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The Carolinas Center for Hospice and End of Life Care – August 31, 2016

Charlotte, North Carolina

Understand the law Know the players Be aware of enforcement/investigative/audit

activity Understand marketing’s roles in compliance Predict and plan for the future

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False Claims Act Anti-Kickback Statute Civil Monetary Penalties Act Combined, these laws create an environment

that prohibits conduct that is commonly accepted and legal in businesses other than health care

Establishes liability for any person who knowinglypresents or causes to be presented a false or fraudulent claim to the U.S. government for payment

The term “knowingly” is defined to mean that a person, with respect to information: has actual knowledge of falsity of information in the claim acts in deliberate ignorance of the truth or falsity of the

information in a claim acts in reckless disregard of the truth or falsity of the

information in a claim

The act does not require proof of specific intent to defraud the government.

Prohibits the offer, solicitation, receipt or payment of remuneration in order to knowingly or willfully induce or reward referrals

Remuneration = anything of value, opportunity to make money, in cash or in kind

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The "safe harbor" regulations describe various payment and business practices that, although they potentially implicate the Federal anti-kickback statute, are not treated as offenses under the statute Personal Services Safe Harbor Lease of Space Safe Harbor Bona Fide Employee Safe Harbor

Prohibits the offer or transfer to a Medicare or Medicaid beneficiary “remuneration” that the person knows or should know is likely to influence the beneficiary’s selection of a particular provider, practitioner, or supplier of Medicare or Medicaid payable items

Remuneration = waivers of copayments and deductible amounts (or any part thereof) and transfers of items or services for free or for other than fair market value OR anything of value

Penalties of up to $50,000 per violation

False Claims Act Fines of up to $11,000 per claim Treble Damages Exclusion CIA Potential for Criminal sanctions of up to 5 years imprisonment and

up to $250,000 fine Anti-Kickback

Offenders face a fine of no more than $25,000 or imprisonment of no more than 5 years

Anyone who receives, offers, or pays illegal remuneration commits a felony

Exclusion from Medicare/Medicaid Corporate Integrity Agreement

Civil Monetary Penalty Fines of up to $50,000 per violation

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Anti-kickback statute applies when . . . .

Provider

Referral Source

$ or Benefit

Patients/Referrals

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Medical Directors Physician Practices Hospitals Assisted Living Facilities Nursing Homes Home Health Agencies Community Groups Employees????? In other words . . . People or groups from whom

you hope will send you referrals. If you aren’t sure, ASK.

AKS is an intent based statute So, what was your intent in entering into the

agreement?

The following list constitutes examples of benefits that were provided to referral sources that the government deemed illegal Educational grants and fellowships Conferences Free dinners and gifts Expenses paid to physicians under purported consulting

agreements Sporting and entertainment event tickets Gift certificates Rounds of golf and golf equipment Fishing trips Meals Advertising expenses Office equipment and medical equipment

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There are exceptions Financially needy individuals can receive co-pay waivers Preventative Services under certain circumstances

(screenings) Analysis

Is the benefit worth more than a nominal value? Would it influence the beneficiary’s choice of provider? Would you or should you know it would influence their

choice? But For Test: But for the fact that the recipient is a

referral source, would you have given this benefit?

Volunteers can be asked to provide services for free – IS THIS A PROBLEM?

It can be, but case by case basis OIG Advisory Opinion 00-3

Approved the provision of free services based on First, the services are provided by unpaid volunteers; Second, the benefits of the Program are primarily intangible and psychic in the

sense that the services are designed to help the patients adjust to their illnesses by helping them and their friends and families to cope with the day to day burdens of life;

Third, the Program provides a substantial benefit to a vulnerable patient group; and

Fourth, there are substantial barriers to a beneficiary's election of hospice care, including the requirement that he or she renounce coverage for curative medical treatment for the terminal condition.

