Ensuring Compliance with the Law - Properly Structuring Innovative Marketing and Creative Joint Ventures. Top 5 Things to Know for CE:

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1 Ensuring Compliance with the Law - Properly Structuring Innovative Marketing and Creative Joint Ventures Clay Stribling, Esq. Top 5 Things to Know for CE: 1. Make sure your BADGE IS SCANNED each time you enter a session, to record your attendance. 2. Carry the Evaluation Packet you received on registration with you to EVERY session. 3. If you re not applying for CE, we still want to hear from you! Your opinions about our conference are very valuable. 4. Pharmacists and Nurses need to track their hours on the Statement of Continuing Education Certificate form as they go. 5. FOR CE: At your last session, total the hours and sign your Statement of Continuing Education Certificate form. Keep the PINK copy for your records. Place the YELLOW and WHITE copies in your Evaluation packet Make sure an evaluation form from each session you attended is completed and in your Evaluation packet Put your name on the outside of the packet, seal it, and drop it in the drop boxes in the NHIA registration area at the convention center Legal Guidelines Medicare/Medicaid Anti-Kickback Statute Stark Law Beneficiary Inducement Statute Anti-Solicitation Statute False Claims Act 1

2 Medicare/Medicaid Anti-Kickback Statute What is prohibited? What are the penalties? What parties can receive kickbacks? Medicare/Medicaid Anti-Kickback Statute Common Kickback Concerns Marketing representatives Patient co-payments and deductibles Gifts to physician offices Medical directors Gifts to beneficiaries Stark Law What is prohibited? What is a designated health service? What types of relationships are covered? 2

3 Stark Law Stark provides that if a physician has a financial relationship with an entity providing designated health services then the physician may not refer patients to the entity unless one of the statutory or regulatory exceptions applies. Stark Law Designated health services include Durable medical equipment Perenal and interal nutrients Prosthetics, orthotics, and prosthetic devices Outpatient prescription drugs among others Safe Harbors and Exceptions Space rental Equipment rental Personal services and management contracts Employees 3

4 Beneficiary Inducement Statute This prohibits offering or giving remuneration to any Medicare beneficiary that the offeror knows or should know is likely to influence the recipient to order an item for which payment may be made under a federal health care program. Beneficiary Inducement Statute Only applies to federal program beneficiaries Does not prohibit the provision of items considered nominal value Anti-Solicitation Statute A supplier of a covered item may not contact a Medicare beneficiary by telephone regarding the furnishing of a covered item unless The beneficiary has given written permission for the contact A supplier has previously provided the covered item to the beneficiary and the supplier is contacting the beneficiary regarding the covered item If the telephone contact is regarding the furnishing of a covered item other than the item already furnished and the supplier has furnished at least one covered item to the beneficiary during the preceding 15 months 4

5 Anti-Solicitation Statute 2010 Special Fraud Alert Contacting patients in response to physician orders What type of contact is appropriate? Be wary of state law False Claims Act All significant fraud settlements in health care ultimately relate to the False Claims Act Any person that knowingly presents to a federal health care program a fraudulent claim for payment or knowingly uses a false record or statement to obtain payment from a federal program is subject to civil monetary penalties Fines and penalties include repayment of up to 3 times the value of the claim plus up to $11,000 per claim in damages False Claims Act How does the False Claims Act relate to marketing? Tie-in between the False Claim Act and the Anti-Kickback Statute Marketing one product, providing another, or marketing one product and billing for another is a common false claim allegation Workflow of a claim from marketing through submission is a significant analytic tool that both suppliers and federal investigators will use to determine if marketing practices might have lead to the submission of false claims. All companies should thoroughly examine their workflow to verify that at no step during the process is inappropriate marketing leading to the submission of inappropriate claims. 5

6 False Claims Act How to prevent problems associated with marketing practices Implement a corporate compliance program Establish a strict budget for marketing efforts Request complete accountability from marketing employees regarding what was spent at what time and for whom Have the corporate compliance officer review all print, radio, television, or other advertising prior to its placement Be very wary of any lead generation contractor companies. Quite often, these arrangements can lead to significant problems, not only under the anti-kickback statute but also related to HIPAA. Joint Ventures 2003 Special Advisory Bulletin 1989 Special Fraud Alert Small Investment Interest Safe Harbor Examples 6

7 True/False Questions The Anti-Kickback Statute applies only to referrals by physicians. The Stark Law prohibits referrals from physicians for all Medicare covered items and services. Many states have implemented statutes prohibiting illegal remuneration. Kickbacks can include non-monetary benefits such as lavish gifts. A company cannot pay a kickback to its bona fide employee. Questions & Answers The Anti-Kickback Statute applies only to referrals by physicians. The Stark Law prohibits referrals from physicians for all Medicare covered items and services. Many states have implemented statutes prohibiting illegal remuneration. Kickbacks can include nonmonetary benefits such as lavish gifts. A company cannot pay a kickback to its bona fide employee. False False True True True The End 7

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