Billing Compliance Basics Coverage Analysis 101 April 27, 2017

Why is research billing compliance important? Need to follow local and federal laws related to patient billing Do not want the patient to be charged for something that should be covered by the study sponsor Serious consequences for non-compliance Important that more than billers are involved in billing compliance

Risks of Poor Billing Compliance Double billing Billing the patient for an item promised free in the consent or an item promised free in the consent Patient receiving incorrect bills Can result from billable designations not being reviewed properly or information being entered incorrectly at the time of visit Fraudulent billing

Consequences of Non-Compliant Billing Fines, paybacks, and penalties Increased government scrutiny Cost associated with investigation and action plan Loss of current or future federal grants Bad publicity Reputational harm Unhappy patients

Internal Consequences of Poor Billing Compliance Confusion from employees and departments Frustrated employees/staff turnover Patient Complaints Delays in the overall process Operational inefficiencies Duplicated work Treatment Delays

Impacts of Poor Billing Compliance Audits, fines, paybacks, and investigations are a concern to sponsors May make it more difficult to be selected for future studies Cannot grow research department and can lose access to beneficial therapies Bad PR Patients may be less willing to enroll in a study when they hear about audits and improper billing at the institution Impacts entire institution, not just the research department Loss of Federal Funds Inability to participate in federally funded studies and/or obtain to federal grants Unhappy patients The patient is already undergoing a stressful health situation and receiving bills and do not need added financial stress from receiving additional medical bills

Billing Compliance Activities That Should Occur Before the Study Opens . . .

Coverage Analysis/ Billing Grid Items that Need to be Reviewed for Compliance Reasons Before the Study Opens Coverage Analysis/ Billing Grid Budget Contract Consent Form CTMS Build All must be consistent to establish billing compliance!

What is a coverage analysis?

Coverage Analysis: Overall Goal Determine if the study sponsor or insurance will pay for each item or service required by the study. Similar to a billing grid, but will include written justification

Reasons for a Coverage Analysis Determines if Items/Services are Financial Responsibility of the Patient or Sponsor Comprehensive Analysis of Clinical Trial Documents Basis of Research Billing Compliance/ Audit Documentation Budget Building Tool

Building a Coverage Analysis Grid that shows each protocol required visit and activities at each visit Includes analysis for why the patient should or should not be billed for each protocol required item or service Ensures each item has a payor Compliance and financial impacts Study calendar

Important Billing Compliance Rules Medicare Clinical Trial Policy (NCD 310.1) Benefit Policy Manual Claims Processing Manual Local Coverage Determinations National Coverage Determinations Institutional Are there institutional billing policies and procedures?

Why are Medicare rules used for billing compliance? Coverage information is publicly available Significant compliance risks present if Medicare is improperly billed Most institutions want to follow a standard set of rules/guidelines

Medicare: What do they cover? Medicare Coverage: Medicare defines items that are medically necessary as “reasonable and necessary to the overall diagnosis and treatment of the patient’s condition.” Medicare generally does not cover services without a patient symptom or complaint

What does reasonable and necessary mean? The item must be proper for the diagnosis and/or treatment of the patient’s condition Used for the diagnosis, direct care, and treatment of the patient’s condition Meet standards of medical practice Are not used for the convenience of the patient, provider, or supplier http://www.wpsmedicare.com/j5macpartb/training/on_demand/_files/2014-0214-basic-principles-medicare.pdf

What if we are not enrolling Medicare patients in our study? Medicare rules may still be cited for research billing consistency A coverage analysis is still required to prevent double billing Do not want patient to receive an incorrect bill! Can use private payor rules, if available Bring up peds

Medicare Rules: NCD 310.1 The Clinical Trial Policy

Medicare’s Clinical Trial Policy (NCD 310.1) Starting Place for Coverage Analysis and Basis of Research Billing Compliance States what will not be covered within a trial States what will be covered within a trial Defines how a trial qualifies for coverage

NCD 310.1 Qualifying Status All four of these conditions must be met to be considered a Qualifying Clinical Trial The investigational item must fall under a Medicare Benefit Category The trial must have therapeutic intent The trial must enroll patients diagnosed with disease The study must be deemed

