The protocol schedule of events drives the services listed in the MCA, which drives what is listed as covered or not covered

CLINICAL TRIAL BILLING GUIDELINES

Version Date: 10 July 2014

1. PURPOSE

2. HOW DOES RESEARCH BILLING DIFFER FROM NON-RESEARCH BILLING?

3. DOES MY RESEARCH STUDY QUALIFY FOR MEDICARE COVERAGE?

4. WHAT DO I DO WITH THE MCA ONCE RECEIVED?

5. WHAT DO I DO IF MY STUDY DOES NOT REQUIRE AN MCA?

6. ONCE I HAVE THE MCA CAN I START THE PROJECT?

7. WHAT IS THE STUDY CODE AND HOW DO I GET ONE?

8. ARE BOTH QUALIFYING AND NON QUALIFYING CLINICAL TRIALS BILLABLE TO A RESEARCH

FUND?

9. WHAT ELSE DO I NEED TO KNOW BEFORE I START BILLING FOR ENROLLED SUBJECTS?

10. HOW DO I LINK PATIENT CARE CHARGES TO A RESEARCH FUND?

11. HOW DO I REQUEST PRE-AUTHORIZATION FROM A NON-MEDICARE INSURANCE COMPANY?

12. HOW DO I BILL TO A RESEARCH FUND FOR STUDIES INVOLVING SOLID ORGAN OR ISLET CELL

TRANSPLANTS?

13. HOW DO I BILL FOR DEVICE & DEVICE ASSOCIATED SERVICES IN A TRIAL WITH AN IDE, PMA OR

510k NUMBER?

14. WHAT IS A HUMANITARIAN DEVICE AND A HDE HUMANITARIAN DEVICE EXEMPTION?

15. HOW DO I MONITOR MY RESEARCH FUNDS TO ENSURE THE CHARGES ARE BEING DIRECTED APPROPRIATELY?

16. WHAT DO I DO IF I FIND AN ERROR?

17. WHAT DO I DO IF ANTICIPATED PATIENT CARE CHARGES DO NOT APPEAR ON MY RESEARCH FUND?

18. WHAT DO I DO IF A RESEARCH SUBJECT CONTACTS ME, THE STUDY COORDINATOR OR MY PI STATING THEY OR THEIR INSURANCE WAS CHARGED FOR SOMETHING THAT SHOULD HAVE BEEN CHARGED TO A RESEARCH FUND?

19. CONTACTS

PURPOSE: The purpose of this document is to provide guidance for charge capture and billing procedures for subjects enrolled in Clinical Research.

HOW DOES RESEARCH BILLING DIFFER FROM NON-RESEARCH BILLING?

Patients may receive care as part of a clinical trial in a variety of settings. Each setting is billed by different organizations such as the hospital (Patient Accounts), the Massachusetts General Physicians Organization (MGPO), or both entities. If a clinical trial involves multiple care settings, each setting needs to be charged and billed appropriately.

Charges for each billing office may be billed to a third party insurer, patient and / or research fund. While some third party insurers may cover research, some may not. Coverage is payer specific. In order to qualify for payment of routine costs by Medicare, the trial must be considered qualifying by meeting three necessary and seven desirable characteristics. This determination is made by PCRO. See Appendix 1 for the Medicare National Coverage Decision regarding Medicare coverage.

DOES MY RESEARCH STUDY QUALIFY FOR MEDICARE COVERAGE?

The Partners Clinical Research Office (PCRO) in collaboration with the study Principal Investigator is responsible for determining, through the evaluation of the research protocol, the studys qualifying status based on Medicare rules and for qualifying trials which services are eligible for Medicare coverage vs. those that are ineligible for Medicare coverage. The end product of the Medicare Coverage Analysis (MCA) is a billing grid/calendar template that is used to create a timeline in Epic.

The MCA is a Partners requirement that involves:

determining the underlying eligibility of the trial to meet Medicares definition of a qualifying clinical trial and

for qualifying clinical trials, the creation of a billing calendar in which items/services specified in the protocol are identified as eligible for Medicare coverage under CMS National (NCD) and Local (LCD) Coverage Decisions.

The informed consent should be consistent with the final MCA with regard to which items and services Medicare/insurance/the subject are financially responsible.

If an item or service is not billable to Medicare/insurance/the subject, it must be charged against the research fund as allowed by the sponsor and budget. Every attempt should be made to get the sponsor to cover services that may not be billed to Medicare/insurance/the subject as a part of the budget.

