Building Clinical Trial Revenue Integrity Compliance Through Auditing and Understanding Payer Requirements

Transcription

1 Building Clinical Trial Revenue Integrity Compliance Through Auditing and Understanding Payer Requirements Kelly Willenberg, DBA, RN, CHRC, CHC, CCRP Kelly Willenberg & Associates Wendy S. Portier, MSN, RN, CHC, CHRC, CCM Kelly Willenberg & Associates 1 2 1

2 Agenda Understand the risk for your hospital and how clinical trial billing compliance impacts revenue integrity Examine insurance payer s clinical trial coverage requirements to decrease denials and build revenue integrity Discuss clinical trial billing auditing approaches and processes including claims and denials review 3 4 Insurance 2

3 5 Clinical Trial Coverage & Billing Compliance Primary Rules* 1995 Medicare s Device Clinical Trial Coverage 2007 Medicare Clinical Trial Policy (CTP) NCD (reconsideration) 2000 Medicare Clinical Trial NCD (MA Device Coverage Mandate) 2014 ACA Commercial Payer Clinical Trial Mandate State Laws Clinical trial coverage laws or cooperative agreements Medicaid Coverage depends on state Medicaid programs Medicare Claims processing rules False Claims Act Protects federal taxpayers from overpayment for services provided *Other laws, regulations, rules also are relevant but are largely captured by and claims requirements 6 Foundation of Clinical Trial Coverage Medicare Clinical Trial Policy National Coverage Determination Medicare may cover the routine costs of qualifying clinical trials, if the routine costs are: NOT paid for by the sponsor NOT promised free in the informed consent form Covered by Medicare Routine costs: Conventional care Detection, prevention, & treatment of complications Administration of investigational item All other Medicare rules apply! Industry Standard: Coverage determined through a Coverage Analysis (CA)! 3

4 7 EXAMPLE: Coverage Analysis Billing Grid 8 Clinical Trial Billing Compliance Synchronous Work Flow is Key Vetting & Feasibility Analysis Coverage Analysis & Billing Plan Budgeting, Pricing & Contracting IRB Approval Enrollment & Informed Consent Identification, Registration, Scheduling & Tracking Authorization & Documentation for Medical Necessity Charge Capture Charge Segregation Claims Submission Denials Management Amendments Compliant Billing 4

5 9 Clinical Trial Revenue Continuum Front End Process Start Budget Coverage Analysis Contract Study Account Setup Coverage Documents Consent Site Initiation Charge Capture and Bill Hold Coding, Billing and Invoicing End Study Account Close Out Financial Management Drugs/Biologics vs. Devices vs. CED Account Monitoring Back End Process 10 Clinical Trial Billing & Coverage Risks Billing for services paid for by the sponsor Billing for services promised free in the informed consent form Identifying subjects enrolled in the study and reviewing claims Keeping up with amendments Denial of coverage and lost revenue 5

6 Insurance Coverage Areas Denials Management Network & Benefits Verification Pre Authorization Financial Counseling 11 All Insurance Plan Rules & Requirements Apply Covered Medical Benefits Covered Drug Benefits Network Requirements Pre Authorization Requirements Payer Medical Management Policies Denials & Appeals Claims Submissions & Coding Cost Share Advocate for resources needed to verify benefits, obtain authorizations & appeal denials for clinical trial subjects!!!! 12 6

7 Payer Clinical Trial Coverage Policy Example Consistent with Centers for Medicare & Medicaid Services (CMS) policy and Patient Protection and Affordable Care Act (PPACA) requirements, XXXX covers medically necessary routine patient care costs in clinical trials (in the same way that it reimburses routine care for members not in clinical trials) according to the limitations outlined below. All of the following limitations apply to such coverage: All applicable plan limitations for coverage of out of network care will apply to routine patient care costs in clinical trials; and All utilization management rules and coverage policies that apply to routine care for members not in clinical trials will also apply to routine patient care for members in clinical trials; and Members must meet all applicable plan requirements for precertification, registration, and referrals; and To qualify, a clinical trial must have a written protocol that describes a scientifically sound study and have been approved by all relevant institutional review boards (IRBs) before participants are enrolled. Providers will not routinely be required to submit documentation about the trial to XXXX, but XXXX can, at any time, request such documentation to confirm that the clinical trial meets current standards for scientific merit and has the relevant IRB approval(s). 13 Clinical Trial Insurance Coverage Keys Coverage Analysis (CA) CAs are generally completed using Medicare rules. Other health plans coverage may differ Network Verification Must be participating in a health plan or insurer s network or have outof network benefits Benefits Verification Routine costs in clinical trials do NOT include services, treatment, or supplies NOT otherwise covered under the benefit plan Financial Counseling Cost of participating in a clinical trial Pre Authorization Pre Authorization must occur per the subject s individual plan requirements 14 7