COPs – 418.78 Household chores, shopping, transportation and companionship. Sewing and quilting

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Why do we have Medical Directors? A. Quality CareB. Because the COPs require us to do soC. Increase referralsD. A & BE. B & CF. All the Above

Set out in writing, signed by the parties and is for a term of not less than one year Covers all of the services to be provided by the physician for the term of the

agreement and specify the services to be rendered If the agreement is intended to provide for services on a periodic, sporadic or part-

time basis, rather than on a full-time basis, then the agreement must specify exactly the schedule of such intervals, their precise length, and the exact charge for such intervals

The aggregate compensation paid to the physician over the term of the consulting agreement must be set in advance, be consistent with fair market value in arms-length transactions and not be determined in a manner that takes into account the volume or value of any referrals or business otherwise generated between the parties for which payment may be made in whole or in part under federal health care programs

The services performed under the agreement must not involve the promotion or counseling of an activity or business arrangement that violates any state or federal law

The aggregate services under the consulting agreement must not exceed those which are reasonably necessary to accomplish the commercially reasonable business purpose of the services.

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Why do you need another Medical Director?

Think back: One purpose rule Commercially reasonable services

Picking Medical Directors based on referrals Tracking Referrals – generally probably OK if

part of overall tracking Meeting with doctor to discuss referral volume Promising more hours if you send more

patients Threatening to terminate agreement if he/she

doesn’t start referring

Picking medical directors based on qualifications in accordance with COP duties

Time Sheets Community need documentation Thorough documentation of any known non-

compliance and reasons No MDs willing to perform services

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If owned or controlled by referral source, remember Anti-Kickback analysis

Lease of Space Safe Harbor Commercially reasonable Must be FMV The term fair market value means the value of the rental

property for general commercial purposes, but shall not be adjusted to reflect the additional value that one party (either the prospective lessee or lessor) would attribute to the property as a result of its proximity or convenience to sources of referrals or business otherwise generated for which payment may be made in whole or in part under Medicare or a State health care program.

FMV, FMV, FMV

BIG focus Remember AseraCare and Harmony Look to safe harbor – but be very very cautious

Are there other mechanisms to accomplish same goal

Bona Fide Employee Safe Harbor The anti-kickback statute excepts from its reach “any

amount paid by an employer to an employee (who has a bona fide employment relationship with such employer) for employment in the provision of covered items or services.” See section 1128B(b)(3)(B) of the Act. The OIG safe harbor regulations provide that the term “remuneration,” as used in the anti-kickback statute, does not include any amount paid by an employer to a bona fide employee for employment in the furnishing of any item or service for which payment may be made in whole or in part under Medicare or a State health care program.

Look to IRS test for employee

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Compliance Strategies Objective Criteria set forth in written policy Ensure “bona fide employees” only Be clear and “honest” as to what you are trying to

accomplish with bonus Balance incentives with disincentives “items and services”

1. Improper certification2. General Inpatient Care3. Keeping patients too long –

Recertification4. Medical Directors5. Marketing to beneficiaries and referral

sources6. Relationships with Nursing Homes

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Initial Eligibility Late Face to Face Promising Hospice Staff to Faclities Benefits to Referral Sources

Box seats at sporting events Pay for funeral expenses

Corporate Quotas

Initial Watch out for non-cancer diagnoses Be careful with aggressive admission strategies Monitor your live discharges

Face-to-Face Have systems in place to ENSURE they are timely Utilize the system and rely upon medical decision

making Do not impose administrative will on clinical

decisions

Provision under False Claims Act that allows a whistleblower to file suit on behalf of the Government

Primary enforcement method Highly Incentivizes employees to turn you in $$$$$ and “vengeance” Sharp increase in qui tam cases

Education Publicity of awards

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Routine Care Eligibility Aggressive Marketing Internal Targets Lack of documentation to support terminal

illness

Two physicians to certify that a person is likely to live no longer than six months in order for a person to be eligible for hospice care

Poor documentation Aggressive Marketing Goals No real proof of false claims and ineligible

patients, but ….. General picture was lack of focus on

compliance Battle of experts

Retroactive review of deceased patients charts Ignored treating physician decision

