(Medicare Claims Processing Manual)

When a hospital replaces a device with a more expensive device and receives a credit in the amount that the device being replaced would otherwise cost, the hospital must append modifier - FB to the procedure code (not on the device code) that reports the se rvice provided to replace the device.  The hospital must charge the difference between its usual charge for the device being implanted and its usual charge for the device for which it received credit.  This charge should be billed in the covered charge fie ld.  Hospitals should not report modifier - FB when the hospital receives a partial credit for a replacement device when the amount of the credit is less than the amount that the device would otherwise cost the hospital.  For example, a device fails in the 6th month of a 1 year warranty and under the terms of the warranty, the hospital receives a credit of 50 percent of the cost of a replacement device.  The hospital should not append modifier - FB to the procedure code in which the device is implanted.  See the  Medicare Claims Processing Manual, Pub 100- 04, Chapter 4, 61.3.3 for billing instructions pertaining to partial credit situations.   61.3.3 - Reporting Requirements When the Hospital Receives Partial Credit for the Replacement Device Prior to January 1, 2014  (Rev. 2903, Issued: 03- 11-14, Effective: 04 -01-14, Implementation: 04- 07-14)  When a hospital receives a partial credit of 50 percent or more of the cost of a new replacement device due to warranty, recall, or field action, the hospital must append modifier - FC to the procedure code (not on the device code) that reports the service provided to replace the device.   61.3.4 - Medicare Payment Adjustment Prior to January 1, 2014  (Rev. 2903, Issued: 03- 11-14, Effective: 04 -01-14, Implementation: 04- 07-14)  Effective January 1, 2007, Medicare payment is reduced by the full offset amount for specified procedure codes reported with modifier -FB.  Effective January 1, 2008, Medicare payment is reduced by the partial offset amount for specified procedure codes reported with modifier -FC.  Effective January 1, 2009, payment is only reduced for procedure codes that map to the Ambulatory Payment Classification groups (APCs) on the list of APCs subject to the adjustment that are reported with modifier -FB or - FC and that are present on claims with specified device HCPCS codes.   The Integrated Code Editor (I/OCE) assigns a payment adjustment flag when a procedure code in an APC subject to an offset adjustment is billed with modifier - FB or -FC and a specified device HCPCS code.  The payment adjustment flag communicates to the OPPS  PRICER that the payment for the procedure code line is to be reduced by the established full or partial offset amount for the APC to which the procedure code is assigned.  The I/OCE uses the offset APC payment rate (APC payment amount minus the establishe d offset amount) as the rate used in the I/OCEs determination of which multiple procedure line(s) will be discounted.   The OPPS PRICER then applies the multiple procedure discounting and terminated procedure discounting factors after offsetting the unadjusted APC payment rate.  The offset reduction also is made to the unadjusted payment rate before wage adjustment, which ensures that the beneficiary's coinsurance is based on the reduced amount.  NOTE : The tables of APCs and devices to which the offset reductions apply, and the full and partial offset amounts, are available on the CMS Web site at: www.cms.hhs.gov/HospitalOutpatientPPS/ .  61.3.5 - Reporting and Charging Requirements When a Device is Furnished Without Cost to the Hospital or When the Hospital Receives a Full or Partial Credit for the Replacement Device Beginning January 1, 2014 (Rev. 3181, Issued: 01- 30-15, Effective: 07 -01-15, Implementation: 07- 06-15)  Effective January 1, 2014, when a hospital furnishes without cost an initial placement of a medical device as part of a clinical trial  or a free sample medical device or when a hospital furnishes without cost a new replacement device or with a credit of 50 percent or more of the cost of a new replacement from a manufacturer, due to warranty, recall, or field action, the hospital must report the amount of the device credit in the amount portion for value code FD (Credit Received from the Manufacturer for a Medical Device).  Also effective January 1, 2014 hospitals must report one of the following condition codes when the value code FD is present on the claim:    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.   No-Cost Device Coding   When a hospital furnishes a device for which it incurs no cost, (these cases include, but are not limited to, devices replaced under warranty, due to recall, or due to defect in a previous device; devices provided in a clinical trial; or devices provided a s a sample) the hospital charge for a device furnished to the hospital at no cost should equal $0.00.  However, some hospitals billing systems require that a charge be reported for separately billable codes in order for the claim to be submitted for payme nt, even items for which the hospital incurs no cost.  Hospitals paid under the OPPS that implant a device furnished at no cost to the hospital shall report a charge of zero for the device, or, if the hospitals billing system requires that a charge be entered, the hospital shall submit a token charge (e.g. $1.00) on the line with the device code.   CMS recognizes that showing a charge for a device that has been furnished without cost is not optimal, but showing a token charge in this circumstance will allow claims for reasonable and necessary services to be adjudicated.   61.3.6 - Medicare Payment Adjustment Beginning January 1, 2014 (Rev. 2903, Issued: 03- 11-14, Effective: 04 -01-14, Implementation: 04- 07-14)  Effective January 1, 2014, Medicare payment is reduced by the amount of the device credit for specified procedure codes reported with value code FD.  The payment deduction is limited to the full device offset when the FD value code appears on a claim.  Payment is only reduced for procedure codes that map to the Ambulatory Payment Classification groups (APCs) on the list of APCs subject to the adjustment that are reported with value code FD and that are present on claims with specified device HCPCS codes .  