Clinical Trials: How to Stay Medicare Compliant

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+ Are the Cat 1 & 2 IDE and FDA Cat A & B info typically in the study description. If not, where is this documented?
+ Can we get clarification on the FB modifier. Our understanding for FB modifier is for warranty codes? Also, would it have to be a dollar, we understand the regulation to be less than 1.01 so it can be a penny etc....
+ Can you apply a markup to category B devices like you would for other devices when billing CMS?
+ Can you please clarify the FB code? Is that only for IDE trials or all clinical trials?
+ Clinical Trial Services for Medicare Managed Care Beneficiaries are paid by Medicare for covered clinical trial services for beneficiaries enrolled in managed care plans is that correct?
+ Do facilities get something in writing that we could ask them to share that would tell if their trial meets Medicare guidelines for coverage?
+ Do the same rules apply for Medicare Advantage plan beneficiaries for IDE trials as for any other clinical trial? In other words, should Medicare FFS pay the claims associated with IDE trials?
+ Do you report the IDE# on inpatient and outpatient claims?
+ For Medicare Advantage Patients how do you determine what is billed to the advantage plan vs. Traditional Medicare?
+ How do we determine what gets billed to the Medicare Advantage Plan vs. Traditional Medicare for those patients who are covered by a Medicare Advantage plan?
+ How do you determine what charges get billed to the Advantage Plan vs. Medicare? For example, with an IDE that has been approved by our local Medicare Contractor. Do we bill all charges related to the device to Medicare or only the device cost or should the entire bill go to the Advantage provider?
+ If a clinical trial is listed in clinical trials.gov, does it meet Medicare guidelines for coverage?
+ If a Medicare contractor approves MC coverage for an IDE is it then considered "standard of car"? If a patient is a Medicare Advantage bene in a study where the only variable is the IDE in an otherwise covered service and the Medicare Contractor approved payment for the IDE, does the facility bill the MA for the entire claim; or Medicare for the IDE and the MA for everything else; or something different?
+ If you have a device that is a revision of an existing device and used in the same procedure does that have to be registered as and IDE? ex. cardiac ablation done with heat and a new device that freezes the cardiac tissue performing the same procedure?
+ In a qualifying clinical trial, we report the Q0 modifier on the line that reports the device. If we are billing CMS there is nothing other than the device that is "investigational" all other services would get the Q1 modifier. Any comment?
+ Is an IDE number REQUIRED on a professional claim as it is on a facility claim?
+ Is it appropriate to use these code (CC 30, v70.7, etc) to bill non-government payers for clinical trials or IDEs?
+ Is it okay to report a token charge for the no cost item for an inpatient also?
+ Is it required to assign a HCPCS for IDE device? If there isn't one due to being new investigational what do you use?
+ Is it required to report non-covered items or services (i.e. experimental drug or device) on the claim, or can you just bill the "administration" charges without the experimental drug or device charge?
+ Is the clinical trial number from clinicaltrials.gov?
+ Is there a resource (other than calling the local Medicare carrier) where there is a list of approved trials by Medicare?
+ Must all clinical trials be registered? And, if so, is there a timeframe a company must register? I'm asking because of the "public domain" aspect of presenter's comments.
+ On the physician claims billing CTP qualifying trials and the IDE trials slide, the first bullet indicates V70.7 as the diagnosis code - should this be the SECONDARY diagnosis?
+ Please describe the difference between "Registry" vs. "Clinical Trial" Studies and how does the billing differ? Where or is there criteria available to help define "Standard of Care" Guidelines?
+ Should an inpatient CMS claim with the investigational service line items be generated if the Institution already has a process to omit such line items? Should an outpatient CMS claim with the investigational service line items (Q0 modifiers) be generated if the Institution already has a process to omit such line items?
+ We do component billing. Would the Q1 modifier go on every CPT code, or only the stent placement (if the stent is the IDE)
+ What if the patient isn't in a clinical trial, but just being entered into a registry for example with automatic cardioverter/defibrillators. Do we need to code the V70.7 as a secondary diagnosis? What documentation needs to be in the medical record to support adding the Q0 modifier (i.e. do we need documentation that the patient was entered in the registry)?
+ What if you have an approved and covered device being used off label, such as billing for a procedure that is covered performed open and then using the same device transcatheter but getting the same results and if coded, codes out the same.
+ Where do you place rev code 0624 on the claim?
+ Where would you see the "condition code" on a claim? Form locator line items 18-28
+ Who is responsible for reimbursing for complications (FFS?)
+ Will Medicare pay for complications of a clinical trial if the trial was not a Medicare approved clinical trial?
+ Will the information presented today be applicable to Research in the Outpatient setting?
+ Would Medicare ever really pay on a healthy volunteer because the patient doesn't have a disease condition (i.e. nothing to improve outcome on)?
+ You stated that the IDE number is required on a professional claim, and then EVERY provider (surgeon, anesthesiologist, etc) who submits a professional claim would have to place it on their claim? (My MAC is NHIC (J14 MAC))