PROS LOWER COSTS BY STRIPPING OUT EXPENSES ASSOCIATED WITH DEVICE - - PDF document

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WHAT, ME WORRY?

• CONFLICT OF INTEREST
• RECOVERY CONTRACTORS
• FALSE CLAIMS ACT – CIVIL TO

CRIMINAL

• HIPAA
• SELF-DISCLOSURE

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PHYSICIAN-OWNED DISTRIBUTORSHIPS - POD

• RISK TO HOSPITAL AND PATIENTS
• COMPANIES SELLING MEDICAL IMPLANTS
• PHYSICIANS AS OWNERS OR INVESTORS

PRO’S

• LOWER COSTS BY STRIPPING OUT EXPENSES ASSOCIATED WITH DEVICE SALES
• INVESTING PHYSICIANS CAN COLLABORATE WITH MANUFACTURES TO FOSTER INNOVATION

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CON’S

• CHARGES ACTUALLY AVERAGE ABOVE NATIONAL AVERAGE RATES FOR IMPLANTS
• ENCOURAGES PHYSICIAN INVESTORS TO INCREASE SURGICAL PROCEDURES
• UNNECESSARY PROCEDURES
• PATIENT HARM

ENFORCEMENT

• OIG SPECIAL FRAUD ALERT
• STRONG POTENTIAL FOR IMPROPER INDUCEMENT BETWEEN POD AND PHYSICIAN INVESTORS AN

HEALTHCARE PROVIDERS THAT PURCHASE MEDICAL DEVICES.

• HOSPITALS PURCHASING DEVICES FROM POD REPORTED RATES OF SPINAL SURGERIES GREW FASTER

THAN HOSPITALS THAT DID NOT CONTRACT PODS.

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FALSE CLAIMS ACTION

• WHISTLE BLOWER SUIT AGAINST RELIANCE MEDICAL SYSTEM, ITS OWNERS ONE NON-INVESTOR

PHYSICIAN AND ONE PHYSICIAN INVESTOR

• INDUCED PHYSICIANS TO USE RELIANCE POD IMPLANTS IN THEIR SURGERIES
• OIG DOES NOT LIKE PHYSICIAN OWNERSHIP OF BUSINESSES.
• HOSPITAL OVERSIGHT IN QUESTION

WHAT YOU NEED TO KNOW

• DEVELOP A CONFLICT OF INTEREST POLICY REQUIRING PHYSICIAN INVESTMENT OR OWNERSHIP OF PODS
• CLARIFY WHO RECEIVES DISCLOSURE: ADMINISTRATION, PATIENTS?
• AUDIT MEDICAL NECESSITY PROCEDURES
• BOARD INVOLVEMENT

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RECOVERY AUDITORS

• 5 RACS – 4 REGIONAL RACS, 1 NATIONAL CONTRACTOR FOR DME/ HOME HEALTH
• EMPHASIS CHANGE:
• DO NOT TARGET PROVIDERS
• OIG, CMS, REPORTS FORMULATE REVIEW ISSUES
• LAW ENFORCEMENT TARGET INDIVIDUALS, SEND ABERRANT/ QUESTIONABLE ISSUE(S) TO RAC

RAC

• RAC DATA WAREHOUSE
• OIG, FBI HAVE ACCESS TO WAREHOUSE
• CAN SUPPRESS OR EXCLUDE FROM THE RAC AUDIT
• SUPPRESS IS TEMPORARY
• DUPLICATE REVIEWS

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FCA – CIVIL AND CRIMINAL

• DOJ AFTER PHYSICIANS, EXECUTIVES, HOSPITALS, HEALTHCARE COMPANIES
• “HEAT” NOW ON FALSE CLAIMS ACTIONS
• 40 ATTORNEYS IN DOJ ON CRIMINAL HEALTHCARE MATTERS

HIPAA

• HHS CONTINUING HIPAA AUDITS
• RISK ANALYSIS AND RISK MANAGEMENT - SECURITY RULE
• NOTICE OF PRIVACY PRACTICES AND ACCESS RIGHTS – PRIVACY RULE
• CONTENT AND TIMELINESS OF BREACH NOTIFICATIONS – BREACH NOTIFICATION RULE

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SELF-DISCLOSURE

• THE HOSPITAL AND THE GOVERNMENT ARE

COLLABORATIVE, NOT COMBATIVE

• NO CORPORATE INTEGRITY AGREEMENT
• NO MORE THAN DOUBLE DAMAGES
• THWART WHISTLE BLOWER FALSE CLAIMS ACTION

SELF-DISCLOSURE STEPS

• COMMUNICATION TO THE BOARD AND SENIOR STAFF –

WHO SHOULD BE IN THE LOOP?

• OUTSIDE COUNSEL AND/ OR CONSULTANTS?
• INVESTIGATIVE TEAM
• DOCUMENTS, COST REPORTS, AUDITS

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THE PROTOCOL

• INITIAL SUBMISSION – A FULL DESCRIPTION OF THE

MATTER BEING DISCLOSED

• INTERNAL INVESTIGATION
• SELF ASSESSMENT OF MONETARY IMPACT
• CERTIFICATION