How to Process Medicare Advantage Claims for Research Billing

Clinical Research Management Webinar Series: 

How to Process Medicare Advantage 

Claims for Research Billing 

Wednesday, September 19, 2012 

12:00 p.m. - 1:00 p.m. CT

About Our Speakers 

Allecia A. Harley 

Director, Life Sciences 

Huron Consulting Group 

P 312. 880. 5628 

aharley@huronconsultinggroup.com 

Allecia has over 17 years of healthcare experience and assists clients with process design, 

research billing assessments, operational support, regulatory compliance evaluations, and 

general healthcare compliance evaluation and enhancement. 

Beth Kettenring 

Director, Office of Grants Management 

Ochsner Clinic Foundation 

P 504.842.3581 

bkettenring@ochsner.org 

Beth Kettenring joined Ochsner in early July 2006 and was recently appointed to the Director 

role. She has more than six years of experience with research claims processing. 

2

Discussion Outline 

• Mini-Review of Clinical Research Billing Compliance 

• Medicare Advantage 

• Regulations 

• Communication 

• The Ochsner Experience 

• Q & A 

3

Mini-Review of Clinical Research Billing 

Compliance

Clinical Research Billing Compliance 

Clinical Research Billing Process 

The research billing process (depicted on the 

left) is complex and requires coordination and 

harmonization between partnering institutions 

(the hospital, the physician practice plan, and 

where applicable, the university). The steps in 

the process are: 

© 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 

• Reimbursement Analysis (Coverage 

Analysis for Research / Medicare Coverage 

Analysis / Prospective Reimbursement 

Analysis) 

• Budgeting and Contracting 

• Patient Identification 

• Registration and Admission 

• Charge Entry and Charge Capture 

• Charge Segregation 

• Claims Processing and Invoicing 

• Study Close-out and Residual Balances 


5

Clinical Research Billing Compliance 

Example of a Billing Grid from a Coverage Analysis 

Billing Grid 

SPEC Study 

Today's Date: 

9/9/2011 

The purpose of this Tab is to make initial assessments of payment responsibility for all items and services provided in the clinical study. A version of this grid 

can be used for budgeting. 

Visit Schedule 

Protocol Related 

Items and Services 

Location 

in 

Protocol 

or ICF 

CPT / HCPCS / DRG / 

APC Codes (or Ranges) 

Q0 or Q1 

Modifier 

Screening / 

Enrollment 

Baseline 

Period 

1 

Hr: 0- 

24 

Period 

2 

Hr: 25- 

48 

Period 

3 

Hr: 49- 

72 

Period 

4 

Hr: 73- 

96 

Period 

5 

Hr: 97- 

102 

Period Period 

6 7 

Post Treatment Period 

Hr: 121- Hr: 145- Therapy 

Day 28 Day 60 

144 168 End 

Comments 

Sign Informed 

Consent 

Screening / Med Rec 

Review 

Serum Pregnancy 

EKG 

CBC w/diff 

pp.5 

pp. 21 

pp.24 

pp.24 

pp.24 

84702, DRG- 682- 

685 

93005, DRG- 682- 

685 

85025, DRG- 682- 

685 

S 

S 

Q1 P S P S P S 

Q1 P D P D P D 

Q1 P S P S P S P S 

This service is paid by the sponsor 

as a part of Study Coordinator time. 

This service is paid by the sponsor 

as a part of Study Coordinator time. 

This item is at Screening, Periods 

4&6 is billable to Medicare per for 

the following reasons... This item at 

Periods 3, 5 & 7 is paid for by the 

Sponsor. 

This item at screening, Periods 4 &6 

is billable to medicare for the 

following reasons... This item at 

Periods 3, 5, & 7 are not billable to 

Medicare nor are they paid for by the 

Sponsor. Therefore, the Department 

will need to cover the costs of this 

item. 

This item at Screening, and Periods 

2, 4 & 6 is billable to Medicare for the 

following reasons... This item at 

Periods 1, 3, 5 & 7 are paid for by the 

sponsor. 


