WHAT, ME WORRY? • CONFLICT OF INTEREST • RECOVERY CONTRACTORS • FALSE CLAIMS ACT – CIVIL TO CRIMINAL • HIPAA • SELF-DISCLOSURE 1
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 2
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. 3
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 4
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 5
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 6
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 7
THE PROTOCOL • INITIAL SUBMISSION – A FULL DESCRIPTION OF THE MATTER BEING DISCLOSED • INTERNAL INVESTIGATION • SELF ASSESSMENT OF MONETARY IMPACT • CERTIFICATION 8
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