Department of Health & Human Services (DHHS) Centers for Medicare & Medicaid Services (CMS) Transmittal 1509 Date: May 16, 2008
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1 anual ystem Pub edicare laims Processing Department of ealth & uman ervices (D) enters for edicare & edicaid ervices () Transmittal 1509 Date: ay 16, 2008 hange equest 5860 NOT: Transmittal 1498, dated ay 2, 2008 is rescinded and replaced by Transmittal 1509, dated ay 16, The instruction was removed from the July 2008 release to October 2008 release. t was inadvertently misstated in the policy in hapter 3, ection reflecting the incorrect date. This instruction has been revised. ll other information remains the same. UBJT: djusting npatient Prospective Payment ystem (PP) eimbursement for eplaced Devices Offered Without ost or With a redit. UY O NG: This provides instructions for billing replaced devices that are received without cost or with a credit. t also includes contractor instructions for how to reduce PP payment based on the amount of the credit received by the hospital for the replaced device. New / evised aterial ffective Date: October 1, 2008 mplementation Date: October 6, 2008 Disclaimer for manual changes only: The revision date and transmittal number apply only to red italicized material. ny other material was previously published and remains unchanged. owever, if this revision contains a table of contents, you will receive the new/revised information only, and not the entire table of contents.. NG N NUL NTUTON: (N/ if manual is not updated) =VD, N=NW, D=DLTD-Only One Per ow. /N/D N hapter / ection / ubsection / Title 3/100.8/ eplaced Devices Offered Without ost or With a redit 32/67.2.1/Billing No ost tems Due to ecall, eplacement, or ree ample. UNDNG: TON : or iscal ntermediaries and arriers: No additional funding will be provided by ; ontractor activities are to be carried out within their operating budgets. TON B: or edicare dministrative ontractors (s): The edicare dministrative ontractor is hereby advised that this constitutes technical direction as defined in your contract. does not construe this as a change to the tatement of Work. The contractor is not obligated to incur costs in excess of the amounts allotted in your contract unless and until specifically authorized by the ontracting Officer. f the contractor considers anything provided, as described above, to
2 be outside the current scope of work, the contractor shall withhold performance on the part(s) in question and immediately notify the ontracting Officer, in writing or by , and request formal directions regarding continued performance requirements. V. TTNT: Business equirements anual nstruction *Unless otherwise specified, the effective date is the date of service.
3 ttachment - Business equirements Pub Transmittal: 1509 Date: ay 16, 2008 hange equest: 5860 NOT: Transmittal 1498, dated ay 2, 2008 is rescinded and replaced by Transmittal 1509, dated ay 16, The instruction was removed from the July 2008 release to October 2008 release. t was inadvertently misstated in the policy in hapter 3, ection reflecting the incorrect date. This instruction has been revised. ll other information remains the same. UBJT: djusting npatient Prospective Payment ystem (PP) eimbursement for eplaced Devices Offered Without ost or With a redit ffective Date: October 1, 2008 mplementation Date: October 6, GNL NOTON. Background: n recent years, there have been several field actions and recalls with regard to failure of implantable cardiac defibrillators (Ds) and pacemakers. n many of these cases, the manufacturers have offered replacement devices without cost to the hospital or credit for the device being replaced if the patient required a more expensive device. n some circumstances, manufacturers have also offered, through a warranty package, to pay specified amounts for un-reimbursed expenses to persons who had replacement devices implanted. Nonetheless, believes that incidental device failures that are covered by manufacturer warranties occur routinely. Though device malfunctions may be inevitable as medical technology grows increasingly sophisticated, believes that early recognition of problems would reduce the number of people who would be potentially adversely affected by these device problems. n addition to concerns for overall public health, also has a fiduciary responsibility to the edicare Trust und to ensure that edicare pays only for covered services. Therefore, believes it is appropriate to reduce the edicare payment in cases in which an implanted device is replaced at reduced or no cost to the hospital or with partial or full credit for the removed device. To address the issue, issued 4058 on November 4, This provided instructions for billing and processing claims with the following condition codes: 49 Product eplacement within Product Lifecycle eplacement of a product earlier than the anticipated lifecycle due to an indication that the product is not functioning properly. 