Qualifying Clinical Trials Wendy McAtee – Research Compliance Manager June 15, 2017 Presented by: Wendy McAtee – Research Compliance Manager

Qualifying Clinical Trials A clinical research study that meets the requirements set forth in the Clinical Trial Policy (CTP) NCD 310.1 by the Center for Medicare and Medicaid Services (CMS). Purpose- Identifies the items and services that are billable to patient payor. Routine Costs- defined by CTP as items and services billable and reimbursable to Medicare.

History of QCT June 7, 2000: Executive Memorandum September 19, 2000: CMS implemented CTP through the National Coverage Determination (NCD) process. July 10, 2006: CMS reconsideration NCD 310.1. July 9, 2007: Routine costs will be covered.

Deemed Automatically Qualifying: Trials funded by NIH, CDC, AHRQ, CMS, DOD, and VA; OR 2.  Trials supported by centers or cooperative groups that are funded by the NIH, CDC, AHRQ, CMS, DOD and VA; 3.  Trials conducted under and investigational new drug application (IND) reviewed by FDA; OR 4.  Drug trials that are exempt from having an IND under 21 CFR 312.2 (b)(1) will be deemed automatically qualified until the qualifying criteria are developed and the certification process is in place. *Important to note device studies have separate regulations.

Mandatory Requirements: 1. The subject or purpose of the trial is an evaluation of an item or service that falls within a Medicare benefit category (e.g., physicians’ services, durable medical equipment, diagnostic test) and is not statutorily excluded from coverage (e.g. cosmetic surgery, hearing aids). 2. The trial is not designed exclusively to test toxicity or disease pathophysiology and must have therapeutic intent. 3. Trials of therapeutic interventions must enroll patients with diagnosed disease rather than healthy volunteers. Trials of diagnostic interventions may enroll healthy patients in order to have a proper control group.

Desirable Characteristics: 1. The principle purpose of the trial is to test whether the intervention potentially improves the participants’ health outcomes; 2. Trial is well-supported by scientific and medical info or is intended to clarify or establish the health outcomes of interventions already in common use; 3. The trial does not unjustifiably duplicate existing studies; 4. The trial design is appropriate to answer the research question; 5. The trial is sponsored by a credible organization or individual capable of executing the proposed trial successfully; 6. Compliance with Federal Regulations relating to the protection of human subjects; 7. Trial conducted according to the appropriate standard of scientific integrity.

Prospective Reimbursement Analysis (PRA)

Types of Qualifying Trials Two Types of Qualifying Studies Non-Device Device Category A IDE Category B IDE

Device Studies Category A IDE: “Experimental Innovative devices believed to be in class III for which absolute risk of the device type has not been established.” Provider must contact their local Medicare carrier or intermediary before billing for this service.

Device Studies Category B IDE: “Nonexperimental and/or investigational devices believed to be in classes I or II or devices believed to be in Class III where the incremental risk is the primary risk in question. It is know that the device type can be safe and effective because other manufactures have obtained FDA approval for that device type.

Registration of Qualified Clinical Trials Clinical trials that meet qualifying requirements must be registered on ClinicalTrials.gov Assist in patients finding clinical trials that might be applicable for them. Safety info, Data Summary Internal funding is departmental responsibility Unfunded studies can be registered. The final rule considers all interventional clinical trials with one or more arms and with one or more pre-specified outcome measures to be controlled clinical trials.

International Committee of Medical Journal Editors (ICMJE) “Any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.“ Stephanie Tanner can assist in this process STanner@ghs.org .

