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Furnishing Your Compliance House: OIG Risk Areas Marie C. Infante, Sr. VP, Chief Compliance Furnishing Your Compliance House: OIG Risk Areas Marie C. Infante, Sr. VP, Chief Compliance Officer, Golden Living & Affiliated Companies Ken Burgess, Esq. Poyner Spruill, LLP

Furnishing Your Compliance House l Our “house” analogy – Structural aspects of compliance program Furnishing Your Compliance House l Our “house” analogy – Structural aspects of compliance program (written) l l l Compliance officer, committee Employee codes of conduct Training and education Auditing and monitoring Reporting Compared to the laws and company policies that make up the interior or “guts” of the program

Stated Differently l Think of compliance in 2 parts: – – l The laws/policies Stated Differently l Think of compliance in 2 parts: – – l The laws/policies you must comply with The mechanical systems that help ensure you do Now, we’re ready to start discussing the “furniture” or, in OIG-speak, the risk areas nursing facilities should focus on in their compliance programs

The Anti-Kickback Statute l Focus: referrals of residents and/or services paid for in whole The Anti-Kickback Statute l Focus: referrals of residents and/or services paid for in whole or in part by any federal health care program (Medicare, Medicaid, Tri. Care, etc. ). Focuses on: – – How you make or receive referrals, and Whether you give, receive, solicit or help arrange anything of value as part of process of obtaining or making referrals.

Major Sources of Referrals We Get l l l MDs Other health care professionals Major Sources of Referrals We Get l l l MDs Other health care professionals Hospital/hospital discharge planners Hospices Home health agencies Other SNFs

Major Referrals We Make l l l l Hospices DME Labs LTC pharmacies Hospitals Major Referrals We Make l l l l Hospices DME Labs LTC pharmacies Hospitals MDs Other SNFs Therapy companies/therapists

Both Types Must Comply with Anti. Kickback Statute l l Places limits on business Both Types Must Comply with Anti. Kickback Statute l l Places limits on business arrangements relating directly/indirectly to federal health care program business which in any other context would be permissible and/or encouraged Examples: free computer from pharmacy, free training of certain types, swapping Part B business for the fixed-price Part A

What the Statute Prohibits l 1) Giving, accepting, soliciting (asking for) or arranging for What the Statute Prohibits l 1) Giving, accepting, soliciting (asking for) or arranging for 2)items of value, in any form (gifts, certain discounts, cross-referrals, cash), 3) directly or indirectly 4) for purpose of inducing or rewarding another party to make referrals of services 5) paid for in whole or part by any federal health care program.

What It Prohibits l Very broad statute covering: – – Referrals of residents or What It Prohibits l Very broad statute covering: – – Referrals of residents or services residents need And purchasing, ordering, leasing Or arranging for or recommending purchase, lease or ordering of services paid for by any federal health care program In exchange for any item of value l Value is broadly defined and interpreted

Criminal Statute l l l Prison time, criminal fines, exclusion from federal health care Criminal Statute l l l Prison time, criminal fines, exclusion from federal health care programs Potential basis for False Claims Act violation Sanctions apply to all parties in transaction – l “Intent” to engage in prohibited act – l Giver, receiver, “arranger” of payment for referrals Not necessarily intent to break the law If even one purpose of transaction is to induce/reward referrals, that’s sufficient for violation

Highly Scrutinized Transactions l Some transactions have characteristics that essentially lead OIG to presume Highly Scrutinized Transactions l Some transactions have characteristics that essentially lead OIG to presume illegal intent – – Does facility or its representatives/affiliates provide anything of value to persons in position to influence or generate referrals of federal health care program business? Does facility or its representatives/affiliates receive anything of value from persons for whom facility generates referrals of federal health care program business?

OIG’s Recommended Queries to Spot “Aggravating Factors” l l l Does arrangement have potential OIG’s Recommended Queries to Spot “Aggravating Factors” l l l Does arrangement have potential to skew or interfere with objective clinical decisionmaking? Or have potential to increase costs to federal health care program? Or increase risk of over-utilization or inappropriate utilization (e. g. , not medically necessary)?

OIG’s Recommended Queries to Spot “Aggravating Factors” l l Or raise patient safety or OIG’s Recommended Queries to Spot “Aggravating Factors” l l Or raise patient safety or qualify of care concerns If arrangement involves appropriate & medically necessary services, is payment made or received consistent with fair market value for similar services?