50 Product eplacement for Known ecall of a Product anufacturer or D has identified the product for recall and therefore replacement. The use of condition codes 49 and 50 allow to identify and track claims billed for replacement devices. B. Policy: edicare is not responsible for the full cost of the replaced device if the hospital is receiving a partial or full credit, either due to a recall or service during the warranty period. Therefore, effective for discharges on or / / G / DO hange equest orm: Last updated 23 ugust 2007 Page 1
4 after October 1, 2008, hospitals are required to bill the amount of the credit in the amount portion for value code, D, redit eceived from the anufacturer for a eplaced edical Device, when the hospital receives a credit for a replaced device that is 50% or greater than the cost of the device. edicare shall reduce the hospital reimbursement, for one of the applicable edical everity Diagnosis elated Groups (-DGs) listed below, by the full or partial credit a provider received for a replaced device. This adjustment is consistent with section 1862(a)(2) of the ct, which excludes from edicare coverage an item or service for which neither the beneficiary, nor anyone on his or her behalf, has an obligation to pay. DGs ubject to inal Policy D - DG Narrative Description of DG P 1 & 2 eart Transplant or mplant of eart ssist ystem with and without, respectively (former -DG 103, eart Transplant or mplant of eart ssist ystem) 1 25 & 26 raniotomy and ndovascular ntracranial Procedure with or with, respectively (former - DG 1, raniotomy ge > 17 With ) 1 26 & 27 raniotomy and ndovascular ntracranial Procedure with or without /, respectively (former -DGs 2, raniotomy ge > 17 Without ) 1 40 & 41 Peripheral & ranial Nerve & Other Nervous ystem Procedure with ; or with or Peripheral Neurostimulator, respectively (former -DG, 7 Peripheral & ranial Nerve & Other Nervous ystem Procedures With ) 1 42 Peripheral & ranial Nerve & Other Nervous ystem Procedure without / (former -DG 8, Peripheral & ranial Nerve & Other Nervous ystem Procedures without ) 1 23 & 24 raniotomy with ajor Device mplant or cute omplex entral Nervous ystem Principal Diagnosis with or hemotherapy mplant; and without [or hemotherapy mplant], respectively (former - DG 543, raniotomy With ajor Device mplant or cute omplex entral Nervous ystem Principal Diagnosis) & 130 ajor ead & Neck Procedures with / or ajor Device; or without /, respectively (former -DG 49, ajor ead & Neck Procedures) 5 216, 217, & , 220, & 221 ardiac Valve & Other ajor ardiothoracic Procedure with ardiac atheterization With ; or with ; or without /, respectively (former -DG 104, ardiac Valve & Other ajor ardiothoracic Procedures with ardiac atheterization ) ardiac Valve & Other ajor ardiothoracic Procedure without ardiac atheterization with ; or with, or without /, respectively (former -DG 105, ardiac Valve & Other ajor ardiothoracic Procedures Without ardiac atheterization) ajor ardiovascular Procedures with or Thoracic ortic neurysm epair (former -DG 110, ajor ardiovascular Procedures With ) ajor ardiovascular Procedures without (former -DG 111, ajor ardiovascular Procedures without ) 5 260, 261, & 262 ardiac Pacemaker evision xcept Device eplacement with, or with, or without /, respectively (former -DGs117, ardiac Pacemaker evision xcept Device eplacement) & 259 ardiac Pacemaker Device eplacement With, and Without, respectively (former -DG 118, ardiac Pacemaker Device eplacement ) / / G / DO hange equest orm: Last updated 23 ugust 2007 Page 2
5 DGs ubject to inal Policy D - DG Narrative Description of DG & 227 ardiac Defibrillator mplant without ardiac atheterization with and without, respectively (former -DG 515, ardiac Defibrillator mplant without ardiac atheterization) Other eart ssist ystem mplant (former -DG 525, Other eart ssist ystem mplant) & 223 ardiac Defibrillator mplant with ardiac atheterization with cute yocardial nfarction/eart ailure/hock with and without, respectively (former -DGs 535, ardiac Defibrillator mplant with ardiac atheterization with cute yocardial nfarction/eart ailure/hock) & 225 ardiac Defibrillator mplant with ardiac atheterization without cute yocardial nfarction/eart ailure/hock with and without, respectively (former -DG 536, ardiac Defibrillator mplant with ardiac atheterization without cute yocardial nfarction/eart ailure/hock) 5 