QCT Modifiers Drug Trials 1450 (UB04/Hospital): ICD-10: Z00.6 as Secondary Diagnosis Q0 and Q1 modifier as needed Condition Code 30 for “Qualifying Clinical Trial” Rev Code 256 – Rev Code Drug Trial NCT # (www.clinicaltrials.gov) 1500 (Professional): ICD-10: Z00.6 as Secondary Diagnosis Q0 and Q1 modifier as needed NCT # (www.clinicaltrials.gov)

QCT Modifiers Device Trials: 1450 (UB04/Hospital): ICD-10: Z00.6 as Secondary Diagnosis Q0 (Device sponsor paying for), and Q1 modifier as needed Condition Code 30 for “Qualifying Clinical Trial” Condition Code 53 for Free Device NCT# (www.clinicaltrials.gov) Rev Code 0624 – Device Trial Rev Code 278 – Medical/Surgical Supplies other than implants IDE Number 1500 (Professional): ICD-10: Z00.6 as Secondary Diagnosis Q0 and Q1 modifier as needed NCT # (www.clinicaltrials.gov)

Research Education Series Clinical Trials Registration Requirements June 15, 2017

www.clinicaltrials.gov Managed by the National Library of Medicine at the NIH Houses >245,000 study records

www.clinicaltrials.gov New look expected June 19, 2017 Improved ability to search, display & review

Why? Enhance availability and transparency of CT information

Regulations Narrow Title VIII of the FDA Amendments Act of 2007 expanded the legal mandate for clinical trial (CT) registration FDA instructed HHS to issue additional regulations 2. HHS Final Rule – effective January 18, 2017 3. International Committee of Medical Journal Editors (ICMJE) trial registration policy Less Narrow Broad!

FDA Amendments Act 2007 Must register CTs of FDA-regulated drug, biologic, and device products Legally defined timeline Report summary results Civil monetary penalties for noncompliance

Purpose is to decrease ambiguity HHS Final Rule 2017 Purpose is to decrease ambiguity Clarifies the information to be reported and the timelines to do so Requires disclosure in study consent form “A description of this clinical trial will be available on www.clinicaltrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.” An applicable clinical trial must be registered by the responsible party

HHS Final Rule 2017 Key Terms 1) Applicable Clinical Trial Interventional study with an outcome measure Use of FDA regulated product Not phase I; not device feasibility Includes at least 1 US site or a product manufactured in US Caveat: Register all CTs funded by NIH 2) Responsible Party Study sponsor Holder of the IND or IDE May be an industry sponsor or a site PI Grantee institution for NIH-funded trial

ICMJE Requirements International Committee of Medical Journal Editors Recommends that journals require CT registration as a condition of consideration for publication CT = any research project that prospectively assigns pts to an intervention, with or without concurrent controls, to study the cause-effect relationship between a health-related intervention and a health outcome

Take Home Messages Although you may not be legally required to register your unfunded investigator-initiated local study, you should do so if you intend to submit results for journal publication. Not all studies with NCT#s are “qualifying clinical trials.” I ICJME HHS FDA

How to Register Protocol Registration and Results System (PRS): “sub-site” of clinicaltrials.gov One master/administrator account per institution Institution administrator can grant access to other individuals within the site (researchers or staff) Current GHS Administrators = Stephanie Tanner and Dr. Chris Wright

Data Needed for Registration Brief Title and Acronym Study Type Status – expected start and end dates Collaborators Brief summary Detailed Description Conditions and Keywords Groups and Interventions Outcome measures Eligibility Location and contacts

Review Process Researcher releases record to Institution Administrator (IA) IA releases record to clinicaltrials.gov Don’t be surprised to receive feedback and questions! Respond promptly. NCT assigned and CT posted usually within 30 days Review every 6mos to keep the record active

Results Submit within 12mos of final data collection for primary outcome Not required to release a narrative summary. The website doesn’t want to spoil your publication! Enrollment and demographics Adverse events Outcomes and statistical analysis for primary measure

GHS Data External sponsor is the “responsible party” for the majority of registered CTs underway at GHS In the last 5 years, <25 CTs registered by GHS. But most of those were in the last 2 years!

Thank you to Stephanie Tanner! Acknowledgments Thank you to Stephanie Tanner!