Sales & Marketing

Compliance Training

Sales & Marketing• This presentation is necessary for the review of

any and all individuals within NRLBH, and distributors involved in the sales and marketing departments for all of NRLBH’ products

• Covered in this presentation:o How to Report Fraud to the OIGo Federal Anti-kickback Statute and Stark Lawo Physician Self-Referral Lawo Civil Monetary Penalties Lawo Criminal Health Care Fraud Statuteo Proper Compliance Documentation

How to Report Fraud to the OIG

• What is the OIG? o The Office of Inspector General: the investigative arm of the Federal

Trade Commission.

• Provider Compliance Training to follow all required laws and statutes for best business practices

• Watch the following video on Reporting Fraud to the OIG

• If you are having trouble viewing the video, check the notes of the slideshow and copy the URL into your web browser’s address bar

OIG’s Self Disclosure Protocol

• What to do when you discover conduct that may violate the federal fraud and abuse laws

• Watch the following video on Provider Self Disclosure Protocol

• Demonstrate a culture of compliance and cooperate with the government with integrity

OIG’s Self Disclosure Protocol

• Action Steps

1) Clarify the issue and confirm that it is a potential fraud issue

2) Consult with a health care attorney who has Federal health care experience

3) Decide where to disclose the conduct

False Claims Act• A US federal law that imposes liability on persons

and companies (typically federal contractors) who defraud governmental programs (in healthcare, this applies to Medicare and Medicaid programs)

• Under the false claims act, those who knowingly submit, or cause another person or entity to submit, false claims for payment of government funds are liable for prosecution and fines

False Claims Act• Examples:1) A contractor falsifies test results or other

information regarding the quality or cost of products it sells to the Government

2) A health care provider bills Medicare for services that were not performed or were unnecessary

3) A grant recipient charges the Government for costs not related to the grant

Federal Anti-kickback Statute

• This statute focuses on referrals of residents or services which are paid for, in whole or in part, by any federal health care program, including Medicare and Medicaid.

• The key here is referrals, how you receive them or make them, and whether you give, receive, solicit or help arrange anything of value as part of the process of obtaining or making referrals.

Federal Anti-kickback Statute

• The Anti-Kickback Statute is a criminal statute which prohibits the giving, accepting, soliciting (i.e., asking for) or arranging items of value in any form (gifts, certain discounts, cross-referrals between parties), either directly or indirectly for the purpose of inducing or rewarding another party for referrals of services paid for by a federal government health care program. 

Federal Anti-kickback Statute

• The statute is very broad and, in addition to the obvious referrals of residents or services residents need, it also covers purchasing, ordering, leasing or arranging for or recommending the purchase, leasing or ordering of services paid for by a federal health care program in exchange for any item of value.

Stark Law or Physician Self-Referral

Law• Stark law, actually three separate provisions,

governs physician self-referral for Medicare and Medicaid patients. The law is named for US Congressman Pete Stark who sponsored the initial bill.

• Penalties for Violationso Claims repaymento False Claims Act Liabilityo Civil Monetary Penaltieso Program Exclusion

Stark Law or Physician Self-Referral

Law• Stark law purpose: Prohibit improper referral

relationships that can harm the Federal health care programs and program beneficiaries

• Watch the video about the Stark Law

• If you cannot view the video, click in the notes section of this presentation, copy and paste the URL into the address bar of your web browser

Federal Anti-kickback Statute and Stark Law• Review the following document and keep it for

reference

• http://oig.hhs.gov/compliance/provider-compliance-training/files/HandoutLegalCitations508.pdf

• If you are having problems viewing this .pdf file, please click in the notes box below to copy and paste the URL into your web browser’s address box

Civil Monetary Penalties Law

• Regulations which apply to any claim for an item or service that was not provided as claimed or that was knowingly submitted as false, and which provides guidelines for the levying of fines for such offenses

Criminal Health Care Fraud Statute

• Whoever knowingly and willfully executes, or attempts to execute, a scheme or artifice—

(1) to defraud any health care benefit program; or

(2) to obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or

property owned by, or under the custody or control of, any health care benefit program,

Proper Compliance Documentation

• Record all customer interactions pursuant to the medical device or medical laboratory tests

• Contracted Sales staff will maintain a CMS to document all customer interactions, providing a report to NRLBH if necessary.

Overview• View the following document to review these

compliance laws and their importance

• Compliance Summary

Next Step1.Sign course/compliance completion form

(next slide) and send to al@AWVProgram.com or mail to:Al Lee & Associates, Inc.PO BOX 702685Dallas, TX 75370-2685

*lab may delay sample processing from physicians whose reps have not completed form

NRLBH Pharmacogenomics Testing Course completion

 Certification of Completion for ______________________ contracted by Al Lee & Associates, Inc.

By signing below, you certify that you have completed Pharmacogenomics and Compliance Training and that you understand and comply with the Training

•Print Name:___________________________________•Signature: ____________________________________ •Date: ________________________________________