242, 243, & , 243, & 244 Permanent ardiac Pacemaker mplant with, with, and without /, respectively (-DG 551, Permanent ardiac Pacemaker mplant with ajor ardiovascular Diagnosis or D Lead or Generator Permanent ardiac Pacemaker mplant with, with, and without /, respectively (former -DG 552, Other Permanent ardiac Pacemaker mplant without ajor ardiovascular Diagnosis) D Lead and Generator Procedures (this is a new -DG, created from D and generator codes moved out of DG 551) & 462 Bilateral or ultiple ajor Joint Procedures of Lower xtremity with, or without, respectively (former -DG 471, Bilateral or ultiple ajor Joint Procedures of Lower xtremity) & 470 ajor Joint eplacement or eattachment of Lower xtremity with or without, respectively (former -DG 544, ajor Joint eplacement or eattachment of Lower xtremity ) 8 466, 467, & 468 evision of ip or Knee eplacement with, with, or without /, respectively (former -DG 545, evision of ip or Knee eplacement). BUN QUNT TBL Use hall" to denote a mandatory requirement Number equirement esponsibility (place an X in each applicable column) edicare tandard ystems shall accept the new value code, D, redit eceived from the anufacturer for a eplaced edical Device edicare tandard ystems shall create edits to ensure that PP claims report condition code 49 or 50 when value code D is present. Note: This requirement is only applicable to PP providers (11X Type of Bills from provider s with a provider range of ), excluding aryland waiver hospitals and ancer hospitals. / B D hared-ystem aintainers V W OT X X N OB X / / G / DO hange equest orm: Last updated 23 ugust 2007 Page 3
6 Number equirement esponsibility (place an X in each applicable column) edicare tandard ystems shall deduct the partial/full credit amount (reported in the amount for value code D) from the final PP reimbursement when the assigned -DG is one of the - DGs listed in the policy section above shall create a line on the cost report for the amount associated with value code D ontractors shall deduct the amount entered on the claim for value code D from the final PP reimbursement amount shall create a line on the P& report for the amount associated with value code D ontractors shall deduct the amount entered on the claim for value code D from the final PP reimbursement amount, for Provider tatistical and eimbursement (P&) report purposes. / B D hared-ystem aintainers V X W OT X X ost- eport X X ost- eport X X P& X X P&. POVD DUTON TBL Number equirement esponsibility (place an X in each applicable column) provider education article related to this instruction will be available at shortly after the is released. You will receive notification of the article release via the established "LN atters" listserv. ontractors shall post this article, or a direct link to this article, on their Web site and include information about it in a listserv message within one week of the availability of the provider education article. n addition, the provider education article shall be included in your next regularly scheduled bulletin. ontractors are free to supplement LN atters articles with localized information that would benefit their provider community in billing and administering the edicare program correctly. / B D X X hared-ystem aintainers V W OT V. UPPOTNG NOTON. or any recommendations and supporting information associated with listed requirements, use the box below: Use "hould" to denote a recommendation. X-ef equirement Number ecommendations or other supporting information: B. or all other recommendations and supporting information, use this space: / / G / DO hange equest orm: Last updated 23 ugust 2007 Page 4
7 V. ONTT Pre-mplementation ontact(s): Joe Bryson at Post-mplementation ontact(s): egional Office V. UNDNG ection : or iscal ntermediaries (s), arriers, and egional ome ealth arriers (s) use only one of the following statements: No additional funding will be provided by ; contractor activities are to be carried out within their operating budgets. ection B: or edicare dministrative ontractors (s), use the following statement: The edicare dministrative ontractor is hereby advised that this constitutes technical direction as defined in your contract. does not construe this as a change to the tatement of Work. The contractor is not obligated to incur costs in excess of the amounts allotted in your contract unless and until specifically authorized by the ontracting Officer. f the contractor considers anything provided, as described above, to be outside the current scope of work, the contractor shall withhold performance on the part(s) in question and immediately notify the ontracting Officer, in writing or by , and request formal directions regarding continued performance requirements. / / G / DO hange equest orm: Last updated 23 ugust 2007 Page 5