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Enormous money at stake FCA Penalties are draconian Legal Fees Potential criminal and administrative action PRIMARY ISSUES

Proving Falsity Statistical Sampling

Significant Developments

Government alleged hospice admitted and retained ineligible patients

Very Aggressive Marketing Practices Executive Pressure to Admit Financial Decisions Trumped Clinical Prizes and Bonuses for Admissions Fired employees who didn’t meet targets Aggressive marketing to “last breath” referrals to

manage CAPs

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DOJ used statistical sampling to arrive at a damages figure of more than $200 million by taking a sample of 124 patients from a pool of 2,181 patients, looking at payments in the sample, extrapolating those payments to a larger universe of claims and then tripling the amount (as treble damages are allowed under the FCA)

Trial was bifurcated. In Phase I of the trial, the jury would consider whether the claims submitted by AseraCare for a sample of 121 patients were objectively false. In Phase II, DOJ would have to prove that AseraCare had knowledge that the claims for those 104 patients were false

Phase 1 Jury verdict against Aseracare Judge took up post-trial motions

Granted retrial on her own jury instructions (1) failing to provide an instruction on objective

falsity or objective evidence of falsity; and (2) overruling the defendant’s request for an instruction that a difference of opinion is not enough to establish falsity.

Then granted summary judgment “sua sponte” in favor of Aseracare

“When hospice certifying physicians and medical experts look at the very same medical records and disagree about whether the medical records support hospice eligibility, the opinion of one medical expert alone cannot prove falsity without further evidence of an objective falsehood.”

“concerned that allowing a mere difference of opinion among physicians alone to prove falsity would totally eradicate the clinical judgment required of the certifying physicians” and that if “all the Government needed to prove falsity in a hospice provider case was one medical expert who reviewed the medical records and disagreed with the certifying physician, hospice providers would be subject to potential FCA liability any time the Government could find a medical expert who disagreed with the certifying physician’s clinical judgment.”

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Nursing Home Case Government alleged a nationwide scheme to

provide medically unnecessary services Government intended to present specific

evidence as to a sample of 400 claims to show violations of FCA

Extrapolate LIABILITY and DAMAGES to total universe of claims of 54,396 7.3% of claims

Court admitted there was no precedence for determining liability through sampling

Lengthy line of cases allowing for sampling for purposes of damages

Court recognized this critical distinction but ….

Ruled Evidence of specific claims - Government could specify in

detail the specific claims for which it alleges are false, but in order to do so, it would require the devotion of more time and resources than would be practicable for any single case.

Falsity – Court acknowledged “medical necessity” for therapy is patient-specific but determined defendant could challenge extrapolation through cross examination and competing witness testimony See Aseracare

Knowledge – Court determined their actual knowledge of the claims was a question for the jury.

Due Process – See Falsity

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Virtually identical allegations Columbia, South Carolina – 4th Circuit

South Carolina and North Carolina

Government declined to intervene Judge denied use of statistical sampling Parties resolved the matter Statistical sampling and government’s ability to

object to settlement on appeal at 4th circuit October oral argument

How will courts in hospice cases reconcile Aseracare and Life Care?

What can you do? Beware of corporate policies that make it easy to

sample Quotas Eligibility determinations Admission policies

Bonuses Particularly for integrated companies Kickbacks/Quid pro quo Quotas Aggressive marketing Lengthy LOS If you are over 6 months, have a review

committee/policy focused on clinical

Non-clinical participation in eligibility determinations

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Any Medicare provider or supplier who has identified an overpayment must return the overpayment within 60 days after the date it was identified or the date applicable cost report was due

“Overpayment” any amount of money you were paid that was in excess of what you should have received for the services provided

Significant elements from final rule When is an overpayment “identified”?