For NIH grants, MCAs may be requested from the Partners Clinical Research Office (PCRO) upon submission to the (IRB) or when the final documents needed to prepare the MCA are available to assist in planning an appropriate budget. Final documents include final protocol, draft consent, draft budget/contract as available; for investigational devices or pre-market approval (PMA) 510K carotid stent studies, the FDA letter and device pricing are also needed. PCRO Contact, Jennifer Meneses, jmeneses3@partners.org

Partners no longer requires billing grids/calendars for non-qualifying observational trials.

For more MCA information, please see http://www.partners.org/Medical-Research/Resources/Research-Support/PCRO/For-Investigators/Medicare-Coverage-Analysis.aspx

Please note that the MCA is not a reimbursement analysis and does not speak to private payers.

WHAT DO I DO WITH THE MCA ONCE RECEIVED?

As the Principal Investigator, you are responsible for all aspects of the study including the finances. You should ensure that your study staff understands which charges should be directed to Medicare/insurance/the subject and which should be directed to the research fund. Pamela Richtmyer, prichtmyer@mgh.harvard.edu, from Research Compliance is available to meet with you and your staff to review the MCA prior to enrolling subjects.

WHAT DO I DO IF MY STUDY DOES NOT REQUIRE AN MCA?

Non-qualifying observational studies do not affect usual and customary care items or services provided around and during the trial. Usual and customary care items or services provided around and during the trial are billed to Medicare/insurance/the subject in the usual manner.

ONCE I HAVE THE MCA CAN I START THE PROJECT?

An MCA is the start of the charge routing process however you will also need IRB approval and a fully executed Clinical Trial Agreement (industry) prior to initiating the project. PATCOM and Special Billing Numbers are no longer used. An active fund must be linked to the IRB protocol in Insight so a new record will be created in Epic with the new Study Code. If the fund number is not already linked to your protocol then you will need to submit an amendment to the IRB linking the fund to the protocol. When the amendment is approved, a new record will be created in Epic.

WHAT IS THE STUDY CODE AND HOW DO I GET ONE?

The Study Code routes the charge to the research fund.

A record is created in Epic with the Study Code after the IRB has approved a fund being associated with a particular protocol either with the initial submission or an amendment.

The Study Code replaces PATCOM and special billing numbers.

The Study Code for non-Oncology clinical studies is the protocol number and the fund number: Example: 2014p003456-123456. The Study Code for Oncology studies is the IRB protocol number: Example: 06-064.

If the study will have patient care charges directed to the research fund and the budget does not have a Patient Care expense line, be sure to inform your Post Award GA that patient care charges will be directed to the fund so that the fund will be set up correctly to post patient care charges. In addition, budget revisions to insert a Patient Care expense line may require sponsor approval which would be addressed at fund set-up. See Post Award GA List per Department: http://resadmin.partners.org/RM_Home/Documents/contact%20lists/MGHDeptAssignments.pdf

ARE BOTH QUALIFYING AND NON-QUALIFYING CLINICAL TRIALS BILLABLE TO A RESEARCH FUND?

Yes, both qualifying and non-qualifying clinical trials may be billable to a research fund, therefore a record must be created in Epic with the study code to support research fund billing for either.

WHAT ELSE DO I NEED TO KNOW BEFORE I START BILLING FOR ENROLLED SUBJECTS?

Document, Document, Document! Documentation is the key to help ensure payment.

Informed Consent A signed and dated copy of the research Informed Consent form (ICF) must be given to the subject and a copy placed in the research record and the subjects medical record. If relevant to the subjects medical care and not sensitive research, a signed copy of the informed consent must be placed in the subjects medical record. Medicare requires the trial name, sponsor and sponsor-assigned protocol number in the medical record which can be found in the informed consent.

If the study involves sensitive research, (e.g., studies that collect information about sexual practices, illegal behaviors, alcohol or drug use) a copy of the research consent form ordinarily should not be placed in the subjects medical record. The IRB is responsible for making the determination whether a study is considered sensitive. Only the protocol number will appear in Epic for sensitive studies. (If the sensitive study involves a drug or otherwise might implicate care decisions, the investigator should discuss with the Institutional Review Board (IRB) how best to make this information available to a caregiver with a need to know.) Informed Consent of Research Subjects Policy-Partners Human Research Office http://healthcare.partners.org/phsirb/infcons.htm

Medical Record Documentation of Services Rendered to Research Subjects If not sensitive research, billing for subjects in clinical trials is consistent with basic patient care billing guidelines that require medical record documentation to support services rendered.

Participation in a clinical trial should be re