The OPPS Pricer deducts the lesser of the device credit or the full unadjusted device offset amount from the Medicare payment for a procedure code in an APC subject to the adjustment when billed with value code FD on the claim.  This deduction is made from the Medicare payment after the multiple procedure discounting and terminated procedure discounting factors are applied, units of service are accounted for, and after the APC payment has been wage adjusted.  When two or more procedures assigned to APCs subject to the adjustment are reported with value code FD the OPPS Pricer will apportion the device credit to the applicable line on the claim for each procedure assigned to an APC subject to the adjustment.  When value code FD is reported on a claim where multiple APCs would be subject to the adjustment, the OPPS Pricer apportions the device credit to each of those lines.  The percentage of the device credit apportioned to each applicable line is based on th e percentage that the unadjusted payment of each applicable line represents, relative to the total unadjusted payment for all applicable lines.   NOTE:  The tables of APCs and devices to which the offset reductions apply, and the full and partial offset amounts, are available on the CMS Web site at: www.cms.hhs.gov/HospitalOutpatientPPS/ .   61.4 - Billing and Payment for Brachytherapy Sources (Rev. 1445, Issued:  02- 08-08; Effective:  01 -01-08; Implementation:  03 -10-08)  61.4.1 - Billing for Brachytherapy Sources - General  (Rev. 2718, Issued: 06- 07-13, Effective: 07 -01-13, Implementation: 07- 01-13)  Brachytherapy sources (e.g., brachytherapy devices or seeds, solutions) are paid separately from the services to administer and deliver brachytherapy in the OPPS, per section 1833(t)(2)(H) of the Act, reflecting the number, isotope, and radioactive intensi ty of devices furnished, as well as stranded versus non- stranded configurations of sources.  Therefore, providers must bill for brachytherapy sources in addition to the brachytherapy services with which the sources are applied, in order to receive payment for the sources.  The separately payable sources are found in Addendum B of the most recent OPPS annual update published on the CMS web site.  New sources meeting the OPPS definition of a brachytherapy source may be added for payment beginning any quarter, and the new source codes and descriptors are announced in recurring update notifications.  Each unit of a billable source is identified by the unit measurement in the respective sources long descriptor.  Seed- like sources are generally billed and paid per source based on the number of units of the source HCPCS code reported, including the bil ling of the number of sources within a stranded configuration of sources.  Providers therefore must bill the number of units of a source used with the brachytherapy service rendered.   61.4.2 - Definition of Brachytherapy Source for Separate Payment   61.4.2 - Definition of Brachytherapy Source for Separate Payment   (Rev. 1445, Issued:  02- 08-08; Effective:  01 -01-08; Implementation:  03 -10-08)  Brachytherapy sources eligible for separate billing and payment must be radioactive sources, meaning that the source contains a radioactive isotope.  Separate brachytherapy source payments reflect the number, isotope, and radioactive intensity of sources furnished to patients, as well as stranded and non- stranded configurations.  61.4.3 - Billing of Brachytherapy Sources Ordered for a Specific Patient  (Rev. 1445, Issued:  02- 08-08; Effective:  01 -01-08; Implementation:  03 -10-08)  A hospital may report and charge Medicare and the Medicare beneficiary for all brachytherapy sources that are ordered by the physician for a specific patient, acquired by the hospital, and used in the care of the patient.  Specifically, brachytherapy sourc es prescribed by the physician in accordance with high quality clinical care, acquired by the hospital, and actually implanted in the patient may be reported and charged.  In the case where most, but not all, prescribed sources are implanted in the patient , CMS will consider the relatively few brachytherapy sources that were ordered but not implanted due to specific clinical considerations to be used in the care of the patient and billable to Medicare under the following circumstances.  The hospital may charge for all  sources if they were specifically acquired by the hospital for the particular patient according to a physicians prescription for the sources that was consistent with standard clinical practice and high quality brachytherapy treatment, in order to ensure that the clinically appropriate number of sources was available for the implantation procedure, and they were not implanted in any other patient.  Those sources that were not implanted must have been disposed of in accordance with all appropriate requireme nts for their handling.  In general, the number of sources used in the care of the patient but not implanted would not be expected to constitute more than a small fraction of the sources actually implanted in the patient.  Under these circumstances, the be neficiary is liable for the copayment for all the sources billed to Medicare.   61.4.4 - Billing for Brachytherapy Source Supervision, Handling and Loading Costs  (Rev. 1445, Issued:  02- 08-08; Effective:  01 -01-08; Implementation:  03 -10-08)  Providers should report charges related to supervision, handling, and loading of radiation sources, including brachytherapy sources, in one of two ways:   1. Report the charge separately using CPT code 77790 (Supervision, handling, loading of radiation source), in addition to reporting the associated HCPCS procedure code(s) for application of the radiation source;   2. Include the supervision, handling, and/or loading charges as part of the charge reported with the HCPCS procedure code(s) for application of the radiation source.  Do not bill a separate charge for brachytherapy source storage costs. These costs are treated as part of the department's overhead costs.   61.4.5 - Payment for New Brachytherapy Sources (Rev. 2718, Issued: 06- 07-13, Effective: 07 -01-13, Implementation: 07- 01-13)