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Clinical Research Tips

What constitutes appropriate medical record documentation for clinical research?

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:

  • Study title
  • Sponsor name
  • Sponsor assigned protocol number
  • Statement regarding study subject’s consent to participate in the clinical research study (applicable to the consent visit)
  • Study subject’s condition (past medical history) prior to enrollment in study and reasons for study-related tests/procedures
  • Interval clinical history as related to clinical research study participation (applicable to follow-up study visits)
  • For device studies – the complete name of the study device and serial number/ identification number
  • For drug studies – the complete name of the investigational drug (if combination treatment, include all drug names)
  • Complete description of the intervention or surgical procedure performed Study participant’s response to treatment and plan of future care

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 .


Investigational Device Study Billing - CMS submission requirements

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 .


Expiration of IRB Approval - Human Subject Clinical Research Studies

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:

  • enrollment of new subjects;
  • provision of protocol required treatment/intervention;
  • conducting protocol required procedures;
  • contact with study subjects for follow-up;
  • data collection; and
  • data analysis.

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.

Resources
  1. OHRP Guidance on IRB Continuing Review of Research – https://www.hhs.gov/ohrp/regulations-and-policy/guidance/guidance-on-continuing-review-2010/index.html
  2. UCLA OHRPP Guidance and Procedure: Closure of Human Subjects Research Studies - http://ora.research.ucla.edu/OHRPP/Documents/Policy/11/Study_Closure.pdf
  3. UCLA OHRPP Guidance: IRB Review Type – Continuing Review – http://ora.research.ucla.edu/OHRPP/Documents/Policy/4/Continuing_Review.pdf
  4. FDA Guidance for Institutional Review Boards and Clinical Investigators – http://www.fda.gov/RegulatoryInformation/Guidances/ucm126420.htm

Documentation of clinical research performed as part of a Medicare Approved Registry

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:

  1. 8-digit Clinical Trial Number (NCT #);
  2. Z00.6 diagnosis code;
  3. Q modifier and other applicable special billing rules.

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 not to link a CareConnect encounter to a clinical research study record

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 .


Billing for Routine Clinical Research Study-related Services Rendered to Healthy Volunteers

The Centers for Medicare & Medicaid Services (“CMS”) covers costs of services rendered to healthy volunteers in a qualified clinical trial under the following conditions:

  • The trial is not designed solely to test toxicity or disease pathophysiology.
  • The therapeutic intent of the trial is clearly stated and can be objectively evaluated.
  • A trial that studies a therapeutic intervention must enroll patients with diagnosed disease rather than only healthy volunteers, although healthy patients may be included as a control group.

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 .


Medical Record Documentation for Clinical Research Studies

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:

  1. Trial Name
  2. Trial Sponsor
  3. Sponsor-assigned protocol number

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 .


Medicare Coverage with Evidence Development ("CED")

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.


3 Top Myths Related to Clinical Study Billing

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.


New CMS Requirements for Investigational Device Study Billing

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.

See: 
MLN Matters® Number: MM8921
CMS.gov:  Medicare Coverage Related to Investigational Device Exemption (IDE) Studies


Required medical record documentation in support of billing for protocol items/services

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:

  • trial name, sponsor name and sponsor-assigned Protocol number (required for Medicare)
  • subject’s condition prior to enrollment in study
  • reasons for study-related tests/procedures required
  • treatment rendered during the clinical study
  • study subject’s response to treatment and plan of future care
  • written precertification/preauthorization (as required by private payor)

Qualified Clinical Trial cost types that are not billable to subjects or insurance

The following qualified clinical trial cost types cannot be billed to subjects or insurance, and must be paid by the study sponsor or covered by other appropriate funding source:
  • Any item/service that is:
    • promised free in the informed consent
    • customarily provided by the research sponsor free of charge for any enrollee in the trial
  • The investigational item/service that is the objective of the clinical trial unless it is otherwise covered outside the study or by other CMS coverage determination.
  • Protocol activity/items/services that are not for the direct clinical safety and management of the subject at the time of the order (e.g., consent, inclusion/exclusion labs/imaging/services, research-only protocol activity, monthly CT scans for a condition usually requiring only a single scan).

Clinical Study Set-Up in CareConnect – Required Elements

The following information is required and must be accurately provided on the Research Study Submission Form when requesting study record set-up in CareConnect:

  • IRB approval date and IRB number – IRB number will be used as study ID
  • Unique Study FAU# - Needed for directing research-related charges to the study

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

 


Mandatory Reporting of the 8-Digit Clinical Trial Number on Claims

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:

  1. Medicare Claims Processing, Pub 100-04, Transmittal 2758, August 9, 2013:
    http://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R2758CP.pdf
  2. UCLA OHRPP Guidelines for Registering in the Clinical Trials.gov Registry (last updated May 27, 2011):
    http://ora.research.ucla.edu/RPC/Documents/Guidelines_for_Registering_in_the_ClinicalTrials_gov_Registry.pdf

 


ALL New and Legacy Clinical Studies Require A Completed and Certified Coverage Analysis

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/


How to Minimize Clinical Research Billing Compliance Risks

 

  • COORDINATE study cost information across all study documents.
  • PERFORM a comprehensive Coverage Analysis. For more information, please see our FAQ: (http://compliance.uclahealth.org/body.cfm?id=189#faq160)
  • COMMUNICATE study information to registration, hospital and professional billing offices, service departments and outside providers delivering study related services. For more information about this process in CareConnect, visit http://careconnect.uclahealth.org/secure.cfm?id=272.
  • REVIEW study account frequently to ensure correct charge direction to the proper payor.
  • MAINTAIN study documents and billing records, and keep readily available for internal and/or external review.