When through the exercise of reasonable diligence: Determined that it has been overpaid Quantified the amount of the overpayment

How far back do you have to go? “Look back period” Changed from 10 years in proposed rule to 6 years

What is “reasonable diligence”? Proactive compliance activities conducted in good

faith by qualified individuals to monitor for the receipt of overpayments and investigations conducted in good faith and in a timely manner by qualified individuals in response to obtaining credible information of a potential overpayment

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CMS’ position is that a single overpaid claim presents sufficient credible information to require a further inquiry

CMS examples Repeated hotline complaints about same/similar

issues Known or discovered kickback schemes to which the

entity is a party Not applicable to third party

Reasonable diligence investigation If you should have started, but don’t, that can trigger

60 days Includes efforts to quantify

CMS believes a 6 month investigation is a benchmark

60 day timeline starts once you complete investigation and determine overpayment exists and how much “approximately”

RAC, MAC, ZPIC, etc. If overpayment is determined, CMS position is

administrative process determined during audit does not stop or delay 60 day requirement

Contact a knowledgeable lawyer. This is a minefield

Do you repay without appeal rights? Lots of issues to analyze

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Eligibility audits Focus on prepayment audits

Face to Face Incomplete documentation Untimely documentation Not applicable to CAP Kickbacks

Compliance program with attention paid to payment accuracy

If you think you have been overpaid: Immediately begin investigation with lawyer

assistance if possible Determine if in fact it is an overpayment Investigate how overpayment occurred and then

breadth of investigation Move diligently but be thorough

Southern Care, Inc., a hospice company that in 2009 paid $24.7 million to settle an FCA case. The alleged frauds were that patients were not eligible for hospice, to wit, were not terminally ill, lack of documentation of terminal illnesses, and that the company marketed to potential patients with the promise of free medications, supplies, and the provision of home health aides. Southern Care also entered into a 5-year Corporate Integrity Agreement with the OIG as part of the settlement

In 2005, Faith Hospice, Inc., settled claims regarding an FCA action for almost $600,000. The hospice fraud allegations were generally that Faith Hospice billed Medicare for providing hospice care to patients more than half of whom were not terminally ill and thus not eligible for hospice Medicare and Medicaid benefits

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In 2008, S-Hospice Group, Inc. d/b/a Home Hospice of North Texas, and its principal owners, Andrew P. Milligan and Neil F. Livingston, settled an FCA claim for $500,000 regarding allegations of fraudulently billing Medicare regarding hospice services. The U.S. alleged Home Hospice: (1) was paid for claims for unallowable hospice items and services; (2) misrepresented to Medicare the medical conditions of patients to ensure such patients would be or continue to be patients; (3) misrepresented to physicians the medical conditions of patients to ensure they would certify or continue to certify that patients were appropriate for admission; and (4) misrepresented the purpose of and coverage criteria of Medicare’s hospice benefit to ensure patients were or continued to be admitted for hospice care. The defendants cooperated with the government during its investigation, and, due to their demonstrated financial problems, the amount of the settlement was substantially reduced and they were allowed to make settlement payments over a several-year time period. The defendants also entered into a five-year Corporate Integrity Agreement with OIG to ensure compliance with applicable Medicare hospice statutes and regulations.

In 2000, Michigan osteopath Donald S. Dreyfuss, who earlier pleaded guilty to several health care fraud charges, including violation of the AKS, 42 U.S.C. § 1320a-7b(b)(1)(B), for receiving illegal kickbacks from a hospice for recommending the hospice to the staff of the osteopath’s nursing home staff, settled civil FCA claims for $2 million. The defendant was sentenced in the criminal case to two years of home confinement and five years probation, and ordered to pay a criminal fine of $213,030.80 and restitution in the amount of $522,225.00. In addition to the kickbacks, the defendant knowingly billed Medicare and Medicaid for providing physician services to nursing home patients when he had never actually provided such services, the services were not medically necessary, or the complexity of the services was exaggerated. The government also alleged that, in connection with a hospice, Dr. Dreyfuss knowingly certified that patients were eligible for Medicare or Medicaid services when, in fact, they were not.