8 edicare laims Processing anual hapter 3 - npatient ospital Billing eplaced Devices Offered Without ost or With a redit eplaced Devices Offered Without ost or With a redit (ev.1509, ssued: , ffective: , implementation: ) Background To identify and track claims billed for replacement devices, issued 4058 on November 4, This provided instructions for billing and processing claims with the following condition codes: 49 Product eplacement within Product Lifecycle eplacement of a product earlier than the anticipated lifecycle due to an indication that the product is not functioning properly. 50 Product eplacement for Known ecall of a Product anufacturer or D has identified the product for recall and therefore replacement. Policy Beginning with discharges on or after October 1, 2008, reduces edicare payment when a replacement device is received by the hospital at a reduced cost or with a credit, and when the assigned -DG for the claim is one of the -DGs applied to this policy. or a list of -DGs for which this policy applies to, please see the PP inal ule. This adjustment is consistent with section 1862(a)(2) of the ct, which excludes from edicare coverage an item or service for which neither the beneficiary, nor anyone on his or her behalf, has an obligation to pay. Billing Procedures (Discharges on or after October 1, 2008) To correctly bill for a replacement device that was provided with a credit or no cost, hospitals must use the combination of condition code 49 or 50, along with value code D. The condition code 49 or 50 will identify a replacement device while value code D will communicate to edicare the amount of the credit, or cost reduction, received by the hospital for the replaced device. Payment (Discharges on or after October 1, 2008) edicare deducts the partial/full credit amount, reported in the amount for value code D, from the final PP reimbursement when the assigned -DG is one of the - DGs applied to this policy.
9 edicare laims Processing anual hapter 32 Billing equirements for pecial ervices Billing No ost tems Due to ecall, eplacement, or ree ample (ev.1509, ssued: , ffective: , implementation: ) ffective pril 1, 2006, two new condition codes were created for institutional use: 49 and 50 (Table 1). These new codes will be used to identify and track medical devices that are provided by a manufacturer at no cost. The no-cost device may be provided due to warranty, replacement, recall or defect issues. Table 1: New ondition odes and Descriptions ondition ode Description 49 Product eplacement medical device is replaced before "end-of-life" because within Product Lifecycle there is an indication that the device is not functioning 50 Product eplacement for Known ecall of a Product properly. (This is a warranty situation.) medical device is replaced because of a manufacturer or D recall. Providers must use the above condition codes to identify medical devices that are provided by a manufacturer at no cost. These condition codes will be used to track nocost recalled or replacement devices. Providers must report these condition codes on any inpatient or outpatient institutional claim that includes a no-cost device when conditions of replacement or recall are met. Outpatient ospital Billing urrently, institutional providers that use the ealthcare ommon Procedural oding ystem (P), bill the device P with a token charge to bypass device and device insertion procedure edits. ffective January 1, 2006, modifier -B will be used to indicate that a device used in a procedure was furnished without cost to the provider and; therefore, it is not being charged to edicare or the beneficiary. lso, effective January 1, 2008, modifier will be used to indicate that a hospital received a partial credit of 50 percent or more of the cost of the new replacement device. ore information on the billing P modifiers B and can be located in ections and 61.3 of the edicare laims Processing anual, hapter 4. NOT: Outpatient hospitals billing no cost devices must append the -B modifier to the procedure code for implanting the no cost device, along with the appropriate condition code (in Table 1 above). The modifier will identify the procedure code line for
10 the no cost device, while the condition code will explain the reason why the device was provided free of cost. Billing under the npatient Prospective Payment ystem (PP) or instructions on how to bill for replaced devices received without cost or with a credit under the PP, please see hapter 3, ection of The laims Processing anual.
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