December 12, 2017 The Sixth Annual Health Law Year in P/Review symposium featured leading experts discussing major developments during 2017 and what to watch out for in 2018. The discussion at this day-long event covered hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law. For more information, visit our website at: http://petrieflom.law.harvard.edu/events/details/sixth-annual-health-law-year-in-p-review

1. Dec. 12, 2017
Anti-Kickback Statute in 2017
(A quieter year for Stark)
Michael B. Lampert
michael.lampert@ropesgray.com
+1 617 951 7095

2. ROPES & GRAY2
2
 Patient Assistance Programs
 Sales
 Where the Lines Blur
All public information
AGENDA

3. 3
Patient Assistance Programs
Press release reports:
 Discounts on drugs and household products
 Policy to exclude Medicare and Medicaid
beneficiaries
 Despite policy, “hundreds of thousands” of
beneficiaries enrolled
 $50M civil settlement
Points of note:
 Little direct government reimbursement
 Failure of policy implementation
“Persons receiving benefits
from a Medicare, Medicaid or
Tricare program are ineligible”

4. 4
Independent Patient Assistance Programs
 Aegerion allegedly participated in creating PSI’s fund
and establishing coverage criteria
 $28.8M settlement and CIA
 Alexion Pharmaceuticals, Celgene, Jazz
Pharmaceuticals, J&J, Novartis, United Therapeutics
Corp., others reported to be involved in probe
 HHS-OIG withdrew favorable Advisory Opinion
issued to Caring Voice Coalition

5. 55
 Patient Assistance Programs
 Sales
 Where the Lines Blur
All public information
AGENDA

6. 6
Sales
 “Whoever knowingly and willfully offers or pays any remuneration (including any kickback,
bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind to any person to
induce such person . . . to purchase, lease, order, or arrange for or recommend
purchasing, leasing, or ordering any good, facility, service, or item for which payment may be
made in whole or in part under a Federal health care program . . . shall be guilty of a felony”
 “As used in section 1128B of the Act, ‘remuneration’ does not include any amount paid by an
employer to an employee, who has a bona fide employment relationship with the employer,
for employment in the furnishing of any item or service for which payment may be made
in whole or in part under Medicare, Medicaid or other Federal health care programs.”

7. 7
Sales
EHR Promotion Using
Customers
• “Refer a friend”
• Telephone references
• Site visits
• Influential user benefits
Sales Employees
• In-house referral
bonuses
Sales Agents
• Allegedly involved in
unlawful promotional
practices

8. 88
 Patient Assistance Programs
 Sales
 Where the Lines Blur
All public information
AGENDA

9. 9
Where the Lines Blur
 Patient-focused care
 Patient-engaging care
 Care amongst integrated providers
 Timely affirmative interventions
 Shifted financial responsibilities
 Reimagined care responsibilities
 “Free” goods or services for patients
 “Free” goods or services for providers
Value-Based Incentives & Outcomes Illegal KickbackOR

10. 10
QUESTIONS
Michael B. Lampert
michael.lampert@ropesgray.com
+ 1 617 951 7095