A physician group practice paid the Government $1 million and entered into a 5-year Corporate Integrity Agreement to settle alleged violations of the AKS, FCA, and Stark law related to medical directorships with a medical center. Allegedly, the agreements were not in writing, the physicians were paid more than fair market value for the services they rendered, and the payment amounts were based on the value of referrals the physicians sent to the medical center

Two orthopedic surgeons paid $450,000 and $250,000 to settle allegations related to improper medical directorships with a company that operated a diagnostic imaging center, a rehabilitation facility, and an ambulatory surgery center. The company allegedly provided the physicians with valuable compensation, including free use of the corporate jet, under the medical directorship agreements, which required the physicians to render limited services in return. The agreements with the physicians allegedly called for redundant services and served to encourage the physicians to refer their patients to the facilities operated by the company.

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SouthernCare, Inc. – Alabama qui tam – $24.7 million to settle allegations that

they improperly billed Medicare for patients treated at Hospice facilities

Kaiser Foundation Hospitals – Physicians & Surgeons agreed to pay $1,830,322.41 in

False Claims Act liability for services allegedly billed w/o written certifications of terminal illness in 2000-2004.

Faith Hospice, Inc. $600,000 Settlement Investigation initiated after a sample review of their

medical records More than half of the patients were ineligible for hospice

care

Odyssey Hospice $12.9 Million Settlement Whistleblower Former VP brought Qui Tam Suit ($2.3 million) 5 year CIA IVO audits annually 2 samples records:

Reliant Hospice – District of South Carolina Allegations were that it improperly admitted patients/gave benefits for

referrals/ including using a sister company to exclusively supply all durable medical equipment; the sister durable medical equipment company also allegedly acted as a generator of leads.

During the DOJ investigation phase, Reliant Hospice's owner sold its patients to another hospice on a pay per patient basis.

After selling its patients, it shut its doors. Relators moved to pierce the corporate veil Executive paid $25,000, Hospice paid $1,500,000

Harmony Care – Columbia, South Carolina Qui Tam suit filed by two former employees Allegations

Ineligible patients Management knew of employee complaints and did

nothing Admissions for CAP management

Marketing Bonuses to employees were violations of the anti-

kickback statute

Settled for $1,286,999.32 and CIA

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Detailed & restrictive agreements that the OIG imposes on providers, when that provider is found to be involved in serious misconduct.

Give a Provider a 2nd chance Increased dramatically in past 5 years 1994 - 4 CIAs; 1998 - 232 CIAs; 2001 – 500+;

Today – 1,000+

Hire a Compliance Officer/appoint committee Develop written standards and policies Implement comprehensive training program Engage Independent Verification Organization Establish confidential disclosure program Restrict employment of ineligible persons Report to OIG certain information and reports

at specified intervals.

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Uninformed consent to elect the Medicare Hospice Benefit

Admitting patients to hospice care who are not terminally ill

Arrangement with another health care provider who a hospice knows is submitting claims for services already covered by the Medicare Hospice Benefit

Under-utilization Falsified medical records or plans of care

Untimely and/or forged physician certifications on plans of care

Inadequate or incomplete services rendered by the Interdisciplinary Group

Insufficient oversight of patients, in particular, those patients receiving more than six consecutive months of hospice care

Hospice incentives to actual or potential referral sources

Overlap in the services that a nursing home provides, which results in insufficient care provided by a hospice to a nursing home resident

Improper relinquishment of core services and professional management responsibilities to nursing homes, volunteers and privately-paid professionals

Providing hospice services in a nursing home before a written agreement has been finalized, if required

Billing for a higher level of care than was necessary Knowingly billing for inadequate or substandard

care

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Pressure on a patient to revoke the Medicare Hospice Benefit when the patient is still eligible for and desires care, but the care has become too expensive for the hospice to deliver

Billing for hospice care provided by unqualified or unlicensed clinical personnel

False dating of amendments to medical records High-pressure marketing of hospice care to ineligible

beneficiaries Improper patient solicitation activities, such as ‘‘patient

charting” Inadequate management and oversight of subcontracted

services, which results in improper billing Sales commissions based upon length of stay in hospice

