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Understand the importance of research billing compliance and how that impacts the hospital and your practice
Understand how billing can advance or
hinder clinical trial participation
2 2 2 © Kelly Willenberg, LLC
Errors in billing Medicare for items or services relative to clinical trials could result in allegations under the False Claims Act (“FCA”)
Many health care and research fraud cases are brought under the FCA Public Settlements • University of Alabama settlement for $3.4 million, 2005 • Weill Cornell Medical Center settlement for $4.3 million, 2005 • Rush University Medical Center settlement for $1 million, 2005 • Tenet Healthcare System, Norris Cancer Center for $1.9 million, 2010
Medicare can audit an institution at any time and “measures” risk of
fraud and abuse by a provider’s reporting of procedures and diagnosis codes on a claim
3 © Kelly Willenberg, LLC
◦ Coordinate and communicate study
information ◦ Promote transparency in study documents
◦ Document a Process for billing in clinical
trials
4 4 © Kelly Willenberg, LLC
◦ Billing for services that are already paid by the sponsor
◦ Billing for services promised free in the informed consent
◦ Billing for services that are for research-purposes only
◦ Billing for services that are part of a non-qualifying clinical trial
◦ Billing Medicare Advantage Plans (Part C) when claims
should be directed to the Medicare Administrative Contractor
5 5 © Kelly Willenberg, LLC
Information that must be coordinated to minimize compliance
risks is traditionally in “silos” ◦ What is billable and not billable ◦ Who is enrolled in a research study ◦ Which services are required by the protocol
Within academic medical setting, many different functions interact with research study and develop study documents that have important information for billing: ◦ University/Campus ◦ Schools of Medicine ◦ Medical Center ◦ Physician Offices ◦ CROs
6 6 © Kelly Willenberg, LLC
Principal Investigator Clinical Research Coordinator
IRB process Budget negotiators
Clinical Trial Agreement negotiators Grant administration Information Technology
Health Information Management Registration/Scheduling
Medical center billing and coding Physician professional fee billing and coding
Study fund managers Managed care contract negotiators ….and others!
7 © Kelly Willenberg, LLC
Billing Compliance
FMV and Contracts with
all Referral Bases
Budget, Contract, Consent, Coverage Analysis
Transparent Documents
and Congruency
Human Subject Protection
Charge Capture,
Segregation, Research Pricing
© Kelly Willenberg, LLC 8
Audit
Potential financial risk Regulatory problems Institutional Values lost Cultural priorities and fear of change Exposure
© Kelly Willenberg, LLC 9
Payback, penalties or fines Audits from other federal agencies Accreditation status jeopardized Loss of Federal Grants Loss of Key Thought Leaders Bad Press and Public Relations
© Kelly Willenberg, LLC 10
Develop database of approved research studies
Identify status of research studies No enrollment Closed to enrollment, but subjects receiving services Open to enrollment and subjects receiving services Long-term follow-up only
Prioritize which studies to develop MCAs Consider two parallel tracks:
1. All proposed studies get MCA for budgeting accurately 2. Begin active studies with those with subjects receiving services
© Kelly Willenberg, LLC 11
• Develop a database of subjects/patients
• Identify patients not in long-term follow-up
• Flag patient accounts for review against an MCA
• Begin reviewing patient accounts against MCA
• Delineate clear roles and responsibilities of all parties
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◦ Clinical research billing rules rely on multiple study documents to determine what is billable to patient or insurance ◦ Study document language should be in harmony,
but documents are often developed for different reasons and by different individuals and units ◦ If the billing process is contemplated early, then
there is a better chance for clear and consistent study documents ◦ Coverage Analysis is the way to achieve
transparency and compliance with Medicare’s clinical trial policy
13 © Kelly Willenberg, LLC
Interpreting the ICF ICF interpreted for MCA from the perspective of the patient
Plain meaning of the words used in the informed consent
Promises made to research patients should be kept
If lines could contradict each other, then tried to reconcile the
lines
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Potential Benefits: Therapeutic Intent In order to meet therapeutic intent criterion, ICF must state some
theory of how the study services could help the patient
ICF need not promise benefit – but it should state a possible benefit
If ICF states that patient will not benefit from participating in the research study, then ICF could be used to show lack of therapeutic intent
© Kelly Willenberg, LLC 15
“Added Costs” Section Regulation:
◦ 45 CFR 46.116(b)(3): “Any additional costs to the subject that may
result from participation in the research”
If the “added costs” section of the informed consent form states that an item or service will not be charged to the patient, then the MCA identifies the service as not billable
© Kelly Willenberg, LLC 16
Examples of language “You or your health plan must provide payment for hospital,
clinic, and other medical costs that are considered routine care for patients with your disease. The sponsor of the study…will provide the study drugs at no cost to you. Medical testing done for the purposes of the study will also be provided to you at no charge.”