Research-related Documents Subject to Review During Claims Audit by Government Agencies

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:

  1. Clinical Study Protocol
  2. Clinical Study Agreement and Budget
  3. Coverage Analysis documents
  4. IRB Approved Informed Consent
  5. FDA Status Documents (IDE Status/IND Status)
  6. Pertinent Medical Records
  7. Any other relevant documents (e.g. Investigator’s Brochure)

Clinical Studies - What Does "Qualified" Mean?

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:

  • http://compliance.uclahealth.org/body.cfm?id=189#faq157
  • http://compliance.uclahealth.org/body.cfm?id=189#faq160

For more information:

  • UCLA Policy 915 - http://www.adminpolicies.ucla.edu/app/default.aspx?&id=915
  • Medicare Clinical Trial Policy: http://www.cms.gov/Medicare/Coverage/ClinicalTrialPolicies/index.html?redirect=/ClinicalTrialPolicies/

Clinical Study-related Procedure Requisition

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:

  1. Short name of clinical study
  2. FAU# and Recharge# if cost of procedure/service is to be charged to grant/study account
  3. FAU# that is valid, accurate, and legible
  4. Name and contact information for Principal Investigator, study coordinator or fund manager

Required Clinical Study Submission and Study Team Training for Go-Live

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.

  • AMB 130 Research I - Clinical
  • AMB 140 Research II - Charge Review and Billing

http://careconnect.uclahealth.org/Workfiles/secure/Training/Catalog_082112.pdf

 


Coverage of Clinical study Services for Beneficiaries Enrolled in Medicare Advantage organizations (MAOS), Effective 6-22-2012

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)


Documents Needed When Preparing a Coverage Analysis for a Clinical Study

The following documents should be referenced when preparing a coverage analysis for a Clinical Study:

  1. Current version of the Study Protocol
  2. Contract/Grant Funding information
  3. Informed consent
  4. FDA documents as applicable (approval letters concerning Investigational Device Exemption, Investigational New Drug Status, or Investigational New Drug Exemption)
  5. Medicare local coverage approval request and determination documents, if coverage is sought
  6. Citation(s) to the objective source(s) used to support a determination that an item/service is standard of care, such as clinical practice guidelines or peer-reviewed journals or articles.

The Principal Investigator should maintain copies of all such reference documents and citations with the study financial records.


Harmonize Study Documents for Financial Responsibility

The primary documents that indicate the financial terms of a Clinical Study are:

  1. The study grant award or study contract
  2. The Coverage Analysis and Budget Grid
  3. The Informed Consent form signed by the subject

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.


Implementation of Coverage Analysis for Clinical Trials and Clinical Research Studies

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.


Clinical Research and Billing/Coding TipsProper Claims for Clinical Trials

Avoid submitting improper claims related to clinical research by:

  1. Pre-determining who is responsible for payment for item/service by performing a coverage analysis.
  2. Identifying patients as research participants when scheduling research-related inpatient admissions, outpatient clinic visits, and office visits for treatment or evaluations.
  3. Reviewing all study-related charge posting and claims to ensure services are billed to the proper payor.
  4. Assuring the service has not been billed to or paid by both the study account and an insurance account.

Avoiding Clinical Research Billing Compliance Pitfalls

Some pitfalls to avoid when billing for services and managing funds in a clinical trial:

  1. Double Billing or "Double Dipping" - if a claim is submitted to and paid by a third party payer or Medicare AND the sponsor reimburses for all or some of the same service, this is considered double dipping and may constitute fraud.
  2. Waiving co-payments and offering free services to volunteers in clinical trials is a violation of government regulations. http://oig.hhs.gov/fraud/docs/alertsandbulletins/SABGiftsandInducements.pdf

Clinical Trial Medical Record Documentation

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:

  1. Trial Name
  2. Trial Sponsor
  3. Sponsor-assigned protocol number

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


Avoid Clinical Research Billing Errors

Tips to avoid clinical research billing errors for services related to Qualified Clinical Trials:

  1. Ensure every research-related encounter is scheduled/ registered as a research visit in the study.  This includes research-related "standard of care" visits.
  2. Do not bill insurance if:
    a. The sponsor  pays for the service.
    b. The services are promised as free in the Informed Consent.
    c. The services are for research purposes only.
  3. Only bill for services that have no external funding source and are medically necessary.
  4. Consider the need to seek pre-authorization from private insurers prior to beginning any protocol services, especially in investigational device trials.

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