Post on 10-Oct-2020
transcript
PHARMACY LAWCASE REVIEW
APA REGIONAL MEETINGS 2018
DISCLOSURE
▪ I DO NOT HAVE A CONFLICT OF INTEREST TO DISCLOSE RELATING TO THIS CONTINUING
EDUCATION PROGRAM.
OBJECTIVES
▪ IDENTIFY AND DISCUSS THE CONTROLLED SUBSTANCES ACT VIOLATIONS IN THE CASE OF DEA AND CHIP
RX, D/B/A CITY CENTER PHARMACY.
▪ UNDERSTAND ADMINISTRATIVE INSPECTION WARRANTS AND APPLY GUIDELINES TO EXAMPLE
SCENARIOS.
▪ EXPLAIN AND IDENTIFY FEDERAL AND ADMINISTRATIVE VIOLATIONS IN THE 2018 TRICARE FRAUD CASE.
▪ COMPARE AND CONTRAST APPROPRIATE PHARMACIST AND TECHNICIAN ACTION(S) WITH
INAPPROPRIATE PHARMACIST AND TECHNICIAN ACTION(S) IN THE 2018 TRICARE FRAUD CASE.
CHIPRX
▪ CHIPRX, LLC (D/B/A CITY CENTER PHARMACY)
▪ CHAPMAN AND HIS WIFE ARE MEMBER-OFFICERS OF THE COMPANY
▪ HAMLIN, WEST VIRGINIA
▪ SHOW CAUSE ORDER WAS ISSUED REGARDING THE REGISTRATION OF CHIPRX
CHIPRX
▪ JUNE 30, 2016 DEA EXECUTED AN ADMINISTRATIVE INSPECTION WARRANT (AIW)
▪ WARRANT ISSUE BASED ON “TIPS THAT PIC CHAPMAN WAS FREQUENTLY IMPAIRED AND WAS
UNLAWFULLY REMOVING CONTROLLED SUBSTANCES FROM THE PHARMACY”.
▪ DURING THE EXECUTION OF THE AIW, CHAPMAN AND SEVERAL EMPLOYEES WERE
INTERVIEWED BY DEA PERSONNEL.
▪ CHAPMAN MADE MATERIAL FALSE STATEMENTS TO THE INVESTIGATORS.
CHIPRX
▪ THE FALSE STATEMENTS INCLUDED:
▪ MINIMIZING THE QUANTITY OF OXYCODONE AND HYDROCODONE THAT HAS BEEN “LOST” IN THE
LAST YEAR;
▪ STATING THAT HE (PIC) HAD REPORTED ALL BUT ONE INCIDENT;
▪ STATING THAT THE LOSSES WERE NOT SIGNIFICANT;
▪ STATING THAT HE DID NOT KNOW OTHER IMPORTANT INFORMATION REGARDING THE LOSSES;
▪ STATING THAT HE WAS NOT ABUSING PRESCRIPTION DRUGS; AND
▪ STATING THAT MANY OF HIS PER DIEM PHARMACISTS WERE PREVIOUS DRUG ABUSERS.
CHIPRX
▪ CHAPMAN IN A SUBSEQUENT INTERVIEW (JULY 22, 2016 – LESS THAN A MONTH LATER):
▪ ADMITTED HE DIVERTED OXYCODONE AND HYDROCODONE PILLS
▪ 200 TO 300 MG EACH DAY.
▪ ADMITTED THAT HE ROUTINELY FALSIFIED INVENTORY RECORDS
▪ ADMITTED THAT HE SHREDDED INVOICE AND SUPPLIER RECORDS
▪ DEA 222 RECORDS AND
▪ CSOS RECORDS
▪ ADMITTED THAT HE HAD RELAPSED
CHIPRX
▪ THEN CHAPMAN STATED THAT HE “COULDN’T WAIT” FOR THE EXPIRATION OF THE MOA HE
HAD PREVIOUSLY EXECUTED TO EXPIRE – SO HE COULD FEED HIS ADDICTION.
▪ CHAPMAN HAD PREVIOUSLY BEEN ADDICTED TO COCAINE
ALLEGATIONS
▪ VIOLATIONS OF THE CONTROLLED SUBSTANCES ACT
▪ TAKING CS FROM PHARMACY WITHOUT A PRESCRIPTION.
▪ TAKING CS TO FUEL HIS ADDICTION.
▪ ORDERING CS OUTSIDE OF THE NORMAL/LAWFUL COURSE OF BUSINESS.
▪ FAILING TO REPORT THEFT OR LOSS OF A SIGNIFICANT QUANTITY OF A CS.
