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The UB40 form plays a crucial role in the way providers and suppliers bill Medicare for services related to clinical trials. Launched based on Change Request (CR) 5790, this form allows for the voluntary reporting of an 8-digit registry number designated by the National Library of Medicine (NLM) Clinical Trials Data Bank. Starting April 1, 2008, providers are encouraged to include this number on claims for items and services rendered to beneficiaries participating in qualifying clinical research studies. The Centers for Medicare & Medicaid Services (CMS) aims to identify and track services covered during clinical trials effectively. The purpose of implementing this requirement stems from a broader initiative to enhance Medicare beneficiaries’ participation in clinical trials, as emphasized in the 2000 Institute of Medicine report. By using the clinical trial number, CMS can inform policy decisions and improve transparency about available studies. Providers must adhere to specific guidelines for including this identifier on institutional and professional claims, creating a streamlined process for reporting and reimbursement. Missing this identifier on claims will not lead to payment rejection, ensuring that providers are not penalized for noncompliance. Comprehensive instructions and additional information are available through the MLN Matters articles and the CMS website, ensuring that all stakeholders can easily access the necessary resources.

Ub40 Pdf Example

Related MLN Matters Article #: MM5790

Date Posted: January 22, 2008

Related CR #: 5790

Use of an 8-Digit Registry Number on Clinical Trail Claims

Key Words

MM5790, CR5790, R310OTN, 8-Digit, Registry, Clinical, Trail, Claims

Provider Types Affected

Physicians, providers, and suppliers who bill Medicare Carriers, Fiscal Intermediaries (FIs), Part A/B Medicare Administrative Contractors (A/B MACs) and Durable Medical Equipment Medicare Administrative Contractors (DME MACs) for services provided to Medicare beneficiaries in clinical research studies

Key Points

The effective date of the instruction is April 1, 2008.

The implementation date is April 7, 2008.

Background

Change Request (CR) 5790 instructs providers and suppliers on new, voluntary reporting for placing a clinical trial number on claims for items and services provided in clinical trials that are qualified for coverage as specified in the Medicare National Coverage Determination Manual, Publication 100-03, Section 310.1. That publication is available at http://www.cms.hhs.gov/Manuals/IOM/list.asp on the Centers for Medicare & Medicaid Services (CMS) website.

The clinical trial number that CMS is requesting to be voluntarily reported is the number assigned by the National Library of Medicine (NLM) Clinical Trials Data Bank when a new study is registered by a sponsor or investigator. Information regarding NLM clinical trials is available at http://clinicaltrials.gov/ on the Internet.

CMS will use this number to identify all items and services provided to beneficiaries during their participation in a clinical trial.

This identifier will permit CMS to meet the recommendations of the 2000 Institute of Medicine report that led to the Executive Memorandum to increase participation of Medicare beneficiaries in clinical trials and the development and implementation of the CMS clinical trials policy.

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Related MLN Matters Number: MM5790

Recommendations from The White House Executive Memorandum included:

Tracking Medicare payments;

Ensuring that the information gained from the research is used to inform coverage decisions;

Making certain that the research focuses on issues of importance to the Medicare population; and

Enabling CMS to better inform Medicare beneficiaries about the clinical studies available for their participation.

Claims submitted without the clinical trial number will be paid the same as claims containing a number.

Institutional clinical trial claims are identified through the presence of all of the following elements:

Value Code D4 and corresponding 8-digit clinical trial number (when present on the claim);

International Classification of Diseases, Ninth Revision (ICD-9) diagnosis code V70.7;

Condition Code 30; and

Healthcare Common Procedure Coding System (HCPCS) modifier Q1: outpatient claims only. (See MLN Matters article MM5805 related to CR5805 for more information regarding modifier Q1.)

Practitioner/DME clinical trail claims are identified through the presence of all of the following elements:

ICD-9 diagnosis code V70.7;

HCPCS modifier Q1; and

8-digit clinical trial number (when present on the claim).

On institutional claims, the 8-digit numeric clinical trial number should be placed in the value amount of value code D4 on the paper claim UB-40 (Form Locators 39-41) or in Loop 2300, HI – Value Information segment, qualifier BE on the 837I.

On professional claims, the clinical trial registry number should be preceded by the two alpha characters of “CT” and placed in Field 19 of the paper Form CMS-1500 or it should be entered WITHOUT the “CT” prefix in the electronic 837P in Loop 2300 REF02(REF01=P4).

Important Links

The related MLN Matters article can be found at http://www.cms.hhs.gov/MLNMattersArticles/downloads/MM5790.pdf on the CMS website.

The official instruction (CR5790) issued regarding this change may be found at http://www.cms.hhs.gov/Transmittals/downloads/R310OTN.pdf on the CMS website.

Providers may see the article related to the Q1 modifier (MM5805) at http://www.cms.hhs.gov/MLNMattersArticles/downloads/MM5805.pdf on the CMS website.

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Related MLN Matters Number: MM5790

If providers have questions, they may contact their Medicare A/B MAC, FI, DME MAC, or carrier at their toll-free number, which may be found at http://www.cms.hhs.gov/MLNProducts/downloads/CallCenterTollNumDirectory.zip on the CMS website.

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Form Characteristics

Fact Name Fact Detail
Related MLN Matters Article MM5790
Date Posted January 22, 2008
Related Change Request CR5790
Effective Date April 1, 2008
Implementation Date April 7, 2008
Provider Types Affected Physicians, providers, and suppliers billing Medicare.
Clinical Trial Identifier 8-digit Clinical Trial Number assigned by NLM.
Claims Processing Claims can be submitted with or without the clinical trial number.
Institutional Claims Requirements Value Code D4, ICD-9 code V70.7, Condition Code 30, HCPCS modifier Q1.
Professional Claims Requirements ICD-9 code V70.7 and HCPCS modifier Q1 with the clinical trial number.

Guidelines on Utilizing Ub40 Pdf

Completing the UB-40 form correctly is essential for processing claims related to clinical trials. Each section of the form must be filled out accurately to ensure timely and proper reimbursement. Follow the steps outlined below to fill out the form correctly.

  1. Obtain the UB-40 form. The form can usually be downloaded from relevant Medicare or healthcare provider websites.
  2. Start by filling in the provider’s information. Include the name, address, and registry number, if applicable.
  3. Enter the patient’s information in the designated section. Provide the patient's name, Medicare number, and date of birth.
  4. In the diagnosis section, include the appropriate ICD-9 code. Use V70.7 for clinical trial claims.
  5. Specify the type of facility or service in the designated area. Check the appropriate box to indicate if the service was provided inpatient or outpatient.
  6. Find the value code section, which may usually be in Locators 39-41. Enter the 8-digit clinical trial number into the value amount of value code D4.
  7. Include condition code 30 in the section for condition codes.
  8. If applicable, add the HCPCS modifier Q1 for outpatient claims. Place it in the appropriate field.
  9. Review the completed form for accuracy. Check all entries and ensure that all required fields are filled.
  10. Submit the form as per your organization’s procedures. Ensure that it is sent to the correct Medicare contractor.

What You Should Know About This Form

What is the purpose of the UB40 PDF form?

The UB40 form is primarily used for submitting claims related to services provided to Medicare beneficiaries, particularly in clinical trials. It allows providers to report an 8-digit clinical trial number alongside their claims. This reporting helps the Centers for Medicare & Medicaid Services (CMS) track the services provided during clinical trials, adhering to guidelines that promote research and informed coverage decisions.

When did the instructions regarding the clinical trial number reporting take effect?

The effective date of the instructions related to the UB40 form was April 1, 2008. Providers were required to start implementing these changes as of April 7, 2008. These instructions stem from a recommendation by the Institute of Medicine aimed at enhancing participation by Medicare beneficiaries in clinical trials.

Are claims submitted without a clinical trial number treated differently?

Claims submitted without the clinical trial number will be compensated in the same manner as those that include the number. This means that regardless of whether the clinical trial number is present, the claims will process without alteration to payment. However, reporting the number is encouraged for better tracking and data collection by CMS.

What details must be included on institutional claims associated with clinical trials?

Institutional claims must include the following elements to be properly identified: the Value Code D4 along with the 8-digit clinical trial number, the ICD-9 diagnosis code V70.7, the Condition Code 30, and the HCPCS modifier Q1. These elements are necessary to ensure claims recognize the services provided in a clinical research setting.

How should the clinical trial number be reported on professional claims?

For professional claims, the clinical trial registry number must be prefixed with "CT" and entered in Field 19 of the paper Form CMS-1500. In electronic submissions, the clinical trial number should be noted without the "CT" prefix in Loop 2300, specifically in segment REF02, with REF01 marked as P4. This consistent reporting format facilitates accurate identification and processing of the claims.

Common mistakes

Filling out the UB40 PDF form can be straightforward, but individuals often make mistakes that can delay processing or lead to complications. One common mistake is failing to include the required 8-digit clinical trial number. This number is essential for claims related to clinical trials and must be reported accurately. Without it, the claim may face unnecessary scrutiny or denial.

Another error occurs when the clinical trial number is placed in the wrong section of the UB40 form. It should be entered in the value amount of value code D4, specifically in Form Locators 39-41. Misplacing this number can lead to confusion and may result in the claim being processed incorrectly.

People also frequently overlook the importance of accompanying codes. For institutional claims, the ICD-9 diagnosis code V70.7 and Condition Code 30 must be included along with the clinical trial number. Omitting these codes weakens the claim's validity and increases the likelihood of rejection by Medicare.

Using the wrong modifiers can cause problems too. Claims for practitioners and durable medical equipment must include the HCPCS modifier Q1. Forgetting to add this modifier can cause the claim to be flagged, leading to delays in payment or approval.

Another issue stems from the format of the clinical trial number itself. Some individuals mistakenly add unnecessary characters or spaces, which can throw off the processing system. It is crucial that the number be reported as a clean, 8-digit identifier.

Inadequate reviews before submission also lead to errors. Some people rush to submit the form without double-checking for accuracy or completeness. Taking a moment to verify all information can save time and headaches later.

Additionally, failing to follow specific instructions for both paper and electronic submissions can result in rejection. For instance, on electronic claims, the clinical trial number should be entered without the "CT" prefix. Understanding these differences is vital to successful claim processing.

Finally, people often forget to provide their contact information. Including it on the form ensures that if there are questions or issues, the relevant parties can reach out directly for clarification. Failing to do this could result in further delays as the authorities seek additional information.

Documents used along the form

When submitting claims involving clinical trials to Medicare, the UB-40 PDF form is often used alongside several other important documents. Each of these forms serves a specific purpose in ensuring that claims are processed correctly and that necessary information is provided.

  • CMS-1500 Form: This form is primarily used for billing professional services. It allows healthcare providers to report services rendered to patients, including services related to clinical trials. The clinical trial registry number must be included when applicable.
  • 837P Electronic Claim: This is the electronic equivalent of the CMS-1500 form. It is used to submit professional claims electronically to Medicare and includes required information about clinical trial participation.
  • 837I Electronic Claim: This form is the electronic version of the UB-40, utilized for institutional claims such as hospital services. Here, the clinical trial number is included in the specific fields designated for that purpose.
  • MLN Matters Articles: These articles provide guidance and updates regarding billing procedures and policies. They play a crucial role in keeping providers informed about changes affecting clinical trial claims, including reporting requirements.
  • Change Request (CR) Documents: These documents detail specific instructions and updates from Medicare regarding billing practices. Providers must pay attention to CRs to ensure compliance with new policies, especially those related to clinical trials.

Understanding the documents that accompany the UB-40 form is essential for providers to ensure correct billing and compliance with Medicare requirements. Utilizing these forms correctly promotes efficient processing and minimizes potential issues during claims submission.

Similar forms

The UB40 PDF form, which is used primarily for outpatient institutional claims in the context of clinical trials, shares similarities with several other important healthcare documentation forms. Here is a list of five documents that are similar to the UB40 PDF form, along with explanations of how they are alike:

  • CMS-1500 Form: This form is utilized for professional claims. Like the UB40 form, it requires specific coding related to services provided and may include clinical trial identifiers, ensuring consistent reporting for claims associated with Medicare beneficiaries.
  • 837I Electronic Claim Format: The 837I format serves as the electronic version of the UB40 form. Both formats require the reporting of clinical trial numbers, facilitating efficient data exchange for institutional claims while adhering to the same coding standards.
  • 837P Electronic Claim Format: Similar to the 837I format, the 837P is used for professional claims. Both formats aim to ensure accurate tracking of clinical trial services through systematic coding, aiding in the processing of claims for research studies.
  • HCFA-1500 Form: Often mistaken for the CMS-1500, the HCFA-1500 has similar uses in documenting provider claims. It supports voluntary reporting mechanisms for clinical trials, aligning with the administrative processes found in the UB40 form.
  • Value Code D4 Documentation: Although not a form per se, the value code D4 is a critical designation used in conjunction with the UB40 form. Both documents require the use of the clinical trial number to identify claims related to clinical trials, highlighting the relevance of accurate record-keeping in Medicare's reimbursement practices.

Dos and Don'ts

When filling out the UB-40 PDF form, it's important to follow certain guidelines to ensure that your submission is accurate and complete. Below is a list of recommended practices as well as some common pitfalls to avoid.

  • Do double-check that you have included the 8-digit clinical trial number in the appropriate fields.
  • Don't forget to enter the correct Value Code D4 on the institutional claims to indicate the clinical trial number.
  • Do ensure all necessary diagnosis codes, such as ICD-9 code V70.7, are correctly filled out.
  • Don't leave out any required condition codes like Condition Code 30 for institutional claims.
  • Do verify that all information is legible to prevent processing delays.
  • Don't use the "CT" prefix in your electronic submissions if you're entering the clinical trial number on the electronic 837P form.
  • Do review the specific instructions for your type of claim, whether it's institutional or practitioner/DME.
  • Don't ignore the links provided for additional guidance and updates related to your submission.

Misconceptions

The following list outlines common misconceptions regarding the UB-40 PDF form, which is critical for billing Medicare claims associated with clinical trials.

  • Only institutional providers need to use the UB-40 form. This is incorrect. Both institutional and professional providers must utilize the appropriate forms for clinical trial claims, including the UB-40 for institutional claims.
  • The clinical trial number is mandatory for all claims. In fact, claims submitted without the clinical trial number will be paid the same as those that include it. The number is recommended but not required for payment.
  • The clinical trial number can be placed anywhere on the UB-40 form. This is misleading. The 8-digit clinical trial number must be documented in specified areas, particularly in value code D4.
  • The clinical trial number is only applicable to certain patient populations. This is not true. Any Medicare beneficiary participating in qualified clinical trials can have claims submitted using the clinical trial number, irrespective of their specific conditions.
  • Claims with the clinical trial number will always be prioritized in processing. While this number aids in tracking and data collection, it does not guarantee expedited processing of the claims.
  • The rules around the clinical trial number reporting change frequently. Regulations are established and communicated through Change Requests. Providers should stay informed, but the instructions provided in CR5790 are consistent since their implementation.

Key takeaways

When filling out and using the UB-40 PDF form for clinical trial claims, there are several important points to keep in mind:

  • Effective Date: The new reporting guidelines became effective on April 1, 2008. Claims submitted should comply from this date onward.
  • Clinical Trial Number: Providers must voluntarily include an 8-digit clinical trial number assigned by the National Library of Medicine when filing claims related to clinical trials.
  • Claim Identification: Institutional and practitioner claims must contain specific codes (e.g., ICD-9 V70.7, Condition Code 30) alongside the clinical trial number to ensure proper identification and processing.
  • Placement of Information: For institutional claims, the clinical trial number should be placed in the value amount of value code D4. On professional claims, it needs to be included in Field 19 of the CMS-1500 form.
  • Payments: Claims without the clinical trial number will be compensated equally to those with the number. This ensures no financial disadvantage for providers opting not to include the information.
  • Resources Available: Helpful resources, including guidelines and instructions, can be found on the CMS website. Providers are encouraged to consult these resources for clarity on the process and requirements.

Being aware of these key points can facilitate a smoother claims process, enhancing participation in clinical research and ensuring compliance with Medicare guidelines.