6

MCA 201 and 202 

Clinical Research Billing, Budget Tools, and Coverage Analysis 

Survey 

December 14, 2011 - “Research Billing and the Revenue Cycle: A Primer” 

Presented By: 

Allecia Harley, Director, Huron Life Sciences 

Nancy Rhodes, Vice President of Revenue Cycle, Thomas Jefferson University Hospitals 

http://www.huronconsultinggroup.com/researchdetails.aspxarticleId=3089 

March 21, 2012 – “Improving Financial Performance, Minimizing Compliance Risks: 

Using the MCA as a Budget Tool in Clinical Trials” 

Allecia Harley, Director, Huron Life Sciences 

Julia M. Campbell, Associate Compliance Officer, Rehabilitation Institute of Chicago 


May 30, 2012 – “Results of Huron's Coverage Analysis Policy Survey” 

Matthew Lester, Managing Director, Huron Life Sciences 



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Medicare Advantage

Medicare Advantage 

Overview 

“A Medicare Advantage Plan is a type of Medicare health plan offered by a private 

company that contracts with Medicare to provide . . . benefits. Medicare Advantage Plans 

include Health Maintenance Organizations, Preferred Provider Organizations, Private 

Fee-for-Service Plans, Special Needs Plans, and Medicare Medical Savings Account 

Plans. . . Medicare services are covered through the plan and aren't paid for under 

Original Medicare.” 

(Source: www.medicare.gov/sign-up-change-plans/medicare-health-plans/medicareadvantage-plans/medicare-advantage-plans.html) 

• Medicare Advantage (MA) enrollees pay monthly premiums in exchange for low, or 

no deductibles, and reduced co-payments for services provided within their network. 


9


Medicare Reimbursement Methodologies 

Medicare 

Part A (technical fees) 

• Hospital inpatient 

services 

• Home health 

services, and 

hospice care 

• Note: Hospital outpatient 

services fall under Part 

B, however, for the 

purposes of coverage 

and payment outpatient 

services are billed 

through Part A. 

Part B (pro fees) Part C Part D 

• Physician services 

in all settings of 

care 

• Laboratory tests 

• Ambulance services 

• Durable medical 

equipment (DME) 

• Office-administered 

drugs 

• Managed care plans 

that offer combined 

Part A and Part B 

Medicare benefits. 

• Also recognized as 


• Formerly known as 

Medicare+Choice or 

Medicare Managed 

Care 

• Medicare’s 

prescription drug 

benefit started on 

January 1, 2006 

• Medicare Part D 

are offered by both 

the standalone 


plans (PDPs) and 

Medicare 

Advantage 


plans (MA-PDs) 


10


Definition of Terms 

• Medicare Administrative Contractors (“MAC”): Medicare Administrative Contractors 

are the entities who process claims from providers on behalf of Medicare. They are 

replacing fiscal intermediaries and carriers across the country. 

• Routine Cost: Routine Costs are the items and services that a Medicare recipient 

would have received if they were not participating in a clinical trial, including the 

administration of the investigational drug, or are provided for one of the following 

reasons: prevention, diagnosis, treatment, or monitoring for complications. 

• Traditional Medicare (“Medicare”): Traditional Medicare is the fee-for-service health 

insurance program administered by the federal government to provide care for the 

elderly and disabled of the United States. 


11


Medicare Guidance 

• Ensuring Only Clinical Trial Services Receive Fee-for-Service (FFS) Payment on 

Claims Billed for Managed Care Beneficiaries 

• www.cms.gov/transmittals/downloads/R1723CP.pdf 

• www.cms.gov/MLNMattersArticles/downloads/MM6455.pdf 

• Medicare Managed Care Manual, Chapter 4, Sec. 10.8 (Co-payments) 

• www.cms.gov/manuals/downloads/mc86c04.pdf 

• Medicare Managed Care Manual, Chapter 8, Sec. 40.4.3 & 4 (CTP & IDE) 

• www.cms.gov/manuals/downloads/mc86c08.pdf 


12


Summary of the Guidance 

• Does not apply to IDE device trials 

• Providers should split outpatient MA claims and route the protocol related routine 

care to traditional Medicare 

• Patients are not responsible for deductibles 

• MA is responsible for co-payments 

• Guidance is unclear on inpatient claims 

Medicare Advantage contractors should be billed for copayments by your institution or 

via instructions to the patient to submit the bills themselves. 


