september 20, 2012 kelly willenberg, mba, bsn, chc, … · understand the importance of research...

September 20, 2012

Kelly Willenberg, MBA, BSN, CHC, CHRC

1 1 © Kelly Willenberg, LLC

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


◦ 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


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


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!


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

Presenter

Presentation Notes

Shouldn’t use graphic for billing if we don’t use any other graphics?

Potential financial risk Regulatory problems Institutional Values lost Cultural priorities and fear of change Exposure


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


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


• 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


◦ 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


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


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


“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


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.”


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


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


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


What is a Medicare Coverage

Analysis?


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.



©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


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


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

26

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


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


http://www.cms.hhs.gov/ClinicalTrialPolicies/

http://questions.cms.hhs.gov/cgi-bin/cmshhs.cfg/php/enduser/std_alp.php

http://www.nccn.org/index.asp

http://www.acc.org/

http://www.acnponline.org/

http://www.guideline.gov/

http://www.acr.org/

http://www.cancer.gov/

http://www.labtestsonline.org/

http://clinicaltrials.gov/

http://www.aapc.com/

http://www.asco.org/

http://www.americanheart.org/presenter.jhtml?identifier=1200000

http://www.nlm.nih.gov/medlineplus/

http://www.rxlist.com/script/main/hp.asp

Kelly Willenberg www.synergism-llc.com [email protected]

864-473-7209


http://www.synergism-llc.com/

mailto:[email protected]

