Centralized Office of Research

Transcription

1 Centralized Office of Research

2 The driving force for creating this model or type of clinical trials office (CTO) at JHS was noncompliance issues in billing. What we discovered was a general lack of education in research compliance, limited infrastructure to drive development of compliant processes, and a lack of transparency between institutions. The hospital was unable to determine the scope and impact of the research being conducted within its four walls given the documentation and knowledge it had on hand.

3 Hospital process Receiving Front end Receive studies & review regulatory, contracts (budget), Creates MCA. reviewing IRB review simultaneous MICROSOFT CORPORATION Legal Department MCA Contracts Review inf. Consent With contract. Study approved Via CRRC Protocol Review against NCDs LCDs, National guidelines, SOC at JHS

4 Hospital s Role in a Study: Hospital serves a large diverse potentially vulnerable population. Contract description: Hospital has facility suitable to conduct this Study in accordance with the Protocol, applicable laws, rules and regulations, and determines it can provide the facility for the performance of the Study. The hospital employs all clinical & technical personnel i.e. RNs, EKG techs. Hospital provides all support services i.e. the pharmacy, radiology etc. Hospital is the custodian of the clinical system and the medical record. The hospital, as the provider, responsible for all facilitybilling. Must drop a clean bill.

5 Hospital staff must receive an orientation on the study before study startup to ensure Hospital staff are familiar with study protocol Protocol time frames All departments involved must work in concert i.e. pharmacy, ED staff, unit nurses, etc. Clinical staff providing standard of care must be aware of possible adverse events resulting from study drug or procedure.

6 Innovative practice up to 3 cases is not considered research but JHS does have a separate policy & approval process. Humanitarian Use Device is NOT an Investigational device but flows through the JHS office of Research. Quality assurance studies not research but must go through IRB & JHS Office of Research if publication is a consideration. Customized Consent forms must be in the chart for the first two listed: Innovative Practice & HUDs.

7 It has been critical for the hospital to have access & transparency to study documents through the IRB system. This shared system expedites study review time. Open correspondence with the IRB facilitates meaningful understanding of study requirements for patient safety. Ensuring that all documents are viewable by JHS The shared view allows the JHS to ensure documents are in harmony with one another. JHS review of ICF ensures appropriate reading level for JHS population.

8 Hospital process Research provider account Created. First patient Enrolled Into study patient Inf. Consent Sent to CTO Bill Hold at patient level BILL SCRUB Bill Released Pt. visit

9 Pitfall # 1 Multiple Clinical & Billing Applications Pitfall #2 Fragmented Information Pitfall #3 Process Not Transparent

10 JHS Policy: Consents must be faxed, ed, dropped off 24 hours of the patient consenting to the trial. CTO staff flags the patient in the Electronic Medical Record (Cerner) system. This initiates the bill hold for CTO.

11 The Centers for Medicare & Medicaid Services (CMS) requires that patients enrolled in a clinical trial (inpatient or outpatient) have: 1. V70.7(Examination of participant in a clinical trial) Diagnosis Code listed as a secondary Dx. Code on each patient visit/service. 2. HCPCS Q1 on outpatient procedures that are SOC but contained in protocol. 3. Device studies require the IDE # on each patient s claim submitted. 4. The ClinicalTrials.gov Identifier number: CMS now requires this 8-digit identifier to be placed on claims.

12 JHS CTO created 1. Medicare coverage analyses (MCA): to establish study related procedures being paid for by sponsor vs. routine care to be billed to insurance companies. This was used internally to scrub bills. 2. Encounter Form: to be used by the study coordinators and submitted to the JHS CTO same day. 3. Bill HOLD: Senior Management in the revenue cycle did not like the bill hold option but this solution provided the necessary time to scrub the bill with the study-calendar in hand and add the necessary CMS required modifiers.

13 First Lesson: Do not start sorting out on the back end, start on the front end. Second lesson: Utilize your IRB and senior executives to support your compliance effort. Third lesson: Understand your own institution s specific requirements. Fourth Lesson: Transparency is a key to success Fifth Lesson: System interfaces are critical to transparency and accurate billing. Sixth Lesson: Include your IT team from the start to develop creative solutions.