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: 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.aspx?articleid=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 http://www.huronconsultinggroup.com/researchdetails.aspx?articleid=3185 May 30, 2012 Results of Huron's Coverage Analysis Policy Survey Matthew Lester, Managing Director, Huron Life Sciences http://www.huronconsultinggroup.com/researchdetails.aspx?articleid=3295 7
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 Advantage 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 Medicare Advantage 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 prescription drug plans (PDPs) and Medicare Advantage prescription drug plans (MA-PDs) 10
Medicare Advantage 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 Advantage 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
Medicare Advantage 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
The Ochsner Experience 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
The Ochsner Experience 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
The Ochsner Experience 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
The Ochsner Experience 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 24
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