclusivity» Size» Placement» Text» Disclaimers» AO 99-8 (Yes); AO 99-12 (No)
Analysis• Exceptions/Safe Harbors: personal
services– Fair market value– Aggregate compensation set in
advance– Volume or value– Full-time versus part-time– One-year term (termination
with/without cause)
Analysis• Risk: Four Factor Test (AO 99-8)
– Party engaged in marketing (physician versus non-practitioner/provider)
– Nature (coerciveness) of marketing (telemarketing versus newspaper advertisement)
– Item or service being marketed (specific item/service versus provider logo)
– Target audience (beneficiaries versus general public)
Analysis• Risk: Other Factors
– Is compensation tied to purchases of covered items/services
– Fixed fee versus compensation based on volume/value of hits or business generated
Analysis• Physician Self-Referral (“Stark”)
– Does supplier/provider “furnish” DHS?– Physician has “compensation
arrangement” with supplier/provider?– If physician makes a “referral,” Stark
law implicated• Exception: personal services;
other?
Physician
Patient
Supplier/Provider
Supplier/Provider-Physician- Patient Relationship
Analysis• Arrangement
– Pharmacy offers discounts (rebates, coupons, “points,”etc.) to patients who access pharmacy website through physician website and purchase items from pharmacy
Analysis• Legal Issues
– Kickback: From pharmacy to patients• Payment to induce “purchases”• What can discount, points, etc. be
used for: covered items versus non-covered items–See AO 99-12 (coupons for non-
covered items only)• Exceptions: discounts
– Kickback: From pharmacy to physician• Payment to induce “referrals”
Analysis• Beneficiary Inducement Law
– Elements• Remuneration• Knows/Should Know• “Likely to influence” beneficiary• Purchase/receive from particular
“provider, supplier, or practitioner”– Penalties
• CMP = $10,000• Exclusion
– Exceptions
Analysis– Analysis
• Points as inducement to use pharmacy– Remuneration = discount/points– Knows/Should Know = possibly– “Likely to influence” = possibly– Purchase covered items = ?
»See AO 99-12 (coupon could not be used re covered items)
– From particular “provider, supplier, or practitioner” = yes, the pharmacy
Analysis– Exceptions
» Discount» Nominal value (?)» Cash Equivalent (?)
Analysis• Points as inducement to use
physician– Remuneration = discount/points– Knows/Should Know = possibly– “Likely to influence” = possibly
» AO 99-12 (no)– Purchase covered items = yes,
physician services– From particular “provider,
supplier, or practitioner” = yes, physician
– Exceptions:
Contact Information
• Guy Collier, Esq.– (202) 663-8138– [email protected]
• Gadi Weinreich, Esq.– (202) 663-8236– [email protected]