Deficient coordination of volunteers Improper indication of the location where hospice

services were delivered Failure to comply with applicable requirements for

verbal orders for hospice services Non-response to late hospice referrals by

physicians Knowing misuse of provider certification numbers,

which results in improper billing Failure to adhere to hospice licensing requirements

and Medicare conditions of participation Knowing failure to return overpayments made by

Federal health care programs

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Department of Justice HHS – OIG

Power to Exclude Providers

FBI IRS Department of Defense – Inspector General/

Criminal Investigations - Tricare State Agencies – Medicaid Fraud Unit Health Care Fraud Working Groups Medicare Contractors

QIO, Program Integrity Units, MAC, RACs, ZPICs

Civil False Claims Act liability

Criminal Mail/Wire Fraud Health Care Fraud Money Laundering False Statements

Administrative Suspension/Debarment

Search Warrants Grand Jury Subpoenas – documents/testimony Undercover Investigations Witness Interviews

Very disruptive

Wiretap investigations - rare Criminal Investigators involved

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Civil Investigative Demands – False Claims Act Admin Subpoenas - HIPPA subpoenas Requests for voluntary disclosure of

information Witness interviews Civil target letter

Insider Complaints – employees, former employees, patients or families

Data Mining Competitors Routine Reimbursement Audits Qui Tams:

private persons (“Whistleblowers” or “Relators”) may initiate a suit on behalf of the government

The government may choose to intervene Often former disgruntled employees – Senior

Management Entitled to share in any recovery

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Software that processes and monitors 4.5 Million Part A, B and DME claims each day

Looks for “outliers” To spot

high claim rejection or recoupment rates higher utilization than area providers high clinical case mix assignment and patients with high lengths of stay

No more guessing. Active investigative mechanism

Creation of ZPICs Medicare Modernization Act of 2003 Implemented late 2008

Goal of ZPICs Program Integrity Manual, Chapter 4, IOM Pub No.

100-08 Identify cases of suspected fraud Develop them thoroughly In a timely manner, and Take immediate action to ensure that Medicare Trust

Fund monies are not inappropriately paid out, and That any mistaken payments are recouped.

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Data analysis, complaints, and referrals are the main triggers for ZPIC audits.

Employee or beneficiary complaints to the Office of Inspector General hotline, fraud alerts, or even directly to the ZPIC can trigger an audit.

What Are The Potential Outcomes From A ZPIC Audit? suspension of payment; recoupment of alleged overpayments; referral to enforcement agencies, such as OIG; and revocation of participation in Medicare

Payment ZPICs not paid on contingency, unlike RAC ZPICs are paid bonuses based on amount of

overpayments found. They need their contracts renewed, so, it’s in ZPIC’s

best interest to find overpayments.

Provider Educations and Warnings Pre-Payment Audit

No payment for Medicare claims until provider submits documentation to prove medical necessity for the billed service.

Has a definite start date but no definite end date. Getting off of pre-payment review is based on approval-

denial percentage. Post-Payment Audit

Method by which Medicare contractor recoups money paid for services that is deemed not medically necessary by the ZPIC.

Extrapolation Post-payment audit has a start and end date.

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Suspension of Payments Suspend payments to Medicare and Medicaid providers and

suppliers pending the outcome of an investigation of credible fraud allegations.

If fraud is suspected, ZPIC can suspend the provider's payments and the provider is notified after the suspension is implemented.

Providers are not allowed to appeal a payment suspension. Payments suspended for at least 180 days.

Revocation of Assignment Refer to Civil and Criminal Enforcement

ZPICs are actively referring providers to HHS-OIG. You will never know if you have been referred to OIG unless

and until OIG shows up at your door.