Qualifying Status: Medicare Benefit Categories The subject or purpose of the trial must be the evaluation of an item or service that falls within a Medicare Benefit Category. A few examples are listed below: Drugs and Biologicals Inpatient Hospital Services Medical Devices and Prosthetics Durable Medical Equipment Oral Anticancer Drugs Oral Antiemetic Drugs

Qualifying Status: Therapeutic Intent and Diagnosed Disease The trial must test efficacy and not just safety Combined Phase 1/2 studies are a unique challenge Diagnosed Disease Trial must enroll patients with diagnosed disease, not just healthy volunteers Study may have healthy control arm as long as there is a corresponding arm that is diagnosed with disease

NCD 310.1 Qualifying Status-Deemed Trial meets the Seven Desirable Characteristics The principle purpose of the trial is to test whether the intervention potentially improves the participants’ health outcomes The trial is well-supported by available scientific and medical information or it is intended to clarify or establish the health outcomes of interventions already common in clinical use The trial does not duplicate existing studies The trial design is appropriate to answer the research question being asked in the trial The trial is sponsored by a credible organization or individual capable of executing the proposed trial successfully The trial is in compliance with Federal regulations relating to the protection of human subjects All aspects of the trial are conducted according to the appropriate standards of scientific integrity

Qualifying Status: Deemed Trials Trials that are automatically deemed to meet the seven desirable characteristics are: Funded by NIH, CDC, AHRQ, HCFA (CMS), DOD, and VA Supported by centers or cooperative groups that are funded by the NIH, CDC, AHRQ, HCFA, DOD, and VA Conducted under an investigational new drug application (IND) reviewed by the FDA Drug trials that are exempt from having an IND under 21 CFR 312.2 (b)(1)

NCD 310.1: What is covered during a clinical trial? Items provided absent a clinical trial (conventional care) Items or services required for the provision of the investigational item or service (IV admin of an investigational drug) Items and services that are reasonable and necessary care for the diagnosis and treatment of complications

NCD 310.1: What is not covered during a clinical trial? The investigational item itself (unless covered absent a trial) Items used only for data collection Items or services provided by the sponsor free of charge Items or services limited by other National or Local Coverage Determinations (NCDs/LCDs)

Use national guidelines Review side effects in the consent form and warnings on the FDA label Review the sponsor budget to see if the sponsor is paying for an item Review the consent to see what is promised free to the patient How does the coverage analysis team determine if something is billable under NCD 310.1?

Challenges for the Analyst Questions for the Study Team Challenges and Possible Questions for the Study Team Related to NCD 310.1 Challenges for the Analyst Questions for the Study Team Guidelines and FDA warnings are not written for the clinical research setting Guidelines often lack frequency recommendations Cannot find guidelines How often do you do this test for non-research patients? Would this test be repeated after the patient is diagnosed? Do you have any guidelines that you would recommend?

Why is this information so important? No one wants the patient to be charged inappropriately!

Patient Billing in Device Trials Medicare will cover “routine care” items for certain device types Routine Care Items Medicare Benefit Policy Manual Chapter 14 Item would be otherwise available to the beneficiary May need Medicare approval to bill for routine care items Device Status Required to Bill Routine Care Items Category A or B IDE PMA 510 (k) Humanitarian Use Device Hospital IRB Approved Non-Significant Risk

Determining What Can be Billed Under Medicare Benefit Policy Manual Chapter 14 Medicare Benefit Policy Manual Chapter 14 (not NCD 310.1) Supports coverage for certain investigational devices and services incident to the device under conditions National and local coverage determinations (and any other rules/regulations) still apply May require Medicare Administrative Contractor Approval Medicare coverage ceases if device loses FDA status

Types of Devices Potentially Covered By Medicare Category B IDE 510(K) PMA Hospital IRB Approved Humanitarian Use Devices

Investigational Device Exemption Studies (IDE)-Category A and Category B Significant Risk Devices Generally, implanted in the body Only distributed through research studies Require labeling, monitoring, and reporting Study sponsor is responsible for FDA submission (could be PI in IIT) Notes: Medicare will cover routine costs associated with Category A and Category B devices Medicare will cover the Category B device, but not the Category A device Study needs to be submitted to Medicare and approved by Medicare prior to billing

Similar/Equivalent Legally Marketed Device Must Exit 510 (k) Cleared Devices Similar/Equivalent Legally Marketed Device Must Exit Must be at least as safe and effective as the legally marketed device Medicare may cover the device and routine costs Indications/limitat-ions for Medicare coverage may be found in NCDs/LCDs

