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Michael B. Lampert, "Anti-Kickback Statute and Stark Law Updates"

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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

Published in: Health & Medicine
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Michael B. Lampert, "Anti-Kickback Statute and Stark Law Updates"

  1. 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. 2. ROPES & GRAY2 2  Patient Assistance Programs  Sales  Where the Lines Blur All public information AGENDA
  3. 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. 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. 5. 55  Patient Assistance Programs  Sales  Where the Lines Blur All public information AGENDA
  6. 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. 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. 8. 88  Patient Assistance Programs  Sales  Where the Lines Blur All public information AGENDA
  9. 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. 10 QUESTIONS Michael B. Lampert michael.lampert@ropesgray.com + 1 617 951 7095

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