8 Network Requirements Network definition: The facilities, providers and suppliers the health plan has contracted with to provide health care services. The ACA does not guarantee individuals access to health care providers who are not participating in a health plan or insurer s network. Payers are only required to cover routine costs of items and services delivered by out of network providers if out of network benefits are part of the subject s coverage or plan. If the out of state investigator is not within the health plan s network, the plan may deny coverage for services provided by that investigator, unless the subject has coverage for out of network providers. 15 EXAMPLE: Network Benefits 16 8

9 EXAMPLE: Network & Authorization 17 EXAMPLE: Covered Benefits Limitations & Exclusions 18 9

10 EXAMPLE: Benefit Limitations & Exclusions 19 Network & Benefit Verification Best Practices Conduct routine insurance verification process that includes network verification & covered benefits with potential clinical trial subjects Validate network coverage to retain clinical trial subjects and maintain subject / provider relationships Out of network coverage is not guaranteed Validate covered benefits 20 10

11 21 Financial Counseling What influences a subject s decision to participate in a clinical trial? Cost of participating Length of treatment Location of treatment Health insurance coverage More. Subject questions related to clinical trials: What expenses will I have if I join a clinical trial? What costs are already covered? How do the costs of a clinical trial compare with the costs of the standard treatment? Does one option cost more than another? Can I be reimbursed for any costs of the clinical trial? Financial Counselor / Navigator Best Practices Organizes, creates and assists with information to support services for clinical trial subjects Creates information packets (FAQs, glossary, ICF, study calendar/coverage analysis) Advises subject on costs related to clinical trial participation. Orients subjects to research versus conventional care Meets with subjects to answer questions Assists with resolving billing issues with subjects Coordinates information flow between key (research, finance, billing, etc.) Meets with subjects prior to signing consent departments 22 11

12 What is Pre Authorization? A decision by health plans that requested health care services are medically necessary Sometimes called prior authorization, prior approval or precertification Review includes benefit coverage, medical necessity, Experimental / Investigational, appropriate place and level of care A request for services sent to payer utilization management department prior to services rendered Health plans require preauthorization for certain services before they are received, except in an emergency Service request reviewed and decision rendered usually within 14 days for nonemergent requests; can request expedited reviews 23 Clinical Trial Pre Authorization Requirements 24 12

13 Pre Authorization for Clinical Trials: Organizational Best Practices Proactive approach: Identify TOP 5 Payers Discuss clinical trials, authorization policies, contractual & and other requirements Identify a point person at each payer to facilitate authorization: Medical Director or Chief Medical Officer (Peer to Peer) Medical Management or Utilization Management Nurse Implement clinical trials benefits verification and pre authorization processes including financial counseling for subjects 25 Decrease Denials and Build Revenue Integrity 26 13

14 Denial Received What to do? Understand reason for denial Benefit Medical Necessity Out of Network Denial options Appeal the denial Peer to peer Exception request process & single case agreements Denial or Adverse Benefit Determination (ABD) Types Pre service denial before the service occurs Post service denial after the service occurs Tracking denials & appeals can inform better front end processes!!! 27 General Causes for Denials: Pre & Post Service Not a covered benefit Not enough information Not medically necessary Lack of pre authorization (clinical trial, procedures) Complete disconnect between hospital and physician billing Documentation by physicians inadequate in some instances Coverage Determinations: LCD prohibits payment Ordered test with certain ICD 9 / ICD 10 codes and there is an LCD that prohibits payment Coding: Government codes on commercial payer claims Z00.6 not in secondary position so it is removed from the claim by coders Lack of NCT# when there is a Z00.6 and a condition code