© Kelly Willenberg, LLC 17
Patients enrolled in a research study receive core services according to the protocol’s schedule of events
The protocol is a “road map” ◦ Up side: each study can follow a consistent tool ◦ Down side: billing errors replicate easily
Study documents may not be written with billing in mind and can create systemic issues ◦ Example: A diagnostic test may be characterized in an
investigator-initiated Protocol as being performed for “research” and regulator may consider that to mean data collection only and the service not billable
18 © Kelly Willenberg, LLC
Most clinical trial billing rules in the United States are generally shaped by the Medicare Program’s Clinical Trial Policy and Medicare’s device trial coverage regulations
UC Davis’ billing rules for clinical research are set according to Medicare standards
While Medicare has complicated rules, there is logic to them and generally allows billing for medically necessary services as long as all subjects in a study billed the same way Medicare normally is billed
19 © Kelly Willenberg, LLC
Medicare requires that it not be billed for a trial‐related service if any enrollee or enrollee’s insurer would not be billed for the service ◦ Example: If a CXR at 6 weeks is not billed to commercial
insurance patient, then it cannot be billed to Medicare
Utilize Medicare clinical research billing rules as a baseline for budget negotiations and for billing Use pre‐authorization process for commercial and
group health plans as additional way to put payors on notice
20 © Kelly Willenberg, LLC
Follows Medicare Coverage principles to comply with the National Coverage Decision and Clinical Trials Policy
Acts as a way to manage, coordinate and communicate study
information
Acts as a “translation tool” to brings the world of a research study into the world of billing
Acts as a way to communicate study information but it’s not the “end of the story” as a Coverage Analysis is fluid
Systematic review of research related documents to determine
the Medicare billing status of both the study itself and the items and services provided to the research subjects that are outlined in the documents.
22 © Kelly Willenberg, LLC
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©2012 Kelly Willenberg,
Hypothetical MCA: Manage theLLCinformation
Code Infusion 1 Infusion 2 2 weeks 12 weeks 24 weeks Comment
Physical Exam
99201- 99215
M M M M
EKG 93000 M M M
Drug 123 J0123 S S
Infusion 96400 M M
Urinalysis 81000 NB NB
Ultrasound 93990 ICF
Patient Diary
N/A NB NB NB NB
M=Medicare S=Sponsor ICF=Free in Informed Consent NB=Not billable to Medicare
Is it a Qualifying Trial?
The first step in the CA process is determining if a clinical trial “qualifies” for Medicare
coverage
Medicare has explicit language in their national clinical trial policy that lists the requirements for qualification
Determining if the trial “qualifies” for Medicare coverage is the foundation for complying with the National Clinical Trial Policy and the first step towards billing compliance
If answer is yes List the schedule of events in a “Grid” Perform Coverage Analysis Put appropriate codes and modifiers on bills being sent to government payors
24 © Kelly Willenberg, LLC
A Clinical Trial Agreement (CTA) is a contract between
the Study Sponsor and the Institution for the conduct of the research.
CTAs list the types of support provided by the sponsor: ◦ Items and services that will be paid by the Sponsor ◦ Items and services that will be provided by the
Sponsor ◦ Payment schedule ◦ Indemnity ◦ Payment for subject injury
25 25 © Kelly Willenberg, LLC
Cause of most research billing non-compliance: Breakdown in coordination
What are some historical things that might come into play? History of institution Culture Existing structure Size and availability of resources Scope of the research program and scalability of it
Important information to coordinate What research studies are being conducted at a facility? Which patients are enrolled in a research study? Which services should be charged to payors and which charged to
study account?
© Kelly Willenberg, LLC
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Ensure compliance with Federal, state, and local regulations by using the Coverage Analysis as a standard approach to all payers
Develop the Coverage Analysis as a tool to ensure compliant claims processing and minimize patient billing errors
Minimize denials and/or claims processing errors by including a “marker” to identify charges that require the V70.7 diagnosis, modifiers, or condition codes
Identify the claims to be split before billing by flagging Medicare HMO (Advantage) patients who are enrolled in research studies
Identify the charges to be submitted to the study sponsor in the detailed billing grid with charge codes
27 © Kelly Willenberg, LLC
Centers for Medicare & Medicaid Services, "Medicare Coverage ~ Clinical Trials" http://www.cms.hhs.gov/ClinicalTrialPolicies/
Questions and Answers, Medicare coverage of clinical trials http://questions.cms.hhs.gov/cgi-bin/cmshhs.cfg/php/enduser/std_alp.php
National Comprehensive Cancer Network http://www.nccn.org/index.asp American College of Cardiology http://www.acc.org/ American College of Nuclear Medicine http://www.acnponline.org/ Medicare Claims Processing manual ch. 32, §68 and 69 National Guideline Clearinghouse http://www.guideline.gov/ American College of Radiology http://www.acr.org/ National Cancer Institute http://www.cancer.gov/ Lab Tests Online http://www.labtestsonline.org/ Clinical Trials. Gov http://clinicaltrials.gov/ American Academy of Professional Coders http://www.aapc.com/ American Society of Clinical Oncology http://www.asco.org/ American Heart Association
http://www.americanheart.org/presenter.jhtml?identifier=1200000 MedlinePlus Health http://www.nlm.nih.gov/medlineplus/ RxList The Internet Drug Index http://www.rxlist.com/script/main/hp.asp
29 © Kelly Willenberg, LLC