Maintaining good documentation is imperative to ensuring that clinical research study participants receive appropriate care and follow-up from all care providers. Medical documentation also serves as the basis for claims sent to Medicare and other private third party payors.
Including the following information in the study participant’s medical record will help maintain the accuracy and integrity of the source documentation in support of claims submitted to insurance payors:
The above elements together with medical necessity must be documented in real time and prior to the study participant receiving the study related item or service. Regardless of the payor responsible, it is best practice to include the applicable information in the participant’s medical record to ensure completeness and consistency in clinical research documentation.
For Additional information, please visit our FAQ’s .
Coverage of items and services in Category A (Experimental) and B (Non-Experimental Investigational) IDE device studies is determined by the Centers for Medicare & Medicaid Services (“CMS”).
Following receipt of the FDA approval letter, parties seeking coverage determination for Category A or B IDE studies must request coverage approval by submitting a request packet to central CMS .
The local Medicare Administrative Contractor (“MAC”) will only determine/approve coverage for non-significant risk (“NSR”) device studies. The MAC will continue to administer IDE studies approved by the MAC prior to January 1, 2015 (submission to central CMS not required).
For Additional information, please visit our FAQ’s .
Principal Investigators are responsible for submitting sufficient materials and information related to the continuing IRB review of a clinical research study. The applicable information and documentation must be timely submitted (at least one month prior to expiration of approval) to allow the IRB sufficient time to carry out continuing review and issue an approval.If/when an IRB approval expires, all research activities involving human subjects must stop! The only exception to this requirement are activities conducted for study participant safety.
Research activities include, but are not limited to the following:
Retroactive approval for work performed after the expiration date of an IRB approval cannot be granted. Research project activities may resume only after IRB approval has been issued.
By issuing a national coverage determination (NCD), Medicare provides coverage for complex services/procedures rendered as part of a Medicare Approved Registry. The coverage determination stipulates that the medical facility performing the services must meet specific required standards. These standards include ensuring the safety of the beneficiaries receiving services and the provider having the ability and expertise to perform the services/procedures.
Claims submitted to Medicare related to an approved registry must identify the procedures/services by including all of the following:
In all cases, claims submitted to Medicare for services/procedures provided as part of an approved registry must be supported by clinical documentation in the patient’s medical record. The documentation must include information explaining that the services/procedures provided were medically reasonable and necessary in accordance with CMS coverage decision criteria.
For Additional information, please visit our FAQ’s or contact our office directly at 310-794-6763.
When scheduling a patient who is also a clinical research study participant for an evaluation, diagnostic/surgical procedure, or lab test that is unrelated to study participation , the CareConnect encounter should not be associated/linked to the clinical research study in which the patient is designated as “Research: Active.”
For Additional information, please visit our FAQ’s .
The Centers for Medicare & Medicaid Services (“CMS”) covers costs of services rendered to healthy volunteers in a qualified clinical trial under the following conditions:
When billing for routine clinical research study-related services rendered to healthy volunteers, the Z00.6 diagnosis code must be placed in the primary position on the claim, to explain that services were provided to a study participant in the healthy volunteer control group. The other special billing rules (NCT#, condition code 30, Q modifier, revenue code 0624, etc.) are also required, as applicable, depending on the type of claim (hospital/professional/in-patient/out-patient) being submitted.
For Additional information, please visit our FAQ’s .
Every claim submitted to Medicare or a private third party payer must be supported by detailed, accurate, complete and contemporaneous documentation in the patient’s medical record to verify that the services performed were reasonable and necessary, and required the level of service billed.
When billing Medicare for services provided as part of a qualifying clinical trial, the billing provider must include the following clinical research study information in the beneficiary’s (study subject’s) medical record:
While not every study participant will have Medicare coverage, it is best practice to include this information in each subject’s medical record to ensure consistency in documentation of clinical study participation.
For Additional information, please visit our FAQ’s .
Coverage with Evidence Development (“CED”) is a process by which the Centers for Medicare & Medicaid Services (“CMS”) determines coverage and billing of items/services on the condition these are provided in the context of approved clinical studies or additional clinical data collection.
Under CED determination, routine costs of an approved clinical study in both the treatment arm and the control arm are payable by Medicare.
For Additional information, please visit our FAQ’s and the CMS Coverage with Evidence Development webpage.
Myth #1: Medicare will pay for any item/service designated as “Standard of Care” (SOC).
Reality: “Standard of Care” is not a Medicare concept. Payments for clinical study related items/services are issued by Medicare in accordance with coverage rules and defined terms set by statutes, regulations and local Medicare contractors. For more information, please see our FAQs:
http://compliance.uclahealth.org/body.cfm?id=189#faq151
http://compliance.uclahealth.org/body.cfm?id=189#faq156
Myth #2: Unfunded Services on an NIH Grant are billable to Medicare.
Reality: Unfunded patient care costs on a clinical study sponsored by NIH are not necessarily covered by or billable to Medicare. To determine which items/services require study funding and which are billable to Medicare, complete the coverage analysis required under UCLA Policy 915. See Medicare Clinical Trial Policy for detailed information:
http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=1&ncdver=2&fromdb=true
Myth #3: Clinical research billing compliance laws, rules, and regulations apply only to industry sponsored/funded studies.
Reality: Medicare and Private Payor rules and requirements for documentation, coverage, and billing DO apply to ALL clinical studies. The funding source or lack of a funding source is not relevant. Therefore, it is important to perform itemized coverage analysis to identify which protocol services are billable and, when encountered using CareConnect, to enter timely, complete and accurate study, enrollment and encounter information.