15 Denial Received What to do? Physician may request a conversation with Plan physician Often called reconsideration or peer to peer Consider proactive communication prior to initial submission Exception request process and single case agreement Provider Appeal Commercial provider appeals policies vary widely Appeal submission for Adverse Benefit Determination 1st & 2nd level appeals Final appeal Independent Review Organizations (IROs) CMS provider appeal rights Member (Subject) Appeal Highly regulated by Federal and/or State Guidelines Multiple Levels 29 Appeal Submissions What types of decisions can be appealed? The care is not medically necessary or appropriate Not eligible for the health plan Not eligible for the benefit The care is experimental or investigational Anything What are the types of appeal requests? Standard Expedited 30 15

16 EXAMPLES: Appeal Submissions Clinical Trials The health plan denies coverage related to a clinical trial. Drug Tier Change The health plan moves a covered prescription drug to a different tier, and out of pocket costs will go up if you continue to take that drug. Pre Service Authorization The health plan denies a request for pre authorization for more sessions with your mental health provider. Drug Coverage The health plan does not cover a prescription drug your doctor has prescribed for you. Reimbursement Although the service, item or equipment prescribed by a physician was covered by the health plan, the amount reimbursed is much lower than anticipated or think is fair. Network Adequacy The managed care health plan limits the use of health care professionals to in network providers, but there is no provider in their network that specializes in the type of service you need. 31 Your Next Steps at Your Organization Advocate & facilitate: 1. Proactive communication with payers: Identify TOP 5 payers & contacts 2. Coverage analysis process with Principal Investigator input & approval 3. Insurance clinical trial benefits verification & pre authorization process 4. Scripting for authorization staff 5. Financial counseling for clinical trial subjects 6. Identified resources for clinical trial business processes Benefits verification & pre authorization Pre & post service denials & appeals management Exception requests & single case agreements 7. Requests for Case Managers when enrolling subjects 32 16

17 Take Home Points: Pre Authorization & Denials Obtain authorization as required for clinical trial subjects No does NOT mean No Pursue other channels including appeals and peer to peer consults in case of a denial Don t reinvent the wheel Locate the department/personnel who performs authorizations & appeals ordinarily Provide training & scripting for authorization staff No double dipping Ensure that the insurance company is only covering costs that are not covered by the sponsor by performing a coverage analysis Learn from denials Denials can inform process improvement Be persistent 33 Auditing Approaches and Processes Including Claims and Denials Review 17

18 35 Before Audit can be Planned, Identify Standards Audits are designed to track and evaluate existing processes and their results In order to identify audit scope, need to have evaluated the potential failure of existing process(es) to provide intended results: risk assessment of entire process In order to evaluate existing processes, need to compare to minimum necessary to achieve compliance assurance: regulations, other external requirements, and organizational policies What does clinical research billing compliance assurance require? 36 Types of Clinical Trial Billing Audits Process / Internal Control Study Level Document Concordance Coverage Analysis Validation Invoicing Subject Level Claims Denials Invoicing 18

19 37 Audit Scope: One or All of the Following 38 Areas to Understand Prior to Audit Testing Operations Charge Segregation Registration Charge Capture Billing Financial Management Budgeting, Pricing, Contracting Accounts Receivable Professional Fees Compliance Management Investigations & Monitoring Training Personnel Roles & Responsibilities Communication What areas at your organizations do you understand fully? 19

20 39 HCCA Compliance Institute 2018 W7 Payer Issues, Denials and Process for Clinical Trials: How to Audit for Lost Revenue! Date: Wednesday, April 18, 2018 Time: 8:00 AM to 9:45AM Speakers: Kelly Willenberg & Wendy Portier 40 Contact Us Wendy Portier, MSN, RN, CHRC, CHC, CCM Consultant Kelly Willenberg and Associates, LLC Kelly Willenberg, DBA, MBA, BSN, CHRC, CHC, CCRP Owner, Kelly Willenberg and Associates, LLC P kelly@kellywillenberg.com 20