▪ FAILING TO MAINTAIN ADEQUATE/EFFECTIVE CONTROLS AGAINST DIVERSION AND THEFT.
▪ FAILING TO MAINTAIN ACCURATE INVENTORY RECORDS.
▪ DESTROYING CS ORDERING RECORDS.
▪ SIGNING DOCUMENTATION THAT THE CS RECORDS WERE TRUE AND CORRECT.
ALLEGATIONS
▪ CHAPMAN ALSO:
▪ DELETED VIDEO SURVEILLANCE FOOTAGE
▪ EXHIBITED SIGNS OF IMPAIRMENT OR INTOXICATION AT WORK
▪ INCORRECTLY FILLED PRESCRIPTIONS
▪ WAS ADVISED BY PHARMACY PERSONNEL OF SIGNIFICANT CS SHORTAGES
▪ AND THAT THE SHORTAGES OCCURRED ON A REGULAR BASIS
ALLEGATIONS
▪ EVEN WHEN CHAPMAN KNEW THE DEA WAS INVESTIGATING, HE CONTINUED TO DIVERT
▪ SEVERAL EVENTS WERE CAPTURED ON VIDEO THAT WAS NOT ERASED
▪ AND CHAPMAN HAD ALSO BEEN HOSPITALIZED ON 3 RECENT OCCASIONS FOR
COMPLICATIONS RELATED TO OVERDOSE
BECAUSE YOU CANNOT MAKE THIS UP
▪ CHAPMAN WAS REPORTED BY PERSONNEL
AS HAVING BEEN USING MARIJUANA VIA A
VAPORIZER WHILE AT WORK.
VAPORIZER?
THIS IS WHAT I AM THINKING A VAPORIZER
IS
WHEN IN REALITYTHIS IS WHAT THEY WERE TALKING ABOUT
THE REACTION THE ATTORNEY IS TRYING NOT TO MAKE
REVIEW OF THE MAJOR VIOLATIONS
▪ FAILURE TO COMPLY WITH MOA
▪ ENGAGING IN CONDUCT/ACTIVITY THAT ENDANGERS THE PUBLIC
▪ FAILURE TO MAINTAIN RECORDS
▪ MUST MAINTAIN COMPLETE AND ACCURATE RECORDS OF EACH CS RECEIVED, SOLD DELIVERED OR OTHERWISE
DISPOSED OF.
▪ DESTRUCTION OF DEA 222 & CSOS RECORDS
▪ FAILURE TO REPORT THE SIGNIFICANT THEFT OR LOSS OF CS
▪ OBTAINING CS BY FRAUD
▪ MAKING MATERIAL FALSE STATEMENTS TO INVESTIGATORS
OTHER CHARGES
▪ ADMINISTRATIVE
▪ BOARD OF PHARMACY
▪ CHARGES AGAINST PIC/OWNER/MANAGER
▪ WHAT ABOUT CHARGES AGAINST THE OTHER PHARMACISTS?
▪ CRIMINAL
▪ CIVIL
▪ IF SOMEONE WAS INJURED AS A RESULT OF ONE OF THE PRESCRIPTION ERRORS
INSPECTIONS UNDER THE CONTROLLED SUBSTANCES ACT
▪ INSPECTIONS
▪ THE DEA HAS A RIGHT TO ENTER AND INSPECT ANY PLACE WHERE CONTROLLED SUBSTANCES
ARE KEPT OR PERSONS ARE REGISTERED. CSA, 21 U.S.C. § 880; 21 C.F.R. §§ 1316.01-1316.13.
▪ THE INSPECTIONS MAY BE CONSIDERED MORE ROUTINE OR PROCEDURAL
▪ OPENING NEW BUSINESS
▪ REVIEWING PRESCRIPTIVE HABITS OF LOCAL PRACTITIONERS
▪ INSPECTION CAN BE BY
▪ CONSENT
▪ WARRANT
WHEN THE DEA ASKS PERMISSION TO INSPECT
Notice of Inspection
Agree & Sign Consent
InspectionEvidence can be Seized
Refuse
Must Return with Warrant
WHEN THE DEA HAS AN AIW
AIW
Consent NOT Required
Include Info Seizure of information
Refused
Fine & Imprisonment
INFO TO BE INCLUDED ON AIW
▪ NAME & ADDRESS OF PREMISES
▪ STATEMENT OF AUTHORITY
▪ STATEMENT AS TO NATURE & EXTENT OF INSPECTION
▪ STATEMENT REGARDING PREVIOUS INSPECTIONS
▪ SERVED DURING REGULAR BUSINESS HOURS & CONDUCTED WITHIN REASONABLE MANNER
ADMINISTRATIVE INSPECTION WARRANT
▪ AIW THE LEGAL STANDARD IS VALID PUBLIC INTEREST
▪ AIW WAS THE TYPE OF WARRANT USED IN CHIPRX
▪ DEA COULD HAVE REQUESTED A SEARCH WARRANT
▪ LEGAL STANDARD IS PROBABLE CAUSE VS VALID PUBLIC INTEREST
BEST ADVICE
▪ BE POLITE
▪ BE COURTEOUS
▪ DON’T LIE
▪ EXERCISE YOUR RIGHT TO REMAIN SILENT & CONTACT AN ATTORNEY
▪ IF THEY ARE EXECUTING A WARRANT THEY ALREADY BELIEVE THEY HAVE ENOUGH
INFORMATION TO MAKE A CASE – DON’T MAKE IT WORSE
▪ BETTER YET – NEVER GET IN THE POSITION OF CHIPRX
SCENARIO I
▪ YOU AND A BUSINESS PARTNER PLAN ON OPENING A NEW PHARMACY AND A NEW
METHADONE CLINIC IN AN UNDERSERVED COMMUNITY IN SOUTHWEST ALABAMA.
▪ YOU HAVE FILLED OUT THE APPROPRIATE FORMS WITH THE ALABAMA BOARD OF PHARMACY
AND THE DEA.
▪ 30 DAYS PRIOR TO THE SCHEDULED OPENING OF THE PHARMACY AND METHADONE CLINIC,
TWO DEA AGENTS DROP BY, SHOW THEIR ID AND ASK PERMISSION TO INSPECT THE
PHARMACY AND METHADONE CLINIC.
▪ WHAT SHOULD YOU DO?
SCENARIO II
▪ YOU AND YOUR BUSINESS PARTNER HAVE BEEN OPERATING A PHARMACY AND METHADONE CLINIC IN
AN UNDERSERVED COMMUNITY IN SOUTHWEST ALABAMA FOR APPROXIMATELY 2 YEARS.
▪ OVER THE PAST 6 MONTHS, YOU HAVE NOTICED REGULAR SHORTAGES IN THE METHADONE
RECORDS/AUDITS. THE SHORTAGES HAVE NOT BEEN REPORTED & YOU SUSPECT THAT YOUR PARTNER IS
EITHER USING THE PRODUCT OR DIVERTING THE PRODUCT FOR SALE ON THE STREETS.
▪ TWO DEA AGENTS SHOW UP AND ASK TO INSPECT THE METHADONE CLINIC AND ASK FOR YOUR
CONSENT.
▪ WHAT SHOULD YOU DO? AND WHAT CAN YOU LEGALLY DO?
DEA ENTERS YOUR PHARMACY
INSPECTION WARRANT OR EXIGENT CIRCUMSTANCES
2018 TRICARE FRAUD CONVICTION
TRICARE FRAUD
▪ FORMER NFL & UF FOOTBALL PLAYER, MONTY GROW, WAS CONVICTED FEBRUARY 6, 2018 OF
RECEIVING KICKBACKS IN PART OF A $40 MILLION DOLLAR SCHEME TO CHARGE TRICARE
PATIENTS FOR UNNECESSARY DRUGS.
▪ SPECIFICALLY, GROW WAS CONVICTED OF:
▪ HEALTH CARE FRAUD
▪ CONSPIRACY TO DEFRAUD
▪ PAYING AND RECEIVING KICKBACKS
▪ MONEY LAUNDERING
TRICARE FRAUD
▪ PATIENT CARE AMERICA – COMPOUNDING PHARMACY
▪ MGTEN MARKETING GROUP, INC
▪ PRESCRIPTIONS SIGNED-OFF BY TELEMEDICINE COMPANIES USING PRE-PRINTED
PRESCRIPTIONS
▪ NO DETERMINATION OF MEDICAL NEED
▪ ALLEGED THAT BENEFICIARIES ALSO PAID KICKBACKS
▪ GROW PAID KICKBACKS BY PHARMACY
TRICARE FRAUD
▪ HOW BIG WAS THE PROBLEM?
▪ THE PHARMACY CHARGED TRICARE APPROXIMATELY $40 MILLION DOLLARS BETWEEN JULY 2014
AND JUNE 2015.
▪ GROW & GINGER LAY (OWNER OF MED RXSALES, LLC – CHARGED CO-CONSPIRATOR) WERE PAID
APPROXIMATELY $20 MILLION DOLLARS DURING THE SAME TIME PERIOD.
VIOLATIONS
▪ TRADITIONAL COMPOUNDING IN A PHARMACY SETTING IS REGULATED BY ADMINISTRATIVE,
STATE AND FEDERAL LAWS.