Site Visit Team of investigators Interview employees Asks for few records immediately Stay for hours Appear very friendly Leave you with an ADR for many more records

Call an attorney Follow protocol Stay organized from the beginning

Dedicate specific people to documentation Always send records via Certified Mail

Keep track of ZPIC's mistakes and Questions Retain copy of EVERYTHING you send to

ZPIC Do not complain to ZPIC. Be cooperative

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Call an attorney Develop, Implement, Support and FOLLOW a

Robust Compliance Program Clinical Record MUST Support Certification

and all Re-Certification Re-think documentation

- If you didn’t document it, it didn’t happen- “Negative Charting”

Internal Auditing Internal Trending

LOS F2F Timeliness

Government Reports Plan for risk

Live Discharges Discharged alive with LOS < 25 days

Long Length of Stay LOS > 180 days

80th Percentile Considered “at risk”

www.pepperresources.org

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Government audits are drastically and quickly changing how you need to look at documentation No longer just risk management

Don’t assume your documentation is sufficient Take a critical, objective view of all documentation

Understand you are not only documenting services performed, but also supporting your bill

A lawsuit is painful, but an audit gone bad can be catastrophic

Points to consider as you move forward Work on your compliance program with the

understanding this is not just for traditional risk management

Don’t assume you are doing a good job You will be surprised . . . and likely not in a good way

Think globally on your documentation needs Have a policy and follow it

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Compliance Programs will be mandatory for all hospices

Components Compliance standards and procedures for employees and

other agents “that are reasonably capable of reducing the prospect” of criminal, civil, and administrative law Medicare and Medicaid violations

The effective communication of compliance standards and procedures to all employees and agents, including training programs or published materials

The periodic reassessment of its compliance program to identify modifications necessary to reflect changes within the organization

The 60 Day Rule for reporting overpayment Must report and return known overpayments within

60 days of the date identified, or else a False Claims Act violation

Critical that you have systems in place to monitor compliance

What to self-report Known overpayments (FCA) Thorough investigation Make sure it is actually an overpayment

Known kickback violations Physician Agreements – rare Benefits to referral sources

How to self-report OIG Self Disclosure Protocol Fiscal Intermediary DOJ

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United States v. Park - Liability as a responsible corporate officer does not turn upon a corporate officer’s approval of wrongdoing, but rather on whether the officer had, by reason of his or her position in the corporation, responsibility and authority either to prevent, or promptly correct, the violation at issue, and the officer failed to do so

Corporate officers subject to prosecution and exclusion

Very aggressive enforcement activity Novel strategy OIG/DOJ result based prosecution Safe Harbors under attack

Tuomey case FMV Commercial Reasonableness

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Help prevent and detect violations of law or rules Set expectations of behavior for employees and raise

employee awareness Demonstrate commitment of organization Foster prompt reporting of problems Serve as a mechanism for monitoring and corrective

action Promote internal communications and ethical behavior Reduce threat of whistleblower activity Create documentation benchmarks to ensure risk

management, compliance and maximize profit efficiencies

Code of Conduct Chief Compliance Officer Corporate, Board and Leadership Commitment Create a “Culture of Compliance” Policies & Procedures

Concise, straightforward and simple Marry operational objectives with legal and

regulatory constraints Continued ongoing review, evaluation and updating

Auditing and Monitoring Ensure the compliance and ethics program is

followed, including monitoring and auditing to detect criminal conduct, periodic assessment of the organization’s compliance program , and communication mechanisms which allow for anonymous or confidential reporting without fear of retaliation.

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“Reporting Unethical or Illegal Conduct” You control the flow of information

“Billing Procedures” Catch issues before you bill

“Responding to Government Investigations” Maps out what to do when investigators walk in the

door

Not just for fraud and abuse Provides leadership the opportunity to create

culture Reinforces documentation requirements and

provides audit mechanisms to make sure P&Ps are being followed and they are effective

PRE-PAYMENT AUDITS!!! Catch problems before you bill for services You want to do these as opposed to the Government Decreases risk of post-payment audit and increases

likelihood of successful response

Develop a comprehensive compliance program Know the law Educate and train employees Create a culture of compliance Don’t be afraid to self-disclose