The “Safe Harbors” l l l Transactions that fit squarely within one of these The “Safe Harbors” l l l Transactions that fit squarely within one of these will not be prosecuted even if may otherwise seem prohibited by statute See list in our materials at www. ahcancal. org If it doesn’t fit, they don’t have to acquit Must then prove lack of illegal intent or other elements of a kickback offense Risk of heightened scrutiny for these

Help Me! I’m Confused! l Re the Anti-Kickback Statute – Ensure your employees are Help Me! I’m Confused! l Re the Anti-Kickback Statute – Ensure your employees are aware of a general prohibition on items of value exchanging hands between actual or potential referral sources l – – In either direction or through third parties Ensure all such arrangements are in writing and reviewed by legal counsel When possible, fit it within a safe harbor All transactions at fair market value (unless permissible discount applies) When in doubt, don’t

Sub-Risk Areas Under the Anti. Kickback Statute l l l OIG has identified several Sub-Risk Areas Under the Anti. Kickback Statute l l l OIG has identified several specific types of transactions with heightened risk under the statute We’ll cover several over next couple of webinar sessions Today, begin with: – – Free goods and services Services contracts (physician services & nonphysician services)

Strategic Direction l l Align Compliance Goals with Business Objectives More Doing; Less Checking Strategic Direction l l Align Compliance Goals with Business Objectives More Doing; Less Checking – – – l Decision Support Consultation Training & Education Getting to YES – – Identify and remove barriers to compliance Find solutions to business problems

Compliance Business Asset or Necessary Evil? l Compliance ensures that Golden Living & Affiliates Compliance Business Asset or Necessary Evil? l Compliance ensures that Golden Living & Affiliates have the appropriate risk and control framework in place to minimize risks

What Risks? l l l l Regulatory Civil Criminal Transactional Operational Financial Ethical l What Risks? l l l l Regulatory Civil Criminal Transactional Operational Financial Ethical l Strategic – – Competition Market Evolution Brand Image & reputation Technology Innovation

Schizophrenic Role of Compliance Department l Old View: Compliance is Best Procured by Vigorous Schizophrenic Role of Compliance Department l Old View: Compliance is Best Procured by Vigorous Enforcement, Oversight – Police function Militaristic Adherence to rigid rules and regs Enforcement will produce compliance - if only there were enough resources to get the job done Tattletale Shadow Effects; Second Guessing – Learned Helplessness, Disincentives – –

Old Thinking l “We’ve always done it this way…” l “Our hands are tied…” Old Thinking l “We’ve always done it this way…” l “Our hands are tied…” l “Learned helplessness” l “…A moose around your neck…”

Corporate Compliance Programs – A Work in Progress l Why the Supplemental Guidance Helps Corporate Compliance Programs – A Work in Progress l Why the Supplemental Guidance Helps a CCO – Compliance programs are a work in process l l Changed circumstances New developments Employee turnover New leadership direction

Risk Areas l The Federal Anti-Kickback Statute – – Free Goods and Services Service Risk Areas l The Federal Anti-Kickback Statute – – Free Goods and Services Service Contracts l l Physician Services Non-physician Services

Federal Anti-Kickback Statute Establishes criminal penalties for Offering OR providing OR receiving Inducements For Federal Anti-Kickback Statute Establishes criminal penalties for Offering OR providing OR receiving Inducements For the referral of business paid for By Federal healthcare programs

AKS Anxiety l l Tends to ensnare harmless or even beneficial business arrangements Implications AKS Anxiety l l Tends to ensnare harmless or even beneficial business arrangements Implications for healthcare reform efforts? – – Joint ventures or relationships intended to increase efficiency and produce cost-savings may induce referrals May also induce underutilization l Uncertainty of enforcement – – – Priorities of the local US Attorneys Office Personality of the particular prosecutor Uncertainty of the enforcement climate

What is Remuneration? Remuneration: Can be anything of value Money Gifts Vacations Expensive dinners What is Remuneration? Remuneration: Can be anything of value Money Gifts Vacations Expensive dinners Free or below fair market value services or rent Event tickets l Also implicated – – Rental payments Number of Medical Directors Routine waiver of copayments Pricing arrangements for goods and services l l “value added” services Bundled payments

The “One Purpose Test” l If any intent of giving anything of value is The “One Purpose Test” l If any intent of giving anything of value is to induce a referral it is a crime – – l l "knowingly and willfully" "to induce" or "in return for" referring or arranging for program-subsidized business. Proof may rest on a lone email about expected revenue benefits of a deal or relationship Must be able to defend the business purpose for why you provided a referral source with any item of remuneration.

Defensible Arrangements Fit exactly into a “safe harbor” OR, l Are Clinically sound l Defensible Arrangements Fit exactly into a “safe harbor” OR, l Are Clinically sound l Arm’s length l Based on FMV l

Contracting Issues l l Legitimate need for the services Services actually performed & documented Contracting Issues l l Legitimate need for the services Services actually performed & documented FMV- $$$ not related to value or volume of referrals; commensurate with skills, experience Arm’s length transaction – – – no conflicts of interest; manner of selection; ability to influence referrals

Kickbacks in Sheep’s Clothing l l “Value added” services Bundled services De minimus payments Kickbacks in Sheep’s Clothing l l “Value added” services Bundled services De minimus payments or gifts Other excuses – – Our hands are tied Everybody else is doing it!

From Compliance to Commitment l The Best Approach to Compliance is to Minimize the From Compliance to Commitment l The Best Approach to Compliance is to Minimize the Need for It – More Intelligent Use of Data l Dissemination of Information l Evidence-Based Practices, CPGs l Education l Partnerships l Negotiation Alignment of Information Systems – Compliance visibility; Decision support; consultation –