Premarket Approval (PMA) Devices Used for riskiest devices (Class III-support or sustain life) Most stringent level of FDA device review Must submit data from previous studies Classification allows device to be marketed Medicare may cover PMA devices-need to review NCDs/LCDs

Hospital IRB-Approved Devices (non-significant risk) Non-significant risk devices that do not require FDA approval Sponsor makes initial determination and then IRB confirms or rejects decision Medicare contractors make coverage decision (use IDE criteria)

Humanitarian Device Exemptions For devices that benefit patients with rare disease (less than 4,000 patients diagnosed per year) Sponsor must submit to the FDA for HDE approved FDA approved for a specific use LCD L36238 – states HDE devices and procedures will be reviewed on an individual claim basis with the following information: Details about the specific device and FDA HDE approval Clinical indications for why the device was required along with documentation that the benefit outweighs the risk A copy of the institutional IRB approval letter for each patient

Additional Medicare Rules (non-research)

National and Local Coverage Determinations NCD National Coverage Determination Released by CMS Apply nationwide and to US territories LCD Local Coverage Determination Released by Medicare Contractors Apply to contractor’s region only Cannot contradict NCDs Both standardize Medicare coverage for certain tests/procedures Apply to Medicare Part A and Part B

General Information Found in NCDs/LCDs Common NCD/LCD Sections Benefit Category (lists the benefit category of the test/procedure) Item/Service Description (provides general background information regarding the test/procedure) Indications (describes specific situations when an item will be reimbursed for certain patient populations) Limitations (describes specific situations when an item will not be reimbursed for certain patient populations) ICD Code List (these can confirm if the study indication is covered)

Challenges with NCDs and LCDs Not written for the clinical research setting Coverage often dependent on the patient having signs and symptoms Hard to know if every patient will experience certain signs/symptoms Coverage may be limited after a patient has a normal test result

Medicare Benefit Policy Manual Chapter 15- Drug Coverage Several Medicare rules for billing drugs Off-label oncology Off-label non-oncology Oral oncology Oral drugs in the outpatient setting

Rules for Off-Label Drug Coverage May be billed if: Use is supported in a compendium Use is supported in a peer reviewed journal Need documentation to bill! The study team may be asked for documentation to support billing the medication Documentation must be specific to the patient population

Coverage Analysis Sign-Offs What information is needed from the clinical team?

Considerations for CA Sign-Off Goal is to be consistent with billing outside of research Focus on the billing designation Compliance concerns with changing billing designations after a patient enrolls

Considerations for CA Sign-Off Would the test be ordered outside of the trial? Example: CPK testing during chemotherapy Under what circumstances would the test be ordered outside of the study? All patients or only under certain circumstances Is the test required by the protocol what would normally be used to monitor the item?

Considerations for CA Sign-Off Items may be marked as a research cost even if normally billed to the patient when. . . The sponsor is paying for the item There are Medicare billing requirements that cannot be assumed for all patients before the time of care The test is ordered at a greater frequency than standard practice

Billing Compliance After the Study Opens

After the Study Opens . . . Having an approved CA on file does not equal billing compliance Billers and financial/invoicing teams need to use the CA to ensure patients are billed correctly The costs section of the consent needs to be clearly explained to the patient Documentation may need to be provided to the billers and invoicing team

Using the CA Billers – Review the CA to see if any research items need to be removed from the claim Make sure the NCT number and research identifiers are added to the claim for routine costs Invoicing Team Review the CA and budget to determine if any items need to be invoiced to the sponsor

Information Required from the Study Team Standard of care windows Some items are billable for patients if it falls within their standard of care imaging window. If the item falls outside the window (repeated for study enrollment purposes only), then it is research Coordinator or physician will need to provide information about whether or not the item fell within the SOC window

Information Required from the Study Team When certain administrative activities occur: SAEs Screen fail IND safety reports Sponsor pays for administrative work required for these activities (and others), but only pay after the site sends an invoice

Summary Several consequences for poor billing compliance Billing compliance is driven by the coverage analysis Coverage analysis is developed following Medicare rules and regulations Goal is to be consistent with billing in and out of research More than just billers are involved in a successful billing compliance process!

Discussion