▪ TRADITIONAL COMPOUNDING IS REFERRED TO AS COMPOUNDING PURSUANT TO 503 A OF
THE FDCA (503 B IS AN OUTSOURCING FACILITY)
▪ THIS TYPE OF PHARMACY REQUIRES
▪ A PATIENT SPECIFIC PRESCRIPTION
▪ FDA FAQS COMPOUNDING:
HTTPS://WWW.FDA.GOV/DRUGS/GUIDANCECOMPLIANCEREGULATORYINFORMATION/PHARMACY
COMPOUNDING/UCM339764.HTM.
PRESCRIPTION REQUIREMENTS
▪ PRESCRIPTION REQUIRED
▪ IDENTIFIED INDIVIDUAL PATIENT
▪ WHOSE NEEDS CANNOT BE MET BY AN FDA APPROVED DRUG PRODUCT
▪ CLINICALLY NECESSARY
▪ FDA GUIDANCE FOR 503 A FACILITY:
▪ HTTPS://WWW.FDA.GOV/UCM/GROUPS/FDAGOV-PUBLIC/@FDAGOV-DRUGS-
GEN/DOCUMENTS/DOCUMENT/UCM496286.PDF.
VIOLATIONS
▪ VALID PRESCRIPTION
▪ MEDICAL NEED
▪ FRAUD
▪ ADMINISTRATIVE
▪ BOARD OF PHARMACY PRACTICE ACT
▪ STANDARDS OF CARE
▪ CODE OF PROFESSIONAL RESPONSIBILITY/PRACTICE ACT
THINK ABOUT IT
HOW COULD ANYONE THINK THESE TYPES OF SALARIES FOR
PRESCRIPTION REFERRALS IS LEGIT?
ACTIONS
INAPPROPRIATE/TECH & PHARMACIST
▪ FILLING INVALID PRESCRIPTIONS
▪ ASSISTING IN FILLING INVALID RX
▪ SUBMITTING FRAUDULENT CLAIMS
▪ NOT PROTECTING THE PUBLIC
▪ PAYING KICKBACKS
APPROPRIATE/TECH & PHARMACIST
▪ REFUSE TO FILL
▪ REFUSE TO FILL
▪ REFUSE TO SUBMIT
▪ LEAVE & NOTIFY BOP
PROBLEMS & FEARS
▪ AS A GENERAL RULE – ONCE YOU PARTICIPATE IN THE ILLEGAL SCHEME, IT IS VERY HARD TO
GET OUT.
▪ PEOPLE BELIEVE THEY ARE REPORTING THEMSELVES
▪ MANAGEMENT SAYS “THAT IF YOU REPORT ME – YOU GO DOWN TOO”
▪ GROWN DEPENDENT ON INCOME FROM ILLEGAL ACTIVITY
▪ FEAR THAT YOU WILL NO LONGER BE EMPLOYABLE
▪ FEAR THAT THE BOARD/LOCAL LEO/DEA WILL NOT BELIEVE YOUR STORY
▪ IF YOU LEAVE WHEN YOU FIND OUT – STORY IS MORE BELIEVEABLE
TRUSSVILLE, ALAPRIL 4, 2018
▪ TRUSSVILLE NURSE (2 PHYSICIANS & ANOTHER FAMILY MEMBER)INDICTED IN HEALTH CARE
FRAUD CASE.
▪ ALLEGATION: FALSELY BILLING FOR ALLERGY TREATMENTS AND MEDICAL SERVICES
▪ IN EXCHANGE THE PHYSICIANS GAVE PATIENTS PRESCRIPTIONS FOR NARCOTICS
FORMER GA HOSPITAL CEO & PHYSICIANS INDICTEDAPRIL 10, 2018
▪ INDICTMENT ALLEGES THAT THE FORMER GEORGIA HOSPITAL CEO AND 2 PHYSICIANS
ILLEGALLY PRESCRIBED AND OBTAINED THOUSANDS OF DOSES OF PRESCRIPTION PAIN
MEDICATIONS.
NALOXONE
▪ AVAILABLE WITHOUT A PRESCRIPTION – BUT YOU MUST USE THE STANDING ORDER ISSUED BY
THE STATE MEDICAL OFFICER
▪ HTTP://WWW.ALABAMAPUBLICHEALTH.GOV/PHARMACY/ASSETS/NALOXONESTANDINGORD
ER.PDF.
▪ TRAINING VIDEOS
▪ HTTP://WWW.ALABAMAPUBLICHEALTH.GOV/PHARMACY/NALOXONE-DISPENSING.HTML.
QUESTIONS