Research Billing
If your research study involves billing for services or procedures provided to subjects, you must ensure that the appropriate process and forms are used for correct billing to occur. Standardized research billing procedures for inpatient and outpatient services and ancillary testing are outlined in the health system research policy on research billing posted on HealthPort. Click on the Policies tab in HealthPort, then on Research Policies to access policies and forms for reserch billing (e.g. Inpatient and Outpatient Research Registration Forms and Core Lab Special Purpose Fund Account Set Up Form).
Link to: Health System Research Policies
(Note: You will be prompted for your NSLIJ username and password to access the Policies tab)
Billing Compliance Tips
- Develop a detailed study budget & billing grid - that indicates where procedures or services should be billed (e.g. study fund, subject or their insurance, or sponsor) and is consistent with study related documents (e.g. consent form, protocol, schedule of events, contract/agreement, etc.)
- Perform a Coverage Analysis (CA) - if you have any study procedures that may potentiallly generate a claim to Medicare or other insurers this analysis should be performed up front to determine routine cost coverage. Note that separate CA may need to be done for seprate arms of a study.
- Create an internal billing process map or SOP - that will allow you to work out the billing process logistically and ensure appropriate communication in the outpatient and/or inpatient settings with key people involved in the process (e.g. department administrators, research staff, registration staff, patient accounts, finance, etc.).
- Identify research subjects - by using research subject registration forms to notiffy registration/billing staff of procedures that will be covered by the research fund. Other ways to identify subjects are to provide a research card to the subject to present at registration or display a sign at the registration desk asking patients to let registration know if they are in a research study.
- Perform regular fiscal monitoring - to ensure that completed procedures were appropriately billed and to correct any errors in a timely manner.
- Have good documentation practices - by making sure your documentation is transparent and can withstand an audit. Any changes or corrections must accompany documentation about why something occurred and what was done to correct the error.
Billing Errors
Please inform your finance contact who handles billing related to research to correct the charges. Registration or patient accounts may need to be notified as well to correct information and handle any changes. See health system policy on Compliance with Government-Funded Healthcare Claims and Cost Reporting Requirements for any overpayment to Medicare or Medicaid. Note that any overpayments must be returned within 60 days of identification.
Devices
Regulations and coverage policies for devices are separate. Investigational devices require separate approvals from the Medicare Administrative Coordinator (MAC) for coverage. Devices are classified under category A (experimental/investigational) or B (non-experimental/non-investigational). See resources below for the Investigational Device Exemption form to be submitted to the MAC (National Government Services).
Information on Insurance and Denials
Coverage from commercial insurance carriers depends on their individual contracts, which may factor in the subject's plan level coverage. You may need to obtain pre-authorization prior to provision of services or procedures to ensure coverage. See resources below for appeals specific to health insurance coverage denials for procedures in research.
Resources:
- NYS Insurance Department Web site
- Application for health care consumers
- Application for health care providers
- Investigational Device Exemptions
- Research Billing Brochure
Web Sites:
- Center for Medicare and Medicaid Services (CMS) web site for National Coverage Decisions (NCDs), Local Coverage Decisions (LCDs), Benefit Policy Manual, Clinical Trial Policy (NCD 310.1), Medicare Claims Processing Manual (Ch. 32 Special Services): www.cms.gov
- National Government Services - our local Medicare Contractor for LCDs and Medical Director "articles": www.ngsmedicare.com
- Devices: 42 CFR 405.201 - 405.215, 411.15, 411.406; Medicare Benefit Policy (Ch. 14 Devices): www.cms.gov
- CMS Transmittal on New Modifiers (QO, Q1) when billing for patient care in clinical research studies: http://www.cms.gov/transmittals/downloads/R1418CP.pdf
Please contact Emmelyn Kim at (516) 562-0339 or ekim@nshs.edu or Research Compliance at orc@nshs.edu if you have any questions.