Effective January 1, 2015, Medicare coverage of items and services in Category A and B Investigational Device Exemption ("IDE") studies will be determined by the Centers for Medicare & Medicaid Services ("CMS") upon submission by the study sponsor for central approval. The local Medicare Administrative Contractor ("MAC") will only determine/approve coverage for non-significant risk ("NSR") device studies.
IDE studies approved by the MAC prior to January 1, 2015, will continue to be administered by the MAC and do not require submission to CMS for central approval.
Documentation to support billing protocol items/services to insurance must be present in the patient’s medical record, just as for any other care. Supporting documentation required by the payor would include a complete, accurate, and detailed record of the care, such as:
The following information is required and must be accurately provided on the Research Study Submission Form when requesting study record set-up in CareConnect:
Missing/wrong information will delay set-up and ability to schedule protocol visits in CareConnect.
Research Study Submission Form link: http://careconnect.uclahealth.org/secure.cfm?id=122
Effective January 1, 2014, CMS will require the clinical trial number be reported on all claims for items/services related to qualifying clinical trials (i.e. clinical trials, clinical studies, CMS-approved Category A and B Device trials, or registries resulting from studies covered under Coverage with Evidence Development).
The number to be reported on the claim is the number assigned by the National Library of Medicine ClinicalTrials.gov website when a new study is entered in the NLM Clinical Trials database.
Resources:
All new and legacy clinical studies, including Investigator-Initiated studies, (whether funded or unfunded, and regardless of the funding source) that may include any clinical or research items, tests, procedures, interventions or other services on study subjects performed at any UCLA Health System location, must be submitted to the Clinical Trial Administration Office to complete required Coverage Analysis Process under UCLA Policy 915.
Resources:
UCLA Policy 915: http://www.adminpolicies.ucla.edu/pdf/915.pdf Clinical Trials Administration Office (CTAO): http://clinicaltrials.ucla.edu/
Federal and state agencies are increasing efforts to reduce fraud, waste, and abuse in healthcare spending. If you are contacted directly by phone or in writing please contact the Office of Compliance Services. The following research-related documents should be readily available for review when research-related claims are audited by a government agency:
A “Qualified Clinical Trial” is a clinical study that meets stated regulatory requirements to be eligible for Medicare coverage of certain study-related patient care costs, called “routine costs”, under the Medicare Clinical Trial Policy. If you are unsure what is a qualifying clinical trial please visit our FAQs:
For more information:
When submitting a request (requisition) for a clinical study-related procedure, be sure to include the following information in the “Reason for Test” section or alternate prominent location on the form:
Study Record - Clinical study information must be ready in CareConnect for Go-Live March 2013. To allow time for questions, each clinical study team should submit as soon as possible using the Research Study Submission Form available here: http://careconnect.uclahealth.org/secure.cfm?id=122
Training - Please enroll in the following classes if you will conduct or coordinate clinical studies within the UCLA Health System inpatient and/or outpatient setting.
http://careconnect.uclahealth.org/Workfiles/secure/Training/Catalog_082112.pdf
There are special rules for individuals enrolled in a Medicare Advantage Organization (“MAO”) who may also participate in a clinical study that is a qualifying clinical trial. These rules are even more complex than those for individuals who participate in Medicare fee-for-service.
Be sure you understand the specific coverage allowance and billing requirements of a subject’s insurer before billing any clinical study related services to a Medicare Advantage Plan.
For additional information about clinical trial billing to MAOs, please see:
http://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R107MCM.pdf(Section 10.8- Clinical Trials)
The following documents should be referenced when preparing a coverage analysis for a Clinical Study:
The Principal Investigator should maintain copies of all such reference documents and citations with the study financial records.
The primary documents that indicate the financial terms of a Clinical Study are:
Before proceeding with a Clinical Study, ensure that these documents all state exactly the same plan so the institution, investigator, study team, billing offices, and study participant have consistent information regarding who will pay for study-related items and services.
Effective July 15, 2012 per new UCLA Policy 915, a Coverage Analysis is required for all new industry-sponsored, industry-authored, federally funded or non-profit supported (NIH, CMS, foundation grants), and investigator-authored clinical trials and clinical research studies conducted within the UCLA Health System and the DGSOM.
For questions regarding the coverage analysis process, or to access the new Clinical Trial Budget and Coverage Analysis documents, please access the faculty/staff section of the Clinical Trials Administration Office (CTAO) website at: http://clinicaltrials.ucla.edu. If you need a user name and password for the website, please contact the CTAO office at: [email protected].
For additional clinical trial billing information, please visit the Office of Compliance Services website at: http://compliance.uclahealth.org/body.cfm?id=73.
Proper Claims for Clinical TrialsAvoid submitting improper claims related to clinical research by:
Some pitfalls to avoid when billing for services and managing funds in a clinical trial:
Billing for services provided as part of a qualifying clinical trial requires compliance with the following medical record documentation requirements:
The billing provider must include the following clinical trial information in the beneficiary's medical record:
While not every participant will have Medicare coverage, it is best practice to include this information in each subject's medical record since the research team may not know what type of insurance the subject has or may have in the future.
Medicare Claims Processing Manual, Chapter 32, Section 69.3
https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c32.pdf
Tips to avoid clinical research billing errors for services related to Qualified Clinical Trials:
