evekhm/cms_iom_500 huggingface dataset:
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67  No Cost Items (Rev. 1147, Issued: 01- 05-07, Effective: 11 -06-06, Implementation: 02- 05-07)  On occasion, providers may receive an item (such as a device or drug) that is offered by a manufacturer/supplier free of charge.  Such items, for purposes of these instructions, are considered no cost items.  Providers are not to seek reimbursement for n o cost items as noted in Section 1862(a)(2) of the Social Security Act.  67.1  Practitioner Billing for No Cost Items  (Rev. 1657, Issued: 12- 31-08, Effective: 01 -01-09, Implementation: 01- 05-09)  Practitioners typically should not bill for no cost items as there is no non- covered charges field on the claim and there are also no system edits in place to require providers to do so.  However, practitioners are required to report Category A IDE devices  received at no cost on claims as specified in 68.3 of this chapter (although they will not receive payment).   67.2  Institutional Billing for No Cost Items  (Rev. 4013, Issued: 03-30-18, Effective: 01-01-09, Implementation: 06- 29-18)    Generally speaking, institutional, providers should not have to report the usage of a no cost item. However, for some claims (e.g., hospital Outpatient Prospective Payment System (OPPS) claims), providers may be required to bill a no cost item due to claim s processing edits that require an item (even if received at no cost) to be billed along with an associated service (e.g., a specified device must be reported along with a specified implantation procedure).   For OPPS claims, when a drug is provided at no cost, claims processing edits prevent drug administration charges from being billed when the claim does not contain a covered/billable drug charge. Therefore, for drugs provided at no cost in the hospital outpatient department, providers must report the applicable drug HCPCS code and appropriate units with a token charge of less than $1.01 for the item in the covered charge field and mirror this less than $1.01 amount reported in the noncovered charge field.  Providers must also bill the corresponding drug administration charge with the appropriate drug administration CPT or HCPCS  code.
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For OPPS claims, providers must report a token charge of less than $1.01 for the item in the covered charge field, along with the applicable HCPCS modifier (i.e., modifier FB) appended to the procedure code that reports the service requiring a device. For more information on billing no cost items under the OPPS, refer to Chapter 4, 20.6.9 and 61.3.1 of this manual.   By billing in this way, the provider is accomplishing four things:   1) Communicating to the contractor that the provider is not seeking payment for the no cost item;   2) Reflecting, with completeness and accuracy, all services provided to the patient;   3) Preventing the line item or claim from being rejected/denied by system edits that require an item to be billed in conjunction with an associated procedure (such as implantation or administration procedures);   4) Assuring that the patient and provider are not held liable for any charges for the no cost item.   Future updates will be issued in a Recurring Update Notification.   67.2.1  Billing No Cost Items Due to Recall, Replacement, or Free Sample  (Rev. 3181, Issued: 01- 30-15, Effective: 07 -01-15, Implementation: 07- 06-15)  Currently, institutional providers that use the Healthcare Common Procedural Coding System (HCPCS) bill device HCPCS codes for no cost or full credit items with token charges in order for claims to pass OPPS claims processing edits that require certain dev ices to be billed with their associated procedures so that payment can be made.   Effective January 1, 2006, modifier FB is used to indicate that an item used in a procedure was furnished without cost to the provider, and, therefore, it is not being charged to Medicare or the beneficiary.  More information on billing HCPCS modifier FB  can be located in Chapter 4, 20.6.9 and 61.3.1 of this manual.  Effective April 1, 2006, two new condition codes were created for institutional use: 49 and 50 (Table 1).  These new codes are used to identify and track medical devices that are provided by a manufacturer at no cost or with full credit to the hospital due  to warranty for a malfunction or recall.
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Table 1: New Condition Codes and Descriptions  Condition Code  Description  49 Product Replacement within Product Lifecycle  Replacement of a product earlier than the anticipated lifecycle.  50 Product Replacement for Known Recall of a Product  Manufacturer or FDA has identified the product for recall and therefore replacement.    Providers must use these condition codes to identify medical devices that are provided by a manufacturer at no cost or with full credit due to warranty or recall. These condition codes will be used to track no cost/full credit devices replaced due to recal l or warranty.    Providers must report these condition codes on any inpatient or outpatient institutional claim that includes a no cost/full credit replacement device when conditions of warranty or recall are met.   NOTE: OPPS hospitals billing no cost/full credit devices must append modifier FB to the procedure code for implanting the no cost/full credit device, along with the appropriate condition code if applicable (in Table 1 above), in instances when claims processing edits require that certain devices be billed with their associated procedures. The modifier identifies the procedure code line for the no cost/full credit device, while the condition code explains if the device was provided free of cost due to warra nty or recall.  Effective January 1, 2014, an additional new condition code was created for institutional use: 53 (Table 2).  This new code is used to identify and track medical devices that are provided by a manufacturer at no cost or with full credit to the hospital due  a clinical trial or a free sample.   Table 2: New Condition Codes and Descriptions  Condition Code  Description  49 Product Replacement within Product Lifecycle  Replacement of a product earlier than the anticipated lifecycle.  50 Product Replacement for Known Recall of a Product  Manufacturer or FDA has identified the product for recall and therefore replacement.  53 Initial placement of a medical device provided as part of a clinical trial or free sample  Code is for outpatient claims that have received a device credit upon initial medical device placement in a clinical trial or a free sample.    Providers must use these condition codes to identify medical devices that are provided by a manufacturer at no cost or with full credit due to warranty, recall, or free sample.  These condition codes will be used to track no cost/full credit devices replac ed due to recall, warranty, or free sample.
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 Providers must report these condition codes on any inpatient or outpatient institutional claim that includes a no cost/full credit replacement device when conditions of warranty, recall, or free sample are met.   NOTE:  OPPS hospitals billing no cost/full credit devices are no longer required to append modifier FB to the procedure code for implanting the no cost/full credit device, along with the appropriate condition code if applicable (in Table 2 above), in instances w hen claims processing edits require that certain devices be billed with their associated procedures.   68  Investigational Device Exemption (IDE) Studies  (Rev.  3105, Issued: 11- 06-14, Effective: 01 -01-15, Implementation: 01- 05-15)  See Pub. 100- 02, Medicare Benefit Policy Manual, Chapter 14 for complete Medicare coverage requirements for items and services in Category A and B IDE studies, related to these billing requirements.  NOTE:   For information regarding Medicare coverage related to IDEs in Medicare Advantage plans, refer to Pub. 100- 16, Medicare Managed Care Manual, chapter 4, section 10.7.2.  68.1  Billing Requirements for Providers Billing for Routine Care Items and Services in Category A IDE Studies  (Rev.  3105, Issued: 11- 06-14, Effective: 01-01-15, Implementation: 01-05-15)  A.  Institutional Inpatient and Outpatient Billing in Category A IDE Studies   Routine Care Items and Services   Institutional providers shall submit claims only for routine care items and services in Category A IDE device studies approved by CMS (or its designated entity) and listed on the CMS Coverage Website, by billing according to the clinical trial billing instructions found in 69.6 of this chapter, and as described below under subsection C (General Billing Requirements).  The Category A IDE device shall not be reported on institutional claims since Category A IDE devices are not eligible for payment under Me dicare.   B.  Practitioner Billing in Category A IDE Studies  Routine Care Items and Services
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B.  Practitioner Billing in Category A IDE Studies  Routine Care Items and Services   Practitioners shall submit claims for the routine care items and services in Category A IDE studies approved by CMS (or its designated entity) and listed on the CMS Coverage Website, by billing according to the clinical trial billing instructions found in 69.6 of this chapter, and as described below under subsection C (General Billing Requirements).  The Category A IDE device shall not be reported on practitioner claims since Category A IDE devices are not eligible for payment under Medicare.  C.  General Billing Requirements   Effective for claims with dates of service on or after January 1, 2014, it is mandatory to report a clinical trial number on claims for items/services provided in clinical trials/studies/registries, or under coverage with evidence development (CED).  This is the number assigned by the National Library of Medicine (NLM) ClinicalTrials.gov Webs ite when a new study appears in the NLM Clinical Trials data base.  This number is listed prominently on each specific studys page and is always preceded by the letter s NCT.  Contractors verify the validity of a trial/study/registry by consulting CMSs Coverage Website at: http://www.cms.gov/Center/Special- Topic/Medicare-Coverage-Center.html?redirect=/center/coverage.asp.  Providers report the 8 -digit number on the following claims locators:
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CMS -1500 paper form-place in Field 19 (preceded by CT); or  837 PLoop 2300, REF02, REF01=P4 (do not use CT on the electronic claim)  In addition to the clinical trial number, claims shall include:  ICD-9 diagnosis code V70.7/ICD-10 diagnosis code Z00.6 (in either the primary/secondary positions)  HCPCS modifier Q0 or Q1 as appropriate  Claims submitted without a clinical trial number shall be returned as unprocessable reporting the following messages:  CARC 16: Claim/service lacks information which is needed for adjudication. At least one Remark Code must be provided (may be comprised of either NCPDP Reject Reason Code, or Remittance Advice Remark Code that is not an ALERT.)   RARC MA50: Missing/incomplete/invalid Investigational Device Exemption number for FDA -approved clinical trial services.   RARC MA130: Your claim contains incomplete and/or invalid information, and no appeal rights are afforded because the claim is unprocessable. Please submit a new claim with the complete/correct information.   Group Code - Contractual Obligation (CO)  Effective for dates of service on or before December 31, 2007, practitioners must place a QV modifier (Item or service provided as routine care in a Medicare qualifying clinical trial) on the line for the device along with the IDE number.  Effective for dates of service on or after January 1, 2008, practitioners will no longer bill a QV modifier to identify the device.  Instead, practitioners will bill a Q0 (numeral 0 versus the letter O) modifier (Investigational clinical service provided in a clinical research study that is in an approved clinical research study) along with the IDE number.  The following table shows the designated field locations to report the Category A IDE number on practitioner claims:  Data  CMS -1500  837i and 837p  IDE #  Item 23  Segment 2300,  REF02(REF01=LX)
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Contractors will validate the IDE number for the Category A device when modifier Q0 is submitted on the claim along with the IDE number.  Claims containing an invalid IDE number will be returned to the provider using the following messages:  RARC MA50: Missing/incomplete/invalid Investigational Device Exemption Number for FDA approved clinical trial services.   CARC 16: Claim/service lacks information which is needed for adjudication. At least one Remark Code must be provided (may be comprised of either NCPDP Reject Reason Code, or Remittance Advice Remark Code that is not an ALERT).   68.2  Billing Requirements for Providers Billing for Category B IDE Devices and Routine Care Items and Services in Category B IDE Studies  (Rev.  3105, Issued: 11- 06-14, Effective: 01-01-15, Implementation: 01-05-15)  Payment for the device may not exceed the Medicare -approved amount for a comparable device that has been already FDA -approved.  A.  Institutional Inpatient Billing for Items and Services in Category B IDE Studies   Routine Care Items and Services   Institutional providers shall submit claims for the routine care items and services in Category B IDE studies approved by CMS (or its designated entity) and listed on the CMS Coverage Website, by billing according to the clinical trial billing instructions  found in 69.6 of this chapter, and as described below under subsection D (General Billing Requirements).  Category B Device   Institutional providers must bill the Category B IDE number on a 0624 revenue code line with charges in the covered charges field.  Hospital inpatient providers should not bill for the Category B IDE device if receiving the device free -of-charge.   B.  Institutional Outpatient Billing for Items and Services in Category B IDE Studies   Routine Care Items and Services   Institutional providers shall submit claims for the routine care items and services in Category B IDE studies approved by CMS (or its designated entity) and listed on the CMS Coverage Website, by billing according to the clinical trial billing instructions  found in section 69.6 of this chapter, and as described below under subsection D (General Billing Requirements).  Category B Device   On a 0624 revenue code line, institutional providers must bill the following for Category B IDE devices for which they incur a cost:   Category B IDE device HCPCS code, if applicable    Appropriate HCPCS modifier:
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On a 0624 revenue code line, institutional providers must bill the following for Category B IDE devices for which they incur a cost:   Category B IDE device HCPCS code, if applicable    Appropriate HCPCS modifier:  o Q0 or Q1 as appropriate for claims with dates of service on or after January 1, 2014; or  o Q0 (numeral 0 versus the letter O) modifier for claims with dates of service on or after January 1, 2008; or,  o QA modifier for claims with dates of service prior to January 1, 2008.   Category B IDE number   Charges for the device billed as covered charges   NOTE:  If the Category B IDE device is provided at no cost, outpatient prospective payment system (OPPS) providers must report a token charge in the covered charge field along with the applicable HCPCS modifier (i.e., modifier  FB) appended to the procedure code that reports the service to furnish the device, in instances when claims processing edits require that certain devices be billed with their associated procedures.  For more information on billing no cost items under the OPPS, refer to chapter 4, 20.6.9 and 61.3.1 of this manual.  C.  Practitioner Billing for Items and Services in Category B IDE Studies   Routine Care Items and Services   Practitioners shall submit claims for routine care items and services in Category B IDE studies approved by CMS (or its designated entity) and listed on the CMS Coverage Website, by billing according to the clinical trial billing instructions found in section 69.6 of this chapter, and as described below under subsection D (General Billing Requirements).  Category B Device   Effective for dates of service on or before December 31, 2007, practitioners must bill the Category B IDE device on a line with a QA modifier (FDA IDE) along with the IDE number.  However, effective for dates of service on or after January 1, 2008, practitioners will no longer bill a QA modifier to identify a Category B device.  Instead, practitioners will bill a Q0 modifier (numeral 0 versus the letter O) (Investigational clinical service provided in a clinical research study that is in an approved clinical research study) along with the IDE number.   The following table shows the designated field locations to report the Category B IDE number on institutional and practitioner claims:
(Medicare Claims Processing Manual)
The following table shows the designated field locations to report the Category B IDE number on institutional and practitioner claims:   Data  CMS -1450  CMS -1500  837i and 837p  IDE #  FL 43  Item 23  Segment 2300,  REF02(REF01=LX)   Contractors will validate the IDE number for the Category B device when modifier Q0 is submitted on the claim along with the IDE number.  Claims containing an invalid IDE number will be returned to the provider using the following messages:   RARC MA50: Missing/incomplete/invalid Investigational Device Exemption Number for FDA approved clinical trial services.   CARC 16: Claim/service lacks information which is needed for adjudication. At least one Remark Code must be provided (may be comprised of either NCPDP Reject Reason Code, or Remittance Advice Remark Code that is not an ALERT.  D.  General Billing Requirements   Effective for claims with dates of service on or after January 1, 2014, it is mandatory to report a clinical trial number on claims for items/services provided in clinical trials/studies/registries, or under CED.  This is the number assigned by the NLM ClinicalTrials.gov Website when a new study appears in the NLM Clinical Trials data base.  This number is listed prominently on each specific studys page and is always preceded by the letters NCT.  Contractors verify the validity of a trial/study/registry by consulting CMSs Coverage Website at: http://www.cms.gov/Center/Special -Topic/Medicare- Coverage -Center.html?redirect=/center/coverage.asp. Providers report the 8 -digit number on the following claims locators:   CMS -1500 paper form -place in Field 19 (preceded by CT); or    837 P Loop 2300, REF02, REF01=P4 (do not use CT on the electronic claim).  In addition to the clinical trial number, claims shall include:   ICD-9 diagnosis code V70.7/ICD -10 diagnosis code Z00.6 (in either the primary/secondary positions)    HCPCS modifier Q0 or Q1 as appropriate   Claims submitted without a clinical trial number shall be returned as unprocessable reporting the following messages:
(Medicare Claims Processing Manual)
 HCPCS modifier Q0 or Q1 as appropriate   Claims submitted without a clinical trial number shall be returned as unprocessable reporting the following messages:    CARC 16: Claim/service lacks information which is needed for adjudication. At least one Remark Code must be provided (may be comprised of either NCPDP Reject Reason Code, or Remittance Advice Remark Code that is not an ALERT.)    RARC MA50: Missing/incomplete/invalid Investigational Device Exemption number for FDA -approved clinical trial services.    RARC MA130: Your claim contains incomplete and/or invalid information, and no appeal rights are afforded because the claim is unprocessable. Please submit a new claim with the complete/correct information.   Group Code-Contractual Obligation (CO)  68.4  Billing Requirements for Providers Billing Routine Costs  of Clinical Trials Involving a Category B IDE  (Rev. 3181, Issued: 01- 30-15, Effective: 07-01-15, Implementation: 07-06-15)   As noted above in section 68.2, of this chapter, providers shall first notify their contractor of the IDE device trial before submitting claims for Category B IDE devices and the routine costs of clinical trials involving Category B IDE devices.  Once the contractor notifies the provider that all required information for the IDE has been furnished, the provider may bill Category B IDE claims.   When billing for Category B IDEs, providers shall bill for the device and all related procedures.  The Category B IDE device and the routine costs associated with its use are eligible for payment under Medicare. (Payment for the device may not exceed the Medicare-approved amount for a comparable device that has been already FDA-approved.)  Institutional Inpatient Billing   Routine Costs  Institutional providers shall submit claims for the routine costs of a clinical trial involving a Category B IDE device by billing according to the clinical trial billing instructions found in 69.6 of this chapter.   Category B Device   Institutional providers must bill the Category B IDE number on a 0624 revenue code line with charges in the covered charges field.  Hospital inpatient providers should not bill for the Category B IDE device if receiving the device free -of-charge.   Institutional Outpatient Billing   Routine Costs
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Institutional Outpatient Billing   Routine Costs  Institutional providers shall submit claims for the routine costs of a clinical trial involving a Category B IDE device by billing according to the clinical trial billing instructions found in section 69.6 of this chapter.  Category B Device   On a 0624 revenue code line, institutional providers must bill the following for Category B IDE devices for which they incur a cost:   Category B IDE device HCPCS code, if applicable.   Appropriate HCPCS modifier:   Q0 or Q1 as appropriate for claims with dates of service on or after January 1, 2014; or    Q0 (numeral 0 versus the letter O) modifier for claims with dates of service on or after January 1, 2008; or   QA modifier for claims with dates of service prior to January 1, 2008.   Category B IDE number   Charges for the device billed as covered charges   NOTE:  For claims prior to January 1, 2014, if the Category B IDE device is provided at no cost, outpatient prospective payment system (OPPS) providers must report a token charge in the covered charge field along with the applicable HCPCS modifier (i.e., modifie r FB) appended to the procedure code that reports the service to furnish the device, in instances when claims processing edits require that certain devices be billed with their associated procedures.  For more information on billing no cost items u nder the OPPS, refer to Chapter 4, 20.6.9 and 61.3.1 of this manual.   Effective January 1, 2014, if the Category B IDE device is provided at no cost, outpatient prospective payment system (OPPS) providers must report a token charge in the covered charge field along with condition code 53 and Value Code FD. For more information on billing no cost items under the OPPS, refer to Chapter 4, 20.6.9 and 61.3.1 of this manual.  Practitioner Billing   Routine Costs  Practitioners shall submit claims for the routine costs of a clinical trial involving a Category B IDE device by billing according to the clinical trial billing instructions found in section 69.6 of this chapter.  Category B Device