13

Medicare and Reimbursement 

Splitting Medicare Advantage Claims 

Research: Non-Billable Research: Billable Non-Research 

Funding Source Internal Study Account MAC Provider MA Plan 


15

Medicare and Reimbursement 

Ensuring Medicare Advantage Rules are Communicated 

• Use the MCA and the Informed Consent Form to identify the routine care procedures 

and charges. 

• Inform the Participant that co-payments are paid by MA (announced in 2011) 

• Implement a process at pre-authorization or scheduling to identify the MA 

beneficiaries 

• Develop a process to split claims (e.g., services unrelated to the protocol go to MA 

plan and routine care costs related to the trial go MACs) 

• Decide if the institution or the patient is going to submit charges for co-payments to 

MA 

• Develop a communication plan to: 

• Ensure key participants in the process are informed of their role 

• Facilitate understanding of the steps to be completed 

• Promote compliant billing 


16

Polling Question 

Have you seen research-related charge denials from Medicare Advantage or Traditional 

Medicare (Please mark all that apply) 

• Insurer does not cover experimental or investigational items and services 

• This is not a covered benefit 

• Medical necessity is not supported 

• Maximum benefit level is exceeded 

• Q0/Q1 modifier present but the V70.7 diagnosis code is missing 

• V70.7 diagnosis code is present but the condition code 30 is missing 

• None of the above 


17

The Ochsner Clinic Foundation (OCF) 

Experience

The Ochsner Experience 

Overall Process 

Study Start-up 

including MCA 

CRC Logs Patient 

into System with 

Start Date 

Daily Matching 

Against Pro & 

Tech Charges 

All Charges Held 

for Review 

Segregation and 

Designation of 

Charges 

At the End of 

Patient Care 

Phase, CRC Logs 

Patient Stop Date 


19


Process Design 

• Work group was created several years ago to develop a bill review process for 

research 

• Included personnel from claims review, research, compliance and IT 

• Ochsner developed a homegrown system to collect, store, and process research 

charges 

• It is used by both the research department and the claims review staff to complete 

their respective responsibilities 

• Patients are logged into this system by the Clinical Research Coordinator (CRC) 

on the date the informed consent is signed 

• This database is matched to a daily file of all charges incurred (professional and 

technical) 

• All charges for clinical trial patients are held for review by OGM 

• Comparable process in place with recent transition to EPIC 


20


Study Start-up Including MCA 

• Financial activities are the responsibility of the Office of Grants Management (OGM) 

• MCA prepared in conjunction with study budget to ensure sponsor is paying for all 

non-covered services 

• Work with PI to assist in qualifying determination & to identify routine care 

services 

– Currently developing process to provide this information at feasibility 

– Improving process to more actively engage PI & CRC 

• Provide support to confirm routine care services from CMS, etc. 

• Identify services requiring modifier Q0 or Q1 


21


Bill Hold & Review Process 

• OGM uses the MCA to identify services billed to the study or to Medicare (with a 

modifier) 

• OGM reviews patient charges & is responsible for all research non-billable services 

• Claims department : 

• Processes all research billable and non-research charges 

• Responsible for MA Patient Identification and splitting outpatient claims 

• Ensures that V70.7 diagnosis code and Q0/Q1 modifiers are included 

• Institution responsible for submitting co-payments to MA 

• OGM & Claims are both responsible for proper processing 


22


Key Issues in Communication Plan 

• OGM and claims department have constant and direct communication 

• OGM is available to provide assistance to claims department as needed 

• Continual education needed for CRCs to ensure V70.7 is included as secondary 

diagnosis for study related services 

• Communication between OGM & Claims is crucial for an efficient and effective 

process 

• Support provided by Corporate Integrity is necessary in communicating to 

administration the risks & benefits associated with clinical trial bill review 

• OGM contacts patient directly if necessary to ensure billing issues are resolved 

promptly 


23

Polling Question 

What method does your organization currently utilize to “capture” research-related 

routine care encounters when they occur 

A. Electronic 

B. Paper 

C. Combination of electronic and paper 

D. Other 

E. We do not currently systematically capture research-related routine care encounters 

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Thank you for your participation. 

For further information, please contact: 

Allecia A. Harley 

Huron Consulting Group 

P 312.880.5628 

aharley@huronconsultinggroup.com 

Beth Kettenring 

Ochsner Clinic Foundation 

P 504.842.3581 

bkettenring@ochsner.org

How to Process Medicare Advantage Claims for Research Billing

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